SIM UNIVERSITY
SCHOOL OF SCIENCE AND TECHNOLOGY
TO REVIEW COMMON CASES OF
CLINICAL AND RESEARCH VIOLATIONS
IN ASIA, PROPOSE NEW GUIDELINES TO
ADDRESS ONE AREA OF THE LAPSES AND
DEVELOP A DATABASE FOR TREND
ANALYSIS
STUDENT
: PAARI S/O PERUMAL
(PI NO.Y0502509 )
SUPERVISOR
: DR HO TECK TUAK
PROJECT CODE : JAN2010/BME/0012
A project report submitted to SIM University
in partial fulfilment of the requirements for the
Degree of Bachelor of Science in Biomedical Engineering
November 2010
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
Contents
Abstract ....................................................................................................................... 1
Acknowledgements ..................................................................................................... 2
Chapter One ................................................................................................................ 1
Introduction ............................................................................................................. 1
1.1
Project Background .................................................................... 1
1.2
Practitioners Need to Have a Good Understanding of Ethics..... 1
1.3
Project Objective ........................................................................ 1
1.4
Project Scope .............................................................................. 2
Chapter 2 ..................................................................................................................... 3
Literature Review.................................................................................................... 3
2.1
Ethics .......................................................................................... 3
2.2
General Ethical Principles .......................................................... 3
2.2.1
Autonomy or respect for persons ......................................... 3
2.2.2
Informed Consent ................................................................. 4
2.2.3
Beneficence .......................................................................... 4
2.2.4
Non-maleficence .................................................................. 4
2.2.5
Veracity ................................................................................ 4
2.2.6
Confidentiality or Fidelity .................................................... 4
2.2.7
Justice ................................................................................... 5
2.3
Comparison of Ethics in Research Clinical Trials and Clinical
Practices...................................................................................... 6
2.4
Guidelines on Bioethics.............................................................. 7
2.5
Ethical Theories .......................................................................... 7
2.5.1
Consequentialism (outcome-based) ..................................... 7
2.5.2
Deontology (duty-based) ...................................................... 7
2.5.3
Casuistry (previous-case basis) ............................................ 7
2.5.4
Contextualism (case-by-case basis)...................................... 7
2.5.5
Virtue ethics (character and habit based) ............................. 8
2.5.6
Intuitionism .......................................................................... 8
2.5.7
Relativism ............................................................................ 8
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
2.5.8
Principlism ........................................................................... 8
2.5.9
Pragmatism ........................................................................... 8
2.5.10 Liberalism ............................................................................ 8
2.6
Safeguarding The Practices of Bioethics for Clinical Trial ........ 8
2.7
Definition of Human Biomedical Research ............................... 8
Chapter 3 ................................................................................................................... 10
Methodology ......................................................................................................... 10
3.1
Review of Ethics Violation ...................................................... 10
3.1.1
Acquiring Data on Violations ............................................ 10
3.2
Data Consolidation ................................................................... 11
3.3
Trend of Violations .................................................................. 11
3.4
Building of database for Trend Analysis .................................. 13
3.4.1
Choosing the right application ........................................... 13
3.4.2
Database components ......................................................... 14
3.4.3
Flow chart for database implementation plan .................... 14
3.4.4
Database Planning .............................................................. 15
3.4.5
Database tables ................................................................... 15
3.4.6
Data Fields ......................................................................... 16
3.4.7
Step-by-step database development ................................... 18
Chapter 4 ................................................................................................................... 33
Results and Discussion ......................................................................................... 33
4.1
4.2
Trend of Violations .................................................................. 33
4.1.1
Total Data ........................................................................... 33
4.1.2
Clinical Ethics Violation .................................................... 33
4.1.3
Research Ethics Violation .................................................. 34
Trend Analysis Database .......................................................... 35
4.2.1
Clinical Violations Database .............................................. 35
4.2.1.1 Clinical Violations Pivot Tables ........................................ 36
4.2.2
Research Violations Database ............................................ 44
4.2.2.1 Research Violations Pivot Tables....................................... 45
4.3
Current Trend in Violations...................................................... 53
4.3.1
Legislation Shortfalls ......................................................... 53
4.3.2
Informed Consent Lapses ................................................... 53
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
3
4.4
4.5
Proposed Guidelines to Address Lapses................................... 53
4.4.1
Protocol Enforcement ......................................................... 53
4.4.2
Changes in “Informed Consent” Acquisition ..................... 53
Data on Violations .................................................................... 55
Chapter 5 ................................................................................................................... 56
Conclusion and Recommendation ........................................................................ 56
5.1
Conclusion ................................................................................ 56
Chapter 6 ................................................................................................................... 57
Project Timeline .................................................................................................... 57
Project Gantt Chart ............................................................................................... 58
Chapter 7 ................................................................................................................... 59
Future Works ........................................................................................................ 59
Chapter 8 ................................................................................................................... 60
Critical Review and Reflections ........................................................................... 60
References ................................................................................................................. 61
APPENDICES .......................................................................................................... 63
Appendix 1: SMC Ethical Code Guideline ........................................................... 63
Appendix 2: Inter International Ethical Guidelines for Biomedical Research
Involving Human Subjects .................................................................................... 63
Appendix 3: Medical Specialities ......................................................................... 64
Appendix 4: Clinical and Research Violations Data ............................................ 66
Appendix 5: Disciplinary Inquiries 2001 - 2009 ................................................ 115
Appendix 6: 205-012 CIRB SAE Reporting Form v1.3 ..................................... 174
Appendix 7: 207-001 Consent Document Template v2G ................................... 174
Appendix 8: 207-001 Consent Forms Only Original and Modified ................... 174
Appendix 9: Email Correspondences.................................................................. 175
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
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Abstract
In the recent past, media headlines about clinical and research misconduct in Asia has
focused public attention on the ethical problems that can arise during the conduct of
clinical practice and research. In some instances, practitioners and researchers have
been accused and occasionally found guilty of violating guidelines of clinical and
research ethics. [1]
Informed consent has been identified as one of the commonest area where lapses
occur in the field of clinical research and the probable causes were investigated. The
tendency for the research personal to get over with the consent process in the quickest
time and the lack of time for the participant to understand and post questions to get a
clear understanding of the entire process has been identified as a key factor in most
cases. In this project, the National Health Group (Singapore) (NHG)’s Consent Form
has been used as a template to propose the suggested change to address this lapse. A
minor addition of a duration condition has been added to enforce an acquisition of
thoroughly explained “Informed Consent” from the participant.
The second part of the project involves the implementation of a commercially
available application to carry out trend analysis of databases of both clinical violations
and research violations. After much research and discussion with the project
supervisor, Dr. Ho Teck Tuak, it was decided that the “Pivot Table” application in
Microsoft Excel, would be most suited as it has the dynamic capability of producing
trend analysis reports in any number of condition permutations using filters without
having to produce comprehensive Structured Query Language (SQL) queries to
anticipate the types of trends that need to be analysed.
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
i
Acknowledgements
I wish to record my grateful indebtedness to Dr. Ho Teck Tuak, my project supervisor
for his valuable guidance, advice and patience throughout my entire undertaking of
this capstone project.
My appreciation also goes to Mr. Govindhaswamy, whom I consulted on database
applications and taught me how to use Pivot Tables effectively, to realize its potential
in this project and present and past course mates who gave me valuable pointers on
how to manage the various stages of this project.
Finally, I would like to thank my family for being my motivational force and their
kind understanding whenever I could not spend my time with them, when I should
have, during my entire course.
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
ii
Chapter One
Introduction
1.1
Project Background
Bioethics is the study of ethical issues in the biological and biomedical sciences, and
some important aspects of environmental, population and social sciences. It subsumes
traditional medical ethics but is a wider field. It specifically includes ethical issues in
research, and not just in clinical settings governed by the relations between physicians
and patients. [2]
Clinicians, researchers, philosophers, ethicists, and policy-makers must be wellinformed of the facts, circumstances, needs and values of involved agents, and the
contingencies, exigencies and potential consequences that are both intrinsic to
medicine, and that could be affected by guidelines and reforms. The frequent
enactment of reforms in the policies just shows that there is awareness of changing
problems and current inadequacies within the systems and conduct of medicine, and
an expanding conventional wisdom that has identified the need for the health care
system to constantly review and improve its service. [3][4][5]
One common lapse that has lead to numerous ethical violations is, the lack of
importance that is given to the process of obtaining informed consent from
participants of research and clinical trials. Legally, doctors, hospitals and medical
establishments are required to inform participants of risks, benefits and alternatives
before they consent to a clinical trial. [6]
Medical researchers who have violated this requirement often ignore basic standards
of ethical oversight in their rush to conduct experiments. [7]
1.2
Practitioners Need to Have a Good Understanding of Ethics
Ethics (like practice of medicine) is rarely about black and white, but about learning
to discern the shades of grey, deal with uncertainty, and find the best possible course
of action under the circumstances. Having sound knowledge and understanding of
medical and research ethics and keeping abreast with developments and legislatures
pertaining to it will help remove some anxiety in practitioners when they confront
ethical dilemmas in real life situations. [8]
Currently there are numerous sources, especially from online electronic media, from
which a practioner can acquire literature and up to date developments on practices,
violation and legislature changes in biomedical ethics. However there is a lack of
resource in terms of a repository of case notes of actual ethical violations, which could
provide trend analysis and at the same time indicate the areas of lapses in conformity
to the ethical guidelines that are followed where the practitioner is practicing.
1.3
Project Objective
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
1
Informed Consent has been identified as one of the most common lapse in biomedical
ethics, and the first part of the project aims to study the possible causes for the lapses
and to come up with a recommendation to address this issue.
The next part of the project, aims to address the lack of resource in terms of a
repository of case notes of actual ethical violations, which could provide trend
analysis and at the same time indicate the areas of lapses in conformity to the ethical
guidelines that are followed where the practitioner is practicing and to develop and
implement an application that will provide the end-user necessary information on
violations and at the same time allow for trend analysis for various user defined
conditions.
Two different databases will be built to capture clinical violations and research
violations. A commercially available application, Microsoft Excel, is implemented to
carry out trend analysis, using pivot tables, of databases of both clinical violations and
research violations. Summary details of type of violation, based on Singapore Medical
Council (SMC) Guidelines (for clinical) and Council for International Organisations
of Medical Sciences (CIOMS) Guidelines (for research), events leading to the
violation, adverse events (if any), corrective action (if any), and details of guidelines
as mouse over application for quick and easy reference.
1.4
Project Scope
The scope of this project is restricted to these aspects:
(a) Literature research on:
 Clinical Ethics Violations
 Research Ethics Violations
 Ethical Guidelines
(b) Propose change in Informed Consent procedure
(c) Development of separate database for Clinical Violation Cases and Research
Violation Cases
(d) Creation of Pivot Tables to demonstrate five different types of trend analysis.
(e) Final testing of the “Pivot Tables”.
(f) Analysis of results.
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
2
Chapter 2
Literature Review
2.1
Ethics
Ethics is a social concept of good behaviour. It is a collective concept that evolves
gradually, usually over years, as a result of interaction between individuals living or
working together. Over the course of time, based on a common interest an approved
trend becomes established. As such, apart from moral sanctions and personal
disapproval, there is little to ensure that a collective concept is obeyed. Ethics is
therefore a concept with no compelling force other than popular opinion. In that sense,
it is more akin to conscience than to law. In law, graded penalties are advised to suit
the severity of any offence. On the other hand, ethics is seldom enforceable with
threat of punishment and conformity is achieved through the force of public opinion.
Furthermore, the rules and regulations of medical ethics are not set out in writing. The
professional bodies may publish ethical guidelines for information, which includes a
few precedents from previous inquires. This is unlike the law which sets out in
considerable detail the infringements and the severity of punishments. [9]
2.2
General Ethical Principles
Ethical principles in clinical and research application come under three main
categories. They are respect for persons (autonomy), beneficence and justice. The
additional principles that compliment these three principles will be, informed consent,
which is an important aspect in autonomous decision making, non-maleficence,
veracity and confidentiality or fidelity.
2.2.1 Autonomy or respect for persons
Autonomy or respect for persons incorporates two fundamental ethical considerations.
Respect for autonomy, requires that those who are capable of deliberation about their
personal choices should be treated with respect for their capacity for selfdetermination and persons with impaired or diminished autonomy, those who are
dependent or vulnerable should be protected afforded security against harm or abuse.
[10]
The principle is also the basis of numerous other moral precepts such as
confidentiality, freedom of choice, accountability, avoidance of conflict of interest,
and informed consent. Embedded in these precepts is the ability of individuals to be
autonomous in making decisions. The lack of fear or favour, the lack of duress, the
requirements for comprehensibility, and providing sufficient knowledge before a
decision is to be made are related to augmenting and insuring respects for persons.
Each person has intrinsic worth and has specific rights that other individuals nust
respect, including those who lack decisional capacity, and children who lack complete
autonomy to make decisions owing to their inability to weigh risks and benefits to
themselves. Respects for person also require that prospective research subjects should
be given sufficient information regarding risks and benefits in order to weigh properly
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
3
the prospects of enrolment in a research project or a treatment. Furthermore, respect
for the person requires that the enrolment of an individual into a research study should
be voluntary, and in other words, free from any duress, coercion, and undue influence.
[11]
2.2.2 Informed Consent
When a patient or a research participant has given informed consent, he can be said to
have given consent after appreciating and understanding the facts and implications of
a particular medical management or research based upon disclosure by his doctor or
the researcher. The term informed consent implies that the doctor or researcher has the
a duty to disclose to the patient or participant ‘any facts which is necessary to form the
basis of an intelligent consent by the patient or research participant to the proposed
treatment. In discussing the element of risk, a certain amount of discretion must be
employed consistent with full disclosure of facts necessary for an informed consent.
[12]
2.2.3 Beneficence
Beneficence refers to the ethical obligation to do only that which benefits the patient
and to minimize harms. In research, this principle gives rise to norms requiring that
the risks of research be reasonable in the light of the expected benefits, that the
research design is sound, and that the investigators are competent both to conduct the
research and to safeguard the welfare of the research subjects. In clinical application,
the patient’s welfare should be the first consideration and the practitioner is expected
to demonstrate due care, consideration and competence. [13]
2.2.4 Non-maleficence
Beneficence further proscribes the deliberate infliction of harm on persons; this aspect
of beneficence is sometimes expressed as a separate principle, non-maleficence (do no
harm). [14]
It is the duty of the researcher or the practitioner to respect the sanctity of life and to
conduct a trial or a treatment after due diligence is exercised to make a calculated risk
with risk benefit.
2.2.5 Veracity
The principle of veracity refers to the ethics of truth telling. While this principle is not
a law, violation veracity, will result in a loss of credibility and respect with other
professionals and patients alike. As the medical personnel hold a position of trust in
the community, they are held to high standards which promote accountability and
overall professionalism and therefore they have the obligation to provide full and
honest disclosure. [15]
2.2.6 Confidentiality or Fidelity
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
4
Confidentiality is a principle that is based on loyalty and trust. The practitioner or
researcher is expected to treat all personal, medical and treatment information of
patients and research subjects with confidentiality. Information can only be revealed
with consent and for the benefit of the patient, unless when required by law and to
prevent harm. Disclosures should not be beyond what is required. Children, elderly,
mentally disabled and the dead all have the same right to confidentiality. [16]
2.2.7 Justice
Justice and fairness are terms used to connote equality of treatment of each person
before an obligation or an authority. For a researcher or a practitioner, he has to
ensure that his actions are consistent, accountable and transparent. There should be no
discrimination against age, sex, religion, race, position or rank. In research, with
human subjects, justice requires that their selection should be fair to all individuals in
that class. Therefore, those selected for research should reflect a fair sharing of burden
and benefits as to their social, sexual and ethnic characteristics. Social justice requires
that subjects should not be selected because of race, decisional incapacity, or
condition. [16]
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
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2.3
Comparison of Ethics in Research Clinical Trials and Clinical Practices
RELATIONSHIP
CLINICAL ETHICS
RESEARCH ETHICS
Doctor-patient
Researcher-patient.
Competing and conflicting
interests
PRIMARY OBJECTIVE Fiduciary
- Therapeutic
benefit patient
NON-MALEFICENCE
effect
“Above all, do no harm.”
Generalised knowledge
to benefit society
to
Risk of harm always exists
Risk-benefit ratio
INTERVENTION
CONSENT
Proven
or
treatments
established Experimental treatment
Clinical equipoise
Verbal consent applies Written,
signed
and
except
for
special witnessed informed consent
situations, for example, process and documentation
giving emergency treatment
to a patient who is
unconscious and therefore
is not able to give informed
consent
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
6
2.4
Guidelines on Bioethics
In clinical applications, countries with well established healthcare sectors, with sound
governance, follow ethical guidelines that conform to legally, professionally and
internationally accepted norms. They are very similar and thorough in their coverage
of up to date international practices. The Singapore Medical Council Ethics
Guidelines (Appendix 1) is one such collection of code of ethics that is used as both a
decision making tool and at the same time to address lapses in medical practice in
Singapore.
In research applications the International Ethical Guidelines for Biomedical Research
Involving Human Subjects prepared by the Council for International Organizations of
Medical Sciences (CIOMS) in collaboration with the World Health Organization
(WHO) (Appendix 2), is the guideline that most countries around the world use to
conform to the accepted norms stipulated by WHO and CIOMS. The nature of
research collaborations around the world is the reason why this guideline is accepted
as a standard protocol.
2.5
Ethical Theories
There are a number of useful and well-known approaches to ethical decision-making,
although none offers a perfect way of resolving ethical issues.
2.5.1 Consequentialism (outcome-based)
Consequentialism places emphasis on the outcome of an act rather than the act itself.
2.5.2 Deontology (duty-based)
Deontology places value to the correctness of an action, regardless of the possible
benefits or harm it might produce.
2.5.3 Casuistry (previous-case basis)
Casuistry supports decisions, which are based on previous cases.
2.5.4 Contextualism (case-by-case basis)
Contextualism supports making decisions on a case-to-case basis rather than using
some greater theoretical framework.
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
7
2.5.5 Virtue ethics (character and habit based)
Virtue ethics places value on moral character rather than acts or outcomes of acts.
2.5.6 Intuitionism
Intuitionism emphasizes the role of the subject in ethical decision-making
2.5.7 Relativism
Moral relativism is a theory that embraces differing opinions, claiming no moral
absolutes and no fixed, better way of judging right from wrong
2.5.8 Principlism
In principlism, a decision is ethically sound provided certain principles are respected
and balanced.
2.5.9 Pragmatism
Pragmatism is driven by the belief that there is a fundamental link between theory and
practice, and that this link informs both sides.
2.5.10 Liberalism
Liberalism upholds freedom and tolerance, thereby asserting that everyone ought to be
free to act as they choose provided their freedom does not interfere with similar
freedom in others
2.6
Safeguarding The Practices of Bioethics for Clinical Trial
All international guidelines require the ethical and scientific review of biomedical
research alongside informed consent and the appropriate protection of those unable to
consent as essential measures to protect the individual person and the communities
who participate in research. The objective of these Guidelines is to contribute to the
development of quality and consistency in the ethical review of biomedical research.
The Guidelines are intended to complement existing laws, regulations, and practices,
and to serve as a basis upon which ethics committees (ECs) or Institutional Review
Boards (IRB) can develop their own specific written procedures for their functions in
biomedical research. In this regard, the Guidelines establish an international standard
for ensuring quality in ethical review. The Guidelines should be used by national and
local bodies in developing, evaluating, and progressively refining standard operating
procedures for the ethical review of biomedical research. The purpose of an EC in
reviewing biomedical research is to contribute to safeguarding the dignity, rights,
safety, and well-being of all actual or potential research participants. [17]
2.7
Definition of Human Biomedical Research
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
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“Research” is defined as any investigation designed to develop or contribute to
generalisable knowledge. This generalisable knowledge will benefit specific groups,
or the whole, of the human population, rather than any specific individual.
Human biomedical research (HBR) refers to any research on human subjects that
involves:
(a) intervention on, interaction with, or observation of, humans;
(b) use or manipulation of any human biological derivative (e.g. human cells,
tissues and body fluids), including those which were previously acquired and
stored;
(c) review, analysis and publication of previously compiled identifiable data;
for the purpose of studying, diagnosing, treating and/or preventing, any ailment,
injury or adverse condition of the human mind or body.
An activity that is undertaken with the intention of improving the health of the patient
may be considered “therapy”. However, the fact that some therapeutic benefit to the
patient may result from an activity that is designed to develop or contribute to
generalisable knowledge does not alter its status as “research”.
Where conflicts arise between research and therapy, their resolution rests on the
integrity of the physician/investigator. [18]
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
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Chapter 3
Methodology
The main objective of this project is
(a) To review common cases of clinical and research violations in Asia, and
propose new guidelines to address one area of lapse.
(b) Develop a database for trend analysis.
3.1
Review of Ethics Violation
3.1.1 Acquiring Data on Violations
Data acquisition was carried out in two different scopes. Namely they are clinical
violations which included only medical malpractices and research violations which
were kept under the scope of just clinical trials and human biomedical research, in
Asia. There were many obstacles in acquiring actual case notes of ethical breach in
both clinical and research fields. Searching on internet and NUS Law Library for
electric journals, journals and case notes did not produced the results that were
expected as these detailed information are kept very confidential and accessible to
only authorised personnel. However, much knowledge was gained in the process as
there was plenty of literature available at these resources.
For clinical violations, the database had to be built mainly on information available
from tabloid reports, journals and reputable websites dedicated to issues pertaining to
biomedical ethics. Brief write ups on disciplinary enquiries which Singapore Medical
Council (SMC) conducted on complaints received in Singapore have been published
on its annual report since 2001 and are available on SMC’s website. These actual case
information together with information acquired on other clinical violations in Asia,
were used as sample data to review the clinical violation cases.
For research violations, enquiries were made at Yong loo Lin School of Medicine,
National University of Singapore, Centre for Biomedical Ethics and Singapore
Medical Association, Centre for Medical Ethics and Professionalism (CMEP), and it
was found out that there were no registry for fault reporting for research violations in
Singapore and that all records of reports on disciplinary enquiries for research
violations are kept by the Institutional Review Boards and they are not available to the
public due to legal constraints. Lastly, an enquiry was made with the Bioethics
Advisory Committee (Appendix 9), and correspondences were established with
Professor. Leonardo D. de Castro, Research Staff, Capacity Development in
Biomedical Ethics, through Professor. Alastair Campbell, Director, Centre for
Biomedical Ethics, Yong Loo Lin School of Medicine, National University of
Singapore. Prof. Leonardo is in charge of a capacity building programme in research
ethics in Singapore. He clarified on issues that were expected in pursuit of this
information on violations. One of them being the fact that people who are privy to
these information are probably under a responsibility to treat the information, which is
needed for this project, with confidentiality, and therefore unable to pass it on. Prof.
Leonardo himself has served on various ethics committees or review boards and has
BME499 TO REVIEW COMMON CASES OF CLINICAL AND RESEARCH VIOLATIONS IN
ASIA, PROPOSE NEW GUIDELINES TO ADDRESS ONE AREA OF THE LAPSES AND DEVELOP
A DATABASE FOR TREND ANALYSIS
10
access to materials on the topic from a number of countries. The pertinent information
is so confidential that he was not able to provide it for this research work. However,
anonymised cases can be used for such research work, but unfortunately, the IRB
committees do not take the trouble to remove identifiers from cases, because there has
been no need to publish descriptions in reports like that which is done in Singapore.
3.2
Data Consolidation
The next stage of the project research was consolidation of all report information,
published in journals and tabloids available in the public domain, for clinical violation
and research violations, and to establish individual sample sizes based on number of
reports rather than the number of cases as one report might provide information on
more than one case study.
3.3
Trend of Violations
To facilitate this process a template (Figure 3.3) was developed to capture just some
key information that would be used to get a first-hand view of the common violations
and aid in the review process.
Some of the case studies report on one event of a violation while the rest report the
occurrence of violations that have or have been taking place with no definite numbers
on the instances. For the ease of tabulation, a count of ten (10) is given for reports on
violations that indicate multiple occurrences.
The violation that records the most number of occurrences will be studied to uncover
lapses and the underlying causes that have led to its frequent breach of biomedical
ethics. With the aid of SMC’s Ethical Guidelines, which is on par with the highest
international standards and International Ethical Guidelines for Biomedical Research
Involving Human Subjects prepared by the Council for International Organizations of
Medical Sciences (CIOMS), guidelines would be proposed for the chosen area of
lapse.
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Figure 3.3 Sample Data Capture Template
CLINICAL VIOLATION DATA
Case ID:
Year:
Country:
Organisation:
Med. Spec.
Type of Violation
Details of Violation:
Adverse Event:
Guidelines
No. of Instances (if no number count as 10):
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3.4
Building of database for Trend Analysis
3.4.1 Choosing the right application
For the purpose of trend analysis in this project, it was decided to use Microsoft Excel
based Pivot tables and Pivot charts.
Why choose Pivot table for trend analysis?
-
The database structure is small and only requires a “Flat” database. Flat
database, typically only requires a single table to store the required data.
Data analysis does not require a complex query and thus does not warrant a
complex database application which is designed for relational data storage.
Ease is use for users to develop as compared to other database application
which requires considerable skillset.
Introduction to Microsoft Excel Pivot Tables
A Pivot Table is an interactive table that allows one to quickly summarize large
amounts of data. Similar to any database application, data is stored in a database table
and presented in a user defined Pivot Table. When new data is the database table is
updated, the pivot table will be updated to reflect the changes. They enable you to
create new views of worksheet data in seconds. Hundreds or thousands of pieces of
information swing into place, revealing the meanings behind the data.
2 databases have been developed for this project, namely:
- Clinical Violation Database
- Research Violation Database
The rest of this section describes how the database was developed in detailed steps.
[19][20]
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3.4.2 Database components
The database developed for this project contains the following components:
a. Data Table
b. Data fields
c. Pre-defined data selectable with drop down list
d. Pivot table field lists
e. Pivot Tables
f. Pivot Charts
3.4.3 Flow chart for database implementation plan
Plan database
structure
Decide on type of
calculation
required
Decide on type of
report and charts
required
Input sample data
Decide on
predefined data
for input mask
Create Pivot
Table
Create Pivot
Chart
Test database
Remove sample
data
Make changes as
necessary
Implement
database
Choose
database fields
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3.4.4 Database Planning
It’s very important to think thoroughly and plan the development of a database. The
following key pointers were carefully considered to drive the design to produce the
desired output:
- Purpose of this database, with a clear understanding of the desired output.
- Fields for database table which is key in achieving the desired data.
- Type of data format required based on the extend of calculation required.
- Types of charts required to express the results.
3.4.5 Database tables
For this project 2 tables were developed for both Clinical Violation Database and
Research Violation database.
Figure 1
Figure 2
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3.4.6 Data Fields
Before looking at the detailed steps of the creating a table, let’s take a look at the list
of fields chosen for the database.
Case ID
Each report entry is assigned a case ID in the respective database. The
ID number is in running order and there is no repetition of numbers.
Year
The year entry of each case, enables summing up of trends on yearly
basis during trend analysis.
Date
This field was included to store the date information if it was
available.
Country
Since this database was set up for trend analysis of Asian violations, a
drop down list is included for convenience of adding data by just
clicking on the desired entry from the drop down menu. There is
enough of spare field in the list for future addition.
Name of
This field is for the manual name entry of the hospital or scientific
Organisation organisation from where the violation had taken place.
Medical
This list of medical specialist for clinical violations was replicated from
Speciality
SingHealth’s group of 40 clinic specialist [21]
while the research list was replicated from The Five Review Boards of
CIRB SingHealth group. [22]
Medical
The name of the violating personnel and an extra field if there are
Personnel 1 more than one person involved in the violation.
&2
Name of
To enter the patient’s name if it is available.
Patient
Age of
To enter Patient’s age
Patient
Contact
Patient’s contact detail so as to be able to reach should there be any
Detail
future updates.
Type of
For clinical violation cases, the list was drawn up from the categories
Violation
in the SMC Medical Ethics Guidelines. For research violations the
categories are based on ethics principles such as Autonomy,
Beneficence, Confidentiality, Informed Consent, Justice, and NonMaleficence.
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Details of
Violation or
Summary of Case
Violation
A brief account of the ethic violation is entered as mouse over
function against the corresponding field. It is down in this way
to save space as the text box would appear as pop up during
mouse over action and disappear when the cursor is moved out
of the field.
Adverse Event
This field is to report any adverse event that might occur as a
consequence of the violation. The list was adopted from CIRB
Local Serious Adverse Event (SAE) (Appendix 6) Reporting
Form. Using it as a guide it was simplified further for the ease
of data entry.
Details of
This is a mouse over field to capture SMC’s guidelines to
Guidelines or
address the lapse that caused the clinical violation and COIMS
Recommendations guidelines for research violation lapses.
Remedial Action
This is also a mouse over field which allows capturing of the
or Corrective
follow up action that was performed to mend the effects of the
action
adverse event.
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3.4.7 Step-by-step database development
Database table
S/No
01
Description
Visual illustration
Open a new worksheet by
clicking
Start>All Programs>Microsoft
Office>Microsoft Excel
02
The table development was
started by keying in the Database
title in a fresh worksheet.
The various fields were input
vertically in a row
03
Data structure was converted to
table in the following steps.
Select the row of data.
04
Click on Insert Tab, in the Table
group, click Table
05
A dialogue box opened, select
“My table has headers” and click
“OK”.
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06
Data structure is converted to
table. With this Excel will
recognise any data input in the
following rows as table.
07
The tables are created with auto
filters for each field. This enables
easy filtering of data for each
field.
08
Worksheet was renamed
double clicking on the tab.
09
Tab colour was changed by
clicking right on the tab, selecting
Tab Color and choosing Orange
colour.
by
Drop down list for predefined data:
10
List of pre-defined data was listed
outside the defined table area.
11
Select data field to assign drop
down list
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12
Click on Data Tab, in the Data
tools group, click Data validation
13
Change the “Allow” field to
“List”
Update the source data to the
predefined list shown earlier.
Click “OK”.
14
Once assign, the drop down menu
looks like this.
The same steps are repeated for
the following fields:
- Country
- Medical speciality
- Adverse event
- Type of violation (SMC
guideline)
15
VlookUp table: VLookUp was used to match field “Type of violation (SMC guideline) code”
for respective row of field “Type of violation (SMC guideline).
16
List of the violation categories
and respective code from SMC
guideline was plotted in 2
columns.
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17
VLOOKUP formula was
established.
Note that the formula automatically
applies to all new row of data
input.
Lookup_value: refers to field
“Type of violation (SMC
guideline).
Table_array: VLOOKUP is
looking for the above information
in this range $AC$7:$AD$16. This
must be fixed by adding $ sign for
both column and row in order to
prevent data overrun.
Col_index_num- VLOOKUP is
looking for the returning value in
second column of the range.
False - indicates that only an exact
match to the lookup _value
Once a exact match is found
VLOOKUP returns the value of
“Type of violation (SMC
guideline) code “with the right
Code.
18
Comments function was used for
Summary of case violation
Details of Guidelines (SMC).
To add a comment, select cell, right
click and click insert comment.
19
Comments function was used for
Summary of case violation
Details of Guidelines (SMC).
To add a comment, select cell, right
click and click insert comment.
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20
Date collected for various
violations were input in Research
Violation Database and Clinical
Violation Database.
Creation of Pivot tables
Will go thru the creation of the 1st Pivot Table
tables were created similarly with other variables.
21
Select entire database table
22
Click on Insert Tab, in the Tables
group, click PivotTable
23
Check that the “New Worksheet” is
checked and click “OK”
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. Rest of the pivot
22
24
Excel generated an empty pivot
table.
25
On the right side PivotTable Field
List appears.
The top portion listed all fields
available in the database table
header.
The following fields were added to
Pivot table simply by dragging to
the respective “layout” which
appears below:
Year; Country
Medical Speciality
Type of Violations (SMC
Guideline)
Medical Speciality
26
Before selection
After selection
Empty Pivot chart was then upated with the respective data.
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27
Insert Pivot Report Header by
inserting a empty row at Row 1.
Select Row 1, by clicking on 1.
Right click, and select insert.
28
A new row was inserted above the
Pivot chart and the row height was
adjusted to fit in a header.
29
Click on Insert Tab, in the
Illustrations group, click Shapes
Click on Rectangle
30
A rectangle box was created. Size
the rectangle box by dragging on
the points around the box.
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31
Select the box, right click on the
box and select Format Shape..
32
The color was changed to blue
background
33
The background color was
changed.
Next step was to add title, by
selecting the box, right click and
click on Edit Text.
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34
The font color was changed for
better visibility.
35
Completed Pivot table with header.
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36
37
A Pivot Chart was appended, steps as follows:
Select any cell within the Pivot
Table. Note that the selection is
indicated by blue lines around the
Pivot table.
Click on Insert Tab, in the
Illustrations group, click Column,
and select Stacked Column
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38
Excel created a Pivot Chart in the
Pivot table area. The chart was
moved down for visibility of both
Pivot Table and Pivot Chart.
Pivot chart was resized to clarity of
details in the chart.
39
Formatting of axis title was done selecting the Axis, right clikc and clicking on “Format
Axis”.
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40
A dialogue box opens, select
“Alignment” and Select “Rotate all
text 270”
41
Updated chart with cell aligned straight
42
To simply the chart the Pivot
selection buttons on the chart
was hidden. This done by:
Select a Pivot button
Right Click
Click “Hide All Field Buttons
on Chart”
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43
Chart title and Axis title were
added by
Select Pivot Chart, Click on Layout
Tab, in the Labels group, click
Chart title followed by Axis Titles.
44
Updated chart with Chart and Axis titles. Scroll down to see an how the whole page
looks with Pivot table and Pivot chart.
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45
46
The tab was originally created by
default name given by Excel.
Tab name was changed to “Pivot
Med.Specility by double clicking
and overwriting.
Tab color was changed to Blue by
right clicking on the tab, select
“Tab Color”, Select Blue color.
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47
Updated tab.
48
This process was repeated to create
more Pivot tables which were
created for Trend Analysis for this
project. Total of 4 custom Pivot
Tables were created.
Namely:
Pivot Med. Speciality
Pivot Asia
Pivot Age
Pivot Adverse event
An additional empty Pivot chart
was created for users to try and
manipulate the data fields and
create their own Pivot charts
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Chapter 4
Results and Discussion
4.1
Trend of Violations
4.1.1 Total Data
A total of thirty-two clinical violations and nine research violations were entered into
the data templates making a total of forty one seta of data.
4.1.2 Clinical Ethics Violation
The table below (Figure 4.1.2) shows the breakdown and total count of clinical
violations report that have occurred. “Informed Consent” has one of the highest
occurance which is the same number as the violation “Associacion with persons not
qualified to provide medical or medical support services”.
Figure 4.1.2
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4.1.3 Research Ethics Violation
The table below (Figure 4.1.3) shows the breakdown and total count of clinical
violations report that have occurred. “Informed Consent” has the highest occurance.
Figure 4.1.3
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4.2
Trend Analysis Database
4.2.1 Clinical Violations Database
The figure below (figure 4.2.1) shows the clinical violations database.
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4.2.1.1
Clinical Violations Pivot Tables
Pivot Table for Type of Violation vs Medical Specialities (Singapore) Figure 4.2a
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Pivot Chart for Type of Violation by Country (Asia) Figure 4.2b
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Pivot Table for Type of Violation by Country Figure 4.2c
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Pivot Chart for Type of Violation by Country (Asia) Figure 4.2d
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Pivot Table for Type of Violation by Age (Singapore) Figure 4.2e
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Pivot Chart for Type of Violation by Age (Singapore) Figure 4.2f
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Pivot Table for Type of Violation vs Adverse Event (Singapore) Figure 4.2g
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Pivot Chart for Type of Violation vs Adverse Event (Singapore) Figure 4.2g
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4.2.2 Research Violations Database
The figure below shows the research violations database. (Figure 4.2.2)
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4.2.2.1
Research Violations Pivot Tables
Pivot Table for Type of Violation vs Medical Specialities (Singapore), Figure 4.2h
Pivot Table for Type of Violation in Asia, Figure 4.2i
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Pivot Table for Type of Violation in Asia, Figure 4.2j
Pivot Chart for Type of Violation in Asia, Figure 4.2k
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Pivot Table for Type of Violation by Age (Singapore) Figure 4.2l
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Pivot Table for Type of Violation by Age (Singapore) Figure 4.2m
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Pivot Table for Type of Violation by Adverse Event (Singapore), Figure 4.2n
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Pivot Chart for Type of Violation by Adverse Event (Singapore), Figure 4.2o
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Pivot Table for User defined fields, Figure 4.2p
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4.3
Current Trend in Violations
The tables (figure 3.3a and 3.3b) in the previous section showed the
breakdown and total count of clinical violations report that have occurred.
“Informed Consent” has the highest occurance and this figure would most
likely be higher, as there were instances in reports that reflected more than one
occurance for a violation repeatedly commited by a single person or an
organisation. Therefore it can be safely interpreted as “Informed Consent” as
having the highest occurance.
4.3.1 Legislation Shortfalls
Owing to the increasing number of research companies establishing their base
in Asia, and the surge in the need for clinical trials, the occurrences of ethical
violation have also seen a sharp increase in the recent past. Most clinical trials
take place in developing countries where vast population with high illiteracy,
puts them at risk of being exploited. Legislation and enforcement is also lax in
these countries.
4.3.2 Informed Consent Lapses
Proper procedures to get informed consent from participants are not in place
and loopholes in the paperwork procedures are exploited at the expense of the
population.
4.4
Proposed Guidelines to Address Lapses
4.4.1 Protocol Enforcement
Tight legislative enactment of research guidelines must be brought about first
of all to bring about any positive change to the present situation. Parent
companies of ethics violator must be brought to task at the country from which
they came from if there is a slightest hint of violation in their overseas
operations. They must also be monitored by third party assessors during the
entire research and pass their stringent auditing before their research findings
can be accepted.
4.4.2 Changes in “Informed Consent” Acquisition
Apart from these changes, the informed consent acquisition procedure has also
got to be fine-tuned to make it more robust to enforce some form of
conformity to address the issue of rushing to get the process done with.
For this the National Healthcare Group (NHG) Singapore’s Informed Consent
Form was reviewed and used as a template to address the issue of spending
sufficient time with the research participant, so that he is given the opportunity
to not only take his time to listen to the research personnel’s explanation but
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also allow him time to contemplate over what he has heard and understood and
also clarify doubts. The research personnel have also got to sit with the
participant for the full duration of the stipulated timing on the Informed
Consent Form, in this case it is recommended as thirty minutes (Appendix 8).
Extract from original form
Extract from proposed modified form
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The reason why timing is chosen is because there seem to be a lapse in this
area, where although it was stated clearly in the NHG Investigator Manual
that, “Subjects must be given adequate time to consider before making a
decision whether or not to participate.” There is no enforcement of specific
duration to ensure compliance. [33]
4.5
Data on Violations
A total of thirty-two actual Clinical Violations reports and nine actual
Research Violation reports were included in the database. The lack of actual
data has been explained earlier as due to the confidentiality of the subject
matter. Therefore, fictitious data, highlighted in red to distinguish from actual,
has been added in both the database to demonstrate how the application and
pivot tables would work if was able to be filled up with larger data.
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Chapter 5
Conclusion and Recommendation
5.1
Conclusion
The objective of this capstone project was to review the common cases of
clinical and research violations in Asia, to propose guidelines to address one
area of the lapses and to develop a database for trend analysis,
Despite the difficulties faced during the earlier part of the project in acquiring
actual pertinent data on violations, due to confidentiality and insurance policy
requirements of agencies, which are privy to this information, the database on
violations did finally materialise with information gathered from reputable
websites and reports.
A combined review was conducted on both clinical and research violations. It
was then decided that “informed consent” was the area which had the most
frequent lapse and it was taken up to analyse and propose guidelines to address
it. Legislative enforcements, which would complement the COIMS Ethical
Research guidelines, were suggested. As an added feature, an “Informed
Consent” form from NHG was utilised to show an amended field, which
stipulates the consent acquisition process timing. This simple adjustment to an
existing protocol shows that significant improvements can be achieved without
having to overhaul entire systems and procedures. Simplicity also motivates
healthcare and research personnel to proactively lookout for shortfalls and
address them efficiently without apprehension about significant workload
increases.
Microsoft Excel was used to build a database for trend analysis due to the
flexibility of creating pivot tables, where trends in any number of permutations
can be generated. For this report, four pivot tables were created for Clinical
and Research database and an additional “User Defined” pivot table was
created in each database for the user to manipulate, explore and analyse other
trends.
This trend analysis application is user friendly and would be a very useful tool
in Institutional Review Boards (IRB) and learning institutions for analysing
trends quickly and to update the database periodically.
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Chapter 6
Project Timeline
Criteria/Targets
Dateline
Carry out information gathering
End of Apr 2010 Completed
Carry out literature review
End of July 2010 Completed
Draft out project plan
28th Feb 2010
Completed
Proposal report
8th Mar 2010
Completed
Review project plan
28th Mar 2010
Completed
Interim report
10th May 2010
Completed
th
Status
Review Recomendation
14 Aug 2010
Completed
Collate Research Violations in database
6th Jun 2010
Completed
Collate Guidelines to Address Lapses in 30th Jun 2010
database
Completed
Designing database structure and data entry 8th May 2010
template
Completed
Final Report
15th Nov 2010
Compile all information and data required for 27th Nov 2010
Poster and Oral presentation
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Completed
Ongoing
57
Project Gantt Chart
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Chapter 7
Future Works
The database has been developed for a standalone application and it meets its
intended purpose. A future development on this database application could be
one that is made for institutions from remote locations tapping into this
database and having specific rights to modify or add data. This data could be
shared by partner institutions around the world. The advantage of such a
system would result in reduction of redundancies in terms of storage and also
serve as a tool for enforcement purpose against bioethics violators.
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Chapter 8
Critical Review and Reflections
In January 2010, when I chose this capstone project, I was very excited to
embark on it as it has been one of my favourite topics ever since I took up a
subject which had biomedical ethics as one of its component in my course.
There have been some unexpected events and outcomes throughout the
semester. The development of the database application for trend analysis was
only included after I had read the synopsis and submitted this title as my
choice of project. Having no prior experience in developing databases, I was
quite concerned about how I was going to go about it. It took me several
discussions with Dr Ho, my project supervisor, to get a clear picture of the
scope and requirements of the database. On top of the research I had to do on
the subject matter “Ethics”, I had to read up and approach friends and
classmates who have good working knowledge about databases. These
discussions and informal lessons from friends helped me a great deal in
understanding about Microsoft Excel and subsequently proposing to Dr. Ho
about using Excel to achieve a good trend analysis application.
The next obstacle I faced was when I was sourcing for biomedical ethics
violation case data which came from authentic reliable sources. It was
frustrating to find out that agencies with intimate knowledge were reluctant to
share this information. I persevered on this matter and finally was able to
establish correspondence with Prof. Leonardo D de Castro of the Bioethics
Advisory Committee (Singapore), who is a very highly regarded authority on
bioethics not only in Singapore but worldwide. He was kind enough to reply to
my enquiries and explained why the agencies, not only in Singapore, but all
over the world, do not reveal this information to the general public. This turn
of event was a blessing in disguise as I came to understand the workings of
ethics review bodies.
In terms of keeping schedule, I must admit that I had been slow in some of the
project phases and it did affect my progress right up to submission. With the
encouragement of Dr.Ho, my family and friends. I was able to complete and
make it to submission. Apart from the knowledge gained in the pursuit of this
project, as my classmates had told me earlier, this project had definitely
thought me the importance of scheduling and consistent progress. I am glad
that I have managed to meet the requirements of this capstone project with
reasonable success.
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References
1.
2.
3.
4.
5.
6.
7.
8.
9.
Adil E. Shamoo, Ph.D, Felix A. Khin-Muang-Gyi, Pharm.D.,
M.B.A.,Ethics of the Use of Human Subjects in Research, 1st edn,
London and New York
http://www.bioethics-singapore.org/
24. Hogwood BW, Gunn LA: Policy Analysis for the Real World.
Oxford: Oxford University Press; 1984.
25. Hogwood BW, Peters BG: Policy Dynamics. New York: St.
Martin’s Press; 1983.
26. Lester JP, Steward J: Public Policy: An Evolutionary Approach.
Belmont, CA: Wadsworth; 2000)
http://www.bioedge.org/index.php/bioethics/bioethics_article/7227/
http://www.bioedge.org/index.php/bioethics/bioethics_article/7362/
Dr.Chloe-Maryse Baxter, Mark G Brennan, Dr. Yvette G M Coldicott
2002, The Practical Guide to Medical Ethics and Law, 1st edn, p 5
Prof. Arthur Lim, An Introduction to Medical Ethics, 2nd edn, p ix-xi
10.
Council for International Organizations of Medical Sciences
(CIOMS), International Ethical Guidelines for Biomedical Research
Involving Human Subjects, 2002, p 16-18
11.
Adil E. Shamoo, Ph.D, Felix A. Khin-Muang-Gyi, Pharm.D.,
M.B.A.,Ethics of the Use of Human Subjects in Research, 1st edn,
London and New York, p8
12.
Dr. Abdul-Hamid Abdul-Kadir, 2008, Consent, Medical Ethics,Etiquette
and Law, 1st edn, University of Malaya, p 56-57
13.
Council for International Organizations of Medical Sciences
(CIOMS), International Ethical Guidelines for Biomedical Research
Involving Human Subjects, 2002, p 16-18
14.
Council for International Organizations of Medical Sciences
(CIOMS), International Ethical Guidelines for Biomedical Research
Involving Human Subjects, 2002, p 16-18
15.
http://www.ehow.com/about_6648232_principle-veracity_.html
16.
http://www.sma.org.sg/cmep/
17.
Operational Guidelines for Ethics Committees That Review Biomedical
Research, WHO,Geneva, 2000, p. v,1
18.
Biomedical Research Regulation, Ministry of Health Operational
Guidelines for Institutional Review Boards Dec 2007
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19.
https://apps.uwc.edu/training/wlwarchive/Pivot_Tables.doc
20.
http://www.tech-faq.com/flat-file.html
21.
http://www.singhealth.com.sg/PatientCare/ClinicalSpecialties/Pages/Ho
me.aspx
22.
http://research.singhealth.com.sg/Ethics/CIRB/Pages/Default.aspx
23.
http://en.wikipedia.org/wiki/Hwang_Woo-suk
24.
http://www.bioethicssingapore.org/uploadfile/61100%20PMOocyte%20Donation%20%20Clinical%20and%20Scientific%20Aspects.pdf
25.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1125767/
26.
Dr Tan Wah Tze (MBBS, 1998), SARS and Shorvon: The 2 S Forcing a
Re-look at Our Healthcare System
27.
http://www.bioedge.org/index.php/bioethics/bioethics_article/8438/
28.
http://www.atimes.com/atimes/South_Asia/FG23Df03.html
29.
http://www.bioedge.org/index.php/bioethics/bioethics_article/8647/
30.
http://www.bioedge.org/index.php/bioethics/bioethics_article/7362/
31.
http://www.bioedge.org/index.php/bioethics/bioethics_article/7789/
32.
SMC Annual Reports (see appendix 5 on Disciplinary Inquiries)
33.
NHG, Investigator Manual, 2004, Consent Process, p.37
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APPENDICES
Appendix 1: SMC Ethical Code Guideline
Appendix 2: Inter International Ethical Guidelines for Biomedical
Research Involving Human Subjects
03 Appendix
International Ethical Guidelines for Biomedical Research Involving Human Subjects.doc
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Appendix 3: Medical Specialities
Clinical Specialist List from The SingHealth group 40 clinical specialties:
Anaesthesiology
Cardiology
Cardiothoracic Surgery
Colorectal Surgery
Dentistry
Dermatology
Diagnostic Radiology
Emergency Medicine
Endocrinology
Family Medicine
Gastroenterology
General Surgery
Geriatric Medicine
Haematology
Hand Surgery
Infectious Diseases
Internal Medicine
Medical Oncology
Neonatology
Neurology
Neurosurgery
Nuclear Medicine
Obstetrics & Gynaecology
Occupational Health & Epidemiology
Ophthalmology
Oral & Maxillofacial Surgery
Orthopaedic Surgery
Otolaryngology (Ear, Nose and Throat
or ENT)
Paediatric Medicine
Palliative Medicine
Pathology
Plastic Surgery & Burns
Psychological Medicine
Radiation Oncology
Rehabilitation Medicine
Renal Medicine
Respiratory Medicine
Rheumatology & Immunology
Sports Medicine
Surgical Oncology
Urology
http://www.singhealth.com.sg/PatientCare/ClinicalSpecialties/Pages/Home.as
px
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Appendix 3
Research Specialist List from The SingHealth group
The Five Review Boards of CIRB
CIRB A
Ophthalmology
CIRB B
Oncology
Psychiatry
Haematology
Neurology/Neurosurgery
Pathology
CIRB C
Cardiovascular Science
Pharmacology
Emergency Medicine
(Including sleep studies)
Endocrinology
Genetics
Diagnostic Imaging
Geriatric Medicine
Respiratory Medicine
Nursing and
Health Service Research
CIRB D
Obs/Gynaecology
CIRB E
Infectious Disease
Anaesthesia
Gastroenterology
(including acupuncture)
Renal Medicine
Surgery
ENT
Rheumatology/Immunolo
gy
Dentistry
Dermatology
Paediatric Medicine
Sports & Rehab Medicine Family Medicine
Allied Health
(http://research.singhealth.com.sg/Ethics/CIRB/Pages/Default.aspx )
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Appendix 4
Appendix 4: Clinical and
Research Violations Data
Research carried out and compiled by:
P.Paari
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Appendix 4
RESEARCH VIOLATION DATA
Case ID: 001
Year: 2004
Country: S. Korea
Organisation: Hanyang University Medical
Center
Others (eg. Stem cell and Cloning)
Autonomy
Med. Spec.
Type of Violation
Details of Violation:
Stem cell scientist Hwang Woo-suk had lied about the source of the eggs
donated to protect the privacy of his female researchers, and that he was not
aware of the Declaration of Helsinki, which clearly enumerates his actions as
a breach of ethical conduct.. He originally claimed that he had used only 427
eggs to produce 11 human embryonic stem cell lines. This claim has been
proven fraudulent. In January, investigators from Seoul National University
disclosed that he had used 2,061 eggs from 129 donors. A month later, the
National Bioethics Committee found that he had gathered 2,221 eggs from
119 donors.Hwang did not act alone. It also appears that Hanyang University
Medical Center gave eggs to Hwang without obtaining the consent of the
donors. He denied coercing his researchers into donating eggs and claimed
that he found out about the situation only after it had occurred. This was a
clear violation of a Korean bioethics law. [23]
Adverse Event: Not Available
Guidelines
Explicit consent must be obtained from the oocyte donor and there must be no
inducement, coercion or any undue influence. Potential oocyte donors, who
are not part of an ART programme, must be interviewed by a special panel,
which has to be satisfied that the prospective donor is of sound mind, has
fully understood the procedures and implications of the donation and that she
has given her consent voluntarily. -Professor Ng Soon Chye, June 2007,
Oocyte Donation – Clinical and Scientific Aspects for the Bioethics Advisory
Committee, Singapore. [24]
No. of Instances (if no number count as 10): 129
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Appendix 4
RESEARCH VIOLATION DATA
Case ID: 002
Year: 2002
Country: Singapore
Med. Spec.
Organisation:
National Neuroscience Institute
Neurology/Neurosurgery (Including sleep
studies)
Non-Maleficence
Type of Violation
Details of Violation:
A $6m (£3.8m; a5.6m) government sponsored study of genetic factors in
Parkinson's disease and two other disorders. When Professor Shorvon and his
assistants found themselves far short of patient recruitment targets for the
Parkinson's disease arm of the study, they obtained lists of patients from two
hospitals. They recruited 127 patients by calling them directly, bypassing
their neurologists.
The patients' neurologists were not informed of the tests that were done,
which in many cases included altering their treatment. Patients were tested for
Parkinson's disease by an L-dopa test, which usually involved missing one or
two doses before testing of motor function. Missing doses was potentially
harmful to patients, the panel found.
Also, the consent forms signed by the patients made no mention of the Ldopa test, during which several patients were videotaped. Members of the
study's ethics committee also testified that they were unaware of the tests.
[25]
Adverse Event: Not Available
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Appendix 4
Guidelines A doctor who participates in clinical research must put the care
and safety of patients first. If a doctor wishes to enter a patient into a clinical
trial, he must ensure that the trial is approved by an ethics committee and
conforms to the Good Clinical Practice Guidelines. In addition, informed
consent must be obtained from the patient. It is not acceptable to experiment
or authorise experiments or research which are not part of a formal clinical
trial and which are not primarily part of treatment or in the best interest of the
patient, or which could cause undue suffering or threat to the life of a patient.SMC Guideline - 4.1.4 Untested practices and clinical trials
Questionable patient management must be challenged at every level. Every
hospital’s medical and surgical department should be cross-audited by an
equivalent department from another hospital to ensure that patient care is not
compromised. This also ensures that errors and mistakes are not covered
up within the department. Doctors found to have questionable practices
should be reported. . No matter whether the report comes from a House
Officer or a Professor, it should be taken seriously and investigated
thoroughly. If deemed necessary, the doctor in question must be barred from
further practice. All persons involved who failed to check the errant doctor
and who looked “the other way”, are guilty of being accessories to the harm
or death of the patient. [26]
No. of Instances (if no number count as 10): 127
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Appendix 4
RESEARCH VIOLATION DATA
Case ID: 003
Year: 2009
Country: India
Organisation: Not Available
Med. Spec.
Others (eg. Stem cell and Cloning)
Type of Violation
Informed Consent
Details of Violation: Dr Surinder Singh, India's drugs controller general, has
promised to review applications in two to six weeks and push his ossified
operation "from the Stone Age to the Clone Age". He recently announced the
he will allow foreign companies to conduct Phase I, or first-in-human, studies
in India. [27]
Adverse Event: Others
Guidelines Refer to CIOMS Guidelines
Guideline 3: Ethical review of externally sponsored research
Guideline 4: Individual informed consent
Guideline 5: Obtaining informed consent: Essential information for
prospective research subjects
Guideline 6: Obtaining informed consent: Obligations of sponsors and
investigators
Guideline 7: Inducement to participate
Guideline 8: Benefits and risks of study participation
Guideline 10: Research in populations and communities with limited
resources
Guideline 12: Equitable distribution of burdens and benefits in the selection
of groups of subjects in research
No. of Instances (if no number count as 10): 10
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Appendix 4
RESEARCH VIOLATION DATA
Case ID: 004
Year: 2004
Country: India
Organisation: Shanta Biotech and Bangalorebased Biocon India
Med. Spec.
Others (eg. Stem cell and Cloning)
Type of Violation
Informed consent
Details of Violation: Openly conducted illegal clinical trials of new drugs on
unsuspecting patients the two companies had conducted improper clinical
trials of Streptokinnese - a new clot-busting drug used in heart attacks
without requisite permissions (of the Genetic Engineering Approval
Committee) [28]
Adverse Event: Death
Guidelines
Guideline 3: Ethical review of externally sponsored research
Guideline 4: Individual informed consent
Guideline 5: Obtaining informed consent: Essential information for
prospective research subjects
Guideline 6: Obtaining informed consent: Obligations of sponsors and
investigators
Guideline 7: Inducement to participate
Guideline 8: Benefits and risks of study participation
Guideline 10: Research in populations and communities with limited
resources
Guideline 12: Equitable distribution of burdens and benefits in the selection
of groups of subjects in research
No. of Instances (if no number count as 10): 8
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Appendix 4
RESEARCH VIOLATION DATA
Case ID: 005
Year: 2004
Country: India
Organisation: Sun Pharmaceuticals
Med. Spec.
Obstetrics /Gynaecology
Type of Violation
Informed consent
Details of Violation: More than 400 women who had been trying in vain to
conceive were enrolled in 2003 without their knowledge or consent to take
part in clinical trials across India to see if a drug called Letrozole induced
ovulation. Letrozole used in India was copied (with permission) by Sun
Pharmaceuticals, a large Indian generic drug company, from a patented
product of the same name of Novartis, which the multinational drug maker
introduced globally for solely treating breast cancer and not for any other use
in any country, including India. [28]
Adverse Event: Not Available
Guidelines Refer to CIOMS Guidelines
Guideline 3: Ethical review of externally sponsored research
Guideline 4: Individual informed consent
Guideline 5: Obtaining informed consent: Essential information for
prospective research subjects
Guideline 6: Obtaining informed consent: Obligations of sponsors and
investigators
Guideline 7: Inducement to participate
Guideline 8: Benefits and risks of study participation
Guideline 10: Research in populations and communities with limited
resources
Guideline 12: Equitable distribution of burdens and benefits in the selection
of groups of subjects in research
No. of Instances (if no number count as 10): 400
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Appendix 4
RESEARCH VIOLATION DATA
Case ID: 006
Year: 2001
Country: India
Organisation: Regional Cancer-treatment Center
(RCC)
Med. Spec.
Nursing and Health Oncology
Type of Violation
Informed consent
Details of Violation: Clinical trial of nordihydroguairetic acid, a chemical
with anti-cancer properties that was tested by a regional cancer-treatment
center (RCC) in the Indian state of Kerala for a US-based researcher then
associated with Johns Hopkins Hospital in the United States. The drug was
allegedly tried on 26 unsuspecting cancer patients, two of whom died.
Subsequently, a 60-year-old woman was again included for a trial for which
the RCC provided five doses of the experimental drug, worth Rs10,000
(about US$200), free. The woman's condition turned critical as well before
the fifth dose, although she escaped death. [28]
Adverse Event: Death
Guidelines Refer to CIOMS Guidelines
Guideline 3: Ethical review of externally sponsored research
Guideline 4: Individual informed consent
Guideline 5: Obtaining informed consent: Essential information for
prospective research subjects
Guideline 6: Obtaining informed consent: Obligations of sponsors and
investigators
Guideline 7: Inducement to participate
Guideline 8: Benefits and risks of study participation
Guideline 10: Research in populations and communities with limited
resources
Guideline 12: Equitable distribution of burdens and benefits in the selection
of groups of subjects in research
No. of Instances (if no number count as 10): 26
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Appendix 4
RESEARCH VIOLATION DATA
Case ID: 007
Year: 2009
Country: China
Organisation: Not Available
Med. Spec.
Others (eg. Stem cell and Cloning)
Type of Violation
Veracity
Details of Violation: More than 90% of purportedly randomised controlled
trials (RCTs) in Chinese medical journals are flawed. When researchers
examined the articles more closely, they found that "most so called
'randomized controlled trials' were not real randomized controlled trials
owing to a lack of adequate understanding on the part of the authors of
rigorous clinical trial design." [29]
Adverse Event: Not Available
Guidelines Refer to CIOMS Guidelines
Guideline 1: Ethical justification and scientific validity of biomedical
Research involving human beings
Guideline 2: Ethical review committees
Guideline 20: Strengthening capacity for ethical and scientific review and
biomedical research
No. of Instances (if no number count as 10): 10
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Appendix 4
RESEARCH VIOLATION DATA
Case ID: 008
Year: 2005
Country: China
Organisation: Not Available
Med. Spec.
Infectious Disease
Type of Violation
Informed consent
Details of Violation: Chinese medical researchers often ignore basic standards
of ethical oversight in their rush to conduct experiments. Awareness of ethical
regulations and informed-consent procedures is "alarmingly low" and that
some institutional review boards do little more than rubber-stamp proposals.
Participants in some trials told that they had signed informed consent forms
which they could not understand, that doctors made no effort to explain them,
that they had to pay for copies of the consent forms, and that they were not
informed of the results of trials' results. Few scientists in China have training
in bioethics or in running ethics committees. [30]
Adverse Event: Not Available
Guidelines Refer to CIOMS Guidelines
Guideline 3: Ethical review of externally sponsored research
Guideline 4: Individual informed consent
Guideline 5: Obtaining informed consent: Essential information for
prospective research subjects
Guideline 6: Obtaining informed consent: Obligations of sponsors and
investigators
Guideline 7: Inducement to participate
Guideline 8: Benefits and risks of study participation
Guideline 10: Research in populations and communities with limited
resources
Guideline 12: Equitable distribution of burdens and benefits in the selection
of groups of subjects in research
No. of Instances (if no number count as 10): 10
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Appendix 4
RESEARCH VIOLATION DATA
Case ID: 009
Year: 2004
Country: China
Organisation: Shanghai Second Medical
University and Xiangya Medical College
Med. Spec.
Others (eg. Stem cell and Cloning)
Type of Violation
Non-Maleficence
Details of Violation: Dr. Xiangzhong Yang, of the University of Connecticut,
contends that China's main asset is that it lacks the ethical qualms which have
hampered the development of research on human embryos in Western
countries. "In addition," he says, "the relatively easy access to human
material, including embryonic and foetal tissues, in China is a huge advantage
for researchers".
Chinese scientists have already achieved notable progress towards therapeutic
cloning. They have produced transgenic rabbits, goats and cows; they have
cloned goats, cattle and rats. At Shanghai Second Medical University they
have extracted stem cells from embryos by creating rabbit-human hybrids and
at Xiangya Medical College in Changsha they have cloned human embryos to
the multicellular blastocyst stage. Dr Yang also insists that more oversight by
the Chinese government is needed to guarantee minimum ethical standards.
"Regulations are often not followed," he says, "and some very sensitive
embryo-based studied are conducted with little or no institutional review, and
researchers suffer no consequences for not following institutional or national
regulations or guidelines, if they exist." [31]
Adverse Event: Not Available
Guidelines Refer to CIOMS Guidelines
Guideline 1: Ethical justification and scientific validity of biomedical
research involving human beings
Guideline 2: Ethical review committees
Guideline 3: Ethical review of externally sponsored research
Guideline 4: Individual informed consent
No. of Instances (if no number count as 10): 10
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Appendix 4
CLINICAL VIOLATION DATA
Case ID: 001
Year: 2001
Country: Singapore
Med. Spec. :
Type of Violation
Organisation: Not Available
General Practice
Association with persons not qualified to
provide medical or medical
Details of Violation:
A medical practitioner was charged that being a person having management
and control of the clinic, he had allowed it to be used for cosmetic skin
treatment and programmes in breach of the conditions of the licence
prescribed by the Ministry of Health. [32]
Adverse Event: Not Available
Guidelines: 4.1.6 Association with persons not qualified to provide medical
or medical support services. A doctor shall not associate himself with anyone
who is not qualified to provide medical care, or generally accepted support
services such as that provided by dietitians, physiotherapists and occupational
therapists or podiatrists. A doctor shall not in his professional capacity
support the services provided by persons or organisations that do not provide
legitimate medical or medical support services, e.g. beauticians, beauty
parlours, health spas, colonic cleansing services, etc. [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 002
Year: 2002
Country: Singapore
Organisation: Not Available
Med. Spec. :
Not Available
Type of Violation
Untested practices and clinical trials
Details of Violation:
A medical practitioner was charged for selling skincare products including
medical creams improved by him to 2 patients and collecting payment from
them for the products without authority from the hospital administration, and
for his own account. The medical practitioner was employed by a public
sector hospital at the time of the alleged offence. [32]
Adverse Event: Not Available
Guidelines
4.1.4 Untested practices and clinical trials
A doctor shall treat patients according to generally accepted methods and use
only licensed drugs for appropriate indications. A doctor shall not offer to
patients, management plans or remedies that are not generally accepted by the
profession, except in the context of a formal and approved clinical trial. A
doctor who participates in clinical research must put the care and safety of
patients first. If a doctor wishes to enter a patient into a clinical trial, he must
ensure that the trial is approved by an ethics committee and conforms to the
Good Clinical Practice Guidelines. In addition, informed consent must be
obtained from the patient. It is not acceptable to experiment or authorise
experiments or research which are not part of a formal clinical trial and which
are not primarily part of treatment or in the best interest of the patient, or
which could cause undue suffering or threat to the life of a patient. [32]
No. of Instances (if no number count as 10): 2
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CLINICAL VIOLATION DATA
Case ID: 003
Year: 2002
Country: Singapore
Organisation: Not Available
Med. Spec. :
Not Available
Type of Violation
Attitude towards patients
Details of Violation:
A medical practitioner was charged with displaying conduct that was
unbecoming of the medical profession. The Disciplinary Committee found
him guilty of professional misconduct in that during a medical consultation
with his patient he had asked her personal questions which were irrelevant
and unrelated to her medical condition (an upper respiratory tract infection)
and thereby behaved in an inappropriate manner causing embarrassment to
the patient. [32]
Adverse Event: Not Available
Guidelines 4.2.1 Attitude towards patients
Patients shall be treated with courtesy, consideration, compassion and respect.
They shall also be offered the right to privacy and dignity. It is recommended
that a female chaperone be present where a male doctor examines a female
patient. This will protect both the patient’s right to privacy and dignity, as
well as the doctor from complaints of molestation. On the other hand, a
doctor is not obliged to allow himself to be subjected to abuse of any kind by
patients or their relatives. Where such abuse occurs, provided that there is no
need for self-defence against physical harm, doctors shall not retaliate, but
end the engagement with the patient as quickly as possible, in a professional
manner. [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 004
Year: 2002
Country: Singapore
Organisation: Not Available
Med. Spec. :
Neurosurgery
Type of Violation
Public speaking, broadcasting and writing
Details of Violation:
A medical practitioner was charged for publishing an abstract entitled
Radiosurgery: A 15-year Experience with 1,016 Patient Treatments”
presented at the 9th ASEAN Congress of Neurological Surgeons which
contained a statement he knew to be false or misleading. In the Abstract, the
medical practitioner had made the claim that “Since my involvement with
radiosurgery in 1986 at the Cleveland Clinic (USA), I have been involved in
the treatment of 1,016 patients”. The Disciplinary Committee rejected his
defence that he was referring to “1,016 patient treatments” and not “1,016
patients”, and that this was merely a typographical error and that someone
might possibly have amended his original draft abstract. [32]
Adverse Event: Not Available
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Guidelines
4.4.3.1 Public speaking, broadcasting and writing
All information, whether to fellow doctors or the public must conform to the
above standards. This includes information given in the context of education
for doctors or the public, in talks, broadcasts and seminars organised by
professional bodies or healthcare institutions, or in professional journals.
However, unsolicited information that doctors put or allow to be put into the
public domain must come with added responsibility not to be persuasive,
laudatory or misleading. Articles in the press and media that feature doctors
shall also conform to the standards stated above. While it is laudable for
doctors to educate the public on healthcare issues through speaking, writing
and broadcasting to the public, they shall restrict their material content to the
medical topic at hand. A doctor must ensure that he does not encroach into
the area of encouraging the public to seek consultation or treatment from him
or the organisation he is associated with by publishing detailed service or
contact details. Only the doctor’s name, registered field of practice and place
of practice may be mentioned in such instances. Doctors are responsible for
their public statements and for ensuring that journalists do not breach these
standards in reporting about them. Doctors must ensure that press and media
reports based on interviews with them are primarily for public education. In
addition, images used to illustrate medical procedures or treatments or their
outcomes can legitimately be used in educational talks organised by
professional bodies or healthcare institutions, or in professional journals.
However such images must be used much more judiciously in the public
media, where they could be deemed to be laudatory of the doctor named.
Hence any images used in the general media must not be related to
identifiable doctors or their patients either directly or by inference. Where a
doctor writes articles or columns or participates in broadcasts which offer
advice in response to public queries on particular subjects, the guidelines on
good clinical care and the establishment of a proper doctor patient
relationship apply (4.1.1). After public talks, if members of the public
subsequently personally approach speakers for information about themselves
and their services, such information may be provided only on request and
must conform to the standards on information provision described above
(4.4.2). [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 005
Year: 2002
Country: Singapore
Organisation: Not Available
Med. Spec. :
General Surgery
Type of Violation
Prescription of medicine
Details of Violation:
A medical practitioner pleaded guilty to over-prescribing Dormicum to three
of his non-surgical patients. The Disciplinary Committee was surprised that
as a general surgeon, he had agreed to treat these patients for insomnia and to
prescribe Dormicum to them. The Disciplinary Committee felt that he had
failed to exercise a higher standard of prudence and care expected of an
experienced surgeon. [32]
Adverse Event: Not Available
Guidelines
4.1.3 Prescription of medicine
A doctor may only prescribe medicines that are legally available in Singapore
and must comply with all the statutory requirements governing their use. A
doctor shall prescribe, dispense or supply medicines only on clear medical
grounds and in reasonable quantities as appropriate to the patient’s needs.
This includes prescription by a doctor for his own use. Patients shall be
appropriately informed about the purpose of the prescribed medicines,
contraindications and possible side effects. A doctor shall prescribe medicines
only following an adequate personal consultation and relevant investigations.
A decision to prescribe solely based on information provided by telephone or
any electronic means is allowable for continuing care, or for exceptional
situations where a patient’s best interests are being served by doing so. [32]
No. of Instances (if no number count as 10): 3
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CLINICAL VIOLATION DATA
Case ID: 006
Year: 2004
Country: Singapore
Organisation: Not Available
Med. Spec. :
General Practice
Type of Violation
Prescription of medicine
Details of Violation:
A medical practitioner pleaded guilty to 80 charges of inappropriate
prescription of Erimin and/or Dormicum and/or Stilnox and/or Valium to 80
patients over a period of time. The Disciplinary Committee (DC) found that
the practitioner had freely dispensed the hypnotic drugs, which were
addictive, to his patients without any regard to their health, interest, or harm
that might come to them. It was clear that the prescriptions were given
without regard to the medical conditions of the patients. There was little
evidence that he had thoroughly examined the patients before prescribing the
drugs. The practitioner's clinical notes did not record or document sufficient
details of the patients' diagnoses, symptoms and/or conditions, such as to
enable him or other doctors at the various clinics that these patients had
attended to properly assess the medical conditions of the patients over their
period of treatment. It was essentially a systematic prescription of hypnotic
drugs to the patients. The practitioner was the sole licensee of 7 clinics and
had several locum doctors working for him. The DC took a serious view of
the lack of control exercised in the treatment of the patients at these clinics.
[32]
Adverse Event: Not Available
Guidelines
4.1.3 Prescription of medicine
A doctor may only prescribe medicines that are legally available in Singapore
and must comply with all the statutory requirements governing their use. A
doctor shall prescribe, dispense or supply medicines only on clear medical
grounds and in reasonable quantities as appropriate to the patient’s needs.
This includes prescription by a doctor for his own use. Patients shall be
appropriately informed about the purpose of the prescribed medicines,
contraindications and possible side effects. A doctor shall prescribe medicines
only following an adequate personal consultation and relevant investigations.
A decision to prescribe solely based on information provided by telephone or
any electronic means is allowable for continuing care, or for exceptional
situations where a patient’s best interests are being served by doing so. [32]
No. of Instances (if no number count as 10): 80
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CLINICAL VIOLATION DATA
Case ID: 007
Year: 2004
Country: Singapore
Organisation: Not Available
Med. Spec. :
Neurosurgery
Type of Violation
Informed Consent
Details of Violation:
The medical practitioner was convicted of 1 charge of failing to obtain his
patient's informed consent for radiosurgery to treat a brain tumour. The
Disciplinary Committee (DC) held that whilst the practitioner explained the
risks of open surgery, in particular the risk of death, he did not explain to the
patient sufficiently the risks involved in radiosurgery. These were, namely,
that it might kill the surrounding cells, that it might not kill all the tumour
cells, that the tumour might grow again, and the likelihood that radiosurgery
might not succeed. He also did not explain to the patient that radiosurgery
was not a conventional or standard procedure at that time for the treatment of
the patient's tumour. [32]
Adverse Event: Not Available
Guidelines
4.2.2 Informed consent
It is a doctor’s responsibility to ensure that a patient under his care is
adequately informed about his medical condition and options for treatment so
that he is able to participate in decisions about his treatment. If a procedure
needs to be performed, the patient shall be made aware of the benefits, risks
and possible complications of the procedure and any alternatives available to
him. If the patient is a minor, or of diminished ability to give consent, this
information shall be explained to his parent, guardian or person responsible
for him for the purpose of his consent on behalf of the patient. [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 008
Year: 2005
Country: Singapore
Organisation: Not Available
Med. Spec. :
General Practice
Type of Violation
Comments about colleagues
Details of Violation:
A medical practitioner was convicted of 2 charges of distributing and/or
causing to be distributed advertising flyers containing material intended to
discredit a neighbouring clinic and its medical practitioners on 2 separate
occasions. The Disciplinary Committee (DC) accepted the evidence of the
handwriting expert, a Consultant Forensic Scientist, that the practitioner had
written the advertising flyers. They held that the practitioner's behaviour was
unprofessional, and amounted to conduct which was improper, and brought
disrepute to the medical profession. The DC opined that any reasonable
person reading the flyers would have concluded that they were circulated by
the neighbouring clinic and that the conduct of the doctors of this clinic was
disreputable and improper. [32]
Adverse Event: Not Available
Guidelines
4.3.3 Comments about colleagues
A doctor shall refrain from making gratuitous and unsustainable comments
which, whether expressly or by implication, set out to undermine the trust in a
professional colleague’s knowledge or skills. [32]
No. of Instances (if no number count as 10): 2
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CLINICAL VIOLATION DATA
Case ID: 009
Year: 2005
Country: Singapore
Organisation: Not Available
Med. Spec. :
Dermatology
Type of Violation
Delegation of duties
Details of Violation:
A medical practitioner pleaded guilty to 2 out of 3 charges of professional
misconduct. These 2 charges related to improper delegation to her nurse for a
procedure involving a Class 4 medical laser on 2 separate occasions. This was
in contravention of the licence issued to her by the Centre for Radiation
Protection (CRP), Health Sciences Authority (HSA). The DC held that the
practitioner’s breaches of Regulations 9(4) and 15 of the Radiation Protection
(Non Ionising Radiation) Act 1991 by the improper delegation of the use of
the laser to her nurse were serious offences. [32]
Adverse Event:
Guidelines
4.1.1.4 Delegation of duties
A doctor may delegate another doctor, nurse, medical student or other health
care worker to provide treatment or care on his behalf, but this person must be
competent to carry out the care or procedure required. A doctor retains
responsibility for the overall management of the patient when he delegates
care. If the person delegated to is not duly registered as a practitioner, this
must be in the context of a legitimate training programme and the doctor must
exercise effective supervision over this person. [32]
No. of Instances (if no number count as 10): 2
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CLINICAL VIOLATION DATA
Case ID: 010
Year: 2005
Country: Singapore
Med. Spec. :
Type of Violation
Organisation: Not Available
General Practice
Practise within competence and referral of
patients
Details of Violation:
A medical practitioner was convicted of 2 charges of professional
misconduct. The 1st charge alleged that he was in wilful neglect of his duties
and grossly mismanaged the treatment of his patient. The 1st charge alleged
that he was in wilful neglect of his duties and grossly mismanaged the
treatment of his patient. He failed to adequately assess the medical condition
of his patient and to refer him to hospital for further management of a serious
medical condition. i.e. appendicitis. The 2nd charge alleged that he failed to
keep proper medical records of the consultation with his patient. The DC held
that the practitioner’s abdominal examination was not adequately conducted
or documented. He had failed to take an adequate medical history and
examine the patient properly. The fact that the patient’s condition had not
improved despite earlier treatment by another general practitioner should
have alerted him that there could be a serious underlying condition that
merited a referral to the hospital. His professional conduct was deemed to be
dishonourable. The DC also found the practitioner’s medical record-keeping
inadequate. The clinical records of his consultation would not have enabled
another doctor to take over the management of this case. The DC held that
this was important since the practitioner was working as a locum at the clinic.
[32]
Adverse Event: Not Available
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Guidelines
4.1.1.6 Practise within competence and referral of patients
A doctor should practise within the limits of his own competence in
managing a patient. Where he believes that this is exceeded, he shall offer to
refer the patient to another doctor with the necessary expertise. A doctor shall
not persist in unsupervised practice of a branch of medicine without having
the appropriate knowledge and skill or having the required experience. Where
such a referral is transient, for example for a specialised investigation or
specific treatment modality, the doctor retains responsibility for the overall
management of the patient. A doctor shall continue to care for his patient
until the patient is properly handed over to the referred doctor. If a patient
refuses to see a specialist, the doctor shall counsel the patient adequately and
if he still refuses, it is allowable for that doctor to treat the patient in
consultation with a specialist.
4.1.2 Medical records
Medical records kept by doctors shall be clear, accurate, legible and shall be
made at the time that a consultation takes place, or not long afterwards.
Medical records shall be of sufficient detail so that any other doctor reading
them would be able to take over the management of a case. All clinical
details, investigation results, discussion of treatment options, informed
consents and treatment by drugs or procedures should be documented. [32]
No. of Instances (if no number count as 10): 2
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CLINICAL VIOLATION DATA
Case ID: 011
Year: 2005
Country: Singapore
Organisation: Not Available
Med. Spec. :
Obstetrics & Gynaecology
Type of Violation
Adequate clinical evaluation of patients
Details of Violation:
A medical practitioner faced 2 charges of professional misconduct. The first
charge alleged that he failed to deliver a standard of care appropriate to his
specialty by neglecting to perform an ultrasound scan on his patient to
determine the size of her fibroids before performing laparoscopic surgery.
The 2nd charge alleged that he failed to properly inform his patient the results
of laparoscopic surgery, hence giving his patient a false impression that the 2
fibroids he removed were the 2 fibroids that were identified in the patient’s
ultrasound scan report. [32]
Adverse Event: Not Available
Guidelines
4.1.1.1 Adequate clinical evaluation of patients
A doctor is expected to have a sense of responsibility for his patients and to
provide medical care only after an adequate assessment of a patient’s
condition through good history taking and appropriate clinical examination. If
treatment is suggested or offered to a patient without such personal
evaluation, the doctor must satisfy himself that he has sufficient information
available and that the patient’s best interest is being served. Such information
could be transmitted by voice, electronic or other means by a referring doctor.
Only in exceptional or emergency circumstances should a diagnosis or
treatment be offered without personal contact and without the intermediation
of a referring doctor. [32]
No. of Instances (if no number count as 10): 2
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CLINICAL VIOLATION DATA
Case ID: 012
Year: 2006
Country: Singapore
Organisation: Not Available
Med. Spec. :
Not Available
Type of Violation
Relationship with fellow doctors
Details of Violation:
A medical practitioner pleaded guilty to 5 charges of professional misconduct.
These charges were in respect of the statements that she made in a Business
Times article dated 2 July 2004 entitled “Flatter your Skin”. The following
statements made were in breach of Regulation 17 of the Medical Registration
Regulations read with Sections 4.3.1, 4.3.2, 4.3.3, 4.4.2 and 4.4.3.1 of the
SMC’s Ethical Code and Ethical Guidelines The practitioner did not make any
public withdrawal or apology for the offending remarks. The DC held that
remarks made about fellow practitioners especially in public, should not inter
alia, undermine the trust in a professional colleague’s knowledge of skills and
deprecate other practitioners. [32]
Adverse Event: Not Available
Guidelines
4.3 RELATIONSHIP WITH FELLOW DOCTORS
4.3.1 Collegiality
Doctors shall regard all fellow professionals as colleagues, treat them with
dignity, accord them respect, readily share relevant information about patients
in patients’ best interests and manage those under their supervision with
professionalism, care and nurturing.
4.3.2 Respect for other doctors’ patients
A doctor must not attempt to profit at the expense of professional colleagues
by canvassing or touting for patients, improper advertising or deprecation of
other practitioners.
4.3.3 Comments about colleagues
A doctor shall refrain from making gratuitous and unsustainable comments
which, whether expressly or by implication, set out to undermine the trust in a
professional colleague’s knowledge or skills.
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Guidelines (continued)
4.4.2 Standards required of information In general, doctors may provide
information about their qualifications, areas of practice, practice arrangements
and contact details. Such information,where permitted, shall have the
following standards:
a. Factual
f. Not sensational
b. Accurate
g. Not persuasive
c. Verifiable
h. Not laudatory
d. No extravagant claims
i. Not comparative
e. Not misleading
j. Not disparaging
4.4.3.1 Public speaking, broadcasting and writing All information, whether to
fellow doctors or the public must conform to the above standards. This
includes information given in the context ofeducation for doctors or the public,
in talks, broadcasts and seminars organised by professional bodies or
healthcare institutions, or in professional journals. However, unsolicited
information that doctors put or allow to be put into the public domain must
come with added responsibility not to be persuasive, laudatory or misleading.
Articles in the press and media that feature doctors shall also conform to the
standards stated above. While it is laudable for doctors to educate the public
on healthcare issues through speaking, writing and broadcasting to the public,
they shall restrict their material content to the medical topic at hand. A doctor
must ensure that he does not encroach into the area of encouraging the public
to seek consultation or treatment from him or the organisation he is associated
with by publishing detailed service or contact details. Only the doctor’s name,
registered field of practice and place of practice may be mentioned in such
instances. Doctors are responsible for their public statements and for ensuring
that journalists do not breach these standards in reporting about them. Doctors
must ensure that press and media reports based on interviews with them are
primarily for public education. In addition, images used to illustrate medical
procedures or treatments or their outcomes can legitimately be used in
educational talks organised by professional bodies or healthcare institutions, or
in professional journals. However such images must be used much more
judiciously in the public media, where they could be deemed to be laudatory of
the doctor named. Hence any images used in the general media must not be
related to identifiable doctors or their patients either directly or by inference.
Where a doctor writes articles or columns or participates in broadcasts which
offer advice in response to public queries on particular subjects, the guidelines
on good clinical care and the establishment of a proper doctor patient
relationship apply (4.1.1).
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Guidelines (continued)
After public talks, if members of the public subsequently personally approach
speakers for information about themselves and their services, such information
may be provided only on request and must conform to the standards on
information provision described above (4.4.2). [32]
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CLINICAL VIOLATION DATA
Case ID: 013
Year: 2007
Country: Singapore
Organisation: Not Available
Med. Spec. :
General Practice
Type of Violation
Medical record
Details of Violation:
A medical practitioner faced 19 charges of inappropriate management in that
he failed to formulate and adhere to any treatment plan for Subutex treatment,
and to maintain proper medical records.
The Disciplinary Committee (DC) did not accept the practitioner’s
proposition that he had a punitive management plan, and that even if it
existed, was highly unorthodox, and as the Expert stated in his evidence, it
was unlikely to have any effect on the patients’ addiction. The DC also did
not accept the practitioner’s excuse that it was difficult for a sole practitioner
to keep “a fully documented record of each and every patient”. [32]
Adverse Event: Not Available
Guidelines
4.1.2 Medical records
Medical records kept by doctors shall be clear, accurate, legible and shall be
made at the time that a consultation takes place, or not long afterwards.
Medical records shall be of sufficient detail so that any other doctor reading
them would be able to take over the management of a case. All clinical
details, investigation results, discussion of treatment options, informed
consents and treatment by drugs or procedures should be documented. [32]
No. of Instances (if no number count as 10): 19
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CLINICAL VIOLATION DATA
Case ID: 014
Year: 2008
Country: Singapore
Med. Spec. :
Type of Violation
Organisation: Not Available
Ophthalmology
Practise within competence and referral of
patients
Details of Violation:
The case concerned a prematurely delivered infant with extremely low birth
weight who was admitted to the Neonatal Intensive Care Unit and received
into the paediatrician’s care. The practitioner noticed a possible squint in the
left eye of the infant and referred the infant to a paediatric ophthalmologist
for the first time about 7 months after the birth of the infant and 4½ months
after the infant was discharged from the NICU. The infant was subsequently
diagnosed by a paediatric ophthalmologist to be suffering from Stage 5
Retinopathy of Prematurity in the left eye (total retina detachment) and Stage
4 ROP in the right eye (partial retina detachment). The infant had no vision in
the left eye and very low vision in the right eye. The DC heard evidence from
two medical experts on the long standing standard practice of referring a
severely premature and extremely low birth weight baby for ROP screening.
The medical experts stated that at the relevant time, the standard practice was
to refer such a baby within 4 to 6 weeks after birth or at 31 to 34 weeks of
calculated gestation age, whichever is later. They opined that in the
circumstances of this case, the practitioner should have referred the infant for
ROP screening much earlier as is standard practice and not 5 months
thereafter. Had the infant been referred much earlier, the loss of vision could
have been prevented. The DC was deeply concerned that the practitioner’s
defence rested on an assessment, which was possibly flawed, which ignored
several clinical features of great significance. The DC found the practitioner’s
management contrary to what they would have expected of a Paediatrician
managing a pre-term, extremely low birth weight neonate in Singapore at the
time this patient was presented. The patient’s handicap was severe as a result.
[32]
Adverse Event:
The infant was subsequently diagnosed by a paediatric ophthalmologist to be
suffering from Stage 5 Retinopathy of Prematurity in the left eye (total retina
detachment) and Stage 4 ROP in the right eye (partial retina detachment). The
infant had no vision in the left eye and very low vision in the right eye.
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Guidelines
4.1.1.6 Practise within competence and referral of patients
A doctor should practise within the limits of his own competence in
managing a patient. Where he believes that this is exceeded, he shall offer to
refer the patient to another doctor with the necessary expertise. A doctor shall
not persist in unsupervised practice of a branch of medicine without having
the appropriate knowledge and skill or having the required experience. Where
such a referral is transient, for example for a specialised investigation or
specific treatment modality, the doctor retains responsibility for the overall
management of the patient. A doctor shall continue to care for his patient
until the patient is properly handed over to the referred doctor. If a patient
refuses to see a specialist, the doctor shall counsel the patient adequately and
if he still refuses, it is allowable for that doctor to treat the patient in
consultation with a specialist. [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 015
Year: 2008
Country: Singapore
Organisation: Not Available
Med. Spec. :
Not Available
Type of Violation
Prescription of medicine
Details of Violation:
A medical practitioner pleaded guilty to 2 charges of professional misconduct
under section 45(1)(d) of the MRA in relation to a patient. T h e f irst charge
was f o r ( i ) inappropriately prescribing the wrong dosage of 0.25 mg
digoxin daily when she knew or ought to have known that the correct dosage
was 0.0625 mg daily; (ii) failure to schedule the patient for review within 1 to
2 weeks despite the increase in the digoxin dosage prescribed at 0.25 mg
daily to the Patient; (iii) failure to take reasonable steps to ensure that 0.0625
mg digoxin per day was prescribed to the patient (she did not amend the
prescription or issue a new prescription to the pharmacist or pharmacists
before the digoxin was dispensed); (iv) failure to make any note of any verbal
instructions to the pharmacy in the patient’s case notes in respect of the
amended prescription and (v) making the wrong amendment or correction on
the patient’s case notes from 0.25 mg to 0.625 mg even after discovering the
error in her prescription. The second charge was for failure to review the
patient’s International Normalization Ratio (“INR”) in an expeditious and
timely manner after increasing the patient’s dosage of warfarin. [32]
Adverse Event: Not Available
Guidelines
4.1.3 Prescription of medicine
A doctor may only prescribe medicines that are legally available in Singapore
and must comply with all the statutory requirements governing their use.A
doctor shall prescribe, dispense or supply medicines only on clear medical
grounds and in reasonable quantities as appropriate to the patient’s needs.This
includes prescription by a doctor for his own use. Patients shall be
appropriately informed about the purpose of the prescribed medicines,
contraindications and possible side effects. A doctor shall prescribe medicines
only following an adequate personal consultation and relevant investigations.
A decision to prescribe solely based on information provided by telephone or
any electronic means is allowable for continuing care, or for exceptional
situations where a patient’s best interests are being served by doing so. [32]
No. of Instances (if no number count as 10): 2
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CLINICAL VIOLATION DATA
Case ID: 016
Year: 2008
Country: Singapore
Organisation: Not Available
Med. Spec. :
Ophthalmology
Type of Violation
Informed consent
Details of Violation:
An ophthalmologist claimed trial to the following charges that he (i)
recommended glaucoma drainage surgery to his patient to reduce the high
intraocular pressure in the right eye for the purposes of alleviating the pain
and headaches when he knew or ought to have known that it was not the
appropriate treatment; and (ii) did perform glaucoma drainage surgery on his
patient without informing him of all treatment and surgical options available
and without explaining to him all the risks, side-effects and nature of the
surgery. [32]
Adverse Event: Not Available
Guidelines
4.2.2 Informed consent
It is a doctor’s responsibility to ensure that a patient under his care is
adequately informed about his medical condition and options for treatment so
that he is able to participate in decisions about his treatment. If a procedure
needs to be performed, the patient shall be made aware of the benefits, risks
and possible complications of the procedure and any alternatives available to
him. If the patient is a minor, or of diminished ability to give consent, this
information shall be explained to his parent, guardian or person responsible
for him for the purpose of his consent on behalf of the patient. [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 017
Year: 2009
Country: Singapore
Organisation: Not Available
Med. Spec. :
General Practice
Type of Violation
Standards required of information
Details of Violation:
A general practitioner pleaded guilty to 2 charges which arose from his
breaches of Section 65(1)(a) and Section 65(1)(b) of the Medical Registration
Act (MRA) read with Section 4.4.2 of the SMC Ethical Code and Ethical
Guidelines (ECEG). The first charge was in respect of the practitioner falsely
assuming the title of specialist and/or consultant in the practice of plastic
surgery or cosmetic surgery. The Disciplinary Committee (DC) took a serious
view of this breach as the MRA clearly provides that a medical practitioner
must obtain a certificate from the specialists Accreditation Board (“SAB”)
certifying inter alia, that the medical practitioner has completed and obtained
the requisite qualifications and training before the said medical practitioner
can be registered as a specialist and assume the title of a specialist and/or
practise medicine under a recognised specialty. T h e DC n o t e d t h a t wh i
l e t h e practitioner was registered as a medical practitioner with the SMC, he
had not obtained such prescribed specialty training or qualifications. As such,
he was not accredited by the SAB for the purposes of specialist registration
in Singapore, nor did he obtain any specialist registration in the United
Kingdom (UK), as he would like his patients to believe. However, when
queried by members of the public on his training and accreditation, the
practitioner did not clarify that he was not accredited as a specialist and had,
instead, provided information which portrayed himself as a specialist.
Further, the practitioner had declared his area of specialty as “Cosmetic Surge
ry” even though cosme t i c surgery was not a specialty recognised by SAB,
and also claimed that his area of practice was “Private Specialist” in his
membership application form submitted to the Singapore Medical
Association. The law clearly states that a registered medical practitioner
should not hold himself out to be a specialist unless he has obtained the
relevant accreditation from the appropriate governing body, in this case, the
SAB. Further, based on the evidence, the DC was of the opinion that it was
not a simple oversight on the practitioner’s part but, rather, that he
systematically set out to create a false impression of his qualifications and
experience. [32]
Adverse Event: Not Available
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Guidelines
4.4.2 Standards required of information
In general, doctors may provide information about their qualifications, areas
of practice, practice arrangements and contact details. Such information,
where permitted, shall have the following standards:
a.
Factual
b.
Accurate
c.
Verifiable
d.
No extravagant claims
e.
Not misleading
f.
Not sensational
g.
Not persuasive
h.
Not laudatory
i.
Not comparative
j.
Not disparaging
[32]
No. of Instances (if no number count as 10): 2
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CLINICAL VIOLATION DATA
Case ID: 018
Year: 2009
Country: Singapore
Med. Spec. :
Type of Violation
Organisation: Not Available
General practice
Practise within competence and referral of
patients
Details of Violation:
A general practitioner faced two charges; the first charge related to his
misrepresentation to a patient that he was a fully-trained and accredited
specialist plastic surgeon and the second charge related to a liposuction
procedure he performed on the patient. On the first charge, which the
practitioner denied, the DC found that the charge had been proven beyond
reasonable doubt and that the practitioner had misrepresented to the patient,
orally and through the information posted on his website, that he was a fullytrained and accredited specialist plastic surgeon. Thus, the practitioner was
guilty of contravening Section 65 of the MRA. The DC noted that the
practitioner had, during a consultation with the patient, discussed the work
and prices of other plastic surgeons to whom the practitioner compared
himself. The DC found that the practitioner had told the patient of his
overseas training and work experiences, that he was trained in “Cosmetic
Surgery” and of his Consultant appointment in “Cambridge”. However, at no
time did he tell the patient that he was not a plastic surgeon. In respect of the
second charge, the practitioner was charged with professional misconduct
under Section 45(1)(d) of the MRA in carrying out a liposuction procedure on
the patient. [32]
Adverse Event:
Arising from the liposuction procedure, the patient was left with deformities
and scars.
Guidelines
4.1.1.6 Practise within competence and referral of patients
A doctor should practise within the limits of his own competence in
managing a patient. Where he believes that this is exceeded, he shall offer to
refer the patient to another doctor with the necessary expertise. A doctor shall
not persist in unsupervised practice of a branch of medicine without having
the appropriate knowledge and skill or having the required experience. Where
such a referral is transient, for example for a specialised investigation or
specific treatment modality, the doctor retains responsibility for the overall
management of the patient. A doctor shall continue to care for his patient
until the patient is properly handed over to the referred doctor. If a patient
refuses to see a specialist, the doctor shall counsel the patient adequately and
if he still refuses, it is allowable for that doctor to treat the patient in
consultation with a specialist. [32]
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No. of Instances (if no number count as 10): 2
CLINICAL VIOLATION DATA
Case ID: 019
Year: 2005
Country: Singapore
Organisation: Gleneagles Hospital
Med. Spec. :
Haematology
Type of Violation
Adequate clinical evaluation of patients
Details of Violation:
In February 2005, a patient suffering from lymphoma c o n s u l t e d t h e
practitioner. Although it was the usual practice to test lymphoma patients for
Hepatitis-B serology prior to administering chemotherapy on such patients,
the practitioner failed to do so before administering chemotherapy to the
patient between February and April 2005. In May 2005, the patient was tested
and diagnosed to have Hepatitis-B. The patient was hospitalised at Gleneagles
Hospital. The practitioner discharged the patient although it was a serious
condition that was potentially life-threatening. The patient subsequently
passed away in May 2005, with the cause of death being certified as
Hepatitis-B with Non Hodgkin’s Lymphoma as a contributing condition. [32]
Adverse Event:
The patient was tested and diagnosed to have Hepatitis-B. The patient was
hospitalised at Gleneagles Hospital. The practitioner discharged the patient
although it was a serious condition that was potentially life-threatening. The
patient subsequently passed away in May 2005, with the cause of death being
certified as Hepatitis-B with Non Hodgkin’s Lymphoma as a contributing
condition.
Guidelines
4.1.1.1 Adequate clinical evaluation of patients
A doctor is expected to have a sense of responsibility for his patients and to
provide medical care only after an adequate assessment of a patient’s
condition through good history taking and appropriate clinical examination. If
treatment is suggested or offered to a patient without such personal
evaluation, the doctor must satisfy himself that he has sufficient information
available and that the patient’s best interest is being served. Such information
could be transmitted by voice, electronic or other means by a referring doctor.
Only in exceptional or emergency circumstances should a diagnosis or
treatment be offered without personal contact and without the intermediation
of a referring doctor. [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 020
Year: 1999
Country: Singapore
Organisation: Not Available
Med. Spec. :
Orthopaedic Surgery
Type of Violation
Informed Consent
Details of Violation:
An orthopaedic surgeon faced 2 charges in relation to his treatment of his
patient; the first charge being that he performed the surgery for the excision
of a fibromatous lesion of about 2 cm in diameter on the left sole of the
patient, without sufficiently explaining to the patient the risk of nerve damage
to the plantar nerve of the patient’s left sole, and thereby failed to obtain the
informed consent of the patient for the surgery. The second charge was that
the practitioner performed the surgery for the excision of the fibromatous
lesion under local anaesthesia (“LA”), when he knew or ought to have known
that the surgery should have been performed under general anaesthesia
(“GA”). [32]
Adverse Event:
Nerve damage to the plantar nerve of the patient’s left sole
Guidelines
4.2.2 Informed consent
It is a doctor’s responsibility to ensure that a patient under his care is
adequately informed about his medical condition and options for treatment so
that he is able to participate in decisions about his treatment. If a procedure
needs to be performed, the patient shall be made aware of the benefits, risks
and possible complications of the procedure and any alternatives available to
him. If the patient is a minor, or of diminished ability to give consent, this
information shall be explained to his parent, guardian or person responsible
for him for the purpose of his consent on behalf of the patient. [32]
No. of Instances (if no number count as 10): 2
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CLINICAL VIOLATION DATA
Case ID: 021
Year: 2009
Country: Singapore
Organisation: Not Available
Med. Spec. :
General surgery
Type of Violation
Delegation of duties
Details of Violation:
The nurses were given full autonomy, such that they were able to administer
and dispense medication (including benzodiazepines) without the requirement
for a medical consultation or a doctor’s written instructions. It was found that
the practitioner had presumed that the nurses would supply the diazepam only
after the patient had seen him. However, the practitioner took no steps to
check whether the patient had been given diazepam. After seeing the patient,
the practitioner did not give instructions for the diazepam to be administered,
assuming that it would be done. [32]
Adverse Event: Not Available
Guidelines
4.1.1.4 Delegation of duties
A doctor may delegate another doctor, nurse, medical student or other health
care worker to provide treatment or care on his behalf, but this person must be
competent to carry out the care or procedure required. A doctor retains
responsibility for the overall management of the patient when he delegates
care. If the person delegated to is not duly registered as a practitioner, this
must be in the context of a legitimate training programme and the doctor must
exercise effective supervision over this person. [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 022
Year: 2009
Country: Singapore
Organisation: Not Available
Med. Spec. :
Dermatology
Type of Violation
Untested practices and clinical trials
Details of Violation:
A plastic surgeon was charged with offering to and performing on his
patients, cell therapy involving the injection of xenogenic (animal) foetal cells
into humans (“Cell Therapy”) for anti-ageing and rejuvenation purposes, a
procedure that was not generally accepted by the medical profession, outside
the context of a formal and approved clinical trial. [32]
Adverse Event: Not Available
Guidelines
4.1.4 Untested practices and clinical trials
A doctor shall treat patients according to generally accepted methods and use
only licensed drugs for appropriate indications. A doctor shall not offer to
patients, management plans or remedies that are not generally accepted by the
profession, except in the context of a formal and approved clinical trial. A
doctor who participates in clinical research must put the care and safety of
patients first. If a doctor wishes to enter a patient into a clinical trial, he must
ensure that the trial is approved by an ethics committee and conforms to the
Good Clinical Practice Guidelines. In addition, informed consent must be
obtained from the patient. It is not acceptable to experiment or authorise
experiments or research which are not part of a formal clinical trial and which
are not primarily part of treatment or in the best interest of the patient, or
which could cause undue suffering or threat to the life of a patient. [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 023
Year: 2007
Country: Singapore
Med. Spec. :
Type of Violation
Organisation: Not Available
General Practice
Responsibility
to
maintain
confidentiality
medical
Details of Violation:
Sometime in 2007, 2 photographs of the patient, taken in the course of the
patient’s treatment, were published in a local magazine without the patient’s
consent. This resulted in a complaint by the patient against the practitioner.
The practitioner pleaded guilty to (i) a charge of having breached his
responsibility to maintain medical confidentiality in respect of the patient, by
disclosing or allowing the disclosure of two photographs taken by him
without the patient’s consent. [32]
Adverse Event: Not Available
Guidelines
4.2.3.1 Responsibility to maintain medical confidentiality
A doctor shall respect the principle of medical confidentiality and not disclose
without a patient’s consent, information obtained in confidence or in the
course of attending to the patient. However, confidentiality is not absolute. It
may be over-ridden by legislation, court orders or when the public interest
demands disclosure of such information. An example is national disease
registries which operate under a strict framework which safeguards medical
confidentiality. There may be other circumstances in which a doctor decides
to disclose confidential information without a patient’s consent. When he
does this, he must be prepared to explain and justify his decision if asked to
do so. A doctor is expected to take steps to ensure that the means by which he
communicates or stores confidential medical information about patients are
secure and the information is not accessible to unauthorised persons. This is
particularly relevant to sending or storing medical information by electronic
means, via a website or by email. [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 024
Year: 2006
Country: Singapore
Organisation: Not Available
Med. Spec. :
Neurosurgery
Type of Violation
Untested practices and clinical trials
Details of Violation:
A neurologist treated his patient, from 15-18 August 2006 with repetitive
transcranial magnetic stimulation (“rTMS”) and Therapeutic Ultrasound on
his patient for treatment of her medical condition. . The practitioner had,
through a review of the use of diagnostic ultrasound in obstetric and
neurological practice, concluded that Therapeutic Ultrasound (as used by
physiotherapists) could also be reasonably applied to treatment of
neurological diseases of the brain. The DC noted that, as the safety of patients
or “do no harm” is a cardinal principle for doctors, it was incumbent on the
practitioner to satisfy the DC that the application of Therapeutic Ultrasound
on the brain was safe on patients, a burden which he failed to discharge. The
DC found that there was neither experimental evidence nor physical proof of
the safety of this modality on the human brain. Accordingly, the DC found
that the practitioner ’s use of Therapeutic Ultrasound was not generally
accepted by the medical profession and not an appropriate treatment for the
medical condition of the patient. [32]
Adverse Event: Not Available
Guidelines
4.1.4 Untested practices and clinical trials
A doctor shall treat patients according to generally accepted methods and use
only licensed drugs for appropriate indications. A doctor shall not offer to
patients, management plans or remedies that are not generally accepted by the
profession, except in the context of a formal and approved clinical trial. A
doctor who participates in clinical research must put the care and safety of
patients first. If a doctor wishes to enter a patient into a clinical trial, he must
ensure that the trial is approved by an ethics committee and conforms to the
Good Clinical Practice Guidelines. In addition, informed consent must be
obtained from the patient. It is not acceptable to experiment or authorise
experiments or research which are not part of a formal clinical trial and which
are not primarily part of treatment or in the best interest of the patient, or
which could cause undue suffering or threat to the life of a patient. [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 025
Year: 2007
Country: India
Organisation: Not Available
Med. Spec. :
Obstetrics & Gynaecology
Type of Violation
Delegation of duties
Details of Violation:
Dhileepan Raj successfully performed a Caesarean section under the watchful
eyes of his doctor-parents. The proud father, Dr Murugesan, played a video of
his lad at work to shocked colleagues at a medical meeting. [32]
Adverse Event: Not Available
Guidelines
4.1.1.4 Delegation of duties
A doctor may delegate another doctor, nurse, medical student or other health
care worker to provide treatment or care on his behalf, but this person must be
competent to carry out the care or procedure required. A doctor retains
responsibility for the overall management of the patient when he delegates
care. If the person delegated to is not duly registered as a practitioner, this
must be in the context of a legitimate training programme and the doctor must
exercise effective supervision over this person. [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 026
Year: 2005
Country: Australia
Med. Spec. :
Type of Violation
Organisation: Not Available
General Surgery
Practise within competence and referral of
patients
Details of Violation:
Indian-trained Dr Jayant Patel operated on 867 patients in the country town
of Bundaberg between 2003 and 2005. Amongst the 87 who died, some
appear to be victims of gross incompetence. Dr Patel came to Australia from
the US, where he had been banned from practising in New York and found
guilty of gross negligence in Oregon. Working in a country hospital with a
tight budget, a shortage of hospital beds and a scarcity of doctors, he managed
to bluff his way through. Somehow his atrocious record was overlooked by
hospital management and he stifled complaints from staff with a combination
of bullying and apparent productivity. [32]
Adverse Event: Death
Guidelines
4.1.1.6 Practise within competence and referral of patients
A doctor should practise within the limits of his own competence in
managing a patient. Where he believes that this is exceeded, he shall offer to
refer the patient to another doctor with the necessary expertise. A doctor shall
not persist in unsupervised practice of a branch of medicine without having
the appropriate knowledge and skill or having the required experience. Where
such a referral is transient, for example for a specialised investigation or
specific treatment modality, the doctor retains responsibility for the overall
management of the patient. A doctor shall continue to care for his patient
until the patient is properly handed over to the referred doctor. If a patient
refuses to see a specialist, the doctor shall counsel the patient adequately and
if he still refuses, it is allowable for that doctor to treat the patient in
consultation with a specialist. [32]
No. of Instances (if no number count as 10): 87
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CLINICAL VIOLATION DATA
Case ID: 027
Year: 2008
Country: India
Organisation: Not Available
Med. Spec. :
Not Available
Type of Violation
Financial conflicts in clinical practice
Details of Violation
Dr. Amit Kumar was found to be running a sizeable racket in live kidneys. He
is accused of luring poor laborers to his "hospital" in the New Delhi suburb of
Gurgaon with promises of job offers or large sums of money. Typically, they
were promised 300,000 rupees (US$7,500) but paid only 30,000 ($750) after
the surgery, iolation. [32]
Adverse Event: Not Available
Guidelines
4.6.2 Financial conflicts in clinical practice
A doctor shall refrain from:
a. Improperly obtaining money from patients
b. Improperly prescribing drugs or appliances in which he has a financial
interest
c. Fee sharing or obtaining commissions from referral of patients [32]
No. of Instances (if no number count as 10): 10
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CLINICAL VIOLATION DATA
Case ID: 028
Year: 2008
Country: Australia
Organisation: Monash IVF
Med. Spec. :
Obstetrics & Gynaecology
Type of Violation
Informed consent
Details of Violation:
The unnamed couple claim that Monash IVF promised to use preimplantation genetic diagnosis to screen out a cancer gene carried by the
mother. Of eight embryos, six were discarded as defective and two were
cleared for implantation. However, three months after the birth, they
discovered that the child had the gene. [32]
Adverse Event: Congenital anomaly in offspring
Guidelines
4.2.2 Informed consent
It is a doctor’s responsibility to ensure that a patient under his care is
adequately informed about his medical condition and options for treatment so
that he is able to participate in decisions about his treatment. If a procedure
needs to be performed, the patient shall be made aware of the benefits, risks
and possible complications of the procedure and any alternatives available to
him. If the patient is a minor, or of diminished ability to give consent, this
information shall be explained to his parent, guardian or person responsible
for him for the purpose of his consent on behalf of the patient. [32]
No. of Instances (if no number count as 10): 1
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CLINICAL VIOLATION DATA
Case ID: 029
Year: 2007
Country: China
Organisation: Beijing Xishan Hospital
Med. Spec. :
Neurosurgery
Type of Violation
Untested practices and clinical trials
Details of Violation:
Huang Hongyun, of Beijing Xishan Hospital, has treated hundreds of patients
with foetal cells from the olfactory bulb, which links the nose to the brain. He
charges for treatment, even though Western experts who examined some of
his patients say that none had shown significant improvement. [32]
Adverse Event: Not Available
Guidelines
4.1.4 Untested practices and clinical trials
A doctor shall treat patients according to generally accepted methods and use
only licensed drugs for appropriate indications. A doctor shall not offer to
patients, management plans or remedies that are not generally accepted by the
profession, except in the context of a formal and approved clinical trial. A
doctor who participates in clinical research must put the care and safety of
patients first. If a doctor wishes to enter a patient into a clinical trial, he must
ensure that the trial is approved by an ethics committee and conforms to the
Good Clinical Practice Guidelines. In addition, informed consent must be
obtained from the patient. It is not acceptable to experiment or authorise
experiments or research which are not part of a formal clinical trial and which
are not primarily part of treatment or in the best interest of the patient, or
which could cause undue suffering or threat to the life of a patient. [32]
No. of Instances (if no number count as 10): 10
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CLINICAL VIOLATION DATA
Case ID: 030
Year: 2004
Country: China
Organisation: No. 454 People's Liberation
Army Hospital in Nanjing
Neurosurgery
Informed Consent
Med. Spec. :
Type of Violation
Details of Violation:
Since 2004, Wang Yifang, of the No. 454 People's Liberation Army Hospital
in Nanjing, has drilled into the skulls of nearly 1,000 patients and burnt small
areas of brain tissue. . Pre-surgical tests are minimal; post-surgical follow-up
is almost non-existent. Informed consent is dubious. [32]
Adverse Event: Permanent total disability
Guidelines
4.2.2 Informed consent
It is a doctor’s responsibility to ensure that a patient under his care is
adequately informed about his medical condition and options for treatment so
that he is able to participate in decisions about his treatment. If a procedure
needs to be performed, the patient shall be made aware of the benefits, risks
and possible complications of the procedure and any alternatives available to
him. If the patient is a minor, or of diminished ability to give consent, this
information shall be explained to his parent, guardian or person responsible
for him for the purpose of his consent on behalf of the patient. [32]
No. of Instances (if no number count as 10): 1000
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CLINICAL VIOLATION DATA
Case ID: 031
Year: 2005
Country: India
Organisation: Nu Tech Mediworld
Med. Spec. :
Neurosurgery
Type of Violation
Untested practices and clinical trials
Details of Violation:
Dr Geeta Shroff, who runs a genetic research laboratory, is using embryonic
stem cells to treat conditions ranging from spinal cord injury to motor neuron
disease to Alzheimer's and Parkinson's disease. [32]
Adverse Event: Not Available
Guidelines
4.1.4 Untested practices and clinical trials
A doctor shall treat patients according to generally accepted methods and use
only licensed drugs for appropriate indications. A doctor shall not offer to
patients, management plans or remedies that are not generally accepted by the
profession, except in the context of a formal and approved clinical trial. A
doctor who participates in clinical research must put the care and safety of
patients first. If a doctor wishes to enter a patient into a clinical trial, he must
ensure that the trial is approved by an ethics committee and conforms to the
Good Clinical Practice Guidelines. In addition, informed consent must be
obtained from the patient. It is not acceptable to experiment or authorise
experiments or research which are not part of a formal clinical trial and which
are not primarily part of treatment or in the best interest of the patient, or
which could cause undue suffering or threat to the life of a patient [32]
No. of Instances (if no number count as 10): 10
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CLINICAL VIOLATION DATA
Case ID: 032
Year: 2008
Country: India
Organisation: Not Available
Med. Spec. :
Obstetrics & Gynaecology
Type of Violation
Non discrimination of patients
Details of Violation:
High-caste" doctors at a hospital in Uttar Pradesh, including the chief medical
superintendent, refused to treat an "untouchable" woman. [32]
Adverse Event:
Maya Devi gave birth in a corridor outside the maternity ward, but the child
died soon afterwards and Maya Devi, went into a coma. The head of
gynaecology at the hospital was called and she rushed back to treat her. It was
too late; Ms Devi also died.
Guidelines
4.1.7.1 Non discrimination of patients
A doctor is obliged to provide access to medical care and treat patients
without prejudice of race, religion, creed, social standing, disability or
socioeconomic status. A doctor shall not allow his personal beliefs to
influence his management of his patients. Where a doctor feels unable to
continue his care for a patient due to such beliefs, the patient should be
referred to another doctor who is able and willing to care for the patient. An
example of such a situation is a request for an abortion. [32]
No. of Instances (if no number count as 10): 1
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Appendix 5: Disciplinary
Inquiries 2001 - 2009
Source: Singapore Medical Council Annual Reports 2001 - 2009
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Disciplinary Inquiries held in 2001
There were 10 disciplinary inquiries completed in 2001 under the Medical
Registration Act 1997. A brief account of each case is given below.
Sexual relationship with patient
Case 1:
A medical practitioner was charged for having a sexual relationship with his patient.
The complainant subsequently withdrew his complaint prior to the start of the
disciplinary hearing. The Disciplinary Committee (DC) after hearing the submissions
of both counsels and the advice of the DC’s legal assessor, arrived at the conclusion
that it had no power under Medical Registration Act 1997 to proceed with the inquiry
since the complaint had been withdrawn. The medical practitioner was accordingly
discharged.
Improper conduct
Case 2:
A medical practitioner was charged for having deliberately misrepresented himself as
another person and deceived a woman into entering into a sexual relationship with
him.
The Disciplinary Committee (DC) was of the view that there was some doubt as to the
actual representations that the medical practitioner was said to have made to the
complainant. The DC was unable to conclude that the sexual relationship would not
have occurred, but for the misrepresentations that the doctor was alleged to have
made.
On review of the evidence before the DC, they were not satisfied that the ingredients
of the charge had been established and acquitted the doctor of the charge.
Case 3:
A medical practitioner was charged for having practised traditional Chinese medicine
when he was not formally trained to do so and for having prescribed herbal medicine
to his patient.
The prosecution had no evidence to show what the prescribed medicine was, as the
complainant was unable to produce the bottle of “herbal” mixture prescribed. In view
of this, the Disciplinary Committee could not conclude that the medical practitioner
had practised traditional Chinese medicine. The medical practitioner was accordingly
acquitted of the charge.
Outrage of modesty
Case 4:
The medical practitioner was charged for using force on his patient with intent to
outrage her modesty in the course of performing a procedure.
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The Disciplinary Committee (DC), after hearing evidence from an expert witness, felt
that the medical practitioner had taken steps to ensure that the procedure was properly
carried out. The DC was of the opinion that some of the complainant’s perceptions
were probably misconceived and that her sensitivity had most probably led her to
believe that the medical practitioner had taken advantage of her. The DC was of the
view that the charges had not been proved and the medical practitioner was
accordingly acquitted.
Case 5:
A medical practitioner was charged that while performing an internal pelvic
examination on his patient, without a proper chaperone, he had touched the genitals of
the patient in an unprofessional manner which caused discomfort and embarrassment
to the patient.
The Disciplinary Committee accepted the expert opinion that in the conduct of an
internal pelvic examination, it was possible for the medical practitioner to brush the
genitals of a patient.
The medical practitioner’s nurse also testified that she was in the examination room
when the medical practitioner examined the patient.
The Disciplinary Committee acquitted the medical practitioner as the charge against
him had not been proven by the prosecution beyond a reasonable doubt.
Failure to detect pregnancy in a foreign domestic worker
Case 6:
A medical practitioner was charged that he acted in serious disregard of his
professional responsibilities by certifying to the Work Permit Department that the
pregnancy screening he had conducted for a Foreign Domestic Worker was negative,
when in fact, she was in a state of pregnancy. In relation to the facts alleged, he had
been guilty of professional misconduct.
The medical practitioner pleaded guilty to the charge. He was censured, fined a sum
of $5000, ordered to give an undertaking to abstain in future from the conduct
complained of, and to pay the costs of the proceedings.
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Case 7:
A medical practitioner was charged for acting in serious disregard of his professional
responsibilities by certifying to the Work Permit Department that he had examined a
Foreign Domestic Worker (FDW) and that the pregnancy screening he conducted on
her was negative, when he had failed and/ or neglected to properly verify that the
person he examined was indeed the FDW that he was supposed to examine. The FDW
that he was supposed to examine was in fact in an advanced state of pregnancy.
The medical practitioner pleaded guilty to the charge. He admitted that he did not
verify that the FDW he examined was indeed the person he was supposed to examine
as she was unable to produce either her passport or her Work Permit when requested
to do so by his clinic assistant. The medical practitioner was censured, ordered to give
an undertaking not to repeat the conduct complained of and to pay the costs of the
proceedings.
Case 8:
A medical practitioner was charged and found guilty for acting in serious disregard of
her professional responsibilities by certifying to the Work Permit Department that the
pregnancy screening for a Foreign Domestic Worker (FDW) was negative when in
fact, she was in a state of pregnancy.
The Disciplinary Committee heard evidence that the medical practitioner had relied
solely on the report of her staff for the result of the urine test. The Committee was of
the view that it was insufficient to depend on a hearsay report. They ruled that she had
a professional responsibility to interpret the results by checking the urine test result
before she made a certification to the Ministry of Manpower.
The medical practitioner was censured, fined a sum of $5000, ordered to give an
undertaking not to repeat the offence complained of and to pay the costs of the
proceedings. Conviction in court for offence under the Private Hospitals & Medical
Clinics Act
Case 9:
A medical practitioner was charged that being a person having management and
control of the clinic, he had allowed it to be used for cosmetic skin treatment and
programmes in breach of the conditions of the licence prescribed by the Ministry of
Health, and was convicted in court of an offence under the Private Hospitals &
Medical Clinics Act, and by this reason he was guilty of improper conduct which
brought disrepute to his profession.
The medical practitioner pleaded guilty to the charge. He was censured, fined a sum
of $8000, ordered to give a written undertaking not to repeat the conduct complained
of and to pay the costs of the proceedings.
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Abusive behaviour
Case 10:
A medical practitioner was charged for causing bodily harm to his patient by throwing
a packet of medicine at her face and slapping her. The complainant had also
concurrently taken a private summons against the medical practitioner in relation to
the same facts as alleged in the charge before the Disciplinary Committee (DC). The
medical practitioner was acquitted in court. In view of this, the prosecution elected to
present no evidence before the DC to substantiate the charge.
The medical practitioner was accordingly acquitted.
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Disciplinary Inquiries held in 2002
There were 8 disciplinary inquiries completed in 2002 under the Medical Registration
Act 1997. A brief account of each case is given below.
Improper financial transactions
Case 1:
A medical practitioner was charged for selling skincare products including medical
creams improved by him to 2 patients and collecting payment from them for the
products without authority from the hospital administration, and for his own account.
The medical practitioner was employed by a publicsector hospital at the time of the
alleged offence.
The Disciplinary Committee found him guilty of professional misconduct. In
sentencing the medical practitioner, the Disciplinary Committee took into
consideration the mitigating plea and factors that existed in the case.
The practitioner was censured, fined a sum of $2000 on each of the 2 charges and
ordered to pay the costs of the proceedings. The medical practitioner lodged an appeal
to the High Court against the Disciplinary Committee s decision but subsequently
withdrew it.
Failure to detect pregnancy in a foreign domestic worker
Case 2:
A medical practitioner was charged for acting in serious disregard of his professional
responsibilities by certifying to the Work Permit Department of the MInistry of
Manpower that the pregnancy screening for a Foreign Domestic Worker (FDW) was
negative, when in fact, she was in a state of pregnancy.
The Disciplinary Committee heard expert evidence from both the prosecution and
defence. There was some doubt as to whether the pregnancy could have been detected
by physical examination at the time when the FDW was screened. After taking this
and other factors in the case into consideration, the Disciplinary Committee acquitted
the medical practitioner.
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Conduct unbecoming of a medical practitioner
Case 3:
A medical practitioner was charged with displaying conduct that was unbecoming of
the medical profession.
The Disciplinary Committee found him guilty of professional misconduct in that
during a medical consultation with his patient he had asked her personal questions
which were irrelevant and unrelated to her medical condition (an upper respiratory
tract infection) and thereby behaved in an inappropriate manner causing
embarrassment to the patient.
The practitioner was censured, fined a sum of $2000, ordered to give an undertaking
not to repeat the conduct complained of or any similar conduct, and to pay the costs of
the proceedings.
Publishing false or misleading information
Case 4:
A medical practitioner was charged for publishing an abstract entitled “Radiosurgery:
A 15-year Experience with 1,016 Patient Treatments” presented at the 9th ASEAN
Congress of Neurological Surgeons which contained a statement he knew to be false
or misleading. In the Abstract, the medical practitioner had made the claim that “Since
my involvement with radiosurgery in 1986 at the Cleveland Clinic (USA), I have been
involved in the treatment of 1,016 patients”.
The Disciplinary Committee rejected his defense that he was referring to 1,016
patient treatments and not 1,016 patients , and that this was merely a typographical
error and that someone might possibly have amended his original draft abstract.
The Disciplinary Committee found the medical practitioner guilty of professional
misconduct as charged.
The practitioner was censured, ordered to give a written undertaking to abstain in
future from the conduct complained of or any similar conduct, and to pay the costs of
the proceedings.
Excessive prescription of drugs
Case 5:
A medical practitioner pleaded guilty to 5 charges of over-prescribing Dormicum to
five of her patients.
The Disciplinary Committee concluded that the medical practitioner had prescribed
Dormicum, which is addictive, without regard to the medical conditions of the
patients.
The practitioner was censured, and suspended from practice for a period of 18
months. She was also ordered to pay a penalty of $5,000 for each charge, to give an
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undertaking to abstain in future from the conduct complained of or any similar
conduct,and to pay the costs of the proceedings.
Case 6:
A medical practitioner faced 2 charged of engaging in grossly inappropriate
prescribing practice.
The Disciplinary Committee accepted the expert opinion that the medical practitioner
had not shown from his medical records that the practice of repeatedly prescribing
sleeping tablets was appropriate for his patients and that he had not demonstrated that
he had provided an acceptable standard of care.
The practitioner was censured and suspended from practice for a period of 24 months.
He was also ordered to pay a penalty of $5000 for each charge, to give an undertaking
to abstain in future from the conduct complained of or any similar conduct, and to pay
the costs of the proceedings.
Case 7:
A medical practitioner pleaded guilty to over-prescribing Dormicum to three of his
non-surgical patients.
The Disciplinary Committee was surprised that as a general surgeon, he had agreed to
treat these patients for insomnia and to prescribe Dormicum to them. The Disciplinary
Committee felt that he had failed to exercise a higher standard of prudence and care
expected of an experienced surgeon.
The practitioner was suspended for a period of 9 months, ordered to give a written
undertaking to abstain in future from the conduct complained of or any similar
conduct, and to pay the costs of the proceedings.
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Conviction under the Income Tax Act
Case 8:
A medical practitioner had pleaded guilty and was convicted in court of 2 charges of
tax evasion under section 96(1)(a) of the Income Tax Act.
The medical practitioner admitted to the Disciplinary Committee that his conduct was
fraudulent and dishonest.
The Disciplinary Committee was of the view that the tax evasion took place over a
significant period of time and that it was systematic. The tax evaded amounted to a
considerable sum.
The medical practitioner was censured and suspended from practice for a period of 6
months. He was also ordered to give a written undertaking to abstain in future from
the conduct complained of or any similar conduct, and to pay the costs of the
proceedings.
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Disciplinary Inquiries held in 2003
There were 5 disciplinary inquiries completed in 2003 under the Medical Registration
Act (Cap 174). A brief account of each case is given below.
Conviction of an offence involving Dishonesty
Case 1:
A medical practitioner had been convicted in court of 2 charges of tax evasion under
section 96(1)(a) of the Income Tax Act (Cap.134).
The Disciplinary Committee was of the view that the facts in support of the medical
practitioner s conviction revealed the commission of offences, carried out over a
considerable period of time, with the willful intent of evading tax. The sum evaded
was substantial.
The practitioner, who had pleaded guilty to the 2 charges, was suspended from
practice for a period of 6 months on each charge, the periods of suspension to run
concurrently. He was also censured, ordered to give a written undertaking to abstain
in future from the conduct complained of or any similar conduct, and to pay the costs
of the proceedings.
Improper Certification of Death
Case 2:
A medical practitioner was convicted of 3 charges of professional misconduct when
he certified the cause of death of 3 deceased persons as Senile Debility when he
knew, or ought to have known, that this was not an acceptable cause of death, and that
these cases should have been referred to the Coroner.
The Disciplinary Committee accepted the testimony of the expert witness that there
must be a certification of the underlying pathological condition that had resulted in the
death of the deceased. Without a proper identification of the pathological reason for
the death, the actual cause of death is left unestablished. The practitioner was
acquitted of another 3 charges which were related to his association with an
undertaker. Although the practitioner was acquitted of these charges, the Disciplinary
Committee warned him that he was expected to desist from any association with a
person in circumstances which might compromise the professional integrity with
which he was required to discharge his professional obligations.
He was censured, ordered to give an undertaking not to repeat the conduct complained
of or any similar conduct and to pay the costs of proceedings.
Case 3:
A medical practitioner pleaded guilty to 3 charges of professional misconduct. He was
convicted of certifying that the cause of death of 3 deceased persons, aged 60, 89 and
90 years old, as Chronic Anemia , Mental Retardation and Dementia respectively
when he knew, or ought to have known, that these were not acceptable causes of death
and that the cases should have been referred to the Coroner.
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The Disciplinary Committee considered the case to be of importance as improper
certification of death might lead to serious consequences and in some cases, even
perversion of justice. They felt that a message should be sent to the medical
profession that these offences were not viewed lightly.
The practitioner was censured, fined a sum of $3000, ordered to give an undertaking
to abstain in future from the conduct complained of or any similar conduct, and to pay
the costs of proceedings.
Failure to detect pregnancy in a foreign domestic worker
Case 4:
A medical practitioner pleaded guilty to the charge of acting in serious disregard of
his professional responsibilities by certifying to the Work Permit Department of the
Ministry of Manpower that the pregnancy screening for a Foreign Domestic Worker
(FDW) was negative, when in fact she was in a state of pregnancy. The Disciplinary
Committee found that the practitioner had failed to conduct a proper medical
examination of the FDW. He had performed an abdominal examination of the FDW
while she was seated upright, instead of in the supine position. He also failed to take
her menstrual history.
The Disciplinary Committee censured and fined the practitioner a sum of $3000. They
also ordered that he give an undertaking to abstain in future from the conduct
complained of or any similar conduct and to pay the costs of proceedings.
Forgery
Case 5:
A medical practitioner pleaded guilty to 5 charges of forging a colleague s signature
on the prescription sheets of a hospital to obtain 40 tablets of Zolpidem (Stilnox), a
sleeping tablet, on 4 occasions and 30 tablets of the same drug on 1 occasion for his
own consumption.
The Disciplinary Committee suspended the practitioner from practice for a period of 3
months and censured him. He was also ordered to provide a written undertaking to
abstain in future from the conduct complained of or any similar conduct, to seek
medical treatment for such period of time as determined by his psychiatrist and to pay
the costs of the proceedings.
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Disciplinary Inquiries held in 2004
There were 13 disciplinary inquiries completed in 2004 under the Medical
Registration Act (Cap 174). A brief account of each case is given below:
Excessive prescription of drugs
Case 1:
A medical practitioner pleaded guilty to 80 charges of inappropriate prescription of
Erimin and/or Dormicum and/or Stilnox and/or Valium to 80 patients over a period of
time.
The Disciplinary Committee (DC) found that the practitioner had freely dispensed the
hypnotic drugs, which were addictive, to his patients without any regard to their
health, interest, or harm that might come to them. It was clear that the prescriptions
were given without regard to the medical conditions of the patients. There was little
evidence that he had thoroughly examined the patients before prescribing the drugs.
The practitioner’s clinical notes did not record or document sufficient details of the
patients’ diagnoses, symptoms and/or conditions, such as to enable him or other
doctors at the various clinics that these patients had attended to properly assess the
medical conditions of the patients over their period of treatment. It was essentially a
systematic prescription of hypnotic drugs to the patients.
The practitioner was the sole licensee of 7 clinics and had several locum doctors
working for him. The DC took a serious view of the lack of control exercised in the
treatment of the patients at these clinics.
The DC censured the practitioner and his name was removed from the Register of
Medical Practitioners. He was also fined $1000 per charge on 65 of the more serious
charges, i.e. $65,000, and ordered to pay the costs of the proceedings. However, the
fine was later revised to $10,000, which was the maximum allowed under the Medical
Registration Act, after he appealed to the High Court.
Case 2:
A medical practitioner pleaded guilty to 12 charges of inappropriate prescription of
Erimin to her patients over a period of time.
The Disciplinary Committee found that the practitioner had freely dispensed Erimin,
which was addictive, to her patients without any regard to their medical conditions,
health, interest, or harm that might come to them. There was little evidence that she
had thoroughly examined the patients before prescribing the drugs. Her clinic notes
did not document sufficient details of the patients’ diagnoses, symptoms and/or
conditions such as to enable her to properly assess their medical conditions over the
treatment period.
The practitioner was censured and suspended from practice for a period of 16 months.
She was also fined $1,000 per charge on 6 of the more serious charges, ordered to
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give an undertaking to abstain in future from the conduct complained of and to pay
the costs of the proceedings.
Case 3:
A medical practitioner was convicted of 9 out of the 12 charges of inappropriate
prescription of mainly Erimin and in some cases Dormicum and Alprazolam to his
patients over a period of time.
The Disciplinary Committee (DC) held that the practitioner failed to properly exercise
the due care and standard expected of him as a professional doctor in the management
of his patients. He had prescribed hypnotic drugs that were addictive and had harmful
side effects, such as causing cognitive impairment, without sufficient regard to the
medical conditions of the patients involved.
The DC held that for each consultation, the practitioner had the full obligation of
assessing and justifying the need for these drugs before they were prescribed. The DC
highlighted the importance of contemporaneous notes in the consultation process. The
clinical notes served not only to help the practitioner but other doctors in the
management of patients. This was particularly so in a group practice where the
transmission of clear information to all doctors managing the patient was vital,
especially when it involved highly addictive drugs.
The practitioner was censured and suspended from practice for a period of 6 months.
He was also fined $5,000 and ordered to give an undertaking to abstain in future from
the conduct complained of and to pay the costs of the proceedings. Case 4:
A medical practitioner was convicted of 33 out of the 45 charges of inappropriate
prescription of sleeping pills, mainly Erimin and to a lesser extent Dormicum, to his
patients over a period of time.
The Disciplinary Committee (DC) found no proper documentation or comprehensive
assessment for coexisting physical and psychiatric problems of many of those patients
who saw the practitioner for the first time. His subsequent follow-up notes did not
indicate that he had taken steps to reduce the dosages of the sleeping pills prescribed
except in a few patients.
The DC held that a judicious family physician should not solely prescribe hypnotics
for insomnia for more than a few months. They further highlighted the importance of
contemporaneous notes in the consultation process. The practitioner’s clinical notes
were stereotyped in almost every case and did not indicate that he had examined his
patients sufficiently.
The DC censured the practitioner and suspended him from practice for a period of 16
months. He was fined $10,000, ordered to give an undertaking to abstain in future
from the conduct complained of and to pay the costs of the proceedings.
Case 5:
A medical practitioner pleaded guilty to 20 charges of inappropriate prescription of
Dormicum and/or Erimin and/or Stilnox to her patients over a period of time.
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The Disciplinary Committee found her prescriptions of hypnotic medications to these
patients inappropriate. Her case notes were also entirely inadequate for the purpose of
assessing the medical conditions of the patients.
The practitioner was censured and suspended from practice for a period of 18 months.
She was also fined $10,000, ordered to give an undertaking to abstain in future from
the conduct complained of and to pay the costs of the proceedings.
Case 6:
A medical practitioner was convicted of 24 out of the 27 charges of inappropriate
prescription of Erimin and/or Dormicum and/or Stilnox to her patients over the period
of treatment.
The Disciplinary Committee (DC) was of the view that the practitioner’s case notes
were scanty. She tried to justify this on the ground that her patients were
uncomfortable about having their detailed information recorded.
From the case notes, the DC also noted that the practitioner’s stereotyped examination
of each patient was directed mainly to exclude opiate dependency. The physical and
urine examinations carried out were irrelevant to the management of the patients’
complaints of insomnia.
The practitioner was censured and suspended from practice for a period of 20 months.
She was also fined $10,000, ordered to give an undertaking to abstain in future from
the conduct complained of and to pay the costs of the proceedings.
Case 7:
A medical practitioner pleaded guilty to 15 charges of inappropriate prescription of
Erimin and/or Dormicum and/or Valium to her patients over a period of time.
The Disciplinary Committee (DC) found that the practitioner’s prescriptions of the
hypnotic medications, which were addictive, were done without regard to the medical
conditions of the patients, interest or harm that might come to them. There was also
little evidence that she had thoroughly examined her patients before prescribing the
drugs.
The DC stated that for a practitioner of her experience and higher qualifications, her
clinical notes did not record sufficient details of the patient’s medical condition over
the period of treatment. She had not exercised responsibility in the discharge of her
professional duties as a doctor.
The DC censured and suspended the practitioner from practice for a period of 16
months. She was also fined $8,000, ordered to give an undertaking to abstain in future
from the conduct complained of and to pay the costs of the proceedings.
Case 8:
A medical practitioner was convicted of 8 out of 17 charges of inappropriate
prescription of Erimin and/or Dormicum to his patients over the period of treatment.
He pleaded guilty to 3 of the charges.
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The Disciplinary Committee (DC) commented that benzodiazepines were hypnotic
drugs with psychotropic effect and their prolonged use was addictive. These drugs
were known to be abused by users for non-therapeutic reasons. There were instances
when the practitioner prescribed Erimin to patients who had obviously developed a
dependency on it.
The particulars recorded by the practitioner in the medical records of some patients
were scanty and did not provide justification for the continued prescriptions of large
amounts of hypnotics to his patients.
The DC held that a practitioner had a professional obligation to conduct himself
appropriately and the DC iterated that in such cases, the proper thing for him to do
was to refer the patients to a psychiatrist to wean them off the drug and not to feed
their habit.
The practitioner was censured and suspended from practice for a period of 6 months.
He was also fined $3,000, ordered to give an undertaking to abstain in future from the
conduct complained of and to pay the costs of the proceedings.
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Case 9:
A medical practitioner pleaded guilty to 17 charges of inappropriate prescription of
cough mixtures containing codeine and sleeping tablets containing benzodiazepines to
his patients over a period of time and 11 charges of failure to maintain proper medical
records.
The Disciplinary Committee (DC) found that the practitioner had freely dispensed
these drugs, which were addictive, to his patients without due regard to their medical
condition, health, interest, or harm that might come to them. There was little evidence
that he had thoroughly examined the patients before prescribing the drugs.
The practitioner’s clinical notes did not document sufficient details of the patient’s
symptoms and physical examination findings that were necessary to enable him to
properly assess the medical condition of the patient over the period of treatment.
The DC took a serious view of the practitioner’s poor management of the patients.
They censured him and suspended him from practice for a period of 18 months. They
also fined him $10,000, ordered that he give an undertaking to abstain in future from
the conduct complained of and to pay the costs of the proceedings.
Failure to safeguard patients’ interest
Case 10:
A medical practitioner faced a total of 30 charges of professional misconduct which
arose from a study of haplotype structure and SNP frequencies in candidate genes in
neurological disease and drug response. The practitioner was the lead Principal
Investigator (PI) of the Research Project. The study included research on patients with
Parkinson’s Disease (PD). The charges comprised:
a) 13 charges of failure to safeguard PD patients’ best interests and health and thereby
exposed them to unnecessary risks;
b) 13 charges of failure to obtain informed consent from the PD patients to conduct
"on-off" LDopa testing on them ;
c) 2 charges of failure to obtain ethics approval from 2 Hospital Ethics Committees
for the "on-off" LDopa testing carried out on PD patients as part of the Research; and
d) 2 charges of breach of PD patients’ rights to medical confidentiality.
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Some of the main findings of the Disciplinary Committee (DC) are set out below in
brief:
In (a), the DC found that the practitioner had a duty to ensure that the methodology in
the conduct of the
Research included safeguards to protect the best interests and health of the PD
patients.
In (b), the DC found that as the lead PI, the practitioner was under an obligation to
take reasonable steps to ensure that all the 13 PD patients gave informed consent for
the Research.
In (c), DC held that any application for ethics approval of "on-off" L-Dopa testing
must state clearly that such tests were going to be carried out on the PD patients.
In (d), the DC found that the practitioner was aware and approved of the methodology
used by his research team in obtaining confidential information on PD Patients
without their consent, which was in breach of these PD patients’ rights to medical
confidentiality.
The DC convicted the practitioner of all 30 charges and ordered that he be censured,
fined $5,000 on each of the 30 charges, give an undertaking to abstain in future from
the conduct complained of and pay the costs of the proceedings. In respect of the
charges relating to his failure to safeguard the best interests and health of PD patients
and failure to obtain the PD patients’ informed consent, they ordered that the
practitioner’s name be removed from the SMC’s Register of Medical Practitioners.
The practitioner’s fine was subsequently reduced to $10,000 by the High Court after
the SMC, on its own motion, applied to the High Court to review the fine imposed
following a recent court judgement on an appeal case that the maximum fine that
could be imposed under the Medical Registration Act was $10,000.
Case 11:
A temporary registered medical practitioner faced a total of 26 charges of professional
misconduct which arose from a study of haplotype structure and SNP frequencies in
candidate genes in neurological disease and drug response. The study included
research on patients with Parkinson’s Disease (PD). The practitioner was the Project
Manager of the Research Project. The charges comprised:
a) 11 charges of failure to safeguard PD patients’ best interests and health;
b) 11 charges of failure to obtain informed consent for "on-off" LDopa testing on the
PD patients;
c) 2 charges of failure to obtain ethics approval from 2 Hospital Ethics
Committees for the "on-off" LDopa testing that was carried out on PD patients as part
of the Research; and
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d) 2 charges of breach of PD patients’ rights to medical confidentiality.
The DC convicted the practitioner of all the 26 charges and ordered that the
practitioner be censured and fined $10,000, give an undertaking to abstain in future
from the conduct complained of and pay the costs of the proceedings.
They noted that the practitioner was no longer registered on the SMC’s Register of
Medical Practitioners. However, had his name still been on the Register, the DC
would have ordered that his name be removed from the Register on one or more of the
"Failure to safeguard PD patients’ best interests and health" charges and "Failure to
obtain informed consent" charges.
Lack of Informed Consent
Case 12:
The medical practitioner was convicted of 1 charge of failing to obtain his patient’s
informed consent for radiosurgery to treat a brain tumour. The Disciplinary
Committee (DC) held that whilst the practitioner explained the risks of open surgery,
in particular the risk of death, he did not explain to the patient sufficiently the risks
involved in radiosurgery. These were, namely, that it might kill the surrounding cells,
that it might not kill all the tumour cells, that the tumour might grow again, and the
likelihood that radiosurgery might not succeed. He also did not explain to the patient
that radiosurgery was not a conventional or standard procedure at that time for the
treatment of the patient’s tumour.
The practitioner was acquitted of 1 charge of recommending radiosurgery to treat the
patient’s tumour when he knew, or ought to have known, that open surgery was the
treatment of choice.
The practitioner was censured, fined a sum of $2,000, ordered to give an undertaking
to abstain in future from the conduct complained of and to pay the costs of
proceedings.
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Conduct unbecoming of a medical practitioner
Case 13:
A medical practitioner was convicted of 2 charges of distributing and/or causing to be
distributed advertising flyers containing material intended to discredit a neighbouring
clinic and its medical practitioners on 2 separate occasions.
The Disciplinary Committee (DC) accepted the evidence of the handwriting expert, a
Consultant Forensic Scientist, that the practitioner had written the advertising flyers.
They held that the practitioner’s behaviour was unprofessional, and amounted to
conduct which was improper, and brought disrepute to the medical profession. The
DC opined that any reasonable person reading the flyers would have concluded that
they were circulated by the neighbouring clinic and that the conduct of the doctors of
this clinic was disreputable and improper.
The practitioner was acquitted on 1 charge of tampering with the signage of the
neighbouring clinic.
The DC censured and fined the practitioner a sum of $10,000. They also ordered that
he give an undertaking to abstain in future from the conduct complained of and to pay
the costs of proceedings.
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Disciplinary Inquiries held in 2005
There were 7 disciplinary inquiries completed in 2005 under the Medical Registration
Act (Cap 174). A brief account of each case is given below:
Excessive / Inappropriate Prescription of Drugs
Case 1:
A medical practitioner was convicted of 6 charges of inappropriate prescription of
benzodiazepines, hypnotic medication and amphetamine type slimming pills to her
patients without clear documentation of her patients’ diagnoses, symptoms and/or
conditions in her clinical notes over the period of treatment.
The practitioner was under treatment for chronic endogenous depression and was not
present or legally represented at the inquiry. In the psychiatrist’s opinion however, the
practitioner was fully aware of what she was doing when she prescribed the
benzodiazepines and other medications to her patients.
The practitioner was censured and suspended for 12 months. She was also ordered to
pay the costs of the proceedings. Once suspension is completed, her application to the
Medical Council f or a practising cert i fi cat e must be supported by a psychiatric
report certifying fitness to continue practice as a doctor.
Case 2:
A medical practitioner was convicted of 15 charges of inappropriate prescription of
Dhasedyl and/or Sunsedyl to his patients without any clear documentation of the
patient ’s diagnosis or indications for treatment.
The practitioner claimed that the medical records were tampered with and that many
of the entries in the medical records of repeat sales of cough mixtures were made
without his knowledge and consent. However, the Disciplinary Committee (DC)
found that all the disputed entries in the medical records had been initialed and the
practitioner had accepted the initials as his. The disputed entries were also
interspersed with his own accepted entries and consultation notes. Hence, the DC held
that when the practitioner initialed against the accepted entries or wrote his
consultation notes, he could not have failed to notice the disputed entries. The notes in
the clinical records were deemed to be accurate.
The practitioner was censured and suspended for a period of 15 months. He was also
fined $10,000, ordered to give an undertaking to abstain from the conduct complained
of and to pay the costs of the proceedings.
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Improper Delegation of Duties
Case 3:
A medical practitioner pleaded guilty to 2 out of 3 charges of professional
misconduct. These 2 charges related to improper delegation to her nurse for a
procedure involving a Class 4 medical laser on 2 separate occasions. This was in
contravention of the licence issued to her by the Centre for Radiation Protection
(CRP), Health Sciences Authority (HSA).
The DC held that the practitioner’s breaches of Regulations 9(4) and 15 of the
Radiation Protection (Non Ionising Radiation) Act 1991 by the improper delegation of
the use of the laser to her nurse were serious offences. The practitioner claimed trial
on the 3rd charge that related to her failure to properly manage the treatment of her
patient by recommending non-ablative laser therapy based on the patient’s clinical
presentation. The DC held that this error of judgment on the part of the practitioner
did not amount to professional misconduct. Hence, she was acquitted of this charge.
The DC also highlighted to the practitioner that she should correct her poor record
keeping of her patients’ case notes including sloppy notations (ambiguous terms,
incorrect terminology) and the omission of important parameters for laser treatment in
the operative notes.
The practitioner was censured and suspended for a period of 3 months. She was also
fined $10,000, ordered to give an undertaking to abstain from the conduct complained
of and to pay the costs of the proceedings.
Conviction In Court
Case 4:
A medical practitioner pleaded guilty to a charge that she was convicted of an offence
punishable under section 324 of the Penal Code in year 2003. The conviction related
to the practitioner voluntarily causing hurt to her 19-year-old domestic maid by
scalding her with a hot iron on her right forearm. The practitioner had been sentenced
to 4 months’ imprisonment under section 324 of the Penal Code.
The practitioner admitted that what she did was wrong and that it was done
impulsively under trying conditions. She had regretted her action and was extremely
remorseful. She apologised to the Medical Council for the trouble her action had
caused and for disgracing the medical profession.
The practitioner was censured and suspended for 6 months. She was also ordered to
undertake to abstain from the conduct complained of and to pay the costs of the
proceedings.
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Professional Negligence
Case 5:
A medical practitioner was convicted of 2 charges of professional misconduct. The
1st charge alleged that he was in willful neglect of his duties and grossly mismanaged
the treatment of his patient. He failed to adequately assess the medical condition of his
patient and to refer him to hospital for further management of a serious medical
condition. i.e. appendicitis.
The 2nd charge alleged that he failed to keep proper medical records of the
consultation with his patient.
The DC held that the practitioner’s abdominal examination was not adequately
conducted or documented. He had failed to take an adequate medical history and
examine the patient properly. The fact that the patient’s condition had not improved
despite earlier treatment by another general practitioner should have alerted him that
there could be a serious under lying condition that merited a referral to the hospital.
His professional conduct was deemed to be dishonourable.
The DC also found the practitioner’s medical record-keeping inadequate. The clinical
records of his consultation would not have enabled another doctor to take over the
management of this case. The DC held that this was important since the practitioner
was working as a locum at the clinic.
The practitioner was censured and ordered to give an undertaking to take a full
medical history of his patients and keep adequate clinical records. He was fined
$10,000 and ordered to pay the costs of the proceedings.
Case 6:
A medical practitioner faced 2 charges of professional misconduct. The first charge
alleged that he failed to deliver a standard of care appropriate to his specialty by
neglecting to perform an ultrasound scan on his patient to determine the size of her
fibroids before performing laparoscopic surgery.
The 2nd charge alleged that he failed to properly inform his patient the results of
laparoscopic surgery, hence giving his patient a false impression that the 2 fibroids he
removed were the 2 fibroids that were identified in the patient’s ultrasound scan
report.
At the conclusion of the Prosecution’s case, the Defence Counsel informed the DC
that the medical practitioner would not testify and would not call any witnesses. The
DC was disappointed that as a senior member of the profession, the practitioner did
not show the degree of co-operation with the DC as would be expect ed. His failure to
testify gave rise to questions whether he had something to conceal.
The DC held that although the practitioner’s failure to perform an ultrasound scan on
his patient fell short of good clinical practice and this omission may be construed as
negligence on his part, negligence must be of a nature that would reasonably be
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regarded as disgraceful or dishonorable by his professional brethren of good repute
and competency to amount to professional misconduct.
The DC found no evidence on which it could infer an intent that the practitioner’s
omission on the information on the fibroids was a willful attempt to mislead the
patient. Hence, the practitioner was acquitted of both charges.
Breach of Ethical Code
Case 7:
A medical practitioner pleaded guilty to 5 charges of professional misconduct. These
charges were in respect of the statements that she made in a Business Times article
dated 2 July 2004 entitled “Flatter your Skin”. The following statements made were i
n breach of Regulation 17 of the Medical Registration Regulations read with Sections
4.3.1, 4.3.2, 4.3.3, 4.4.2 and 4.4.3.1 of the SMC’s Ethical Code and Ethical Guidelines
The practitioner did not make any public withdrawal or apology for the offending
remarks. The DC held that remarks made about fellow practitioners especially in
public, should not inter alia, undermine the trust in a professional colleague’s
knowledge of skills and deprecate other practitioners. The practitioner was censured,
fined $5000, ordered to give an undertaking to abstain from the conduct complained
of and to pay the costs of the proceedings.
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Disciplinary Inquiries held in 2006
There were 7 disciplinary inquiries completed in 2006 under the Medical Registration
Act (Cap 174). A brief account of each case is given below:
Excessive I Inappropriate Prescription of Drugs
Case 1:
A medical practitioner was convicted of 9 out of the II charges against him for failure
to exercise an acceptable standard of care for II patients while practicing as a locum
doctor in a clinic in Jurong. The charges were for inappropriate prescribing of various
benzodiazepines i.e., Dormicum, Valium or Nitrazepam, to 11 of his patients.
The Disciplinary Committee (DC) found the practitioner guilty of excessive
prescribing of benzodiazepines and for failing to provide counselling for his patients,
and to refer them for psychiatric evaluation in cases of chronic insomnia.
The OC held that the practitioner had breached professional responsibility by not
discharging his professional duties appropriately. Proper prescribing by doctors was a
statutory privilege and carried with it a heavy responsibility. This responsibility must
be safeguarded for the public interest. As the charges against the practitioner were
serious, the DC suspended him for 6 months and imposed a fine of $6000. He was
also censured and ordered to give an undertaking to the Medical Council to abstain
from such conduct or any similar conduct in future and to pay the costs of the
disciplinary proceedings.
Case 2:
A medical practitioner faced 6 charges for failure to exercise an acceptable standard
of care for 6 of his patients. The charges were for inappropriate prescribing of
Dormicum and Nitrazepam.
In addition, the practitioner faced a 7th charge that as licensee and manager of the
clinic, he failed to exercise adequate supervision over the prescribing practices of the
doctors in the clinic by allowing benzodiazepines to be regularly prescribed to patients
of the clinic and not making arrangements for these benzodiazepine-dependent
patients to receive specialist treatment for their insomnia or dependency on
benzodiazepines.
The DC found the practitioner guilty of 4 charges of excessive prescribing of
benzodiazepines and for failing to provide counselling for his patients, and to refer
them for psychiatric evaluation in cases of chronic insomnia or
benzodiazepine-dependency. They held that given the patients' case histories and their
prolonged use of benzodiazepines, the practitioner should not have prescribed the
further use of these dependency forming drugs. The DC did not accept the
practitioner's explanation that he did counsel them and advise them to seek psychiatric
help, or that he did not wish to dispense the medicine to them but did so because the
patients were adamant. This was because his explanations were not supported by the
medical records and notes he kept.
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In convicting the practitioner of the 7th charge, the DC held that he had a duty as a
doctor, who is also a licensee of the clinic under Regulation 4 of the PHMC
Regulations, to ensure that the MOR's Guidelines were complied with. As
manager/licensee of the Clinic, the practitioner was obliged to supervise the work of
the doctors employed. However, he left the running of the clinic and the ordering of
these drugs to his locum doctor, did not review the medical and dispensing records of
the clinic and the patients and delegated his responsibility via private agreements with
his doctors.
The DC was of the view that the practitioner could not delegate such serious statutory
responsibility to other doctors, whether by private agreement of otherwise, or for
whatever reason. If he had carried out this responsibility as licensee/manager of the
clinic, he would have obviously noticed much earlier that the excessive prescription of
benzodiazepines to various repeat patients of the clinic over a period of about 5 years.
After considering all the circumstances and the practitioner's mitigation plea, the DC
suspended him for 3 months and imposed a fine of $2000. He was also censured and
ordered to give an undertaking to the Medical Council to abstain from such conduct or
any similar conduct in future and to pay the costs of the disciplinary proceedings.
Conviction in Court
Case 3:
A medical practitioner pleaded guilty to a charge that on 1 December 2004, whilst still
a regular medical officer of HQ Medical Corps and subject to military law, he was
convicted of an offence of falsification of an official document under Section 50(b) of
the Singapore Armed Forces Act (Cap. 295), an offence involving fraud or
dishonesty. He was sentenced to be discharged with ignominy from the Singapore
Armed Forces.
At the disciplinary hearing, the practitioner was accordingly convicted. The DC
accepted that he had co-operated with the Military authorities in their investigation
and that he was genuinely contrite for this offence. However, the offence that he had
committed was a serious one that breached the high level of trust that the public
places in the profession.
Taking all the circumstances into consideration, including his mitigation plea, the DC
ordered that his medical registration be suspended for a period of 3 months and
censured him. He was also ordered to give a written undertaking to the SMC that he
will not engage in the conduct which gave rise to the charge against him, or any
similar conduct and to pay the costs and expenses of the disciplinary proceedings.
Case 4:
A medical practitioner had pleaded guilty to a charge in the Subordinate Courts of
forging a payment voucher under Section 465 of the Penal Code, Chapter 224. He was
sentenced to a fine of S$10,000, in default 2 months' imprisonment.
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As his offence had involved fraud or dishonesty, the practitioner was referred to
SMC's Disciplinary Committee (DC). The practitioner pleaded guilty to the charge
against him before the DC. The DC ordered that his medical registration be suspended
for a period of 6 months and censured his misconduct. He was also ordered to give a
written undertaking to the SMC that he will not engage in such or any similar
misconduct in future.
Case 5:
A medical practitioner forged a payment voucher and appended a signature purported
to belong to another doctor, making it appear that the doctor was the locum for him
and had received a locum fee of S$9,765.
The practitioner then submitted the forged payment voucher to the NSmen Payment
Centre, MINDEF for reimbursement for the loss of income for his reservist period.
MINDEF later found out that the practitioner had submitted a false claim. The matter
was reported to the police.
The practitioner pleaded guilty to an offence under Section 465 of the Penal Code,
Chapter 224, in the Subordinate Courta and was convicted. He was sentenced to a fine
of S$9,000, in default 2 months' imprisonment on 10 Apr 2006.
Since the practitioner was convicted of an offence involving fraud or dishonesty, he
was referred to a disciplinary inquiry by SMC's DC.
The DC heard and considered the practitioner's mitigation plea submitted by his
Counsel and the fact that he had already been dealt with in the Subordinate Court.
The DC ordered that he be censured and his medical registration suspended for a
period of 5 months. He was also ordered to give a written undertaking to the SMC that
he will not engage in such or any similar misconduct in future and to pay the costs of
the disciplinary proceedings.
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Alleged Professional Misconduct
Case 6:
A medical practitioner was acquitted by the DC of 2 charges of professional
misconduct. The 1st charge alleged that she failed to provide good clinical care to her
patient by making a diagnosis of genital herpes without performing adequate clinical
evaluation, and/or failing to provide a course of treatment that was appropriate to the
patient, in all the circumstances of the case.
The 2nd charge alleged that she had practised outside her area of competence in the
management of the Patient in that she failed to refer him to a competent specialist for
treatment when she should have done so.
On the first charge, the DC found some inadequacy in the practitioner's clinical
evaluation. In diagnosing genital herpes, there were insufficient records in her case
note to show that she has taken in adequate history from the Patient. The DC doubted
that she could make a diagnosis of genital herpes based on her description of the
Patient's lesion. The practitioner had also not appreciated the fact that the serological
test ordered would not confirm whether the Patient had active and/or recurrent genital
herpes infection. The DC felt that she should have taken a culture of the lesion and/or
performed a Tzanck test because it was an atypical presentation.
The DC held that the course of treatment/medicine given to the Patient was not
inappropriate for the diagnosis. The dosages of 800mg Acyclovir per day for the first
week and 400mg Acyclovir per day for the second week were not excessive.
Notwithstanding the DC's finding of the inadequacy of the clinical evaluation, they
were of the opinion that such inadequacy on the practitioner's part was not tantamount
to professional misconduct under the Medical Registration Act.
The DC held that the Prosecution had not proven the 2nd charge beyond a reasonable
doubt. They held that the practitioner was practising within the area of her
competence and in particular in this case, her treatment of the Patient was done in
connection with the treatment of the Patient's wife for infertility.
Management of Patients on Subutex
Case 7:
A medical practitioner faced 19 charges of failing to formulate and/or adhere to any
management plan for the treatment of the patient's medical condition by the
prescription of Subutex. The charges also stated that the practitioner did not record or
document in the patient's record details or sufficient details of the patient's diagnosis,
symptoms andlor condition and/or any management plan such as to enable him to
properly assess the medical condition of the patient.
On the first limb of the 19 charges, the DC by a majority found that with reference to
each of the patients, the practitioner did not formulate and/or adhere to any
management plan for the treatment of the patient's medical condition by the
prescription of Subutex.
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On the second limb of the 19 charges, the DC unanimously found that the medical
record of each of the patients concerned was very scanty and in the opinion of the DC
did not contain sufficient details of the patient's diagnosis, symptoms and conditions
or any management plan such as to enable the practitioner to assess properly the
medical condition of the patient.
The DC found the practitioner guilty as charged and ordered that he be fined $2,500,
censured, give a written undertaking to the SMC that he will not engage in such or
similar conduct in future, be supervised by a mentor to improve his clinical case
recording practice and to pay the costs of the proceedings.
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Disciplinary Inquiries held in 2007
There were 9 disciplinary inquiries completed in 2007 under the Medical Registration
Act (CAP 174). A brief account of each case is given below:
Excessive / Inappropriate Prescription of Drugs
Case 1:
1. A medical practitioner pleaded guilty to 12 charges of inappropriate prescription of
a benzodiazepine (i.e. Dormicum) without exercising an acceptable standard of
diligence and care, clear documentation of the patient’s symptoms, medical condition
and diagnosis, and failure to properly counsel and refer for specialist treatment.
2. The Disciplinary Committee (DC) noted from the histories of the patients that they
were repeatedly prescribed Dormicum to excessive amounts. The DC held that the
practitioner’s prescribing practice fell short of the diligence and care that was to be
expected of a general practitioner and that he had paid scant regard to the Ministry of
Health’s Guidelines for Prescribing Benzodiazepines. Further, patients’ medical
records were scanty and several patients with sleep disorders were not referred for
specialist treatment which was unsuitable and unprofessional as the practitioner was
neither psychiatry trained nor a specialist in the treatment of sleep disorders. The DC
found that the practitioner had thereby acted in disregard of his professional duties.
3. The practitioner was censured and suspended from practice for a period of 12
months. He was al so fined $8,000 and ordered to give an undertaking to abstain in
future from the conduct complained of and to pay the costs of the proceedings.
Case 2:
1. A medical practitioner faced 10 charges of inappropriate prescription of
benzodiazepines and failure to maintain proper medical records. The practitioner
pleaded guilty to 8 charges and was acquitted of 2 charges.
2. The Disciplinary Committee (DC) found that the practitioner had acted in disregard
of his professional duties since the prolonged prescription of benzodiazepines without
specialist referral was unsuitable and unprofessional. The DC did not accept the
practitioner’s mitigation plea that he was unaware of the Ministry of Health’s
Guidelines for Prescribing Benzodiazepines which was sent to every doctor. As a
practitioner, he ought to have known of the said Guidelines. Ignorance of such an
important medical notice was not an excuse.
3. The practitioner was censured and suspended from practice for a period of 12
months. He was al so fined $5,000 and ordered to give an undertaking to abstain in
future from the conduct complained of and to pay the costs of the proceedings.
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Case 3:
1. A medical practitioner pleaded guilty to 15 charges of inappropriate prescription of
a benzodiazepine (i.e. Erimin) without exercising an acceptable standard of diligence
and care, clear documentation of the patient’s symptoms, medical condition and
diagnosis, and failure to properly counsel and refer for specialist treatment.
2. The Disciplinary Committee (DC) accepted that the practitioner’s record keeping
was of reasonably acceptable standard, and that he appeared to be a family physician
treating patients belonging to family groups who had genuine sleep problems. The
DC, however, found that the practitioner had acted in disregard of his professional
duties since the prolonged prescription of benzodiazepines without specialist referral
was unsuitable and unprofessional.
3. The practitioner was censured and suspended from practice for a period of 3
months. He was also fined $1,000 and ordered to give an undertaking to abstain in
future from the conduct complained of and to pay the costs of the proceedings.
Case 4:
1. A medical practitioner faced 19 charges of inappropriate management in that he
failed to formulate and adhere to any treatment plan for Subutex treatment, and to
maintain proper medical records.
2. The Disciplinary Committee (DC) did not accept the practitioner’s proposition that
he had a punitive management plan, and that even if it existed, was highly
unorthodox, and as the Expert stated in his evidence, it was unlikely to have any effect
on the patients’ addiction. The DC also did not accept the practitioner’s excuse that it
was difficult for a sole practitioner to keep “a fully documented record of each and
every patient”. The DC found that the practitioner consistently breached Article 4.1.2
of the SMC Ethical Code and Ethical Guidelines, and that he was guilty of
professional misconduct within the meaning of Section 45(1)(d) of the Medical
Registration Act (CAP 174).
3. The practitioner was censured and suspended from practice for a period of 3
months. He was also fined $1,000 and ordered to give an undertaking to abstain in
future from the conduct complained of and to pay the costs of the proceedings.
However, the suspension was later ordered to be set aside and the fine increased to
$2,500 after he appealed to the High Court.
Case 5:
1. A medical practitioner pleaded guilty to 18 charges of inappropriate prescription of
benzodiazepines, and failure to maintain clear documentation in the patients’ medical
records.
2. The Disciplinary Committee (DC) found that the practitioner had acted in disregard
of his professional duties since the prolonged prescription of benzodiazepines
without specialist referral was unsuitable and unprofessional. The DC did not accept
the practitioner’s mitigation plea that he was unaware of the Ministry of Health’s
Guidelines for prescribing Benzodiazepines which was sent to every doctor. As a
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practitioner, he ought to have known of the said Guidelines. Ignorance of such an
important medical notice was not an excuse. The DC, however, took into
consideration the practitioner’s mitigation plea that he was a physician of long
standing of over 30 years and did not have many years of practice left.
3. The practitioner was censured and suspended from practice for a per i od of 9
months. He was also fined $5,000 and ordered to give an undertaking to abstain in
future from the conduct complained of and to pay the costs of the proceedings.
Case 6:
1. A medical practitioner pleaded guilty to 14 charges of inappropriate prescription of
benzodiazepines, failure to provide counseling for the patients and/or refer the patients
to a medical specialist for further management, and failure to maintain clear
documentation in the patients’ medical records.
2. The Disciplinary Committee (DC) found that the practitioner had acted in disregard
of his professional duties since the prolonged prescription of benzodiazepines without
specialist referral was unsuitable and unprofessional. The DC did not accept the
practitioner’s mitigation plea that he was unaware of the Ministry of Health’s
Guidelines for Prescribing Benzodiazepines which was sent to every doctor. As a
practitioner, he ought to have known of the said Guidelines. Ignorance of such an
important medical notice was not an excuse. The DC, however, accepted that the
practitioner had intended to treat the patients concerned who had various sleep
disorders and medical conditions.
3. The practitioner was censured and suspended from practice for a period of 6
months. He was also fined $5,000 and ordered to give an undertaking to abstain in
future from the conduct complained of and to pay the costs of the proceedings.
Case 7:
1. A medical practitioner pleaded guilty to 14 charges of inappropriate prescription of
benzodiazepines, and failure to maintain clear documentation in the patients’ medical
records.
2. The Disciplinary Committee (DC) found that the practitioner had acted in disregard
of his professional duties since the prolonged prescription of benzodiazepines without
specialist referral was unsuitable and unprofessional. The DC did not accept the
practitioner’s mitigation plea that he was unaware of the Ministry of Health’s
Guidelines for prescribing Benzodiazepines which was sent to every doctor. As a
practitioner, he ought to have known of the said Guidelines. Ignorance of such an
important medical notice was not an excuse. The DC, however, accepted that the
practitioner’s prescription of benzodiazepines was not driven by profit but by concern
for the patients’ interests.
3. The practitioner was censured and suspended from practice for a period of 6
months. He was also fined $5,000 and ordered to give an undertaking to abstain in
future from the conduct complained of and to pay the costs of the proceedings.
Conviction in Court
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Case 8:
1. A medical practitioner, whilst still a house-officer practising with the National
Healthcare Group, was arrested for drug possession by the Central Narcotics Bureau
on 1 April 2006. He pleaded guilty in the District Court, to one charge of
unauthorized possession of controlled drugs under Section 8(a) of the Misuse of
Drugs Act (Cap 185). Three other similar charges were taken into consideration for
the purpose of sentencing. He was sentenced to 8 months’ imprisonment under Sect i
on 33 of the Misuse of Drugs Act.
2. At the disciplinary hearing, the practitioner was charged under the Medical
Registration Act (Cap 174) for having been convicted of an offence implying a defect
in character which made him unfit for his profession, arising from his conviction for
drug possession charges under Sect i on 8(a) of the Misuse of Drugs Act (Cap 185).
He pleaded guilty to the charge and was accordingly convicted by the Disciplinary
Committee (DC).
3. The practitioner’s Counsel submitted in mitigation that he had committed the
offence during a difficult period when he was under extreme anxiety whilst awaiting
the result of an examination he had to resit, and under tremendous stress due to the
financial consequences he had to bear should he fail his examination.
4. The DC took into account several factors, namely the fact that the house officer had
effectively been suspended from his medical practice for almost a year, the nature of
the criminal offence committed, the punishment received from the court and the fact
that he was a house officer and that on resumption of his housemanship, he would be
under supervision for at least eight months.
5. The house officer was censured and ordered to give an undertaking to abstain in
future from the conduct complained of and to pay the costs of the proceedings.
Case 9:
1. The practitioner was convicted by a Subordinate Court on 27 February 2007 for
insulting the modesty of 2 ladies by using his mobile phone to record a video clip of
their underwear and buttocks without their knowledge. In court, he pleaded guilty to
two of the charges. Two of her charges were taken into consideration. He was
sentenced to one month’s imprisonment to run consecutively for each of the two
charges.
2. The practitioner pleaded guilty before the Disciplinary Committee (DC) and was
accordingly convicted of the charge. The DC considered that the charges for which he
was convicted in the Subordinate Court were serious and implied a defect in character
which made him unfit for the medical profession. The DC felt that the penalty had to
be adequate to uphold confidence of the public on the integrity of the profession as a
whole.
3. The practitioner was censured and suspended from practice for a period of 24
months. He was also fined $5, 000, ordered to give an undertaking to abstain in future
from the conduct complained of, and continue his psychiatric treatment for such
period of time as determined by his psychiatrist. On the expiry of the suspension
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period, before he can resume practice, he was to produce the reports of two
psychiatrists that he was fit for practice, and practise only within a supervisory
framework approved by the Medical Council for a period of 1 year. He was ordered to
pay the costs of the disciplinary proceedings.
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Disciplinary Inquiries held in 2008
There were 12 disciplinary inquiries, 1 health inquiry and 1 appeal which were heard
in the High Court in 2008. A brief account of each case is given below:
Professional Negligence / Incompetence
Case 1:
The case concerned a prematurely delivered infant with extremely low birth weight
who was admitted to the Neonatal Intensive Care Unit and received into the
paediatrician’s care. The practitioner noticed a possible squint in the left eye of the
infant and referred the infant to a paediatric ophthalmologist for the first time about 7
months after the birth of the infant and 4½ months after the infant was discharged
from the NICU. The infant was subsequently diagnosed by a paediatric
ophthalmologist to be suffering from Stage 5 Retinopathy of Prematurity in the left
eye (total retina detachment) and Stage 4 ROP in the right eye (partial retina
detachment). The infant had no vision in the left eye and very low vision in the right
eye.
The DC heard evidence from two medical experts on the long standing standard
practice of referring a severely premature and extremely low birth weight baby for
ROP screening. The medical experts stated that at the relevant time, the standard
practice was to refer such a baby within 4 to 6 weeks after birth or at 31 to 34 weeks
of calculated gestation age, whichever is later. They opined that in the circumstances
of this case, the practitioner should have referred the infant for ROP screening much
earlier as is standard practice and not 5 months thereafter. Had the infant been
referred much earlier, the loss of vision could have been prevented.
The DC was deeply concerned that the practitioner’s defence rested on an assessment,
which was possibly fl awed, which ignored several clinical features of great
significance. The DC found the practitioner’s management contrary to what they
would have expected of a Paediatrician managing a pre-term, extremely low birth
weight neonate in Singapore at the time this patient was presented. The patient’s
handicap was severe as a result.
The practitioner was suspended from practice for a period of 3 months; censured;
ordered to give a written undertaking to the Medical Council that he will not engage
in the conduct complained of or, any similar conduct and to pay the costs and
expenses of the incidental to these proceedings including the costs of the solicitors to
the Council and the Legal Assessor.
Excessive / Inappropriate Prescription of Drugs (non-Subutex)
Case 2:
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The doctor initially claimed trial to all 20 charges. However, he later pleaded guilty
to 6 charges of failing to exercise due care in the management of his patients, having
engaged in inappropriate prescribing practice by regularly prescribing
benzodiazepines (Erimin, Dormicum, Nitrazepam, Midazolam and/or other drugs of
similar nature) without exercising an acceptable standard of diligence and care.
After the first tranche of the inquiry, the Prosecution applied to the DC to withdraw 3
of the 14 remaining charges and, with regard to the remaining 11 charges, the doctor
also pleaded guilty. Having heard the evidence for the charges, including the evidence
from parties' respective experts, and having also considered the written and oral
submissions of solicitors for both the Prosecution and the Respondent, the DC found
the medical practitioner guilty of the 17 charges, in respect of inappropriate
prescribing practice by regularly prescribing benzodiazepines to patients without
exercising an acceptable standard of diligence and care.
In considering the proper sentence, the DC took into account the doctor’s previous
clean record during his practice. The DC also felt that the sentence meted out had to
fit the gravity of the charges in order to uphold the integrity of the medical profession.
The practitioner was suspended from practice for a period of 12 months; fined $8,000,
censured, ordered to give a written undertaking to the Medical Council that he will not
engage in the conduct complained of or any similar conduct and to pay the costs and
expenses of the incidental to these proceedings including the costs of the solicitors to
the Council and the Legal Assessor.
Case 3:
A general practitioner pleaded guilty to 16 charges of failing to exercise due care in
the management of his patients in that he (i) engaged in inappropriate prescribing
practice in the prescription of a benzodiazepine (Dormicum) to these 16 patients; and
(ii) failed to properly record or document details of the patients’ symptoms, medical
conditions and diagnosis, and/or counselling with the patient (if any) and/or referral of
the patients to specialist treatment (if any) in the case notes for the period of
treatment.
The practitioner was suspended from medical practice for 3 months; fined the sum of
$2,000; censured; ordered to give a written undertaking to the Medical Council that he
will not engage in the conduct complained of, or in any similar conduct and to pay the
costs and expenses of and incidental to these proceedings, including the costs of the
solicitor to the Council and the Legal Assessor.
Case 4:
A general practitioner pleaded guilty to 11 charges of professional misconduct under
Section 45(1)(d) of the Medical Registration Act (“MRA”) for failing to exercise due
care in the management of his patients in that he (i) inappropriately prescribed
hypnotic medication to these patients; and (ii) did not record or document in the said
patients’ Patient Medical Records details or sufficient details of the patients’
diagnosis, symptoms and/ or condition and/or any management plan such as to enable
him to properly assess the medical condition of the patient over the period of
treatment.
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The practitioner was suspended from medical practice for 3 months; censured;
ordered to give a written undertaking to abstain in future from the conduct complained
of or, any similar conduct and to pay the costs and expenses of and, incidental to these
proceedings, including the costs of the solicitor to the Medical Council and the Legal
Assessor.
Case 5:
A medical practitioner pleaded guilty to 2 charges of professional misconduct under
section 45(1)(d) of the MRA in relation to a patient.
The first charge was for (i) inappropriately prescribing the wrong dosage of 0.25 mg
digoxin daily when she knew or ought to have known that the correct dosage was
0.0625 mg daily; (ii) failure to schedule the patient for review within 1 to 2 weeks
despite the increase in the digoxin dosage prescribed at 0.25 mg daily to the Patient;
(iii) failure to take reasonable steps to ensure that 0.0625 mg digoxin per day was
prescribed to the patient (she did not amend the prescription or issue a new
prescription to the pharmacist or pharmacists before the digoxin was dispensed); (iv)
failure to make any note of any verbal instructions to the pharmacy in the patient’s
case notes in respect of the amended prescription and (v) making the wrong
amendment or correction on the patient’s case notes from 0.25 mg to 0.625 mg even
after discovering the error in her prescription.
The second charge was for failure to review the patient’s International Normalization
Ratio (“INR”) in an expeditious and timely manner after increasing the patient’s
dosage of warfarin.
The practitioner (who was temporarily registered at the time of the alleged offence
and no longer practising as a doctor) was fined the sum of $3,000; censured; ordered
to provide a written undertaking to the SMC that she will abstain in future from the
conduct complained of or any similar conduct and, to pay the costs and expenses of
and incidental to these proceedings, including the costs of the solicitor to the SMC
and the Legal Assessor.
Case 6:
A general practitioner pleaded guilty to all 20 charges of professional misconduct
under Section 45(1)(d) of the MRA in that he failed to exercise due care in the
management of his patients in relation to the prescribing of Dormicum, Erimin,
Stilnox and Valium.
The practitioner was variously charged with inappropriate prescribing practice and/or
failing to record or document the patients’ symptoms and his diagnosis, and/or failing
to refer the patient for specialist treatment, each charge involving the prescribing of
one or more of the drugs.
The practitioner was suspended for a period of 3 months; fined a sum of $2,000;
censured; ordered to provide a written undertaking to the SMC that he will abstain in
future from the conduct complained of or any similar conduct and to pay the costs and
expenses of the disciplinary proceedings.
Excessive / Inappropriate Prescription of Drugs (Subutex and Benzodiazepines)
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Case 7:
A medical practitioner contested the 38 charges of professional misconduct under
Section 45(1) (d) of the MRA at the start of the inquiry. Of the 38 charges, 2 charges
related to the prescription of hypnotic medication. The other 36 charges involved the
prescription of Subutex (Buprenorphine). After the Prosecution had closed its case
and midway through his defence, the practitioner pleaded guilty to all 38 charges.
The medical practitioner had failed to exercise due care in the management of 2
patients in the prescription of hypnotic medication. He had not carried out, in
sufficient detail, a proper assessment of the patients before he prescribed hypnotic
medication. He also did not record or document in the said patients’ Patient Medical
Records, details or sufficient details of these patients’ diagnosis, symptoms and/or
condition and/or any management plan to justify the continued prescription of
hypnotic medication over the period of treatment. The practitioner also failed to refer
these patients to a medical specialist and/or psychiatrist for further assessment and/or
management until after the Ministry of Health (“MOH”), Clinical Assurance and
Audit (“CAA”) Branch inspected his clinic.
The practitioner had failed to exercise due care in the management of his patients in
the prescription of Subutex by not recording in the said patients’ Patient Medical
Records, details or sufficient details of these patients’ diagnosis, symptoms and/or
condition and/or any management plan to properly assess the medical condition of
these patients over the period of treatment by the prescription of Subutex. He also did
not refer the said 36 patients to a medical specialist and/ or psychiatrist for further
assessment and/or management until after MOH CAA Branch inspected his clinic or
at all.
The practitioner was suspended from practice for a period of 3 months; fined the sum
of $4,000; censured; ordered to give a written undertaking to the Medical Council that
he will not engage in the conduct complained of or any similar conduct and, to pay the
costs and expenses of the incidental to these proceedings, including the costs of the
solicitors to the Council and the Legal Assessor.
Case 8:
A general practitioner pleaded guilty to 14 charges of professional misconduct under
Section 45(1)(d) of the MRA in that he failed to exercise due care in the management
of his patients. Of the 14 charges, 12 charges related to the dispensation of the drug
Subutex (Buprenorphine) and, 2 charges related to the dispensation of various
benzodiazepines.
The DC, in the course of its deliberations, noted that the practitioner had prescribed
Subutex in combination with a benzodiazepine to 1 patient on one occasion. The
concomitant use of Subutex and a benzodiazepine has been known to cause death in
patients. In view of the potentiating effect, the Ministry of Health (“MOH”) had
brought this to the notice of all registered medical practitioners by their Professional
Circular No. 21/2005 dated 26 October 2005. He also prescribed Subutex for 2
patients on 28 August 2006 and 4 September 2006 respectively, after the cut-off date
of 27 August 2006, in contravention of MOH’s Circular No. 27/2006 on “(1)
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Classification of Buprenorphine As a Class A Controlled Drug and (2) Voluntary
Rehabilitation Program for Opiate Dependent Patients” which was issued to all
registered medical practitioners on 8 August 2006 (“MOH Directive”). The MOH
Directive prohibited registered medical practitioners from prescribing Subutex to
patients who did not sign up for the Subutex Voluntary Rehabilitation Programme
(“SVRP”), Subutex being classified as a Controlled Drug with effect from 14 August
2006. He only carried out urinary tests for 6 of the 12 patients on Subutex after
MOH’s Clinical Assurance and Audit Branch inspected his clinic and (iv) failed to
carry out any urinary tests for 2 patients during their period of treatment.
The practitioner was suspended from medical practice for 6 months; fined the sum of
$5,000; censured; ordered to give a written undertaking to abstain in future from the
conduct complained of or, any similar conduct; and to pay the costs and expenses of
and incidental to these proceedings, including the costs of the solicitor to the Medical
Council and the Legal Assessor.
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Excessive / Inappropriate Prescription of Drugs (Subutex)
Case 9:
A general practitioner pleaded guilty to 42 charges of professional misconduct under
Section 45(1)(d) of the Medical Registration Act (“MRA”) in that he failed to exercise
due care in the management of these patients.
Of the 42 charges, 41 charges related to the practitioner failing to exercise due care in
the management of his patients in the prescription of Subutex. His breaches were that
he failed to formulate any long term management plan for the treatment of the said
patient’s medical condition. He failed to record or document in the patient’s Patient
Medical Records sufficient details of the patient’s diagnosis, symptom and condition
throughout the patient’s period of treatment save for the initial consultation. He also
failed to carry out an adequate assessment of the patient’s medical condition over the
period of treatment. The general practitioner also failed to refer the patient to a
medical specialist for further assessment and management and only referred the
patient to CAMP after the MOH HRD Branch inspected his clinic. The practitioner
was also in breach of the relevant 26 Oct 2005 MOH Guidelines. For the remaining 1
patient, the practitioner failed to administer Subutex with direct visual supervision at
the initial phase of therapy for the patient (a requirement under the MOH Guidelines).
The practitioner was suspended from medical practice for 3 months; fined the sum of
$2,000; censured; ordered to give a written undertaking to the Medical Council that he
will not engage in the conduct complained of or any similar conduct; and pay the
costs and expenses of the incidental to these proceedings including the costs of the
solicitors to the Council and the Legal Assessor.
No Informed Consent
Case 10:
An ophthalmologist claimed trial to the following charges that he (i) recommended
glaucoma drainage surgery to his patient to reduce the high intraocular pressure in the
right eye for the purposes of alleviating the pain and headaches when he knew or
ought to have known that it was not the appropriate treatment; and (ii) did perform
glaucoma drainage surgery on his patient without informing him of all treatment and
surgical options available and without explaining to him all the risks, side-effects and
nature of the surgery.
The DC was of the view that the practitioner’s action, being a senior member of the
medical profession, was a serious breach of professionalism.
The practitioner was fined the sum of $7,000; censured; ordered to give a written
undertaking to the Medical Council that he will not engage in the conduct complained
of, or in any similar conduct; and pay the costs and expenses of and incidental to these
proceedings, including the costs of the solicitor to the Council and the Legal Assessor.
Case 10’s Appeal to the High Court
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Subsequently the practitioner appealed against the decision of the DC before the High
Court of 3 judges. The Court dismissed his appeal with cost. In their oral judgment,
the Court stated their agreement of the standards the DC had upheld, and fully
endorsed the findings and judgment of the DC. The Court also commended the SMC
for ensuring that high standards of medical profession are maintained. The DC was
commended for making a fi rm stand on maintaining high standards in the medical
profession and for the detailed grounds in the judgment.
Conviction in Court
Case 11:
A Gynaecologist was convicted in court of 6 charges in 2001 for failure to comply
with the demand of the Comptroller of Income Tax to produce accounts of the
company for the Years of Assessment 1994 to 1999. In 2004, the practitioner was also
convicted in court of (i) 6 charges (for the second time) for failure to comply with the
demand to produce accounts of the Company for the Years of Assessment 1994 to
1999; and (ii) 2 charges for failure to comply with the demand of the Comptroller to
produce accounts for the Company for the Years of Assessment 2000 to 2001.
The practitioner faced charges of contravening Section 45(1)(b) of the MRA for the
14 offences of which she had been convicted in court. The DC also noted that she
failed to appear in Court on the date of her convictions on or about 26 April 2004 and
warrants for her arrests were issued. The question before the DC was whether the
multiple convictions of the offences the practitioner had committed implied a defect in
character which made her unfi t for the medical profession. In the opinion of the DC,
her multiple convictions of the offences considered together did imply a defect in
character which made her unfit for the medical profession. The DC therefore found
her guilty of the charges relating to the 14 offences of which she had been convicted.
The Committee was of the view that this was not a case of “occasional instances of
carelessness”. What was more serious was that she did not appear in Court to answer
to the summons, and warrants for her arrest were issued. The practitioner’s persistent
failures to comply with the requirement of the Comptroller were intentional and
wilful. Her attitude was one of complete disregard for the due requirements of the law
and her persistence over a period of years to ignore the requirements of the
Comptroller reflected poorly on her professional attitude.
The practitioner was suspended from medical practice for 3 months; censured;
ordered to give a written undertaking to the Medical Council that he will not engage
in the conduct complained of or any similar conduct; and to pay the costs and
expenses of the incidental to these proceedings including the costs of the solicitors to
the Council and the Legal Assessor.
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Outrage of Modesty / Sexual Relationship with Patient
Case 12:
A Gynaecologist pleaded guilty to the following charges: (i) improper conduct which
brings disrepute to the medical profession by engaging in a sexual relationship with a
patient and failing to preserve the absolute confidence and trust of a doctor-patient
relationship, acted in breach of Regulation 17 of the Medical Registration Regulations
(MRR) read with Section 4.2.5.1 of the SMC’s Ethical Code and Ethical Guidelines
(ECEG); (ii) improper conduct which brings disrepute to the medical profession by
tampering with and/or improperly causing inaccurate changes to be made to the
biodata of a patient and thereby failing to keep medical records which were accurate,
acted in breach of Regulation 17 of the MRR read with Section 4.1.2 of the SMC’s
ECEG; (iii) professional misconduct by failing to record or properly document details
of the patient’s visits, medical condition and results on medical examinations in the
case notes for the period of treatment; and (iv) professional misconduct by failing to
properly maintain patient confidentiality by improperly disclosing to a third party,
confi dential information relating to the treatment and care of 2 patients.
The DC noted that the practitioner’s conduct transgressed the professional boundary
between the doctor and his patient. The DC was of the view that the practitioner’s
action was a serious breach of professionalism and that the SMC had to send a clear
signal to the profession that gross improper behaviour between a doctor and his
patient cannot be tolerated.
Having regard to all the circumstances, the practitioner was suspended for a period of
24 months; censured; ordered to give a written undertaking to abstain in future from
the conduct complained of or any similar conduct; and to pay the costs of and
incidental to these proceedings, including those of the solicitor of the Council and the
Legal Assessor.
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Health Inquiry
Case 13:
An anaesthesiologist pleaded guilty to and was convicted of 2 charges in the
Subordinate Courts of Singapore namely, (i) an offence of drink driving under section
67(1)(b) of the Road Traffic Act (Cap.276); and (ii) an offence of inconsiderate
driving under section 65(1) of the Road Traffic Act (Cap.276). The practitioner was
sentenced to a fi ne totaling $4,100 and disqualified from driving all classes of
vehicles for 2 years.
The SMC in exercise of its powers under section 39(2) of the MRA, referred the
information on his conviction to the Chairman of the Complaints Panel. The
Complaints Committee appointed to investigate the matter subsequently referred the
practitioner to a formal inquiry by the Health Committee (HC) for possible alcohol
addiction and health issues.
Two medical reports on the practitioner’s condition were obtained for the purpose of
the Inquiry. Having considered the Counsel’s submissions and all the documents
presented before it, the HC found that the practitioner’s fitness to practise was not
impaired by reason of his physical or mental condition and dismissed the Inquiry.
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Disciplinary Inquiries held in 2009
18 disciplinary inquiries were heard by the Disciplinary Committees in 2009 and 1
appeal was heard in the High Court.
A brief account of each case is given below:
(A) Misrepresentation as an Accredited Specialist
Case 1:
A general practitioner pleaded guilty t o 2 charges which arose from his breaches of
Sect i on 65( 1) ( a) and Sect i on 65( 1) ( b) of the Medical Registration Act (MRA)
read with Section 4.4.2 of the SMC Ethical Code and Ethical Guidelines (ECEG). The
first charge was in respect of the practitioner falsely assuming the title of specialist
and/or consultant in the practice of plastic surgery or cosmetic surgery. The
Disciplinary Committee (DC) took a serious view of this breach as the MRA cl earl y
provides that a medical practitioner must obt ai n a cert i fi cat e from the Specialists
Accreditation Board (“SAB”) certifying inter alia, that the medical practitioner has
completed and obtained the requisite qualifications and training before the said
medical practitioner can be registered as a specialist and assume the title of a
specialist and/or practise medicine under a recognised specialty.
The DC noted that while the practitioner was registered as a medical practitioner with
the SMC, he had not obtained such prescribed specialty training or qualifications. As
such, he was not accredited by the SAB for the purposes of specialist registration in
Singapore, nor did he obtain any specialist registration in the United Kingdom (UK),
as he would like his patients to believe. However, when queried by members of the
public on his training and accreditation, the practitioner did not clarify that he was not
accredited as a specialist and had, instead, provided information which portrayed
himself as a specialist.
Further, the practitioner had declared his area of specialty as “Cosmetic Surgery” even
though cosmetic surgery was not a specialty recognised by SAB, and also claimed that
his area of practice was “Private Specialist” in his membership application form
submitted to the Singapore Medical Association.
The law clearly states that a registered medical practitioner should not hold himself
out to be a specialist unless he has obtained the relevant accreditation from the
appropriate governing body, in this case, the SAB. Further, based on the evidence, the
DC was of the opinion that it was not a simple oversight on the practitioner’s part but,
rather, that he systematically set out to create a false impression of his qualifications
and experience. The DC would not tolerate such actions where, in effect, the public
were being misled. The second charge related mainly to the practitioner causing to be
published, misleading statements on the website of the clinics at which he practised.
The information on the website created a false impression that he was a specialist
and/or consultant in the practice of plastic surgery or cosmetic surgery. The website
contained numerous misleading and unsubstantiated statements, including claims on
his experience, training and qualifications.
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The DC did not accept that the information posted by the practitioner could have been
the result of an oversight or misunderstanding as there were numerous instances
where the information provided was false or misleading. The DC further held that the
offence was serious, especially since the misleading information had been
disseminated through the internet where it is envisaged that the information will reach
a wide audience.
The DC felt that appropriate action had to be taken bearing in mind that this was the
first time a medical practitioner was charged with a breach of Section 65 of t he MRA.
The DC was al so of the opinion that the fact that the practitioner breached the MRA
before the SMC’s guidelines on the Display of Titles and Designations by Medical
Practitioners came into effect was not a relevant factor. Public safety should not be
compromised and it was vital that the public should be protected from such false and
misleading statements by registered medical practitioners.
The practitioner was suspended for a period of 6 months; censured; ordered to give a
written undertaking to abstain in future from the conduct complained of or any similar
conduct; remove all misleading statements contained on the said website and in any
publication forthwith; and to pay the costs and expenses of and incidental to these
proceedings, including the costs of the solicitor to the Council and the Legal Assessor.
Appeal to the High Court
Subsequently, the practitioner appealed against the 6-month suspension before the
Cour0t of 3 Judges. The Court dismissed his appeal with cost.
(B) Professional Misconduct
Case 2:
A general practitioner pleaded guilty to 1 charge of acting in serious disregard of her
professional responsibilities by falsely certifying to the Controller of Work Permits in
a medical report / form that she had carried out Veneral Disease Research Laboratory
(VDRL) and pregnancy screenings on her foreign domestic worker when she had in
fact failed or neglected to carry out the tests so stated in the medical report / form. The
DC accepted that there were extenuating circumstances at the material time which
resulted in the false declaration being submitted to the Ministry of Manpower and also
accepted that the practitioner was remorseful for the act or conduct complained of.
The DC also noted that the practitioner had pleaded guilty to the charge at the earliest
opportunity and had co-operated fully with the authorities.
However, the DC highlighted that it was a serious error which could not be condoned
by the medical profession in view of the important role which medical practitioners
play in screening foreign domestic workers. As such, the DC was of the view that the
subject-matter of the charge was a serious professional misconduct which warranted
the imposition of a penalty.
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The practitioner was fined $3, 000; censured; ordered to give a written undertaking to
abstain in future from the conduct complained of or any similar conduct, and to pay
the costs and expenses of and incidental to these proceedings, including the costs of
the solicitor to the Council and the Legal Assessor.
(C) Professional Misconduct and Misrepresentation
Case 3:
A general practitioner faced two charges; the first charge related to his
misrepresentation to a patient that he was a fully-trained and accredited specialist
plastic surgeon and the second charge related to a liposuction procedure he performed
on the patient.
On the first charge, which the practitioner denied, the DC found that the charge had
been proven beyond reasonable doubt and that the practitioner had misrepresented to
the patient, orally and through the information posted on his website, that he was a
fully-trained and accredited specialist plastic surgeon. Thus, the practitioner was
guilty of contravening Section 65 of the MRA.
The DC noted that the practitioner had, during a consultation with the patient,
discussed the work and prices of her plastic surgeons to whom the practitioner
compared himself. The DC found that the practitioner had told the patient of his
overseas training and work experiences, that he was trained in “Cosmetic Surgery”
and of his Consultant appointment in “Cambridge”. However, at no time did he tell
the patient that he was not a plastic surgeon.
In respect of the second charge, the practitioner was charged with professional
misconduct under Section 45(1) (d) of the MRA in carrying out a liposuction
procedure on the patient. Arising from the liposuction procedure, the patient was left
with deformities and scars which required corrective procedures in the form of both
liposuction of residual fat followed by fat grafting.
The DC accepted the evidence of the Prosecution’s expert witness, as well as the
attending doctors for the patient, who all confirmed that the results of the surgery
indicated that harm was caused as a consequence of incompetent treatment.
The DC concluded that although the result was far from satisfactory and the manner
the practitioner carried out the procedure may amount to negligence, it did not
amount to professional misconduct within the meaning of Section 45(1)(d) of the
MRA. Accordingly, the DC acquitted the practitioner of the second charge.
In sentencing the practitioner, the DC took into account an earlier disciplinary inquiry
against him whereby he pleaded guilty to two charges under section 65 of the MRA
and was suspended from practice for 6 months. After hearing a mitigation plea from
counsel for the practitioner, and taking into account all the relevant circumstances, the
practitioner was censured and fined $10,000 and further ordered to provide a written
undertaking to abstain in future from the conduct complained of or any similar
conduct in the first charge. The DC also ordered the practitioner to pay 50% of the
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costs and expenses of and incidental to these proceedings in respect of the costs of the
solicitor to the Council and the Legal Assessor.
(D) Inappropriate treatment
Case 4:
A haematologist pleaded guilty to (i) a charge of failing to exercise due care to his
patient in that he failed to make an adequate clinical evaluation of the patient’s
medical condition by failing to carry out the appropriate clinical examination and/or
clinical tests pertaining to the treatment of the patient’s condition of Non Hodgkin’s
Lymphoma, and (ii) a charge of failing to exercise due care to his patient in that he
failed to properly manage the Hepatitis-B infection that the patient developed during
the course of treatment of Stage IVA Low-Grade Lymphoma with chemotherapy.
In February 2005, a patient suffering f r o m l y mp h o ma c o n s u l t e d t h e
practitioner. Although it was the usual practice to test lymphoma patients f or
Hepatitis- B serology prior to administering chemotherapy on such patients, the
practitioner failed to do so before administering chemotherapy to the patient between
February and April 2005.
In May 2005, the patient was tested and diagnosed to have Hepatitis-B.
was hospitalised at Gleneagles Hospital. The practitioner discharged
although it was a serious condition that was potentially life threatening.
subsequently passed away in May 2005, with the cause of death being
Hepatitis-B with Non Hodgkin’s Lymphoma as a contributing condition.
The patient
the patient
The patient
certified as
With respect to the first charge, the DC noted that since chemotherapy is a wellknown cause for reactivation of Hepatitis-B and that we are in an area of moderate
endemicity of Hepatitis-B, these 2 facts taken together should have prompted the
practitioner to screen this patient for Hepatitis-B. Although the DC noted that the
screening of Hepatitis - B before commencement of chemotherapy was not uniformly
practised in Singapore in 2005, there was still sufficient medical literature urging
testing before chemotherapy.
With respect to the second charge, the practitioner had admitted, amongst of her
things, that he had failed to discuss with the patient the options of consultation with a
hepatologist and/ or to consult a hepatologist to assist in the management of the
patient’s development of Hepatitis-B.
The DC then carefully considered the points made in mitigation by the practitioner’s
counsel and took into account his unblemished record for the past 44 years and
testimonials from members of the profession.
The practitioner was suspended from medical practice for 3 months; censured;
ordered to give a written undertaking that he will not engage in the conduct
complained of or any similar conduct and to pay the costs and expenses of and
incidental to these proceedings, including the costs of the solicitor to the Council and
the Legal Assessor.
Case 5:
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A neurologist f aced 2 charges i n relation to the treatment of his patient, from 15-18
August 2006. The charges concerned his application of repetitive transcranial
magnetic stimulation (“rTMS”) and Therapeutic Ultrasound on his patient for
treatment of her medical condition.
At the hearing, a legal issue was raised by the practitioner’s solicitors on the nonattendance of the complainants. The practitioner argued that the proceedings should
be dismissed on this ground. The prosecution resisted this application and argued that
the Agreed Statement of Facts contained sufficient factual basis to support the
charges.
The other issues which the DC had to investigate did not relate to the complainants’
evidence. The DC agreed with the prosecution that the fact that the complainants were
not called as witnesses did not nullify the proceedings. It was further noted that under
the present MRA and Regulations, it was not necessary for either the patient or the
complainants to testify. On this basis, the inquiry hearing proceeded.
Legal arguments were al so made in relation to the patient’s medical condition. In this
respect , the prosecution took the position that the actual diagnosis was not relevant to
the main issues as the 2 treatments, rTMS and Therapeutic Ultrasound, were
inappropriate, regardless of the patient’ s medical condition. The practitioner said he
diagnosed the condition as Atherosclerotic Parkinson’s Disease (“PD”), Diffuse Small
Vessel Disease in the Brain, and an element of Psychosis, and the DC accepted this
diagnosis.
At the conclusion of the Inquiry, the DC acquitted the practitioner of the first charge
relating to rTMS and convicted him of the second charge relating to Ultrasound.
For the first charge relating to rTMS, the DC accepted that the treatment modality
had not found general acceptance in medical practice . However, the DC was of the
view tha t the practitioner had done a review of the experience of others in the
treatment of PD with rTMS and there was evidence through the medical research
papers quoted by the practitioner that rTMS did result in temporary improvement in
motor function.
As such, the DC took the position that the application of rTMS as an extended
indication or auxiliary treatment for a patient suffering from PD, especially one who
had failed other treatment options (as in this case), can be supported. Accordingly, the
DC was unable to find, beyond all reasonable doubt, that the practitioner’s use of
rTMS on the patient was inappropriate for the patient’s medical condition, and
therefore acquitted him of the first charge.
In passing, the DC did, however, make it a point to also note that it did not agree with
the assertion by the practitioner that the Bioethics Advisory Committee’s (“BAC’s”)
Guidelines, in particular paragraph 3.22, sanctions all activities as therapies when they
are undertaken with the sole intention of benefiting patients, thereby overriding
Section 4.1.4 of the SMC Ethical Code and Ethical Guidelines which, among other
things, states that “A doctor shall treat patients according to generally accepted
methods ” and that “A doctor shall not offer to patients, management plans or
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remedies that are not generally accepted by the profession, except in the context of a
formal and approval clinical trial ”.
For the second charge relating to Ultrasound, the DC took issue with the practitioner’s
reasoning for use of Ultrasound on the patient. The practitioner had, through a review
of the use of diagnostic ultrasound in obstetric and neurological practice, concluded
that Therapeutic Ultrasound (as used by physiotherapists) could also be reasonably
applied to treatment of neurological diseases of the brain.
The DC noted that, as the safety of patients or “do no harm” is a cardinal principle for
doctors, it was incumbent on the practitioner to satisfy the DC that the application of
Therapeutic Ultrasound on the brain was safe on patients, a burden which he failed to
discharge. The DC found that there was neither experimental evidence nor physical
proof of the safety of this modality on the human brain.
Accordingly, the DC found that the practitioner’s use of Therapeutic Ultrasound was
not generally accepted by the medical profession and not an appropriate treatment for
the medical condition of the patient.
The practitioner was fined $5,000; censured; ordered to give a written undertaking
that he would not continue with the therapeutic use of Ultrasound for insonation on a
patient’s brain other than for indications as generally accepted by the community of
neurologists; and to pay the full cost of the Legal Assessor as well as 60% of the costs
of the solicitor to the Council.
In closing, the DC also cautioned the practitioner that it was not seeking to discourage
his desire for innovation but any novel treatment which he contemplated should be
considered in accordance with the BAC’s Guidelines for Institutional Review Boards.
The practitioner appealed to the High Court in respect of the orders made by the DC.
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(E) No informed consent and inappropriate treatment
Case 6:
An orthopaedic surgeon faced 2 charges in relation to his treatment of his patient; the
first charge being that he performed the surgery for the excision of a fibromatous
lesion of about 2 cm in diameter on the left sole of the patient, without sufficiently
explaining to the patient the risk of nerve damage to the plantar nerve of the patient’s
left sole, and thereby failed to obtain the informed consent of the patient for the
surgery. The second charge was that the practitioner performed the surgery for the
excision of the fibromatous lesion under local anaesthesia (“LA”), when he knew or
ought to have known that the surgery should have been performed under general
anaesthesia (“GA”).
The complaint was noted to be made by the patient some 7 years after the incident.
The recollection of witnesses of fact and its reliability were difficult because the
records of the patient’s primary case notes had been destroyed by end of 2004, about 5
years after the patient’s last consultation in 1999.
Given the time lapse and the destruction of medical records and after hearing the
patient, the practitioner, the experts and witnesses, the Prosecution could not satisfy
the DC that it had been proven beyond all reasonable doubt that the complainant and
prosecution’s versions of facts were correct or that the respondent’s version was
wrong.
The DC decided to dismiss the case against the practitioner and acquit him of both
charges.
(F) No informed consent and improper delegation of duty
Case 7:
A hand surgeon faced 2 charges in relation to carrying out a body contouring
procedure by laser lipolysis, known as Smart Lipo (“Surgery”) on one of his patients.
The first charge involved the issue of informed consent. The second charge involved
the issue of medication given prior to a personal consultation with the patient. The
practitioner contested both charges.
At the conclusion of the inquiry, the DC acquitted the practitioner of the first charge
and convicted him on the second charge.
In relation to the first charge, the DC emphasised the importance of doctors ensuring
that proper informed consent is obtained. The purpose of obtaining informed consent
was to ensure that the patient had been informed of all options and that the doctor had
sufficiently explained the risks, side effects and nature of the procedure, and that the
patient understood these two elements. Taking of consent involves more than just
signing the consent form.
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However, the DC emphasised that there were inherent risks of obtaining informed
consent after the consumption of sedatives, as sedation is a potential barrier to
consent. The presence of sedation diminishes the likelihood that a patient can provide
informed consent, though it may not entirely preclude it. Doctors have a duty to
ensure that information is given to the patient in the most appropriate way and that
steps are taken to try to enhance the patient’s capacity to give informed consent.
Doctors must bear in mind the possibility that medication may adversely affect
capacity.
For the second charge, the DC referred to the SMC’s Ethical Code and Ethical
Guidelines (ECEG) which emphasise the importance of adequate personal
consultation by a medical practitioner before he supplies or prescribes medicines. This
was of particular importance considering that the present medication involved the
supply of diazepam, which has sedative effects.
The DC found that the Clinic had protocols and standing instructions in place for the
diazepam to be given to Smart Lipo patients as a standard pre-procedure medication.
The DC also noted that:- (i) the practitioner was the only medical practitioner
involved in the running of the Clinic, even though he was not the holder of the clinic
licence; (ii) the practitioner was aware of the protocols and standing instructions in the
Clinic; and (iii) the keys to the dispensary cabinet were held by the nurses.
The DC found from the evidence that the nurses were given full autonomy, such that
they were able to administer and dispense medication (including benzodiazepines)
without the requirement for a medical consultation or a doctor’s written instructions.
It was found that the practitioner had presumed that the nurses would supply the
diazepam only after the patient had seen him. However, the practitioner took no steps
to check whether the patient had been given diazepam. After seeing the patient, the
practitioner did not give instructions for the diazepam to be administered, assuming
that it would be done. The DC was of the view that there was an absence of
accountability and control measures which are normally expected in a medical clinic,
in particular, with regard to the control of, access t o and prescription and
administration of medicines. In this regard, the DC also emphasised that the
practitioner had not demonstrated the clinical responsibility, supervision and
leadership expected of him, as the only doctor in the clinic.
The DC relied on the terms of SMC’s ECEG, which, while permitting the delegation
of duties, imposes upon the doctor the need to ensure effective supervision. In short,
the doctor may delegate his duties but not his responsibilities.
In these circumstances, the DC was satisfied beyond a reasonable doubt that the
practitioner had extensively delegated his power and duty to prescribe and supply
diazepam, and had failed to exercise the necessary supervision in relation to the
prescription and supply of the diazepam.
Accordingly, the DC was of the view that the second charge was made out beyond
reasonable doubt and convicted the practitioner of the second charge. The practitioner
was fined $2,000; censured; ordered to give a written undertaking that he will not
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engage in the conduct complained of in the second charge or any similar conduct and
to pay 80% of the costs and expenses of and incidental to these proceedings, including
the costs of the solicitor to the Council and the Legal Assessor.
(G) Breach of SMC ethical code and ethical guidelines
Case 8:
A plastic surgeon was charged with offering to and performing on his patients, cell
therapy involving the injection of xenogenic (animal) foetal cells into humans (“Cell
Therapy”) for anti-ageing and rejuvenation purposes, a procedure that was not
generally accepted by the medical profession, outside the context of a formal and
approved clinical trial. The practitioner pleaded guilty to the charge.
The DC found that the Cell Therapy offered and performed by the practitioner was not
a generally accepted method of treatment and was of the view that the only situation
where Cell Therapy could be offered and performed was in the context of a formal
and approved clinical trial.
The DC noted that patients primarily rely on the advice given to them by their doctors
due to the imbalance in the level of knowledge and experience between doctor and
patient. The DC pointed out that most patients who seek treatment from doctors who
perform aesthetic procedures, do so out of a perceived sense that their appearances
can be improved. Such patients will naturally seek out doctors who are known to be
experienced in aesthetic procedures. Whilst such patients may have a cursory
knowledge of the laudatory claims made in magazines and articles regarding aesthetic
procedures, they are unlikely to have the necessary knowledge or experience to make
determinations on the appropriateness of medical procedures. It is therefore important
that patients can trust and rely on the advice of their doctors.
The DC referred to the SMC Ethical Code and Ethical Guidelines (ECEG) which
provide, inter alia, that “A doctor shall not offer to patients, management plans or
remedies that are not generally accepted by the profession, except in the context of a
formal and approved clinical trial ”.
The DC stated that strict adherence to the ECEG is necessary to uphold the trust that
the public reposes in doctors. Each time a doctor fails to abide by the provisions of the
ECEG, this trust is eroded. The profession, as a self-regulating body, then has to take
the necessary steps to ensure that this trust is restored.
The DC emphasised that doctors must be subject to the exacting standards that the
profession has set for itself. A doctor is not at liberty to perform a particular procedure
without ensuring that the general body of doctors approve. The basis for requiring
such exacting standards from doctors is to protect the public from harm that may be
caused by methods of treatment that are not evidence-based or not generally accepted
by the medical profession. Such standards are also necessary for the medical
profession to maintain the trust and confidence of society. The public is entitled to
believe that doctors will guarantee professional competence and integrity to society.
The DC commented that current knowledge is inadequate in determining the desired
action of human or autologous cells injected into human anti-ageing and rejuvenation,
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and it is even more doubtful when xenogenic cells are used for this purpose. Any
such experimental procedure ought to be rigorously reviewed by an Institutional
Review Board before it can be performed. The DC noted that the practitioner was
aware from the outset that Cell Therapy was not a generally accepted method of
treatment, and as a senior doctor, must have been aware of the requirement to obtain
the approval of an Institutional Review Board to conduct a clinical trial.
The practitioner was fined $5, 000; censured; ordered to give a written undertaking to
abstain in future from the conduct complained of or any similar conduct; and to pay
the costs and expenses of and incidental to these proceedings, including the costs of
the solicitor to the Council and the Legal Assessor.
Case 9:
The proceedings arose out of a complaint by a patient against a general practitioner. In
September 2006, one of his patients consulted the practitioner for aesthetic treatment.
From October 2006 to April 2007, the practitioner administered aesthetic LASER
treatment on the patient’s face.
Sometime in 2007, 2 photographs of the patient, taken in the course of the patient’s
treatment, were published in a local magazine without the patient’s consent. This
resulted in a complaint by the patient against the practitioner.
The practitioner pleaded guilty to (i) a charge of having breached his responsibility to
maintain medical confidentiality in respect of the patient, by disclosing or allowing
the disclosure of two photographs taken by him without the patient’s consent (the
“First Charge”); and (ii) a second charge in that he had associated himself with
persons not qualified to provide medical or medical support services (the “Second
Charge”).
In coming to its decision, the DC considered the mitigating factors presented by the
practitioner’s counsel: (i) that the practitioner had pleaded guilty and had co-operated
with the authorities at all times; (ii) that, in respect of the First Charge, the offence
was not committed deliberately and was due to an inadvertent error; (iii) upon
discovery of the disclosure, the practitioner had taken immediate steps to ascertain the
circumstances and tendered an apology to the patient; (iv) in respect of the Second
Charge, that the practitioner had taken steps to ensure that the clinic complied with the
relevant regulations governing the licensing of the clinic, and to disassociate the spa
business from the operations of the clinic; (v) there was no act which brought the
medical profession into disrepute; and (vi) that the practitioner will seek to terminate
the arrangement for the supply of medical services to the clinic. The DC concluded
that the confidentiality of a patient’s treatment and records is a fundamental tenet of
medical practice. The DC al so highlighted that the SMC Ethical Code and Ethical
Guidelines had stated very clearly the obligations and duties of a medical practitioner
to preserve the confidentiality of a patient.
The DC viewed that this failure to maintain the confidentiality of a patient’s record is
a serious breach by a medical practitioner and that in the present case, the breach was
all the more disconcerting as it involved the publication of photographs of the patient
from which she could be and was identified in a local magazine. While the DC noted
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that the disclosure might be due to an inadvertent error by the practitioner, the DC
also noted that the patient was distressed by her discovery of the publication.
The DC also took the view that in respect of the Second Charge, the association by a
medical practitioner with persons not qualified to provide medical or medical support
services is wholly unacceptable. Notwithstanding the attempts to disassociate the
clinic’s operations from that of the spa’s business, the practitioner should not have put
himself into that difficult position in the first place by entering into the service
agreement with the clinic.
The practitioner was fined $5,000; censured; ordered to give a written undertaking
that he will not engage in the conduct complained of or any similar conduct; that he
will furnish to the Council within 30 days written evidence of the termination of the
service agreement with the clinic; and to pay the costs and expenses of and incidental
to these proceedings, including the costs of the solicitor to the Council and the Legal
Assessor.
(H) Excessive / inappropriate prescription of drugs (Benzodiazepines)
Case 10:
A general practitioner contested 21 charges related to the prescription of hypnotic
medication (benzodiazepines) to 21 of his patients. The charges were that he failed to
exercise due care in the management of his patients in the prescription of hypnotic
medication. He di d not record or document i n the Patient Medical Records, details or
sufficient details of his patients’ diagnosis, symptoms and/or condition, and/ or any
management plan to justify the continued prescription of hypnotic medication over the
period of treatment. The practitioner also failed to refer the patients to a medical
specialist and/or psychiatrist for further assessment and/or management. The DC
convicted the practitioner of 20 charges and acquitted him of the remaining charge.
The DC considered the various factors brought to their attention including, in
particular, the following:
the credibility of the practitioner’s testimony. The practitioner had changed his case
on the use of benzodiazepines for certain patients to being treatment for anxiety, when
it was his initial case that the treatment was for chronic insomnia;
the practitioner’s disagreement with the report on concurrent prescription by his
expert witness;
the practitioner had an antecedent conviction as he was previously convicted of 7
charges of over prescription of hypnotic drugs and 1 charge of failing to keep proper
records. For those past offences, the DC ordered that the practitioner’s name be struck
off the Register of Medical Practitioners (“the Register”) in 1993. The practitioner
was restored to the Register some 2 years later in 1995. The DC also noted that during
the practitioner’s application for restoration, he had assured the Council of better
management and treatment of his patients. However, in spite of that assurance, the
practitioner’s misconduct in the present charges had the same elements as those of the
charges against him in his previous antecedent. The DC noted that the present
offences involved long periods of usage of benzodiazepines and hypnotics by the
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patients involved, with little attempt on the practitioner’s part to taper off the dosage
and eradicate the dependence of these patients on such medication. Accordingly, the
DC was not convinced that the practitioner was remorseful for his acts; and
the DC was al so of t he vi ew that a more serious punishment was war r ant ed becaus
e of t he publ i c interest element, i. e. the necessity to keep away from the public,
harm which may be caused by inappropriate prescription of hypnotic medication.
Further to that, the DC was also of the view that there was a need to send a clear
signal to all medical practitioners that blatant disregard of the standards of the
profession or of the guidelines prescribed to the profession will not be taken lightly.
Also, given the facts of t he pr esent case as wel l as t he overwhelming evidence in
support of the charges against the practitioner, the DC was of the view that it was
entitled to take into consideration the fact that there was no plea of guilt by the
practitioner in determining the sentence against him.
The practitioner’s name was removed from the Register of Medical Practitioners and
he was ordered to pay the costs and expenses of and incidental to these proceedings,
including the costs of the solicitor to the Council and the Legal Assessor.
Case 11:
A general practitioner pleaded guilty to 7 charges of failing to exercise due care in the
management of his patients in the use of hypnotics / benzodiazepines, specifically:
his management of his patients was inappropriate in that he did not formulate any
long-term management plan for the treatment of his patients’ medical conditions;
he did not record or document in his patients’ Patient Medical Records, sufficient
details of his patients’ diagnoses, symptoms and conditions;
he failed to carry out adequate assessment s of his patients’ medical conditions over
the periods of treatment;
he failed to refer his patients to specialist treatment for his patients’ conditions in a
timely manner; and
where benzodiazepines were prescribed, he had breached the MOH’s Guidelines for
Prescribing Benzodiazepines dated 17 August 2002.
The practitioner was suspended from medical practice for 3 months; fined $2,000;
censured; ordered to give a written undertaking that he will not engage in the conduct
complained of or any similar conduct and to pay the costs and expenses of and
incidental to these proceedings, including the costs of the solicitor to the Council and
the Legal Assessor.
Case 12:
The Complaints Committee referred a general practitioner to the Disciplinary
Committee (DC) and the Interim Orders Committee (IOC). The IOC held its inquiry
against the practitioner and ordered under Section 52(1)(a) of the MRA that the
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practitioner be suspended f or a per i od of 1 year with immediate effect , or until the
conclusion of the DC inquiry, whichever was earlier.
The practitioner faced 18 charges of professional misconduct under Section 45(1)(d)
of the MRA in that he failed to exercise due care in the management of his patients.
All 18 charges related to inappropriate prescription of benzodiazepines as hypnotic
medication and cough mixtures containing codeine. The practitioner pleaded guilty to
all 18 charges.
The DC noted that benzodiazepines are prescribed as hypnotic medication for patients
who have insomnia or as anxiolytics for the short-term relief of anxiety and that longterm consumption of benzodiazepines and hypnotics may lead to drug dependence
and tolerance. The DC also noted that cough mixtures containing codeine carry the
potential for abuse by drug addicts and require careful practices in respect of
prescription. By the practitioner’s improper prescription of benzodiazepines and
cough mixtures, the DC considered that the practitioner had acted in disregard of his
professional duties and in a manner which was inappropriate, unprofessional and not
in accordance with the SMC Ethical Code and Ethical Guidelines.
The DC took cognizance of the fact that the practitioner underwent similar
proceedings in 2008 and that he was convicted on similar charges in 2008. The DC al
so noted by way of the practitioner’s mitigation, that he had not renewed his clinic
licence for practice since February 2009.
Whilst accepting that the previous conviction did not amount to an antecedent, the
practitioner’s previous conviction was nevertheless a factor taken into consideration
by the DC in relation to its decision to impose a heavier sentence on him.
The practitioner was suspended from medical practice for 30 months; fined $10,000;
censured; ordered to give a written undertaking that he will not engage in the conduct
complained of or any similar conduct and to pay the costs and expenses of and
incidental to these proceedings and the Interim Orders Committee Inquiry, including
the costs of the respective solicitors to the Council and the Legal Assessors.
Case 13:
A general practitioner pleaded guilty to 7 charges of failing to exercise due care in the
management of his patients, inappropriate prescription of benzodiazepine and failure
to record or document in the said patients’ Patient Medical Records, details or
sufficient details of the patients’ diagnoses, symptoms and/or conditions, and/or any
management plan such as to enable him to properly assess the medical condition of
the patients over the period of treatment.
In considering the appropriate sentence, the DC noted that benzodiazepines are
prescribed as hypnotic medication for patients who have insomnia or as anxiolytics
for the short-term relief of anxiety and as long-term consumption of benzodiazepines
may lead to drug dependence and tolerance, it is incumbent on all medical
practitioners to be appraised of current medical standards and prescribing practice, in
the interests of their practice and patients.
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In the light of the above, the DC considered the practitioner to have acted in disregard
of his professional duties since the prolonged prescription of benzodiazepines without
specialist referral or proper medical records was inappropriate and unprofessional.
In coming to a decision on the sentence, the DC was also mindful of the mitigating
factors presented, including the fact that the benzodiazepines were of low dosages,
that the practitioner had pleaded guilty and co-operated fully, that he had a long clean
record and that he had ceased practice after December 2008. The DC also took into
consideration the relatively low number of 7 charges.
The practitioner was suspended from medical practice for 3 months; fined $1,000;
censured; ordered to give a written undertaking that he will not engage in the conduct
complained of or any similar conduct and to pay the costs and expenses of and
incidental to these proceedings, including the costs of the solicitor to the Council and
the Legal Assessor.
(I) Excessive/ inappropriate prescription
codeine containing Medication)
of
drugs (Benzodiazepines and
Case 14:
A general practitioner pleaded guilty to 15 charges of failing to exercise due care in
the management of his patients. Of the 15 charges, 8 related to the dispensation of
hypnotic drugs (benzodiazepines) and cough mixtures containing codeine while the
remaining 7 related to the dispensation of cough mixtures containing codeine.
The practitioner failed to exercise due care in the management of his patients in that
he had inappropriately prescribed the various medications to his patients; failed to
record or document in the Patient Medical Records, details or sufficient details of his
patient’s diagnosis, symptoms and/or conditions, and/or advice given and/or any
management plan such as to enable him to properly assess the medical condition of
his patient over the period of treatment; and he had failed to refer his patients to a
medical specialist and/or psychiatrist for further management.
The DC was of the view that benzodiazepines and cough mixtures containing codeine
were two types of common medication that were abused by patients. The intent of the
Ministry of Health in implementing the Guidelines for Prescribing Benzodiazepines
(2002) and Guidelines in relation to the Sale and Supply of Cough Mixtures
containing Codeine (2000) was therefore to prevent such substance abuse. The DC
expressed a need to send a strong reminder to medical practitioners to be more
circumspect when prescribing such medication.
In considering the orders to be made, the DC acknowledged that the practitioner was a
first time offender who indicated, at the earliest opportunity possible, that he intended
to enter a plea of guilt. The DC noted that the practitioner had voluntarily closed down
his practice and also took into account the various testimonies of his character.
The practitioner was suspended from practice for a period of 6 months; fined $5,000,
censured, ordered to give a written undertaking that he will not engage in the conduct
complained of or any similar conduct and to pay the costs and expenses of and
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incidental to these proceedings, including the costs of the solicitor to the Council and
the Legal Assessor.
Case 15:
A general practitioner pleaded guilty to 22 charges of failing to exercise due care in
the management of his patients. Of the 22 charges, 16 were related to the
inappropriate prescription of benzodiazepines and codeine containing medication, 4
were related to the inappropriate prescription of benzodiazepines and 2 were related to
the inappropriate prescription of codeine-containing medication.
In considering the appropriate sentence, the DC considered the mitigating factors
presented by the practitioner’s counsel. In particular, the DC noted his remorse for his
actions which was manifested in the fact that the practitioner had chosen to enter a
plea at the earliest opportunity, the fact that he was a first-time offender and the
written testimonials of his patients who had spoken well of him.
The DC had also considered the fact that the misconduct by the practitioner was of a
serious nature. There was undoubtedly an issue of public interest and doctors must be
reminded that the failure to exercise due care i n prescribing such hypnotic medicines
may lead to problems of addiction and drug abuse. In particular, the DC noted that in
some instances, such medications were issued in high quantities within very short
periods to his patients.
The practitioner was suspended from medical practice for 6 months; fined $10,000;
censured; ordered to give a written undertaking that he will not engage in the conduct
complained of or any similar conduct and to pay the costs and expenses of and
incidental to these proceedings, including the costs of the solicitor to the Council and
the Legal Assessor.
(J) Excessive / inappropriate prescription of drugs (Benzodiazepines and other
drugs)
Case 16:
A general practitioner pleaded guilty to 23 charges (ranging from as early as 1988 to
2003) of failing to exercise due care towards his patients in that he inappropriately
prescribed medication to patients without consultation and/or medical examination.
The medications prescribed included Dormicum, Valium, Phensedyl, Phenobarbitone,
Amoxicillin, Artane, Carbimazole and Atenolol. In particular, the DC noted that the
practitioner had engaged in inappropriate prescribing practice by regularly prescribing
benzodiazepines to patients without exercising diligence and care, thereby making the
patients physically and/ or psychologically dependent on the drugs.
The practitioner was suspended from medical practice for 6 months; fined $3,000;
censured; ordered to give a written undertaking to abstain in future from the conduct
complained of or any similar conduct and to pay the costs and expenses of and
incidental to these proceedings, including the costs of the solicitor to the Council and
the Legal Assessor.
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(K) Excessive / inappropriate prescription of drugs (Subutex)
Case 17:
A general practitioner pleaded guilty to 11 charges of failing to exercise due care in
the management of his patients in that: (i) he did not formulate and/or adhere to any
management plan for the treatment of the patients’ medical condition by the
prescription of Subutex; and/or (ii) he did not record or document in the patients’
Patient Medical Records, details or sufficient details of the patients’ diagnoses,
symptoms and/or condition and/or any management plan such as to enable him to
properly assess the medical condition of the patients over the period of treatment. The
practitioner also admitted that he had failed to exercise due care in the management of
his patients by not registering the patients and their prescriptions in the Central
Addiction Registry of Drugs (“CARDS”) after 26 October 2005.
The practitioner was suspended from medical practice for 3 months; fined $2,500;
censured; ordered to give a written undertaking that he will not engage in the conduct
complained of or any similar conduct and to pay the costs and expenses of and
incidental to these proceedings, including the costs of the solicitor to the Council and
the Legal Assessor.
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(l) Excessive /
Benzodiazepines)
Inappropriate
prescription
of
drugs
(Subutex
and
Case 18:
A general practitioner pleaded guilty to 14 charges for failing to exercise due care in
the management of his patients. Of the 14 charges, 8 charges related to inappropriate
prescription of both Subutex and benzodiazepines as hypnotic medication and 6
charges related to inappropriate prescription of Subutex alone.
The practitioner had appeared before two other Disciplinary Committees prior to the
proceedings. These two other Disciplinary Committee (DC) Inquiries were concluded
in 2008 and 2009, respectively. The practitioner was currently serving a 30-month
suspension sentence resulting from the 2009 proceedings. This suspension will
terminate in April 2012.
With regard to the prescription of Subutex and benzodiazepines, the DC, in the course
of its deliberations, noted that :
the raid on the practitioner’s clinic in March 2006 led to the 2008 proceedings relating
to the prescription of Subutex and benzodiazepines to patients;
the Subutex and benzodiazepines charges that the practitioner faced in the 2009
proceedings were in relation to another separate and distinct raid which took place in
August 2006;
the DC noted that the practitioner had continued to prescribe Subutex and
benzodiazepines despite the March 2006 raid.
In general, sentences are ordered to run from the date of the order. However, in
determining the appropriate period of the sentence, the DC was of the view that there
were sufficient reasons for the sentence to r un only after the end of the practitioner’s
current suspension.
The practitioner was suspended from medical practice for a further 3 months to
commence at the end of his current 30-month suspension; fined $5,000; censured;
ordered to give a written undertaking that he will not engage in the conduct
complained of or any similar conduct and to pay the costs and expenses of and
incidental to these proceedings, including the costs of the respective solicitors to the
Council and the Legal Assessors.
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APPENDIX 6 - 8
Appendix 6: 205-012 CIRB SAE Reporting Form v1.3
03 Appendix
205-012 CIRB SAE Reporting Form v1.3.doc
Appendix 7: 207-001 Consent Document Template v2G
03 Appendix
207-001 Consent Document Template v2G.doc
Appendix 8: 207-001 Consent Forms Only Original and Modified
03 Appendix
207-001 Consent Forms Only Original and Modified.doc
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APPENDIX 9
Appendix 9: Email Correspondence
Confirmation email from Professor Leonardo D de Castro (then Head of Capacity
Development, Bioethics Advisory Committee).
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