Legal and Ethical Issues in
Medicines Information
Maggie Fitzgerald
Medicines Information Pharmacist
8th January 2008
Acknowledgements: Richard O’Neill; Advancing the
Provision of Pharmacy Law and Ethics Teaching - APPLET
(Nottingham University)
Session aim
 Identify legal and ethical problems that may
be encountered when providing medicines
information.
Plan
Medical Heath Law & ethics
 Legal aspects
 Professional codes
 Ethics
Legal aspects
 DEFINITIONS
– Statutory law
– Common (case) law
– Public law and Private law
– Criminal law and Civil law
The concept of medical (health
care) law
 A branch of law.
 Healthcare professionals (including institutes) and
patients.
 Covers a lot of areas of law: tort, criminal, public
and administrative law, and family law.
 Ethical issues are involved in all the problems that
arise in medical law.
Professional Negligence
 Negligence
“We must take reasonable care to avoid acts and
omissions which you can reasonably foresee
would be likely to injure your neighbour ...”
Lord Atkin in Donoghue v Stevenson (1932)
Professional Negligence
Requirements for proving negligence:
– Duty
– Breach
– Causation
Professional Negligence
 English Law
 The duty of a health care professional is to
exercise reasonable care and skill.
– What is reasonable?
Bolam v Friern Hospital
Committee 1957
“A person is not negligent if they acted in
accordance with accepted practice at the
time as decided by a responsible body of
competent professional opinion.”
Professional Negligence
 Gross negligence.
 Criminal prosecution.
 Prosecution must prove (beyond reasonable
doubt)
– Existence of duty
– Breach of duty causing death
– Gross negligence to justify a criminal
conviction
Data Protection Act 1998
 DPA 1998 effective from March 2000.
 Provides a framework that governs the
processing of personal data of the living.
 Seeks to strengthen the individual’s right to
privacy in terms of data processing by
applying 8 principles.
Data Protection Act 1998
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1. Personal data shall be processed fairly and lawfully
2. Personal data shall be obtained for one or more specified lawful
purposes and not further processed
3. Personal data shall be adequate, relevant and not excessive
4. Personal data shall be accurate and kept up to date
5. Personal data shall not be kept for longer than is necessary for that
purpose
6. Personal data shall be processed in accordance with the rights of
data subjects under this Act
7. Measures shall be taken against unauthorised or unlawful processing
of personal data and against accidental loss or damage
8. Personal data shall not be transferred out of the European Economic
Area
Freedom of Information Act 2000
 The Act gives right to access information held by
public bodies including the NHS
 If patients wish to obtain information about
themselves then the DPA 1998 applies.
 If the information is not about them but about a
public authority then the FOI applies.
Copyright
 Changes in NHS licence
 centrally negotiated NHS copyright agreement with
CLA www.cla.co.uk
 What’s allowed
 Staying legal
 Outcomes of breaching
Confidentiality
 Professional obligation – moral duty
– Hippocratic oath
• Whatever I see or hear, professionally or privately,
which ought not to be divulged, I will keep secret
and tell no one.
– Geneva Declaration
• I WILL RESPECT the secrets which are confided in
me, even after the patient has died
– Professional guidelines
• Codes of Ethics & Practice
Human Rights Act 1998
 Establishes the right to respect for private
and family life.
 Underscores the duty to protect the privacy
of individuals and preserve the
confidentiality of their health records.
Information
information confidential in nature
information imparted in circumstances that
impose/confer obligation on confident to
respect confidentiality
Breach of confidentiality
Justifications:
– Statutory requirements
 patient threatens harm to self
 patient threatens harm to others
 when required by law:
– communicable disease
– occupational diseases
– suspected abuse
Confidentiality in the NHS
Ethics & Guidelines
Statutes relating to
patient information
in health records
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professional ethical codes
professional guidelines
NHS guidelines
contract of employment
Caldicott Guardians
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Data Protection Act 1998
Access to Medical Reports
1988
Access to Health records Act
1990
Access to Personal Files Act
1987
Caldicott Principles
– Principle 1 - Justify the purpose(s) for using
confidential information
– Principle 2 - Only use it when absolutely necessary
– Principle 3 - Use the minimum that is required
– Principle 4 - Access should be on a strict need-to-know
basis
– Principle 5 - Everyone must understand his or her
responsibilities
– Principle 6 - Understand and comply with the law
Confidentiality breach in the
NHS
Possible consequences
• complaint to the Information Commissioner for breach of
the Data Protection Act 1998
• professional disciplinary proceedings (misconduct)
• employer disciplinary proceeding (breach of contract of
employment)
• civil court action - breach of confidence
• criminal court action where breach of statute
Case Study: Confidentiality
 You’re in MI and have completed an
enquiry due for 5.30pm. It’s now 5.25pm
and the caller really wanted the answer by
the end of the day.
 You call the enquirer on their landline and
get voicemail. It’s the only contact number
you have for them. Their answer phone
activates.
Gillick Competence - Consent
Special cases
– children
• with capacity– obligation of confidence
• without capacity– law requires ‘best
interests’ approach
Case Study: Consent
 A patient doesn’t speak English and is receiving
chemotherapy at the hospital.
 Her family translate to her what the hospital staff
say.
 You tell the family that this particular chemo can
cause hair loss as a side effect.
 The family decide not to tell the patient this since
they know it will upset her.
 The patient has to sign the consent form for
chemo.
Professional codes
 DEFINITIONS
– Accountability
– Character traits
– Ethical code
– Professional etiquette
– Responsibility
Code of ethics
 Codes of Ethics
 Professional responsibilities
• duties and obligations
 Professional relationships
• professional behaviour
• good communication
 Accountability
Guidance
• General
– Medicines, Ethics and Practice Guide: a guide for
pharmacists
• Act in the interest of patients and other members of
the public
• Ensure knowledge, skills and practice are up to date
• Demonstrate integrity and probity, adhere to
accepted standards of conduct and do not bring the
profession into disrepute
• Specific
– UKMi Guidance
• Police, media, third party, legal proceedings…..
Ethics
 DEFINITIONS
– Values
– Morals
– Ethics
– Ethical dilemma
 THE CONCEPT OF ETHICS
– ‘ethics’ is derived from the Greek term ethos,
which means customs, habitual usage, conduct,
and character
Common ethical (moral) theories
 Teleology - actions are ‘right’ or ‘wrong’ according to the
balance of their good or bad consequences
 Utilitarianism is a teleological theory that judges acts
based on their utility or usefulness
 Deontology - actions are performed out of duty or moral
obligation; every person is an end and not solely a means
to another person’s end.
 Virtue theory - places value on the moral character of
the actor rather than acts or outcomes of acts
 Consequentialism – considers the consequence of the
action with a view to doing the greatest good for the
greatest number.
Bioethical principles
 Four Major Bioethical Principles in
Healthcare
 The Principle of Autonomy
 The Principle of Non-Malficence
 The Principle of Beneficence
 The Principle of Justice
The Principle of Autonomy
 Principle of self-rule
 right to participate in and decide on a course
of action; freedom to act independently
 competent adult’s informed decision to
refuse (even life-saving) treatment
supersedes offer of treatment
The Principle of NonMaleficence
 Principle of avoiding harm to the patient
 justification for ‘acts and omissions’
distinction in law (withholding/withdrawing
treatment that is not benefiting patient)
The Principle of Beneficence
 Principle of doing what is best for the
patient
 promotion of patient’s best interests
 prevent or remove harm
 encompasses sanctity of life principle
 when in conflict, non-malficience
supersedes the principle of beneficence.
The Principle of Justice
 Principle based on fairness, equity and
equality
 treat similar cases in similar ways
 distribute health care resources (goods and
service) fairly
 proper distribution of benefits and burdens
Ethical decision-making within
healthcare
 Autonomy, non-malficience; beneficence; and
justice.
 Principles for ethical decision-making:
- respect the autonomy of the individual
- avoid harm
- where possible achieve benefit
- consider, fairly, the interests of all those
affected
Case Study : Ethics
 What should you say to a patient who
phones the Helpline to ask how many
tablets of drug X they need to take to kill
themselves?
Framework for ethical decisionmaking
Begin by learning to recognise a moral issue
Step 1: Gather all relevant information
Step 2: Identify and clarify the ethical problem(s)
Step 3: Analyse the problem by considering the
various ethical theories or approaches
Step 4: Explore the range of options or possible
solutions
Step 5: Make a decision
Step 6: Implement and then reflect on the decision
Guiding principles when dealing
with dilemmas
 respect for autonomy of the patient (self-
determination)
 beneficence (do good)
 non-malficience (do no harm)
 fidelity (truthfulness and confidentiality)
 veracity (honesty)
 justice (equitable distribution of benefits/burdens)
There is often no right answer
Any questions?