Introduction to Laws, Rules and Regulations
Course
Practicum in
Health SciencePharmacology
Unit
Ethics and Legal
Responsibility
Essential
Question
Why is it
important for a
pharmacist to
follow local and
federal laws that
apply to their
career?
TEKS
130.205 (c)
2A, 3A, 4A, 4B,
4C
Prior Student
Learning
none
Estimated time
3 to 5 hours
Rationale
Pharmacists have a legal and ethical responsibility to their clients to provide
quality service.
Objectives
Upon completion of this lesson, the student will be able to:
 Know the ethical and legal responsibilities of pharmacist and
pharmacy technicians
 Describe the legal terms and consequences associated with
prescription errors
 Explain the meaning of the terms negligence and malpractice, product
liability, contributory negligence, and regulatory law
 Describe how to act in case of medication errors and what potential
liabilities may ensue
 Discuss the elements of a lawsuit
 Define professional liability
Engage
View online video clips showing pharmacists arrested for illegally trafficking
prescription drugs. Many options available with Internet search.
* Remember to follow your school district policy for viewing videos.
Or
Discuss the sale of prescription drugs brought from Mexico and sold at flea
markets. What are the legal problems associated with selling and buying
these drugs? Why do people risk getting medication from other sources?
Key Points
I. Competent adults are liable, or legally responsible, for their own acts,
both on the job and in their private lives.
A. Employers are liable for their employees in regards to
1. Building and grounds – adequate upkeep to prevent injury
2. Automobiles – if an employee uses their own car or their
employer’s car, the employer must be adequately insured in case
of an accident
3. Employee safety – a comfortable and safe work environment
II.
As professionals we are responsible for our actions (or failure to act)
under a reasonable standard known as the Standard of Care
A. Professionals are held to a higher standard and may be held liable
for negligence.
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B. Healthcare workers must be careful in the duties they perform; if they
perform duties commonly assigned to those with a higher level of
training and expertise, they may legally be held to a higher standard
of care.
III. Privacy, Confidentiality, and Privileged Communication
A. It is a healthcare professional’s ethical and legal duty to safeguard a
patient’s privacy
B. Confidentiality is the act of holding in confidence information that is
not to be released to unauthorized individuals
C. Privileged communication is information held confidential within a
protected relationship
D. Medical office confidentiality should be maintained:
1. Do not release information to a third party without a signed
consent
a. when talking on the phone regarding test results, be sure no
one else can hear
b. when leaving a message on an answering machine, just tell
the patient to call the office regarding their recent appointment
2. Do not decide confidentiality on the basis of your personal
approval of the thoughts and actions of the patient
E. Confidentiality may be waived
1. If the patient sues the physician for malpractice
2. If the patient signs a waiver to release information
IV. Tort of Negligence
A. Unintentional tort of negligence is the basis for malpractice claims
1. Tort -- a civil wrong committed against a person or property,
excluding a breach of contract.
2. Negligence -- an unintentional tort alleged when one may have
performed or failed to perform an act that a reasonable person
would or would not have done under similar circumstances
B. Medical professional liability claims are classified in three ways:
1. Malfeasance – a performance of a totally wrongful and unlawful
act
2. Misfeasance – a performance of a lawful act in an illegal or
improper manner
3. Nonfeasance – a failure to act when one should have
C. The four elements that must be present to prove a healthcare
professional is guilty of negligence:
1. Duty – a person charged with negligence owed the duty of care to
the victim
2. Derelict – a healthcare provider breached (failed to comply) the
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duty of care to the patient
3. Direct Cause – a breach of duty was the direct cause of the
patient’s injury
4. Damages – monetary awards sought by the plaintiffs (patients) in
the lawsuit where there is a legally recognizable injury to a person
D. Product liability – representatives who make products available to the
public are held responsible for the injuries those products cause
V. Contributory Negligence – in common law jurisdictions, if a person was
injured in part due to his/her own negligence, the injured party would not
be entitled to collect any damages from the other party who may have
caused the injury.
VI. Elements of a Lawsuit
A. Patient feels he or she has been injured
B. Patient seeks the advice of an attorney
C. Attorney believes the case has merit, and requests copies of
patient’s medical records
D. Pleading Phase
1. Patient’s attorney files a complaint with the court
2. Summons is issued by the court, and is delivered to the
defendant
3. Defendant’s attorney files an answer to the summons
4. Cross complaint is made and the patient files a reply
E. Interrogatory or Pretrial Discovery Phase
1. Trial date is set by the court
2. Pretrial motions may be made, such as a dismissal or
amendment of the original complaint
3. Court order (subpoena) is issued requiring that a deposition
(sworn testimony) be taken from a medical office employee;
[someone] may request an interrogatory, which is a written set of
questions requiring written answers
4. Pretrial conference with the judge, where attorneys discuss the
issues in the case
F. Trial Phase
1. Jury selection
2. Opening statements by both attorneys
3. Witnesses take the stand
4. Closing statements by both attorneys
5. Jury’s verdict
6. Final judgment is handed down by the court
G. Appeals Phase
1. Post-trial motions filed
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2. Appeal the case to a higher court
H. Nine out of ten lawsuits are settled out of court, but many times
healthcare practitioners are asked to give testimony. There are two
kinds of testimony:
1. Fact – these are only the actual facts the witness has observed
2. Expert – must have relevant education, skills, knowledge, and
experience in order to be judged as an expert in the trial
VII. Alternative Dispute Resolution
A. As court calendars become overcrowded, alternative dispute
resolution has become increasingly popular. Alternative Dispute
Resolution consists of techniques for resolving civil disputes without
going to court.
B. Methods used are arbitration and mediation:
1. Arbitration -- a method of settling disputes where both parties
abide by the decision of an arbitrator and the arbitrator is selected
directly by both parties.
2. Mediation -- a method in which a neutral third party listens to both
sides and resolves the dispute; the mediator does not have
authority to impose a solution
VIII. Regulatory Agencies
A. U.S. Food and Drug Administration (FDA)
B. Drug Enforcement Administration (DEA)
C. Texas Department of Public Safety (TxDPS)
D. Texas State Board of Pharmacy
IX. Medication Errors and Lawsuits
A. Imperative that steps are taken to prevent or minimize injury to the
patient
1. Notify individual in charge that error has occurred
2. When the error occurred
3. What was entailed in the error
4. Wrong medication should be retrieved
5. Proper medication provided along with notification of proper
authorities
6. If adverse reaction result of error notify appropriate personnel
7. In institutional setting consult Operations and Policy Manual in
effect
8. Failure to comply may be regarded as deviation from standard of
care
9. Documentation regarding error should not be altered – even
innocent changes may later be alleged as attempt to cover up;
not all medically related errors lead to litigation – very few do
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Activity
I. Complete the Contributory Negligence Worksheet.
II. Locate, analyze, and evaluate a newspaper/journal article regarding
legal issues in the pharmaceutical practice. See Journal Review
Guidelines.
III. Visit Food and Drug Administration and Drug Enforcement Agency
websites and write summative report of information available, include
laws and regulations. See worksheet.
Assessment
Writing Rubric
Materials
Articles about legal issues in pharmaceutical practice
Policy and procedure manual (copies) from hospital and community
pharmacies
Computer with Internet Access
U.S. Food and Drug Administration (FDA)
http://www.fda.gov/
Drug Enforcement Administration (DEA)
http://www.justice.gov/dea/index.shtml
Texas Department of Public Safety (TxDPS)
http://www.txdps.state.tx.us/
Texas State Board of Pharmacy
http://www.tsbp.state.tx.us/
Accommodations for Learning Differences
For reinforcement the student will design chart comparing various laws,
rules, and regulations with practical applications to the field of pharmacy.
For enrichment the student will research on actual law suits and present
summative report, written or verbal, e.g., editorial, TV-news documentary,
covering the class jigsaw project
National and State Education Standards
TEKS 130.205(c) (2)(A) accurately describe and report information, according to
facility policy, observations, and procedures;
130.205(c) (3)(A) demonstrate proficiency in medical terminology and skills
related to the health care of an individual
130.205(c) (4)(A) appraise individual ethical and legal behavior standards
according to professional regulatory agencies;
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130.205(c) (4)(B) integrate legal and ethical behavior standards such as
Patient Bill of Rights, Advanced Directives, and the Health Insurance
Portability and Accountability Act into the scope of practice; and
130.205(c) (4)(C) critique court cases related to professional liability and
ethics
Texas College and Career Readiness Standards
I. Nature of Science: Scientific Ways of Learning and Thinking
C. Collaborative and safe working practices
1. Collaborate on joint projects.
E. Effective communication of scientific information
1. Use several modes of expression to describe or characterize natural
patterns and phenomena. These modes of expression include narrative,
numerical, graphical, pictorial, symbolic, and kinesthetic.
2. Use essential vocabulary of the discipline being studied.
Copyright © Texas Education Agency, 2013. All rights reserved.
Contributory Negligence
A pharmacist refilled a patient's prescription incorrectly. The pharmacist admitted that he made
the mistake. However, he argued that the patient had been taking the medication for over 5
years and therefore should have known that the medication looked different and should not
have consumed it. The courts agreed that both the pharmacist and patient were negligent.
Research and present findings to the class.
What is negligence?
What is contributory negligence?
Does this scenario represent contributory negligence? Explain.
What states would allow this as contributory negligence?
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Journal Review Guidelines
1.
Journal:
 Write the name of the journal
 Underline the title
2.
Date:
 Write the date of the journal (journal articles must be less than two years old
3.
Main Idea:
 In your own words, write one complete sentence – subject and verb – that describes
the main idea of the entire article
4.
Supporting Details:
 Copy two sentences – exactly as they appear in the article – that support the main
idea
 Place quotation marks around each sentence
 Highlight the two sentences in the article
5.
Fact:
 Copy one factual sentence – exactly as it appears in the article
 Place quotation marks around the sentence
 Highlight the sentence in the article
6.
Non-Fact/Opinion:
 Copy one non-factual sentence – exactly as it appears in the article
 Place quotation marks around the sentence
 Highlight the sentence in the article
7.
Generalization:
 In your own words, describe the conclusion(s) you reached using complete
sentences. This must be something that is not stated directly in the article, but
something that you were led to believe after reading the article.
8.
Health Emphasis:
 In a complete sentence, describe how the article relates to health care.
9.
Occupations/Agencies:
 In a complete sentence, identify the agencies and occupations in the article.
10. Relationship to Health Science:
 In a complete sentence, list any units of study that relate to the article.
Copyright © Texas Education Agency, 2013. All rights reserved.
Food and Drug Administration and Drug Enforcement Agency
Scavenger Hunt
Go to the following links and find a recent update on the following:
http://www.fda.gov/
Drugs – drug safety
Medical devices – recalls and alerts -- product safety information – what items have been
recalled or what alters are posted
Radiation emitting products – tools and resources
Vaccines, Blood and Biological -- Navigate the Vaccines, Blood & Biologics Section
Animal and Veterinary – approvals and clearances
Cosmetics – the basics
http://www.justice.gov/dea/index.shtml
Resource center – controlled substances act
About – DEA history
-- Resource center – Controlled Substance Act
-- Drug disposal
Drug info – drug fact sheets – select one and print or download
-- Drug scheduling
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Writing Rubric
Student: ________________________________
Scoring criteria
Date: ___________________
4.
3.
Excellent Good
2. Needs
1. Needs
Some
Much
N/A
Improvement Improvement
The writing has all required parts from introduction to
conclusion in smooth transition.
The writing is interesting, supportive, and complete.
The writing demonstrates that the writer comprehends
the writing process.
Accurate spelling, grammar, punctuation.
Content of paragraphs emphasizes appropriate points.
The writer shows an understanding of sentence
structure, paragraphing, and punctuation.
All sources and references are clearly and accurately
documented.
NOTE: N/A represents a response to the performance which is "not appropriate."
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