Introduction to Laws, Rules and Regulations
OBJECTIVES/RATIONALE
Pharmacists have a legal and ethical responsibility to their clients to provide quality service. The
student will know the ethical and legal responsibilities of pharmacist and pharmacy technicians
and will describe the legal terms and consequences associated with prescription errors. The
student will explain the meaning of the terms negligence and malpractice, product liability, and
regulatory law, describe how to act in case of medication errors and what potential liabilities may
ensue, discuss the proceedings of a lawsuit, explain how to defend oneself and act appropriately
in case of litigation, describe the concepts of duty, liability, causation, and burden of proof,
define professional liability, explain the employer’s responsibility for the acts of and employee,
the rights of the employers against the employee to recoup losses, and cite the distinctions among
various areas of the law.
TEKS: 121.25 1C, 1E, 1F, 3A, 3B, 3C, 3D, 3E, 3F, 3G, 5G
TAKS ELA 1, 2, 3, 4, 5
Social Studies 4
KEY POINTS
I.
II.
Regulatory Authority
A.
Regulatory Law
1.
rules and regulations promulgated by government agencies, e.g. FDA,
DEA, pharmacy boards, etc., at local, state and federal levels
2.
“enabling statute” enacted by legislative body empowers regulatory agency
with rights to make rules and regulations for enforcement of law
3.
pharmaceutical industry and related professions highly regulated
4.
imperative for practitioner to be familiar with rules and regulations
pertaining to pharmacy practice in area of practice
5.
if practitioner moves to another area must familiarize self with laws and
regulations of new area
6.
violation of regulation can be considered negligence per se and can lead to
disciplinary action
B.
Regulatory Agencies
1.
FDA
2.
DEA
3.
DPS
4.
Pharmacy Board
Negligence/Malpractice
A.
in professional practice negligent act commonly referred to as malpractice
1.
differs from common negligence in that it requires a breach of a duty arising
from professional relationship
2.
different than breach of general duty of care people commonly owe to each
other
3.
negligence includes
a.
nonfeasance – failure to act
b.
malfeasance – commission of a substandard act
i.
example: in France vs. State of New York “Failure of
druggist to provide claimant with his medication for one
month did not meet requisite level of care for a druggist;
therefore he was negligent.” This represents nonfeasance
which resulted in injury
ii.
knowledge of medication error and failure to act to correct
it can be considered negligent because of nonfeasance
iii.
dispensing wrong medication malfeasance because
involves negligent act
B.
when professional obligation to act ignoring situation not a defense
III.
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
a.
not all medically related errors lead to litigation – very few do
b.
in case of lawsuit
i.
don’t panic
ii.
don’t threaten anyone
iii.
be careful regarding what he or she says and with whom to
discuss the matter
IV. Rules and regulations
A.
a rule is an operating procedure by which an agency goes about implementing its
processes
B.
a regulation is analogous to law
C.
failure to comply with regulation can result in disciplinary action against
noncomplier
ACTIVITIES
I.
II.
Collect newspaper articles regarding legal issues in the pharmaceutical practice.
Discuss in small groups.
Visit Federal Drug Administration and Drug Enforcement Agency websites and write
summative report of information available, include laws and regulations.
MATERIALS
Newspaper clippings and periodicals about legal issues in pharmaceutical practice
Policy and procedure manual (copies) from hospital and community pharmacies
Computer with Internet Access
ASSESSMENT
Writing Rubric
ACCOMMODATIONS
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.
REFLECTIONS