Pharmacy Law and Ethics

(Pharmaceutical Jurisprudence)

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 - Part –I Ethics

Part II- Pharmacy Law

( Pharmaceutical JURISPRUDENCE )

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 Learning Objectives

• At the end of this course you will be able to -

• Distinguish among different types of law
used in pharmaceutical sectors.
• Discuss the role of pharmaceutical Law
executive agencies
• Explain the potential for tort actions under the
common law related to negligence and other
forms of malpractice

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 Pharmacy Law and Ethics

• Brain storming

• WHAT is Ethics & what is Law? ?

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 Ethics
 Is the science of Moral value.
 It is composed of moral beliefs and rules about
right and wrong.
 “ DO GOOD & AVOID EVIL”

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 Law
 Is a body of principles that govern conduct &
observance of which can be enforced in court.
 It demarcates what is permissible from what is
not.
 It must be obeyed & followed by citizens and is
subjected to legal citizens sanction or
consequences

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 Differences
• Both Ethics and Law are related to each other in that
both share the social purpose of encouraging the right
conduct. While,
• Law attempt to achieves its purpose through the
sovereign power of the government but
• Ethics attempt to achieves its purpose with out
government intervention.

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 Pharmaceutical Law

(Pharmaceutical jurisprudence? )

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 Pharmaceutical Law

 The science or philosophy of law governing

the pharmaceutical sector.
 deals with the aspect of law and legal concepts
in relation with the practice of pharmacy.

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 Contd…

• It is also restrictive like other laws.

- Pharmacy law give certain rights for a
pharmacy professional and it takes away
freedom for.
- e.g., It says a pharmacy personnel should
- possess certain training
- be registered & licensed to practice
pharmacy.
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 Types of Law
 Law occurs in a variety of hierarchical forms.
There is different types of law and the most
common ones are
 - Constitution
 - Treaty/ Convention
 - Statutes
 - Regulation

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 Constitution
• A broad statement of power of government & its
branches.
• It is the highest form of law
• All other forms of law must be consistent with this
law.
• It determines the political , economical & socio
cultural rights and obligations of government and
citizens.

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 Treaty/ Convention
 Agreement between nations or states of the
same or different countries
E.g. Narcotic and Psychotropic control
convention

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 Statutes
• written laws passed by legislative body.
i.e. – Parliament ( HPR )
Regulation
• Administrative enactment of the executive
branch of government that full fill statutory
policy and procedure.
• E.g. Regulation issued by FMHACA Or DEA

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Do We Need A Law?

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“ In order to appreciate Law try to imagine what
will happen if there is no law.”

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 Discussion

 Why we need a Pharmaceutical Law ?

What are the dangers of inadequate control of

drugs and medications?

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 Pharmaceutical Law …….
Pharmaceutical law is needed for the following major
reason
 To ensure proper implementation of pharmaceutical
policy.
 To determine the role of Pharmacy law executive
agency, Medical practitioners, pharmacy personnel,
manufacturers, whole sellers, retail outlets, health
institution, and consumers in ensuring a availability,
quality assurance, proper storage, distribution & use
of Pharmaceuticals.
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 To ensure that the final consumers receive
pharmaceuticals of proven quality, safety and
efficacy.
 To ensure the implementation of the
pharmaceutical sector as to the required
standard.
 To ensure fair trade in pharmaceutical sector.

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 THE TYPE / scope OF
PHARMACEUTICAL LAW

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 The scope of Pharmaceutical law
• The scope of a law on pharmaceutical depends
on the range of elements included in the
definition of pharmaceutical & accordingly the
law can be divided in to two on such basis.
1/ Law dealing with drugs
2/ Law that covers other substances & items as
well as drugs.

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Substances & items other than drugs that may be
covered in the law include

• Food • Chemical, reagents

• Cosmetics • Pesticides
• Poisons • Insecticides
• Medical supplies • Toiletries
• Medical Device • Detergents……….

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 Examples of Types of Pharmaceutical Law
• Many countries have different laws governing
pharmaceuticals and related items.
• E.g
o Drug Act/ Law
o Food and Drug Act
o Food, Drug, and Cosmetic (FDC) Act
o Comprehensive Drug Abuse Prevention and Control Act
o Poison Prevention Packaging Act
o Drug, cosmetics & medical device act
o Drug & cosmetics act…………………………
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 Pure Food and Drug Act of 1906/ 1938

• The most important piece of legislation in

pharmaceutical history.
• Purpose was to prohibit the interstate
transportation or sale of adulterated and
misbranded food and drugs
• Created the FDA
• Gave FDA the power to conduct inspections of
manufacturing plants to ensure compliance

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 Durham-Humphrey Amendment of 1951

 Distinguished between legend (prescription)

drugs and over-the-counter (OTC)
(nonprescription) drugs
Kefauver-Harris Amendment of 1962
Extended the FDC Act of 1938 to require that
drugs not only be safe for humans but also be
effective

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 Comprehensive Drug Abuse Prevention and
Control Act of 1970

• Commonly referred to as the Controlled Substances

Act (CSA)
• Created to combat and control drug abuse
• Created the Drug Enforcement Administration
(DEA), an arm of the Department of Justice
– charged with enforcement and prevention related to the
abuse of controlled substances like many narcotic pain
medications

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 Drug Listing Act of 1972

• Gives the FDA the authority to compile a list of

currently marketed drugs
• Each drug is assigned a unique and permanent product
code .
 & too many pharmaceutical law found in USA.

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 Are more laws needed?

How the various laws changed the way drugs

have been used over the years?

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• Answer: The laws have addressed a broad
scope of issues and provided a basic structure
for the safe use of drug products and for the
practice of pharmacy.

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 Other Types of Pharmaceutical Law

• Tort law ( Negligence, intentional torts,

privacy, business premises liability etc )
• Commercial Law (business, contract, agency,
private product ownership, insurance plans …
• Health & safety of workers and consumer
protection.

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 LEGAL SYSTEM

WHAT IS LEGAL SYSTEM?

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 LEGAL SYSTEM
Legal system: is process of making, enforcing,
and interpreting of law.
It includes
• legislative
• executive &
• judicial systems.

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 Legislative system
- is law making process
• Who should make a Law?
In USA- senate , In Ethiopia- HPR
The pharmaceutical sector in ETH. is regulated by
 pharmacy regulation Legislation 288/1964
 DACA legislation 176/ 1999
 FMHACA legislation 661/ 2009.
 EFDA Legislation 1112/2019
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 Executive system
• An authorized governmental body responsible
to administer and enforce a law.
• In Ethiopia FMHACA to administer and
enforce Food, medicine & Health care
administration and control proclamation no
661/ 2009
• In USA – DEA to administer & enforce the
controlled substance act

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Executive body may also be authorized to do
• Legislative action
- They are authorized to issue regulation,
prepare draft law.
- Judicial Action
- Interpret law
- E.g. suspending & revoking license
- Revoke professional registration certificate.
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 Judicial systems.

A process of judicial which includes:

• Interpreting a law
• Holding trials
• Receiving of evidence or testimony
• Taking measures accordingly
• Appeal
• The judicial action is carried by different types
of courts.
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 PHARMACY LAW
EXECUTIVE AGENCY

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• Who is Responsible to Govern Pharmaceutical
law in Ethiopia & USA ??

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 PHARMACY LAW EXECUTIVE AGENCY

• Most countries have more than one laws governing

the practice of pharmacy and like wise more than
one executive agencies.
E.g. in USA-
• The FDA and DEA oversee and enforce the
standards for drug use that the laws have established
 controlled substance act….. DEA
 Food, Drug, and Cosmetic (FDC) Act….FDA
• EPA
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• In Ethiopia
FMHACA – control Food, Medicine and
Health Care Administration .
VDFACA- Veterinary drug & Feed
Administration & control Authority….
Regulatory organ established at state level.

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 FMHACA
• Food, Medicine and Health Care Administration and
Control Authority of Ethiopia is a federal agency
established by Proclamation No. 661/2009.
 it is found necessary to protect the public health from
unsafe, inefficacious and poor quality modern and
traditional medicines; 
 it is found necessary to protect the public from
health risks emerging out of unsafe and poor quality
food

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 it is found necessary to control and deter illicit
production, trafficking and use of narcotic drugs,
psychotropic substances, and precursor chemicals;
 it is found necessary to avert health problems due to
substandard health institutions, incompetent and
unethical health professionals, poor environmental
health and communicable disease;

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 Drug Enforcement Administration (DEA)

• Branch of the U.S. Justice Department

responsible for regulating sale and use of
drugs with abuse potential
– responsible for enforcing laws regarding both legal and
illegal addictive substances
– directs most of its efforts toward illegal drug trafficking
– supervises legal use of narcotics and other controlled
substances

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 FDA
• Has primary responsibility and authority to
enforce the law and create regulations to assist
in providing the public with safe drug products
• EPA- "Environmental Protection Agency“
• created for the purpose of protecting human
health and the environment

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Discuss some powers and duties of
Pharmaceutical Executive Agency?
What are the main duties of national oversight
agencies?

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powers and duties of Pharmaceutical Executive Agency

 Professional registration
 Evaluation & registration of pharmaceuticals
 Licensing of premises
 Inspection
 Setting of standards/ sources of standard

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 powers and duties of Pharmaceutical Executive Agency

 Laboratory testing/ analysis

 Control of quality & reliability of drug
information
 Control of advertisement & promotion
 Post marketing surveillance……………..

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 1-Professional registration

• No pharmacist or other pharmacy personnel

are legally allowed to practice the profession
pharmacy unless s/he is registered.

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Why should Professional be registered?

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• Professionals should be registered in order to
ensure their competence.

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 Who should do registration of pharmacist & other
pharmacy personnel?

• pharmacist or other pharmacy personnel

registration can be issued by
- Drug regulatory authority
- Board of Pharmacy
- Professional association
- Ministry of health
N.B. the law should clearly indicate who should
do the professional registration.
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• FMHACA- registering and licensing
insufficiently available health professionals;
• registering and licensing health professionals
coming from abroad to deliver health service;

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 Requirements to be registered

• Education • Experience as part of

• Age not less than 21 the training
years • Health condition
• Good moral character • Citizen ship
- Non drug addict • Examination
- Non alcohol addict • Registration fee.
- Free from violation of
laws governing the
sector

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 Validity period
• Validity period of the registration or re-
registration ranges from 5-10 years.

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 Suspension & Revocation of the registration

Revocation of the registration of pharmacist is not a punishment

rather it is a protection of the public.
Conditions for Revocation
1/ if registration is obtained by fraud, mis -interpretation or
mistake.
2/ if the pharmacy personnel is unfit, because of
-drug addiction
- mental illness
- physical condition
- violation of law governing the sector
- violation of controlled substance

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3/ Less common ground for revocation
 Gambling in the store
 Intentional adulteration of drugs
 Aiding of un registered person to practice
pharmacy
 Un professional conduct
 False advertisement
 Negligence etc…
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 Who should suspend and revoke registration

• Suspension & Revocation of the registration can be

done by:
- Drug regulatory authority
- Board of Pharmacy
- Professional association
- Ministry of health
• N.B. the law should clearly indicate who should do
the Suspension & Revocation of professional
registration.
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 2- Evaluation & registration of
pharmaceuticals
• Placing of pharmaceutical on a market of a
country requires a market authorization which
is also called “ Licensing” or “ registration” or
Evaluation and registration from concerned
pharmacy law executive agency.
• Pharmaceutical Evaluation & registration is a
process of evaluation the quality, safety and
efficacy of pharmaceutical before and after it is
marketed or made available for use.
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• The procedure includes an assessment of both
pharmaceutical product and of manufacturing
procedures & facilities.
• In comprehensive evaluation and registration system,
data on pharmaceutical, pharmacological,
toxicological, therapeutically, clinical and pre
clinical investigations ( for new drugs ) are analyzed.
• If pharmaceutical product is registered certificate of
registration is issued by the Executive agency.

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 Re registration of pharmaceutical product

• Registration certificate of pharmaceutical is

valid for a limited period. It has to be renewed
every certain years. The validity period of
certificate of registration is varies from 3-5
years.

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 3-Licensing of premises

• No one is allowed to establish pharmacy

establishments to practice pharmacy with out
getting license

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 Types of Pharmacy establishments

o Manufacturer of pharmaceutical
o Importer
o Exporter
o Retail out lets
- Pharmacy
- Drug shop
- Rural drug Vendor
o Pharmaceutical quality control lab
o Pharmaceutical promotion offices
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Why license is needed ?

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 The need of license
1/ To ensure the quality, safety & efficacy as
well as proper management and utilization of
pharmaceuticals
2/ to ensure the fulfillment of requirement or
standards i.e. Personnel, premises, equipment,
facilities, SOP, etc…

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 Who should issue license
• Issuance of license is by:
 Drug regulatory authority
 Board of Pharmacy
 Ministry of health
• FMHACA- licensing and regulating specialized
health institutions;

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 Validity period of the license issued/ renewal

• License has to be renewed at certain intervals.

In most countries including Ethiopia license is
renewed at the beginning of every fiscal year.

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Suspension & Revocation of the license
• A license issued by authorized competent body
could be revoked and suspended
• Due to different condition
• Failure to renewal license
• Providing pharmaceutical service in the absence
of license
• Importing, distributing & dispensing drugs which
are adulterated counterfeited and substandard ,

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• Make change of address or modify the
premises with out getting authorization
• Obtaining pharmaceutical from illegal sources
• Dispensing drugs with out adequate
information
• Undertaking activities that are not allowed by
law.

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 4- Setting of standards/ sources of standard

 Preparation or adoption of specifications of quality ,

safety and efficacy of pharmaceutical.
• Many developed countries have developed such
specifications.
E.g. -USA has USP
- India has IP
-Japan has JP
UK has BP
• Many developing countries developed the specifications
adapted by developed countries
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Preparation of requirements to be fulfilled by the
above pharmacy establishment.

• Manufacturer of • Retail out lets

pharmaceutical - Pharmacy
• Importer - Drug shop
• Exporter - Rural drug Vendor
• Whole seller • Health institution
- hospital pharmacy
- health center pharmacy

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 Requirements
The requirement include
 personnel,
 premises,
 equipment &
 standard operational procedure etc…

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Types of personnel premises Equipme
pharmacy Requirements nt
establishment

Importer Experienced For receiving, Required

pharmacist storing, materials
dispatching,
doing
administrative
work
Whole seller Experienced ‘’ ‘’
pharmacist
Retail out lets Appropriate ‘’
- Pharmacy -Led by R.Pharmacist room
- Drug shop -‘’ ‘’ R. Druggist -dispensing
- Rural -‘’ ‘’ non pharm -Cpding
drug Vendor -- storage
--toilet

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Health Appropriate ‘’
institution Led by R.Pharmacist room
- hospital Led by RPhrmcis/ -dispensing
pharmacy drg -Cpding
- health center -- storage
pharmacy --toilet

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 Requirements
• No one is allowed to establish pharmacy establishment
s/ practice pharmacy with out getting license.
License exemption
Import pharmaceutical for personal use, research,
laboratory testing, donation in Emergency &
compelling condition may not require getting license.
Most countries assurance fulfillment of the
requirements for rendering pharmaceutical service by
health institutions when assuring the fulfillment to
establish health institution.
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 Prescribing and Dispensing of Medicines

• Medicine shall only be prescribed & dispensed by

a medical practitioner who is licensed by the
appropriate organ.
Drugs / pharmaceuticals is classifying in to different
categories.
 Prescription only
 OTC
 Pharmacy only drugs
 General sale drugs
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 They also categorized by level of

• health institution
 Hospital
 HC
 Clinic/H.station
• Drug retail out let
 Pharmacy
 Drug shop
 Rural drug vendor
Prescriber & dispenser level
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 Prescription only
OTC

Discussion
• Do you dispense prescription only drugs
orally?

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• Prescription only drugs, except controlled drugs,
may be supplied at the request of a doctor who
because of any emergency unable to furnish a
prescription immediately.
• The prescriber shall provide the dispenser with
prescription with in 72 Hrs.
• Prescription only drugs except controlled drugs
may supplied at the request of patient if
 The pharmacist has interviewed the patient, is
satisfied that there is an immediate need.
 The pharmacist is required to keep detailed
quantity , labeling & record.
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• Prescription only drugs shall only be
prescribed & dispensed by a medical
practitioner who is licensed by the appropriate
organ.
• The licensed professional shall review and
confirm legibility of a prescription before
dispensing. s/ he shall consult the prescriber or
reject illegible / wrong prescription.

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• Controlled drugs should be dispensed in accordance
with a special prescription , which is meant for such
purpose, given by an authorized prescriber.
• Do not refill controlled drug prescription except
schedule v drugs
• Registered and filled prescription for control drugs
shall be kept for 5 yrs & for other 2 years.

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• OTC shall not be dispensed & administered to
patient in hospital
• & it could be dispensed on patient request in a
professional way in community pharmacies.
• The maximum quantity of OTC drugs to be
dispensed at a time is decided by Drug
Regulatory Authority of most countries

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 compounding
 Done at hospital & community pharmacy level.
 Compounding shall be done following appropriate
compounding procedures and the community
pharmacy is accountable for quality, safety and
efficacy problems associated with compounding
process.
 Separate license is not required to compound drugs
on the bases of prescription for individual patient in
community & hospital pharmacies which is legally
authorized
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 Storage of pharmaceuticals

• Any Drug retail out let shall

a/ store pharmaceuticals properly in accordance with
the storage conditions stated on their label
b/ store pharmaceuticals which requires special
storage condition accordingly
o Cold storage
o Storage for Narcotic & psychotropic drugs
o Expired , deteriorated, damage, banned
pharmaceuticals.
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 5- Inspection
• Pharmacy law executive Agency is legally
authorized to undertake pharmaceutical inspection
on pharmacy establishment in order to ascertain
whether their has been a contravention of law / act.
• The agency should assign persons, with adequate
knowledge and experience of the sector, policy,
law regulations and directives, as inspectors.
• The rights & obligations of inspectors have to be
clearly indicated in the law.

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 Type of inspection
• Pre- licensing inspection is the type of inspection undertaken
in order to ensure the fulfillment of requirements by pharmacy
establishment before a license is issued
• Post licensing inspection is the type of inspection undertaken
in order to ensure the fulfillment of requirements by pharmacy
establishment in order to ascertain whether there has been a
contravention of the law.
• Emergency inspection
• Regular inspection.
• During inspection due consideration should be given to
individual rights and privacy.

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 Power of inspector
• To enter any premises, ship, aircraft…
• To take sample of any medicinal product
• To take copies of any entry..
• To seize and detain any substance or articles or
document which they have reasonable cause to
believe may be required for proceedings under
the law.

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 Obligation of inspector

• s/he should keep the trade secrecy of the

premises
• Should give due respect to the right of the
individual/ premises
• Should give receipt for the sample, document
they have taken & seized.

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Take an action in response to the inspection

• An appropriate action should be taken on individual or

premises that match to the mistake/ offence
committed.
• The actions could be:
• Educational
• Suspension or revocation of license, professional
registration certificate, product registration certificate.
• The action could be taken by agency or by taking the
case in to court

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