Pharmacy Level - Iii: Learning Guide #5

PHARMACY LEVEL -III
NTQF Level -III
Learning Guide #5
Providing Compassionate,
Unit of Competence: -
Respectful and Caring Service
Providing Compassionate,
Module Title: -
Respectful and Caring Service
LG Code: HLT PHS3 M01 0919
TTLM Code: HLT PHS3 M01 0919TTLM0919v1
LO 5: Functioning with legal and ethical framework

Instruction Sheet Learning Guide #5
Pharmacy Level III Vision :01 Sep. 2019: Page 1 of 62

Copyright Info/Author: Federal TVET Agency
This learning guide is developed to provide you the necessary information regarding the
following content coverage and topics –
 Introduction to legal bases of pharmacy practice
 National drug policy
 Ethical issues in pharmacy practice areas
 Ethical dilemma in the pharmacy practice areas
 Laws Governing the Practice of Pharmacy
This guide will also assist you to attain the learning outcome stated in the cover page.
Specifically, upon completion of this Learning Guide, you will be able to –
 understood Legislation and common laws relevant to work role
 Comply with policies and procedures

 Ensured Confidentiality of individual’s record.
 prevented Disclosure of patient’s information to another person without patient’s
consent is
 recognized Ethical issues and ethical dilemma in the workplace
 Handled Patients who are not able to communicate in case of emergency or other
conditions.
 Released to only authorize users Patient-specific data.
 Publicized Ethical standards related to patient privacy rights.
 Conducted and solutions on privacy issues/problems recommended assessments.
 Conducted training programs for health care providers and other staff on privacy and
confidentiality of patient information.
 Recognized and reported Learning Instructions unethical conduct.
1. Read the specific objectives of this Learning Guide.
2. Follow the instructions described below 3 to 6.
3. Read the information written in the information “Sheet 1, Sheet 2, Sheet 3 and Sheet 4, in
page 3, 9, 17,28 and 32 respectively.
4. Accomplish the “Self-check 1, Self-check t 2, Self-check 3 and Self-check 4” ” in page 7,
15, 26, 30 and 59 respectively

Introduction to legal bases of pharmacy
Information Sheet-1 practice
CONTENT-1
5.1.1. Definition of terms

Law
 Is the boy of principles that govern conduct and observance of which can be enforced
in courts.
 It demarcates what is permissible from what is not.
 It must be obeyed and followed by citizens and is subject to legal citizens sanctions or
consequences.
 Is developed in order to ensure that the relationship among persons conform to
certain standard
Pharmaceutical law/ Pharmaceutical Jurisprudence
What is pharmaceutical?
The definition of pharmaceutical depends on the scope of pharmaceutical law, if the law
covers so many items such as drug, cosmetics, medical supplies and sanitary items, it can
be defined as follow: Pharmaceutical shall mean drug, cosmotic, medical supplies, medical
instrument and sanitary item.
Drug is any substances or mixture of substances used in the diagnosis, prevention and
treatment of a disease affecting human and animal. This will include narcotic drugs &
psychotropic substances, pesticide, medicated animal feeding stuff, poisons, radio
pharmaceuticals, blood & blood products, vaccines.
Narcotic drug: is any drug product subject to control according to Narcotic drug control
convention of the United Nations ratified by the country
Psychotropic substance is any substance subject to control according to psychotropic
substance control convention of the united Nations ratified by the country.
Poison is a substance that may cause danger to human, animal, plant or environment when
taken in a small quantity.
Cosmetic is any preparation intended to be applied to human body for cleansing beautifying,
promoting attractiveness or altering the appearance with out affecting the body’s structure or
function. Includes like skin cream, lotions, perfumes, lipstick, shampoos etc. Sanitary item is
any preparation used in the maintenance of cleanliness of human, animal & household

Medical supply is any article that may be used on the inner or outer part of the body for
diagnosis or treatment of disease in human or animal. This includes suturing materials,
syringes, needles, bandages, guaze, cotton & other laboratory, surgery and dental
instruments such as x-ray machine, ultrasound, microscope etc.
Substances and Items other than drug that may be covered in the law include:
 Food
 Cosmotics
 Poisons
 Medical device
 Chemicals
 Pesticides
 Insecticides
 Herbicides
 Toiletries
 Detergents
Pharmaceutical laws/ Pharmaceutical jurisprudence
 is the “Science or philosophy of law governing pharmaceutical sector or services”

 is a rule of human conduct binding up on all persons engaged in practice of
Pharmacy.
 It is also restrictive like other laws.
 Pharmacy law gives certain rights for a Pharmacy personnel and it takes away
freedom.
 It says a Pharmacy personnel should:
 Possess certain training.
 Be registered and licensed to practice Pharmacy
The scope of pharmaceutical law
 The scope of law on pharmaceutical depends on the range of elements included in the
definition of pharmaceutical and accordingly the law can be divided into two on such
basis.
 Law dealing with drugs
 Law that covers other substances and items as well as drugs

5.1.2. The need for legislation on pharmaceuticals
The major reasons for legislation dealing with pharmaceuticals are:
1. To ensure proper implementation of pharmaceutical policy.

2. To determine the role of Pharmacy law executive agency, medical practitioners,
Pharmacy personnel, manufacturers, whole sellers, retail outlets, health institution and
customers in ensuring availability, quality assurance, proper storage, distribution and
use of pharmaceuticals.
3. To ensure that the final customers receive pharmaceuticals of proven quality, safety
and efficacy.
4. To ensure the implementation of the pharmaceutical sector as to the required
standard. i.e. pharmaceutical:
 Manufacturing
 Import
 Export
 Local procurement
 Storage
 Inventory control
 Whole distribution
 Use
 Prescribing
 Dispensing
 Patient use
 Control & administration
 Licensing
 Registration of professionals
 Marketing Authorization/Evaluation & Registration
 Inspection
 Clinical trials
 Post marketing surveillance
 Adverse drug reaction reporting
 quality defective drug reporting
 Efficacy related complaint reporting

 Promotion & advertisement
 Laboratory Analysis
 Provision & control of pharmaceutical information
 Control of controlled substances
 Narcotic drugs & psychotropic substances
 Poisons
 Radiopharmaceutical
5. To ensure fair trade in pharmaceutical sector

Self-Check -1 Written Test
Directions: Answer all the questions listed below. Use the Answer sheet provided in the
next page:
Part I Write true if the statement is correct or writes false if the statement is incorrect on the
space provided.
1. Narcotic Drug means any drug subject to control according to Narcotic Drugs
Conventions of the United Nations ratified by Ethiopia.
2. Cosmetic is any preparation intended to be applied to human body for cleansing
beautifying,
Part II. Choose the best answer from the given alternatives and encircle your best answer.
3. Which one of the following substance is may cause damage to man, animal, plant
and environment when taken in small quantity.?
A. Food C. Drug
B. Poisons D. Cosmetic
4. The major reasons for legislation dealing with pharmaceuticals are?
A. To ensure proper implementation of pharmaceutical policy.
B. To determine the role of Pharmacy law executive agency and medical practitioners,
use of pharmaceuticals.
C. To ensure that the final customers receive pharmaceuticals of proven quality, safety
and efficacy.
D. All of the above.

Note: Satisfactory rating - 3 points Unsatisfactory - below 3 points
You can ask you teacher for the copy of the correct answers.
Answer Sheet
Score = ___________
1. ________
2. ________ Rating: ____________
3. ________
4. ________
Name: _________________________ Date: _______________

National drug policy
Information Sheet-2 CONTENT-2
 is a guide for action, containing the goals, set by the government for the pharmaceutical
center, set by the government for the pharmaceutical sector and the main strategies and
approaches for attaining them.
 It provides a frame work to coordinate activities of pharmaceutical sector participants the
public and private sectors, nongovernmental organization, donors and other interrelated
parties nation’s drug policy although similar in many ways to those of other countries,
may different objectives, strategies and approaches
What is a national drug policy?

 A political commitment to a goal and a guide for action.
 It expresses and prioritizes the medium- to long-term goals set by the government for
the pharmaceutical sector, and identifies the main strategies for attaining them.
 It provides a framework within which the activities of the pharmaceutical sector can be
coordinated.
 It covers both the public and the private sectors, and involves all the main actors in the
pharmaceutical field.
Why is a national drug policy needed?
 To present a formal record of values, aspirations, aims, decisions and medium- to
long-term government commitments;
 To define the national goals and objectives for the pharmaceutical sector, and set
priorities;
 To identify the strategies needed to meet those objectives, and identify the various
factors responsible for implementing the main components of the policy;
 To create a forum for national discussions on these issues.
Objectives of a National Drug policy
The general health related objectives
 To ensure:
 Access: equitable availability and affordability of essential drugs
 Quality: the quality, safety and efficacy of all medicines
 Rational use: the promotion of therapeutically sound and cost-effective use of drugs
by health professionals and consumers.
Other Goals of NDP
 Economic related goals
 To reduce foreign exchange for pharmaceutical import
 To provide jobs (dispensing, pre-packaging, production of pharmaceuticals)
 National development goal
 Develop national pharmaceutical production
 To take a stand on intellectual property rights
 Although specific objectives differ according to the priorities set by the government, most
common are
 To ensure essential drugs available and affordable to those who need them.
 To ensure the safety, efficacy and quality of all medicines provide to the public
 To improve rational prescribing and dispensing practices
 Economic goal
 Lower the cost to the government, other health care providers and the public
 Reduce the foreign exchange expenditures for drugs
 National development goals
 Increase skills of personnel in drug management
 Protect intellectual property rights
Drug policies differ by country due to difference in፡
1. The structure of health care system

2. The number of trained pharmacist and physicians
3. The capacity of the drug regulatory agency
4. Features of pharmaceutical distribution system and
5. The levels of funding for pharmaceuticals.
Example: Objectives of Ethiopian NDP
 To meet the country’s demand for essential drugs and to systematize its supply,
distribution and use.
 To create conducive situations to make the prices of drugs compatible with the
people’s purchasing power.
 To ensure the safety, efficacy and quality of drugs.
 To develop a domestic drug manufacturing capacity and gradual supply to the export
market
 To expand the training of manpower and drugs research and development.
 To devise ways and means for the utilization of traditional drugs in the regular health
services after ensuring their safety and efficacy.
Major components of a national drug policy
1. National pharmacy and medicines regulatory authority

The NDP seeks to promote the authority of the national pharmacy and medicines control
administration which is the Federal Board of Pharmacy and Poisons (FBPP) which is the
national drug regulatory authority that has the jurisdiction and powers. Action should be
taken to strengthen FBPP administrative, organizational and technical and control
capabilities. Effective cooperation between the Federal Board and state health and
veterinary authorities should be maintained in order to ensure effective management and
control of manufacture, import, distribution and pricing of medicines, assurance of their
safety, efficacy and quality, monitoring their adverse reactions, availing accurate drug
information and restricting improper promotional activities.Hence action should be taken to
achieve the following:-
1.1. Federal Board of Pharmacy and Poisons

To enable the FBPP to carry out its duties properly the responsible authorities concerned
should take action to achieve the following:-
1. To maintain the practical and legal autonomy of the FBPP as a national administration
for pharmacy and medicines control and as the only federal authority responsible for
the organization, regulation and control of medicines at the national level, and for the
selection of medicines and for specifying their standards and specifications, and for
regulating their storage, distribution and dispensing.
2. To legally enable the Directorate General of Pharmacy Federal Ministry of Health to
act as the General Secretariat of the FBPP and for the Director General of Pharmacy
to be the Board Secretary General by virtue of his post.
3. The FBPP should care for its independence and hold to its powers and should not
allow any person, local or foreign body to bypass the Board or its Secretariat on any
matter which is within the jurisdiction of the Board, its Secretariat or its authorized
committees.

4. The Government should provide the Directorate General of Pharmacy in the Federal
Ministry of Health with the human and material resources necessary for its speedy
and efficient performance as the General Secretariat of the FBPP.
1.2. Drug information, pharmacovigilance and statistics

The Quarter Century National Pharmaceutical Strategy indicated the importance of
these activities in drug management, regulation and control. So the Directorate
General of Pharmacy should rehabilitate and activate these activities and develop
their respective departments; and should start with developing a national drug
information system that incorporates drug information and pharmacovigilance that
monitors drug adverse reactions, and drug statistics; and should publish a periodical
that contains recent scientific and technological advances in pharmacy and
medicines.
The Drug Information Section should extend its activities to include promotion of
rational prescribing and drug use, and public education in rational use of drugs.
1.3. Pharmacy and drug legislation
The official bodies responsible for organization, regulation and control of medicines
need basic laws, regulations and orders that indicate requirements and prohibitions
and provide these bodies with the jurisdiction and authority that enable them to ensure
compliance of all with these legislations and to take appropriate legal action needed
for that purpose.
The Pharmacy and Poisons Act (P&P Act) enacted in 2001 contains some lingual
errors that need to be corrected. Hence the FBPP should take steps to achieve the
following:-
1. To correct all lingual errors especially in the section concerned with the registration of
cosmetics and medical devises.
2. To incorporate in the Act provisions that protect the health of humans and the community
from any negative impact resulting from the WTO Agreement on intellectual property
rights and tenable the Sudan to make use of the exemption provided for in the TRIPS
Agreement for public health consideration.
3. To speed up the updating and issue of regulations, orders, rules, by laws and guidelines
as provided for by the P&P Act; especially the new Registration of Pharmaceutical
Products Regulations, Poisons Regulations and Schedules, Cosmetics and Medical
Devises Regulations, the Poisons Lists Order, Control of Drug Trials on Humans and
Animals Regulations and other regulations needed for application of the Act.
2. Quality assurance of medicines
One of the most important functions and major duties of the federal regulatory
authority or the state authority concerned is to assure maintenance of the quality of
medicines throughout its supply chain of its manufacture or import, its transport,
storage, distribution, prescription, dispensing and use. So the State should be
responsible for providing the resources and capacity building of the professional,
administrative, regulatory and executive personnel needed at the federal and state
levels in order to assure the quality of medicines used by the public. So the FBPP
should endeavor to implement and/or achieve the following:-
2.1. Standards, specifications and legal requirements
1. Revise and update all legislations, standards, specifications, requirements, codes
of practice and guidelines that should legally be complied with in medicinal
products and pharmaceutical facilities; taking into consideration assurance of
stability of medicines in Sudan extreme climatic conditions.
2. Conduct a scientific study aiming at formulating a national protocol for stability
testing of pharmaceutical products based on Sudan climatic conditions, and the
effect of transport of medicines by various means to all parts of the country on the
stability and quality of medicines.
2.2. Registration of medicinal products
1. The drafting of the new regulation for the registration of medicinal products should
be completed, enacted and applied as soon as possible, then a plan of action
should be instituted for the revision of all registered products in accordance with
the provisions of the new regulations.
2.3. Licensing of pharmaceutical establishments
1. Strict compliance with licensing requirement of different pharmaceutical
establishments should be enforced; and in particular requirements that assure the
sustainability of the quality of medicinal products inside their premises as specified
in regulations, and this should be assured by periodic inspection by drug control
inspectorates.
2.4. Pharmaceutical inspection
1. The capacities of pharmaceutical inspectorates at the federal and state levels should
be upgraded, and administrative and field control of manufacture, transport, storage,
distribution and sale of medicines should be activated. Attention should be paid to
combat smuggled and counterfeit medicines.

2. The policy of periodical inspection of foreign drug manufacturing facilities should be
continued to ensure their existence and compliance with prescribed current good
manufacturing practice.
2.5. Pharmaceutical control in the states
1. Federal and state governments should establish and strengthen state drug control
departments in order to be capable and effective in ensuring compliance of all
concerned with pharmaceutical and drug legislation in every aspect of
manufacture, import, storage, distribution, sale and use of medicines and
maintenance of its safety, efficacy and quality.
3. Supply of medicines (Drug supply)
The objective of the NDP is to make available and accessible the needs of the
population of essential medicines of assured safety, efficacy and quality at affordable
prices and ensure equitable distribution.
4. Rational use of medicines
Appropriate strategies should be established to improve drug use through pre service
and in service training of health workers; and by providing them with accurate
scientific drug information; and by forming drug and therapeutic committees in
hospitals; and by establishing drug information and poisons centers; and by
monitoring adverse drug reactions; and by containment of microbial resistance to
antibiotics; and by public education in proper use of drugs; and by control of drug
promotion.
Other
1. Selection of essential drugs
 Based on the country’s health problems, trained manpower, financial resources and
infrastructure, a national drug list will be formulated with full consideration of safety,
efficacy, quality & cost.
 A national drug advisory committee composed of highly skilled professionals in

medicine & pharmacy shall be established.
2. Legislation registration and quality assurance
3. Drug procurement distribution and storage
4. Local production
5. Drug pricing
6. Economic strategies for drugs
7. Educational and training
8. Access to information
9. Research and development
10. Drugs for veterinary use
Directions: Answer all the questions listed below. Use the Answer sheet provided.:
Part I. chooses the best answer from the given alternatives and encircles your best answer.
1. Which of the following guide for action, containing the goals, set by the government
for the pharmaceutical center, set by the government for the pharmaceutical sector
and
the main strategies and approaches for attaining them?
A. National drug policy
B. Drug supply system
C. National drug formality
D. CR
2. Drug policies differ by country due to difference in፡
A. The structure of health care system
B. The number of trained pharmacist and physicians
C. The capacity of the drug regulatory agency
D. Features of pharmaceutical distribution system and
Short Answer Questions
3. List out the Major components of a national drug policy?

Answer Sheet
Score = ___________
1. ___________
2. ___________ Rating: ____________
3. __________
A. _______________
B. _______________
C. _______________
D. _______________
Name: _________________________ Date: _______________

Information Sheet-3 Ethical issues in pharmacy practice areas
CONTENT-3
Introduction to legal basis of Pharmacy practice
Law
 is the boy of principles that govern conduct and observance of which can be enforced in courts.
 It demarkets what is permissible from what is not.
 It must be obeyed and followed by citizens and is subject to legal citizens sanctions or
consequences.
Pharmaceutical laws
The science and philosophy of law governing a pharmaceutical sector or servic
What are pharmaceuticals?
Usually, pharmaceutical includes drug, cosmetic, medical supplies&instruments and sanitary

items.
 Drug is any substance or mixture of substances used for prevention, diagnosis and treatment
of a disease affecting humans or animals. It includes: narcotic drugs & psychotropic
substances, pesticides, medicated animal feed stuffs, poisons, radio pharmaceuticals,
vaccines, blood & blood products.
o Poison is a substance that may cause danger to human, animal, plant or environment when
taken in a small quantity.
 Cosmetic is any preparation applied to human body for cleansing, beautifying, promoting
attractiveness or altering appearance without affecting the body’s structure or function.
 Sanitary item is any preparation used in maintenance of cleanliness of human, animal and
household. Eg. Detergents.
 Medical supply is any article that may be used on the outer or inner part of the body for
diagnosis or treatment of disease in human or animal. Eg. Syringe & needle, laboratory
equipments and reagents, etc.

Types of law
Law occurs in a variety of hierarchal forms.
1. Constitution -a broad statement of power of government and 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 and socio-cultural rights and obligations of
government and citizens.
2. Treaty/Convention – agreement between nations or states of the same country or among
countries; e.g. Narcotic and Psychotropic substances control convention.
3. Statues – written laws passed by legislative body; e.g. parliament.
4. Regulations – administrative enactment of the executive branch of government that fulfills
statutory policy and procedure; e.g. Drug enforcement administration (DEA).
Legal System
 Legal system is process of making, enforcement and interpreting law

 It includes legislative, executive and judicial system.
Legislative system - is law making process.
 Who should make a law? E.g. in Ethiopia HPR
 What should a law include?
 The content depends on political, economic and socio-cultural development as well as
international situation.
N.B. There is no one law that can serve every country or there is no one internationally
accepted law. However, the laws of different countries share so many principles in common.
Executive system
 is an authorized governmental boy responsible to administer and enforce a law.
 In Ethiopia – FHACA is responsible to administer and enforce drug administration and
control proclamation No. 176/1999.
 In USA, DEA - to administer and enforce the controlled substance act.
Executive body may also authorized to do
a. Legislative action
 Authorized to issue regulation principle draft law.
b. Judicial action

 Interpret law; e.g. suspending and revoking license, revoke professional registration
certificate.
Judicial system
Judicial process includes
 Interpreting a law
 Holding trails
 Receiving of evidence or testimony
 Taking measures accordingly
 Appeal
The need for legislation on pharmaceutical
Pharmaceutical law – is a rule of human conduct binding up on all persons engaged in practice of
Pharmacy. It is also restrictive like other laws.
Pharmacy law gives certain rights for a Pharmacy personnel and it takes away freedom. It says a
Pharmacy personnel should:
 Possess certain training.

 Be registered and licensed to practice Pharmacy.
The scope of pharmaceutical law
The scope of law on pharmaceutical depends on the range of elements included in the definition of
pharmaceutical and accordingly the law can be divided into two on such basis.
1. Law dealing with drugs

2. Law that covers other substances and items as well as drugs
The major reasons for legislation dealing with pharmaceuticals are:
 To ensure proper implementation of pharmaceutical policy.

 To determine the role of Pharmacy law executive agency, medical practitioners, Pharmacy
personnel, manufacturers, whole salers, retail outlets, health institution and customers in
ensuring availability, quality assurance, proper storage, distribution and use of
pharmaceuticals.
 To ensure that the final customers 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.
Strategies for the assuring drug quality, safety and efficacy

A. Professional registration
 No Pharmacist or other Pharmacy personnel are legally allowed to practice the profession
Pharmacy unless or otherwise he/she is registered.
 Professionals should be registered in order to ensure their competence.
 Pharmacists and 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 should do the professional registration.
Requirements to be registered
 Education
 Age usually not less than 21 years
 Good moral characters
 Non-drug addict
 Non – alcohol addict
 Free from violation of laws governing the sector
 Experiences and training
 As part of training
 After graduation – apprentices
 Health conditions
 Free from mental illness, physical condition
 Citizenship
 Examination
 Theoretical
 Practical
 Registration fee
 Validity period of the registration /re-registration: It ranges from 5-10 years.
.
Suspension and revocation of the registration:

 Revocation of registration is not a punishment rather it is protection of the public
Conditions for revocation
 If registration is obtained by fraud

 If the professional is unfit, b/c of
 Drug addiction
 Intoxication liquor
 Mental illness
 Physical conditions
 Violations of laws governing sector
 Violation of controlled substances law
 Less common ground for revocation
 International adulteration of drugs
 Aiding of an unregistered person to practice pharmacy
 Unprofessional conduct
 False advertisement
 Negligence
 The law should indicate who should suspend & revoke registration
 Ministry of health
 Board of pharmacy
 Professional association
 Drug regulatory association
B. Evaluation and registration of pharmaceutical

placing of pharmaceutical product on a market of a country requires a marketing authorization,
which is also called” Licensing” or “registration” or “evaluation & registration” from concerned
pharmacy law executive Agency. The procedure includes an assessment of both
pharmaceutical product & manufacturing procedures and facilities.
In comprehensive evaluation and registration system data on

 Pharmaceutical
 Pharmacological
 Toxicological
 Therapeutic

 Clinical investing actions
 Pre-clinical investigations (for new drugs) are analyzed. If pharmaceutical product is
registered “certificate of registration” is issued by the executive agency.
Re-registration of pharmaceutical product
 Registration certificate of pharmaceutical is valid for a limited period. It has to be renewed

every certain year. The validity period of certificate of registration varies from three to five
years.
Re-registration of pharmaceutical is necessary in order to accommodate the change in quality, .
C. Licensing of premises
 No one is allowed to establish Pharmacy establishments/practice without getting license
/authorization to do so from legally authorized bodies after assuring the fulfillment of
requirements.
 Types of Pharmacy establishments
- Manufacturer of pharmaceuticals
- Importer of pharmaceuticals
- exporter of pharmaceuticals
 Pharmaceutical retail outlets
 Pharmacy
 Drug shop
 Rural drug vender
 Pharmaceutical quality control lab.
 Pharmaceutical promotion offices
The need of license is,

1. to insure the quality, safety, efficacy as well as proper management and utilization of
pharmaceuticals.
2. to ensure the fulfillment of requirements or standards i.e. personnel, premises, equipment,
facilities, standard operation procedures (SOP), etc…
Issuance of license is by:
- Board of Pharmacy
- Drug Regulatory Authority
- MOH

 License has to be renewed at certain intervals. In most countries (including Ethiopia) license
is renewed at the binging of every physical year.
D. Inspection
 Pharmacy law exclusive agency is legally authorized to undertake pharmaceuticals inspection
in Pharmacy establishments in order to ascertain to whether there has been a contravention on
law act.
 The agency should assign persons with adequate knowledge and experience of the selected
and policy laws, regulations and directives as inspectors.
 The rights and obligations of inspectors have to be clearly indicated in the law.
 Inspectors are empowered to:
 enter any premises.
 enter any ship, air craft, and vehicle.
 take sample of any medicinal product sold/supplied
 take copies of any entry
 seize and detain any substance or article or document which they have reasonable cause to
believe
Types of inspection
1. Pre-licensing inspection – It is the type of an inspection undertaken in order to ensure the

fulfillments of requirements by Pharmacy establishment before a license is issued.
2. Post- licensing inspection - It is the type of an inspection undertaken on licensed Pharmacy
establishments in order to ascertain whether there has been a contravention of the law.
Two types of post-licensing inspection
a) Emergency inspection
b) Regular inspection
N.B.
 During inspection due consideration should be given to individual rights and privacy.
 Prior notice must be given to the occupier if it is intended to enter any premise used only as a
private dwelling house.
 It is an offence willfully,
 to obstruct a dully authorized person or
 to fail to comply with any proper request by inspector

 Without reasonable cause to fail to give them information or any assistance they may
require.
 to give to inspectors false information.
Obligations of inspectors
 He/she should keep the trade secrecy of the premises inspected.

 they should give receipt for the sample document they have taken and seized
Inspectors report
1. Should write inspectors report showing the strong and weak sides of the inspected
premises.
2. Should also include directives given at the site.
3. All necessary evidences have to be attached.
Actions in response to the inspection
An appropriate action should be taken on individual or premises that matches to the
mistake/offense committed.
The actions should be:
 Educational
 Suspension or revocation of license, professional registration certificate, product
registration certificate.
 The actions should be taken by the agency or taking the case into court Control of
E. import of pharmaceuticals
 Import of pharmaceuticals must be legally controlled in order to ensure that the imported
pharmaceuticals are
 of proven quality, safety, and efficacy.
 on the basis of the country’s need.
Requirements to import pharmaceuticals
1. License/authorization to import pharmaceuticals
No one is allowed to import drugs, medical supplies and other pharmaceuticals unless otherwise
licensee/authorized by regulatory authority to do so.
Exemption from license
Drugs
 for personal use
 for research
 for laboratory testing
 From donation in emergency and compelling conditions.
License to import pharmaceuticals is issued by drug regulatory authority after assuring the
fulfillment of requirements shown below
a. Personnel
b. Premises – for receiving, storing, dispatching and doing administrative works.
c. Equipments and facilities – for receiving, storing, inventory control
d. Standard operation procedures (OSP) – to be followed when ordering, port clearance,
inventory control, distributing compliant collection and analysis, product recall, etc…
2. Market authorization of pharmaceuticals
Obtaining license to import pharmaceuticals especially drugs and medical supplies is not sufficient,
obtaining market authorization for each product from regulatory authority is legally needed in most
countries.
Obligations of importer of Pharmaceuticals
 Not import and distribute pharmaceuticals which are adulterated, counterfeited and
substandard.
 Not use the premises for purpose other than specified in the license.
 Not make change of address or modify premises.
1. Distribute pharmaceuticals only to those licensed or authorized institutions and in accordance
with their level.
2. Keep and provide information’s as may be requested by
F. Control of Pharmaceutical outlets
 No person is allowed to run drug retail outlet without getting/licensed from pharmaceutical
regulatory authority.

Directions: Answer all the questions listed below. Use the Answer sheet provided in the next
page:
Multiple choose
1. All of the following is required for professional registration, except.
A. Education
B. Age usually not less than 21 years
C. drug addict
D. Experiences and training
2. License may be issued by:
A. Board of pharmacy
B. Drug regulatory authority
C. Ministry of health
D. All of the above
3. Which of the following type of licensing isorder to ensure the fulfillment of requirements by
pharmacy establishment before a license is issued?
A. Pre-licensing
B. Post-licensing
Short answer
4. What is rationality of Inspection of pharmaceutical

Answer Sheet
Score = ___________
1. ______
Rating: ____________
2. ______
3. ______
4. ______
Name: _________________________ Date: _______________

Ethical dilemma in the pharmacy practice areas
Information Sheet-4
CONTENT-4
Ethical Dilemmas arise when principles cannot be respected and people disagree on what the best
solution is; as legitimate solutions philosophically or practically. The values in conflict must be
prioritized as the essence of 'doing ethics' to justify the breaching of the values and principles that are
not respected. The choice to be made should be handled systematically, inclusively with due
considerations of ethical and practical reasoning and documented in a CRC model health care
services.
The following are among common ethical dilemmas encountered in the healthcare:
5. Resource Scarcity Related Dilemmas:
Health care is resource intensive and there is always gap between demand and supply. This dilemma
is a universal phenomenon though particularly severe in low-income countries where there is a large
population and high burden of disease. Handling such dilemmas fairly in a companionate, respectful
and caring manner should be satisfying to all parties.
6. Refusal of Treatment:
This can happen in many ways including withdrawal from treatment against medical advice for different
reasons, because of cultural and/or religious beliefs or personal reasons.
7. Disclosure and Truth Telling Dilemma:
Healthcare providers have the responsibility to tell the truth about the diagnosis, treatment, prognosis
and related issues to the patient, parent or legitimate care taker. However, it is quite a common
dilemma that relatives of patients come and ask health workers not to tell the truth to the patient with
an excuse of protecting the patient from stress. The patient should be allowed to plan his/her life based
on firsthand information on his/her health status.
8. End of Life dilemma
Futility is when it is known that all possible efforts would not reverse the patient’s condition or patient is
brain dead. In such situations, the dilemma of withholding or withdrawal of treatment arises. Health
care providers and families get conflicted whether continuing the treatment is actually helping or
hurting the patient, prolonging suffering.
b. Disagreement/conflict:
 Amongst colleagues:

 The cost of treatment for the patient always matters the CRC health workforce role as financial
risk protector for the patient – providing updated information
 A colleague’s knowledge and practice is not of acceptable standard and the issue is brought up
for possible corrective measures.
 Among patients/professionals and family members:
 Among family members: in case the patient is not able to make decisions (i.e. patient is in
coma or has a mental health problem)
 On consent for procedures…
 Mostly on treatment cost if it is covered by someone (relatives, friends…) other than the
patient
 Withholding and withdrawal of treatment in case of futility Possible corrective measures.

 Among patients/professionals and family members:
 Among family members: in case the patient is not able to make decisions (i.e. patient is in
coma or has a mental health problem)
 On consent for procedures…
 Mostly on treatment cost if it is covered by someone (relatives, friends…) other than the
patient

Directions: Answer all the questions listed below. Use the Answer sheet provided.
Multiple Choose
1. Which one of the following ethical dilemma happen in many ways including withdrawal from
treatment against medical advice for different reasons, because of cultural and/or religious
beliefs or personal reasons.
A. Refusal of Treatment:
B. Disclosure and Truth Telling Dilemma
C. End of Life dilemma
D. Disagreement/conflict:
2. Healthcare providers have the responsibility to tell the truth about the diagnosis, treatment,
prognosis and related issues to the patient,
A. True
B. False

Answer Sheet
Score = ___________
1. _________
2. _________ Rating: ____________
3. ________
Name _______________________________ date________________

Laws Governing the Practice of Pharmacy
Information Sheet-5
CONTENT-5
5.1.1. Food, Drugs and Cosmetics Act
Food, Medicine and Health Care Administration and Control Proclamation (Proclamation
No. 661/2009)
This Proclamation may be cited as the “Food, Medicine and Health Care Administration and
Control Proclamation No. 661/2009”.
In this Proclamation
”food” means any raw, semi-processed or processed substance for commercial purpose or to be
served for the public in any way intended for human consumption that includes water and other
drinks, chewing gum, supplementary food and any substance which has been used in the
manufacture, preparation or treatment of food, but does not include tobacco and substances used
only as medicines
Food safety and quality administration and control
Registration and License
1. Any food may not be manufactured, imported, exported, stored, distributed, transported or
made available for sale or use to the public without permit of the appropriate organ.
2. Any food production institution shall not change the type and production process of the food
without obtaining a permit from. And having it registered with, the executive organ.
Food Safety and Quality Control
1. No food or its raw material, additive or packaging material shall be put into use unless it
complies with the international and national safety and quality standards.
2. Any food shall be preserved in accordance with the standards set or adopted by the
appropriate organ.
3. Any person may not operate a laboratory established for food quality control unless it is
receives certificate of competence from the executive organ.

4. Any person may not operate a food catering service without obtaining a certificate of
competence from the appropriate organ.
5. A certificate of competence issued in accordance with sub-article (4) of this Article shall be
renewed every year.
6. It is prohibited for any institution that engages in food production, processing, storing,
distribution and transportation to hire an employee having contact with the product and who is
infected with communicable disease.
Food Import and Export
1. Any imported food shall be accompanied by a certificate of quality and safety authenticated by
the concerned government organ of the exporting country.
2. The executive organ may issue safety certificate for export food that needs the same.
Food Irradiation
Radiation treatment of food shall be carried out upon ascertaining by the executive organ that it is
designed to meet the requirements of safety and good hygienic practice of food processing.
5.5.2. Narcotic Drugs and Psychotropic Substances Act
Narcotic Drug means any drug subject to control according to Narcotic Drugs Conventions of
the United Nations ratified by Ethiopia. This shall also include a drug that is categorized as
narcotic drug by the Authority;
Psychotropic Substance means any substance subject to control according to psychotropic

Substances Convention of the United Nations ratified by Ethiopia. This shall also include a
substance that is categorized as psychotropic substance by the authority;
Narcotic Drugs and Psychotropic Substances
Special License Requisite
A special license issued by the Authority shall be required to import, export, manufacture or
distribute narcotic drugs.

A special license to import, export, manufacture, possess or store narcotic drugs psychotropic
substances shall be issued only to persons having drug trade license shall be issued only to
persons having drug trade license organizations
Import and Export
1. Any person having a permanent special license to import or export narcotic drugs or
psychotropic substances. shall apply for a special import or export permit for each
consignment; such special permit shall be valid only for ninety (90) days.
2. No person shall import or export narcotic drugs or psychotropic substances through post office
or by ship.
3. No person shall import or export narcotic drugs or psychotropic substances packing them with
other drugs or articles.
4. Any person who imports or exports narcotic drugs or psychotropic substances shall comply
with packaging guidelines issued by the Authority(Federal Negarit Gazeta - No. 60 29 th June,
1999- Page 1113)
Prescriptions
1. Only a medical practitioner who is registered and have a special license shall prescribe narcotic
drugs.
2. Psychotropic substances shall be prescribed by a licensed and registered medical practitioner.
3. No medical practitioner shall prescribe narcotic drugs and psychotropic substances for himself.
4. Narcotic drugs and psychotropic substances shall only be prescribed on a special prescription
paper.
5. The management of and standard that any prescription for narcotic drugs or psychotropic
substances shall fulfill would be set forth in the regulation to be issued pursuant to this
Proclamation
Storage
 Narcotic drugs and psychotropic substances and invoices, registers, and prescriptions shall
be stored in a lockable metal cupboard or in a special room the key of which shall at all
times remain in the hands of the authorized professional.
Disposal

 Any person shall keep damaged, expired, or seized narcotic drugs or psychotropic
substances in a separate place and shall dispose them in accordance with the directive to
be issued by the Authority pursuant to this Proclamation
Cessation of Business
 Any person who is licensed pursuant to this Proclamation and who ceases to operate his
business shall deal with the stocks of narcotic drugs, psychotropic substances, invoices,
other documents, and prescriptions related to same as directed by the Authority
Recording and Reporting
 Any person who is licensed pursuant to this Proclamation shall keep records and send
reports about narcotic drugs or psychotropic substances in accordance with a directive that
shall be issued by the Authority
5.5.3. Drug Abuse Prevention; Poisons Act
 “Poisons” means a substance that may cause damage to man, animal, plant and
environment when taken in small quantity. A poison by its action on tissue organ of the body
can impair function or destroy life.
 Is a law governing poisons in order to ensure their proper handling transportation storage
and use as well as proper record keeping and reporting
o The lists of poisons are usually divided into two parts:
Poisons in part I
 These poisons can be sold only by authorized seller of poisons i.e. from retail pharmacies
or whole sale by or under the supervision of a pharmacist
Poisons in part II
 These poisons can be sold from retail pharmacy or whole sale and other shop keeper who
are listed or authorized by local regulatory authorities
5.5.4. Tort Law

 Tort is a Latin word meaning twisted and refers to conduct that is wrong of twisted
 Most of the torts of pharmacists are
 Act of Negligence
 Violation of law as negligence
 Liability for Negligence
5.5.5. Commercial Law

Directions: Answer all the questions listed below. Use the Answer sheet provided.
Part I:-Choose the best answer from the given alternatives and encircle your best answer
1. Which one of the following substances is may cause damage to man, animal, plant and environment
when taken in small quantity.
A. Food
B. Poisons
C. Drug
D. Cosmetic
2. Most of the torts of pharmacists are
A. Act of Negligence
B. Violation of law as negligence
C. Liability for Negligence
D. All of the following
3. Which one of the following drug retail out-let run by a regiDrug store
A. Drug shop
B. Community pharmacy
C. Drug vendor
D. Community pharmacist.
Part II:-Instruction Give short answer for the following questions(out of 3%)
4. List out the Prohibited activities by pharmacist/druggist(2pts)
A. _______________________________
B. _______________________________
C. _______________________________
D. _______________________________
5. Write Type of inspection(1pts)
A. _______________________________
B. _______________________________

Answer Sheet
Score = ___________
1. _________
2. _________ Rating: ____________
3. _________
4. _________
5. _________
Name: _________________________ Date: _______________

Pharmaceutical Laws and Regulations
Information Sheet-6
CONTENT-6
5.6.1. Pharmaceutical legal systems

The role of pharmaceuticals has become more prominent on international agendas as health
indicators have been increasingly linked with a country’s successful development.
In addition, the legal and economic issues that surround pharmaceuticals have become more
complex and politicized because of the increase in global trade.
Realistic and effective laws and regulations are neededfor the pharmaceutical sector because—
 Pharmaceuticals concern the whole population
 Many parties are involved: patients, health provid-ers, manufacturers, and salespeople
 Serious consequences, including injury and death,can result from the lack or misuse of
medications
 The consumer has no way to determine productquality
 Informal controls are insufficient
Why pharmaceutical laws and regulations are necessary?
The use of ineffective, poor-quality, or harmful medicines can result in therapeutic failure, exacerbation of
disease, resistance to medicines, and sometimes death. It also under-mines confidence in health systems,
health professionals, pharmaceutical manufacturers, and distributors. To protect public health, governments
need to approve comprehensive laws and regulations and to establish effective national regu-latory
authorities to ensure that the manufacture, trade, and use of medicines are regulated appropriately and that
the public has access to accurate information on medicines.
Pharmaceutical legal systems (legislative, executive, judicial systems);

Legal System
 Legal system is process of making, enforcement and interpreting law
 It includes legislative, executive and judicial system.
1. Legislative system - is law making process.
 Who should make a law? E.g. in Ethiopia HPR
 What should a law include?
o The content depends on political, economic and socio-cultural development as well as
international situation.
N.B. There is no one law that can serve every country or there is no one internationally accepted
law. However, the laws of different countries share

2. Executive system
 Is an authorized governmental boy responsible to administer and enforce a law
 In Ethiopia – DACA/FMACA is responsible to administer and enforce drug administration
and control proclamation No. 176/1999.
 In USA, DEA - to administer and enforce the controlled substance act.
 Executive body may also authorized to do
 Legislative action
 Authorized to issue regulation principle draft law.
 Judicial action
 Interpret law; e.g. suspending and revoking license, revoke professional registration
certificate.
3. Judicial system
 Judicial process includes
 Interpreting a law
 Holding trails
 Receiving of evidence or testimony
 Taking measures accordingly
 Appeal
The judicial action is carried by different types of courts
5.6.2. Drug nomenclature requirements
 A pharmacy law of a country should include a statement regarding on drug nomenclature
1. Chemical Name
 Each drug on the market has chemical name
 The use of such a name is not always easy
 As many drugs’ chemical names are complicated and difficult to remember
2. Brand Name/proprietary name
 Is a name chosen by the manufacturer or distributor to facilities recognition and
association of the product with a particular firm for marketing purpose
 In many countries, new pharmaceutical products are protected by a patent, brand, or both
for a fixed number of years
 Patent right is a protection of intellectual property
 When the patent expires, the pharmaceutical product may become a commodity the
competitors can produce and sell

 The original companies in most cases continue to sell the product, using the brand name
originally adopted
 New drug competitor may also give the product their own brand name
 When one brand name is used for a product from multiple sources, the term “brand
generic” is employed
3. Generic Name
 The international nonproprietary name is the drug official name regardless of who
manufactures or makes it
 Regardless of the manufacturer, every drug is ‘generic drug’, Although it may have a
brand-trade name, it will always have generic name
5.6.3. Labeling and packaging requirements of pharmaceuticals
 Labeling and packaging of pharmaceutical to be made available for use must be controlled
by law governing the sector
 No pharmaceutical shall be marketed or by any means distributed unless it is duly
packaged or labeled by any pharmaceutical manufacturer, importer, distributer, retailer or
health institution
 A pharmacy Law executive Agency of a country shall prepare requirements for labeling and
packaging of pharmaceuticals
 Violating the labeling and packaging requirements means violating the law governing the
purity, safety and efficacy of pharmaceutical
Labeling of container and packaging of pharmaceutical
All labeling of containers and packages must be:
 Easily Legible
 Clearly comprehensible
 Indelible (that cannot rubbed out)
 In the language of the country/state or any other language accepted by the country
The label of pharmaceutical/drug must include:
 The name of the medical product
 The name and quantity/strength of the active ingredient(S);
 The net contents of the package
 The method and route of administration
 The name and address of the manufacturer, packer or distributor
 Batch Number and license number

 Manufacturing and expiry date
 Storage condition (special)
 Cautions and warnings for the protection of the user
Example
 Do not apply on the broken skin
 Do not exceed recommended dosage
 Discontinue use if
 “Keep out of reach of children”
 “Shake well before use”
 “Law prohibits dispensing without prescription”
Labeling of small containers of drug products
When the container of any drug product is not a blister, but it is too small to include all the
standard particulars it must be labeled with:
 The name of the product, if necessary the strength and ROA
 The method of administration
 The expiry date
 The batch number
 The pack size / quantity
Labeling of prescription Drugs
“Warning Law prohibits dispensing without prescription”
Labeling of Non-Prescription Drug
OTC/over the counter/ Drugs must bear adequate directions for safe and effective use in lay
language
Labeling of dispensed drug products
A dispensed drug products means drug product prepared or dispensed in accordance with a
prescription given by an authorized prescriber
The standard labeling requirements do not apply to dispensed drug products
The container of the dispensed drug must be labeled as follow:
 The name of the person to whom the drug is dispensed
 The name and address of the institution
 The date of dispensing
 On the drug product
 Drug name, strength and dosage form
 Quantity of the drug dispensed
 Precautions related to the use and storage of the product
Example
 “Keep out of reach of children”
 “For External use”
Labeling of hazardous substances
The hazardous substances act requires labeling of hazardous substance with:
 The name and address of manufacturer, distributor and seller
 The common name
 The signal word “danger” on extremely flammable, corrosive or highly toxic substances
 The signal words “Warning” or “caution” on all other hazardous substances including
 Flammable
 Toxic
 Harmful if swallowed, etc
 Precautionary statements
 First aid instruction
 The signal word “poison” for highly toxic substances
Package insert/Leaflets
The content and format of package insert of pharmaceutical is controlled by laws governing
the sector
The package insert must contain a summary of essential scientific information that is needed
for safe and effective use of the pharmaceutical
The insert must be informative, accurate and neither promotional in tone nor false or
misleading
The package insert for prescription drug product must contain the following:
 Description (proprietary and or Generic) of the product
 Clinical pharmacology
 Indications and usage
 Contraindications
 Warnings and precautions
 Adverse reaction
 Drug abuse and dependence
 Over dosage
 Dosage and administration and how supplied

5.6.4. Administration/quality assurance
Quality assurance (QA)
 It is the sum of all activities and responsibilities intended to ensure the products meet
all the applicable quality specifications in the final dosage form.
 Quality assurance is a wide ranging concept covering all matters that individually or
collectively influence the quality of a product.
 Is not the duty of one organization unit in the company alone
 The responsibility of all staff members who can influence product quality
 Must be independent of financial pressure
 Must ensure the quality policies are followed
Rationale
 To ensures the safety, efficacy and quality of pharmaceutical products .
 It is important to gain the information about the qualitative and quantitative composition of
substances i.e. to find out what a substance is composed of and exactly how much
 Today analysis of drugs and pharmaceuticals is performed by:
 analyst specializing in chromatographic, spectroscopic and wet chemical analyses.
 ‘Every country has legislation on bulk drugs and their pharmaceutical formulations
 that sets standards and obligatory quality indices for them.
 Pharmaceutical analysis deals not only with medicaments (drugs and their formulations)
 But also with their precursors i.e., with the raw material on which degree of purity and
the quality of medicament depends.
Determinants of Medicine Quality
 Identity: Active ingredient
 Purity: Not contaminated with potentially harmful substances
 Potency: Usually 90–110% of the labeled amount
 Uniformity: Consistency of color, shape, size
 Bioavailability: Interchangeable products?
 Stability: Ensuring medicine activity for stated period
Quality is "Invisible when GOOD, Impossible to ignore when BAD"
 The totality of features and characteristics of a medicinal product and its ability to
satisfy the stated and/or implied needs
 Meeting requirements of specific customer needs

 Compliance with specifications
5.6.5. Control of fulfillment of requirements to practice pharmacy:

5.6.5.1. Pharmaceutical retail outlets
 Pharmaceutical Retail outlet means a business organization, which sell drugs (not on a
general sale list) on retail basis of patents
 No person is allowed to run drug retail outlet without getting license from pharmaceutical
regulatory authority
Objective:
 To ensure the quality, safety and efficacy of drugs and made available
 To ensure god dispensing practice or pharmaceutical
Requirement of License/Registration
The requirements to establish drug retail out-let
3. Personnel
 Procurement, storage, inventory control, dispensing, record keeping, reporting, etc. of drugs
and medical supplies or Drug Retail Out-let should done by or under the supervision or
registered adequately qualified and experienced professional
 The type of technical personnel required and level of dug out-lets are:
a. Community pharmacy – a drug retail out-let run by a registered pharmacist .
b. Drug shop (drug store) –led by a registered druggist or pharmacy technician.
c. 3rd Grade drug Retail out-let- usually fund in developing counties, is led usually by a
registered non-pharmacy personnel, which could be
 Physician or
 Veterinarian or
 Nurse or
 Health assistant
 Junior pharmacy technician

 In many countries including in some developed countries physicians, Dentists,
veterinarians, and Nurse are allowed to dispense or sell drugs only to their patients
 The 2nd and 3rd type of Drug out-lets are not found in most developing counties. They are
common in countries that have shortage of pharmacists and other pharmacy personnel.
4. Premises
 Appropriate area (rooms) for storage, compounding (only in a community pharmacy) and
dispending as well as toilet are required to establish drug retail outlet
5. Equipment and facilities
 Required for proper storage, dispensing, compounding (community pharmacy), record
keeping, etc. shall be fulfilled in order to open drug retail out-let
 In many countries, the owner of a community pharmacist shall be a pharmacist or group or
pharmacist or the licensed pharmacist shall have a share
 When the owner of a community pharmacist is group of pharmacist, dispensing of drug is
done under the management and supervision of one of them, and license is given in the
name of him/her
6. Standard Operation Procedures
Limiting distribution of drug retail outlet
 Most countries have a provision in their drug legislation/regulation which determines where
each type of drug out-let should be opened
 The 2nd and 3rd type Drug Out-let are usually opened in a place where there is
no/inadequate community pharmacies
Control of Practice or Drug Retail Out-let
4. Premises and hours of business
Pharmaceutical service- shall be provided at the premises specified and registered at the
time of licensing or authorization
The drug retail out-let shall:
 Be open for provision of pharmaceutical service during working hours specified by the
licensing authority including night and holiday duties
 Have a clearly legible sign on the outside of building as near to the main entrance as is
practicable stating
 The name, level and address of the drug retail out let
 Opening and closing hours name and address of drug retail out-lets which are on duty

 Type and Quality of pharmaceutical that shall be made available
Any drug retail out let shall:
 Obtain pharmaceutical only from legal source

 Make available needed pharmaceutical
 Make available pharmaceutical in accordance with its level.
 Only community pharmacy can handle almost all type of pharmaceutical/drug
 Dispense pharmaceutical of proven quality, safety, and efficacy
 Immediately report when counterfeit and substandard pharmaceuticals are encountered to
an appropriate
 Drug regulatory authority following and appropriate channel
 Storage of pharmaceuticals
Any drug retail out-let shall:
 Store pharmaceuticals properly in accordance with the storage conditions stated on their
label
 Store pharmaceuticals, which requires special storage condition accordingly
5.6.5.2. Manufacturing of pharmaceuticals

 Pharmaceutics is the general area of study concerned with the formulation, manufacture,
stability and effectiveness of pharmaceutical dosage forms.
 Pharmaceutics deals with the formulation of a pure drug substance into a dosage form.
 The word pharmaceutics is used in pharmacy and pharmaceutical sciences to encompass
many subject areas which are all associated with the steps to which a drug is subjected
towards the end of its development i.e. it is the stages that follow its discovery or synthesis, its
isolation and purification and testing for advantageous pharmacological effects and absence of
serious toxicological problems
5.6.5.3. Import/export of pharmaceuticals
 Import of pharmaceutical must be legally controlled in order to ensure that the imported
pharmaceuticals are of proven quality, safety and efficacy as well as they are on the basis of
the country need
Stringency and scope of control of import

 Is vary from country to country and with type of pharmaceuticals are of proven quality, safety
and efficacy as well as they are on the basis of the country need
 Most developed countries exercise stringent control on the import of pharmaceuticals
 The control of import in most developing countries is less stringent
 More control stringent is exercised on import of drugs and medical supplies than on
cosmetics and sanitary preparation
Requirements to import pharmaceuticals
6. License/Authorization to import pharmaceutical

 Unless and otherwise licensed by regulatory authority ,no one allowed to import
pharmaceuticals
 However, not require getting license to import pharmaceutical for personal use, research,
laboratory testing, donation in emergency and compelling conditions License to import
pharmaceutical is issued by Regulatory Authority after assuring the fulfilment of
requirements:
A. Personnel:
 Import and whole distribution of drugs and medical supplies shall be carried out under
supervision of experienced and qualified personnel usually pharmacist in most countries
 In some countries, the supervision can be done by non-pharmacy personnel
B. Premises : for receiving, storing, dispatching and doing administrative works
C. Equipment and facilities: for receiving, storing, inventory control, dispatching and doing
other administrative work
D. Standard operation procedures: to be followed when ordering, port clearance, inventory
control, distributing, complaint collection and analysis, product recall, etc.
1) Marketing Authorization of Pharmaceutical
 Obtaining license to import pharmaceutical especially drugs and medical supplies is not
sufficient
 Obtaining marketing authorization for each product from Regulatory Authority is also legally
needed in most countries
2) Obligations of importer of pharmaceutical

Any importer of pharmaceutical shall:
 Not import and distribute pharmaceutical, which are adulterated, counterfeited and
substandard
 Not use the premises for purpose other than specified in the license
 Not make change of address or modify premises without getting authorization from regulatory
authority
 Distribute pharmaceutical only to those licensed or authorized institutions and in accordance
with their level
 Keep and provide information as may be requested by the licensed authority
 Allow inspection and keep records of imported, stocked, distributed and disposed
pharmaceuticals
 Institute and emergency plan, which ensure effective implementation of any recall from the
market and withhold sale/ distribution of products that have quality problems
 Keep records and show to regulatory authority when requested the following documents
 Marketing authorization certificates
 Batch analysis certificates
 Records of imported, stocked, distributed and disposed pharmaceuticals
 Name and address or organization and personnel to whom pharmaceuticals are distributed
or sold
 Directives and other relevant matter
 License of clients
Control of export of Pharmaceuticals
Export of pharmaceutical shall be controlled legally
 No one is allowed to export pharmaceutical without getting export authorization and /or
export permit for each consignment
 Manufacturers can export their products and the requirements and other control are more or
less the same as importer
 In most counties, pharmaceuticals to be exported are exempted from marketing
authorization requirement
The stringency of control on pharmaceutical to be exported varies from country to county and
with the type or product

The control on export item is usually dependent on the requirements of importing countries
Most countries give exports certificate of pharmaceutical for each consignment
5.6.5.4. Wholesale distribution of pharmaceuticals

The control of whole sale of pharmaceutical is more or less the same as the control of import
Responsibility of pharmacy law executive agency
 Set standard of premises, personnel, equipment/facilities, and standard operation
 Issue, renew, suspend and revoke license of premises when justifiable
 Issue port clearance permit when there is import
5.6.5.5. Health institutions involved in use and dispensing of pharmaceuticals

5.6.5.6. Management and use of controlled substances, poisons, radiopharmaceuticals
Poisons
1. The Authority, based on international standards, shall prepare a list of poisons and
communicate to all concerned bodies, and issue a detailed directive on their storage,
sale and disposal.
2. No person shall manufacture, import and distribute poisons unless he first have
obtained a special permit from the Authority.
3. Any person who manufactures imports or distributes poisons shall keep detailed
records of such poisons in accordance with the directives that may be issued by the
Authority and reports to same.
(Federal Negarit Gazeta - No. 60 29th June, 1999- Page 1114)
Radio pharmaceuticals
1. The Authority shall issue regulations and directives regarding the storage,
distribution, use and disposal of radio pharmaceuticals in accordance with the
recommendations that it may receive from the International Atomic Energy Agency.
2. No person shall manufacture, import, distribute or sell radio pharmaceuticals unless

he first have obtained a special permit from the Authority.

3. Any person who has a special permit pursuant to this Proclamation shall keep records
and send reports of manufactured, imported or distributed radio pharmaceuticals, in
accordance with the directives that may be issued by the Authority
5.6.5.7. Prohibitions
Prohibited activities
 Failure to renew license/registration timely
 Providing pharmaceutical service in the absence of license or equivalent delegated

professional
 Handing dispensing or supplying of substandard, counterfeited drugs and failure to report
when such products are encountered
 Obtaining drugs and medical supplies from illegal resource/supplies
 Creating obstacle of pharmaceutical inspectors so as to jeopardize the inspection
 Using the premise of the drug, retail out-let activities that do not go with the intended
purpose
 Changing of address and modifying of the drug retail out-let without the consent of the
license issuing authority.
 Undertaking of activities that are not allowed by law
 Allowing to practice unregistered and unauthorized pharmacist or to her pharmacy or
health personnel
 Selling of free medical samples
 Dispensing drug without adequate information
 Other activities that contravene this and related guideline issued by drug regulatory
authority
5.6.5.7. Clinical trials
Clinical Trial means testing a drug on human or animal subjects to prove its efficacy and
safety.
A clinical trial shall be conducted only on a human being who has given his consent in writing
and on domestic animals with the consent of the owner and on wild and sea animals when
permission of the Government is obtained, and all of which are subject to the authorization of
the Authority in accordance with the regulations issued for the implementation of this
proclamation (Federal Negarit Gazeta - No. 60 29 th June, 1999- Page 1112)

 Notwithstanding Sub Article (1) of this Article, a clinical trial shall not be conducted on
nursing and pregnant women, on children under the age of 18 on prisoners, on insane
persons, and on persons dependent on the investigator or on the institution.
 No clinical trial result which has not been evaluated and approved by the Authority shall be
published or disseminated in any way.
 Any identifying data about the trial subjects shall be kept confidential
5.6.5.9. Legal procedures for offenses and penalties
Illegal Drug Trade
Except penalizing in accordance with the penal code is stronger than the following:
1. Any licensed person who:
 Impedes the work of inspector assigned pursuant to Article 14 of this Proclamation shall be
punishable with imprisonment for not more than six months or with a fine not exceeding ten
thousand Birr or with both.
 Transfers the licenses issued to him to any person by way of any means shall be punishable
with imprisonment of not less than one year and not more than three years and a fine of not
less than five thousand Birr and not exceeding twenty thousand Birr.
 Transfers the licenses issued to him to any person by way of any means shall be punishable
with imprisonment of not less than one year and not more than three years and a fine of not
less than five thousand Birr and not exceeding twenty thousand Birr.
2. Any licensed drug manufacturer, importer, exporter or wholesaler who sales drug to a
person without a license shall be punishable with imprisonment of not less than two years
and not exceeding five years and with a fine of not less than five thousand Birr and not
exceeding twenty thousand Birr.
Administers or causes or permits to be administered narcotic drugs or psychotropic

substances without having a license to prescribe;
3. Without sufficient reason or above the standard dose, prescribesnarcotic drugs or

psychotropic substances, even if he has a license;
4. Any person who trades drug without a certificate of competence shall be punishable with
imprisonment for not less than five years and not exceeding seven years and with a fine of
not less than twenty thousand Birr and not exceeding fifty thousand Birr

5. Any licensed drug retailer who wholesales, or dispenses drugs in excess or less quantity
than that justified by medical practice or purchase drugs from a person who is not licensed
pursuant to this proclamation shall be punishable with imprisonment of not less than two
. Administers or causes or permits to be administered narcotic drugs or psychotropic substances
without having a license to prescribe;
4. without sufficient reason or above the standard dose, prescribesnarcotic drugs or psychotropic
substances, even if he has a license;
years and not exceeding five years and with a fine of not less than five thousand Birr and
not exceeding twenty thousand Birr.
6. Any person exercising unfair trade practice by counterfeiting, or adulterating or affixing or

enclosing mislabel to packaging material, or buying or selling substandard or expired drugs
shall be punishable with imprisonment of not less than ten years and not exceeding twenty
years and with a fine of not less than twenty thousand Birr and not exceeding fifty thousand
Birr.
7. Any person who fails to comply with the provisions of this Proclamation, or regulations and
directives issued pursuant to this Proclamation, shall be punishable with imprisonment of
not exceeding two years and with a fine of not exceeding ten thousand Birr
8. For the execution of this Article drug shall mean any substance excluding narcotic drugs
and psychotropic substances (Federal Negarit Gazeta - No. 60 29 th June, 1999- Page 1115)
Offenses Facilitating Abuse of Narcotic Drugs and Psychotropic Substances
Any person who:
1. By way of any means, publishes or displays, or causes or permits to be published or displayed

and anything promoting or encouraging the abuse of narcotic drugs or psychotropic
substances;
2. Is owner or occupier of a house, a compound or any place, causes or permits there the abuse
of narcotic drugs or psychotropic substances.
3. Sells or supplies narcotic drugs or psychotropic substances on presentation of a prescription,
where he knows that the presentation is forged, unlawfully altered, cancelled or expired,shall
be punishable with imprisonment ofnot less than 7 years and not exceeding 15 years and with
a fineof not less than thirty thousand Birr and not exceeding fifty thousand Birr. not less than 7

years and not exceeding 15 years and with a fine of not less than thirty thousand Birr and not
exceeding fifty thousand Birr.
Confiscation
 All properties used to or derived from the Commission of the offenses mentioned in Articles 33
and 34 of this Proclamation shall be confiscated
Other offenses Related to Drug
1. Any civil servant or official assigned to perform duties related to Drug Administration and Control
activities who by taking bribes or through nepotism or favoritism or other illegal relationships by
violating the Proclamation and regulations to be issued pursuant to this Proclamation;
a. Issues and renews a certificate of drug trade competence and certificate of professional
registration or mislead others to do so;
b. Authorizes the use of drugs and raw materials without making adequate evaluation or
investigation of their quality, safety and efficacy or mislead others to do so;Shall be punished with
imprisonment of not less than ten years and not exceeding fifteen years and with a fine not less
than Birr thirty thousand and not exceeding Birr fifty thousand.
3. When the offense provided for under Sub-Article (1) of this Article is committed by more than
one person, if one of them first give adequate information on the commission of the offense and
the role of the major role player(s) before the case was seen by court, Ministry of Justice may free
the person from criminal liability
Directions: Answer all the questions listed below. Use the Answer sheet provided:

Instruction: Choose the best answer from the given alternatives and encircle your best
answer.
1. Any person having a permanent special license to import or export narcotic drugs or
psychotropic substances shall apply for a special import or export permit for each consignment;
such special permit shall be valid only for ______ days.
A. 90
B. 120
C. 360
D. 30
2. Which of the following legal system is responsible for making of law?
A. Legislative system
B. Executive system
C. Judicial system
3. ____Is a name of theGeneric Name
A. Chemical Name
B. Brand Name
C. None Propriety Name
D. drug chosen by the manufacturer
.Short Answer Questions
4. What is the rationality of Labelling and packaging of pharmaceuticals?
Note: Satisfactory rating – 5 points Unsatisfactory - below 5 points
Answer Sheet
Score = ___________
Rating: ____________
1. __________
2. _________
3. _________
4.
a. ______________
b. ______________
c. ______________
d. ______________
Name: _________________________ Date: _______________
Laws, regulations and directives pertaining to pharmaceutical

Information Sheet-7 services in Ethiopia
CONTENT-7

5.7.1. Product registration
 Placing of pharmaceuticals 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 and registration is a process of evaluation the quality, safety and
efficacy of pharmaceutical before and after it is marketed or made available for use.
 The procedure includes an assessment of both pharmaceutical product and of manufacturing
procedures and facilities.
 In comprehensive evaluation and registration system, data on pharmaceutical,
pharmacological, toxicological, therapeutics, clinical and preclinical investigations (for new
drugs) are analyzed.
 The scope and stringency of pharmaceutical evaluation and registration vary from country to
country and also from product to product.
Registration of Pharmaceuticals
 Registration of certificate of pharmaceutical is valid for limited period.
 It has to be renewed every certain year.
 The validity period of certificate of registration varies from three years to five years.
 Re-registration of pharmaceutical is necessary in order to accommodate the change in
quality, safety, efficacy, strength, pack size that might happen in between.
5.7.2. Pharmaceutical marketing and promotion

 It is expressly forbidden for a member of the pharmaceutical profession to use his/her
professional status to promote or endorse or in any other manner support publicly any
product or medicinal or otherwise.
 Members of the pharmaceutical profession must not participate in promotional methods that
encourage patients and society to equate medicines with ordinary items of commerce
Promotion:
Shall refer to all informational and persuasive activities by manufactures and distributors the
effect of which is to induce the prescription.
The information provided shall be:

 Accurate, fair and good taste and in such a way to conform not only to legal requirement but
also to ethical standards.
 Based on up- to- date evaluation of all the available scientific evidence
 Sufficient to the therapeutic -usefulness of the preparation
 Sample of informational and promotional must be submitted to the authority for approval prior
to any promotional activity.
 Information for advantages of pharmaceutical preparation should be with its disadvantages
 Exagerated claims must not be made and superlative must not be used
 No commercially interested party, and no person should issue an advertisement without the
consent of pharmacy law executive agency.
5.7.3. Professional licensing requirements

Directions: Answer all the questions listed below. Use the Answer sheet provided :
Instruction: Choose the best answer from the given alternatives and encircle your best
answer.
1. Re-registration of pharmaceutical is necessary in order to accommodate the change
in________
A. Quality
B. Safety
C. Efficacy
D. Strength
E. All of the above
.Short Answer Questions
2. What is Product registration and Registration of Pharmaceutical
Note: Satisfactory rating – 2points Unsatisfactory - below 2 points

Answer Sheet
Score = ___________
Rating: ____________
1. __________
2. _________
Name: _________________________ Date: _______________

Reference
1. DiMatteo, M.R. (1994). Enhancing patient adherence to medical recommendations.
2. National CRC Manual June 2017 ethiopia
3. Dispensing of Pharmaceuticals-III | ORHB december 2017
4. Beth A. Lown, Julie Rosen and John Marttila. An Agenda For Improving
Compassionate Care: A Survey Shows About Half Of Patients Say Such Care Is
Missing. Health Affairs 30, no.9 (2011):1772-1778.
5. FDRE, Regulation No ,299/2013, Food, Medicine and Health Care Administration and
Control, Council of Ministers Regulation
6. J Med Ethics-2003-Macklin-275-80.pdf
7. J Med Ethics-2008-Molewijk-120-4.pdf
8. Harry Chambers, Harry E. Chambers Effective Communication Skills for Scientific and
Technical Professionals 2000
9. EMA, Code of Ethics for Doctors practicing in Ethiopia, 2009
10. Royal Pharmaceutical Society of Great Britain, Code of Ethics for Pharmacists and
Pharmacy Technicians, Aug, 2007

Prepared By
Educationa
N l LEVE Phaone
Name Region College Email
o Backgroun L Number
d
1 oromi Nagelle deebisaaseenaa12@gmail.co 092179872
Debisa Taressa Pharmacy B a HSC m 8
oromi Nagelle 093067505
2 Tamene Galchu Pharmacy B a HSC maatigelchu@gmail.com 5
3 Somal 091048018
Ebrahim Dawud Pharmacy A i Jigjiga HSC ebraadaa@yahoo.com 6
Alemseged 091373979
4 Workneh Pharmacy A Harari Harar HSC yealemwerk@gmail.com 2
5 091750409
Habtamu Tarekegn Pharmacy B BGRS Pawi HSC htarekegn25@.gmail.com 4


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PHARMACY LEVEL -III

NTQF Level -III

LO 5: Functioning with legal and ethical framework

Pharmacy Level III Vision :01 Sep. 2019: Page 1 of 62

 Comply with policies and procedures

Pharmacy Level III Vision :01 Sep. 2019: Page 2 of 62

5.1.1. Definition of terms

Pharmacy Level III Vision :01 Sep. 2019: Page 3 of 62

Pharmaceutical laws/ Pharmaceutical jurisprudence

 is the “Science or philosophy of law governing pharmaceutical sector or services”

Pharmacy Level III Vision :01 Sep. 2019: Page 4 of 62

1. To ensure proper implementation of pharmaceutical policy.

Pharmacy Level III Vision :01 Sep. 2019: Page 5 of 62

Pharmacy Level III Vision :01 Sep. 2019: Page 6 of 62

Pharmacy Level III Vision :01 Sep. 2019: Page 7 of 62

Name: _________________________ Date: _______________

Pharmacy Level III Vision :01 Sep. 2019: Page 8 of 62

What is a national drug policy?

Drug policies differ by country due to difference in፡

1. The structure of health care system

Example: Objectives of Ethiopian NDP

1. National pharmacy and medicines regulatory authority

1.1. Federal Board of Pharmacy and Poisons

Pharmacy Level III Vision :01 Sep. 2019: Page 11 of 62

1.2. Drug information, pharmacovigilance and statistics

Pharmacy Level III Vision :01 Sep. 2019: Page 13 of 62

 A national drug advisory committee composed of highly skilled professionals in

Self-Check -2 Written Test

Pharmacy Level III Vision :01 Sep. 2019: Page 15 of 62

Name: _________________________ Date: _______________

Pharmacy Level III Vision :01 Sep. 2019: Page 16 of 62

Introduction to legal basis of Pharmacy practice

The science and philosophy of law governing a pharmaceutical sector or servic

What are pharmaceuticals?

Usually, pharmaceutical includes drug, cosmetic, medical supplies&instruments and sanitary

Pharmacy Level III Vision :01 Sep. 2019: Page 17 of 62

Law occurs in a variety of hierarchal forms.

1. Constitution -a broad statement of power of government and its branches.

 Legal system is process of making, enforcement and interpreting law

Pharmacy Level III Vision :01 Sep. 2019: Page 18 of 62

The need for legislation on pharmaceutical

 Possess certain training.

1. Law dealing with drugs

 To ensure proper implementation of pharmaceutical policy.

Pharmacy Level III Vision :01 Sep. 2019: Page 19 of 62

Strategies for the assuring drug quality, safety and efficacy

Pharmacy Level III Vision :01 Sep. 2019: Page 20 of 62

Conditions for revocation

 If registration is obtained by fraud

B. Evaluation and registration of pharmaceutical

In comprehensive evaluation and registration system data on

Pharmacy Level III Vision :01 Sep. 2019: Page 21 of 62

 Registration certificate of pharmaceutical is valid for a limited period. It has to be renewed

Re-registration of pharmaceutical is necessary in order to accommodate the change in quality, .

The need of license is,

Pharmacy Level III Vision :01 Sep. 2019: Page 22 of 62

1. Pre-licensing inspection – It is the type of an inspection undertaken in order to ensure the

Pharmacy Level III Vision :01 Sep. 2019: Page 23 of 62

 He/she should keep the trade secrecy of the premises inspected.

Name: ___________ Date: _

Name: ___________ Date: _

Name: ___________ Date: _

Name _______________ date

Name: ___________ Date: _