The document outlines a pharmacy law and ethics course that covers topics such as ethical decision making, health professional relationships, and laws regulating pharmaceutical services. The course aims to help students apply ethical and legal reasoning to pharmaceutical care decisions through case studies. Upon completing the course, students will be able to explain policy development, identify pharmacy laws and standards, and describe ethical principles in pharmacy practice.

1.  Course title: Pharmacy Law & Ethics
 Course code: Phar4173
 Course EtCTS: 3
 Pre-requisite if any: - successful completion of
the previous modules
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Pharmacy Law & Ethics Course
Syllabus

2.  Course Description:
 The course offers topics on principles of
 ethical decision making
 health professional patient relationship
 frameworks for ethical analysis
 ethical theories, principles and moral values
 ethical codes, laws, regulations and directives
pertaining to pharmaceutical services internationally
and in Ethiopia
 product registration and licensing requirements
 regulations related to narcotic and psychotropic drugs.
 Case-study practice scenarios will also be presented to
allow students make pharmaceutical care decisions
based upon ethico-legal reasoning.
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3.  Upon completion of the course, students will
be able to:
 Explain the process of policy development and
evaluation
 Identify laws governing the practice of pharmacy
 Describe the ethical principles in pharmacy
practice of Ethiopia
 Identify standards and guidelines governing
pharmacy practice in Ethiopia
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Course Objectives:

4.  Mode of delivery:
 Illustrated Lectures
 Active learning methods (brain storming,
group, discussion, etc),
 Individual and group exercises and
assignments
 Presentations
 Case study
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5.  Mode of Assessment:
 Attendance: 16%
 Assignment: 20%
 Final Exam: 64%
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6.  Reference Materials:
1. Remington’s: The Science and Practice of Pharmacy, 21st
edition,
University of The Sciences in Philladelphia,2005,USA.
2. Dale and Appelbe's Pharmacy Law and Ethics, 8th
edition, Pharmaceutical
Press, 2005, London
3. De. Marco, C. T. Pharmacy & the law, Aspen Systems Corp., Rochville,
MD, 1984.
4. Drug Administration and Control Proclamation No. No. 661/2009
5. Standards for the Establishment and Practice of Pharmaceutical
Manufacturing Plant, Drug Administration and Control Authority, 2001,
Addis Ababa.
6. Directive for the Regulation of Promotion and Advertisement of Drugs,
Drug Administration and Control Authority, 2005, Addis Ababa.
7. Guideline to Control and Promote Proper Use of Narcotic Drugs and
Psychotropic Substances, Drug Administration and Control Authority,
2004, Addis Ababa.
8. Code of Ethics and Standards of Practice for Pharmacists Practicing in
Ethiopia, 2nd edition, Ethiopian Pharmaceutical Association, 2006, Addis
Ababa.
6

7. 10. Requirements and Guidelines for the Registration of Human
Drugs, Drug Administration and Control Authority, Addis
Ababa.
11. Drug Import and Wholesale Guidelines, DACA.
12. Drug Retail sale guidelines, DACA.
13. Fink III, J.I., Marquard K.W & Simonsmeir, KM, Pharmacy
Law Digest, Facts and Comparison, St. Souio, MD 1998.
14. Pharmacoethics: A Problem-Based Approach (Pharmacy Educat
, David A. Gettman and Dean Arneson, CRC, 2003
15. Law, Liability & Ethics for the Medical Office Professional,
Myrtle R. Flight, 4th edition, Delmar Cengage Learning, 2003.
16. Mappes, T.A., and Zembaty, J.S. (1991). Biomedical ethics
(3rd ed.). New York, NY: McGraw-Hill.
17. US Food, Drug and Cosmetic Act , URL:
http://www.fda.gov/RegulatoryInformation/Legislation/Federal
FoodDrugandCosmeticActFDCAct/default.htm04/20/18
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8. Pharmaceutical Ethics
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9. Outline
 Introduction
 Pharmaceutical law and ethics
 The eight star pharmacist
 Control of fulfilment of requirements to practice
pharmacy
 Power and Duties of FMHACA of Ethiopia

10. Introduction
 Profession Vs Vocation
Profession: is a form of employment or a field
that is respected in the society and that
requires extensive study and mastery of
specialization in knowledge.
Professional: A person who earns his living from
a specified activity
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11. Intro…
 Characteristics of Profession:
 Specializing in knowledge
 Rigorous training and schooling, problem-solving skills
 Providing essential services to the society
 Deriving force: not fortune (gain) but rather the service
they render (ministering)
 High degree of self-control of behavior
 Codes, guidelines, oaths, commitment statements,
etc.
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12. Intro…
 Mutual trust b/n professionals and the patron
 b/c there is information asymmetry b/n the provider and
the receiver
 Social Sanction
 professionals given exclusive right to practice the
profession
 Association
 Ever changing/growing field of study
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13. Intro…
 Vocation
 An inclination to undertake a certain kind of work,
especially a religious career ..priesthood, musician etc.
 Training is given for short time; mainly to develop
habitual skills
 Vocational skills are useful under stable conditions
where the problems are routine
 Vocational education is highly dogmatic
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14. Intro…
Is pharmacy a true profession?????
Yes
Why?
Because it assists the public and individuals
make the best usage of medications and
fulfils the above basic feature of a profession.
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15. PHARMACEUTICAL LAW AND ETHICS
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16. Outline
 Introduction to Pharmaceutical Jurisprudence
 Laws Governing the Practice of pharmacy
 Pharmaceutical Laws and Regulations
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17. Introduction to Pharmaceutical
Jurisprudence
 Pharmaceutical Jurisprudence is the philosophy of law
governing the pharmaceutical sector.
Pharmaceutical Law and Ethics:
 Law :- is the body of principles that govern conduct & the
observance of which can be enforced in courts.
 Demarcates what is permissible from what is not
 It must be obeyed & followed by all citizens and
 Subject to legal sanctions or consequences.
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18. Introduction...cont’d
 Ethics :- is the systematic study of what is right
and good with respect to conduct.
 Its basic foundation is “Do Good and Avoid Evil”
 Ethics:- are rules promulgated by a profession
or groups and imposed upon all members of the
profession by its own organization.
 Ethical standards are enforced by the profession
itself.
 Law often originates from ethical codes and
promulgated by the state.
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19. Introduction...cont’d
 Law is also enforced by government
 While ethics is a principle achieved by voluntary self
discipline.
 Adherence to ethics is expressed through taking
professionaloathand accepting professionalcodeof ethics.
 Law attempts to achieve its purpose through the power of
the government,
 Ethics attempts to achieve its purpose without the
intervention of the government.
 Ethics and law are related in that both share the social
purpose: ENCOURAGE THE RIGHT CONDUCT.
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20. Professional characteristics of pharmacists
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A. Possession of specialized body of knowledge:
Enables the practitioner to perform highly useful social
function for:
 Advising patients and prescribers
 Detecting potential drug-drug interactions
 Selecting proper products and product sources
 Exercising professional judgment
B. Sets of specific attitudes that influence professional
behavior manifested by altruism: an unselfish concern
for the welfare of others. 04/20/18

21. 21
 “The professional does not work in order to be paid; he/she is
paid in order that he/she may work.”
 The decision he/she makes in the course of the career is
based on his/her sense of what is right and not on estimation
of what is profitable.
C. Social sanction: whether the society views it as a measure of
social sanction; granting of exclusive right of practice through
the licensingpower of the country.
Licensing: protects the public from incompetent practitioners
and creates a relationship of trust between the society and
professional.
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22. Code of Ethics
22
These are rules of conduct based on moral values, which
are stated by a recognized association.
Pharmacists are health professionals who assist
individuals in making the best use of medications.
The pharmacy code of ethics is intended to state the
principles that form the fundamental basis of the roles and
responsibilities of pharmacists based on moral obligations
and virtues established to guide pharmacists with patients,
health professionals and society.
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23. 23
 Why code of ethics?
 To define accepted/acceptable behavior
 To promote high standards of practice
 To provide a benchmark for members to use for self
evaluation
 A framework for behavior and responsibilities
 As a vehicle for occupational identity
 As a mark of professional maturity
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24. Basic code of ethics for pharmacists BY FIP AND
EPA IN ETHIOPIA
24
1. A pharmacist respects the covenantal relationship
between the patient and the pharmacist
 moral obligation in response to gift of trust from the
society.
2. A pharmacist promotes the good of every patient in
a caring, compassionate and confidential manner.
 A pharmacist places concern for the well-being of the
patient at the center of professional practice.
 Protect the dignity of the patient.
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25. 25
3. A pharmacist respects the autonomy and dignity of each
patient.
 A pharmacist respects personal and cultural differences
among patients.
4. A pharmacist acts with honesty and integrity in professional
relationship.
 Has a duty to tell the truth and to act with conviction of
conscience.
5. A pharmacist maintains professional competence as new
Medications, devices, technological advances and health04/20/18

26. 26
6. A pharmacist respects the values and abilities of
colleagues and other health care professionals.
7. A pharmacist serves individuals, community and societal
needs.
8. A pharmacist seeks justice in the distribution of health
care resources
 Fair and equitable health resource distribution balancing
needs of patients and the society.
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27. The Eight-StarPharmacist
 To be effective healthcare team members,
pharmacists need skills and abilities enabling them
to assume many different functions.
 The concept of the “eight-star pharmacist” was
introduced by WHO in 2000 in its policy statement
on Good Pharmacy Education Practice to cover
the roles of
Caregiver decision-maker
Manager Communicator
life-long learner teacher
Leader researcher

28. The eight-Star…
1. Caregiver:
 Pharmacists provide caring services
 Services must be of the highest quality
2. Communicator:
 The pharmacist is in an ideal position to provide a link
between prescriber and patient, and
 To communicate information on health and medicines
to the public

29. The eight-Star…
3. Manager:
 Pharmacists must be able to manage resources (human,
physical and financial) and information effectively
 They must also be comfortable being managed by others,
whether by an employer or the manager/leader of a health
care team.

30. The eight-Star…
4. Life-long-learner:
 It is impossible to acquire in pharmacy school all the
knowledge and experience needed to pursue a life-long career
as a pharmacist.
 The concepts, principles and commitment to life-long learning
must begin while attending pharmacy school and must be
supported throughout the pharmacist’s career.
Pharmacists should learn how to keep their knowledge and
skills up to date.

31. The eight-Star…
5. Teacher:
 The pharmacist has a responsibility to assist with the
education and training of future generations of
pharmacists and the public.
Participating as a teacher not only imparts knowledge to
others, it offers an opportunity for the practitioner to gain
new knowledge and to fine-tune existing skills

32. The eight-Star…
6. Leader:
 In multidisciplinary (e.g., team) caring situations or in
areas where other health care providers are in short
supply or non-existent the pharmacist is obligated to
assume a leadership position in the overall welfare of the
patient and the community.

33. The eight-Star…
7. Researcher:
 The pharmacist must be able to use the evidence base
(e.g., scientific, pharmacy practice, health system)
effectively in order to advise on the rational use of
medicines in the health care team.

34. The eight-Star…
8. Decision-maker:
 The appropriate, efficacious, safe and cost-effective use
of resources (e.g., personnel, medicines, chemicals,
equipment, procedures, practices) should be the
foundation of the pharmacist’s work.
 At the local and national levels, pharmacists play a role in
setting medicines policy.
 Achieving this goal requires the ability to evaluate,
synthesize data and information and decide upon the most
appropriate course of action

35. Oath of a pharmacist
35
I vow to devote my professional life to the service of
mankind through the profession of pharmacy.
I will consider the welfare of humanity and relief of
human suffering my primary concerns.
I will use my knowledge and skills to the best of my
ability in serving the public and other health
professionals.
I will do my best to keep abreast of developments and
maintain professional competency.
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36. 36
I will obey laws governing the practice of pharmacy and
will support enforcement of such laws.
I will maintain the highest standards of moral and ethical
conduct.
I take these laws voluntarily with the full realization of
the trust and responsibility with which I am empowered
by the public.
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37. Ethical principles and obligations during practicing pharmacy
in relation to otherstakeholders
37
I. Pharmacist in Relation to his/herpatients
Always follow patient first or service first rule
 Good pharmacy practice and relationship between the
patient and the pharmacist has significant contribution to
better treatment outcomes.
Obligations
The pharmacist should:
 Respect the covenantal relationship with the patient
 Be morally obliged in response to the trust received from the
society 04/20/18

38. 38
Not show partiality between the patrons
Not abuse his/her relationship with the patient for personal gain
Dedicate him/her self to protect the dignity of the patient
Therefore:
Provide the service only when needed
Provide the required service to the best of one’s
knowledge
Be compassionate
Be confidential
Be impartial
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II. The pharmacist in relation to the public
Always provide quality service
Therefore , the pharmacist should:
 Act at all times in a manner which promotes and safeguards
the interest of the public
 Be responsible for providing appropriate public health
education and pharmaceutical services
 Rational drug use
 The profession in general 04/20/18

40. 40
 Maintain good personal qualities:
 Be on duty with clear mind
 Be presentable
 Master good communication skills
 Be knowledgeable
 Provide accurate and appropriate information
 Always update yourself
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 Offer services in premises which reflect the professional
character of pharmacy
 Clean environment
 Paint/color/lighting
 Controlled substances in a safe
 Price clearly labeled
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III. Pharmacist in relation to fellow professionals
 The pharmacist should extend all support, respect and
cooperation to fellow members of his/her profession during
needs for scientific and technical information
 The pharmacist shall have the responsibility to expose any
act of misconduct ormalpractice committed by fellow
professionals.
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43. 43
IV. Pharmacist in relation to otherhealth professionals
The pharmacist should:
 Respect the skills and competencies of other health care
providers and endeavor to work cooperatively
 Not recommend a particular medical practitioner to the patient
 Maintain the confidence and trust placed in other health
professionals by patients
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Expose any act of malpractice committed by other health
professionals through the appropriate channels
Things not to do:
 Not enter into any secret arrangement or negotiations
with any health professional by way of giving any offer,
commission, etc.
 Favorism
 Partiality
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V. Pharmacists as active professional member
 Actively participate in professional association
VI. The pharmacist in relation to his/herjob
 Practice the profession after being registered and/or
licensed
 Give comprehensive service
 Immediately report any observed unwanted reactions,
side effects, ADRs
 Carry responsibility within his/her professional
responsibility
 Maintain professional competence
 Provide current drug information 04/20/18

46. 46
VII. Pharmacists as a memberof the community
 Be a good citizen!
 Be a person of high principles and integrity
 Be law abiding citizen
 Conform to the positive norms and values of the society
 Actively participate in community services and social
development activities
 Address the needs of special groups society such as under
aged, disabled people and Mentally ill
 Always maintain high standards of professional conduct
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VIII. Management and utilization of pharmaceuticals
 Manufacture pharmaceuticals of good quality, safety and
efficacy
 Do not make available for sale substandard, counterfeit,
deteriorated & mislabeled pharmaceuticals
 Confirm legibility of prescription
 Accept prescription only in written form except in
emergency
 Give advice and counseling
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 Do not fill prescription of drugs written for prescriber
his/her personal use
 Properly procure, distribute and use drugs
 Keep records properly
 Not self advertise
 Do not promote products of a particular
manufacturer
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IX. The pharmacist in relation to his/hertrade
 Do not promote unethically
 Promote fair distribution of pharmaceuticals
 Do not put medical samples for sale
 Obtain pharmaceuticals from genuine source
 Have strong moral obligation not to come under
commercial pressure
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50. 50
 Conflict of interest is a set of conditions in which
professional judgment concerning a primary interest
(research objective) tends to be unduly influenced by a
secondary interest e.g. Financial
 Its severity rely on
 the likelihood that professional judgment will be influenced
 the seriousness of the harm likely to result from such
influence.
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Conflict of
Interest

51. 51
It could be prevented by
 educating researchers,
 Supervising research and
 disclosing the conflict of interest
Example
A study was carried to see the relationship b/n homosexuality
and the spread of HIV/AIDS. The study indicated that there
was no association between homosexuality and HIV/AIDS.
The investigators were homosexuals.
The results may not be reliable as PI could be biased due to
conflict of interest.
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52. Ethical Dilemmas
 Ethical dilemmas occur when there are
disagreements on ethical behaviour or
application of ethical principles.
 Ethical dilemmas can occur between
pharmacists and clients, pharmacists and
physicians, and among pharmacists because
the values, sense of justice and fairness of each
party may differ.
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53. 53
A. Principlist Approach
• It is the process of resolving a conflict of interest through
an appeal to a set principles
• It presupposes that in the patient-health professional
relationship, ethical dilemmas are the responsibility of the
health professional. In contrast the patient is assumed to
be largely passive
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Approaches to Solving Ethical Dilemmas:

54. 54
Accepted principles
Non-maleficence (avoiding unnecessary harm)
Beneficence (do good)
Autonomy (respect the autonomy of the patient)
 Confidentiality (respect the confidential and private
information of the patient)
 Informed consent (provide adequate and relevant
information about the research)
Justice (treat subjects equally and fairly; respect similarities
and differences between subjects)
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55. 55
B. Discourse Ethics Approach
This is an approach to prevention and resolution of ethical
dilemma through open debate and discussion between
the health professional and the patient
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56. The health professional–patient relationship
56
The general rule accepted as a fundamental medical ethical norm
, “As to dise ase , m ake a habit o f two thing s— to he lp o r, at
le ast, to do no harm ”.
The patient-professional relation
 is the central focus of ethical concerns,
 built on ethical confidentiality, trust and honesty
 first consider the welfare of the patient as the basis of all ethical
judgments
 founded on the three pillars of ethics (beneficence, autonomy and
justice)
The closeness between the provider and patient
 often enriches relationships,
 fosters trust, and
 deepens understanding.
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57. 57
What is Unethical???
 Providing and seeking compensation for therapies that
have no benefit to the patient.
 Not respecting person and cultural difference
 Creating partiality among clients
 Sexual misconduct on part of the professional
 the abuse of professional power and violation of the
professional ethical conduct
Therefore, any sexual contact or romantic relationship b/n
the heath care provider and the patient is unethical.
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58. Laws governing the practice of
pharmacy
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59. Laws governing the practice of pharmacy
 Pharmacists employed in all pharmaceutical sectors must be
aware of the legal requirements that apply to their daily
professional activities.
 There are different laws that govern the practice of
pharmacy. Among these the following are the major ones:
 Food, drug and cosmetic Act
 Controlled substances Act
 Poisons Act/poison prevention packaging Act
 Tort law
 Commercial law
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60. Food, drug and cosmetic Act (FDCA)
 Provided the basis for categorizing drugs as prescription
only and non-prescription drugs
 A drug will be prescription only if it depicts either of the
following.
 It is habit forming
 It is not safe for self medication
 It is a new drug that has not been proved to be safe.
 The act requires that prescription only drugs should be
labeled as “Law prohibits dispensing without
prescription”
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61. FDCA…cont’d
 In general, Food, Drug and Cosmetic Act and
its amendments are designed to prevent two
evils, tribulations -
 Adulterationand
 Misbranding of drug products
 Adulteration relates to the impurity of product
via change of composition of the product
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62. FDCA…cont’d
A drug is deemed to be adulterated if
 It consists in whole or in part any filthy, putrid or
decomposed substance.
 It has been prepared, packed or held under insanitary
condition
 It was manufactured, processed, packed or held under
conditions that don’t comply with the FDA’s CGMP
regulations.
 Its container is composed of any poisonous or deleterious
substance that may render the drug injurious to health.
 If its strength differs from its labeled strength
 If it fails to meet compendia standards.
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63. FDCA…cont’d
Misbranding deals primarily with labeling violations.
 A drug will be considered misbranded if:
 Its labeling is false or misleading in any particular
 Its label doesn’t bear the name & address of the
manufacturer, packer or distributer as well as an
accurate statement of the quantity of the contents.
 It contains a habit-forming substance specified in the
regulations & doesn’t bear the statement warning.” May
be habit-forming” directly adjacent to the name of the
agent.
 It doesn’t bear the name of the agent
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64. FDCA…cont’d
 Its labeling doesn’t bear adequate directions for use &
is not in accordance with compendia standards.
 Its container is so made, formed or filled as to be
misleading
 Its advertisement doesn’t meet the standards
contained in Pharmaceutical law and regulations.
 It was manufactured or processed in a plant that was
not registered.
 Its packaging and labeling are not in conformity with
the poison prevention packaging Act of 1970.
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64

65. FDCA…cont’d
 According to the FDCA or its amendments, non-
prescription drugs must bear a seven point label:
 The name of the product
 The name & address of the manufacturer, packer or
distributor
 The net contents of the package
 The name & quantity of all ingredients
 The name of any habit forming drug contained in the
preparation
 Cautions & warnings needed for the protection of the user
 Adequate directions for safe & effective use.04/20/18
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66. Controlled substances Act (CSA)
 The CSA is the legal basis by which the manufacture,
importation, possession, distribution delivery &
dispensing of drugs or substances that have the
potential forphysical & psychological dependence and
abuse are regulated.
 The Act created five schedules/ classifications with
varying qualifications for a drug to be included in each.
 The classification was made on the criteria of potential
forabuse, accepted medical use and potential for
addiction
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67.  What differences do you see among
 Abuse of drugs
 Drug dependence (physical and psychological )
 Addiction to drugs
 Misuse of drugs
 Drug tolerance
 Drug resistance
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68. Controlled substances…cont’d
Schedule I
 The drugs under this
category have:
 High potential for abuse
 No accepted medical
use
 Lack of safety
 eg. heroin, marijuana,
benzyl morphine
Schedule II
 The drugs in this
category have:
 High potential for abuse
 Accepted medical use
 Severe psychological or
physical dependence
 eg. opium, morphine,
codeine.
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69. Controlled substances…cont’d
Schedule III
 Lesser abuse potential
than I & II
 Accepted medical use
 Moderate or low physical
& high psychological
dependence
 Eg. Chlorphentermine
Schedule IV
 Less abuse potential
than III
 Accepted medical use
 Lower dependence than
III
 Eg. long acting
barbiturates, certain
hypnotics & minor
tranquilizers.
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70. Controlled substances…cont’d
Schedule V
 Lowest abuse potential & dependency
 Have accepted medical use
 e.g. most OTC drugs.
 The quantity of substance in a drug product often
determines under which schedule it will be controlled.
 For e.g. Amphetamines & codeine are generally
included in schedule II. However, certain products
containing smaller quantities are controlled in schedules
III & V.
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71. Poisons Act/poison prevention packaging
Act
 It is a law governing poisons to ensure their proper
handling, transportation, storage & use as well as
proper record keeping and reporting.
 A poison - a substance that may cause damage to man,
animal, plant and environment when taken in small
quantity.
 The act considers all prescription & some non-
prescription medications as hazardous substances &
 Consequently they must be dispensed with child
resistant closures
 A poison by its action on tissue or organ of the body can
impair function or destroy life. 04/20/18
71

72. Poisons Act…cont’d
 Therefore, practicing pharmacists shall be aware of the
general nature, storage labeling and packaging,
recording & warning provisions
 The list of poisons is usually divided into two:
A. Poisons in part I: those poisons that can be sold only by
an authorized seller of poisons. i.e. from retail
pharmacies or wholesaler by or under the supervision of
a pharmacist
B. Poisons in part II : these poisons can be sold from
retail pharmacy or wholesaler & other shopkeeper who
are listed or authorized by local regulatory authorities.
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73. Poisons Act…cont’d
Storage of poisons
 Poisons should be stored separately from drugs and
medical supplies in a secured manner in premises. The
key shall be kept in the hand of authorized person
Labeling and packaging
 Poisons shall be packaged in appropriate container and
labeled properly. The label shall include:
 The name and full address of a supplier
 The name and other description of the substance
 The indication(s) & danger and the corresponding
symbol
04/20/18
73

74. Tort Law
 Tort is a Latin word meaning twisted and refers to
conduct that is wrong or twisted.
 Tort law is subdivision of the civil law that deals with
relationships b/n individuals created by law rather
than by the parties themselves
 Tort law deals with a private injury a rising from a
breach of duty.
 Torts could be either negligent orintentional.
 Most torts of pharmacists are negligent torts
Negligent tort means omission to do something that a
reasonable person would do 04/20/18
74

75. Tort Law…cont’d
 Elements of Negligence
A legal cause of action for negligence has 4 elements:
1. Duty of care
2. Breach of duty
3. Causation
4. Damage
04/20/18
75

76. Tort Law…cont’d
1. Duty of care:
 Pharmacists have a duty to provide patients with the
best care possible.
 The well-established rule is that a pharmacist must use
the degree of care that a reasonable & prudent person
would use under similar circumstances.
 Pharmacist should give best service of the time.
04/20/18
76

77. Tort Law…cont’d
2. Breach of Duty: may be in the formof:
i. Dispensing Error: a pharmacist who fills a prescription in
a way other than the way it was ordered by prescriber
has breached a duty of ordinary care owed to the
patient.
 The pharmacist is said to be breached his/her duty even
if the error is b/c of
 Illegible hand writing or
 Slurred speech of the prescriber;
 B/c the pharmacist always has the last opportunity to
clarify unclear communication.
04/20/18
77

78. Tort Law…cont’d
ii. Doctrine of Negligence perse : A pharmacist who
violates a regulation concerning the distribution of
pharmaceutical products may be liable under the
doctrine of negligence per se .
 Eg. A pharmacist who substituted a generic drug
product for a brand name product in a way that is not
permitted by law had breached the duty of care if the
patient was harmed b/c of the bioinequivalence of the
two drugs.
04/20/18
78

79. Tort Law…cont’d
3. Damage/Harmto the patient
 The pharmacist will not be considered as negligent if a
significant damages does not result to the patient.
 Eg. temporary skin rash will not be considered as
damage. If the mistake is detected & rectified before any
physical harm could occur, there will be no need of
compensation for the patient.
04/20/18
79

80. Tort Law…cont’d
4. Causation
 Even if a pharmacist owes a duty of care & that duty is
breached, malpractice under the law requires proof that
the pharmacists misconduct caused the damage.
04/20/18
80

81. Defenses to Negligence
 Even if the plaintiff can proof the four elements of an
action for negligence, the dependant may be able to
prove affirmative defenses that will free him/her from
being liable.
1. Contributory orcomparative negligence
 If the plaintiff could have avoided the consequences of
the defendant’s negligence by ordinary care, then there
is no recovery under the defense of contributory
negligence
(= the pharmacist will not be liable)
04/20/18
81

82. Defenses to Negligence…cont’d
2. Statute of limitations
 Under the statute of limitations, a plaintiff must bring a
claim to the court in a specified period of time after the
cause of action occurs.
 The Purpose is to prevent the litigation of state claims
years after the events that allegedly lead to the harm,
after memories have faced, witnesses have
disappeared.
3. Vicarious Liability
 The employed pharmacist who commits a negligent act
that harms a patient is liable for the act
04/20/18
82

83. Commercial law
 Pharmaceutical trade is a combination of trade and
professional activities; hence it is affected by
commercial law
 Commercial law is a loose term of all those rules related
to how a business ought to be fairly conducted. It
includes:
 The law of private product ownership
 The law of insurance plan
 The law of business ownership
 The law of contract
04/20/18
83

84. Law of private product
ownership
I. Patent law
 A patent is an exclusive right granted by a government
to exploit an invention.
 Although it differs in detail from one country to another, it
is intended to protect the inventor from others who
would like to profit from the invention.
 Patents are often enforceable internationally
 Patents can completely shield a product from
competition for the period of the patent 17 to 25 years
04/20/18
84

85. Law of private product
ownership cont…
II. Trade marklaw
 A trade mark is a product trade name and
description of its package, which a producer is likely
to register in countries, where the product is being
distributed.
 The trade mark is the means by which a product is
recognized,
 Therefore, it is vital that other companies be
protected from marketing products that would be
easily confused with the original.
04/20/18
85

86. Pharmaceutical Laws and Regulations
04/20/18
86

87. Outline
 Pharmaceutical legal systems
 Drug nomenclature;
 Labelling and packaging requirements of
pharmaceuticals; and administration / Quality assurance
04/20/18
87

88. Introduction to Pharmaceutical Law
 Pharmaceutical law is a rule of human conduct binding
up on all persons engaged in the practice of pharmacy
 It is also restrictive like other laws.
 Pharmacy law gives certain rights for pharmacist and it
takes away freedom from it
04/20/18
88

89. The scope of pharmaceutical
law
 The definition of pharmaceutical law depends on
the range of elements included in the definition of
pharmaceutical &
 Accordingly the law can be divided into two on such
basis:
 Law dealing only with drugs and
 Law that covers other substances and items as
well as drugs
04/20/18
89

90. What is Pharmaceutical?
 The definition of pharmaceutical determine the scope
of pharmaceutical law.
 If the law covers so many items as drug, cosmetics,
medical supplies and sanitary items, it can be defined
as:
 Pharmaceutical shall mean drug, cosmetics, medical
supplies and sanitary items
 Drugis any substance or mixture of substances used
in the diagnosis, prevention and treatment of a
disease affecting human and animal
04/20/18
90

91. What is Pharmaceutical?
cont…
 Cosmetic: is any preparation intended to be applied to
human body for cleansing, beautifying, promoting
attractiveness or altering the appearance without
affecting the body’s structure or function.
 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 animals or human.
 This includes, suturing materials, syringes, needles,
bandages, gauze, x-ray machine, ultra-sound,
microscope, BP apparatus, stethoscope, forceps, etc
04/20/18
91

92. Pharmaceutical Law…cont’d
Why do we need pharmaceutical Law?
1. To ensure proper implementation of pharmaceutical
policy.
 What is Ethiopian pharmaceutical policy?
2. To determine the role of pharmacy law executive
Agency, medical practitioners, pharmacy personnel,
manufacturers, whole distributors, retail outlets
personels, health institutions and consumers in ensuring
availability, quality assurance, proper storage,
distribution & use of pharmaceuticals.
04/20/18
92

93. Pharmaceutical Law…cont’d
3. To ensure that the final consumers receive
pharmaceutical of proven quality, safety & efficacy
/usefulness
4. To ensure the implementation of the pharmacy practice
in the pharmaceutical sector as to the required standard
5. To ensure fair trade of pharmaceutical
04/20/18
93

94. Need of legal instruments
 Assuring continuous availability of needed
pharmaceuticals of proven quality, safety, and efficacy,
and their rational use requires acceptable
pharmaceutical policy, which should be backed by Legal
instruments /tools
 Pharmaceutical legal system and other relevant
regulations
04/20/18
94

95. Legal system
 Legal system is the “process of making, enforcing and
interpreting of law.”
What similarities and differences do you see of among the
following , act, law , regulation and legislation ???
04/20/18
95

96. Legal system…
The legal system includes:-
1. Legislative system
 Law making process
2. Executive system
 Pharmaceutical law executive agency( PLEA)
administer & enforce a law
 In Ethiopia, FMHACA is responsible to administer &
enforce pharmaceutical law
 DACA, Proclamation No. 176/1999
 Later, Food, Medicine and Health care Administration
and Control Authority (FMHACA), Proclamation No.
661/2009 has been undertaking the responsibility.04/20/18
96

97. Legal system…
 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. Suspend or revoke license of premises or products
 * There should exist clear procedure on how to enforce
& administer a law.
04/20/18
97

98. Legal system…
3. Judicial system
It is a process of judgment which include:
 Interpreting a law
 Holding trials
 Receiving of evidence or testimony
 Taking measures accordingly
 Appealing procedures
04/20/18
98

99. Drug Nomenclature
 In order to avoid confusion and ease exchange of
information, there should exist an accepted international
naming system of drug nomenclature
 A pharmacy law of the country should include a
statement regarding drug nomenclature
1. Chemical name
 The use of chemical name is not always easy, as many
drug’s chemical names are complicated & difficult to
remember
04/20/18
99

100. Drug Nomenclature…
2. Brand name
 Brand or proprietary name is chosen by the
manufacturer or to facilitate recognition and association
of the product with particular firm for marketing purpose
 New pharmaceutical products are protected by a patent,
brand or both
 Patent right is a protection of intellectual property
 When the patent expires, the product can be produced
by other companies
04/20/18
100

101. Drug Nomenclature…
 The original companies may continue to sell the product
using the 1st
brand name, new drug manufacturers may
give the product their own brand name
3. Generic name
 The generic/international non proprietary name is the
drug official name regardless of who manufactures or
makes it.
04/20/18
101

102. Labeling and Packaging 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 unless it is duly
packed or labeled
 The type, quality & size of the packaging & containers
used should be suitable for intended purpose
 A pharmacy law executive agency shall prepare
requirements for labeling & packaging of
pharmaceuticals
04/20/18
102

103. Labeling and Packaging…
Labeling of container& Packaging
All labeling of containers and packages must be
 Easily legible
 Clearly comprehensible (easily understandable)
 Indelible (that can not rubbed out)
 In the language of the country/other language accepted
by the country
04/20/18
103

104. The label of pharmaceutical/drug must
include:
 The name of the medicinal product;The name of the medicinal product;
 The name and quantity /strength of the active ingredient(s);The name and quantity /strength of the active ingredient(s);
 The net contents of the packageThe net contents of the package
 The method and route of administrationThe method and route of administration
 The name and address of the manufacturer or distributorThe name and address of the manufacturer or distributor
 Batch no. - Storage condition (special)Batch no. - Storage condition (special)
 The marketing authorization number/license numberThe marketing authorization number/license number
 Manufacturing date - Expiry dateManufacturing date - Expiry date
 Cautions and warnings that are needed for the protection of theCautions and warnings that are needed for the protection of the
user Eg. Don’t exceed recommended dosage, discontinue use if …user Eg. Don’t exceed recommended dosage, discontinue use if …
, Don’t apply on broken skin; shake well before use, etc., Don’t apply on broken skin; shake well before use, etc.
04/20/18
104

105. Labeling of small containers of drug
products
 When the container of any drug product is 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 &
route of administration.
 The method of administration
 The expire day
 The batch number
 The pack size/quantity
04/20/18
105

106. Labeling of Dispensed (compounded) drug
products
The container of dispensed drug product must be labeled
with following particulars:
 The name of the person to whom the drug is
dispensed/to be administered
 The name and address of the institution from whom
the drug is dispensed.
 The date of dispensing
 The name, strength, dosage form, dosage & quantity
of the drug dispensed.
 Precautions related to the use & storage of the
product.
 Eg. for external use only, keep out of reach of children.
04/20/18
106

107. Labeling and Packaging…
Labeling of prescription drugsLabeling of prescription drugs
 Warning “law prohibits dispensing with out prescription”Warning “law prohibits dispensing with out prescription”
Labeling of non prescription drugLabeling of non prescription drug
 OTC drugs must bear adequate directions for safe andOTC drugs must bear adequate directions for safe and
effective use in lay languageeffective use in lay language
Labeling of hazardous substancesLabeling of hazardous substances
 The signal word “danger” on extremely flammable,The signal word “danger” on extremely flammable,
corrosive or highly toxic substances.corrosive or highly toxic substances.
 The signal word “warning” or “Caution” on all otherThe signal word “warning” or “Caution” on all other
hazardous substances including: flammable, toxic, harmfulhazardous substances including: flammable, toxic, harmful
it swallowed, etcit swallowed, etc
 The signal word “poison” for highly toxic substancesThe signal word “poison” for highly toxic substances04/20/18
107

108. Control of fulfilment of requirements
to practice pharmacy
04/20/18
108

109. Outline
 Manufacture of pharmaceuticals
 Import/ Export of Pharmaceuticals
 Whole sale of Pharmaceuticals
 Utilization of pharmaceuticals
 Pharmaceutical Retail-out lets
 Health Institutions Pharmacies
 Compounding Pharmaceuticals
 Management & Use of controlled drugs
 Prohibited Activities
04/20/18
109

110. Control of Manufacturer of Pharmaceuticals
 Manufacturer of pharmaceutical must be controlled
legally to
 Ensure the quality, safety & efficacy of pharmaceutical
manufactured and
 Prevent the manufacture of counterfeit , adulterated and
substandard pharmaceuticals
04/20/18
110

111. Requirements to manufacture
pharmaceuticals
 License authorization to manufacture
Requirements to obtain manufacturing license
1. PremisesPremises (ware house, production & packaging area,
QC lab., maintenance work shop, first aid clinic, toilet
with shower, administrative office etc)
2. PersonnelPersonnel
 Manufacture of pharmaceuticals should be carried out
under the supervision of qualified & experienced
adequate no. of personnels
04/20/18
111

112. Requirements to manufacture
pharmaceuticals
3. EquipmentEquipment
 Necessary to carry out all manufacturing operation such
as ware housing, production & QC are required
4. Standard operation procedure (SOP)Standard operation procedure (SOP)
 There shall exist SOP to be followed
 The executive agency shall set standards of premises,
personnel, equipment, & SOP and
 Issue, renew, suspend or revoke license of
manufacturing and marketing authorization with
justification
04/20/18
112

113. Control of Import of Pharmaceuticals
 Import of pharmaceutical must be legally controlled
in order to ensure that the imported pharmaceuticals
are of proven quality, safety & efficacyproven quality, safety & efficacy as well as
they are on the basis of the country needcountry need
Requirements of import of pharmaceuticalsRequirements of import of pharmaceuticals
1. License/authorization to import
 No one is allowed to import pharmaceuticals unless
& otherwise licensed.
 However, import of pharmaceutical for personal use,
research lab. testing, donation in emergency,
compelling conditions may not require licensenot require license
04/20/18
113

114. Control of Import…cont’d
 License is issued after assuring the fulfillment of the
followings:
 Personnel, premises, equipment and facility, and
Standard operation procedure (ordering, port
clearance, inventory control, distribution, compliant
collection and analysis, etc)
2. Market Authorization of pharmaceutical
 Obtaining license is not sufficient, marketing
authorization for each product from regulatory authority
is also legally needed.
 To ensure that a medicinal product has been adequately
tested and evaluated for safety, efficacy and quality; and
the product information provided by the manufacturer is
04/20/18
114

115. Control of Import…cont’d
3. Obligation of importerof pharmaceuticals
 Not import & distribute pharmaceuticals which
adulterated, counterfeited, and substandard
 Not use the premises for purpose other than specified in
the license
 Not make change of address or modify premises with
out getting authorization from regulatory authority
 Distribute drugs only to those licensed & in accordance
with their level
04/20/18
115

116. Control of Import…cont’d
 Keep & provide information as may be requested by
licensed authority
 Allow inspection & keep records of imported, stocked,
distributed and disposed pharmaceutical
 Renew license and marketing authorization certificate
timely
04/20/18
116

117. Control of Whole sale of Pharmaceuticals
 The control of whole sale is more or less the same as
the control of the import of pharmaceuticals.
Responsibility of Pharmacy Law Executive Agency
 Set standard of premises, personnel, equipment/
facilities & SOP for whole sale of pharmaceuticals
 Issue, renew, suspend & revoke license and marketing
authorization when justifiable
04/20/18
117

118. Control of Export of Pharmaceuticals
 No one is allowed to export pharmaceuticals with out
getting export authorization and/ or export permit for
each consignment (batch)
 Manufacturers can export their products and the
requirements and other control are more or less the
same with the importer
04/20/18
118

119. Control of Utilization of Pharmaceuticals
 Proper utilization of pharmaceuticals is legally controlled
by Pharmacy Law Executive agency
Controlling mechanism
1. Deciding who should prescribe and dispense drugs
2. Standardization of prescription paper
3. Classification of pharmaceuticals
04/20/18
119

120. Control of Utilization…cont’d
1. Deciding who should prescribe drugs
 Registered physicians, dentists, veterinarians & other
health personnel such as midwife nurse, other nurses,
health officers, etc are legally authorized to prescribe
drugs
2. Deciding who should dispense drugs
 Registered pharmacists & pharmacy technicians are
legally authorized to dispense drugs in most country
04/20/18
120

121. Control of Utilization…cont’d
3. Standardization of prescription paper
 The minimum requirements of a prescription should be
indicated in the pharmacy law
 The prescription shall
 Be signed and written in ink with her/his own name by
the prescriber
 Contain the following particulars
1. The name & address of the health institution
2. The appropriate date
04/20/18
121

122. Control of Utilization…cont’d
3. The name, age, sex, address & card no. of the patient
4. The name, strength, dosage form,& quantity of the
prescribed drugs(s)
5. Direction for use/ compounding
6. Name, qualification(title), registration no.,& signature of
the prescriber and the dispenser
7. Refill authorization for refillable drugs
04/20/18
122

123. Control of Utilization…cont’d
4. Classification of pharmaceuticals/drugs
 It is another means of controlling drugs
A. Prescription only drugs
 Are drugs dispensed with only prescription
B. Overthe counter/Non-prescription
 Drugs recognized among experts to be safe and
effective.
 Such drugs are sold “sold over the counter” with out
prescription, thus called OTC.
 They have to be labeled with direction for lay man
04/20/18
123

124. Control of Utilization…cont’d
C. General sale list of pharmaceuticals
 Drugs (safe) sold under supermarkets, groceries etc
 Subject to certain pack sizeSubject to certain pack size
 E.g. paracetamol 500mg tablets not more than 30 tabs
 Bisacodyl 5 mg not more than 12 tabs etc
04/20/18
124

125. Control of Pharmaceutical Retail-outlets
 No person is allowed to run Drug Retail-Outlet with out
getting license/ authorization from drug regulatory
 Objective
1) To ensure the quality, safety and efficacy of
pharmaceutical and made available
2) To ensure good dispensing practice of pharmaceuticals
 Pharmaceutical Retail Out lets means a business
organization which sell drugs on retail basis to patients
04/20/18
125

126. Retail-out lets…
Types of Drug Retail-Outlets
A. Community pharmacy - is a drug retail out let run by a
registered pharmacist
B. Drug Shop(Drug Store) - is a drug retail out let run by a
registered druggist (pharmacy technician)
C. 3rd
Grade Drug Retail Outlet – which is usually found in
developing countries, is led usually by a registered non-
pharmacy personnel (Physician/ Nurse/ health assistant/
veterinarian/ some times by junior pharmacy
technicians)
04/20/18
126

127. Retail-out lets…
Requirements to Establish Drug Retail outlets
A. Personnel (procurement, storage, inventory control,
dispensing, record keeping, reporting etc of
pharmaceuticals)
B. Premises
C. Equipment/facilities
D. SOP
04/20/18
127

128. The Drug Retail out let shall
 Be open for provision of pharmaceutical service during
working hours specified by licensing authority including
night & Holiday duties
 Have clearly legible sign on the out side of the building
as near to the main entrance stating
 The name, level & address of the retail outlet
 Opening and closing hours
 Name & address of drug retail outlets which are on duty
04/20/18
128

129. The Drug Retail out let shall…
 Obtain pharmaceutical only from legal source
 Make available pharmaceutical in accordance with its
level
 Only community pharmacy can handle almost all types
of pharmaceuticals
 Dispense pharmaceutical of proven quality, safety and
efficacy
 Immediately report when counterfeited and sub standard
drugs are encountered
 Store pharmaceuticals properly in accordance with
storage condition stated (special) etc
04/20/18
129

130. Control of Health Institutions Pharmacies
 Drugs are prescribed, dispensed and administered to
patients in health institution, include hospital, health
centers, clinics, and health posts
 The pharmaceutical service rendered by health
institution should be controlled by law
Requirements forrendering pharmaceutical service
 Health institution shall give pharmaceutical service after
fulfilling the personnel, premises, equipment & facilities
and SOP
04/20/18
130

131. Health Institutions Pharmacies…cont’d
 Hospital Pharmacy – led by registered pharmacist &
there shall exist assistants including pharmacists, &
other pharmacy personnel
 Health CenterPharmacy - led by registered pharmacist
or other pharmacy personnel
04/20/18
131

132. Compounding Pharmaceuticals
A compounding pharmacist should
 Foster the triad relationship b/n patient, the prescriber,
and the pharmacist
 Make sure only personnel authorized by the responsible
pharmacist should be involved in drug compounding
operation
 Ensure that all personnel involved in compounding
procedures should refrain from compounding if their
health conditions may be an adverse effect on the drug
products
04/20/18
132

133. Compounding…cont’d
 Have written procedures for the compounding of drug
products (SOP), cleansing procedures
 The pharmacist working in manufacturing of drugs and
medical supplies should
 Develop and supply useful pharmaceutical products and
services, giving due consideration to safety, efficacy and
quality
 Ensure all products are manufactured in accordance
with CGMP
04/20/18
133

134. Compounding…cont’d
 Ensure that products carry unique batch no.,
manufacturing date and expiry date
 Maintain records of all key processes
 Only engage in fair, transparent and free competition
and maintain sound and ethical relation with other
bodies out side the company
 Provide employees with work place conditions, which
are safe and comfortable and respect the professional
character of the establishment
04/20/18
134

135. Management & Use of Narcotic Drugs &
psychotropic Substances
 Keep each of these substances under separate and
strict security storage areas to avoid access to
unauthorized staff
 Dispense these substances through special prescription
paper approved by regulatory and dispensing should be
carried out by the pharmacist only
 Keep proper registration of these products and submit
records to the control authority
 Properly label, mark, store, and dispense poisons to
avoid undue intermixing that may cause harm
04/20/18
135

136. Management & Use…cont’d
 Shall not dispense in excess quantities
 Not fill prescriptions for signed by prescriber for self use
 Keep expired and damaged products in separate safe
place and dispose them according to the procedures set
up by the authority
 Refrain from abuse of controlled drugs
04/20/18
136

137. Prohibited Activities
 Failure to renew license/ registration timely
 Providing pharmaceutical service in the absence of
licensed or equivalent delegated professional
 Handling, dispensing or supplying of substandard,
counterfeited drugs and failure to report when such
products are encountered
 Obtaining drugs from illegal source
 Creating obstacle of pharmaceutical inspectors
 Using the premises that do not go with the intended
purpose
04/20/18
137

138. Prohibited Activities…cont’d
 Dispensing drugs without adequate information
 Changing address and modify without the consent of the
licensing authority
 Undertaking activities that are not allowed by law
04/20/18
138

139. Power and Duties of Food, Medicine and
Health Care Administration and Control
Authority of Ethiopia
04/20/18
139

140. Outline
 Setting of standards/ sources of standards
 Control of practice of pharmacy
 Licensing of premises
 Evaluation & registration of pharmaceuticals
 Inspection of pharmaceuticals & premises
 Laboratory testing/analysis
 Control of quality & reliability of drug information
 Control of advertisement & promotion
 Post marketing surveillance
04/20/18
140

141. Setting standards/sources of standards
 Preparation or adoption of specification for quality,
safety & efficacy of pharmaceuticals. eg.
Pharmacopoeia (USP, BP, JP, IP…)
 Many developing countries adopt the specifications
adopted by developed countries.
 Preparation of requirements to be fulfilled by
pharmaceutical establishments.
 The basic requirements include: personnel, premises/personnel, premises/
facilities, standard operational proceduresfacilities, standard operational procedures, etc.
04/20/18
141

142. Control of practice of pharmacy
Professional registration
 No pharmacy personnel is legally allowed to practice the
profession of pharmacy unless and other wise s/he is
registered.
Why should professional be registered?
 In order to ensure the competencecompetence of the professional
04/20/18
142

143. Control of practice…cont’d
Who should do registration of pharmacy personnel?
 Depending on the country pharmaceutical law, it may
be made by:
 Drug regulatory authority
 Board of pharmacy
 Professional Association
 Ministry of health
04/20/18
143

144. Control of practice…cont’d
Requirements to be registered
1. Education
2. Age usually not less than 21 years
3. Good moral characters
 Non-drug addict
 Non-alcohol addict
 Free from violation of laws governing the sector
1. Experiences, usually of one year, under the
licensed pharmacist
 As part of training
 After graduation
04/20/18
144

145. Control of practice…cont’d
Requirements to be registered
5. Health conditions;
 Free from mental illness, physical conditions & other
health problems that may prevent him/ her from
practicing the profession.
6. Citizenship
7. Examination - theoretical plus Practical
 Examination is not a pre-requisite by many
countries to be registered.
8. Registration fee
 Validity period of registration/ re-registration ranges
from 5 to 10 years.
04/20/18
145

146. Control of practice…
cont’d
Suspension and revocation of the
registration
 Suspension or revocation of registration may be
performed before the end of the validity period if
conditions deem necessary;
 Revocation is not a punishment but it is protection of the
public.
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147. Control of practice…
cont’d
Suspension and revocation of the
registration
 If registration is obtained by fraud
 If the professional is unfit, b/c of
 Drug addiction
 Intoxicating liquor
 Mental illness
 Physical conditions
 Violations of laws governing sector
 Violation of controlled substances law
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148. Control of practice…cont’d
Suspension and revocation of the
registration
 Less common ground for revocation
 International adulteration of drugs
 Aiding of an unregistered person to practice pharmacy
 Unprofessional conduct
 False advertisement
 Negligence
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149. Control of practice…
cont’d
Suspension and revocation of the
registration
 The law should indicate who should suspend & revoke
registration
 Ministry of health
 Board of pharmacy
 Professional association
 Drug regulatory authority
 There should exist a clear procedure on how to suspendThere should exist a clear procedure on how to suspend
or revokeor revoke
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150. Licensing of premises
 No one is allowed to establish pharmacy establishments
without getting license.
 Types of pharmacy establishments include:
 Manufacturer of pharmaceuticals
 Importer &/ or exporter
 Wholesaler/ distributor
 Pharmaceutical retail outlets
 Health institutions’ pharmacy section
 Pharmaceutical quality control laboratory
 Pharmaceutical promotion offices, etc.
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151. Why license is needed?
1. To ensure the quality, safety, efficacy, proper
management and utilization of pharmaceuticals.
2. To ensure the fulfillment of requirements/ standards
( premises, personnel, equipments/ facilities, standard
operational procedures & others as the specific case
may require)
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152. Licensing…cont’d
Who should issue license?
 It may be issued by drug regulatory authorities, board
of pharmacy, or ministry of health; depending on the
specific country pharmaceutical law.
Validity period of licenses
 In most countries license is renewed at the beginning of
every fiscal year.
 Similar to registration, suspension or revocation of
licenses may be practiced when conditions require.
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153. 2.3. 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 (cGMP).
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154. Evaluation and registration …cont’d
In comprehensive evaluation and registration systemdata 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 the04/20/18
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155. Scope and stringency of Evaluation and
Registration
 Scope & stringency of E & R varies with countries &
products.
 In most developed countries, all pharmaceuticals are
not marketed unless they are evaluated & registered.
 In many countries, only drug products are subject to E
& R.
 During registration, drugs can be structured
 by level of prescribers
 by level of dispensers
 into OTC & prescription, etc.
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156. Evaluation and registration …cont’d
Re-registration of pharmaceutical product
 Registration certificate of a pharmaceutical is valid only
for a limited period.
 It has to be renewed every year.
 The validity period of a registration varies from 3 to 5
years.
Exemption fromregistration
 There may be certain conditions where drugs are
exempted from registration. E.g.: during emergency.
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157. Inspection of pharmaceuticals & premises
Why inspection?
 In order to ascertain whether there has been a
contravention of the law
 PLEA is legally authorized to undertake pharmaceutical
inspection on pharmacy establishments
 The agency should assign persons with adequate
knowledge & experience of the sector, policy, law
regulations & directives, as inspectors
 The rights & obligations of inspectors have to be clearly
indicated in the law
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158. Inspection…cont’d
 Inspectors having produced the credential if requested to
do so, are empowered to:
 Enterany premises; to ascertain weather there has been a
contravention of the law/ act or general for the purposes of
performing the function of the enforcing authority.
 Enterany ship, aircraft or hover vehicle to ascertain
whether there is in it any article or substance imported to
contravention of the law.
 To take samples of any medicinal product sold or supplied
or any substance to be used in the manufacture of
pharmaceutical
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159. Inspection…cont’d
 To take copies of any entry in any such books or
documents
 To require the production of any books or documents
related to the business
 To seize & detain any substance or articles or any
document, which they have reasonable cause to
believe, may be required for proceedings under the
law.
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160. Types of Inspection
1. Pre-licensing inspection
 The type of inspection undertaken to ensure the
fulfillment of requirements by pharmacy
establishment before a license is issued.
2. Post- licensing inspection:
 The type of inspection undertaken on licensedon licensed
pharmacy establishmentspharmacy establishments to ascertain whether there
has been a contravention of the law.
 It is further classified as emergency inspection &emergency inspection &
regular inspectionregular inspection.
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161. Types of Inspection…cont’d
 During inspection due consideration should be given to
individual rights & privacy.
 Prior notice should be given to the occupier if it is
intended to enter any premise used only as a private
dueling house
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162. Obligations of inspectors
 S/he should keep the trade secrecy of the premiseskeep the trade secrecy of the premises s/
he inspected
 They should give due respect to the rightsgive due respect to the rights of the
individual or premises
 They should give receiptgive receipt for the sample, documents they
have taken & seized
 Inspectors should also write inspection report showingwrite inspection report showing
the strong & weak sidesthe strong & weak sides of the inspected premises.
 The report should also include directives
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163. Control of Quality & Reliability of Drug
Information
 InformationInformation on promotion of pharmaceuticals may
greatly influence their supply & use.
 The reliability & usefulness of information related to drug
to be disseminated to public & health personnel have to
be monitored by the PLEA.
 The executive agency shall regulate the quality &
reliability of drug information in order to ensure that the
health professionals as well as consumers are provided
with accurate scientific & other relevant data aboutaccurate scientific & other relevant data about
drugsdrugs.
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164. Control ling …cont’d
 The executive agency shall develop techniques for
controlling or monitoring the dissemination of
information. The information should deal with:
 Safety of the drug
 Its approved use & indications
 Its contraindications to its use
 Adverse reactions
 The dosage, etc.
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165. Control of advertisement & promotion
Advertisement:
 Is any presentation, by whatsoever means, for
promoting directly the manufacture, sale or dispensing
of any pharmaceutical.
Promotion:
 Refers to all informational & persuasive activities by
manufacturers to effect or induce the prescription.
 is a method of announcing your product or service using
more dynamic means you can more easily modify or
change.
 promotion is often an expense
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166.  Advertisements may not refer to
recommendations from scientists, healthcare
professionals or celebrities who could
encourage consumption of the medicine.
 'fast acting' or 'provides 24 hour relief needs
clinical data
 the advertisement shall contain the information
necessary for correct use of the medicinal
product.
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167. The information provided in advertisement &
promotion shall be:
 Accurate, fair, objective, good-taste & presented in such
a way as to conform not only to legal requirements but
also to ethical standards.
 Based on up to date evaluation of all the available
scientific evidence & shall be presented in a manner
appropriate to the intended recipients.
 Honest, verifiable & must conform to the facts in the up
to date and approved
 Sufficient to the therapeutic usefulness of the
preparation
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168. The information shall be…cont’d
 The information shall not contain misleading &
unverifiable statements or omission, likely to induce
medically unjustifiable use or to give rise to undue risks
 All the information & promotional materials must be
consistent with the information provided in the product
monograph approved by the authority.
 Sample of informational & promotional material must be
submitted to the authority for approval prior to any
promotional activity.
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169. The information shall be…cont’d
 The pharmaceutical law shall decide:
 The mode of advertisement to be used
 The type of pharmaceuticals not to be advertised to
the general public
 The content of the information used to advertise to:
 Health professionals
 The general public
 The amount & type of promotional activity should be
consistent with the terms & conditions of product
approval.
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170. The information shall be…cont’d
 Any pharmaceutical product is promoted only in
accordance with its marketing authorization.
 No commercially interested party, and no person on his/
her behalf, should issue an advertisement related to
medicinal product/service without the consent of PLEA.
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171. Advertisement to health professionals
The advertisement to health professionals shall:
 Contain essential information compatible with the
summary of product characteristics
 Contain the following particulars:
 The name, strength, dosage form, indication, dosage, methodThe name, strength, dosage form, indication, dosage, method
of use of the productof use of the product
 List of active ingredientsList of active ingredients
 License/ registration numberLicense/ registration number
 Name & address of the marketing authorization holderName & address of the marketing authorization holder
 Classification of the product as prescription or OTCClassification of the product as prescription or OTC
 Side effects, precautions & relevant contraindications.Side effects, precautions & relevant contraindications.
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172. Mode of advertisement to health
professionals
 Audio- visual advertisement. Eg. Radio, TV, Cinema
 Promotional aids
 Written material accompanying promotions
 The written material shall:
 Contain essential information
 Classification of the product
 Be accurate, up to date, verifiable & complete
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173. Mode of advertisement…cont’d
 Free samples are supplied only to persons qualified to
prescribe medical product &/ or pharmacy personnel.
 Free sample of narcotic drugs & psychotropic
substances are not allowed.
 Free samples must be marked “Free medical sample-
not for sale”.
 Every free sample must be accompanied by summary
product characteristics.
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174. Advertisement to the general public
 No advertisement may be issued, which is likely to lead
to the use of medicinal product on:
 Narcotic drugs and psychotropic substances
 Drug which is for human use & is prescription only
 Medicinal product or any other substance or article used
for the purpose of inducing abortion.
 No person who is a marketing authorization holder or
wholesaler may sale or supply to the public for
promotional purposes any unsolicited (uncalled-for)
relevant medicinal product.
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175. Post marketing surveillance
 Assuring the quality, safety & efficacy is not a one-
time job; it requires continuous surveillance after the
drug is marketed
 PLEA of a country is legally authorized to assure the
quality, safety and efficacy of pharmaceuticals
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176. Legal obligations of health institutions and
professionals
 All health institutions & professionals, involved in the
activities starting from manufacturing until it is used by
the final consumer, are legally & ethically responsible to
report any deviation related to quality, safety and
efficacy of pharmaceutical following an appropriate
procedure.
 PLEA shall:-
 prepare clear guideline for PMS
 Approve the results of PMS
 Take an action according to the result of the PMS
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177. Legal obligations…cont’d
 The actions that could be taken by the executive agency
may include:
 Ban the manufacture or use of pharmaceutical
 Revoke the certificate of registration
 Use the information from results of PMS for re-
registration
 Disseminate the information locally & outside the
country to the concerned bodies.
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178. Thank You
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