Ch 8. laws governing the practice of pharmacy

Ch 8. Laws Governing the Practice
of Pharmacy
Instructor’s Name: Berhanemeskel W/Gerima
Email: aberhaneth@gmail.com
Cell Phone: +251912024213
1
Introduction to Pharmacy Law & Ethics
(Phar 4173)

Regulations
• A regulation is a written rule and procedure that exists to carry out a law.
• Regulations include drug approval processes, distribution and dispensing
allowances.
• Regulations can also affect pharmacy practice like, licensure, registration,
and certification requirements.
• When there is a conflict between a state and a federal law or
regulation, the more stringent law or regulation always applies.
2

Standards
• A standard is a set of criteria to measure product quality or
professional performance against a norm.
• Standards exist for both drug products and professional behavior.
– The USP
• Professional standards are guidelines for acceptable behavior
and performance.
• Professional organizations help advance the pharmacy profession
by setting high professional standards, above and beyond what is
required by law and regulation.
3

8.1. Food, Drugs and Cosmetics Act
Need for Food, Drugs and Cosmetics Control
• To protect the public health from
– unsafe, inefficacious and poor quality modern and traditional medicines;
• To protect the public from health risks emerging out of unsafe and poor quality
food;
• To avert health problems due to
– substandard health institutions,
– incompetent and unethical health professionals,
– poor environmental health and communicable disease
• To control and deter
– illicit production,
– trafficking and use of narcotic drugs, psychotropic substances, and precursor chemicals;
• In order to make the fragmented and poor quality administrative and regulatory
system in the health sector efficient and effective, it is found necessary to
establish a new and coordinated food, medicines and health care regulatory
system;
4

History of Statutory Pharmacy Law
USA
Pure Food and Drug Act of 1906
– Passed to fight abuses in drug formulation, labeling, and
marketing
– Forbade drug labels from containing false information
– Proved to be unenforceable
5

Food, Drug, and Cosmetic Act of 1938
• Response to manufactured drugs that were more powerful and
potentially dangerous
• Created the FDA
• Required drug makers to
– File new drug applications (NDAs)
– Prove that the product was safe for human use
– Conduct studies and submit results
• Required drugs to be safe, but not necessarily effective
• The Act expanded the definitions of adulterated and
misbranded drugs.
6

Food, Drug, and Cosmetic Act of 1938

Poison Prevention Packaging Act of 1970
• Passed to prevent accidental childhood poisonings
• Applies to both prescription and OTC drugs
• Requires child-resistant containers that
– Cannot be opened by 80% of children
– Can be opened by 90% of adults
• The Act allows some drugs to be dispensed in non-childproof
packages.
8

Poison Prevention Packaging Act of 1970
9

8.2. Narcotic Drugs and Psychotropic Substances Act
• Created to combat and control drug abuse and to supersede
previous federal drug abuse laws
• Classified drugs with potential for abuse as controlled
substances
• Ranked controlled substances into five categories, or schedules
– ranging from those with great potential for abuse (Schedule I) to those
with little such potential (Schedule V)
– narcotics are most highly regulated
10

8.2. Narcotic Drugs and Psychotropic Substances Act
Schedule Medical Use Examples
I For research only Heroin, LSD
II Dispensing severely restricted Morphine, oxycodone, meperidine
III Prescriptions can be refilled up to 5 times
in 6 months
Codeine with aspirin, anabolic
steroids
IV Same as for Schedule III Benzodiazepines, meprobamate
V Some sold w/o a prescription; must be 18 Liquid codeine combination preps.
11

8.3. Drug Abuse Prevention and Control Act
• Drug Abuse Prevention and Control requires the pharmaceutical industry
– to maintain physical security and
– strict record keeping for certain types of drugs.
• Controlled substances are divided into five schedules (or classes) on the basis
of their
– potential for abuse,
– accepted medical use, and
– accepted safety under medical supervision.
12

8.3. Drug Abuse Prevention and Control Act
• Substances in Schedule I
– have a high potential for abuse,
– no accredited medical use, and
– a lack of accepted safety.
• From Schedules II to V substances
– decrease in potential for abuse.
• The schedule a substance is placed in
– determines how it must be controlled.
– Prescriptions for drugs in all schedules
• must bear the physician's federal Drug Enforcement Administration license
number,
• but some drugs in Schedule V do not require a prescription.
13

8.4. Poisons Act
• Passed to prevent accidental childhood poisonings from prescription and
nonprescription products
• Enforced by the Consumer Product Safety Commission
• Requires most over-the-counter (OTC) and legend drugs be
packaged in child-resistant containers
– cannot be opened by 80% of children under five
– can be opened by 90% of adults
• Older patients may request a non-child-resistant container;
– other exceptions are provided for by law
14

8.5. Tort Law
• A tort, in the context of civil law, refers to personal injuries; wrongs
that one citizen commits against another.
• Local, state, and federal governments do not take part in lawsuits that
involve crimes that occurred between two citizens, not against the
government and/or its laws and regulations.
What are some examples of torts?
• In a tort, the injured party sues the party that caused the injury
• Governments do not take part in tort lawsuits
– the wrong was between two citizens and not against the government and/or
its laws and regulations
• The simplest tort is the “broken” contract
15

8.5. Tort Law
• Standard of care is a level of care expected to be provided by
various healthcare providers
• Used to judge the type of care provided to a patient based on
• Two criteria always taken into account include:
– the level of training of the healthcare provider
– normal practices for the geographical area in which the healthcare provider
works
• Only those healthcare providers who work in the same geographical
area and have the same level of training would be compared
16

8.5. Tort Law
• Malpractice a form of negligence in which the standard of care was not met
• In a case of negligence or malpractice, the burden of proof is on the plaintiff
to prove the four Ds of negligence:
– duty – damages
– dereliction – direct cause
• The burden of proof in civil court is lower than in a criminal case
– plaintiff must prove his/her case by a “preponderance of the evidence”
• In malpractice, a guilty defendant found guilty may be ordered to pay an
award of money to the plaintiff
– contributory negligence may be determined if two or more causes are a factor in the
negligence and personal injury to the patient
• All pharmacies, most practicing pharmacists, and some pharmacy technicians
carry professional liability insurance to protect their business and personal
assets
17

8.5. Tort Law
• Cases exist where the patient is found to have contributed to his or
her own injury (e.g., not taking medication as directed) and found
to be comparatively negligent.
• In this case, the total award may be reduced by a certain
percentage, depending on the judge or jury’s determination.
• When a crime is committed in violation of a state or federal law,
the party is prosecuted
– the victim or his or her family also sue the party in civil court for monetary
damages
• The person may be tried twice, facing two separate plaintiffs
– in the criminal case, the defendant might face monetary fines, probation, or
prison
– the civil case might result in monetary awards to the victim/plaintiff
18

8.5. Tort Law
• What kinds of penalties are assessed in judgments involving civil
law?
Answer: Penalties under civil law generally involve monetary
repayment equivalent to damages suffered, although sometimes will
include loss of licensure.
19

8.5. Tort Law
Negligence and Standard of Care
• The most common tort in the medical/pharmacy arena is negligence –
the failure to provide the minimum standard of care.
• Standard of care – the level of care expected to be provided by
various healthcare providers in the local community.
• When the standard of care is not met and results in injury, a patient may
sue the provider for malpractice, a form of negligence.
• (1) Level of training and (2) geographic area are taken into account
when considering standard of care.
• Why do you think level of training and geographic area are always taken
into account when considering standard of care?
• Standard of care criteria apply to pharmacists as well as technicians.
20

8.5. Tort Law
Negligence and Burden of Proof
• When negligence or malpractice case is brought, burden of proof is on
the plaintiff to prove the four Ds of negligence: duty, dereliction,
damages, and direct cause.
• The plaintiff must prove the defendant had a duty to provide care;
that the defendant was derelict in their duty (failure to do one’s job);
that the dereliction cause actual damages; that damages were a direct
cause of the dereliction.
• Burden of proof is lower in civil courts; the plaintiff must prove
“preponderance of the evidence” or that the defendant is more likely
than not to be guilty.
• Professional liability insurance protects businesses and personal assets
from a civil lawsuit involving negligence and malpractice.
21

8.6. Commercial Law
• Pharmacists should understand the general principles of the
commercial laws to realize the responsibility
– to realize the responsibility that they undertakes when entering a business
obligations or an employment relationship
• Laws applicable to commercial activities includes:
– Law of contracts
– Law of advertising
– Ownership of prescriptions and antitrust laws
22

Contract Law
Definition:
1. A contract is a promise or set of promises for the breach of which the law
provides a remedy, or the performance of which the law, in some way,
recognizes as a duty.
– Yet, the law requires much more for a contract to result than a mere exchange of
promises.
2. More complete definition of a contract is an agreement between legally
competent individuals based on genuine assent of the parties and
supported by consideration, made for a lawful purpose and in the form
required by law, if any.
23

Law of Agency and Contracts
• A contract is made in the pharmacy when the pharmacist receives a
prescription from the patient at the window by agreeing to get the
prescription filled an implied contract now exists:
• pharmacy and pharmacist are obligated to provide the patient with a
service
– If a mistake is made, the pharmacy and/or pharmacist
• may be held liable, even though he or she was not the one who entered
into the contract to provide service
• The pharmacist must “answer” for all of the acts of the employees
24

Liabilities
Liabilities
• Liability is legal recognition that an acceptable accounting was not provided by a party
who was in a position of responsibility when a problem occurred.
• Types:
– Criminal Liability
– Civil Liability
– Administrative Liability
• Tort–causing injury to a person intentionally or because of negligence
• Negligence–an action taken without the forethought that should have been taken by a
reasonable person; a mistake
• Intentional mistake–penalty ranges from criminal charges to awarding of damages
• Negligent mistake–affect employment and can result in punitive damages
• Be aware of rights and responsibilities
25

Violation of Laws and Regulations
Violation of Laws and Regulations
• Certain violations can result in a case being brought against the party who violated
the law.
• Plaintiff is the party or person filling a case, the party being sued or the case is
against is the defendant.
• The plaintiff must provide sufficient evidence to prove his or her case; this is burden
of proof.
• Reasonable doubt is the standard of proof in a case involving crime against local,
state, or federal government.
• The prosecutor or plaintiff must provide convincing evidence that the party committed
the act beyond any “reasonable” doubt.
• Cases involving a licensed or registered healthcare provider may be examined by the
state board and determine whether the defendant’s license should be revoked or
suspended.
26

Violations of the Law
• Crime – an act that violates a criminal law
• Criminal – a person who has committed a crime or has been
proven guilty of a crime
• Accessory – a person who contributes to or aids in the
commission of a crime
• Felony – a serious crime punishable by death or imprisonment
• Misdemeanor – a crime that is less serious
• Tort – a civil wrong committed against a person or property
27

• Intentional torts
– Assault
– Battery
– Defamation of character
– False imprisonment
– Fraud
– Invasion of privacy
– Trespass
– Infliction of emotional distress
28

• Burglary – the act of breaking and entering into a building with
the intent to commit a felony, especially in order to steal
• Unintentional torts – acts that are not intended to cause harm
but are committed without regard to the consequences
• Tortfeasor – a person who commits a tort either intentionally or
unintentionally
29

The Legal System
• Defendant – the accused in court
• Plaintiff – the person who files a lawsuit
• Litigant – a party to a lawsuit
• Litigation – a lawsuit or a contest in court
• Jurisdiction – power, right, and authority given to a court to hear
a case and make a judgment
• Layperson – an individual without training in a specific profession
30

9. Pharmaceutical Laws and Regulations
9.1. Pharmaceutical legal systems
9.2. Drug nomenclature
9.3. Labeling and packaging requirements of pharmaceuticals
9.4. Administration/quality assurance
31

• Practice of pharmacy–governed by series of laws,
regulations, and rules enforced by
– federal, state, local government;
– institutions and pharmacy management
• Pharmaceutical legal systems constitutes:
– Legislative legal system
– Executive legal system and
– Judicial legal system
32

Laws
• A law is a rule that is passed and enforced by the legislative branch of
government.
• Law is a collection of rules imposed by authority
• The law offers a minimum level of acceptable standards.
• The legislature sees to the passing and enforcement of laws for the protection of
the public.
• Violation to laws may result in damages, fines, probation, loss of licensure or
incarceration.
 Law systems are often based on ethical or religious principles and are enforced
by the police and criminal justice systems such as the courts
33

Laws
 Law systems are often based on ethical or religious principles and
are enforced by the police and criminal justice systems such as the
courts
• Sources of law
– Legislative branch – passes laws
– Executive branch – implements laws
– Judicial branch – interprets laws
– Administrative branch- Rulemaking, investigative, adjudicatory
and enforcement role
34

Regulations
• A regulation is a written rule and procedure that exists to carry
out a law.
• Regulations include drug approval processes, distribution and
dispensing allowances.
• Regulations can also affect pharmacy practice like, licensure,
registration, and certification requirements.
• When there is a conflict between a state and a federal law
or regulation, the more stringent law or
regulation always applies.
35

Function of law:
• defines relationships among members of society
• allocates authority and define who may exercise physical
coercion
• disposition of trouble cases as they arise
• redefines relations between individuals and groups
Classification of Law
• Criminal Law
• Civil Law
• Administrative Law
36

 In Ethiopia, major categories of law apply,
 Criminal law
 Civil law
 Administrative law
 Healthcare is governed by legislation intended to
 protect the public and prevent harm and
 advanced practitioners require a knowledge of relevant legislation and
 their responsibilities to the public and their employer.
Pharmacy Law
• It is a body of law concerning manufacturing of drugs, drug distribution, drug
therapy, practice of pharmacy and other issues related with medication use
• It is majorly intended to protect peoples from harm because of medications
and services.
37

Civil Laws
• Civil law is given to areas of the law that concern citizens and wrongs they may
commit against each.
• Relates to disputes between two or more private parties
• Object is to compensate the injured party
• Penalties include damage awards, enforcement of contracts, or
injunctions against action
• Tried before a court
• Covers issues such as:
– Contracts
– Tort: a wrong against another
38

Administrative law
• Administrative law covers the procedures that are put in place for ensuring that
the decision-making processes and systems are regulated.
• Shortfalls in relation to administrative justice are dealt with through tribunals
and inquiries.
• It is unlikely that many pharmacists would become involved in this aspect of
legislation;
• however, it does have an impact on the way the professional regulator is set up
and how it deals with misbehavior of members.
39

Administrative law
• Investigations of violations of rules or regulation made by administrative agencies
• Directly affects only those individuals subject to the agency’s jurisdiction
• Object is to correct professional or business behavior, and/or to remove a person from a
profession if he or she poses a danger to the public
• Involves hearings before the agency
• Results in payments of fines and/or probation, suspension, or revocation of license or
other permit
• May be appealed to a court
40

• A marketed drug has three names: a chemical name, a generic
name, and a brand name.
Chemical Name
• It is given when a new chemical entity (NCE) is developed.
• It is a scientific name based on the compound's chemical structure
and is almost never used to identify the drug in a clinical or
marketing situation.
• Often, the name is long and difficult to pronounce, and, since it has
numbers,
– the number in the name might become confused with the numbers in the
prescription.
41

The generic name (or non-proprietary name)
• Is granted by the USAN Council and is commonly used to identify a drug during
its useful clinical lifetime.
• The generic name does not belong to the company that discovers the drug (or
owns the patent).
• Once the patent lifetime is expired, any company may market the drug under
the generic name.
• The generic name must be screened to assure that it does not resemble any
other generic or brand name.
• The generic name must also be appropriate for the class of drug.
Brand name (trademark)
• The company that patents the drug creates the brand name (trademark). This
name identifies the drug during the 17 years that the company has exclusive
rights to make, sell, and use it under patent law.
42

9.3. Labeling and packaging requirements of pharmaceuticals
• Any producer, importer, distributor, retailer or health
institution of medicine shall not supply it to the market or
distribute it otherwise unless it is duly packed and labeled
• The label of any medicine shall be written either
–in the Amharic or
–English language
43

Importance of Packaging and Labeling in Pharmaceutical Industry
• The products manufactured to resolve health issues would be of no use if they
are not packed and labeled appropriately.
• It is vital for any pharma product that it remains in its original form and
maintains its quality until it reaches the hands of end users. Packaging and
labeling are two individual activities that have to be performed as per
their significance.
44

LABELING
• The U.S. Federal Food, Drug and Cosmetic Act (FFDCA) defines "labeling" as all
labels and other written, printed, or graphic matter upon any article or any of its
containers or wrappers, or accompanying such article.
• The term 'accompanying' is interpreted liberally to mean more than physical
association with the product.
– It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites,
etc.
• Drug labeling refers to all of the printed information that accompanies a drug,
including the label, the wrapping and the package insert.
• one of the crucial factors that determines the safety and integrity of the product.
– This operation includes both printing on the carton and leaflets provided individually with the
pharma products.
• The primary purpose of labeling is to make identification of the product clear and
unambiguous.
– It conveys essential information to the patient on the use of the preparation.
45

Properly Labeling Pharmaceutical Product
1. Labeling Responsibilities
• According to the FDA, all labels printed for use in the pharmaceutical and healthcare industry are required
to be designed and applied so they can remain in place and be read in different environments through
distribution, storage and use.
• The label print must be legible and will remain that way throughout the product’s life span.
Product manufacturers are responsible for complying with content and format requirements.
2. Displaying Product Information
• All types of labeling have content requirements for what types of information and claims can be stated on a
label.
• Checklist of important things to include on a pharmaceutical or healthcare product label:
Official product name
Active and inactive ingredients
Drug Facts table
Purpose and use
Warnings
Directions
Allergic reactions
46

Additional labelling
1. Batch number
2. “ for animal treatment only” on verterinary prescriptions.
3. Storage conditions
4. Precautions relating to use of products
Ex. “ caution: Flammable” keep away from flame.
“Not to be consumed by mouth”
• Other examples:
DO not swallow
Take X times a day
Put two drops in the affected eye.
For creams and ointments: spread thinly
For pessaries/ suppositories: Gently put on into the vagina/ rectum
47

3. Formatting Labels for FDA Approval
• Labels must be designed in the appropriate FDA format for a product’s
classification like OTC medications, oral contraceptives, combination
products, etc.
• Some things to be considered when designing labels for FDA approval:
 Font size and type (must be legible)
 Language (appropriate use of abbreviations, grammar, advertised claims,
etc.)
 Format (organization and appearance of sections like Drug Facts,
warnings, uses, etc.)
 Materials (depending on the nature of the product)
48

4. Choosing Approved Materials
• Label materials for pharmaceuticals aren’t as stringently regulated as the
packaging/container that will touch the drug product. Label materials can be
made from standard white paper stock to holographic films to shrink
sleeve labels.
• Multi-layer labels (also known as booklet labels) are often used because
pharmaceutical and healthcare products are required to share large amounts
of information. For further product safety, adhesives, coatings and inks must
be “low migration” meaning that little to no substances transfer from the
materials to the drug or device.
5. Controlling Label Quality
• Every label printed should be inspected thoroughly to ensure the information
is consistent and accurate. Industry standards must be met for safety and
liability reasons.
49

Printing multiple pharmaceutical labels:
• The products should be separated to prevent any mix-ups or switches.
• Product separation can be physical or spatial, or can be completed by
performing press runs at different times to avoid confusion.
Proper control of storage:
• An important consideration, proper storage control is necessary for
preventing any mix-ups or switches when dealing with labels printed
for use in the pharmaceutical industry.
• Labels should be carefully examined to ensure they comply with FDA
standards and specifications.
50

How should you label a patient's prescribed medication ?
 The label on the patient's medicine should contain the instructions that the
doctor wrote out on the prescription.
 The information on the medicine's dispensing label usually includes:
• patient's name
• doctor's name
• the name and address of the pharmacy that dispensed the medicine
• the date the medicine is dispensed
• the generic & the brand name of the medicine
• the dose the patient should take, how to take it and how often
• the amount of medicine in the container and the dosage strength
• if necessary, any cautions or warning messages that apply to the medicine
51

1. All labels must have a patient's info such as:
• (Mr., Mrs., Ms.) not to confuse with the other family members.
• Name & Address of the pharmacy & the date when it was dispensed
2. Must state the Name, Strength, & the Quantity of the medication
dispensed.
3. Products for internal use should have White Label and Red Label for
external use.
4. It is required to indicate the Month and Year after which the product
should not be used such as:
discard after 03-01-16
Detailed Requirements for Labeling a Patient's
prescribed medication
52

5. Warning Labels such as:
Suppository - "For rectal use only, don't swallow."
• Gargles & Mouthwash - "Not to be swallowed."
• Pessaries - "For vaginal use only, don't swallow."
6. Use of Active Verbs such as:
• Take two - NOT - "Two to be taken"
• Use one - NOT - "One to be used"
• Insert one - NOT - "One to be inserted"
53

7. Frequency and Quantity of formulations should be expressed in Words rather than in
Numerals.
× Take 1 cap 2 x a day (misinterpreted)
 Take one capsule two times a day
× Take two three times a day (misinterpreted)
 Take two tablets three times a day.
8. Dosage instruction should be appropriate.
× Never use "Take" if it is NOT for oral route
 Use "Apply"
9. Be prepared to give VERBAL explanation on the label.
54

Proper Positioning of Label
• Medicine Bottles
• Label should be on the front of a medicine bottle about third
of the way down the container.
• Cartons
• Label should be on the large side of the carton.
• or placed around the carton.
• Ointment Jars/ Tubes
• Label should be placed on the side of the jar or tube.
55

 Are containers that preserve the quality of a medicine for the stated
shelf life.
 This containers must maintain the safety, stability of the medicine &
protect the product against physical, climatic, chemical & biological
hazards.
• In the pharmaceutical industry it is vital that package selected
adequately preserve the integrity of the product.
• The selection of a package therefore begins with the determination
of the product's physical & chemical characteristics, its protective
needs and marketing requirements.
PACKAGING
56

PACKAGING
 Materials for packaging SHOULD:
－ protect the product from physical damage
－ protect the product from chemical & contamination
－ protect the product from light & moisture
－ protect the product from environmental condition
－ be FDA approved
 Materials selected should NOT:
－allow product leakage
－ chemically react with the product
－ release components
－ uptake product components
－ be toxic
－ impart odor or taste to the product
57

9.4. Administration/Quality Assurance
• Any medicine or raw material or packaging material of a medicine shall meet quality
standards and requirements prescribed in
– the pharmacopoeia issued or adopted by the appropriate organ or,
– where it is not included in such pharmacopoeia, those standards and requirements prescribed
by manufacturing companies and accorded with international or the appropriate organ’s
acceptance.
• Where any medicine lacks the expected use of safety, efficacy and quality for which
its permit is granted , or its risk outweighs its benefit,
– its use shall be banned and its registration shall be revoked.
• Any medicine shall be available for use in accordance with the standard and working
directives to be issued by the executive organ to ensure the appropriate use of
medicine.
58

9.4. Administration/Quality Assurance
• Where any medicine lacks the expected use of safety, efficacy and
quality for which its permit is granted , or its risk outweighs its
benefit, its use shall be banned and its registration shall be revoked.
• Any medicine shall be available for use in accordance with the
standard and working directives to be issued by the executive
organ to ensure the appropriate use of medicine.
59

10. Laws, Regulations and Directives Pertaining to
Pharmaceutical Services in Ethiopia
Laws and Regulations
– FMHACA. Food, Medicine And Healthcare Administration And Control
Proclamation No. 661/2009
– FMHACA Regulation No 189 2010
– Food Medicine and Healthcare Administration And Control Councils
Of Ministers Regulation No 299/2013
– Requirements & Guidelines For Registration Of Human Drugs
– Institutions Registration And Licensing Council Of Ministers
Regulation Page 8729 Schedule 8735/2015
60

10. Laws, Regulations And Directives Pertaining to Pharmaceutical Services in Ethiopia
Directives
– GMP Guideline For Pharmaceutical Products
– Directive For Medicine Manufacturing Establishment 2013
– Small Scale Medicine Establishment Directive 2014
– Pharmaceutical Promotion Directive
– Guidelines For Conducting Clinical Trials In Ethiopia
– Guideline For Registration Of Medicines 2014
– Medicine Retail Outlet Model Directive 2013
– Health Institution Promotion 2014
– Medicine Import, Export & Wholesalers Control Directive
61

10. Laws, Regulations And Directives Pertaining to Pharmaceutical Services in Ethiopia
Directives
– Health Professionals Registration and Licensing Directive 2014
– Rate Of Service Fees For Food, Medicine, Health Professional And
Health
– Institutions Registration And Licensing Council Of Ministers
Regulation Page 8729 Schedule 8735/2015
– NPS Prescription Paper Directive 2013
– NPS Control Directive 2013
Etc…
62

Ch 8. laws governing the practice of pharmacy

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