Drug Regulation and
Control
Chapter 3
Chapter 3 Objectives
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Understand the importance and role of drug regulation.
Knowledge of the history of drug regulation.
Understanding of the drug development and approval
process.
Become familiar with the Behind-the Counter OTC
Medications and regulations for dispensing them.
Knowledge of label and labeling requirements.
Knowledge of controlled substance schedules and
requirements for handling controlled substances.
Understand the recall process.
Understand health care provider’s responsibilities under
HIPAA.
Food and Drug Administration
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The leading enforcement agency at the
federal level for regulations concerning
drug products.
Drug Enforcement Administration
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The agency which controls the distribution
of drugs that may be easily abused.
Drug Regulation – A Timeline
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Food and Drug Act of 1906:
 Prohibited
interstate commerce in foods and drugs
that have added inferior materials and misbranded
drinks and drugs.
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1914 Harrison Tax Act:
 In
response to growing addiction to opiates and
cocaine-containing medicines, the Harrison Tax Act
established that manufacturers, pharmacists,
importers, and physicians prescribing narcotics
should be licensed and required to pay a tax.
Timeline begins on page 30
Drug Regulation – A Timeline
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1938 Food, Drug and Cosmetic Act:
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In response to the fatal poisoning of 107
people, primarily children, by an untested
sulfanilamide concoction, this law requires
new drugs to be safe before marketing.
1951 Durham-Humphrey
Amendment
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October 26, 1951:
The Durham-Humphrey Amendment is passed.
The bill requires any drug that is habit-forming or
potentially harmful to be dispensed under the
supervision of a health practitioner as a
prescription drug and must carry the statement,
"Caution: Federal law prohibits dispensing
without prescription."
Defines what drugs require a prescription
The Thalidomide Lesson
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Sleeping pill developed in
1962 that was found to
cause severe birth
defects when used by
pregnant women.
1962 Kefauver-Harris
Amendment
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Requires drug
manufacturers to provide
proof of both safety and
effectiveness before
marketing a drug.
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Now used as a safe and
effective treatment for multiple
myeloma, prostate cancer, and
leprosy. User must under
stand risks of taking this Rx.
Drug Regulation – A Timeline
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1970 Poison Prevention Packaging Act:
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Requires child-proof packaging on all
controlled and most prescription drugs
dispensed by pharmacies.
1970 Controlled Substances Act:
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Classifies drugs that may be easily abused
and restricts their distribution. Enforced by
the DEA.
 This law established that the DEA is part of
the US Justice Department
Drug Regulation – A Timeline
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1983 Orphan Drug Act:
 Provides incentives to promote research,
approval, and marketing of drugs needed for
the treatment of rare diseases
1984 Drug Price Competition And Patent
Term Restoration Act (Hatch-Waxman):
 Extension of drug patent terms and quicker
introduction of lower cost generic drugs
1990 Anabolic Steroid Control Act:
 Passed to address abuse of steroids in
children
Drug Regulation – A Timeline
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1990 Omnibus Budget Reconciliation
Act (OBRA):
 Act
Requires pharmacists counsel Medicaid
patients regarding medication.
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1996 Health Insurance Portability and
Accountability Act (HIPAA):
 Provided
broad and stringent regulations to
protect patients’ privacy.
Bell Work 1/19, 1/20
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Which act provides incentives to promote
research, approval, and marketing of drugs
needed for the treatment of rare diseases?
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Orphan Drug Act of 1983
Which act requires drug manufacturers to
provide proof of both safety and effectiveness
before marketing a drug?
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1962 Kefauver-Harris Amendment
New Drug Approval
All new drugs, whether made domestically
or imported, require FDA approval before
they can be marketed in the United States.
 Before it will be approved, a new drug
must be shown to be both safe and
effective by the manufacturer and that its
benefits outweighs the risks.
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Page 32, 33
Clinical Trials
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Extensive testing begins in the laboratory doing
chemical analysis, animal testing and then
clinical trials with people. Trial participants
must give their informed consent. Children are
only part of the trial after the drug has been fully
tested on adults.
Proof that the drug is both safe and effective is
based on results of clinical trials.
Testing Phases in Humans
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Phase 1
20-100 patients
Time: several months
Purpose: mainly safety
Phase 2
Up to several hundred patients
Time: several months to two years
Purpose: short-term safety but mainly
effectiveness
Phase 3
Several hundred to several thousand patients
Time: one to four years
Purpose: safety, dosage, and effectiveness
Only about 25% of drugs tested in phase 1 successfully complete phase
3 and are approved for marketing.
Clinical Trial Phase
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The proposed new drug is called an
investigational new drug (IND).
Drug is only available to those in the trial, but
sometimes it will be given to groups outside the
trial who are critically ill.
Placebo drugs are often used. A placebo is an
inactive substance given in place of a
medication.
Trials are always “blind.” Patients are not told
which group they are in.
Marketed Drugs
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A patent for a new drug gives its manufacturer
an exclusive right to market the drug for a
specific period of time under a brand name. A
drug patent is in effect for 17 years from the date
of the drug’s discovery.
Once a patent expires, other manufacturers may
copy the drug and release it under its
pharmaceutical or “generic” name.
Page 34 and 35
Marketed Drugs
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Generic drugs must be pharmaceutically
equivalent to the patented drug – it must
have the same active ingredients, same
dosage form, same route of
administration, and same strength. And it
must be therapeutically equivalent – that
the body’s use of the drug is the same.
Bell 1/25
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What is Med Watch?
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Why is generic ibuprofen the same as
Motrin?
OTC Labels
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Over-The-Counter (OTC) are drugs that do not require
a prescription.
OTC medications are not without risks. Package inserts
and labels are designed so the consumer can take them
without medical advice.
The label should include:
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The product name
Name & address of the manufacturer
List of all active and other ingredients
Amount of contents
Adequate warnings
Adequate directions for use
Behind-The-Counter OTC Meds
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While most OTC medications are not kept
behind the pharmacy counter, some are,
even if a prescription is not required.
 Combat
Methamphetamine Epidemic Act
(CMEA) Federal law that sets daily and monthly
limits on OTC sale of pseudoephedrine and
ephedrine.
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Records of sales must be kept for 2 years
 Exempt
narcotics. (pg 37)
 Emergency contraception
Page 36, 37
Bell Work 1/24, 25
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Limits on the sale of pseudoephedrine are
monitored _______ and _________.
 Daily
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and monthly
Name two Behind the Counter OTC
medications.
 Plan
B and pseudoephedrine
Prescription Drug Labels
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Manufacturer Stock Label includes:
 Generic
and brand name
 NDC number – National Drug Code
 Manufacturer's name and address
 Drug form
 Package quantity
 Warnings
 Lot number and expiration date
 Storage requirements
 Dispensing container required
 Active ingredients and strength
Page 38, 39
Sample Labels
Bell Work 1/25, 1/26
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What is the generic
name of this drug?
What is the dosage
form?
What is the package
quantity?
Controlled Substances
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Controlled Substances Act of 1970 (CSA)
established by US Congress, identifies 5
groups or schedules of drugs as controlled
substances and put strict guidelines on
their distribution.
 This
act also requires dispensers of these
substances register with the DEA.
Page 40, 41
The Five Schedules Are:
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Schedule I – High potential for abuse and no accepted
medical use in the US.
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Schedule II – High potential for abuse and may lead to
physical or psychological dependence, but also has a
currently accepted medical use in the US.
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Heroin, some opium derivatives, and hallucinogenic substances
Amphetamines, cocaine, methadone, and various opiates
Schedule III – Potential for abuse is less than those in
Schedules I and II and there is a currently accepted
medical use in the US, but abuse may lead to moderate
or low physical dependence or high psychological
dependence.
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Anabolic steroids , compounds that contain codeine
The Five Schedules con’t
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Schedule IV – Low potential for abuse relative to
Schedule III and current accepted medical use in the US,
but abuse may lead to limited physical dependence or
psychological dependence.
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Phenobarbital, sedative chloral hydrate, and some anesthetics
Schedule V – Low potential for abuse relative to
Schedule IV and current accepted medical use in the
US, but abuse may lead to limited physical dependence
or psychological dependence.
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Limited amounts of codeine included in this group
Exempt narcotics are in this group
In case you were wondering?
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Opiates and Opioids are drugs that are most
commonly used for their euphoric and/or
analgesic effects.
Opiates are drugs that are derived from the
Opium poppy plant.
The term 'Opioid' is used to describe a
compound that binds opioid receptors in the
brain, and produces effects characteristic of
naturally occurring opiates.
Opiate drug names.
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Some of the more well known semisynthetics opiates, that is to say narcotic
drugs, created from morphine, codeine
and thebaine are heroin, hydrocodone,
hydromorphone, oxycodone,
oxymorphone, and there are many others.
Medical Marijuana Debate
Medical marijuana is not approved by the
FDA
 Federal law does not recognize the
difference between medical and
recreational use of the drug
 MM is treated like cocaine or heroin by the
federal government and users can be
imprisoned by federal drug enforcement
agents
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Public Safety
The FDA process is thorough but it is
impossible to fully prove that a drug is safe
for use.
 To monitor this the FDA has a monitoring
system called MedWatch.
 Prescribers are encouraged to voluntarily
report any adverse effects by approved
drugs.
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Page 44, 45
Recalls
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Action to remove a drug from the market
and are voluntary on the part of
manufacturer
I – strong likelihood that the product will
cause serious adverse effects or death
 Class II – product may cause temporary but
reversible adverse effects, little likelihood of
serious adverse effect
 Class III– the product is not likely to cause
adverse effects
 Class
Law and the Technician
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Federal law provides a foundation for state
laws that govern pharmacy practice.
 These
laws guarantee patient rights including
rights to privacy, confidentiality, right to file
complaints, right for informed consent and the
right to refuse treatment.
Page 46, 47
Law and the Technician
State Law is responsible for licensing all
prescribers and dispensers.
 Many states have stricter regulations than
federal law.
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A
few states allow pharmacists to prescribe
under limited conditions.
 States regulate pharmacy technician by
holding the pharmacist responsible for the
technicians performance.
Liability
Legal liability means you can be
prosecuted for misconduct.
 You can be guilty of misconduct by simply
failing to do something you should have
done.
 You are liable even if you are directed to
do something by your supervisor.
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 Misconduct
is called negligence
Liability
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Ways the pharmacy tech can be negligent:
 Incorrectly
labeling the prescription
 Breaking confidentiality
 Failing to recognize expired drugs
 Calculation errors
 Dispensing the wrong medication
 Incorrect handling of a controlled substance
 Inaccurate record keeping
Other standards
ASHP – American Society of HealthSystem Pharmacists
 USP – United States Pharmacopeia
 JCAHO – Joint Commission on
Accreditation of Health Care Organizations
 ASCP – The American Society for
Consultant Pharmacists.
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