Exam (elaborations)
Pharm 895 Safety & Prescriptive Authority (1)
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Pharm 895 Safety & Prescriptive Authority (1)
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Pharm 895 Safety & PrescriptiveAuthority
Pure Food & Drug Act 1906 - CORRECT ANSWER--Restricted manufacture & sale
of drugs, outlawed misbranding and adulteration.
Sherley Amendment 1912 - CORRECT ANSWER--Barred fraudulent therapeutic
claims, but required to show intent to defraud to prosecute.
Federal Food, Drug, and Cosmetic Act (FFDCA) 1938 - CORRECT
ANSWER--Replaced Pure Food & Drug Act.
-Removed requirement to demonstrate intent to defraud in drug misbranding cases.
-Passed after a drug with antifreeze killed over 100 people.
-Granted FDA authority to regulate food, drugs, & cosmetics.
-Required proof of safety.
-Labels must include adequate directions for use.
Durham-Humphrey Amendment 1951 - CORRECT ANSWER--Sale and use of
prescription drugs must be under medical supervision.
-Established written prescription system through pharmacists.
Kefauver-Harris Amendments 1962 - CORRECT ANSWER--Requires proof of safety
AND efficacy for drugs released since 1938.
-Established guidelines for reporting info about adverse reactions, clinical testing,
and advertising of new drugs.
Drug development timeline - CORRECT ANSWER-1: In vitro studies.
2: Animal testing.
3: Clinical testing, three phases.
4: Marketing, can include phase 4 studies.
In vitro studies - CORRECT ANSWER--Takes 2 years on average.
-Determining what the lead compound will be
Animal testing - CORRECT ANSWER--Takes 2 years on average.
-Testing in animals to determine efficacy, selectivity, and the mechanism of action.
-At conclusion of animal testing, if approved, it is an Investigational New Drug [IND].
Phase 1 clinical trials - CORRECT ANSWER--Involving 20 to 100 subjects.
-Subjects are any healthy individuals, usually white men. Not necessarily the target
population for the drug.
-Determining whether the drug is safe, and studying its pharmacokinetics.
, Phase 2 clinical trials - CORRECT ANSWER--Involving 100 to 200 patients.
-Patients are in the drug's target population.
-Effectiveness: does the drug work?
Phase 3 clinical trials - CORRECT ANSWER--Involving 1000 to 6000 patients.
-Large RCT, double blind, compared against active control or placebo.
-Effectiveness: does the drug work better than placebo?
-At conclusion of Phase 3, if approved, a New Drug Application [NDA] is filed.
Marketing - CORRECT ANSWER--Drug has been released to the public.
-Phase 4 clinical trials begin now if the FDA gave conditional approval at Phase 3
trials, requiring collection of more data.
Controlled Substances Act 1970 - CORRECT ANSWER--Set up schedules I - V to
control dangerous substances.
Schedule I definition - CORRECT ANSWER--High potential for abuse.
-No currently accepted medical use.
-Not safe for use even under medical supervision.
Schedules II and III definition - CORRECT ANSWER--High potential for abuse.
-Accepted medical use.
-May lead to severe psychological or physical dependence.
Schedules IV and V definition - CORRECT ANSWER--Low potential for abuse.
-Accepted medical use.
-May lead to limited psychological or physical dependence.
Prescribing Schedule II drugs - CORRECT ANSWER--Written or electronic [with
additional requirements]. If long term care/hospice, may note & fax with written to
follow.
-No refills.
-Invalid after 6 months.
Prescribing Schedule III and IV drugs - CORRECT ANSWER--May be written, faxed,
electronic, or verbal.
-Maximum 5 refills.
-Invalid after 6 months.
Prescribing Schedule V drugs - CORRECT ANSWER--May be written, faxed,
electronic, or verbal.
-Some products are available OTC in some states
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