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Pharm 895 Safety & Prescriptive Authority Study Guide 2024
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Pharm 895 Safety & Prescriptive Authority Study Guide 2024
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©PREP4EXAMS @2024 [REAL EXAM DUMPS] Wednesday, July 17, 2024 1:27 AMPharm 895 Safety & Prescriptive Authority Study Guide 2024
Pure Food & Drug Act 1906 - ✔️✔️-Restricted manufacture & sale of drugs, outlawed
misbranding and adulteration.
Sherley Amendment 1912 - ✔️✔️-Barred fraudulent therapeutic claims, but required to show
intent to defraud to prosecute.
Federal Food, Drug, and Cosmetic Act (FFDCA) 1938 - ✔️✔️-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 - ✔️✔️-Sale and use of prescription drugs must be
under medical supervision.
-Established written prescription system through pharmacists.
Kefauver-Harris Amendments 1962 - ✔️✔️-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 - ✔️✔️1: In vitro studies.
2: Animal testing.
3: Clinical testing, three phases.
4: Marketing, can include phase 4 studies.
In vitro studies - ✔️✔️-Takes 2 years on average.
-Determining what the lead compound will be
Animal testing - ✔️✔️-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].
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, ©PREP4EXAMS @2024 [REAL EXAM DUMPS] Wednesday, July 17, 2024 1:27 AM
Phase 1 clinical trials - ✔️✔️-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 - ✔️✔️-Involving 100 to 200 patients.
-Patients are in the drug's target population.
-Effectiveness: does the drug work?
Phase 3 clinical trials - ✔️✔️-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 - ✔️✔️-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 - ✔️✔️-Set up schedules I - V to control dangerous
substances.
Schedule I definition - ✔️✔️-High potential for abuse.
-No currently accepted medical use.
-Not safe for use even under medical supervision.
Schedules II and III definition - ✔️✔️-High potential for abuse.
-Accepted medical use.
-May lead to severe psychological or physical dependence.
Schedules IV and V definition - ✔️✔️-Low potential for abuse.
-Accepted medical use.
-May lead to limited psychological or physical dependence.
Prescribing Schedule II drugs - ✔️✔️-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 - ✔️✔️-May be written, faxed, electronic, or verbal.
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