100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
Pharm 895 Safety & Prescriptive Authority (1) $7.99   Add to cart

Exam (elaborations)

Pharm 895 Safety & Prescriptive Authority (1)

 6 views  0 purchase
  • Course
  • Institution

Pharm 895 Safety & Prescriptive Authority (1)

Preview 2 out of 8  pages

  • July 18, 2024
  • 8
  • 2023/2024
  • Exam (elaborations)
  • Questions & answers
avatar-seller
Pharm 895 Safety & Prescriptive
Authority
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

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

Guaranteed quality through customer reviews

Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.

Quick and easy check-out

Quick and easy check-out

You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.

Focus on what matters

Focus on what matters

Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!

Frequently asked questions

What do I get when I buy this document?

You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.

Satisfaction guarantee: how does it work?

Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.

Who am I buying these notes from?

Stuvia is a marketplace, so you are not buying this document from us, but from seller lydiaomutho. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for $7.99. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

75057 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 14 years now

Start selling
$7.99
  • (0)
  Add to cart