UT Arlington PSYC 3303 - Drug post marketing procedures and OTC meds (5 pages)

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Drug post marketing procedures and OTC meds



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Drug post marketing procedures and OTC meds

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Lecture notes on drug post marketing procedures and OTC meds


Lecture number:
6
Pages:
5
Type:
Lecture Note
School:
University of Texas at Arlington
Course:
Psyc 3303 - Drugs and Behavior
Edition:
1

Unformatted text preview:

Psych 3303 Edition 1nd Lecture 6 Outline of Last Lecture I Brain Function and Structure cont A Forebrain B Cerebral Cortex Frontal Temporal Occipital Parietal C Association Cortex Unilateral Neglect Broca s Area Wernicke s Area Lateralization D Neuroplasticity II Drug Development A Over The Counter OTC B Process For Approving Prescription and OTC Drugs Outline of Current Lecture III Drug Postmarketing phase A Pharmaceutical reps B Specific Procedures of OTC IV FDA A GRAS GRAE GRAHL B Packaging C Standardizing labels V Major OTC analgesics A Aspirin B Acetaminophen C Ibuprofen D Cold and Allergy Meds These notes represent a detailed interpretation of the professor s lecture GradeBuddy is best used as a supplement to your own notes not as a substitute Current Lecture III Drug Postmarketing Phase A Pharmaceutical reps Drugs are protected by pattern for a while then generics can come out Pharmaceutical reps try to get physicians to prescribe their drugs 70 80 pharmaceutical companies budget money goes into marketing B Specific procedures for OTC In 1962 there was the Kafauver Harris Amendment so that all OTC drugs need to be evaluated to be safe by the FDA Children were being born with birth defects due to the mothers taking Thalidomide found in OTC drugs for morning sickness not in North America Was never tested in non human primates Now used for anemia but is NEVER given to a woman in child bearing years OR to a man living with a female in child bearing years IV FDA After that event the FDA started testing all OTC drugs by grouping them into categories and testing the active ingredients A GRAS GRAE GRAHL GRAS Generally Regarded As Safe GRAE Generally Regarded As Effective GRAHL Generally Regarded As Honestly Labeled B Packaging FDA is also involved in simplifying labels and ensuring safe packaging In 1982 the FDA started implementing tamper resistant packaging for all drugs following a Tylenol poisoning event where the Tylenol packaging was tampered with and cyanide



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