Module 1: Introduction to Pharmacology Flashcards

1
Q

Legislature

A
  1. Federal Pure Food and Drug Act (1906): established quality and purity standards for meds. and prohibited the sale of misbranded or adulterated food and drugs
  2. Food, Drug, and Cosmetic Act (1938): required drugs to be tested for safety before marketing approval
  3. Harris-Kefauver Amendment (1962): required drugs to show they were scientifically effective
  4. Controlled Substance Act (1970): reduced the chance that drugs originating from legitimate sources would be diverted to abusers
  5. Prescription Drug User Free Act (1992): created an accelerate approval process specifically for pts that required HIV or CA meds.
  6. Best Pharmaceuticals for Children Act (2002): promotes drug advocacy and safety in ped. meds.
  7. Pediatric Research Equity Act (2003): required testing on drugs expected to be used in children
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2
Q

Drug Approval Process

A
  1. In vitro studies (yrs. 0-2): Chemical synthesis and optimization of biological products to produce a lead compound
  2. Animal testing (yrs. 2-4) for efficacy, selectivity, and mechanism
  3. Classified as an Investigational New Drug (IND - yr. 4)
  4. Clinical testing (yrs. 4-8): Drug metabolism and safety assessment; Phase 1 (safe PK?; 20-100 subjects), phase 2 (does it work in pts?; 100-200 pts), and phase 3 (does it work, double blind?; 1,000-6,000 pts)
  5. Classified as a New Drug Application (NDA - yrs. 8-9)
  6. Marketing (yrs. 9-20): Phase 4 (post-marketing surveillance); Patent expires 20 yrs. after filing of application (generics become available)
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3
Q

Limitations

A
Special populations (may not be represented in pre-marketing trials): 
1. Women — few child-bearing and pregnant women participate in drug trials
  1. Children
  2. Transgenders — hormone therapies
  3. Elderly
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4
Q

Complimentary and Alternative Medicines (CAMs)

A

CAMs are not considered drugs by the FDA; they are considered dietary supplements, and are not required to go through strict regulations that drugs are required to go through

“Safe until proven hazardous”; serious DDIs with some CAMs

Used commonly:

  1. Black Cohosh
  2. Coenzyme Q-10
  3. Echinacea
  4. Garlic
  5. Gingko Biloba
  6. St. John’s Wort
  7. Valerian

Harmful - AVOID!:

  1. Comfrey
  2. Kava
  3. Ma Huang
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5
Q

OTC Products

A

No prescription is required; provides symptomatic relief (does not treat underlying cause)

FDA regulations:
1. Must be safe and effective

  1. No harmful side effects when used properly
  2. Not habit-forming
  3. Does not require professional expertise
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6
Q

Prescription (Rx) Drugs

A

EXPERIMENTAL (Pre-marketing)

CONTROLLED SUBSTANCES:
1. Controlled Substances Act (1970)

  1. Drug Enforcement Agency (DEA): concerned with controlled substances only; enforce laws relating to illegal drugs
  2. Requirements: Record keeping, prescribing, labeling, and schedule (I-V)
  3. Schedule — I (Most restrictive and high abuse potential, i.e. heroin, LSD); V (least restrictive and low abuse potential, i.e. codeine)
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7
Q

Dosage Forms

A

Means by which drugs are delivered to the sites of action within the body

Classified by:

  1. ROUTE (impacts absorption; dose may vary by route) — Oral, topical, rectal, parenteral, vaginal, inhaled, ophthalmic, otic, nasal
  2. PHYSICAL FORM — Solid, semisolid, liquid

Need for a variety of forms:

  1. Provide an accurate dose
  2. Protection of drug (i.e. ECT)
  3. Masking taste and/or odor
  4. Extend effects
  5. Optimize drug action at site of action
  6. Ease admin.
  7. Minimize AEs

Warnings:

  • *Do not crush, chew, or cut ECT, ER, or DR (delayed release) tablets
  • *Orally disintegrating tablets (ODT) can be split prior to administration
  • *Suspensions must be shaken well prior to admin.
  • *Patches cannot be cut
  • *Dry powder inhalers (DPI) require ability to inspire (not suitable for children <4 yrs. old)
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