Module 1: Introduction to Pharmacology Flashcards
Legislature
- 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
- Food, Drug, and Cosmetic Act (1938): required drugs to be tested for safety before marketing approval
- Harris-Kefauver Amendment (1962): required drugs to show they were scientifically effective
- Controlled Substance Act (1970): reduced the chance that drugs originating from legitimate sources would be diverted to abusers
- Prescription Drug User Free Act (1992): created an accelerate approval process specifically for pts that required HIV or CA meds.
- Best Pharmaceuticals for Children Act (2002): promotes drug advocacy and safety in ped. meds.
- Pediatric Research Equity Act (2003): required testing on drugs expected to be used in children
Drug Approval Process
- In vitro studies (yrs. 0-2): Chemical synthesis and optimization of biological products to produce a lead compound
- Animal testing (yrs. 2-4) for efficacy, selectivity, and mechanism
- Classified as an Investigational New Drug (IND - yr. 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)
- Classified as a New Drug Application (NDA - yrs. 8-9)
- Marketing (yrs. 9-20): Phase 4 (post-marketing surveillance); Patent expires 20 yrs. after filing of application (generics become available)
Limitations
Special populations (may not be represented in pre-marketing trials): 1. Women — few child-bearing and pregnant women participate in drug trials
- Children
- Transgenders — hormone therapies
- Elderly
Complimentary and Alternative Medicines (CAMs)
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:
- Black Cohosh
- Coenzyme Q-10
- Echinacea
- Garlic
- Gingko Biloba
- St. John’s Wort
- Valerian
Harmful - AVOID!:
- Comfrey
- Kava
- Ma Huang
OTC Products
No prescription is required; provides symptomatic relief (does not treat underlying cause)
FDA regulations:
1. Must be safe and effective
- No harmful side effects when used properly
- Not habit-forming
- Does not require professional expertise
Prescription (Rx) Drugs
EXPERIMENTAL (Pre-marketing)
CONTROLLED SUBSTANCES:
1. Controlled Substances Act (1970)
- Drug Enforcement Agency (DEA): concerned with controlled substances only; enforce laws relating to illegal drugs
- Requirements: Record keeping, prescribing, labeling, and schedule (I-V)
- Schedule — I (Most restrictive and high abuse potential, i.e. heroin, LSD); V (least restrictive and low abuse potential, i.e. codeine)
Dosage Forms
Means by which drugs are delivered to the sites of action within the body
Classified by:
- ROUTE (impacts absorption; dose may vary by route) — Oral, topical, rectal, parenteral, vaginal, inhaled, ophthalmic, otic, nasal
- PHYSICAL FORM — Solid, semisolid, liquid
Need for a variety of forms:
- Provide an accurate dose
- Protection of drug (i.e. ECT)
- Masking taste and/or odor
- Extend effects
- Optimize drug action at site of action
- Ease admin.
- 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)