Module 1: Introduction to Pharmacology

Question 1

Legislature

Answer 1

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

Question 2

Drug Approval Process

Answer 2

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)

Question 3

Limitations

Answer 3

Special populations (may not be represented in pre-marketing trials): 
1. Women — few child-bearing and pregnant women participate in drug trials

2. Children
3. Transgenders — hormone therapies
4. Elderly

Question 4

Complimentary and Alternative Medicines (CAMs)

Answer 4

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

Question 5

OTC Products

Answer 5

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

FDA regulations:
1. Must be safe and effective

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

Question 6

Prescription (Rx) Drugs

Answer 6

EXPERIMENTAL (Pre-marketing)

CONTROLLED SUBSTANCES:
1. Controlled Substances Act (1970)

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

Question 7

Dosage Forms

Answer 7

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)