Chapter 2 Medication Development Regulations and Resources Elsevier items and derived items © 2006 by Saunders, an imprint of Elsevier Inc.

Discuss federal and state roles in regulating drugs. Objective 1 Discuss federal and state roles in regulating drugs.

Federal and state roles Federal government Protect consumers Regulate the industry State government Practice acts Dispensing and administration

Federal and state roles Federal Pure Food and Drug Act 1906: intended to protect consumers from harmful, impure, untested and unsafe medications. Standards for Quality Labeling

Federal and state roles Federal Food, Drug, Cosmetic Act — 1938 Drug effectiveness had to be shown thru: Animal testing Approval to market based on tests

Federal and state roles Food, Drug, Cosmetic Act Durham-Humphrey amendments 1952 Prescription drugs require physician order Over-the-counter drugs do not

Federal and state roles Controlled Substance Act 1970 Classifications (schedules) of drugs that had abuse potential Based on level of abuse and dependence and medical uses

Federal and state roles Controlled Substance Act 1970 C-I example LSD High abuse potential No medical use

Federal and state roles Controlled Substance Act 1970 C-II examples Alfentanyl, cocaine, morphine High abuse potential Appropriate for medical use

Federal and state roles Controlled Substance Act 1970 C-III Moderate abuse potential C-IV and C-V Low abuse potential

Federal and state roles

Federal and state roles Drug Enforcement Administration (DEA) of the Department of Justice Tasked with enforcement of Controlled Substances Act Set standards for handling

Federal and state roles DEA and surgery practice Whenever “narcotics” are given Medically referred to as opioids Careful record-keeping Patient name, date, person obtaining, person administering

Federal and state roles Other federal agencies OSHA Worker safety/sharps safety Occupational Exposure to Blood-borne Pathogens Standard 2001

Federal and state roles OSHA — employer must provide Plan for post-exposure treatment and follow up per CDC guidelines US Dept of Health and Human Services

Federal and state roles CDC prophylactic policy 1995 for post-exposure Zidovudine (ZDV) 600 mg/day Laminvudine (3TC), 150 mg/2xday For four weeks

Federal and state roles CDC alternate post-exposure Laminvudine (3TC) and stavudine (d4T) Didanosine (ddl) and stavudine (d4T) Indinavir (IDV) or saquinavir (SQV)

Federal and state roles State Practice Acts Who may prescribe drugs Pharmacy practices How dispensed By whom Substitution laws

Federal and state roles State Practice Acts Medical Licensing Boards Delegatory power: Lend Physician extenders: ie surg tech Surgical technologists perform roles in medication handling under this authority

Federal and state roles State Practice Acts Vary by state Know the rules in your state Don’t trust hearsay Practice under those rules Know and follow local policies

Additional influence JCAHO - voluntary accreditation Sets practice standards Patient safety 2004 published “Do not use” list of terms and abbreviations associated with medication errors

Define medication development and testing. Objective 2 Define medication development and testing.

Objective 2 Medication development is a process regulated by the Federal Food and Drug Administration (FDA) Testing conducted for proof of safety and effectiveness

Objective 2. Med development FDA Pregnancy Categories Categories A and B are considered safe for use during pregnancy.

Objective 2. Med development FDA testing Initial 2 species of mammals Both genders Look for toxicity and safe dose

Objective 2. Med development FDA testing - Human phases I. Clinical Pharmacology Healthy volunteers - male Determine toxicity and dose in humans

Objective 2. Med development FDA testing - Human phases II. Clinical Investigation Given to persons with the disease Determine effectiveness and optimum dosage

Objective 2. Med development FDA testing - Human phases III. Clinical Trials Given to large numbers of patients Research and study Safety, effectiveness, side effects

Objective 2. Med development FDA testing - Human phases IV. Post-Marketing Study On-going study and reporting Document safety and effectiveness

Discuss pharmacogenetics and pharmacogenomics. Objective 3 Discuss pharmacogenetics and pharmacogenomics.

Objective 3. Pharmacogenetics Pharmacogenetics is the study of genetic factors in predicting a medication’s action and how it could vary from its intended response.

Objective 3. Pharmacogenomics Pharmacogenomics refers to the general study of all genes which determine medication behavior Terms used virtually interchangeably

Objective 3. Pharmacogenomics Create medications based on human genome Possible new medications Revive some old medications for new purposes Facilitate approval process

Objective 3. Pharmacogenomics Disadvantages Complex science High cost Training professionals for this field is a challenge

Distinguish between brand, generic, and chemical medication names. Objective 4 Distinguish between brand, generic, and chemical medication names.

Objective 4 Brand name of medication Selected by manufacturer after FDA approval; marketing purposes Exclusive rights to market it for 17 years

Objective 4 Brand name of medication Also known as trade name or proprietary name Followed by ® indicating name and formula are registered

Objective 4 Brand name of medication Note: In your textbook, the brand name is capitalized and given in parentheses after the generic name of a medication.

Objective 4 Generic name of medication Selected by manufacturer when in development USP/NF assigns official name, usually the generic name

Objective 4 Generic name of medication Note: In this textbook, the generic name of a medication is presented first in lower case letters (unless it begins a sentence).

Objective 4 Chemical name of medication The chemical formula Used only be chemists Look at various ones in the PDR to see how complicated chemical names are

List information found on medication labels. Objective 5 List information found on medication labels.

Objective 5 Brand name Generic name Manufacturer’s name Dosage strength Drug form

Objective 5 Supply dosage Total volume Administration route Label alerts Expiration date

Objective 5 Lot or control numbers Bar code symbol National drug code NDC XXXX-XXXX-XX

Obtain medication information from pharmacology resources. Objective 6 Obtain medication information from pharmacology resources.

Objective 6. References Physician’s Desk Reference PDR United States Pharmacopoeia and National Formulary USP/NF

Objective 6. References American Hospital Formulary Service AHFS The Medical Letter Drug Facts and Comparisons Hospital Pharmacist

Objective 6. References Computerized data bases Internet Micromedex CliniSphere Internet Government agencies Web pages