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

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

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

4. 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

5. 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

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

7. 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

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

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

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

11. Federal and state roles

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

13. 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

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

15. 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

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

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

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

19. 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

20. 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

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

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

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

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

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

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

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

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

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

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

31. 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.

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

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

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

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

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

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

38. 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.

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

40. 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).

41. 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

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

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

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

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

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

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

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

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