2. The Evolution of Medicinal Drugs
Chapter 1
The Evolution of Medicinal Drugs

3. Chapter 1 Topics The History of Medicinal Drugs
Present-Day Pharmacology Practice
Drug Legislation and Regulation
Drug Testing and Approval
FDA Food Health Claims

4. Learning Objectives
Recognize the important figures, events, and resources in the development of pharmacology through the ages.
Know what is meant by pharmacology.
Define drugs, identify their sources, and understand how they work.
Be familiar with the federal laws that regulate drugs and the agencies that administer them.
Be familiar with the procedure for getting a new drug to market.

5. History of Medicinal Drugs
Knowledge of healing properties of natural substances grew from trial and error
Historically, medical treatment controlled by religious leaders
Pharmakon, Greek word meaning magic spell, remedy, or poison

6. History of Medicinal Drugs
Hippocrates
c B.C.
Propose that disease came from natural, not supernatural causes
Favored empirical learning
Used dissection to study human body’s organs’ functions

7. History of Medicinal Drugs
Galen
c. A.D
Humors (blood, phlegm, black bile, yellow bile)

8. History of Medicinal Drugs
Dioscrides
First century A.D.
de Materia Medica
Described and classified 600 plants by substance not disease they were intended to treat

9. History of Medicinal Drugs
Paracelsus
Challenged teachings of Galen, denouncing humors
Advocated use of individual drugs, not mixtures and potions

10. History of Medicinal Drugs
Pharmacopoeias
Official listings of medical preparations
Florence, Italy: Nuovo Receptario
Nuremberg, Germay: Dispensatorium

11. History of Medicinal Drugs
Claude Bernard
Certain drugs have specific sites of action in the body
Started field of experimental pharmacology

12. History of Medicinal Drugs
Pharmacopoeia of the United States
1820
First official listing of drugs in the U.S.
Massachusetts Medical Society

13. History of Medicinal Drugs
American Civil War
Defined boundaries between practice of physicians and pharmacists
1852, formation of the American Pharmaceutical Association

14. History of Medicinal Drugs
Medical Breakthroughs
1847, Semmelweis
Handwashing with chlorinated lime water in maternity wards
1860s, Lister
Introduced antiseptics into surgery
1907, Ehrlich
Introduced arsphenamine to treat syphilis

15. History of Medicinal Drugs
Medical Breakthroughs
1923, Banting and Best
Extracted insulin from the pancreas to treat diabetes
1935, Domagk
First antibiotic, sulfa drug prontosil
1945, Fleming
Introduction of penicillin

16. Discussion
As the use of medicinal drugs has developed, how has the role of the pharmacist changed?
How are biopharmaceuticals changing the options for treating diseases?

17. Present-Day Pharmacology Practice
Pharmacist
Responsible for appropriate dispensing and use of drugs
Directs patient care and counseling

18. Present-Day Pharmacology Practice
Pharmacy Technician
Assists the pharmacist
Role depends on state law
Manages computer systems
Ensures that safe and effective systems are in place

19. Present-Day Pharmacology Practice
Pharmacy Technician Certification Board (PTCB)
Maintains national certification program
Develops standards
Credentialing agency
Certified technicians must be recertified every two years by the PTCB

20. Present-Day Pharmacology Practice
Medicinal Drugs
Pharmacologic effects
Drug actions on living system
Classifications
Therapeutic drugs: relieve symptoms of a disease
Prophylactic drugs: used to prevent or decrease the severity of disease

21. Present-Day Pharmacology Practice
Pharmacognosy
Study and identification of natural sources for drugs
plants, animals, minerals, chemicals, recombinant DNA
Biopharmaceuticals
Produced by recombinant DNA technology

22. Present-Day Pharmacology Practice
Drug Source
Drug Name
Therapeutic Effect
plant: foxglove
digoxin
cardiotonic
animal: stomach of hog and cow
pepsin
digestive enzyme
mineral: silver
silver nitrate
anti-infective
synthetic: omeprazole
Prilosec
gastric acid inhibitor
bioengineering: erythropoietin
Epogen
stimulates RBC formation

23. Discussion How is the role of the pharmacy technician changing?
Why is it important for there to be national certification for technicians?

24. Drug Names and Classifications
Chemical Name
Chemical makeup
Long and difficult to pronounce

25. Drug Names and Classifications
Chemical Name
Chemical makeup
Generic name
Name the manufacturer gives a drug
USAN
Nonproprietary drug, not protected by trademark
Lowercase letter

26. Drug Names and Classifications
Chemical Name
Chemical makeup
Generic name
Name the manufacturer gives a drug
USAN
Nonproprietary drug, not protected by trademark
Brand name
Trade name
Copyrighted and used exclusively

27. Drug Names and Classifications
Guidelines for drug names
Active component in single word
When two or more components, list principal, active ingredient first
Use of common stems for drug groups

28. Drug Legislation and Regulation
Food and Drug Administration (FDA)
1906, first attempt by U.S. government to regulate the sale of drugs or substances that affect the body
1927, formation of Food, Drug, and Insecticide Administration
1930, name changed to FDA

29. Drug Legislation and Regulation
Food and Drug Administration (FDA)
1938, passage of Food, Drug, and Cosmetic Act
New Drug Application (NDA)
1951, Durham-Humphrey Amendment
Legend drug
Over-the-counter drug

30. Controlled Substances
Controlled Substances Act
1970
Combat escalating drug abuse
1973, establishment of DEA

31. Controlled Substances
Label
Abuse Potential
C-I
highest potential
C-II
high possibility, which can lead to severe dependence
C-III
less potential
C-IV
low potential
C-V
lowest potential

32. Discussion
How does the schedules for controlled substances help protect patients?
What are examples of drugs in each of the controlled schedule categories?

33. Drug Testing and Approval
FDA requires the manufacturer of a new drug to provide evidence of the drug’s safety and effectiveness
New Drug Application (NDA)
Specifies the proposed labeling
Documents the drug’s development and testing
Details manufacturing, processing, packaging
Quality control

34. Clinical Trials Phase I Phase II Phase III Phase IV
Studied in healthy people
Phase II
Studied in patients who have the condition it is intended to treat
Phase III
Compared to commonly used treatments
Phase IV
Continuation of testing after approved for marketing

35. FDA Pregnancy Categories
Category
Risk Level A
No risk B
Risk cannot be ruled out C
Caution is advised D
Is a definite risk X
Do not use

36. Discussion
What do you do if an obviously pregnant woman is picking up a prescription for a drug with a FDA Pregnancy Category B rating?
Why might a pregnant woman take such a drug?

37. Discussion
Does FDA approval mean that a drug is guaranteed to be safe?

38. Discussion
Do you remember drugs that were originally considered safe, but were then removed from the market?
What was your experience with those drugs?

39. FDA Food Health Claims Primary objectives of FDA
Weighing risks against benefits
Protect consumers
1999, FDA authorized food companies to promote disease-fighting and cancer-fighting benefits of whole grains in breakfast cereals
1999, FDA authorized use of health claims about the role of soy protein in reducing risk of coronary heart disease

40. Discussion
What would you do if a customer/patient told you they were not going to continue a prescribed cholesterol-lowering medication because they were going to be eating more whole grain cereals?