Comprehensive Overview of Drug Development, Regulations, and Pharmacology

1. Chapter 35 Basic Pharmacology

2. Uses of Medications • Therapeutic • Diagnostic • Curative • Replacement • Preventive or prophylactic

3. Research and Development • Up to 15 years for drug to make it to market • Understand process of change from health to illness from level of cellular components (targets) • Design chemical compounds and biopharmaceuticals

4. Research and Development • 2003: Human Genome Project completed • Pharmacogenomics • Study of response of body to various chemical compounds based on individual’s genetic inheritance

5. Drug Names • Chemical name • Generic name • Trade or brand name

6. History and Sources of Drugs • Drugs from roots, herbs, bark, plant life earliest known pharmaceuticals • Drugs derived from animals and minerals • Produced in laboratories using chemical, biochemical, biotechnologic processes

7. History and Sources of Drugs • Plant sources • Animal sources • Mineral sources • Herbal supplements • Synthetic drugs • Genetically engineered pharmaceuticals

8. Drug Regulations and Legal Classifications of Drugs • Must comply with federal and state laws • Laws govern: • Manufacture • Sale • Possession • Administration • Dispensing • Prescribing of drugs

9. Drug Regulations and Legal Classifications of Drugs • Federal Food, Drug, and Cosmetic Act • Protects public by ensuring purity, strength, and composition of foods, drugs, and cosmetics • Prohibits movement in interstate commerce of altered and misbranded food, drugs, devices, and cosmetics • Enforced by Food and Drug Administration (FDA)

10. Drug Regulations and Legal Classifications of Drugs • Controlled Substances Act of 1970 • Regulates drugs with potential for abuse or addiction • Controls manufacture, importation, compounding, selling, dealing in, giving away of drugs that have potential for abuse • Controlled substances

11. Drug Regulations and Legal Classifications of Drugs • Controlled Substances Act of 1970 • Drug Enforcement Agency (DEA) • Provider registration • Controlled Substances Schedules I–V

12. Drug Regulations and Legal Classifications of Drugs • Controlled Substances Act of 1970 • Storage of controlled substances • Separation from other drugs • Well-constructed metal box or compartment with double lock • Separate record book • Counted, verified, recorded at end of workday

13. Drug Regulations and Legal Classifications of Drugs • Controlled Substances Act of 1970 • Controlled Substance Disposal Policy (per DEA) • Medical assistant role and responsibilities • Monitor provider’s DEA registration renewal date • Maintain legally designated records and inventories of drugs • Provide security for all drugs, in particular controlled substances

14. Drug Regulations and Legal Classifications of Drugs • Controlled Substances Act of 1970 • Medical assistant role and responsibilities • Provide security for prescription pads • Properly destroy expired drugs and document • Know and understand federal and state laws that regulate drugs, including controlled substances and samples

15. Drug Regulations and Legal Classifications of Drugs • Prescription drugs • Also called legend drugs • E-prescribing • Nonprescription drugs • Over-the-counter (OTC) drugs • Readily accessible to public • Do not require prescription

16. Drug Regulations and Legal Classifications of Drugs • Proper disposal of drugs • Expired drugs removed from shelf and destroyed • Expired drugs could be harmful • Pharmacists have medications incinerated • DEA sponsors annual National Take-Back Initiative

17. Drug Regulations and Legal Classifications of Drugs • Administer, prescribe, dispense • Prescribe: licensed practitioner gives written order to be taken to pharmacist to be filled • Dispense: provide medication as ordered by provider to patient • Administer: give to patient by mouth or injection or other method

18. Drug References and Standards • U.S. Pharmacopeia/National Formulary • List drugs for which standards have been established • Compendium of Drug Therapy • Desk Reference for Nonprescription Drugs • Physician’s Desk Reference (PDR) • Each medication described using manufacturer’s package insert

19. Drug References and Standards • How to use the PDR • Brand name and generic name index, section 2 • Classification or category, section 3 • Product identification guide, section 4 • Product information and alphabetical arrangement by manufacturers, section 5

20. Drug References and Standards • Other reference sources • Refer to another drug reference book • Research medications online; make sure source reliable • Ask pharmacist about drug • Refer to packet insert that comes in drug package

21. Classification of Drugs • Drugs used to treat or prevent disease • Drugs that have principal action on body • Drugs that act on specific body systems or organs • Drug preparation

22. Principal Actions of Drugs • Act directly on one or more tissues of body • Act on microorganisms • Replace body chemicals • Local action • Remote action • Systemic action • Synergistic action

23. Principal Actions of Drugs • Factors that affect drug action • Absorption • Distribution • Biotransformation • Elimination

24. Principal Actions of Drugs • Undesirable actions of drugs • Side effect • Drug interaction • Adverse reactions

25. Drug Routes • Route of administration determined by: • Action of medication on body • Physical and emotional state of patient • Characteristics of drug

26. Drug Routes • Oral • Parenteral • Direct application to skin • Sublingual • Buccal • Rectal • Vaginal • Inhalation • Instillation

27. Forms of Drugs • Liquids, solids, and semisolids Tablets and capsules >>

28. Forms of Drugs • Other drug delivery systems • Transdermal system • Inhalation medications • Eye-curing lens • Implantable devices

29. Storage and Handling of Medications • Goal: store in original containers in separate room in locked cabinet • Darkness • Refrigeration • Glass containers • Consult drug label for storage • Organization of storage area

30. Storage and Handling of Medications • Please refer to the video library on the Instructor Resources CD to view video “Medical Assistant’s Role in Drug Orders.”

31. Emergency Medications and Supplies • Tray, box, cabinet, crash cart • Emergency drugs • Emergency supplies and equipment

32. Emergency Medications and Supplies • Bioterrorism • Use of biologic weapons (pathogenic microorganisms) • Most diseases treated with pharmaceutical agents (antibiotics and antitoxoids) • Dangerous disease threats: anthrax, botulism, pneumonic/bubonic plague, smallpox, tularemia

33. Drug Abuse • Recognizing symptoms of drug abuse • Drug abuse programs • Examples of drug types commonly abused • Effects of drug abuse • Prevention programs