1. Chapter 2 Law and Ethics of Pharmacy
Copyright © 2004 by Elsevier Inc.  All rights reserved.

2. Introduction
Practice of pharmacy–governed by series of laws, regulations, and rules enforced by federal, state, local government; institutions and pharmacy management
Technician–needs to understand these laws for passing the PTCB Certification Exam and for employment

3. 1906 Federal Food and Drug Act
Enacted to stop the sale of inaccurately labeled drugs
Manufacturers were required to put truthful information on the label before selling the drug
Manufacturers had to prove their drug’s effectiveness

4. 1914 Harrison Narcotic Act
Enacted because of the excessive number of opium addicts in the United States
People could no longer obtain opium without a prescription

5. 1938 Food, Drug, and Cosmetic Act
Enacted because the earlier Food and Drug Act was not worded strictly enough and did not include cosmetics
Required drug companies to include directions to the consumer regarding use and package inserts on drugs
All narcotics were required to be labeled “Warning: May be habit-forming”

6. 1938 Food, Drug, and Cosmetic Act
Defined the exact labeling for products and defined misbranding and adulteration as being illegal
Proves the legal status for the Food and Drug Administration (FDA)

7. 1951 Durham-Humphrey Amendment
Required the labeling ”Caution: Federal law prohibits dispensing without a prescription”
Made certain drugs require a doctor’s order and supervision
Made the initial distinction between legend drugs (by prescription only) and over-the-counter (OTC) medications

8. 1962 Kefauver-Harris Amendment
Enacted in an attempt to ensure the safety and effectiveness of all new drugs on the market
Burden put on manufacturing companies to have good manufacturing practices (GMP)
Prevented the sale of thalidomide in the United States because children were born with birth defects after usage in pregnancy

9. 1970 Comprehensive Drug Abuse Prevention and Control Act
The Drug Enforcement Agency (DEA) was formed to enforce the laws concerning narcotics and their distribution
Created a stair-step schedule of controlled substances

10. Orphan Drug Act of 1983
Allowed drug companies to bypass the lengthy time requirements of testing a new drug and the cost that accompanied them to provide a medication to persons who had rare disease(s) (disease that affected 1 in every 200,000 people)

11. 1987 Prescription Drug Marketing Act
Controlled the use of drugs in animals
Required the labeling “Caution: Federal law restricts this drug to use by or in order of a licensed veterinarian”

12. 1990 Anabolic Steroids Control Act
Helped stiffen regulation on the abuse problems of anabolic steroids and their misuse by athletes

13. 1990 Omnibus Budget Reconciliation Act (OBRA 90)
Deals specifically with practicing pharmacists
Enacted because of reimbursement regulations for people who are covered under Medicaid or Medicare Insurance
States that a pharmacist must counsel (at the time of purchase) all patients who receive new prescriptions

14. 1990 Omnibus Budget Reconciliation Act
All patients must be given information on the drug that they are taking, its name, when to take it, how long to take it, and any side effects or possible interactions
Many states adopted OBRA to apply to all new prescriptions. Federal law deals only with Medicare and Medicaid

15. Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Has been only partially implemented
Deals with patient’s right to continuance of health insurance even when changing employers
Changes for pharmacy: Technician has direct knowledge of patient’s medical information on a daily basis –consent form to access this information will have to be signed by the patient

16. FDA/DEA Important with respect to pharmacy
FDA was created under the department of Health and Human Services
Main function–to enforce guidelines for manufacturers to ensure the safety and effectiveness of medications

17. FDA/DEA DEA–created under the Department of Justice
Its function is to prevent the illegal distribution and misuse of narcotics
DEA–issues licenses to practitioners, pharmacies, and manufacturers of controlled substances

18. FDA Reporting Process and Adverse Reactions
Toll free number (1-800-FDA-1088) for reporting any defect found in OTC medications and any other drug problems
Any medication reaction that may cause disability, hospitalization, or death should be reported
Patient’s identity must be kept confidential

19. FDA Reporting Process and Adverse Reactions
MedWatch–program under the FDA that allows consumers and health care professionals to report any discrepancies in medication or adverse reactions to medications

20. Controlled Substances
Commonly known as narcotics and are addictive
Narcotics are derived from opium or opium-like substances
Opium comes from the poppy seed plant and has analgesic effects and also effects mood and behavior

21. Controlled Substances
Opiates, such as codeine and morphine, are substances created from opium
Opioids are narcotics that are produced synthetically in the laboratory
Each type of narcotic is assigned a rating that depends on its addiction potential

22. Registration Required for Maintaining Narcotics
DEA–three main registration forms
Form 224–needed by pharmacy to dispense controlled substances
Form 225–to manufacture or distribute controlled substances
Form 363–to run a narcotic treatment program or compound narcotics

23. Ordering Controlled Substances
Pharmacy obtains C-II substances from a distributor
Form 222 must be filled out by the receiving pharmacy in pen, typewriter, or indelible pencil
Top copy and middle copy with carbon paper are sent to the supplier or manufacturer

24. Ordering Controlled Substances
Second Copy with carbon paper–returned to distributor or wholesaler
Third copy–sent by distributor or wholesaler to the DEA
Errors–forms become invalid; cannot be erased or thrown away

25. Ordering Controlled Substances
C-III, C-IV, C-V–ordered on normal invoice forms but must be filed and retained for DEA or BOP inspection
Should be kept separate from other nonscheduled drugs
Forms kept for 2 years

26. Ordering Controlled Substances
Receipt of controlled substances–pharmacist compares copy of Form 222 to invoice
Both copies signed for accuracy
Documents stapled together and retained for 7 years

27. Record Keeping
Three Methods of Filing Controlled Substances and Legend Drugs System Drawer 1 Drawer II Drawer III 1 C-II C-III All other separate through C-V prescriptions
2 C-II C-III–C-V* and separate all legend drugs
3 C-II All other through C-V* prescriptions
*If any C-III, C-IV, or C-V controlled drugs are kept with non-controlled drugs (System 2) or mixed with C-II drugs (System 3), they must be stamped with a red “C” for easy identification. All records must be kept on site for no less than 2 years. Many states, however, have longer requirements for keeping records; remember the strictest law is the one that must be followed. When taking inventory it is necessary to have exact counts of C-II controlled substances at all times. The final count can only be inventoried by a licensed pharmacist.

28. Ratings of Scheduled (Controlled) Substances
Letter “C,” meaning controlled substances, is used in addition to Roman numerals to indicate the addictiveness or abuse potential of narcotics
Five levels based on potential for abuse
C-I–strongest potential for abuse; no medicinal use in the USA–LSD, Heroin

29. Ratings of Schedules (Controlled) Substances
C-II, C-III, C-IV, C-V–all medicinal narcotic drugs
C-V–kept OTC in some states because of low potential abuse
C-II–must be locked up because of high potential abuse
Attorney General decides which schedule to place a drug under
Refer to Table 2.2

30. Refilling Controlled Substances
Strict guidelines
C-II or C-IV–can be refilled a maximum of 5 times or within 6 months from the original order, whichever comes first
Record must be kept with pharmacist’s initials and date it was dispensed

31. Monographs/Package Inserts
Contained in the Physicians’ Desk Reference (PDR) in doctor’s office and Facts and Comparisons in pharmacy
Contains the following: Adverse reactions, Clinical pharmacology, Contraindications, Description, Dosage, Drug abuse and dependence, How supplied, Indications and usage, Precautions, and Warnings

32. Prescription Regulations
Who can prescribe? FDA and DEA have no authority in determining prescribers
Prescribers are licensed by their governing bodies
Standard practitioners in all 50 states are: physicians, surgeons, doctors of osteopathy, dentists, podiatrists, veterinarians, and optometrists

33. Who Can Receive a Prescription?
Pharmacy Technicians–takes in prescriptions, interprets them, and fills them
Technicians cannot take phone orders
Pharmacists–give the final check, take verbal telephone orders, and transfer prescriptions to another pharmacy

34. Receiving Prescriptions for Controlled Drugs
Pharmacists can receive an oral prescription for a controlled drug over the phone by reducing it to written form
C-II has strict guidelines–refer to guidelines on page 21

35. Prescription Label
The information on a prescription label differs from a prescription order
Two necessary components: pharmacy information and patient information
Refer to list on page 21
Special labeling–sometimes required because of possibility of teratogenicity on an unborn fetus

36. DEA Verification
All prescribers must be registered with the DEA to write prescriptions for controlled substances
Prescribers are given a nine character identification code, which is different for each prescriber

37. DEA Verification
First two characters are letters–A or B followed by first letter of prescriber’s last name
Next seven digits are composed of numbers added together
Refer to Box 2.3 for DEA Verification Process

38. Childproof Caps
The Poison Prevention Act addresses the issue of accidental poisoning of children
Childproof caps were created
Adults–can require no childproof caps by requesting it
Pharmacy–keeps information on patient’s record and may require a signed release form

39. Mailing Prescription Drugs
Online and mail-order pharmacies provide an option to patients to receive their prescription via the mail
U.S. Postal Service will not allow narcotics to be sent by mail unless it’s a veteran through the Veterans’ Administration

40. Mailing Prescription Drugs
For mailed prescriptions–envelope must be unmarked as to contents
Pharmacy must be registered with the DEA
Manufacturer to patient–must be sent registered mail with a return receipt

41. Recalled Drugs
Manufacturers must recall items that have been found to be either defective or somehow tainted
Three classes of recalls
Refer to list on page 23 for levels of recall

42. Records and Labeling Requirements
Repackaging–done from bulk to unit dose by technicians
Following information is needed on each label: Drug name, strength, dosage form, manufacturer, lot number, and expiration date

43. State Laws
Each state has their own set of laws that must be followed by all employees in the pharmacy
States have laws that differ from federal law
The strictest law is the one you follow

44. Liabilities
Tort–causing injury to a person intentionally or because of negligence
Negligence–an action taken without the forethought that should have been taken by a reasonable person; a mistake

45. Liabilities
Intentional mistake–penalty ranges from criminal charges to awarding of damages
Negligent mistake–affect employment and can result in punitive damages
Be aware of rights and responsibilities
Refer to list on page 25

46. Morals Versus Ethics in the Workplace
The pharmacy technician has a clear responsibility to the patient on many levels
Ethics are morals in the workplace and in the public domain
Work ethics will guide your behavior
Working within pharmacy guidelines will ensure that patients are getting the best service possible