1. 2
Law and Ethics of Medications

2. Introduction
All health-care workers who work with medications should understand the legal and ethical requirements of their jobs.
Controlled substances are those drugs that are prone to abuse and fall under the 5 drug schedules established by the Controlled Substances Act.

3. Pharmacy Regulations
Federal Laws
State Laws
Professional Ethics

4. The Need for Drug Control
In the 19th century, there was virtually no regulation of the sale of drugs in the United States.
Many people became addicted to opiates or relied on false claims of manufacturers of drugs and other substances, resulting in passage of the first Pure Food and Drug Act in 1906.

5. Pearson Education / PH College
Figure During the nineteenth century in the United States, over-the-counter opium could be purchased at pharmacies and grocery stores. As a result, addiction became a problem, leading to programs such as the one advertised in this poster. However, in 1906, the Pure Food and Drug Act put an end to the sale of unsafe and untested drugs, such as opium.

6. Federal Drug Control
Pure Food and Drug Act (1906): first law to regulate standards of drug strength and purity, and proper labeling
Sherley Amendment (1912): prohibits fraudulent therapeutic claims

7. Pure Food and Drug Act of 1906 (cont.)
Ultimately proved to be inadequate because it did not:
Cover cosmetics
Provide the authority to ban unsafe drugs
Prohibit false statements about drugs
Require labeling to identify product contents

8. Food, Drug, and Cosmetic Act of 1938
Prompted by the sulfanilamide disaster of 1937
Limited interstate commerce in drugs to those that are safe and effective
Established the Food and Drug Administration (FDA)
Regulated labeling of drugs
Regulated who could prescribe legend (prescription-only) drugs

9. Federal Drug Control
Federal Food, Drug, and Cosmetic Act (1938): ensures that drugs comply with standards of safety and efficacy; authorized FDA to approve new drug applications
This act was prompted in part by the sulfanilamide disaster of 1937, which caused many birth defects

10. Drugs and Birth Defects
Drinking alcohol while pregnant can cause fetal alcohol syndrome, characterized by abnormalities of the face and head, growth disturbances, and mental deficiency.
Smoking during pregnancy is linked to smaller birth-weight babies and abnormal infant reflexes.

11. Federal Laws
Durham-Humphrey Amendment (1951): prohibits dispensing of legend drugs without a prescription; allows nonlegend (OTC) drugs to be sold without a prescription

12. Durham-Humphrey Amendment of 1951
Also known as the Prescription Drug Amendment
Required prescription drugs to bear the legend, "Caution: Federal law prohibits dispensing without a prescription."
Later amendments approved a substitute legend that reads "RX only."

13. Federal Laws
Kefauver-Harris Amendment (1962): passed in response to thalidomide disaster; requires adverse effects to be reported to FDA and proof of safety and efficacy

14. Federal Laws: Drug Abuse
Drug Abuse Control Amendment (1965)
Allowed only certain authorized registrants to manufacture stimulant drugs
Contained first guidelines for determining classifications of drugs subject to abuse

15. Pearson Education / PH College
Figure Amphetamines, Schedule II drugs, have a high abuse potential and are sold illegally under many street names.

16. Keeping Medications Safe in the Hospital
All restricted substances must be stored in locked storage facilities.
This prevents access by unauthorized persons.

17. Occupational Safety and Health Act of 1970
Administered by Occupational Safety and Health Administration (OSHA)
Revised in 1992: requires medical facilities to comply and prove compliance with the Bloodborne Pathogens Standard

18. Occupational Safety and Health Administration (OSHA)
Division of the U.S. Department of Labor
Assures the safety and health of American workers by setting and enforcing protective standards
Enforces occupational safety standards in all 50 states
Provides technical assistance and consultation programs

19. Michal Heron / Pearson Education / PH College
Figure In 1992, the Occupational Safety and Health Administration’s Final Ruling on Bloodborne Pathogens became law. Safety measures, such as sharps containers for the disposal of needles and syringes, were implemented to stem the spread of HIV/AIDS and other bloodborne diseases.

20. Comprehensive Drug Abuse Prevention and Control Act of 1970
Also known as the Controlled Substances Act of 1970
Combined all federal laws dealing with narcotics, stimulants, depressants, and abused designer drugs
Established the Drug Enforcement Administration (DEA)
Established five "classes" or schedules for controlled substances

21. Controlled Substances Act (1970)
Gave sole drug control to the DEA
Classified drugs according to abuse potential
Provided research into drug abuse and dependence and drug abuse treatment and rehabilitation

22. Schedule I Symbol: C-I No accepted medical use in the U.S.
Example – heroin, LSD, marijuana

23. Schedule II Symbol: C-II No refills permitted
Example – morphine, cocaine, Ritalin®

24. Schedule III Symbol: C-III May be refilled up to 5x – within 6 months
Example – anabolic steroids, Noludar®

25. Schedule IV Symbol: C-IV May be refilled up to 5x – within 6 months
Example – Vicodin®, Valium®, Librium®

26. Schedule V Symbol: C-V No refill restrictions – for up to one year
Example – Lomotil®

27. Table Drug Schedules

28. Table 2-1 (continued) Drug Schedules

29. Additional Control of Drug Abuse
Anabolic Steroids Control Act (1990): placed anabolic steroids under CSA’s regulatory provisions

30. Anabolic Steroids Control Act of 1990
Anabolic steroids are hormonal substances related to estrogen, progestins, testosterone, and corticosteroids.
This act was established to control illegal use of anabolic steroids to increase physical performance (mostly by athletes).

31. Anabolic Steroids Control Act of 1990
Abuse of anabolic steroids may lead to heart, liver, immune function, and mood-related conditions that may become fatal.

32. Orphan Drug Act of 1983
Intended to stimulate the development of drugs for rare diseases
Rare disease: affects 200,000 people or fewer

33. Orphan Drug Act of 1983 (cont.)
Provides three primary incentives:
Seven-year market exclusivity to sponsors of approved orphan products
Tax credit of 50 percent of the cost of conducting human clinical trials
Federal research grants for clinical testing of new therapies to treat and/or diagnose rare diseases

34. Orphan Drug Act of 1983 (cont.)
Congress created an additional incentive in 1997
Companies developing orphan products receive an exemption from the usual drug application or user fees charged by the FDA

35. Prescription Drug Marketing Act
Prohibits the reimportation of a drug into the United States by anyone but the manufacturer; adopted in 1987
Prohibits the trading or sale of drug samples and controls their distribution

36. Prescription Drug Marketing Act of 1987
Enacted to address certain prescription drug marketing practices
Distribution of free samples
Use of coupons redeemable for drugs at no cost or low cost
Sale of deeply discounted drugs to hospitals and healthcare entities

37. Prescription Drug Marketing Act of 1987 (cont.)
These marketing practices helped create a secondary grey market
grey market—an unofficial or unregulated market

38. Michal Heron / Pearson Education / PH College
Figure Pharmaceutical company representatives provide drug samples to physician offices. These samples may not be sold.

39. Medical Device Amendment of 1976
Requires life-sustaining and life-supporting devices to have premarket approval from the FDA

40. Safe Medical Devices Act (1990)
Requires reporting of serious injury, illness, or death caused by medical devices, including:
Dialyzers and ventilators
Electronic equipment and monitors
Implants, syringes, thermometers, and catheters
Restraints
Components, accessories, software

41. Omnibus Budget Reconciliation Act of 1990 (OBRA ’90)
Focused on federal funding of Medicare and Medicaid
Increased the necessity for pharmacy technicians
Mandated that pharmacists perform drug utilization reviews (DURs) and offer counseling to patients

42. Omnibus Budget Reconciliation Act of 1990
Requires pharmacists to offer to discuss prescription information with Medicaid and Medicare patients
Limits Medicare/Medicaid reimbursement to drugs approved as safe and effective

43. Combat Methamphetamine Epidemic Act of 2005 (CMEA)
Regulates retail over-the-counter sales of ephedrine, pseudoephedrine, and phenylpropanolamine products, including:
Daily sales limits
30-day purchase limits
Placement of product out of direct customer access
Sales logbooks
Customer ID verification
Employee training

44. Health Insurance Portability and Accountability Act of 1996
Also known as HIPAA; has four parts:
Electronic health transaction standards
Unique identifiers
Security and electronic signature standards
Privacy and confidentiality standards

45. Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Enacted to ensure patient confidentiality and privacy
Gave patients the right to review their medical records
Established the requirement of patient consent for the transfer of medical records

46. Mike Gallitelli / Pearson Education / PH College
Figure The electronic transmission and storage of medical records is protected by the Health Insurance Portability And Accountability Act.

47. FDA Modernization Act of 1997
This act focused on safe pharmacy compounding, user fees, food safety, and medical devices.
It gave patients increased access to experimental drugs and devices.
It also gave extension to manufacturers developing new pediatric drugs.

48. Health Insurance Portability and Accountability Act of 1996 (HIPAA) (cont.)
Defines protected health information (PHI) as:
Any information created or received by the pharmacy
Information relating to a patient’s health—mental or physical; past, present, or future
Information that may identify a patient

49. Medicare Modernization Act of 2003
This act created new “Advantage” plans providing better patient care.
It partially privatized Medicare.
Medicare Part D was established to cover FDA-approved drugs, and is a voluntary program with varied plans and co-payment amounts.

50. Combat Methamphetamine Epidemic Act of 2005
This act was designed to stop illegal use of methamphetamine and regulated trafficking of this drug and others, when these activities are used to finance terrorism.
Ingredients used to manufacture methamphetamine are now limited for sale, and buyers must be registered with the U.S. Attorney General.

51. Federal Agencies
Food and Drug Administration (FDA): part of U.S. Department of Health and Human Services; controls all drugs for legal use
Drug Enforcement Administration (DEA): part of the Federal Bureau of Investigation (FBI); enforces controlled substance laws

52. Federal Agencies
Centers for Disease Control and Prevention (CDC): ensures infection control regulations and provides statistics and information to health professionals about disease treatment

53. Food and Drug Administration (FDA)
Reviews/approves new drugs, generic equivalents, and therapeutic indications for existing medications

54. Food and Drug Administration (FDA) (cont.)
Responsible for protecting public health
Assures safety, efficacy, and security of:
Drugs
Biological products
Medical devices
Food
Cosmetics

55. Drug Enforcement Administration (DEA)
Regulates legal trade in narcotic and dangerous drugs
Manages national narcotics intelligence system
Works with other agencies to support drug traffic prevention
Shares jurisdiction over drug offenses with Federal Bureau of Investigation (FBI)

56. Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
Evaluates and accredits nearly 15,000 healthcare organizations and programs
Establishes and enforces standards that improve quality and safety of healthcare organizations

57. Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (cont.)
Evaluates and accredits:
Hospitals
Hospice facilities
Nursing homes
Long term care facilities
Rehabilitation centers
Other healthcare organizations

58. State Law
The states are the main regulators of laws governing pharmacy practice.
No one may practice pharmacy without a state license except those exempted by state legislation.
Certificates of registration are granted for 1 or 2 years in most states.

59. State Board of Pharmacy (SBOP)
State agency that registers and regulates:
Pharmacy facilities
Pharmacists
Pharmacy technicians
Responsible for the actual practice of pharmacy within state domain
Granted the authority to monitor, reprimand, and revoke licensures

60. Ethics and Pharmacology
Ethics: standards of behavior that encompass the concepts of right and wrong beyond a given situation’s legal considerations
Confidentiality: health professionals must maintain strict confidentiality

61. Ethics and Pharmacology
Health-care workers must know laws of state in which they work, including rules that apply to phoning prescriptions to pharmacists.

62. Ethics
The considered reflection and systematic analysis of the morality of certain behavior when required actions are unclear

63. Ethics Derived from the Greek word ethos, referring to one’s character
Discipline of evaluating the merits, risks, and social concerns
Commonly defined as considered reflection or systematic analysis when required actions are unclear

64. Ethics (cont.)
Based on certain universal principles such as justice, doing no harm, etc.
Ethics are not morals, but can be influenced by personal morals

65. Ethical Decisions
Not clear-cut, either/or, correct or incorrect (binary) decisions
Require a balance between a professional code of ethics and personal morals
Are not emotional reactions, but courses of conduct that have been weighed and measured carefully

66. Pharmacy Technician Code of Ethics, Part 1
Health and safety
Ensure the health and safety of the patient
Never assist in dispensing or distributing medications or devices that are not of good quality or do not meet the standards required by law

67. Pharmacy Technician Code of Ethics, Part 1 (cont.)
Respect and integrity
Support and promote honesty and integrity in the profession
Respect and value the abilities of other healthcare professionals
Respect and support the patient’s individuality, dignity, and confidentiality
Respect the confidentiality of the patient’s records

68. Pharmacy Technician Code of Ethics, Part 2
Professional development
Use knowledge and skills to serve others
Maintain competency and continually enhance professional expertise
Do not engage in any activity that will discredit the profession
Associate with organizations that promote the profession of pharmacy

69. Reasonable Standards of Care
Always maintain reasonable standards of patient care regarding medication management duties.

70. Ensuring Clarity of Orders
Ensure that orders and prescriptions clearly include in writing the drug’s:
Name
Dosage
Route
Frequency of administration
Ensure that prescriber signed the order

71. Ensuring Specificity of Orders
An order or prescription must clearly state the specific circumstances and conditions under which the drug must be given.
Do not accept nonspecific orders, such as “if needed,” “if indicated,” or “as warranted.”

72. Label vs. Labeling The Label of a Drug
A display of written, printed, or graphic matter upon the immediate container; the information on the outer portion of the package
The Labeling of a Drug
All labels and other written, printed, or graphic matter either upon or accompanying the drug
Broader in scope – includes the package insert

73. Labeling Requirements – Dispensed Prescriptions
Pharmacy name and address
Serial (Rx) number
Date of fill
Expiration date
Prescriber’s name
Patient’s name
Directions for use
Cautionary statements (if needed)

74. A Sample Prescription Label

75. Label Requirements – Legend Drugs
Established name and quantity of each active ingredient
Statement of new quantity
Statement of usual dosage
Federal legend
Route of administration
In the case of habit-forming drugs – the federal warning
Name of all inactive ingredients (if not oral)
Unique lot/control number
Statement specifying the type of container to be used in dispensing
Name/address of manufacturer/distributor
Expiration date, if applicable

76. Labeling Requirements – Legend Drugs
Description (chemical structure)
Clinical pharmacology
Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Drug abuse and dependence
Dosage
Statement as to how supplied
Date of the most recent revision to the labeling
(in addition to the label requirements)

77. Monographs Commonly known as package inserts
A necessary component of drug labeling
Provides all the clinical information required by the FDA

78. Figure 4.4
Sample package insert, or monograph, for Keppra® injection. (Courtesy of UCB, Inc.)

79. Figure 4.4 (continued)
Sample package insert, or monograph, for Keppra® injection. (Courtesy of UCB, Inc.)

80. Figure 4.4 (continued)
Sample package insert, or monograph, for Keppra® injection. (Courtesy of UCB, Inc.)

81. Figure 4.4 (continued)
Sample package insert, or monograph, for Keppra® injection. (Courtesy of UCB, Inc.)

82. Labeling Requirements – OTC Drugs
Product name
Name/address of manufacturer/distributor
Established name of all active ingredients and the quantity of certain ingredients
Net contents
Required warnings/cautions
The name of any habit-forming drug contained in the formula
Adequate directions for use

83. A Sample OTC Label (courtesy of Walgreen Co.)