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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. 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.

4. 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

5. 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

6. 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.

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

8. 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.

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

10. 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

11. 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

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

13. 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

14. Table Drug Schedules

15. Table 2-1 (continued) Drug Schedules

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

17. 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.”

18. 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

19. Orphan Drug Act of 1983
Orphan drugs: used to treat diseases that affect fewer than 200,000 people
Orphan Drug Act: offers financial incentives to nonprofit and commercial organizations to develop and market new orphan drugs in the United States
Provides a 7-year monopoly on orphan drug sales and tax breaks to new drug developers

20. 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

21. 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

22. Safe Medical Devices Act (1990)
Requires reporting of serious injury, illness, or death caused by medical devices, including:
In vitro equipment
Disposables
Parts, components, accessories, related software

23. 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).

24. 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.

25. 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

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

27. 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

28. 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.

29. 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

30. 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.

31. 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.

32. 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.

33. 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.

34. 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

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

36. 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.

37. 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

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

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