1. Pharmacy Law and Ethics for Technicians
Chapter 3
Pharmacy Law and Ethics for Technicians
Please update all information to be labeled “Third Edition”

2. Law and Ethics in Pharmacy
Laws, standards, and ethics can exercise controls on pharmacy and drugs
A law is a rule or regulation established by a governing body
Ethics is the study of values or principles governing personal relationships
Standards are guidelines for practice established by professional organizations
Medical ethics is the discipline of evaluating merits, risks, and social concerns about medical activities

3. Code of Ethics in Pharmacy
The five principles of the pharmacy code of ethics are:
Beneficence
Fidelity
Veracity
Justice
Autonomy

4. Legal Language
Defendant – the person or group against whom charges are brought in a court action
Deposition – an oral testimony taken by a court reporter at a location outside the courtroom
Jurisdiction – the power, right, and authority given to a court to hear a case and make a judgment (continues)

5. Legal Language
Plaintiff – the person who files a lawsuit initiating a civil legal action
Statute of limitations – the law that limits the period during which a person can sue
Subpoena – a court order that requires an individual to appear as a witness in court or to make himself or herself available to be deposed

6. Governing Bodies
Laws are created and upheld by federal, state, and local government
In the United States, the federal government is divided into three branches:
Legislative
Executive
Judicial

7. Types of Law Types of law include: Constitutional Statutory
Administrative
Common
International
Criminal
Civil (case)
Tort
Contract

8. Criminal Law
Governs the relationship of the individual to society as a whole
Violations against the government or the state are governed by criminal law
These offenses include misdemeanors, felonies, and treason
When a person is accused of a criminal violation, he or she has the right to due process, meaning the accused will be allowed the opportunity to defend him- or herself against all charges

9. Misdemeanors
Misdemeanors are usually punishable by fines and/or imprisonment up to one year, usually in a city or county jail
Lesser misdemeanors are called infractions
Each state lists its own unique classes and subclasses of misdemeanors

10. Felonies
Felonies are serious crimes punishable by larger fines and/or imprisonment for more than one year in a state penitentiary
Felonies include murder and rape
Convicted felons commonly lose many of the rights they had as private citizens

11. Treason
Treason is considered the most serious type of crime as it consists of attempts to overthrow the government of the country
Treasonous acts differ from acts against the United States (such as the 9/11 attacks) that may deemed to be acts of war

12. Civil Law Governs the relationship between individuals within society
Focuses on noncriminal acts involving private individuals against other individuals, government agencies, or organizations
Civil law is commonly referred to as case law
Civil law cases are decided by judges or juries and include tort and contract law

13. Tort Law
Tort law allows for a person who has suffered harm from the wrongful acts of another to seek a remedy (which is usually monetary)
A tort is a private wrong against another person or their property
Medical malpractice is regulated under tort law

14. Types of Torts
Intentional torts are committed when a person’s rights are infringed upon intentionally
Unintentional torts are those committed inadvertently against another person
Examples of unintentional torts include negligence and malpractice

15. Contract Law
Contract law involves agreements that create obligations between several parties
Written and oral contracts both provide for legal recourse
Contract law is directly affected by the Uniform Commercial Code

16. Administrative Law
Administrative law consists of rules and regulations established by agencies of the federal government
This type of law is also called regulatory law
Laws enacted by the legislature are referred to as statutory law

17. Violations of the Law A violation of the law is a crime
The individual in violation of the law is called a criminal
An individual who helps someone commit a crime is called an accessory

18. Violations of Pharmacy Laws
Fraud – dishonest and deceitful practices
Libel – defamatory writing
Slander – defamatory speech
Negligence – failure to use reasonable care
Abuse – improper use of equipment, a substance, or a service

19. Pharmacy Law and Regulation at the State Level
Regulation of pharmacy practice is primarily a function of the state and not of the federal government
State pharmacy law requires minimal qualifications for a class of individuals who are involved with pharmacy practice
In most states, certificates of registration to practice are granted for 1-2 years

20. Pharmacy Law and Regulation at the Federal Level
Pharmacy practice is regulated by a series of rules, regulations, and laws that are enforced by local, state, and federal governments
The first important law to regulate the development, compounding, distribution, storage, and dispensing of drugs was passed by Congress in 1906

21. The Pure Food and Drug Act of 1906
The Pure Food and Drug Act of 1906 prohibited interstate distribution or sale of adulterated and misbranded food and drugs
The act did not include cosmetics or provide authority to ban unsafe drugs, stop manufacturers from making false statements, or require that labels identify contents
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22. The Pure Food and Drug Act of 1906
In 1912, Congress addressed the false statement problem and included within the definition of misbranding false or fraudulent claims for the curative powers of drugs
Today, package inserts (monographs) must be supplied along with medications to ensure their safe and effective use

23. The Harrison Narcotics Act of 1914
This act was a response to recreational use of opium
It stated that opium could no longer be purchased without a prescription
The act also required registration of practitioners, documentation, and more restricted importation, sale, and distribution of opium

24. The Food, Drug, and Cosmetic Act of 1938
This act created the Food and Drug Administration (FDA) and required pharmaceutical manufacturers to file New Drug Applications with the FDA
The act required manufacturers to be concerned with the purity, strength, effectiveness, safety, and packaging of drugs

25. The Durham – Humphrey Amendment of 1951
During the 1940s, the FDA began to use internal regulations to create classifications of prescription (legend) drugs and nonprescription (over-the-counter or OTC) drugs
This amendment prohibited dispensing of legend drugs without a prescription

26. The Kefauver – Harris Amendments of 1962
This act required that drug products, both prescription and OTC, must be effective and safe
It placed prescription drug advertising under supervision of the FDA, regulated qualifications of drug investigators, regulated manufacturers and their sites of operation, and required more accountability from manufacturers

27. The Comprehensive Drug Abuse Prevention and Control Act of 1970
This act, also called the Controlled Substances Act (CSA), directs the manufacture, distribution, and dispensing of controlled substances that have the potential for addiction and abuse
The act replaced most previous narcotic and drug abuse control laws
Drugs with potential for abuse were classified into 5 schedules (I, II, III, IV, V)

28. Schedule I Schedule I agents have a high potential for abuse
Schedule I drugs are not accepted for medical use in the United States
Properly registered people may use Schedule I substances for research purposes

29. Schedule II Schedule II agents also have a high potential for abuse
Schedule II substances are currently accepted for medical use in the United States
Abuse may result in severe psychological or physical dependence
Prescriptions for Schedule II drugs must be written, not faxed or called in, except under certain specific guidelines

30. Schedule III
Schedule III agents have accepted medical uses in the United States
They have a lower potential for abuse than Schedule I and Schedule II drugs
Schedule III drugs contain limited quantities of certain narcotic and non-narcotic drugs

31. Schedule IV
Schedule IV agents have a low potential for abuse relative to those in Schedule III
Schedule IV drugs are generally:
long-acting barbiturates
certain hypnotics
minor tranquilizers

32. Schedule V
Schedule V agents have the lowest abuse potential of the controlled substances
They consist of preparations containing limited quantities of certain narcotic drugs
They are generally used for antitussive and antidiarrheal purposes
They usually, though not always, require a prescription

33. Drug Schedules and Examples
Schedule I – heroin, LSD, marijuana
Schedule II – cocaine, codeine, methamphetamine
Schedule III – certain drugs compounded with small quantities of narcotics and certain barbiturates
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34. Drug Schedules and Examples
Schedule IV – barbital, chloral hydrate, diazepam
Schedule V – cough syrups with codeine, diphenoxylate HCl with atropine sulfate

35. Registration
Individuals who manufacture, dispense, or distribute any controlled substance are obligated to register with the DEA unless they are exempt
Registrations vary in length from 1 to 3 years
The DEA can suspend or revoke a registration if the registrant has falsified the application or has been convicted of a felony under the federal Controlled Substances Act

36. Ordering Controlled Substances
DEA Form 222 is used to order controlled substances from Schedules I or II
Anyone attempting to order controlled substances must have a DEA license
DEA Form 222 is not required when ordering Schedule III, IV, or V substances, which can be ordered directly from manufacturers or drug wholesalers

37. Theft of Controlled Substances
If a controlled substance is stolen or lost from a pharmacy, the nearest DEA office must be notified, using DEA Form 106
A complete report must be made, and the pharmacy should keep the original copy, send two copies to the DEA, and in most states, send one copy to the board of pharmacy
Sometimes, one copy is required to be sent to the local police

38. Dealing with Outdated or Damaged Controlled Substances
When controlled substances become out of date, DEA Form 41 must be used
The pharmacist must write a cover letter:
Explaining the situation
Requesting DEA permission to destroy the substances
Two witnesses must observe the destruction of the substances

39. Returning Controlled Substances
When controlled substances from Schedule II are returned, DEA Form 222 must be used
These substances may only be returned from one DEA registrant to another
Any facility that does not have a DEA number cannot return controlled substances

40. Record Keeping
Any pharmacy that handles controlled substances must keep complete and accurate records of all drugs received and dispensed
The records must be kept for 2-5 years
Schedule II drug records must be kept separately from all other records

41. Inventory
The CSA requires each registrant to make a complete and accurate record of all stocks of controlled substances on hand every two years
When the inventory of Schedule II controlled substances is done, an exact count or measure must be made

42. Prescriptions
A prescription for a controlled substance must be issued by a practitioner for a valid medical purpose
No prescription for a Schedule II controlled substance may be refilled
Prescriptions for Schedule III, IV, and V controlled substances may be refilled if authorization is given by a practitioner

43. Prescriptions
Most states prohibit pharmacy technicians from taking phone orders for prescription (legend) drugs
All states require pharmacists to authorized phoned-in prescriptions for controlled substances per DEA regulations

44. The Poison Prevention Packaging Act of 1970
This act authorizes the Consumer Product Safety Commission to create standards for child-resistant packaging
It requires that most OTC and legend drugs be packaged in child-resistant containers
These containers cannot be opened by 80% of children younger than age 5, but can be opened by 90% of adults

45. The Occupational Safety and Health Act of 1970
OSHA is administered by the Occupational Safety and Health Administration to ensure safety and a healthy environment within the workplace
OSHA’s Bloodborne Pathogens Standard requires rigid workplace compliance to avoid exposure to body fluids and substances that may carry diseases such as HIV-AIDS and hepatitis B

46. The Occupational Safety and Health Act of 1970
In 1986, OSHA began requiring a material safety data sheet (MSDS) for every potentially dangerous chemical used in the workplace
Each MSDS contains:
Storage requirements
Handling procedures
Steps to take if the chemical contacts the eyes or skin

47. The Drug Listing Act of 1972
Under this act, each new drug is assigned a unique and permanent product code, known as a National Drug Code (NDC)
Using this code, the FDA is able to maintain a database of drugs by use, manufacturer, and active ingredients
The NDC for one product may not be used for another if any changes occur in product characteristics

48. The Medical Device Amendments of 1976
These amendments required manufacturers to register and list their products, follow good manufacturing practices, and report device failures
Devices have to be reviewed by a panel of
scientists to ensure accuracy and preciseness before they can be marketed
Class I devices have lowest potential for harm
Class II devices have established standards
Class III devices include life support systems

49. The Orphan Drug Act of 1983
The Orphan Drug Act offers federal financial incentives to commercial and nonprofit organizations to develop and market drugs previously unavailable in the United States
Drugs that affect fewer than 200,000 persons in the United States are referred to as orphan drugs
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50. The Orphan Drug Act of 1983
This act offers tax breaks and a 7-year monopoly on drug sales to induce companies to undertake the development and manufacture of certain drugs

51. The Drug Price Competition and Patent-Term Restoration Act of 1984
This act was designed to lower drug prices by providing a mechanism to increase competition in the drug industry
It provides abbreviated New Drug Applications and an accelerated procedure for approval of generic versions of approved drugs whose safeguard protection is about to expire

52. The Prescription Drug Marketing Act of 1987
This act deals with safety and competition issues raised by secondary markets for drugs, and prohibits reimportation of a drug into the United States by anyone but the manufacturer
The act also prohibits sale or trading of drug samples, distribution of samples to those not licensed to prescribe them, and distribution of samples except by mail or a common carrier

53. The Anabolic Steroids Control Act of 1990
This act placed anabolic steroids under the regulatory provisions of the CSA
Anabolic steroids are hormonal substances that promote muscle growth and are used by athletes, sometimes illegally, to increase physical performance

54. The Omnibus Budget Reconciliation Act of 1990
OBRA ’90 requires pharmacists to offer to discuss information about new and refill prescriptions with Medicaid patients
Pharmacists usually now counsel all patients
With few exceptions, only costs for drugs that are approved as “safe and effective” will be reimbursed
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55. The Omnibus Budget Reconciliation Act of 1990
Drug utilization evaluation (DUE) must be conducted to ensure that all prescribed medications are reviewed for appropriateness
States must require pharmacists who provide services under the program to give consulting
services

56. The Dietary Supplement Health and Education Act of 1994
This act clarified the regulatory framework applicable to nutritional supplements and created specific labeling requirements
Supplements whose safeness is questioned have to be proved harmful by the FDA
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57. The Dietary Supplement Health and Education Act of 1994
This act covers:
Vitamins
Minerals
Herbs
Botanicals
Amino acids
Other dietary supplements
Concentrates
Metabolites
Constituents
Extracts
Any combination of the above

58. The Health Insurance Portability and Accountability Act of 1996
HIPAA is composed of four parts:
Electronic Health Transaction Standards – health organizations were required to adopt standard code sets to be used in all health transactions
Unique Identifiers – specific, standardized identifiers used between organizations
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59. The Health Insurance Portability and Accountability Act of 1996
HIPAA is composed of four parts:
Security and Electronic Signature Standards – mandated safeguards for physical storage and maintenance, transmission, and access to individual health information
Privacy and Confidentiality Standards – limited nonconsensual use and release of protected health information

60. The Drug Addiction Treatment Act of 2000
This act allows physicians to prescribe DEA-approved controlled substances from Schedules III, IV, or V to people who are addicted to opioids, as part of maintenance or detoxification treatments
Patients must be in a treatment program that includes additional support services, and attending physicians must be specially trained and DEA registered/certified

61. Medicare Act of 2003
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003
This act was designed to provide senior citizens and disabled individuals with a prescription drug benefit, additional choices, and more Medicare benefits
It established Medicare Part D, which is a voluntary prescription drug benefit program
It also offered tax breaks for prescription drugs and partially privatized Medicare

62. The Combat Methamphetamine Epidemic Act of 2005
This act was designed to stop illegal use of drugs such as methamphetamine, crack cocaine, and others
It is an extension of the Patriot Act
It regulates drug trafficking that is used to financially support terrorism

63. Accutane iPledge Program of 2006
This program was designed to mandate distribution in the United States for the drug known as isotretinoin (Accutane)
It was intended to prevent the drug’s use during pregnancy or potential pregnancy due to the high risk of birth defects
A specific Web site must be used by doctors and pharmacists to order and receive this medication

64. Ryan Haight Online Pharmacy Consumer Protection Act of 2008
Amended the CSA to prohibit the delivery, distribution, or dispensing of a controlled substance that is a prescription drug over the Internet without a valid prescription
It exempted telemedicine practitioners
It imposed registration and reporting requirements and increased criminal penalties

65. Patient Protection and Affordable Care Act of 2010
Overhauled the U.S. healthcare system more than any act since Medicare / Medicaid
Its goals were to increase health care quality and affordability, lower the uninsured rate, and reduce costs
It also required insurers to cover all applicants within new minimum standards

66. Synthetic Drug Abuse Prevention Act of 2012
Banned synthetic compounds in synthetic marijuana products as well as synthetic stimulants
Placed them under Schedule I of the CSA
Was part of the FDA Administration Safety and Innovation Act of 2012, which gave the FDA authority to collect user fees to fund new drug, device, and biologics reviews

67. Drug Quality and Security Act of 2013
Created FDA oversight for large-volume compounding operations
Allowed pharmacists to provide traditional compounding services to individual patients
Created track-and-trace requirements for drug products as they move through the nation’s supply chain

68. Federal Regulatory Agencies
The FDA oversees:
All domestic and imported food
Bottled water
Wine beverages with less than 7% alcohol
Cosmetics
Medicines
Medical devices
Radiation-emitting products
Feed and drugs used for farm animals
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69. Federal Regulatory Agencies
The Centers for Disease Control and Prevention (CDC) oversees all foods and food-borne diseases
The Drug Enforcement Administration (DEA) oversees controlled substances, including their investigation and prosecution

70. Food and Drug Administration
The FDA controls all drugs for legal use
The FDA is part of the U.S. Department of Health and Human Services
All laws pertaining to drug administration are initiated, implemented, and enforced by the FDA

71. Centers for Disease Control and Prevention
The CDC provides facilities and services for the investigation, identification, prevention, and control of disease
It provides statistics and information to health professions about the treatment of diseases worldwide
Its primary function is to issue regulations for infection control

72. Drug Enforcement Administration
The DEA’s mission is to enforce controlled substances laws and regulations, and to prosecute individuals and organizations who grow, manufacture, or distribute illegal substances
It also targets people who use violence to coerce others to help them in their illegal activities
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73. Drug Enforcement Administration
It interfaces with worldwide governments to assist in drug trafficking prosecutions

74. Drug Recalls
The FDA determines the health hazard potential of a product and assigns drug recall classifications:
Class I – can cause severe adverse reactions or death
Class II – may cause temporary or medically reversible adverse health hazards
Class III – is not likely to cause adverse health hazards

75. Drug Standards
Drug standards are the set of requirements for the formulation of drug substances, ingredients, and dosage forms
Drugs stocked in the pharmacy must be compendia (listed) drugs
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76. Drug Standards
A drug formulary (list of drugs) stocked by the pharmacy must be maintained
Drug standards are contained in the United States Pharmacopeia (USP) and the National Formulary (NF)

77. The Ethical Foundation of Pharmacy
Ethics concerns the thoughts, judgments, and actions about issues that have implications of moral right and wrong
Providing information about the risks and side effects of drug regimens is an ethical responsibility of physicians, pharmacists, and nurses
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78. The Ethical Foundation of Pharmacy
Bioethics is a discipline dealing with the ethical and moral implications of biological research and applications, especially as they relate to life and death