Pharmacy Law and Ethics for Technicians

1. Chapter 3 Pharmacy Law and Ethics for Technicians

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 (continues)

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 (continues)

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 (continues)

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