Chapter 3 Pharmacy Law and Ethics for Technicians

Chapter 3 Pharmacy Law and Ethics for Technicians Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

Code of Ethics in Pharmacy • The five principles of the pharmacy code of ethics are: – – – Beneficence Fidelity Veracity Justice Autonomy Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

Types of Law • Types of law include: – – – – – Constitutional Statutory Administrative Common International Criminal Civil (case) Tort Contract Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

The Durham – Humphrey Amendment of 1951 • During the 1940 s, 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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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, III, IV, V) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

Drug Schedules and Examples • Schedule IV – barbital, chloral hydrate, diazepam • Schedule V – cough syrups with codeine, diphenoxylate HCl with atropine sulfate Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 (continues) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 (continues) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 (continues) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

The Drug Addiction Treatment Act of 2000 • This act allows physicians to prescribe DEAapproved 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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

Accutane i. Pledge 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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 (continues) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 • Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 (continues) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

Drug Enforcement Administration • It interfaces with worldwide governments to assist in drug trafficking prosecutions Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 (continues) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 (continues) Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.

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 Copyright © 2016 Cengage Learning. ALL RIGHTS RESERVED.