Paradigm Publishing Inc 2 Pharmacy Law Regulations and

© Paradigm Publishing, Inc.

2 Pharmacy Law, Regulations, and Standards © Paradigm Publishing, Inc.

Chapter Topics • The need for drug control • History of U. S. statutory pharmacy law • Regulatory law–the role of national oversight agencies • Legal duties of pharmacy personnel • Violation of laws and regulations • Drugs and professional standards © Paradigm Publishing, Inc.

Learning Objectives • Differentiate between laws, regulations, professional standards, and ethics. • Describe how statutory law has impacted the pharmacy profession in the twentieth century. • Discuss the impact of the Patient Protection and Affordable Care Act of 2010 on health care and pharmacy practice. • Discuss the roles of government regulatory agencies and the state boards of pharmacy. • Differentiate between licensure, registration, and certification for pharmacy technicians. • List the duties that may legally be performed by pharmacy technicians. • Define standard of care and its legal impact on the responsibilities of the pharmacy technician. • Explain the potential for tort actions against a pharmacy technician. • Discuss the importance of drug and professional standards. © Paradigm Publishing, Inc.

The Need for Laws and Standards • Laws allow pharmaceutical manufacturers to bring safe products to market. • Laws allow pharmacy personnel to provide safe and effective patient care. • Standards guide pharmacy personnel in their practice. • Pharmacy personnel must have a thorough understanding of laws and standards to ensure that medications are dispensed safely. © Paradigm Publishing, Inc.

Definitions • Law: a rule that is passed by the government. The law offers a minimum level of acceptable standards. • Regulation: a rule and procedure that exists to carry out a law. For example, the DEA regulates all aspects of controlled substances. © Paradigm Publishing, Inc.

Definitions (continued) • Standards – Sets of criteria are used to measure product quality or professional performance against a norm. For example, the Joint Commission specifies standards of care in healthcare facilities. • Ethics – Pharmacy personnel must follow standards of personal conduct and behavior adopted by their profession. © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law • Medicines in United States were unregulated during the 19 th century. • Medicines did not have to be proven safe or effective. • Some products contained opium extracts or high alcohol content. • Concerns about purity undermined confidence in medicinal treatments. • Death and injury sometimes occurred. • Statutory laws were established to protect the public. © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law (continued) • Pure Food and Drug Act of 1906 – This act prohibited the interstate transportation or sale of adulterated and misbranded food and drugs. – It required that labels not contain false information about the drugs’ strength and purity. – Coca-Cola changed its product’s active ingredient from cocaine to caffeine. – The act ultimately proved unenforceable. © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law (continued) • Federal Food, Drug, and Cosmetic (FD&C) Act of 1938 – The act formed after 100 people died from sulfa products containing a chemical found in antifreeze. – The FD&C created the Food and Drug Administration (FDA). – The law required manufacturers to file a new drug application (NDA) for FDA approval. – It required that drugs be proven to be safe but not necessarily effective. © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law (continued) • Federal Food, Drug, and Cosmetic (FD&C) Act of 1938 (continued) – Adulterated product • Product that is inconsistent in strength, quality, and purity • A drug contaminated with other drugs or chemicals that may or may not be harmful (A recent incident of adulteration was linked to a fungal meningitis outbreak. ) – Misbranded product • A product whose label contains false or inaccurate statements about its identity or ingredients © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law (continued) • Durham-Humphrey Amendment of 1951 – Prescription containers to be labeled “Caution: Federal Law Prohibits Dispensing without a Prescription” – Established the distinction between legend (prescription) drugs and patent (OTC) drugs • Kefauver-Harris Amendment of 1962 – Required that drugs be proven both safe and effective – Was passed in response to thalidomide’s association with birth defects © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law (continued) • Comprehensive Drug Abuse Prevention and Control Act of 1970 – Controlled drugs ranked into five schedules • Poison Prevention Packaging Act of 1970 – OTC and prescription drugs required to be packaged in a child-resistant container © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law (continued) • Drug Listing Act of 1972 – Each form of a drug assigned an NDC number • Orphan Drug Act of 1983 – Provided incentives for development of orphan drugs (drugs used in rare disorders) © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law (continued) • Drug Price Competition and Patent-Term Restoration Act of 1984 – The development of generic drugs was encouraged to reduce healthcare costs. • Prescription Drug Marketing Act of 1987 – All drug wholesalers must be licensed by states. – Only prescribers can obtain medication samples. – Drugs may not be reimported into the United States by anyone other than the manufacturer. © Paradigm Publishing, Inc.

In the Know: Short Answer • Which agency was created as a result of the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938? Food and Drug Administration (FDA) • Which act established the distinction between prescription and OTC drugs? Durham-Humphrey Amendment of 1951 • The Drug Price Competition and Patent-Term Restoration Act of 1984 encouraged the development of _____ drugs to decrease costs. generic © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law (continued) • Anabolic Steroid Act of 1990 – Designated anabolic steroids as a Schedule III class • Omnibus Budget Reconciliation Act of 1990 (OBRA 90) – Requires through State Medicaid programs that pharmacists review patient profiles and offer counseling – Medicaid reimbursement provided only to pharmacies offering counseling © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law (continued) the FDA does not regulate dietary supplements • Dietary Supplement Health and Education Act (DSHEA) of 1994 – Manufacturers of dietary supplements are not required by the FDA to prove efficacy or standardization. – Only had to prove safety of the supplement and make truthful claims © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law (continued) • Health Insurance Portability and Accountability Act (HIPPA) of 1996 – Patients can move health insurance from one employer to another without denial for pre-existing conditions. – Patient records are strictly confidential. • Medicare Modernization Act (MMA) of 2003 – It’s also known as Medicare Part D. – Prescription drug coverage is provided to patients who are eligible for Medicare on a voluntary basis. • Food and Drug Administration Modernization Act of 2004 – Prescription container labels were changed to include “Rx only. ” © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law (continued) • Combat Methamphetamine Epidemic Act of 2005 – Restricts the sale of pseudoephedrine (PSE), an OTC medication used to make methamphetamine • Patient Protection and Affordable Care Act (ACA) of 2010 – Mandated universal healthcare coverage for all U. S. citizens by 2014 © Paradigm Publishing, Inc.

History of U. S. Statutory Pharmacy Law (continued) • Patient Protection and Affordable Care Act (ACA) of 2010 (continued) – Impact on the healthcare system • The revenue needed for the program is to come from lower reimbursements to healthcare providers and hospitals. • Overpayments and subsidies to existing insurance programs are decreased. • Fraud and waste are targeted. © Paradigm Publishing, Inc. Laws and regulations vary from state to state

Regulatory Law: National Oversight Agencies • Food and Drug Administration (FDA) – Watchdog agency for public safety – Responsible for ensuring the safety and efficacy of food and drugs prepared for the market – No legal authority over pharmacy practice in each state © Paradigm Publishing, Inc. The FDA regulates labeling so it is understandable to a layperson

Regulatory Law: National Oversight Agencies (continued) • Food and Drug Administration (continued) – Requires manufacturers to file new drug applications – Provides guidelines for packaging, labeling, and advertising – Oversees product recalls – Publishes the FDA Orange Book © Paradigm Publishing, Inc.

Regulatory Law: National Oversight Agencies (continued) • Drug Enforcement Administration (DEA) – Enforces laws regarding legal and illegal addictive substances – Maintains an audit trail of controlled substances from manufacturer to warehouse to pharmacy to patient – Requires registration for all individuals, institutions, and businesses involved in controlled substances © Paradigm Publishing, Inc.

Regulatory Law: National Oversight Agencies (continued) • Drug Enforcement Administration (continued) – Determines and monitors which practitioners may prescribe controlled drugs – Limits prescriptions to legitimate medical purposes in the course of pharmacy practice – Requires written prescriptions for controlled substances unless in an emergency situation © Paradigm Publishing, Inc. When a conflict occurs between a state and a federal law or regulation, the more stringent law or regulations always applies.

Regulatory Law: National Oversight Agencies (continued) • Occupational Safety and Health Administration (OSHA) – Ensures the safety and health of U. S. workers – Regulates healthcare environments • Protects workers against inadvertent needle sticks • Ensures safe disposal of syringes • Protects employees from unnecessary drug exposure © Paradigm Publishing, Inc.

Regulatory Law: National Oversight Agencies (continued) • National Association of Boards of Pharmacy (NABP) – Develops the national pharmacist license examination – Coordinates reciprocation of pharmacists practicing in other states – Verifies the licensure of online pharmacies for the state boards of pharmacy – Provides a model of pharmacy practice standards for the state boards – Has no regulatory authority like that of the FDA or DEA © Paradigm Publishing, Inc.

In the Know: True or False • The FDA has legal authority over the practice of pharmacy in each state. false • The FDA regulates labeling so it is understandable to a layperson. true • The DEA develops the national pharmacist license examination. false • The DEA maintains an audit trail of controlled substances. true © Paradigm Publishing, Inc.

Regulatory Law: State Level • State Boards of Pharmacy – Review applications for licensure and registration – Administer NABP exams and the state law exam – License applicants – Inspect all new pharmacies – Regulate the practice of pharmacy personnel – Regulate controlled and nonscheduled substances © Paradigm Publishing, Inc.

Regulatory Law: State Level (continued) • State Boards of Pharmacy – Licensure • The process by which a state board grants permission to an individual to engage in a given occupation • Reviews documentation showing that the applicant has attained the minimum degree of necessary competency – Registration • The process of being enrolled on a list created by the state board of pharmacy © Paradigm Publishing, Inc. The processes of licensure and registration are both in place to safeguard the public.

Legal Duties of Pharmacy Technicians • Not defined by federal statute • No uniform definition • Changes as the role of pharmacists change © Paradigm Publishing, Inc.

Legal Duties of Pharmacy Technicians (continued) • In most states, under the direct supervision of a pharmacist: – Dispensing of medication – Keeping pharmacy medication records – Pricing and billing of medications – Preparing doses of premanufactured products © Paradigm Publishing, Inc. 32

In the Know: Explain the Difference • What is the difference between being licensed vs. being registered by the state board? Licensure shows that the applicant has attained a minimum level of competency, whereas registration means the person is enrolled on a list. © Paradigm Publishing, Inc.

Legal Duties of Pharmacy Technicians (continued) • In most states, under the direct supervision of a pharmacist: – Compounding sterile and nonsterile medications – Performing customer service during prescription dropoff and pickup – Transporting medications to patient care units in the hospital – Checking and replenishing drug inventory © Paradigm Publishing, Inc. 34

Legal Duties of Pharmacy Technicians (continued) • Differences in regulations among states – Some states specify the scope of practice of pharmacy technicians, others define it by what the pharmacist must do. – Many states specify a ratio of technicians to pharmacists. – Some states allow any pharmacy technicians to compound IV solutions, others only allow certified pharmacy technicians to do this. Still, others only allow pharmacists to compound IV solutions. © Paradigm Publishing, Inc. 35

Violation of Laws and Regulations • Civil laws – Areas of the law that concern the wrongdoings that citizens commit against one another – Tort • Refers to personal injuries • Injured party is plaintiff • Whomever caused injury is defendant • Examples: negligence, malpractice, broken contracts © Paradigm Publishing, Inc.

Violation of Laws and Regulations (continued) • Standard of care – The level of care expected to be provided by various healthcare providers in the local community – Two criteria to consider when judging care provided to a patient: • Level of training • Geographic area © Paradigm Publishing, Inc.

Violation of Laws and Regulations (continued) • How standard of care applies to pharmacy technicians: – Behavior of a pharmacy technician would be compared to that of a pharmacy technician in same geographic area – A certified technician held to a higher standard than one who is not certified © Paradigm Publishing, Inc.

Violation of Laws and Regulations (continued) • Negligence – Failure to provide the minimum standard of care • Malpractice – Failure to meet an ordinary standard of care resulting in injury, loss, or damage © Paradigm Publishing, Inc.

Violation of Laws and Regulations (continued) • In a negligence or malpractice lawsuit, watch for the four Ds: – – Duty to provide care was established between the parties. Dereliction: defendant was derelict in his or her duty. Damages were done to the plaintiff. Direct cause is established linking the defendant’s dereliction to the damages done. • If the defendant is found guilty, he or she may be ordered to pay an award of money to the plaintiff. © Paradigm Publishing, Inc.

Violation of Laws and Regulations (continued) • Law of agency and contracts – Applies to the employee–employer relationship – Employee is an “agent” of employer, may enter into contracts on employer’s behalf – A pharmacy technician may act as an agent for a pharmacist or pharmacy © Paradigm Publishing, Inc.

Violation of Laws and Regulations (continued) • How the law of agency and contracts applies to pharmacy technicians: – A technician agrees to fill a patient’s prescription. – The pharmacist and technician are obligated to provide a service. – If a mistake is made, the pharmacy and/or pharmacist are liable. – The pharmacist must answer for all of the acts of his employees. – Technician can be liable if dispensed the prescription without being checked by the pharmacist. © Paradigm Publishing, Inc.

In the Know: True or False • If a mistake is made in filling a prescription, the pharmacy and/or pharmacist is liable. true • A pharmacy technician can be liable if a prescription is dispensed without being checked by the pharmacist. true © Paradigm Publishing, Inc.

Violation of Laws and Regulations (continued) • Law of agency and contracts – Invasion of privacy may result in a lawsuit. • Intellectual property contained in the medical record is the property of the patient. • Protected information may not be shared without consent of the patient. • The pharmacy is held responsible for the actions of its personnel if a violation occurs. – Heavy personal fines – Immediate termination of employment © Paradigm Publishing, Inc.

Drug and Professional Standards • United States Pharmacopeia (USP) – Sets standards for prescription drugs, OTC drugs, and dietary supplements • Book of standards is called the United States Pharmacopeia-National Formulary (USP-NF) • All new drugs approved by the FDA must meet applicable USP-NF standards © Paradigm Publishing, Inc.

Drug and Professional Standards (continued) • United States Pharmacopeia (USP) – Sets standards regarding the practice of pharmacy by pharmacists and pharmacy technicians • USP-NF General Chapter <795> addresses nonsterile compounding standards. • USP-NF General Chapter <797> addresses sterile compounding standards. • USP standards are adopted by state boards of pharmacy and the Joint Commission. © Paradigm Publishing, Inc.

Drug and Professional Standards (continued) • National Professional Organizations – Organizations advocate high standards of practice in order to advance the pharmacy profession. – Mission statements provide a standard of care that is above and beyond the minimum of what is required by federal and state pharmacy laws and regulations. – Several organizations have jointly developed a curriculum for pharmacy technicians. © Paradigm Publishing, Inc.

Drug and Professional Standards (continued) • Certification – Voluntary process by which a nongovernmental organization recognizes an individual who has met predetermined qualifications set by that organization – Pharmacy Technician Certification Board (PTCB) • Mission is to develop, maintain, promote, and administer a high-quality certification and recertification program for pharmacy technicians • Certified pharmacy technicians earn higher salaries, work more effectively with pharmacists © Paradigm Publishing, Inc.

Chapter Summary • Government and professional organizations exercise control over drugs to ensure quality and prevent harm. • Controls over the use of drugs are embodied in laws, regulations, and drug standards. • Statutory laws have improved public safety by ensuring the safety and efficacy of drugs. • The DEA provides regulatory oversight of controlled substances. • The Medicare Modernization Act of 2003 provides voluntary drug insurance for Medicare beneficiaries. • The Affordable Care Act of 2010 mandates healthcare coverage for all citizens of the United States. • The FDA regulates and enforces investigational and new drug applications to further protect the public. © Paradigm Publishing, Inc.

Chapter Summary (continued) • OSHA regulations protect workers when handling hazardous substances. • State boards license pharmacies, pharmacists, and pharmacy technicians. • The legal status of pharmacy technicians varies from state to state, but they must always act under the direct supervision of licensed pharmacists. • Pharmacy has the potential for tort actions because of negligence. • Violations of patient confidentiality can result in legal issues and termination of employment. • Standards for drugs are set by the United States Pharmacopeia (USP). • Standards for the practice of pharmacy are set by state board of pharmacy and various professional organizations. • National pharmacy organizations support the advanced training and skills necessary for pharmacy technicians to become certified. © Paradigm Publishing, Inc.