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Pharmacy Practice, Fourth Edition
Chapter 2 Pharmacy Law, Regulations, and Standards © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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The Need for Drug Control
Pharmacy Practice, Fourth Edition The Need for Drug Control Laws in the US are generally stricter than in other countries. Many organizations exercise control: Courts Federal and state legislatures Federal and state agencies US Pharmacopeia Professional organizations Individual institutions (hospitals, pharmacies, etc.) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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History of US Statutory Pharmacy Law
Pharmacy Practice, Fourth Edition History of US Statutory Pharmacy Law During the 1800s, drugs in the US were unregulated. Opium was widely available without a prescription. Traveling medicine shows proclaimed the latest “miracle cure.” There were major concerns regarding the purity of imported drugs. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Pure Food and Drug Act of 1906
Pharmacy Practice, Fourth Edition Pure Food and Drug Act of 1906 Passed to fight abuses in drug formulation, labeling, and marketing Forbade drug labels from containing false information Proved to be unenforceable © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Food, Drug, and Cosmetic Act of 1938
Pharmacy Practice, Fourth Edition Food, Drug, and Cosmetic Act of 1938 Response to manufactured drugs that were more powerful and potentially dangerous Created the FDA Required drug makers to File new drug applications (NDAs) Prove that the product was safe for human use Conduct studies and submit results Required drugs to be safe, but not necessarily effective © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Pharmacy Practice, Fourth Edition
Terms to Remember new drug application (NDA) the process through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Durham-Humphrey Amendment of 1951
Pharmacy Practice, Fourth Edition Durham-Humphrey Amendment of 1951 Established distinction between prescription and non-prescription drugs Authorized verbal prescriptions Allowed prescription refills © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Kefauver-Harris Amendment of 1962
Pharmacy Practice, Fourth Edition Kefauver-Harris Amendment of 1962 Passed in response to thalidomide-caused birth defects Required drugs to be not only safe but also effective Required drug makers to file investigational new drug application (INDA) Lengthened time to market – balanced by patent protection for drug makers © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Pharmacy Practice, Fourth Edition
Terms to Remember Controlled Substances Act (CSA) laws created to combat and control drug abuse controlled substance a drug with potential for abuse; organized into five schedules that specify the way the drug must be stored, dispensed, recorded, and inventoried © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Comprehensive Drug Abuse Prevention and Control Act of 1970
Pharmacy Practice, Fourth Edition Comprehensive Drug Abuse Prevention and Control Act of 1970 Referred to as the Controlled Substances Act Created to combat drug abuse Classified drugs according to their potential for abuse Schedule I: not legally dispensed Schedule II: no refills Schedule III – V: limits on refills © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Comprehensive Drug Abuse Prevention and Control Act of 1970
Pharmacy Practice, Fourth Edition Comprehensive Drug Abuse Prevention and Control Act of 1970 CSA ranked drugs according to their potential for abuse and addiction. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Pharmacy Practice, Fourth Edition
Terms to Remember child-resistant container a medication container with a special lid that cannot be opened by 80% of children but can be opened by 90% of adults; a container designed to prevent child access in order to reduce the number of accidental poisonings © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Poison Prevention Packaging Act of 1970
Pharmacy Practice, Fourth Edition Poison Prevention Packaging Act of 1970 Passed to prevent accidental childhood poisonings Applies to both prescription and OTC drugs Requires child-resistant containers that Cannot be opened by 80% of children Can be opened by 90% of adults © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Poison Prevention Packaging Act of 1970
Pharmacy Practice, Fourth Edition Poison Prevention Packaging Act of 1970 The Act allows some drugs to be dispensed in non-childproof packages. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Pharmacy Practice, Fourth Edition
Drug Listing Act of 1972 Gives FDA authority to compile a list of currently marketed drugs Each drug is given a unique National Drug Code (NDC) Allows FDA to maintain a database of drugs by Use Manufacturer Active ingredients © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Pharmacy Practice, Fourth Edition
Terms to Remember orphan drug a medication approved by the FDA to treat rare diseases © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Pharmacy Practice, Fourth Edition
Orphan Drug Act of 1983 Developing and marketing orphan drugs is prohibitively expensive. Orphan Drug Act encourages their development by Giving tax incentives Granting exclusive licenses Allowing expedited review and approval Over 250 orphan drugs have been approved by FDA. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Pharmacy Practice, Fourth Edition
Terms to Remember brand name the name under which the manufacturer markets a drug; also known as the trade name © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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© Paradigm Publishing, Inc.
Pharmacy Practice, Fourth Edition Terms to Remember generic name a common name that is given to a drug regardless of brand name; sometimes denotes a drug that is not protected by a trademark; for example, acetaminophen is the generic drug name for Tylenol © Paradigm Publishing, Inc. 19 © Paradigm Publishing, Inc. 19
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Drug Price Competition and Patent-Term Restoration Act of 1984
Pharmacy Practice, Fourth Edition Drug Price Competition and Patent-Term Restoration Act of 1984 Was a response to pressure to reduce drug costs Encouraged the creation of generic drugs Extended patent licenses to allow manufacturers to recoup research and development costs © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Drug Price Competition and Patent-Term Restoration Act of 1984
Pharmacy Practice, Fourth Edition Drug Price Competition and Patent-Term Restoration Act of 1984 Generics are comparable to brand name drugs in Dosage form Safety Strength Quality Performance Generics must demonstrate bioequivalence to brand name product. Over 60% of prescriptions in community pharmacies are filled with generics. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Prescription Drug Marketing Act of 1987
Pharmacy Practice, Fourth Edition Prescription Drug Marketing Act of 1987 Prohibits re-importation of drugs into US by anyone but the manufacturer Passed in response to concerns over safety and competition issues Has become a major issue as seniors travel to Canada for prescriptions or order medications by mail © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Anabolic Steroid Act of 1990
Pharmacy Practice, Fourth Edition Anabolic Steroid Act of 1990 Anabolic steroids are a synthetic version of testosterone. Abuse by athletes has been widely reported. Adverse side effects are serious and permanent. Act identifies anabolic steroids as a Class III drug, allowing greater restrictions. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Omnibus Budget Reconciliation Act of 1990
Pharmacy Practice, Fourth Edition Omnibus Budget Reconciliation Act of 1990 Requires state standards of practice for drug utilization reviews Pharmacist must screen for Therapeutic duplication Drug-disease contraindication Drug-drug interactions Incorrect dosage or duration of treatment Drug-allergy interactions Clinical abuse/misuse Possibility of loss of Medicaid reimbursements used to enforce rules © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Omnibus Budget Reconciliation Act of 1990
Pharmacy Practice, Fourth Edition Omnibus Budget Reconciliation Act of 1990 Also requires pharmacist to offer to review and discuss with the patient name and description of medication dosage form dose route of administration duration of drug therapy action to take after a missed dose common severe side effects or adverse effects © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Omnibus Budget Reconciliation Act of 1990
Pharmacy Practice, Fourth Edition Omnibus Budget Reconciliation Act of 1990 Also requires pharmacist to offer to review and discuss with the patient —continued interactions and therapeutic contraindications, ways to prevent the same, and actions to be taken if they occur methods for self-monitoring of the drug therapy prescription refill information proper storage of the drug special directions and precautions for preparation, administration, and use by the patient © Paradigm Publishing, Inc. 26 © Paradigm Publishing, Inc. 26
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Dietary Supplement Health and Education Act of 1994
Pharmacy Practice, Fourth Edition Dietary Supplement Health and Education Act of 1994 FDA has limited oversight in diet supplement market. Manufacturers are not required to prove Safety Effectiveness Standardization © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Dietary Supplement Health and Education Act of 1994
Pharmacy Practice, Fourth Edition Dietary Supplement Health and Education Act of 1994 Act provided definitions and guidelines on diet supplements. FDA may only review “false claims” advertisements and monitor safety. FDA may remove unsafe supplements, but burden is on FDA to prove that the product is unsafe. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Health Insurance Portability and Accountability Act of 1996
Pharmacy Practice, Fourth Edition Health Insurance Portability and Accountability Act of 1996 HIPAA has wide-ranging provisions. For pharmacies, impact is mostly on confidentiality of patient records: Must document and provide to patient information on how health information is safeguarded Must have an employee training program with yearly renewals © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Food and Drug Administration Modernization Act
Pharmacy Practice, Fourth Edition Food and Drug Administration Modernization Act Passed to update labeling on prescription medications Authorizes new drug application (NDA) fees which are used by FDA to accelerate review of new drugs © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Medicare Prescription Drug, Improvement, and Modernization Act of 2003
Pharmacy Practice, Fourth Edition Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Better known as Medicare Part D Provides prescription drug coverage to patients eligible for Medicare Voluntary program Patients pay an extra premium Usually have a deductible Also established health/savings accounts (HSAs) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Combat Methamphetamine Epidemic Act of 2005
Pharmacy Practice, Fourth Edition Combat Methamphetamine Epidemic Act of 2005 Methamphetamine Highly addictive stimulant Made from OTC products Restricts the availability of products used to make it: Pseudoephedrine Ephedrine Products must be stored “behind the counter” and purchases must be documented. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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National Oversight Agencies
Pharmacy Practice, Fourth Edition National Oversight Agencies Food and Drug Administration (FDA) Drug Enforcement Administration (DEA) Occupational Safety and Health Administration (OSHA) National Association of Boards of Pharmacy (NABP) State boards of pharmacy © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Food and Drug Administration (FDA)
Pharmacy Practice, Fourth Edition Food and Drug Administration (FDA) Under Department of Health and Human Services (HHS) FDA’s Center for Drug Evaluation and Research (CDER) impacts pharmacy: New drug development and review Generic drug review Over-the-counter drug review Post-drug approval activities © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Food and Drug Administration (FDA)
Pharmacy Practice, Fourth Edition Food and Drug Administration (FDA) Primary responsibility and authority to enforce the law Has no legal authority over the practice of pharmacy in each state FDA activities Requires manufacturers to file applications for investigative studies and drug approvals Provides guidelines for packaging and advertisement Oversees the recall of dangerous products Produces annual Orange Book reference © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Food and Drug Administration (FDA)
Pharmacy Practice, Fourth Edition Food and Drug Administration (FDA) The FDA regulates OTC labeling so it is understandable to a layperson. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Pharmacy Practice, Fourth Edition
Terms to Remember Drug Enforcement Administration (DEA) the branch of the US Justice Department that is responsible for regulating the sale and use of drugs with abuse potential © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Drug Enforcement Administration (DEA)
Pharmacy Practice, Fourth Edition Drug Enforcement Administration (DEA) Most of its effort spent on illegal drug trafficking, but also supervises legal use of controlled substances Inspects medical facilities and pharmacies; usually just those where suspicious activity has been detected Maintains an audit trail of narcotics from manufacturer to warehouse to pharmacy to patient © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Drug Enforcement Administration (DEA)
Pharmacy Practice, Fourth Edition Drug Enforcement Administration (DEA) DEA registration is required for all individuals, institutions, and businesses involved in controlled substances, including Manufacturing Distributing Dispensing Researching Instructional activities Detoxification programs Importing / exporting Compounding © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Drug Enforcement Administration (DEA)
Pharmacy Practice, Fourth Edition Drug Enforcement Administration (DEA) CSA defines who may prescribe controlled substances. Prescriptions must be written for a legitimate reason related to the physician’s practice (e.g., dentist can prescribe narcotics for dental pain but not for back pain). Except for emergencies, prescription must be written rather than phoned or faxed. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Occupational Safety and Health Administration (OSHA)
Pharmacy Practice, Fourth Edition Occupational Safety and Health Administration (OSHA) Ensures the safety and health of US workers OSHA’s role in pharmacies, hospitals, and home health care is to Protect against inadvertent needle sticks Ensure safe disposal of syringes Oversee policies to protect employees from unnecessary drug exposures © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Pharmacy Practice, Fourth Edition
Terms to Remember National Association of Boards of Pharmacy (NABP) an organization that represents the practice of pharmacy in each state and develops pharmacist licensure exams reciprocation the administrative process for relicensure of pharmacists in another state © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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National Association of Boards of Pharmacy (NABP)
Pharmacy Practice, Fourth Edition National Association of Boards of Pharmacy (NABP) Has no regulatory authority Primary role is to develop national pharmacist license examination Coordinates reciprocation of pharmacists practicing in other states Provides guidance to state boards of pharmacy Developed Model State Pharmacy Practices Act for national continuity © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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State Boards of Pharmacy
Pharmacy Practice, Fourth Edition State Boards of Pharmacy Consist of leaders from the pharmacy community and also consumer members Review applications and administer examinations developed by NABP Maintain a database of active pharmacists Inspect all new pharmacies Provide regulations regarding refilling of prescriptions © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Legal Duties of Pharmacy Personnel
Pharmacy Practice, Fourth Edition Legal Duties of Pharmacy Personnel Role of the pharmacy tech Not defined by federal statute Not uniformly defined from state to state Constantly changing Some states limit the ratio of pharmacy techs to pharmacists. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Legal Duties of Pharmacy Personnel
Pharmacy Practice, Fourth Edition Legal Duties of Pharmacy Personnel Duties not required to be done by pharmacists may be carried out by the pharmacy technician. All technicians’ duties must be carried out under the direct supervision of the pharmacist. © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Duties Typically Performed by Pharmacists
Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacists Dispensing, recordkeeping, and pricing receiving a verbal, or oral, prescription in person or by telephone preparing the written form of the verbal prescription from a doctor’s office or another pharmacy interpreting and evaluating prescriptions reviewing patient profile (e.g., medication history, duplication of medications, allergies, drug interactions) verifying and certifying records transferring prescriptions to other pharmacies (See Table 2.5) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Duties Typically Performed by Pharmacists
Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacists Preparing Doses of Precompounded Medications checking/verifying finished prescriptions Preparing Doses of Extemporaneously Compounded, Nonsterile Medications checking and verifying that drugs were selected properly calculating weights and measures verifying that weighing and measuring were done properly verifying finished product (See Table 2.5) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Duties Typically Performed by Pharmacists
Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacists Transporting Medications to and from floors/units in a hospital (especially controlled substances) checking and verifying delivery records examining returned medications for integrity and reusability emptying returned medications into stock containers (See Table 2.5) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Duties Typically Performed by Pharmacists
Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacists Replenishing floor stocks (especially controlled substances) checking and verifying replenishing stocks certifying and checking drug stations disposing of unused items and discontinued medications Verifying finished product against original order or prescription (See Table 2.5) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Duties Typically Performed by Pharmacy Technicians
Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Dispensing, recordkeeping, and pricing receiving written prescriptions and conveying them to the pharmacist answering and properly directing telephone calls preparing records, including patient profiles and billing records (See Table 2.6) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Duties Typically Performed by Pharmacy Technicians
Some states allow certified pharmacy technicians to accept prescriptions over the telephone.
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Duties Typically Performed by Pharmacy Technicians
Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Preparing Doses of Precompounded Medications retrieving medications from shelf or supply cabinet selecting containers preparing labels counting or pouring medications reconstituting prefabricated medications pricing prescriptions (See Table 2.6) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Duties Typically Performed by Pharmacy Technicians
Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Preparing Doses of Extemporaneously Compounded, Nonsterile Medications retrieving medications from shelf or supply cabinet selecting equipment for the compounding operation weighing and measuring compounding preparing labels selecting containers packaging maintaining and filing records of extemporaneous compounding cleaning area and equipment (See Table 2.6) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Duties Typically Performed by Pharmacy Technicians
Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Transporting Medications to and from floors/units preparing cart, tray, or other means of conveyance delivering controlled drugs maintaining delivery records distributing medications to wards organizing medications for administration to patients retrieving, reconciling, and recording credit for medications not administered returning unused medications to unit dose bins and injectables to stock (See Table 2.6) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Duties Typically Performed by Pharmacy Technicians
Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Some states allow a “tech check tech” system in which one technician is allowed to check another technician’s work preparing unit dose carts. © Paradigm Publishing, Inc. 56 © Paradigm Publishing, Inc. 56
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Duties Typically Performed by Pharmacy Technicians
Pharmacy Practice, Fourth Edition Duties Typically Performed by Pharmacy Technicians Replenishing Floor Stocks Checking for expiration dates Removing overstocks (See Table 2.6) © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Pharmacy Practice, Fourth Edition
Terms to Remember United States Pharmacopeia (USP) the independent scientific organization responsible for setting official quality standards for all drugs sold in the United States as well as standards for practice © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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Pharmacy Practice, Fourth Edition
Terms to Remember United States Pharmacopeia–National Formulary (USP–NF) a book that contains US standards for medicines, dosage forms, drug substances, excipients or inactive substances, medical devices, and dietary supplements © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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United States Pharmacopeia
Pharmacy Practice, Fourth Edition United States Pharmacopeia Publishes United States Pharmacopeia–National Formulary (USP–NF) Contains standards for Medicines Dosage forms Drug substances, excipients, inactive substances Medical devices Dietary substances Rose out of the FDC Act of 1938 Recognized by FDA and accrediting agencies © Paradigm Publishing, Inc. © Paradigm Publishing, Inc.
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