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106 Cards in this Set
- Front
- Back
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What entity primarily governs pharmacy practice?
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State government, not federal
State has control of licensing requirements, disciplinary action and other elements of practice Federal govt regulations pertaining to controlled substances must be followed by the state State must follow the minimum federal standard |
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What section numbers is Virginia Code for pharmacy cited in?
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54.1 or 18.1
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What are Virginia regulations cited as?
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VAC - Virginia Administration code
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What are US laws cited as?
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USC - United States Code
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What are US rules cited as?
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CFR - Code of Federal Regulations
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What is US proposed legislation cited as?
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H.R. _______ for House of Representatives
S. _______ for Senate |
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What are US proposed rules are cited as?
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FR - Federal Register
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Who makes federal laws and rules?
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US Congress and federal agencies
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Who makes state laws and rules?
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State legislatures, agencies, and licensing bodies
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What does Case law deal with?
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Decisions made by courts in the US to deal with conflicts of laws between states, interpretation of laws, and civil and criminal issues
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What does the Food and Drug Administration regulate?
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Manufacture, wholesale, and distribution of drugs into interstate commerce
Not directly involved in practice of pharmacy but plays important oversight role |
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What does the Consumer Products Safety Commission regulate?
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Packaging of drug products and ensures safety of packaging
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What does the Drug Enforcement Administration regulate?
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Controlled substance distribution, registration, and recordkeeping
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What does Virginia State Board of Pharmacy Regulate?
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That states meet the minimal federal requirements where applicable
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What are statutes?
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Bills proposed and passed by a legislative body
In some cases, the statute is the source of information In most cases, statutes have regulations that clarify them |
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What does the Virginia Code consist of?
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Laws passed by Virginia General Assembly and approved by the Govenor
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What does then United States Code (USC) consist of?
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Laws passed by US Congress and approved by the President
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What are regulations?
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Implemented by an agency based upon statutes approved by the state legislature or the US Congress
Clarifies and puts into operation statutory provisions |
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What did the Pure, Food & Drug Act of 1906 prevent?
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The sale, manufacture, transportation of adulterated or misbranded drugs, and medicine liquors
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What did the Pure, Food & Drug Act of 1906 establish/ define?
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The definitions of "drug" and "food" and "misbranded" and "adulterated"
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What did the Food, Drug & Cosmetic Act of 1938 require?
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Safety of drugs be established before a drug reaches the market
Expanded the 1906 law and gave the federal government the authority to punish violators |
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What were the 1962 Amendments to the Food, Drug & Cosmetic Act of 1938 require?
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Efficacy to requirement for drugs before they reach the market
Manufacturers are required to prove efficacy before marketing drugs |
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What is the FDA's mission?
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To promote and protect the public health by helping safe and effective products reach the market in a timely way
To monitor products for continued safety after they are used To help the public get the accurate, science-based information needed to improve health |
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Specifically, what does the FDA regulate in pharmacy practice?
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The safety and efficacy of medicines, biologics, and medical devices
Does NOT regulate the practice of pharmacy directly Pharmacies are NOT required To register with the FDA Provides guidance regarding pharmacy compounding that does not equal manufacturing |
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What did the DEA establish?
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the Drug Control Act of 1970
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What is the purpose of the Drug Control Act of 1970?
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To research, treat, and prevent drug dependence and abuse
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What did the Drug Control Act of 1970 establish?
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Schedules of controlled substances by potential for abuse
Registration criteria for physicians, pharmacies, manufacturers, and other entities to prescribe, dispense, transfer, and distribute controlled substances |
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Who is required to register with the DEA?
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Pharmacies that dispense controlled substances, but not Pharmacists
Pharmacies are required to maintain records in accordance with the DEA and Virginia requirements |
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What are State Boards of Pharmacy designed to do?
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Protect the public's health and welfare in a state by licensing and regulating the practice of pharmacy
Discipline pharmacies Propose regulations and laws that govern the practice of pharmacy |
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What act was first to establish food and drug regulations in the US?
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Pure Food and Drug Act of 1906
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What established the FDA?
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Pure Food & Drug Act of 1906
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What is the goal of the Pure Food & Drug Act of 1906?
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To protect health and safety associated with unsanitary and poorly labeled food and drugs
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Which entity deals with adulterated and misbranded food and drugs in interstate commerce?
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Pure Food & Drug Act of 1906
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Who required drugs to be safe as labeled?
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Food, Drug, & Cosmetic Act of 1938
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What must a label contain?
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Adequate instructions for use and warnings
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What did the Durham-Humphrey Amendment of 1951 establish?
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Prescription and OTC classes of drugs
Federal caution requirement for all prescription drug products Requirements for oral prescriptions Requirements for prescription refills |
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What is the federal caution?
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Requirement on all prescription drug products
"Caution: Federal law prohibits dispensing without a prescription" |
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What amendment resulted from the thalidomide disaster in Europe?
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Kefauver-Harris Amendment of 1962
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What did the Kefauver-Harris Amendment of 1962 add?
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Safety to requirements for marketing and sales of drugs
Gave FDA control of prescription drug marketing and advertising Established good manufacturing practices Required more research requirements and reporting of adverse drug events |
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Who has primary authority over food and drug advertising?
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FDA
FTC primarily oversees OTC advertising - has authority to regulate prescription drug advertising if found to be false/ misleading, but FDA has to approve the adds that go on the air (Rx drugs) but not for OTC drugs |
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What does the Prescription Drug Marketing Act of 1987 restrict/ prohibit pharmacies from doing?
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Receiving or distributing drug samples from manufacturers
Prohibits sale of drug samples by hospitals or other health care entities Established state licensure requirements for pharmaceutical wholesalers |
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What did the streamlining of the FDA approval process (FDA Modernization Act of 1997) allow?
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Expedited availability of drugs and devices - allowed drugs for certain health conditions (i.e. AIDS) to be approved more quickly
Expanded manufacturer's ability to communicate information regarding off-label uses Required the FDA to establish public standards regarding approval process and a mission statement Established a databank with clinical trial information Authorized review of clinical investigations |
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What entity gave the FDA full authority to establish labeling requirements for OTC agents?
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FDA Modernization Act of 1997
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What must manufacturers pay fees to the FDA for?
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Drug approval process
Prescription Drug User Fee Act of 1992 |
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The Orphan Drug Act of 1983 expanded access to what kind of drugs?
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Drugs for rare diseases
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What act streamlined requirements for bringing generics to market?
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Drug Price Competition and Patent Term Restoration Act of 1984
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What entities recognize the FDA definition of a drug?
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USP, official Homeopathic Pharmacopoeia of US, National Formulary
Any supplement to these |
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What is the FDA's definition of a drug?
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Used for diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal
Indended to affect the structure or any function of the body of man or other animals |
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What are the FDA's requirements for the definition of a food?
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Must not be intended to affect the structure of the human body and is not intended to be used for disease states
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How are food and dietary supplements regulated?
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NOT as OTC or Rx drugs - they have to ensure their advertising doesn't qualify it to be a "drug"
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What are dietary supplements?
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Vitamins, minerals, herbs or other botanicals, amino acids, concentrate, metabolite, extract
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Does the FDA permit health claims for dietary supplements?
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Yes, so long as certain scientfic agreement exists for the claim
Pharmacists may recommend certain dietary supplements based on scientific and clinical information about the product |
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What is the Gold Standard for information pertaining to dietary supplements?
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The USP
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What dietary supplements are often paid for by health plans?
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Vitamin B12 and Niacin
Generally, health plans do not provide reimbursement for dietary supplements such as vitamins and minerals Some payers, including state Medicaid programs, will pay for enteral food supplements such as Ensure that help to prevent wasting and cachexia New Medicare Part D program excludes payment for dietary supplements and for enteral food supplements |
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What is the definition of a label?
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written, printed, or graphic matter upon the immediate container of any article
includes container or wrapper |
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What is the definition of labeling?
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Information on the label and all other written, printed, or graphic matter upon any article or any of its containers or wrappers
Information not sent directly with the drug may be considered labeling if part of the integrated distribution process Includes OTC and Rx labeling |
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What must OTC labeling include?
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Very specific information related to warnings to stop use
Phone number for consumers to call for more information Specific information regarding the dosages and the patient population intended Specific information regarding the route of administration, appropriate time of administration |
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What must Rx labeling include?
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The "Federal Caution"
Information for type of container used to dispense |
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Where must the Professional Package Insert be included?
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With the labeling of the prescription drug
Must accompany the drug product |
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What must the Professional Package Insert provide?
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Essential scientific and medical information needed for the safe and effective use of the drug by health care professionals
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Who requires the Patient Package Insert to be given with each prescription dispensed?
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The FDA
Manufacturers must notify pharmacists to insert leaflet in each prescription dispensed Applies in both community pharmacy and institution settings - in institutions, can be provided upon administration of 1st dose and then once every 30 days |
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What types of medications must be accompanied with a Patient Package Insert?
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Products containing estrogens, DES, oral and intrauterine contraceptive devices
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What information must be provided in a Patient Package Insert?
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General information regarding the risks associated with use and potential adverse effects, and pulmonary embolism
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What is a medication guide required for?
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Certain products posing a serious and significant concern other than estrogen-containing products if the FDA finds: that the labeling could help prevent serious adverse effects; product has serious risks that the patient could benefit from knowing; patient adherence crucial to effectiveness of drugs
Accutane, Lariam, antidepresants, NSAIDs, Tikosyn, Thalomid, etc. |
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What entity must approve a MedGuide?
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The FDA
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What makes a drug "misbranded"?
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The label or labeling is false or misleading
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What must a package contain to prevent being called misbranded?
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Label or labeling must not be false or misleading
Package must contain information on manufacturer, packer, or distributor Must contain all statements, words, or designs required or approved by the FDA Controlled substances must contain "Warning - May be Habit Forming" Prescription drugs must have established name or ingredient prominently displayed |
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How must a prescription drug name be displayed on a label?
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Established name or ingredient prominently displayed
Proprietary name must be included in type 1/2 the size of the established name VA Board of Pharmacy may grant exceptions |
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What are some key points that cause a drug to be called misbranded?
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Information regarding dosages that might be dangerous to health or unsafe
Information related to dangers of use in children Special packaging requirements to prevent deterioration If it fails to meet conditions of the Poison Prevent Packaging Act |
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What are adulterated drugs?
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Includes drugs that consist in whole or in part of filthy, putrid, or decomposed substances
Drugs prepared, packed, or held in unsanitary conditions Drugs prepared, packaged, processed, or held under conditions that violate GMPs Drugs that purport to be those recognized in official compendia but quality or purity falls below the standards Drugs mixed or packed to reduce quality or strength |
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What do adulteration standards apply to?
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Preparation conditions for the drugs, not the drug itself
Mostly applies to manufacturers but can apply to pharmacies if a pharmacy receives an adulterated drug and then sells the drug A pharmacy compounds medications under conditions that result in adulteration |
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What are Current Good Manufacturing Practices (CGMPs)?
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FDA regulations that establish minimal requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product
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What does the FDA ensure CGMPs meet?
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FDA quality and purity requirements
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Who does CGMPs apply to?
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Only manufacturers except if a pharmacy engages in activities deemed manufacturing
If a pharmacy is truly compounding, they are exempt from CGMPs |
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Who is required to register with the FDA to comply with CGMPs and FDA Registration?
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Manufacturers
Pharmacies are NOT required but in some cases could be inspected |
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How long is manufacturer registration with the FDA for CGMPs valid?
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2 years
The FDA will inspect one time within the 2 year period |
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What is the purpose of FDA inspections?
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To ensure that production and control procedures properly identify strength, quality, and pruity of drugs
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What happens when a manufacturer fails a FDA CGMP inspection?
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Manufacturer could be required to recall drugs from market or FDA could seize all adulterated drugs
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Whick entities are associated with product tampering violations?
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Joint authority of FBI, Department of Agriculture, and the FDA
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How does the FDA require some OTC products be dispensed?
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In tamper-resistant packaging
Must ensure that packaging provides visible evidence that tampering has occurred |
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What must an applicant provide to be approved for a new drug?
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Reports of drug safety and efficaciy
Drug components and composition methods, facilities, and controls used in manufacturing, processing, and packaging Samples of drugs Proposed labeling |
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What must be included on an investigational new drug application?
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Drug name, composition, manufacture and quality control data, preclinical animal investigations regarding pharmacological, pharmacokinetic, and toxicological evaluations
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How long does it take for an investigational new drug application to be approved?
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Within 30 days - then the drug moves to clinical trials
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What occurs during Phase I of a human clinical trial?
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Examination of adverse effects in small studies, toxicity, metabolism, bioavailability, elimination, and other pharmacological effects
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What occurs during Phase II of a human clinical trial?
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Testing for efficacy on patients with the disease/ condition
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What occurs during Phase III of a human clinical trial?
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Large clinical trials for safety and efficacy
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What occurs during Phase IV of a human clinical trial?
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Post-marketing surveillance
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When can an invastigational new drug be used for treatment?
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Patient with serious or life-threatening injury with:
Serious or immediate life-threatening disease or condition No comparable or satisfactory alternative Drug is under investigation for treatment of condition Sponsor seeking marketing approval Sufficient evidence of safety and effectiveness for serious diseases Reasonable basis to conclude the drug may be effective and would not expose individuals with immediate life-threatening diseases to unreasonable and significant risk |
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What is the FDA MedWatch program?
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Voluntary, confidential system for healthcare professionals to report ADRs to the FDA
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What does the Drug Efficacy Study Implementation (DESI) allow generic competitors of approved brand name drugs to do?
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Submit an abbreviated new drug application (ANDA) showing proof of bioavailability, bioequivalence, and information on manufacturing and controls
Designed to speed approval time of generics and allow lower prices |
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How does a DEA number designate intern, resident, or foreigh-trained physician?
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Hospital provides a specific internal code used to designate each individual practioner
OR Suffix to DEA's registration number |
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What are Virginia's controlled prescription requirements for interns, residents, and foreigh-trained physicians?
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Prescriber's signature
Printed name Address, telephone number Hospital DEA number plus assigned suffix Only applicable to course of duties within the hospital |
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What are the registering requirements for dispensers conducting research on controlled substances?
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Do not need a separate registration for CII-V
Applicant must submit protocol including name and qualifications of the investigator, institutional affiliation, description of the project, copies of the IND and description of the security procedures used |
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What are the hiring considerations for employees handling controlled substances?
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Felony convictions in the past 5 years
Misdemeanors or any pending convictions in the past 2 years Use of narcotics other than by prescription in the past 3 years Cannot employ any individual whose application for registration has been denied or revoked |
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What is the DEA's definition of dispensing?
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Delivering a controlled substance to an ultimate user or research subject OR
pursuant to the lawful order of a practioner including prescribing and administration of a controlled substance and ht epackaging, labeling, or compounding necessary to prepare the substance for such delivery Dispenser that is the entity that delivers the controlled substance to the ultimate user or research subject Under this section, a pharmacy is a practitioner - DEA recognizes pharmacists as individual practitioners if authorized by state law A hospital is also a practitioner |
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What must be included on a prescription for a controlled substance?
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Minimum DEA requirements of drug name, strength, dosage form, quantity prescribed, and directions for use
Dated and signed by a practitioner/ prescriber on the date written (post-dated and undated Rx not acceptable) Full name and address of patient or owner of animal for vet Rxs (may be added by the pharmacist) Full name, address, and DEA number of the prescriber |
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What is required on the label of a controlled prescription?
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Serial number or name of drug
Date of initial filling Name and address of pharmacy or pharmacist (no phone number required) Name of patient (address not required) Name of prescriber Directions for use |
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Edit flashcard with info about narcotic treatment progrmas - Form 225. Is NOT form 225!
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Edit flashcard with info about narcotic treatment progrmas - Form 225. Is NOT form 225!
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What activities are involved in controlled substance manufacturing?
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Production, preparation, propagation, compounding, or processing of a drug
Includes packaging, repackaging, labeling, or relabeling Activites coincidental to manufacturer registration, including chemical analysis and preclinical research Excludes activities by practitioners, including pharmacists, incidental to administering or dispensing controlled substances in the course of professional practice Manufacturer must be registered for each class of controlled substance |
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What amount of controlled inventory may a pharmacy transfer without being labeled as "manufacturing"?
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20% of controlled inventory
Pharmacies that manufacture and distribute to other practitioners may provide without registration an aqueous or oleaginous solution or solid dosage form containing a narcotic substance in a preparation not exceeding 20% of the complete product Pharmacy might have to register as manufacturer under FDA based on these activities |
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Who may deliver controlled substances to other registrants by means ouside of administration or dispensing?
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DEA registrants permitted to dispense
The distribution must occur between DEA registrants The distribution must be recorded with the proper information by the distributing and receiving entities If CI or CII, a DEA Form 222 must be executed! Number of dosage units distributed must not exceed 5% of the total units of controlled substances dispensed in 1 year Long-term care pharmacies that distribute controlled substances to long-term care facilities in automated dispensing systems are exempt from this requirement |
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What form must be executed to distribute a controlled substance among DEA registrants?
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DEA Form 222
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What is the maximum number of dosage units of a controlled substance that is allowed to be distributed among DEA registrants?
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5% of the total units dispensed in 1 year
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Who is exempt from the 5% max of total units of controlled substances that can be distributed among DEA registrants?
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Long-term care pharmacies that distribute controlled substances to long-term care facilities in automated dispensing systems
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When returning a controlled substance to a wholesaler or a manufacturer by a registrant, what must be included with the controlled substance?
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If CI or CII, must use a Form 222
Written record of the transfer and the following information: Date of transaction Name, form, and quantity of substance name, address, and registration number of the person making the distribution Name, address, and registration number of supplier or manufacturer - If the DEA number of the person making the distribution or the supplier is unknown, then can still make the transfer for CIII-CV but not CII Exemption from registering as a distributor when returning controlled substances to a wholesaler or a manufacturer by a registrant |
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What are Virginia's requirements for distribution?
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CII-VI by manufacturers and wholesalers
May distribute CII drugs via official written order forms (DEA Form 222) to other manufacturers or wholesalers registered by the DEA and the state of VA, licensed pharmacists, permitted pharmacies, or licensed practitioners including MD, OD, podiatrists, dentists, veterinarians, or other prescribers otherwise authorized Manufacture or wholesaler may distribute drugs in CIII-VI without official written order form |
