Pharmaceutical Industry Quiz
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Questions and Answers

Match the following drug categories with their descriptions:

Legend Drugs = Require supervision for safe and effective use OTC = Deemed safe and effective for unsupervised use for intended indication Controlled Substances = Have liability to cause dependence or have abuse potential Orphan Drugs = Treatment of rare diseases or conditions

Match the following terms with their definitions:

New Drugs = Contains new substance or new combo of approved drug Biologics = Derived from living organisms Drug Recalls = Typically voluntary, reported through FDA's MedWatch Pregnancy Categories = Old system ranged from A to X, new system more focused on information provision

Match the following terms with their definitions:

Behind the Counter Drugs = Nonprescription under conditions of safe use National Drug Code (NDC) = Manufacturer # - Drug # - Package Size The Orange Book = Helps pharmacists choose bioequivalent generic product Narrow Therapeutic Index/Ratio Drugs = Requires careful dosage titration and patient monitoring

Match the following new drug types with their descriptions:

<p>Novel drug = Amlodipine 5mg New dose = Amlodipine 10mg New Indication = Raynaud’s Syndrome New Combo = Amlodipine/Benazepril</p> Signup and view all the answers

Match the following agencies with their primary responsibilities:

<p>FDA = Enforce the controlled substances laws and regulations of the US DEA = Assuring safety, effectiveness, and security of drugs, vaccines, and biological products CMS = Regulating tobacco products FTC = Regulating food supply, cosmetics, dietary supplements, and products that give off radiation</p> Signup and view all the answers

Match the following documents with their sources:

<p>Federal US Code (USC): Title 21 = Product of Congress Federal Code of Federal Regulations (CFR): Title 21 = Product of administrative agencies Tennessee Code Annotated (TCA) = Official Compilation of Rules and Regulations of the State of TN Preemption Doctrine = Supremacy Clause</p> Signup and view all the answers

Match the following actions with the responsible agency:

<p>Enacting the TN BoP, Durham-Humphrey Amendment (1951), establishing the DEA = Congress Regulating tobacco products = FDA Prescription drug monitoring programs = DEA Recognition as a provider = CMS</p> Signup and view all the answers

Match the following statements with the correct law or doctrine:

<p>If state laws are less strict than federal follow federal = Preemption Doctrine Federal trumps state law if conflicting = Supremacy Clause Anything involved with safety and efficacy = FDA regulations Enforce the controlled substances laws and regulations of the US = Controlled Substances Act</p> Signup and view all the answers

Match the following acts with their primary focus:

<p>1906 Pure Food and Drug Act = Adulteration and misbranding 1914 Harrison Anti-Narcotic Act = Taxing drug abuse 1938 Food Drug and Cosmetic Act = Safety and FDA approval of drugs 1951 Durham-Humphrey Amendment = Establishing prescription drug class</p> Signup and view all the answers

Match the following organizations with their descriptions:

<p>Federal Trade Commission (FTC) = Prevents unfair methods of competition in commerce TN Board of Pharmacy = Given power by TN Pharmacy Practice Act (1996) TN Pharmacists Association (TPA) = Promotes the enhancement of knowledge, ethics, and skills of pharmacists TN Colleges of Pharmacy = Influences board decisions and rules</p> Signup and view all the answers

Match the following terms with their definitions:

<p>Legend drugs = Drugs that had the Federal Legend on the label Collaborative practice act = An act supported by the TN Pharmacists Association Sulfanilamide incident = An incident in 1937 involving a dangerous ingredient in a children's drug Tripartite Committee = A committee comprising the Board, TPA and Colleges</p> Signup and view all the answers

Match the following entities with their roles:

<p>MTM via MMA in 2006 = Instrumental in pharmacist involvement in drug therapy optimization Antitrust laws = Promote competition and prohibit monopolies TN Pharmacy Practice Act of 1996 = Gave power to the TN Board of Pharmacy The Rules of the Board (1140) = Part of the regulations pharmacists in TN pay attention to</p> Signup and view all the answers

Match the following laws and amendments with their descriptions:

<p>Kefauver-Harris Amendment = Established that drugs had to be safe and effective to be marketed in the US Controlled Substance Act = Served to correct and consolidate a hodge-podge of controlled substance statues that existed prior Dietary Supplement Health and Education Act (DSHEA) = Treated dietary supplements more like a type of food rather than drug Federal Anti-Tampering Act = Concerns only consumer products and involves criminal acts such as tampering</p> Signup and view all the answers

Match the following terms with their definitions:

<p>DESI drugs = Drugs from 1938-1962 that were safe but not effective Phocomelia = A condition resulting in fetal abnormalities, caused by off-label use of Thalidomide Adulteration = Something bad with the drug Misbranding = Something bad with the label/labeling</p> Signup and view all the answers

Match the following types of health claims with their descriptions:

<p>Unqualified = Significant scientific agreement exists Qualified = No significant scientific agreement, claims must contain qualifying language</p> Signup and view all the answers

Match the following drug statuses with their time frames:

<p>DESI drugs = 1938-1962 Drugs subjected to higher standards for safety and efficacy = 1962-present Thalidomide released in Europe = Late 1950s-early 1960s</p> Signup and view all the answers

Match the following laws and regulations with their descriptions:

<p>Prescription Drug Marketing Act = Regulates re-importation and diversion of prescription drug samples 1970 -- Poison Prevention Packaging Act (PPPA) = Enforced by Consumer Product Safety Commission to prevent accidental poisoning in children TCA 53-10-104 = Details who is legally permitted to prescribe medication TCA 53-10-109 = Prohibits prescribing of Schedule II stimulants for weight management</p> Signup and view all the answers

Match the following terms with their definitions:

<p>Biosimilar = A drug that is very similar to a biologic, but not exactly the same Interchangeable = A biosimilar that can be swapped with the original biologic without any changes in treatment Adulteration = The process of making a drug impure by adding inferior substances Misbranding = False or misleading labeling of a drug</p> Signup and view all the answers

Match the following exemptions with their descriptions:

<p>Wholesalers selling to pharmacists = An exemption to the rule that legend drugs can only be dispensed with a prescription Patient waiver = Allows easy-open caps to be used for all prescriptions Exemptions from Consumer Product Safety Commission (CPSC) = Allows certain drugs to be dispensed in easy-open caps without further permission Prescriber waiver = Allows easy-open caps to be used for specific prescriptions</p> Signup and view all the answers

Match the following organizations with their responsibilities:

<p>FDA = Regulates prescription/legend drug advertising FTC = Regulates non-prescription drug advertising Board of Pharmacy = Can inspect pharmacies Consumer Product Safety Commission = Enforces the Poison Prevention Packaging Act (PPPA)</p> Signup and view all the answers

Match the following terms with their definitions:

<p>Adulteration = Drug may not meet safety, identity, strength, quality, purity standards Tamper-Evident Labeling = Identifies evident features, must be prominently placed, in place so that it will not be lost if the tamper-evident features are removed Misbranding = Labeling is false OR misleading Risk Evaluation and Mitigation Strategy (REMS) = FDA requires manufacturers to develop these approved risk management programs</p> Signup and view all the answers

Match the following examples with the correct term:

<p>Insulin at manufacturing plant is stored in a broken refrigerator. The intended potency is 100u/mL, because it is improperly stored, the actual potency is 50u/mL = Adulteration Labeling only the trade name when the generic equivalent is in the container = Misbranding Identifies evident features, must be prominently placed, in place so that it will not be lost if the tamper-evident features are removed = Tamper-Evident Labeling Drugs that require significantly more monitoring = Risk Evaluation and Mitigation Strategy (REMS)</p> Signup and view all the answers

Match the following requirements with the correct term:

<p>Must accompany the drug product from the manufacturer = Package insert Must have its established name (generic name) on its label = Drug Must be understandable by an ordinary individual under customary conditions of purchase and use = Required info Must be prominently placed, in place so that it will not be lost if the tamper-evident features are removed = Tamper-Evident Labeling</p> Signup and view all the answers

Match the following descriptions with the correct term:

<p>Container that gets sent from the manufacturer/distributor to the pharmacy = Commercial container Scientific and medical info targeted at health professionals = Package insert All labels and other written printed or graphic matter upon any article or any of its containers/wrappers or accompanying such article = Labeling GIVE W/ EVERY NEW PRESCRIPTION required if drugs pose 'serious and significant concern' = Consumer Medication Information (CMI)</p> Signup and view all the answers

Match the following regulations with their descriptions:

<p>111 Death of prescriber = No controls can be dispensed after prescriber dies 202-204 Generic Dispensing = Pharmacists should substitute with generic to save money 210: Anti-epileptic drugs = Notification prior to interchanging if epilepsy/seizures are currently controlled 401: Tamper-proof prescriptions = Prevent copying of prescription forms, erasure/altering info on forms/making counterfeit forms</p> Signup and view all the answers

Match the following regulations with their corresponding numbers:

<p>Prevention of Drug Abuse = 112 Off Label Drug Use = 113 Generic Substitution = 208 Biologics interchange = 211</p> Signup and view all the answers

Match the following conditions with their corresponding regulations:

<p>New prescription, never filled fill within 90 days = 111 Death of prescriber Shall make reasonable effort to prevent abuse of drugs = 112 Prevention of Drug Abuse TN allows truthful promotion of off-label uses = 113 Off Label Drug Use Applies to all written and printed Rxs from TN prescriber = 401: Tamper-proof prescriptions</p> Signup and view all the answers

Match the following regulations with their corresponding actions:

<p>111 Death of prescriber = CIII, CIV, CV refills void 90 days after death 202-204 Generic Dispensing = Prescriber shall allow for substitution unless Brand is medically necessary 210: Anti-epileptic drugs = Change in mfr Generic brand Brand generic Generic different generic 401: Tamper-proof prescriptions = Pharmacists shall not fill, but can give emergency supplies based on third party payers</p> Signup and view all the answers

Match the following regulations with their corresponding provisions:

<p>111 Death of prescriber = Non-scheduled refills void 180 days after death 202-204 Generic Dispensing = Prescribers must not on Rx if brand is necessary 210: Anti-epileptic drugs = Not applicable to institution patients 401: Tamper-proof prescriptions = Can include serial numbers, but pharmacists don’t bear liability</p> Signup and view all the answers

Match the following regulations with their corresponding requirements:

<p>111 Death of prescriber = CII NOT dispensible 202-204 Generic Dispensing = 204: prescriber shall allow for substitution unless Brand is medically necessary 210: Anti-epileptic drugs = Interchange Change in mfr Generic brand Brand generic Generic different generic 401: Tamper-proof prescriptions = CMS standards apply</p> Signup and view all the answers

Thalidomide was a non-barbiturate ______.

<p>sedative</p> Signup and view all the answers

DESI drugs safe but NOT ______.

<p>effective</p> Signup and view all the answers

Drugs now had to be ______ and effective to be marketed in the US.

<p>safe</p> Signup and view all the answers

Federal CSA is strict, so states don’t tend to add ______.

<p>much</p> Signup and view all the answers

______ trumps state law if conflicting (Supremacy Clause)

<p>Federal</p> Signup and view all the answers

The ______ is responsible for protecting public health and assuring the safety, effectiveness, and security of drugs, vaccines, and biological products, medical devices, food supply, cosmetics, dietary supplements, and products that give off radiation.

<p>Food and Drug Administration (FDA)</p> Signup and view all the answers

The ______ is under the US Department of Justice and is responsible for enforcing the controlled substances laws and regulations of the US.

<p>Drug Enforcement Administration (DEA)</p> Signup and view all the answers

The ______ is under the US Department of Health and Human Services and is responsible for recognizing providers.

<p>Centers for Medicare and Medicaid Services (CMS)</p> Signup and view all the answers

Pharmacists’ cognitive services have been instrumental in pharmacist involvement in drug therapy optimization in ______ facilities and in OBRA-90 requirements.

<p>LTC</p> Signup and view all the answers

______ laws promote competition, 'prohibit' monopolies, 'make illegal certain practices deemed to hurt business or consumers or both, or generally violate standards of ethical behavior'.

<p>Antitrust</p> Signup and view all the answers

The TN Board of Pharmacy is comprised of 7 pharmacists and 1 non-pharmacist ______.

<p>consumer</p> Signup and view all the answers

The TN Pharmacists Association works to represent the profession of pharmacy as an integral component of the health care delivery system to entities outside the profession and to develop ______ of practice which ensure delivery of quality pharmaceutical care as a means of protecting and enhancing public health.

<p>standards</p> Signup and view all the answers

Clozaril, opioids, thalidomide) Legend Drugs (Rx only) Require supervision for safe and effective use Supervision by “practitioner” (defined by States) ARE NOT unreasonably dangerous ARE unavoidably unsafe ______: deemed safe and effective for unsupervised use for intended indication ______ vs Rx only – decision that supervision is not needed with labeling (indication)

<p>OTC</p> Signup and view all the answers

New Drugs ______: Amlodipine 5mg New dose: Amlodipine 10mg New Indication: Raynaud’s Syndrome Contains new substance New combo of approved drug New Combo: Amlodipine/Benazepril Proportion of ingredients in combo is changed Dose, method, or duration of admin is changed New Release Form: Amlodipine IV NOT deemed GRAS or GRAE by the FDA

<p>Novel drug</p> Signup and view all the answers

______ schedule classes Orphan Drugs: tx of rare diseases or conditions Rare = 200,000 or fewer Or manufacturer has virtually no chance to make profit Govt provides tax and exclusive licensing incentives Drug does not lose orphan status if found to be useful in tx common illness

<p>5</p> Signup and view all the answers

Pregnancy Categories (OLD) ______ – OK, tested and passed B – May be OK C – May be OK if benefits outweigh risks D – Known risk to human fetus X – NOT OK Pregnancy (NEW) More focused on information provision than categorization Dosing, potential risks, registry information

<p>A</p> Signup and view all the answers

The dispensing of CII controls is not allowed after the prescriber ______

<p>dies</p> Signup and view all the answers

Refills for CIII, CIV, and CV drugs are void ______ days after the prescriber's death

<p>90</p> Signup and view all the answers

Refills for non-scheduled drugs are void ______ days after the prescriber's death

<p>180</p> Signup and view all the answers

A pharmacist may decline to dispense a drug if it lacks ______ or a ______

Signup and view all the answers

According to the Prescription Drug Marketing Act, retail pharmacies should not have ______ drug samples.

<p>legend</p> Signup and view all the answers

Hospitals get special pricing for drugs and they cannot resell drugs except to another qualified hospital, nonprofit affiliate, hospitals or healthcare facilities under common control, or in ______ situations.

<p>emergencies</p> Signup and view all the answers

The Poison Prevention Packaging Act (PPPA) is enforced by the Consumer Product Safety Commission and aims to protect children under the age of 5 from accidental poisoning. Compliance with PPPA standards should keep such a child from receiving a dangerous amount of hazardous household substances in a reasonable period of time. However, PPPA requirements do not apply to ______, injectables, suppositories, eye drops, sprays, inhalers, ear drops, or other similar products.

<p>topicals</p> Signup and view all the answers

Prescribers can give waivers for easy-open caps on prescription medications one-by-one, or patients/patient's representatives/prescribers can provide ______ waivers.

<p>blanket</p> Signup and view all the answers

111 Death of ______ CII NOT dispensible – NO CONTROLS CAN BE DISPENSED AFTER PRESCRIBER DIES New prescription, never filled fill within 90 days CIII, CIV, CV refills void 90 days after death (NO CONTROLS FEDERALLY) Non-scheduled refills void 180 days after death

<p>prescriber</p> Signup and view all the answers

112 Prevention of Drug Abuse Professional judgment shall be protected/respected Shall make reasonable effort to prevent abuse of drugs A ______ may decline to dispense Lack of therapeutic value Lack of legitimate medical purpose Class A misdemeanor: knowingly restrict or interfere with a ______’s duty to counsel & exercise professional judgment

<p>pharmacist</p> Signup and view all the answers

113 Off Label Drug Use ______ allows truthful promotion of off-label uses

<p>TN</p> Signup and view all the answers

202: ______ should substitute with generic to save $$$

<p>pharmacists</p> Signup and view all the answers

204: ______ shall allow for substitution unless Brand is medically necessary Prescribers must not on Rx if brand is necessary Generic not available Anti-epileptic drug

<p>prescriber</p> Signup and view all the answers

210: Anti-epileptic drugs Interchange Change in mfr Generic brand Brand generic Generic different generic Notification PRIOR TO interchanging if epilepsy/seizures are currently controlled Patient/relative/close personal friend AND Prescriber Not applicable to institution patients

<p>interchange</p> Signup and view all the answers

Tamper-Evident Labeling: identifies evident features, must be prominently placed, in place so that it will not be lost if the tamper-evident features are removed One or more indicators or ______, which if breached or missing will provide visible evidence of tampering

<p>barriers</p> Signup and view all the answers

Adulteration 'filthy, putrid, decomposed' 'prepared, packed, held under unsanitary conditions' 'Drugs manufactured where: methods used, facilities and control for manufacture, processing, packing, or holding do not conform to cGMP' Drug may not feet safety, identity, strength, quality, purity standards Mainly targeted at manufacturers Examples: IS or contains an unsafe coloring agent Purports to be an official drug Strength differs from quality, purity, fall below the official compendium standards (unless plainly stated 'NOT USP' on the label Misrepresentation of strength (concentration/potency does not match what it is intended to be)

<p>adulteration</p> Signup and view all the answers

Misbranding: labeling is false OR misleading If not labeled with name and place of business of the manufacturer, packer, or distributer (DRUG is misbranded, not the container) If required info is not prominently displayed: must be understandable by an ordinary individual under customary conditions of purchase and use Drug must have its established name (generic name) on its label Label must contain names of inactive ingredients, and the kind and percentage of alcohol Don't have to compromise a Trade Secret If there is a brand/trade name and an established generic name, established name can be no less than 1/2 the size of the trade name Misleading containers, imitations, sold under the name of another drug (ex. labeling only the trade name when the generic equivalent is in the container) Drugs from non-registered establishments (FDA registration is a cGMP requirement) If packing or labeling is in violation of law

<p>misbranding</p> Signup and view all the answers

Prescription Label Contents Name and address of dispenser Serial number Date of the prescription or its filling Name of prescriber If stated in prescription: Name of patient Direction for use Cautionary statements

<p>prescription drug labeling</p> Signup and view all the answers

Which category of drugs requires careful dosage titration and patient monitoring?

<p>Controlled Substances</p> Signup and view all the answers

Which category of drugs is licensed under the Public Health Service Act?

<p>Biologics</p> Signup and view all the answers

Which schedule class of drugs is used to treat rare diseases or conditions?

<p>Schedule I</p> Signup and view all the answers

Which pregnancy category indicates a known risk to the human fetus?

<p>Category D</p> Signup and view all the answers

What is the purpose of the Orange Book?

<p>To identify drugs with therapeutic equivalence</p> Signup and view all the answers

Which act established the FDA Investigational New Drug/New Drug Application and Good Manufacturing Practices?

<p>Kefauver-Harris Amendment</p> Signup and view all the answers

Which act corrected and consolidated controlled substance laws in the US?

<p>Controlled Substance Act</p> Signup and view all the answers

Which act treated dietary supplements more like a type of food rather than a drug?

<p>Dietary Supplement Health and Education Act</p> Signup and view all the answers

Which act prohibited tampering, tainting, and communicating false information about consumer products?

<p>Federal Anti-Tampering Act</p> Signup and view all the answers

Which act established the FDA and is responsible for regulating drugs and devices?

<p>FDCA</p> Signup and view all the answers

Which type of prescription refills are void 90 days after the prescriber's death?

<p>CIII</p> Signup and view all the answers

According to Tennessee law, when can a pharmacist decline to dispense a drug?

<p>Both of the above</p> Signup and view all the answers

Which drugs should a pharmacist dispense if they are cheaper and covered by insurance?

<p>Generic drugs</p> Signup and view all the answers

What is the maximum time frame for refills of non-scheduled drugs after the prescriber's death?

<p>180 days</p> Signup and view all the answers

Which drugs require notification to the prescriber prior to interchanging?

<p>Anti-epileptic drugs</p> Signup and view all the answers

Which of the following is NOT a requirement for tamper-evident labeling?

<p>The labeling must be easily removable.</p> Signup and view all the answers

Which of the following is an example of drug adulteration?

<p>The drug contains an unsafe coloring agent.</p> Signup and view all the answers

Which of the following is NOT a requirement for drug labeling?

<p>The label must prominently display the name and place of business of the manufacturer.</p> Signup and view all the answers

Which of the following is a form of drug misbranding?

<p>The drug is manufactured in a non-registered establishment.</p> Signup and view all the answers

Which of the following is a requirement for prescription drug labeling?

<p>The label must provide cautionary statements.</p> Signup and view all the answers

Which act established the requirement for drugs to be safe when used as directed on the label and be approved by the FDA to be sold and marketed?

<p>Food Drug and Cosmetic Act</p> Signup and view all the answers

What incident in 1937 led to the targeting of drugs used in liquid formulations, specifically those targeted at children?

<p>Sulfanilamide incident</p> Signup and view all the answers

Which act established the prescription drug class and further defined it, even though it was already somewhat established by a previous act?

<p>Durham-Humphrey Amendment</p> Signup and view all the answers

Which act focused on adulteration and misbranding of drugs, with a particular emphasis on labeling?

<p>Pure Food and Drug Act</p> Signup and view all the answers

Which act tried to address drug abuse by taxing drugs, but was not effective in curbing the issue?

<p>Harrison Anti-Narcotic Act</p> Signup and view all the answers

Which agency is responsible for protecting public health and assuring the safety, effectiveness, and security of drugs, vaccines, and biological products, medical devices, food supply, cosmetics, dietary supplements, and products that give off radiation?

<p>Food and Drug Administration</p> Signup and view all the answers

Which drugs are exempt from the Poison Prevention Packaging Act (PPPA)?

<p>Topicals and injectables</p> Signup and view all the answers

Which agency does not routinely inspect pharmacies but can inspect them without a warrant and without stating a reason for being there?

<p>Food and Drug Administration (FDA)</p> Signup and view all the answers

Which drugs are considered legend drugs and require a prescription from a licensed healthcare professional?

<p>Any item that federal law prohibits dispensing without a prescription</p> Signup and view all the answers

Which drugs are exempt from the requirement of being dispensed in special packaging under the Poison Prevention Packaging Act (PPPA)?

<p>Topicals and injectables</p> Signup and view all the answers

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