Podcast
Questions and Answers
Match the following drug categories with their descriptions:
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:
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:
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:
Match the following new drug types with their descriptions:
Match the following agencies with their primary responsibilities:
Match the following agencies with their primary responsibilities:
Match the following documents with their sources:
Match the following documents with their sources:
Match the following actions with the responsible agency:
Match the following actions with the responsible agency:
Match the following statements with the correct law or doctrine:
Match the following statements with the correct law or doctrine:
Match the following acts with their primary focus:
Match the following acts with their primary focus:
Match the following organizations with their descriptions:
Match the following organizations with their descriptions:
Match the following terms with their definitions:
Match the following terms with their definitions:
Match the following entities with their roles:
Match the following entities with their roles:
Match the following laws and amendments with their descriptions:
Match the following laws and amendments with their descriptions:
Match the following terms with their definitions:
Match the following terms with their definitions:
Match the following types of health claims with their descriptions:
Match the following types of health claims with their descriptions:
Match the following drug statuses with their time frames:
Match the following drug statuses with their time frames:
Match the following laws and regulations with their descriptions:
Match the following laws and regulations with their descriptions:
Match the following terms with their definitions:
Match the following terms with their definitions:
Match the following exemptions with their descriptions:
Match the following exemptions with their descriptions:
Match the following organizations with their responsibilities:
Match the following organizations with their responsibilities:
Match the following terms with their definitions:
Match the following terms with their definitions:
Match the following examples with the correct term:
Match the following examples with the correct term:
Match the following requirements with the correct term:
Match the following requirements with the correct term:
Match the following descriptions with the correct term:
Match the following descriptions with the correct term:
Match the following regulations with their descriptions:
Match the following regulations with their descriptions:
Match the following regulations with their corresponding numbers:
Match the following regulations with their corresponding numbers:
Match the following conditions with their corresponding regulations:
Match the following conditions with their corresponding regulations:
Match the following regulations with their corresponding actions:
Match the following regulations with their corresponding actions:
Match the following regulations with their corresponding provisions:
Match the following regulations with their corresponding provisions:
Match the following regulations with their corresponding requirements:
Match the following regulations with their corresponding requirements:
Thalidomide was a non-barbiturate ______.
Thalidomide was a non-barbiturate ______.
DESI drugs safe but NOT ______.
DESI drugs safe but NOT ______.
Drugs now had to be ______ and effective to be marketed in the US.
Drugs now had to be ______ and effective to be marketed in the US.
Federal CSA is strict, so states don’t tend to add ______.
Federal CSA is strict, so states don’t tend to add ______.
______ trumps state law if conflicting (Supremacy Clause)
______ trumps state law if conflicting (Supremacy Clause)
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.
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.
The ______ is under the US Department of Justice and is responsible for enforcing the controlled substances laws and regulations of the US.
The ______ is under the US Department of Justice and is responsible for enforcing the controlled substances laws and regulations of the US.
The ______ is under the US Department of Health and Human Services and is responsible for recognizing providers.
The ______ is under the US Department of Health and Human Services and is responsible for recognizing providers.
Pharmacists’ cognitive services have been instrumental in pharmacist involvement in drug therapy optimization in ______ facilities and in OBRA-90 requirements.
Pharmacists’ cognitive services have been instrumental in pharmacist involvement in drug therapy optimization in ______ facilities and in OBRA-90 requirements.
______ laws promote competition, 'prohibit' monopolies, 'make illegal certain practices deemed to hurt business or consumers or both, or generally violate standards of ethical behavior'.
______ laws promote competition, 'prohibit' monopolies, 'make illegal certain practices deemed to hurt business or consumers or both, or generally violate standards of ethical behavior'.
The TN Board of Pharmacy is comprised of 7 pharmacists and 1 non-pharmacist ______.
The TN Board of Pharmacy is comprised of 7 pharmacists and 1 non-pharmacist ______.
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.
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.
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)
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)
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
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
______ 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
______ 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
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
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
The dispensing of CII controls is not allowed after the prescriber ______
The dispensing of CII controls is not allowed after the prescriber ______
Refills for CIII, CIV, and CV drugs are void ______ days after the prescriber's death
Refills for CIII, CIV, and CV drugs are void ______ days after the prescriber's death
Refills for non-scheduled drugs are void ______ days after the prescriber's death
Refills for non-scheduled drugs are void ______ days after the prescriber's death
A pharmacist may decline to dispense a drug if it lacks ______ or a ______
A pharmacist may decline to dispense a drug if it lacks ______ or a ______
According to the Prescription Drug Marketing Act, retail pharmacies should not have ______ drug samples.
According to the Prescription Drug Marketing Act, retail pharmacies should not have ______ drug samples.
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.
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.
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.
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.
Prescribers can give waivers for easy-open caps on prescription medications one-by-one, or patients/patient's representatives/prescribers can provide ______ waivers.
Prescribers can give waivers for easy-open caps on prescription medications one-by-one, or patients/patient's representatives/prescribers can provide ______ waivers.
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
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
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
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
113 Off Label Drug Use ______ allows truthful promotion of off-label uses
113 Off Label Drug Use ______ allows truthful promotion of off-label uses
202: ______ should substitute with generic to save $$$
202: ______ should substitute with generic to save $$$
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
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
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
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
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
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
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)
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)
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
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
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
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
Which category of drugs requires careful dosage titration and patient monitoring?
Which category of drugs requires careful dosage titration and patient monitoring?
Which category of drugs is licensed under the Public Health Service Act?
Which category of drugs is licensed under the Public Health Service Act?
Which schedule class of drugs is used to treat rare diseases or conditions?
Which schedule class of drugs is used to treat rare diseases or conditions?
Which pregnancy category indicates a known risk to the human fetus?
Which pregnancy category indicates a known risk to the human fetus?
What is the purpose of the Orange Book?
What is the purpose of the Orange Book?
Which act established the FDA Investigational New Drug/New Drug Application and Good Manufacturing Practices?
Which act established the FDA Investigational New Drug/New Drug Application and Good Manufacturing Practices?
Which act corrected and consolidated controlled substance laws in the US?
Which act corrected and consolidated controlled substance laws in the US?
Which act treated dietary supplements more like a type of food rather than a drug?
Which act treated dietary supplements more like a type of food rather than a drug?
Which act prohibited tampering, tainting, and communicating false information about consumer products?
Which act prohibited tampering, tainting, and communicating false information about consumer products?
Which act established the FDA and is responsible for regulating drugs and devices?
Which act established the FDA and is responsible for regulating drugs and devices?
Which type of prescription refills are void 90 days after the prescriber's death?
Which type of prescription refills are void 90 days after the prescriber's death?
According to Tennessee law, when can a pharmacist decline to dispense a drug?
According to Tennessee law, when can a pharmacist decline to dispense a drug?
Which drugs should a pharmacist dispense if they are cheaper and covered by insurance?
Which drugs should a pharmacist dispense if they are cheaper and covered by insurance?
What is the maximum time frame for refills of non-scheduled drugs after the prescriber's death?
What is the maximum time frame for refills of non-scheduled drugs after the prescriber's death?
Which drugs require notification to the prescriber prior to interchanging?
Which drugs require notification to the prescriber prior to interchanging?
Which of the following is NOT a requirement for tamper-evident labeling?
Which of the following is NOT a requirement for tamper-evident labeling?
Which of the following is an example of drug adulteration?
Which of the following is an example of drug adulteration?
Which of the following is NOT a requirement for drug labeling?
Which of the following is NOT a requirement for drug labeling?
Which of the following is a form of drug misbranding?
Which of the following is a form of drug misbranding?
Which of the following is a requirement for prescription drug labeling?
Which of the following is a requirement for prescription drug labeling?
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?
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?
What incident in 1937 led to the targeting of drugs used in liquid formulations, specifically those targeted at children?
What incident in 1937 led to the targeting of drugs used in liquid formulations, specifically those targeted at children?
Which act established the prescription drug class and further defined it, even though it was already somewhat established by a previous act?
Which act established the prescription drug class and further defined it, even though it was already somewhat established by a previous act?
Which act focused on adulteration and misbranding of drugs, with a particular emphasis on labeling?
Which act focused on adulteration and misbranding of drugs, with a particular emphasis on labeling?
Which act tried to address drug abuse by taxing drugs, but was not effective in curbing the issue?
Which act tried to address drug abuse by taxing drugs, but was not effective in curbing the issue?
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?
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?
Which drugs are exempt from the Poison Prevention Packaging Act (PPPA)?
Which drugs are exempt from the Poison Prevention Packaging Act (PPPA)?
Which agency does not routinely inspect pharmacies but can inspect them without a warrant and without stating a reason for being there?
Which agency does not routinely inspect pharmacies but can inspect them without a warrant and without stating a reason for being there?
Which drugs are considered legend drugs and require a prescription from a licensed healthcare professional?
Which drugs are considered legend drugs and require a prescription from a licensed healthcare professional?
Which drugs are exempt from the requirement of being dispensed in special packaging under the Poison Prevention Packaging Act (PPPA)?
Which drugs are exempt from the requirement of being dispensed in special packaging under the Poison Prevention Packaging Act (PPPA)?
