(Solution) Indiana MPJE Review 2020 Part 1, Indiana MPJE Review 2020 Part 2, Indiana MPJE Review 2020 Part 3, Indiana MPJE Review 2020 Part 4

(Solution) Indiana MPJE Review 2020 Part 1, Indiana MPJE Review 2020 Part 2, Indiana MPJE Review 2020 Part 3, Indiana MPJE Review 2020 Part 4 Which federal act discusses adulteration and misbranding of drugs? Food Drug and Cosmetic Act T/F Adulteration/Misbranding can occur with both a drug and a device. True T/F A drug must be contaminated to be considered adulterated. F - if held under unsanitary conditions where it MAYA have been contaminated A container that contains a drug is made of poisonous or harmful materials. However, there is no harm to the drugs inside the container. Is the drug considered adulterated? Yes T/F: If a product does not meet standards of USP, but plainly states on it's label "Not USP" it is not considered adulterated. True - can deviate from USP standards if it says on package plainly "Not USP" T/F If quality or purity falls above the stated amount on the bottle it is considered adulterated. False - no only considered adulterated if it falls below purity/quality stated T/F If a strength of a drug does not match what is stated on the bottle, it is both adulterated and misbranded. True T/F: Providing a drug product other than the one that is written on the bottle is considered misbranding only. False - Misbranding and Adulteration An Rx product dispensed directly to a patient is misbranding when it does not contain name and place of business of the manufacturer, packer, and/or distributor. False - commercial products must contain this, but not Rx products dispensed to a patient do not have to have this A commercial product must accurately contain the quantity listed on the bottle, but an Rx dispensed directly to a patient does not have to have this information on it. True - considered misbranding if a commercial product does not have an accurate quantity listed on it On a commercial product, generic names but be _______ the height of the brand name. Half If a legend drug is dispensed without a prescription or drug order, it is considered misbranding. True If a drug may decompose, it must state this on the label or it is considered misbranding. True A drug dispensed after the written Rx has expired is considered adulteration. False - this is misbranding cGMP applies to who? Manufacturers Manufacturers must go through the inspection process every ____ years. Once every 2 years Moving a drug manufacturer facility oversees exempts a manufacturer from cGMP. False - cGMP applies to facilities in the US and making products for use in the US What 3 things constitute pharmacy compounding? 1. For an individual patient 2. Based on receipt of valid Rx or drug order from licensed practitioner 3. Compounded by a licensed pharmacist or physician If something meets criteria for pharmacy compounding, it is exempt from what 3 regulations? cGMP Misbranding New drug requirements T/F Pharmacists may compound something before the receipt of an Rx? True If a location does not meet requirements of pharmacy compounding, what are they considered? An outsourcing facility Which medical device is the simplest device? Class I Medical Device Class: Stethoscope Class I Medical Device Class: Scissors Class I Medical Device Class: Toothbrushes Class I Medical Device Class: Syringes Class II Medical Device Class: Tampons Class II Medical Device Class: Condoms Class II Medical Device Class: Hgb A1c Assays Class II Which device class requires special controls to assure safety and effectiveness of the device such as performance standards, postmarket surveillance, patient registries, etc Class II Which device Class requires premarket approval? Class III Medical Device Class: pacemakers Class III Medical Device Class: replacement heart valves Class III Medical Device Class: Soft contact lenses Class III All new devices automatically fall into this class unless FDA determines that they are substantially equivalent to other classes? Class III What types of devices require an Rx due to the potential harm and need for collateral measures to ensure their proper use? Restricted devices What are some examples of restricted devices? Contact lenses and diaphragms What is currently the only banned device? Prosthetic hair fibers What type of devices are excluded from the US market? Banned devices Which of the following does the FDA NOT have the authority to mandate a recall? A. Devices B. Drugs C. Foods D. Biological products B - Drugs - they can only be voluntarily issued by the manufacturer What kind of action can the FDA take if they believe a drug should be recalled, but the manufacturer is unwilling to issue the recall? Seizure or injunction action Who is responsible for notifying consumers of recalls? The sellers Who is responsible for notifying sellers about a recall? The manufacturers Recall Class: Missing batch # on medication bottle Class III Recall Class: Valsartan contains NMDA Class I Recall Class: microbial contamination of a personal lubricant Class II Recall Class: microbial contamination of non-injectable, non-ophthalmic sterile product that can cause medical issue Class II Recall Class: insecure or incorrect closures for medicines such as cytotoxics Class II Recall class: hardware or software failures in ventilators resulting in shut down during its use Class I Recall Class: microbial contamination of sterile injectable Class I Recall Class: a false result on an IVD test for digoxin levels Class I: Digoxin has a narrow therapeutic range and if overdose could cause serious damage Recall Class: False negative result on an IVD test for HIV Class I Recall Class: blood components accidently released after donation tested initial-positive Class I Recall Class: infusion pumps giving visual or audible alarms due to software or hardware issues resulting in delay in infusion Class II Recall Class: IVD test kit that could identify the wrong strain of micro-organism Class II Recall Class: the outer packaging of a medical device indicates a different size to that which is actually in the supplied in the box, but it is obvious to the clinician it is the incorrect size Class III What is the goal of the PPPA? To prevent accidental poisoning in children under the age of 5 The PPPA gives which organization the authority to require special packaging of "hazardous substances"? Consumer Product Safety Commission What are the 3 requirements for CRC packaging? 1. 90%+ adults should be able to open without difficulty 2. 85% of children 5 who have never seen this packaging and were not given directions should not be able to open the package in 5 min 3. At least 80% 5 yo still cannot open the package after an adult shows them how to open the container in 5 minutes Which route of administration of drugs does the PPPA apply to? Oral drugs ONLY! T/F Prescribers and patients can issue a blanket waiver for non-child resistant packaging for their Rxs. F: Patients can issue a blanket waiver for their Rxs to have the easy-open caps Providers can only issue a prescription-by-prescription waiver T/F: A prescriber requests easy-open caps for a patient's amlodipine Rx that has 5 refills. This waiver stays in place for all of the patient's refills for this amlodipine Rx unless requested otherwise. True What are the #21 medication exceptions to the PPPA? 1. SL NTG 2. SL & chewable ISDN 3. EES granules for oral suspension 4. Cyclical OC in memory aid packaging 5. Anhydrous cholestyramine in powder form 6. Unit dose forms of KCl 7. NaF drug prep containing 264 mg of NaF/pack & no other drugs with it 8. Betamethasone tabs in dispenser packs 9. Pancrelipase 10. Deltasone Dosepak (or equivalent) /= 105 mg pred 11. Mabendazole tabs w/ 600 mg of AI 12. Medrol Dosepak (or equivalent) /= 84 mg AI 13. Colestipol powder /= 5 g 14. Conjugated estrogens USP /= 32 mg AI 15. Norethindrone in memory aid packs 50 mcg 16. Sucrase in glycol & water 17. HRT relying solely on one or more progesterone or estrogen 18. Celesevelam /= 3.75 mg 19. Sevelamer carbonate /= 2.4 g/pack 20. Certain iron-containing animal feeds 21. Iron-containing dietary supplements If a patient brings in a the last Rx bottle to the pharmacy when they request a refill, can we reuse it? No - only if it is glass We can reuse Rx containers if their are glass provided what? New cap or closure is provided Package inserts are designed for who? Healthcare professionals T/F You are not allowed to give PIs to patients. False - you can give to patients T/F: For drugs approved before 2001 it is not required for them to update their PIs. True Drugs approved after what year were required to have a new format PI? 2006 Drugs approved in these date ranges were required to slowly update their PIs to follow the new format PIs? Drugs approved after 2001 but before 2006 PPIs must be dispensed for the required drugs in which settings: A. Retail pharmacies B. Hospitals C. Long-term care facilities D. Provider's offices E. All of the above E - must be given to everyone getting this medicine in all of these places PPIs are only currently required for...? Estrogens & oral contraceptives T/F: PPIs and Med Guides must be given both on new Rxs and refills. True If a patient in a hospital is given a medication that requires a PPI, when are they usually given to patients? With first dose of medication and at least every 30 days thereafter T/F Med guides are not required to be given to patients in a hospital. True - only have to give to patients who are outpatients and not under direct supervision of a healthcare provider Under the Prescription Drug Marketing Act, drugs may not be reimported in the US unless what? Unless reimported by the manufacturer of the drug or for emergency use after review by the FDA T/F Hospitals (with preferential pricing) are not allowed to sell drugs to any entity. F - they can sell drugs to a hospital under common ownership or to another entity that is allowed to purchase those preferential pricing drugs Which type of pharmacies are not allowed to have drug samples under the PDMA? Retail pharmacies Practitioners that would like drug samples must request them how? Must request them in writing How long must you keep records relating to the PDMA? 3 years What does the PDMA say about drug coupons? Prohibits the sale, purchase, trade, and counterfeiting of drug coupons T/F Records relating to PDMA can be kept in electronic format. True What is a whistleblower award with respect to the PDMA? If you provide information on someone violating the PDMA and that info leads to a conviction you are entitled to 1/2 of the criminal fine imposed and collected for such violation up to $125,000 What is the maximum amount of money that a whistleblower can receive under the PDMA? $125,000 What are the 5 crimes under the Federal Anti-Tampering Act? 1. Tampering of attempting to tamper with a product's packaging or labeling 2. Tainting a product 3. Communicating false info that a product has been tainted