CPJE | 290 QUESTIONS| WITH COMPLETE SOLUTIONS

Poison Prevention Packaging Act- place ORAL (only) Rx meds in child-resistant safety containers. What are the exceptions? correct answer: - Nitroglycerin SL tab - Erythromycin ethylsuccinate granules for oral suspension - colestipol powder (Colestid- BAS) - oral contraceptives in manufacturer's memory-aid dispenser packages - Doctor or patient may request a non-complying container (keep documentation if that occurs) erythromycin oral counseling correct answer: Base, PCE or stearate dosage forms should be taken on an empty stomach Ethylsuccinate (E.E.S. Granules) or delayed-release (Ery-Tab) admin without regard to meals-- May consider administering after food to decrease GI discomfort. DEA Form 222 correct answer: Ordering of Schedule I & II C.S requires DEA Form 222 - keep record for 3 YEARs - Pharmacies can sell to other pharmacies or to prescribers with DEA 222 form (C I & II) -- can sell MAX 5% of their C.S dispensing (ie. can sell 1,000 to another pharmacy if dispense 20,000 C.Subs) - Valid for up to 60 days - The reverse distributor issues DEA Form 222 for C.S. II. Transfer of Schedule II C.S correct answer: Schedule II C.S canNOT be transferred (DEA Form 222 is NOT used to transfer prescriptions) Filing of prescriptions correct answer: Schedule III, IV, or V C.S prescriptions REQUIRE a 1-inch red 'C' on lower right corner if filed along with NON-scheduled prescriptions - does not apply for electronic filing systems - EXCEPTION: Schedule II C.S prescriptions MUST be filed separately Paper or electronic C.S prescription records must be kept for: correct answer: - Federal: 2 years - CA: 3 years - When there's a conflict between a federal and a state statute, the federal statute outweighs the state statute or regulation, unless the state law is more stringent and, thus, mandates over the less stringent federal rule. Refill PRN (non-scheduled drugs) correct answer: valid for 1 year from the date prescription was written CA Continuing Education Requirements correct answer: - 30 hours CE/2 years - 2 of the 30 CE hours MUST be law & ethics from a course provided by the Board - retain CE certificates for 4 years REMS (Risk Evaluation and Mitigation Strategies) correct answer: - required by the FDA for some drugs - developed by manufacturer and approved by FDA to ensure benefits outweigh risks, ensure appropriate prescribing and minimize patient risk Recalls, Market Withdrawals, & Safety Alerts correct answer: Recall: remove a product from market by a firm's own initiative, FDA request/order - Class I recall: reasonable probability of serious adverse health consequences/death - Class II: may cause temporary/reversible S.E; probability of serious consequence is remote - Class III: not likely to cause adverse health consequences - Market withdrawal: firm removes the product from market and/or corrects minor violation