NC MPJE Questions and Answers with Certified Solutions

NC MPJE Questions and Answers with Certified Solutions DEA Form 222 Required for purchase of CI and CII drugs 1 item per line, number of lines noted at the bottom List name and address of supplier Copies 1 and 2 are submitted to supplier, copy 3 kept for record Should record each item received and date received on copy 3 Orders may be partially filled as long as the balance is shipped within 60 days Supplier may substitute 5x100 when 1x500 is requested After order is filled, supplier sends copy 2 to Special Agent in Charge at the DEA Form must be complete and legible, show no signs of alteration or erasure Order forms must be maintained for 2 years Software to order CII's electronically is available Must report stolen or lost forms to the DEA immediately Must use 222 form to sell to doctor's office for office use Initial and Biennial Inventory Within 10 days of becoming pharmacist-manager Any time a drug is reclassified from non-controlled to a controlled substance CIIs must be an exact count or weight CIII, IV, and V can be estimated unless the bottle contains more than 1000 tabs or caps Keep record for 2 years, 3 years in NC Inventory must include: Name, address, and DEA number of registrant Date and time inventory was taken Signature of person doing inventory Name, dosage form, strength of CS Number of units or total volume Emergency Refills May give up to a 30 day supply of any drug except a CII, must notify provider within 72 hours Medication must be essential to the maintenance of life or to the continuation of therapy in a chronic condition If the physician is unable to provide services to the patient (dies, moves, unable to practice) the pharmacist may dispense a one-time emergency refill of up to a 90-day supply Order CII, CIII, and CIV for office use Schedule II: must use a DEA Form 222 and send to the supplier CIII and CIV may use an invoice Identification for CS pick-up Required for all CII and some CIII Acceptable forms: driver's license, special ID issued by NC DMV, military ID, passport Other pharmacy staff may review the ID 1938 Food, Drug, and Cosmetic Act Following sulfonilamide tragedy, required companies to prove safety to the FDA 1951 Durham-Humphrey Amendment Distinguished RX from OTC, label must read RX only 1961 Kefauver Harris Required to prove drug safe and effective if introduced after 1962 Labels on commercial containers Name and address of manufacturer Ingredient information Identity (brand and generic name) Quantity Net quantity of package (# of pills) Dosage statement or package insert Lot number NDC Prescription Drug Marketing Act of 1987 1. Reimportation of drugs in US banned 2. Prohibits sale (except emergency) of RX drugs by hospital to non-hospital 3. Prohibits sale of human drugs bought by charitable institutions at reduced prices 4. Bans sale of samples 5. Requires prescribers to request samples in writing 6. Mandates storage and records of samples DEA Form 41 Destruction of controlled substances Must list all drugs to be destroyed Must submit a letter requesting permission to destroy the drugs stating proposed date of destruction, method of destruction, and name of 2 witnesses Witnesses may be physicians, pharmacist, mid-level practitioner, nurse, or law enforcement officer Must submit 2 signed copies of DEA form 41 to be forwarded to DEA 2 methods of destruction: incinerator or flush into city sewer system Must keep perpetual inventory of all substances waiting destruction Hospital: continuous destruction, retail: once a year If pharmacy transfers CII to a distributor for destruction, distributor must issue a DEA form 222 to the pharmacy, CIII-CV may be documented in writing