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CPJE
Within how many days must the board be notified of a change of pharmacy ownership - correct answer 30 days Within how many days must the board be notified of a change of address or name - correct answer 30 days Within how many days must the board be notified of a change of the pharmacist-in-charge - correct answer 30 days Within how many days must the board be notified in the case of a bankruptcy, insolvency, or receivership - correct answer To be reported immediately in writing Within how many days must the board be notified of drug loss (by destruction or pilferage) - correct answer 30 days (if controlled substance DEA notified immediately) Within how many days must the board be notified regarding any change in pharmacy permit - correct answer 30 days Within how many days must the board be notified by the PIC if a licensed employee of the pharmacy is involved in the theft, diversion, or self-use of a drug or exhibits behavior representing an impairment that affects that person ability to practice - correct answer 30 days How long should community pharmacy prescription records be kept - correct answer At least 3 years after last filling of prescription
How long should hospital pharmacy prescription records be kept - correct answer At least 7 years after last filling of prescription How long should clinic pharmacy prescription records be kept - correct answer At least 3 years after last filling of prescription How long should patient medication profile records be kept - correct answer At least 1 yr from date of last entry. NON CONTROLLED meds must be maintained on premises How long should pharmacy technician compliance records be kept - correct answer 3 yrs from time of making How long should controlled substance inventory records be kept - correct answer 3 yrs from taking of inventory How long should certificates of CE course completion be kept - correct answer 4 yrs from date of course completion How long should DEA form 222 order records be kept - correct answer 2 yrs self-assessment pharmacy records - correct answer Kept for 3 yrs. Completed by July 1st each ODD year. Complete self assessment within 30 days of a new pharmacy permit issuance or change of PIC How long should patient medication error documentation records be kept - correct answer For at least 1 year
If no security rx for schedule II drug is sent by prescriber pursuant to an emergency oral order-time period notification to DEA - correct answer within 6 days after 7 days of the emergency oral order Time period a schedule III or IV prescription must be filled or refilled before it is void - correct answer Usually within 6 months from date written. Total supply received (NOT per refill) shall not to exceed 120 days supply of medication in 6 mo period AND refills shall NOT exceed 5 times in a 6 month period Expiration data for any compounded prescription - correct answer 6 months or less (if any ingredient expires before 6 mo) Expiration date for extemporaneous unit dose preparations - correct answer 1 yr or less if manufacturer's expiration date is less than 1 year Renewal time period on a pharmacy permit - correct answer Must be renewed yearly Temporary permit issued upon transfer of ownership - correct answer 180 days Period one must renew license to continue to practice pharmacy - correct answer Every 2 yrs. If license not renewed within 3 yrs of date renewal was due, it shall not be renewable Max amount of time a pharmacist may leave the pharmacy and leave other non-pharmacists in the pharmacy - correct answer No more than 30 min for meal or other breaks
Period of time rx records must be produced from an off-site storage facility when requested - correct answer Within 48 hours Period of time PIC must do investigation & report once a medication error is discovered - correct answer Within 48 hours of discovery error Max amount that may be charged as an administrative fee in addition to the cost of an emergency contraceptive agent (no admin fee may be charged if OTC on Plan B) - correct answer $ Notice Requirement by board & response to notice by licensee - correct answer After notice licensee must respond within 10 days Upon closure of a pharmacy, a transfer of drugs notice must be provided to the board - correct answer Within 10 days of the closure, and must be in writing Definition of a pharmacy being Closed down - correct answer Pharmacy no longer engaged in activity it was licensed for, or not operating at least 1 day per wk in a 120 day period Must report to DEA within how many days any loss/theft of controlled substances - correct answer 1 business day If mobile pharmacy is started after main pharmacy is destroyed/damaged, when must the mobile pharmacy halt business after original pharmacy is restored - correct answer 48 hours after restoration
DEA 222 - correct answer Use anytime a CII is ordered, distributed, transferred. Each book has 7 forms. Max of 6 books supplied at a time. 1st copy is wholesaler, 2nd is DEA, 3rd = pharmacy. Loss of forms must be immediately reported to DEA providing serial numbers DEA 224 - correct answer to register with DEA. Renewed Q3 years within 60 days of expiration date DEA 106 - correct answer to report any loss/theft of CS. Must be reported within 1 business day DEA 41 - correct answer Report any destruction of a CII (planned disposal or accidental breakage/spillage DEA 363 - correct answer Separate DEA registration as a Narcotic Treatment Program. Must request to be a DATA waved practitioner. May treat 30-100 patients at a time. Has unique ID number beyond DEA number Transferring of business (with controlled substances) - correct answer Must notify special agent in charge at least 14 days before transfer. A complete inventory must be done the day of transfer. Form 222 must be issued to transfer CII Transfer CII to original supplier - correct answer Form 222 needs to be issued Disposal of controlled substances - correct answer Transfer to DEA registered reverse distributor (contact local DEA for listings). Reverse
distributor needs to issue a Form 222. Reverse distributor should issue form 41 for the destruction of controlled substances Central location recordkeeping for controlled substances - correct answer May occur 14 days after DEA received notice CII records should be separate from other records - correct answer CIII-V can be separated entirely from both CII & non-controlled OR CIII-V can be incorporated with non-controlled files if marked with a red C Inventory requirement for controlled substances - correct answer ACTUAL count for ALL CII!!! Estimated count for CIII-V UNLESS bottle of > 1000 then need ACTUAL count. Records must be retrievable on premises for 2 years Exemption for fax CII (able to treat fax as original) - correct answer 1. If drug is to be compounded for direct admin to patient by parenteral, IV, IM, SC, intraspinal
- If for residents of long term care facilities transmit rx to the dispensing pharmacy
- If patient enrolled in hospice program certificed by medicare Multiple CII scripts given to 1 patient - correct answer Ok & valid if meets all CII requirements & ONLY for max of 90 day supply CII - correct answer Registration is required. Receiving records = DEA form
- Written RX. No refills. Separate filing. Distribution between registrants require DEA form 222. Locked cabinet or dispersed among noncontrols. Report to DEA in 1 business day & complete DEA form 106. Maintain all records for 2 years unless state law requires longer
Information on RX prices - correct answer Pharmacy must place BOP notice to consumers of the availability of RX price info. Pharmacy shall give current retail price for any drug sold if requested. If patient request price for > 5 rx & no valid rx - correct answer Pharmacy may request that price request is in writing & prices can be given in 10 days; may charge fee for EACH prescription price quote but inform patient first; NOT required to respond to > 3 requests for a single person in 6 mo period; CS telephone requests don't have to honor; do not have to respond to competitor, do not have to respond to out of state requester Compounding sterile injectables from nonsterile ingredients - correct answer ISO class 5 laminar airflow hood with ISO class 5 cleanroom. Certification for sterile compounding records should be maintained for at least 3 yrs. For parenteral cytotox agents --> MUST use Class II type A or type B vertical laminar air flow hood with bag in bag out design Requirements for pharmacy license - correct answer 18 yo, graduated college of pharmacy or dept of pharmacy of a university. If foreign then certified by FPGEC. Completed 150 units of collegiate study in the US or equivalent in foreign country. No less than 90 units must have been a resident of US. Complete 1500 hours of pharmacy practice. Passed written & practical exam given by board. Proof of qualifications supplie to board. Paid fees On site storage requirements - correct answer On site also includes a building/storage area directly attached to the premises (or the same address). Compounding ahead of time - correct answer ONLY allowed if a limited quantity of compounded product in advance if that quantity is necessary to ensure continuity of care for an identified population of patients based on documented history. Not more than 72 hr supply for office use.
Master compounding formula - correct answer Active ingredients. Inactive ingredients. Process/procedures used. QA reviews at each step. Post- compounding process or procedures if any. Exp date requirements (not to exceed 6 mo or shortest exp date of any component of compounded drug) Combat Methamphetamine Epidemic Act of 2005 - correct answer Pseudoephedrine/ephedrine/phenylpropanolamine. Must be behind the counter or locked in cabinet. Record keeping: name of purchaser, address, date & time of saline, amount of product sold. Maintain for 2 yrs. 3.6 g/day per individual or 9 g/mo, no more than 7.5 g can be imported. Sold in blister packs. Report loss/theft within 15 days in writing, also report orally to local DEA. Exception: single purchase of 1 60 mg pseudoephedrine unit dose package or a unit dose package containing 2-30 mg tabs = no log entry required When nonschedule & schedule III, IV, & V are lent, borrowed, sold or bought btwn pharmacies, what is the responsibility of the pharmacist & pharmacy - correct answer Both pharmacies must keep a log of the transfer whether it is lent, sold, borrowed or bought. CII requires form DEA 222 What schedule is ketamine - correct answer CIII both in California & federally The resale of drugs acquired at preferentially low prices is prohibited EXCEPT
- correct answer 1. When sold to a walk-in customer w/RX & those sales represent < 1% of the purchasing pharmacy's annual purchases
- Emergency situation where no other sources are readily available in the community ***For profit must return exact drug & exact amount to non-profit pharmacy when drug comes in.
until MD available. RECORD on reverse side of RX: date & quantity given, note MD not available, & judgment for dispensing Apomorphine shedule - correct answer CII in California but not a schedule federally Patient Consultation Regulation - correct answer Pharmacist or pharmacy intern must provide ORAL consultation to patient. If hospital discharge, someone other than pharmacist may provide discharge counseling to patient about new meds. When RX is delivered then responsibility of patient to request consultation. INCLUDE: directions, storage, importance of compliance, precuation & warning ADR Patient presents to pharmacy from out-of-state with empty labeled RX for digoxin that she's been on for 10 yrs. No refills remaining. Can pharmacist refill? - correct answer In best interest of patient to refill, but violation of law b/c pharmacy doesn't have record of medication. If pharmacist call out-of state pharmacy & request copy of RX then may fill emergency supply. Human chorionic gonadotropin schedule - correct answer CIII in california Faxed RX - correct answer May accept as original RX if sent by MD, PA, NP, CNM, & ND for nonscheduled & CIII, IV, & V. If faxed by patient, need original or call MD to take telephone order. Require initials of sender Internet RX - correct answer Need name or initials of person sending whether the MD or his or her designee & assurances med was ordered as result of good faith exam on the part of the MD
If the CIII indicates that it may be refilled PRN then the pharmacist must respond to this by... - correct answer Filling original X, but unable to refilled the med until clarify with MD the number of refills (1-5 in 6 mo period). NO RX that is controlled is allowed to be PRN refills. If a RX is written by a PA, NP, CNM, or Rph pursuant to MD authorized protocol, does MD name still need to be on RX label? - correct answer No, only name of PA, NP, CNM, or Rph is fine. May prescribe controlled meds pursuant to MD protocol IF registered with DEA Drug sample - correct answer No person may sell, purchase, or trade or offer to sell, purchase, or trady any drug sample. Rph can not even charge dispensing fee for preparing drug sample. Must provide at no charge What is not a legal requirement of pharmacy techs? - correct answer Pass an exam administered by BOP in order to be granted pharmacy tech certification Patient package insert - correct answer Required for all drugs containing estrogenic agent A pharmacy may order CII from out-of-state wholesaler, manufacturer, or other supplier as long as pharmacy forwards a true & correct copy of the order, contract, or agreement for procurement of such a CII drug to who & within what time period - correct answer State's Attorney General's office within 24 hours of transmitting order What should pharmacist do if MD fills scheduled medication incorrectly - correct answer Contact MD for clarification. Make correction on security RX. Document changes & note that it was authorized by MD. NOT required that MD send new security RX.
If licensed employee admits to using drugs illegally - correct answer Must report to BOP within 30 days. It is customary to suspend employee from work pending an investigation or terminated from employment. Non-licensed parties such as clerks don't have to be reported, but incident must be reported within 30 days to board of missing or stolen drugs Who may sign for receipt of prescription drugs delivered to pharmacy after pharmacy orders from wholesaler - correct answer pharmacist & pharmacy intern
