Pharmacist-Manager Responsibilities and Prescription Handling Regulations, Exams of Pharmacy

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North Carolina MPJE

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2024 - 2025 Graded A+

North Carolina MPJE Question Bank

150 RX/Day Rule - CORRECT ANSWER If a mistake occurs and a Board hearing results and the pharmacy filled more than 150 RX/Day/Pharmacist, then the pharmacy will suffer the same penalty as given to the pharmacist Typically used as an aggravating factor during a hearing, difficult to enforce 1938 Food, Drug, and Cosmetic Act - CORRECT ANSWER Following sulfonilamide tragedy, required companies to prove safety to the FDA 1951 Durham-Humphrey Amendment - CORRECT ANSWER Distinguished RX from OTC, label must read RX only 1961 Kefauver Harris - CORRECT ANSWER Required to prove drug safe and effective if introduced after 1962 Absence of Pharmacist - CORRECT ANSWER When the health care facility pharmacy is not open 24 hours:

• Policies and procedures for provision of drugs and pharmaceutical care after hours is required
• On call pharmacist coverage is required during all absences
• Ancillary drug cabinets are permitted Who may enter pharmacy after hours:
• Only if the drug is needed and not in ancillary cabinet
• Nurse authorized by the pharmacist manager Pharmacist must maintain a list of restricted medications:
• Removal of these medications can occur only after consultation with the on- call pharmacist

Automated dispensing devices not in a facility with a pharmacy - CORRECT ANSWER Must have a limited service permit Board of Pharmacy members - CORRECT ANSWER Consists of 6 members 5 licensed pharmacists residing in NC, each from 5 geographic areas Elected by all pharmacists, not just those in area Voted on by all pharmacists with paid active or inactive license who resides in the state 1 public member (not a pharmacist) appointed by governor When elected, go onto Board for 1 year internship, then serve their 5 year term Meets monthly to conduct hearings and other work of the Board Board hires an executive director (Jay Campbell) Acts as prosecuting attorney- MUST investigate violations, may file complaint and prosecute offender at Board hearing BOP Disciplinary Authority - CORRECT ANSWER Issues letters of: Warning Caution Reprimand Suspends, restricts, revokes, or refuses to grant or renew license Can require remedial education Calculation of overpayment (Audit) - CORRECT ANSWER Calculation does not include a dispensing fee unless:

• The RX was not dispensed
• The RX was not approved by the prescriber
• The RX dispensed was a medication error
• The overpayment was due to an extra dispensing fee
• There is insufficient documentation
• Fraud Can an NP prescribe refills for a CIII or CIV substances - CORRECT ANSWER Yes, may prescribe up to 5 refills but continue to be limited to a 30 day supply

Can electronically receive CII drugs - CORRECT ANSWER DEA has certain approved vendors to send through Can I give prescription records to investigators from the Medical and Dental Boards? - CORRECT ANSWER Yes, if they prescribed something for a mutual patient Can patients get prescriptions from physician's offices free through patient assistance programs sponsored by manufacturers? - CORRECT ANSWER Provision of patient specific drugs for such programs must comply with statute and rules dealing with out of state pharmacies- this would require an out of state pharmacy permit Central fill pharmacies - CORRECT ANSWER Must be contracturally related Must share common computer system with each sharing access Label must identify pharmacy who filled RX and pharmacy who received it to provide to the patient Must indicate which one patient is to call with questions Child-resistant packaging - CORRECT ANSWER At least 85% of children must be unable to open within the first 5 minutes or at least 80% unable to open after demonstration/use of teeth instruction May dispense without a child-resistant feature if patient requests (usually written waiver) or prescriber requests for an individual patient Reuse plastic of safety containers is prohibited, may reuse non-safety containers or glass vials Clinical Pharmacist Practitioner - CORRECT ANSWER Must obtain 35 hours of CE each year Must wear a nametag spelling out "Clinical Pharmacist Practitioner" Any pharmacist may become a CPP May prescribe controlled substances DEA will issue a DEA number starting with the letter M Compounding OTC products - CORRECT ANSWER Doing so without an RX is a violation of state and federal law

Continuing Education - CORRECT ANSWER Must complete 15 hours of CE, at least 5 hours must be contact CME and CNE are also accepted Pharmacists applying for first time renewal are exempt from CE for that year, except for reciprocity May request waiver or extension for reasons such as military service Retired pharmacist may hold an "inactive" license, must pay renewal fee, does not have to complete CE Continuing education - CORRECT ANSWER Must list on the application for license renewal all the hours you have received that year. 5 out of the 15 must be contact or live hours The Board will require 250 pharmacists a year to send in certificates and verify those hours Controlled Substance Reporting - CORRECT ANSWER Must be done every three business days Must report method of payment in addition to normal information File of all controlled RXs filled sent electronically to a central data base MDs and RPH may access this information with patient's name, address, or date of birth Confidential law enforcement may have limited access Contact Steve Epsy at 1- 800 - 225 - 6998 ext. 3049 to get access Must agree to keep information confidential but sharing information with prescribers and other dispensers is allowed DEA # or Federal Registration # - CORRECT ANSWER Must register to handle controlled substances DEA registration is valid for 36 months at pharmacies, distributors and manufacturers must renew yearly Prescribers: A, B, or F followed by 7 numbers Midlevel: M Verify: Add digits 1, 3, 5; Add digits 2, 4, 6 and multiple by 2, add sums, last digit of the sum should match the 7th digit in the DEA number DEA Form 106 - CORRECT ANSWER Must notify regional office of the DEA in writing immediately (within 1 business day) and local police if there is suspected theft or loss of a controlled substance

Drug disaster and loss report must be filed with the NCBOP within 10 days of drug loss/theft Copies 1 and 2 must be sent to DEA, copy 3 kept at pharmacy DEA Form 222 - CORRECT ANSWER 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 DEA Form 41 - CORRECT ANSWER 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 physicicorrect answer , 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 trcorrect answer fers CII to a distributor for destruction, distributor must issue a DEA form 222 to the pharmacy, CIII-CV may be documented in writing Death reporting - CORRECT ANSWER When there is a probability a prescription drug or device caused or contributed to the death of a patient, it must be reported

• Will include chronological information including the identity of the person responsible
• Will be open to the Board of Pharmacy
• Will include action taken as part of a quality assurance plan
• Will not be released except as required by law Dispensing more than face amount - CORRECT ANSWER Patient may receive more than the face amount of a prescription as long as your medical judgement deems appropriate
• Cannot be done on medicaid or insurance prescriptions without calling the prescriber and documenting on hard copy
• Cannot be done with controlled substances
• Cannot be done with psychotherapeutic drugs (suicide risk) Distribution of RX drugs samples - CORRECT ANSWER Not permitted in a pharmacy May be done in free clinics under guidance of physicicorrect answer , would not need a pharmacy permit Does not prohibit NPs or PAs DME records - CORRECT ANSWER Must be available to Board inspectors or agents on site Must be retrieved within 48 hours of request for inspection for a period of 3 years May be maintained electronically If you dispense medical supplies, you must have a permit Current pharmacy license- do not need a DME permit Drug Distribution and Control - CORRECT ANSWER Medication shall be dispensed upon receipt of a medication order
• Way to verify authenticity
• Oral or verbal orders allowable if signed in the appropriate time frame established by the facility
• All orders must be reviewed by a pharmacist Orders shall contain:
• Patient name, location, MRN, and account number
• Medication name, strength, dosage form, route
• Date of order

• Prescriber's signature Medications must be entered on a patient profile, electronic or manual. Profile must contain:
• Patient name, location, and important clinical data
• Medication name, strength, route
• Start and discontinue date
• Indication of pharmacist responsible for order entry Labeling of dispensed product:
• Shall be labeled up to the point of administration
• Labels for parenteral admixtures shall include the name and amount of drug added, expiration date and time
• Pharmacist-manager responsible for policies and procedures for admixtures prepared outside the pharmacy Drug schedule changes - CORRECT ANSWER Carsiprodol (Soma): Schedule IV Tramadol: Schedule IV Hydrocodone/APAP: Schedule II Drug Supply Chain Security Act - CORRECT ANSWER Must keep track of all who have had possession of drugs Pharmacy must retain invoices for 6 years Emancipated minor - CORRECT ANSWER Under 18 years of age and: Is or has been married Is or has been a parent Parent surrendered rights to minor's services and earnings Emancipated by court orders Emergency Dispensing of Schedule II Drugs - CORRECT ANSWER Must be written and signed by the prescriber In an emergency, prescriber may call in an order Oral order must be reduced to writing Quantity prescribed is limited to the amount needed to treat the patient during the emergency period Pharmacist should verify the legitimacy of the RX if they do not know the prescriber

Faxed prescriptions for CII drugs - CORRECT ANSWER Schedule II substances to be compounded for direct administration to a patient by parenteral, IV, IM, or SQ, or intraspinal infusion may be faxed by prescribing practitioner or his agent. Fax will serve as the original RX in this case CII RXs for patients in a long term care facility may be faxed. Fax will serve as original CII RXs for patients in hospice may be faxed (permitted by federal law). Prescriber must note on RX that patient is in hospice. Fax will be accepted as original FDA Orange Book - CORRECT ANSWER Source of generic equivalency information Pharmacist makes substitution decision based on professional judgement in NC FDA purple book - CORRECT ANSWER lists biological products, including biosimilars and interchangable biosimilars Highly similar reference drug: filgrastim vs. filgrastim-sndz Biosimilar can be expected to produce same results as the reference drug, switching back and forth would be considered safe and effective NC allows substitution of biosimilars, requires pharmacist to communicate to the prescriber the name of the product as well as the manufacturer within a "reasonable" time Federal Law 503A - CORRECT ANSWER In reference to compounding Cannot compound a drug that has been withdrawn or removed from market because it is unsafe or not effective FDA encourages compounders to register Track and trace of drug purchases Filing of prescriptions - CORRECT ANSWER Pharmacies may choose to have: 3 separate files: one for non-controlled, one for CII, one for CIII-CV 2 separate files: one for schedule II prescriptions and one for all others, CIII- CV must be stamped with a red C 2 separate files: one for non-controlled and one for CII-CV, CIII-CV must be stamped with a red C

Filling of Schedule II Drugs - CORRECT ANSWER Cannot be refilled- if the prescriber indicates refills on the RX, then the RX is valid but the refills are not DEA is now allowing the MD to write 3 scripts for the same CII for a total of up to a 90 day supply. Must indicate the earliest date that the script can be filled NC: places a 6 month time limit on time you can fill a schedule II drug from the date written by the doctor, federal law does not a place a limit Formal Hearing - CORRECT ANSWER May have an attorney with you May call witnesses may petition for disqualification of any Board member who may be personally biased Decisions can be appealed for judicial review Have 90 days to appeal decision with judge Health Department Pharmacist Manager - CORRECT ANSWER - Develop a system of control and accountability of all drugs dispensed

• Verify accuracy of records either weekly or daily depending on prescription volume
• Personally responsible for compliance with all laws governing the practice of pharmacy and distribution of drugs
• Formulary consists of antibiotics for TB and STD, birth control, and topicals for lice, scabies, impetigo, diaper rash, vaginitis, and other related skin conditions
• Dispensing is done by RN
• Can only dispense to patients of the health department, naloxone may be dispensed to anyone Health Insurance Portability and Accountability Act (HIPAA) - CORRECT ANSWER Must give new patients a notice of privacy practice and obtain signatures of people who may access their information Can release information to other health care professionals ID required to fill RX - CORRECT ANSWER Pharmacist may require a valid photographic ID to fill a RX. If you refuse to fil the RX then you must document on the back the reason for refusal (ie. No valid ID)

Name, dosage form, strength of CS Number of units or total volume Internet Pharmacy - CORRECT ANSWER NC law requires all prescriptions from internet pharmacies must comply with NC law including being a VIPPS (Verified Internet Pharmacy Practice Site) Only controlled substance prescriptions must be pursuant to a physical exam Label on a compounded RX - CORRECT ANSWER Must include all active ingredients or the commonly used name ("Duke's Mouthwash, Magic Mouthwash, UNC's Mucositis Mixture, Sleepy Butter) BUD of swish and swallow is 14 days refrigerated, BUD for swish and spit is 30 days at room temperature Labeling requirements of a schedule II, III, IV, and V - CORRECT ANSWER Name and address of pharmacy Name of patient Name of prescriber Directions for use Serial number of prescription Date of fill or refill (not required on CV) On II, III, and IV: "Caution: Federal law prohibits the trcorrect answer fer of this drug to any person other than the patient for whom it has been prescribed." Labels on commercial containers - CORRECT ANSWER 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 Legend Drugs - CORRECT ANSWER Drug that is required by state or federal law to be dispensed pursuant only to a prescription; must bear one of the following legends:

"RX Only" "Caution: Federal Law prohibits dispensing without a prescription" Mailing of RX Drugs - CORRECT ANSWER All classes of drugs can now be mailed Do not indicate on the package that it is from a pharmacy to prevent theft May a pharmacist disclose to a treating physician that a patient is receiving a prescription for the treatment of substance abuse? - CORRECT ANSWER Depends on where the pharmacist is working: If pharmacist works in a federally funded substance abuse treatment facility, then the Substance Abuse Confidentiality Regulations prohibit pharmacists from disclosing a patient's substance abuse history with a treating physician. Pharmacists must have patient's permission to disclose this information If pharmacist does not work for a federally funded treatment facility, then HIPAA permits disclosure to treating physician. If patient's pharmacological history indicates that the patient has problems with substance abuse, then pharmacist may discuss openly with treating physician May I dispense quinine sulfate for leg cramps? - CORRECT ANSWER No OTC sale allowed- FDA determined unsafe Only FDA approved product- Qualaquin for malaria, may not dispense this product under indication of leg cramps, worry about QTc prolongation Medication in Emergency Departments - CORRECT ANSWER All medications must be dispensed by a pharmacist in facilities with a 24 hour pharmacy Without a 24 hour service, may be dispensed from the ED by an MD or RN under MD supervision

• Only to registered patients of the ED
• System of control shall be developed by pharmacist-manager
• ED formulary required
• Drugs to be dispensed must be pre-packaged by the pharmacy with appropriate closures, labels, etc. At time of dispensing, label must include:
• Date of dispensing
• Name of patient
• Directions for use

Levothyroxine sodium (Levothyroid, Levoxyl, Synthroid, others) Lithium (Eskalith, Cibalith, others) Phenytoin (Dilantin, others) Procainamide HCl Tacrolimus (Prograf) Theophylline (Elixophyllin, Slo-phyllin, Slo-Bid, Theo-Dur, Theo-24, Uniphyl, others) Warfarin sodium (Coumadin, others) NC Physicicorrect answer Health Program - CORRECT ANSWER NC Board has dissolved relations with the Pharmacist Recovery Network (PRN), new agreement with the NC Physicicorrect answer Health Program to evaluate and monitor pharmacists and personnel If the Board refers you, they are privy to your actions If your employer or friend refers you, the Board will not know Nuclear pharmaceuticals - CORRECT ANSWER Must be dispensed to a qualified nuclear pharmacist pursuant to a prescription from a practitioner authorized to possess, use, and administer radiopharmaceuticals OBRA 90 - CORRECT ANSWER Established guidelines that states must follow in order to be reimbursed by the federal government for Medicaid services North Carolina requires an offer to counsel on all new and trcorrect answer ferred prescriptions and refills at the pharmacists' professional judgement Offer to counsel may be made by ancillary personal, counseling must be done by pharmacist Offer must be made in a positive manner to encourage acceptance Required counseling: Name, description, and purpose of RX Route, dosage, administration, continuity of therapy Special directions for use Common severe side effects or interactions, how to avoid, what to do if they occur Techniques for self-monitoring Proper storage Recall information

Action to be taken in the event of a missed dose Document if patient refuses counseling Counseling required in hospitals upon discharge, may be done by authorized non-pharmacists (nurses) Offers of counseling to inmates need not be face-to-face Order CII, CIII, and CIV for office use - CORRECT ANSWER Schedule II: must use a DEA Form 222 and send to the supplier CIII and CIV may use an invoice Parial fills for CIII and CIV - CORRECT ANSWER Permissible Must record each partial fill as you would a refill Must not dispense more than the total quantity prescribed May not dispense past the 6 months from date of issuance NC does not count partial refill as a complete refill Partial fill of CII RXs - CORRECT ANSWER Allowable under Comprehensive Addiction and Recovery Act of 2016 (CARA) Must be requested by patient or prescriber May be filled no later than 30 days from date of RX LTC facility or terminal illness: may fill partial fills up to 60 days Verbal order: may give partial fill in emergency, must provide RX within 72 hours Pharmacist-Manager (Health Care Facility) - CORRECT ANSWER - Must be assisted by a sufficient number of pharmacists and supportive personnel

• Must develop policies and procedures to specify the duties to be performed by pharmacists employed
• Must ensure a sufficient number of qualified, trained, and adequately supervised supportive personnel are present (technicicorrect answer )
• Shall establish written procedures for the safe and effective distribution of pharmaceutical products
• Responsible for the safe and effective distribution, control, and accountability for drugs, including IV and irrigation solutions
• Duty may be delegated, responsibility may not
• Establish specifications for drug procurement