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North Carolina BOP

Pharmacy Rules for North Carolina

QuestionAnswer
How does the board regulate the practice of pharmacy? 1-determining qualifications of those seeking to practice 2-enforcing the laws
3 roles of a consultant pharmacist 1-reviews the appropriateness 2-identifies/resolves drug duplications 3-considers patient specific contra's
What is a limited services pharmacy permit? issued by the board to an applicant that wishes to render pharmacy services limited to time, not scope
What services can a pharmacy intern provide? While under supervision of licensed pharmacist, perform all acts constituting pharmacy
What written procedures must the pharmacy manager provide? 1-duties performed by pharmacists 2-procedures for safe and effective distribution of medications 3-procedures for disposing of medications
How soon must PM be notified of CS inventory abnormalities? must be notified within 24 hours. reported recurring losses or significant amounts
How often must PM inspect patient care units? Inspect units monthly; quarterly for LTCF; make sure drugs are in-date and stored properly, conversion charts must be available
Does parenteral area need to be physically separate from the rest of the pharmacy? Yes, all drugs shall be stored in designated areas and secure.
Who can access the pharmacy in a 24h facility that is not open 24h? PM shall maintain a current list of authorized persons and document their continuing training. PM maintains a list of drugs that can only be dispensed after contacting the oncall RPh. MUST BE UNIT-OF-USE packaging
How much time is allowed for a pharmacist to verify the nurse drug removal? record requirement? RPh must verify removal within 24 hours. records of removal must be kept for 3 years.
Can controlled drugs be removed in the absence of a pharmacist from the pharmacy? No, controlled drugs are not allowed to be removed in the absence of a RPh.
How often should drugs in an ancillary cabinet be reviewed? these drugs should be review not less than quarterly for purity, potency, and strength. written procedures are required for checking
How often should emergency drug kits be inspected? inspected at least q 30 days (90 days for LTCF). Pharmacy must be notified when a kit is opened
What records does a PM have to keep about staff? Develop a system for daily accountability and ID of pharmacists and tech's. Daily log must be kept for 30 days.
4 of 7 things PM records and keeps for 30 days about Rph's and techs 1-interpretation/appropriateness of new med orders 2-profile entry of new med orders 3-dispensing of new med orders 4-daily cart fills
last 3 things PM records and keeps for 30 days about RPh's and techs 5-who mixes parenterals 6-compounded meds 7-periodically assessing quality of procedures for entering orders and filling carts
How should med errors be recorded? must be available for 3 years and recorded on health care facility forms. PM must document incorrect med or dose.
What are the reqirements of controlled substance inventories of transferred drugs? perpetual inventories are required for ADM's and emergency kits. also perpetual inventory is required for controlled substances awaiting destruction
How much time is given to comply with request of rx records? Records must be given to the board within 48 hours of request.
How to dispense from an ED without a 24h pharmacy? only dispense to patients; specific formulary; prepackaged drugs not to exceed 24h supply/smallest available; record of dispensing shall be maintained and PM reviews it monthly
What is required of repackaged drugs? per page 12: generic name, manufacturer, lot number, exp date, cautionary notations. can use a pharmacy created batch number
do Remote Medication Order Processing (RMOP) pharmacies/RPh's register with the board? Yes, they register as out of state pharmacies and pharmacists. They are required to maintain a policy manual and a list of everyone involved in RMOP and annually review it
What are 3 requirements of validating technicians? 1-must follow written procedures to stock floor unit dose systems 2-must have facility specific training 3-record keeping similar to 30 day RPh / 3 year error rule
Can a technician validate parenteral floor stock? only after a pharmacist has verified that the compounded/admixed drug has been prepared correctly
Who can be a validating tech? 1-Certified 2-holds an associates degree 3-assists pharmacists in drugs that will be administered inpatient
Medical library requirements? 1. medical dictionary 2. books about pharmacology and interactions 3. USP DI 4. if parenteral, reference on parenteral incompatibilities
Must hours be posted? What about water req's? Yes, hours must be conspicuously posted. Hot and cold running water must be present.
What are mail order phone requirements? must be available 6 days/week min 40 hours/week
Must a pharmacy be physically separated from other businesses? Yes, and it must be separately identified o the public. transactions must be completed within the pharmacy
How are pharmacy licenses renewed? Issued pursuant to a joint application from the owner and PM
When is a new permit required? new permit required when changing location, business entity, or controlling interest (>50%)
Are in person interviews required for initial permits? Yes, the PM and the person in charge of the facility must appear in person before the board
What about rx's for acute illness for patients of a mail order pharmacy? written procedure must exist for patients. written procedure must also exist for when an rx did not arrive on time.
What mail order info must be disclosed? location, names and titles of all officers/partners. names and license numbers of RPh's. report made annually and within 30 days of changes
must out-of-state pharmacy notify board of med-related deaths? yes, within 14 days by a form provided by the board
How much time is allowed for out-of-state pharmacies to notify the board of disciplinary actions by home state? pharmacy shall notify the board within 5 days.
what are the limitations for PA's and NP's dispensing? Pharmacist prepares everything except the name and directions for use on the med. pharmacist must provide weekly RDUR
Is it ever acceptable to dispense a drug without a physical exam? Yes, provided reasonable exceptions, e.g. psychiatrist, flu vaccine protocol, or travel medications for a group.
Are 90 day fills authorized even in only 30 day fills are written? Yes, you can dispense up to the full face amount of the rx. Exception: not for controlleds or psychotherapeutics
Who can receive rx's? Only bona fide pharmacy employees or pharmacists.
Can technicians transfer rx's? Yes, provided the are certified and the rx is not a controlled. Manufacturer or brand of drug dispensed is required on a transfer!
How long are transfers good for? Transfer may not be refilled and expires within 1 year of the transfer date
emergency prescription dispensing limits (4 things) if prescriber cannot be contacted 1-not cII 2-essential for maintenance/harm avoidance 3-RPh creates a written order 4-notify the prescriber within 72 hours
Can one compounding pharmacy sell a compounded drug to another pharmacy? No, but may sell to a prescriber for administration. not pursuant to an rx, rather use an invoice
Is a compounding log required? Yes, record should be maintained of who made the rx and who checked the rx. retain the ingredient pedigree for 3 years.
Fax requirements (3) 1-transmitted directly w/o intermediate 2-identify phone, time/date, and intended pharmacy 3-transmitted by an authorized agent
ADM requirements. timeline for review? who has access? only authorized personnel from PM can access; drugs must be reviewed monthly;
emergency dispensing limits if interruption in medical services if prescriber retires/dies/loses license pharmacist can auth 1x up to a 90 day supply. No CII's, essential to maintenance, creates written order, contacts within 72 hours
What label requirements are required by central fill pharmacies? Must show both the filling and dispensing pharmacy's name and address. both pharmacies must retain complete records
If a pharmacist does not want to fill an rx, what can he do? ask for photo ID and if not satisfied, may refuse to fill the rx and note the refusal on the rx. person acting on behalf of the pharmacist can do this
Can individuals file a request for an administrative hearing? yes, if they feel that their rights have been infringed. must exhaust all other possibilities. 15 days notice are given
How much time must be given in order to request a board member to be excused due to personal interest in a case? 10 days notice must be given
When are final decisions issued? final decisions are issued within 60 days after the boards next regularly scheduled meeting
who can vote in board elections? eligible pharmacists will be residents of NC as of March 15 prior to the board's election
How to be nominated? get 10 eligible voters from 1 geographic district. written consent must be obtained. (N,NE,SE,W,Central)
CE req's 15 hours obtained annually. 8 hours must be live-give opportunity for 2 way comm. records retained for 3 years. carry up to 5 hours to the next year.
are Automated data processors required to make paper printouts yes, must be sight-readable at the request of the board
How soon must the 3 year records be available? must be presented within 48 hours of the board's request.
Is a written plan required for providers of parenteral and enteral nutrition services? Yes, counseling is also required.
Are device and medical equipment permit holders allowed to store rx drugs? nope, neither collect nor store rx drugs.
Is emergency dispensing of radiopharmaceuticals allowed by law? Yes, the PM (board cert and and auth user) must have written policies and procedures in place for who can access the pharmacy
Additional radiopharmacy labels? caution-radioactive materials; tamper-evident seal must be applied. Up to 72 hours is allowed to apply patients name
additional library requirements where parenterals are mixed? ASHP handbook on injectable drugs; king's guide to parenteral admixtures; AHFS; procedure for handling cytotoxic drugs
parenteral environment requirements? (3) fridge/freezer; proper disposal containers; class 100 environment
requirements for preparing anti-neoplastic agents? vertical class II cabinet; written procedures; proper disposal
is quality assurance program required? Yes, page 58 says monitor performance, equipment, and facilities. Think about sterile technique audits
Rule on returning expired drugs? in order for a drug to be eligible for product selection, manu. must accept returns and give full credit up to 6 months past expiration. doesn't apply to antidotes
Can a CPP be a CPP without a physician supervising? Nope, must notify BOTH boards within 10 days of d/c'ing arrangement. renewal separate from regular license. rx's from CPP MUST contain Med board #
What relevant CPP CE? 35 hours/annually and must be kept on site
CPP agreement? must be specific to pharmD and MD, as well as pt and dz. weekly face to face conference
How many CPP's can the MD have? 3RPh's:1MD max ratio; must stay within scope of practice
Suspected impairment? pharmacists are required to appear for personal interviews
when do tech permits expire? annually on 12/31. not allowed to work 60 days after 12/31; "grace period"
high vs. low risk ADM drug neither requires pharmacist approval because high risk means delay could result in patient harm. RDUR required by consultant
How can automated medication systems be replenished by a technician? Tech must be supervised. pharmacist must either a daily audit/random daily sample or quarterly sampling. Quarterly sampling will only be allowed if barcoding is used.
replacing meds in automated dispensing system? meds must be examined by pharmacist. certain exceptions apply.
what 2 things happen in order for a pharmacist to without seeing the med? 1-review the initial med order 2-med is distributed by health care professional
What records must be retained pursuant to an automated dispensing system? (2) daily audits of outputs and QA reports
Created by: nickh88