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MO Practice Guide

pharmacy law for missouri

QuestionAnswer
If a license is revoked, how long does it stay that way? up to 7 years. to reinstate, applicant must sit for naplex and mpje again.
extra license for vaccine admin? no extra license, must file "notification with the board"
does vancomycin dosing by a pharmacist required additional paperwork? yes, "certificate of medication therapy services"
CE requirements licensed in even numbered years. 30 hours from Nov. 1 - Oct. 31. Random audits, must retain records for 2 renewal cycles
change of address notification? Job change notification? immediately for address. 15 days for job change
Who can own a pharmacy? anyone can own. only pharmacist can practice pharmacy
class a, b, c, a-ambulatory, b-hospital, only for hosp. people, c-long-term care
class d, e, f d-non-sterile compounding, e-radiopharmaceutical, f-renal dialysis
class g, h, i g-medical gas, h-sterile compounding, i-consultant
class j, k, L j-shared service, k-internet pharmacy (>90% of rx's from internet in 1 day), L-veterinary pharm
class m, n, o m-bleeding disorder drugs/therapies, n-automated dispensing system at a health care facility, o-auto dispenser at an ambulatory care facility
class p pharmacy operating in a physician's office, not physician dispensing
minimum equipment for pharmacy license (6) 1. basic equipment from USP definition 2. machine for numbering rx's 3. printing equipment 4. Drug info reference 5. current edition of statutes and rules of MO 6. proper temp control including fridge/freezer
how many pharms per PIC? no limit, however be responsible
timeframe to notify if no longer PIC? immediately. The pharmacy may not continue operations until a new PIC has been designated.
who is responsible for control count when PIC changes? The permit holder and PIC are responsible for completing an inventory of controlled substances at the time of a PIC change.
maternity leave for PIC... Should new PIC be named? up to PIC and permit holder
When does MO law require security paper? when rx is generated electronically. security paper is not required for controlled sub's except for those generated electronically
can physicians prescribe legend or controlled substances for themselves or family members? only controlled sub's for themselves in emergencies; can prescribe legend or controlled drugs for family members.
must controlled substance rx include patients address? yes, per MO Law
are rubber stamp signatures allowed for rx's? nope, must sign the same way a check or other legal document is signed.
how long are CII Rx's good for? quantity limit? 6 months. quantity limit to 30 days or 90 days with a medical documented reason
how long are CIII-IV good for? quantity limit? 6 months. 90 days. 5 refills max.
How long are CV rx's good for? quantity limit? good for 1 year. 90 day quantity limit. refills up to 1 year.
Are out of state prescribers given different treatment? they are allowed to write rx's based on the authority and quantity limit of their home state.
Must the PA/APRN's rx's contain the name/address/______ of supervisor? yes. blank - telephone
can PA's or APRN's dispense CII's? yes, only hydrocodone.
Schedule II (hydrocodone only)/ III (Opiates) limit on PA auth? 5 day supply. no refills allowed. rx valid for 6 months.
Schedule III (non-opiates) limit on PA? 5 day supply. no refills allowed. rx valid for 6 months.
Schedule III (non-opiates) limit on aprn? full authority. *different than PA*
Schedule IV and V limits on PA/aprn auth? full auth. 90 day supply. 6 month expiration
family or self prescribing for PA/aprn? no, neither. family - Immediate family +1 - great's count (great grandma/grandpa); also includes in-laws and adopted/step people
rx transfer mandatory? yes, within 1 business day. orders for long-term care patients are not transferable
may pharm tech's transfer controlled drugs? nope, must be between 2 licensed pharmacists
for controlled drugs, can PA/aprn name only appear on rx label? No, both pa/aprn and supervising physician must be on label.
is there a law stating the brand name must be on the label when substitution takes place? No, does not need brand name.
should manufacturer of generic be on the rx label? Yes, or in the pharmacy's records.
are pharmacies allowed to dispense drug products for office use? No, dispensing must be for a specific patient.
how to dispense epipens or asthma rescue meds for school districts? school district must be the patient and school nurse's name must be on the rx.
what procedures are required for delivered rx's? must have written policies for delivery and ensure proper temp ranges
does board have a statement on using a heat sealer to repackage drug? Yes, it is discouraged per usp guidelines
Is tablet splitting allowed? Yes, provided 1. literature says it can be done 2. prescriber has approved any change 3. patient has been counseled if necessary
can patient med paks contain controlled substances? nope, patient med paks are not allowed to contain this.
expiration date for patient med pak? max of 60 days
can med pak be reused? In general, no. Only ok if same patient and pharmacy are involved and it keeps its expiration date. removed med's cannot be saved for the patient in the future or returned to stock.
can you reuse drugs dispensed to a ltcf? Yes, provided the drugs go back to the same pharmacy and they were under usp storage conditions.
can a pharmacy accept returns for disposal from a patient for disposal? Nope
when should a pharmacy register as a drug distributor? when the pharmacy transfers more than 5% of the pharmacy's annual prescription drug sales to other providers/pharmacies
are vacuum tube delivery systems allowed? yes, system should only have 1 point of delivery outside of pharmacy and direct line or sight or a 12 inch video monitor
Define automated filling system an automated system used by a pharmacy to assist in filling a rx order by selecting, labeling, filling or sealing medication for dispensing.
is a pyxis an automated filling system? nope, afs excluding machines that dispense to a hcp for admin to a patient.
does a pharmacist need to inspect every rx from automated filling system? yes, unless 5 things, first 3: 1. rx is checked prior to filling 2. rph checks the loading of the machine 3. filling process is fully automated from the time the process is initiated
2 more requirements for afs not requiring post fill pharmacist check. 4. electronic check for proper rx for patient 5. daily random quality testing by a pharmacist on at least 2% of the rx's filled by the AFS on the date tested or last operation date. proof must be documented
can pharmacist still physically verify final product from afs? Yes, then the 5 qualifiers do not apply
can a pharmacist dispense emergency supply? Yes, the pharmacy must have previously dispensed the med and max of 7 days supply. only up to 30 day supply if provider is incapacitated.
what is reasonable compounding inventory? 3 month supply of a batched product or 1 year of a compound intended for external use. compounding may only be done by prescription.
cost or convenience allow compounding of a commercial product? No, must be a medical reason or backorder product. must be documented in the record.
is magic mouthwash accepted on the label of a compound? No, must be a list of active or therapeutic ingredient.
What is required in a separate drug compounding log? quantity, lot, exp date, and manufacturer of each ingredient, date of compound, compound directions, pharmacist involved, rx number
How many days allowed to notify board of a recall of a compound? 3 days
what is included in a recall notification 1. the nature of the recall 2. the problem identified 3. recommended actions. if patient harm possible, patient must be notified as well.
3 reasons a CII can be faxed 1. rx documents hospice 2. rx documents long-term care facility 3. rx is for a narcotic for infusion
when should a MO pharmacy register as a distributor with the BNDD and DEA when dispensing compounded medication for infusion directly to a prescriber
how to report lost or stolen controlled substances? quantity? Immediately reported to BNDD and file a report within 7 days of the loss. In Missouri, any amount of lost or stolen drug should be reported. may request an extension to the 7 days.
what vaccines can be administered by protocol? Age limit? tdap, hep a, hep b, meningitis, pneumonia, shingles and viral influenza vaccines by protocol with a physician. 12 years and older
qualifications to admin vaccines? 3 things 1. current cpr 2. ACPE accredited vaccine course. 3. 2 hours of CE in administering vaccines annually from the date of issuance of notification
does intent to vaccinate need to be renewed? Yes, every year. must complete 2 hours of CE in administering vaccines annually
who can serve as an authorizing physician for a vaccine protocol? must be within 50 miles of the pharmacy using the most direct route by road
who signs vaccine protocol? how often for renewal? each pharmacist and the protocol physician must sign the form. renewal must be yearly. must be maintained for 8 years.
Is a rx required to be created for each vaccination? Yes, each rx must be created.
must protocol physician be notified of each vaccination? adverse reactions? Yes, within 3 days. if the patient has a pcp, then they must be notified within 14 days. adverse reactions must be reported within 24 hours.
how long should rx records be maintained? 5 years. 8 years for vaccine protocol. 2 years for vaccine records.
can interns vaccinate? yes, under direct supervision of the pharmacist.
what is required for a technician list in a pharmacy? must have each tech's name, registration number, and duties.
does patient counseling need to be offered on all rxs? Yes, every rx, every time.
APRN II/III limited opiate prescribing. APRNs are limited to a 5-day supply of all opiates in Schedule 3. Schedule II is for hydrocodone only (same 5-day supply applies).
Missouri Pharmacy Board 6 pharmacists, 1 non-pharm. must be practicing. 5 years per term. no term limit. 1 pharmacist must be in a hospital setting.
Does board license training sites or preceptors? No and No. Only licenses interns
how many automated dispensing/storage systems can a pharmacist remotely supervise? max of 3 automated dispensing/storage systems which are simultaneously open per pharmacist
how much MTM CE is required for medication therapy certificate? 6 hours every 2 year renewal.
how soon should pharmacist notify protocol physician/authorized person of adverse reaction or change in medication therapy? notify within 24 hours
record retention for mtm? patient records-7 years; protocols-8 years; prescription orders for MT Services-7 years
what are technicians prohibited from doing? 1. drug utilization review 2. transferring controlled substances 3. final verification 4. patient counseling
when does tech registration expire? tech license expires annually on may 31st
class C (LTC pharm) manual must contain 5 things. what are the first 2? 1. methods for timely dispensing 2. procedure for notifying facility when drug is out of stock.
class C (LTC pharm) manual must contain 5 things, what are the last 3 3. labeling requirements 4. policies for medication destruction 5. policies for e-kits
Created by: nickh88