Idaho MPJE
In what milligram ratios of ephedrine/guaifenacin are deemed exempt from prescription status?
12.5mg/200mg and 25mg/200mg
What is the expiration date for an Rx for a legend drug?
15 months
What are the CPE requirements for renewal?
15hrs annually (30hrs biannually) 8hrs ≥ ACPE/CME accredited 6hrs ≤ not-ACPE/CME accredited 1hr ≥ Pharmacy law 3hrs ≥ live attendance (or synchronous online program) 1hr ≥ Immunization CPE to maintain immunization qualification
What is the minimum age requirement for purchase of a Schedule V OTC?
18
You own a pharmacy, and have 2.5 bottles and a RTS pharmacy prepared unit-dose-package of PO amoxacillin, and a partial box of IM Rocefin, and 2 unused vials of insulin you are considering donating to a qualifying charitable clinic. Which may be donated and why?
2 unopened bottles of Amox and the Rocefin are acceptable if non-expired, properly labeled and lot/exp are visible. The opened bottle, and that which is not in the orignal packaging are not. Also, the insulin is not acceptable because it requires refrigeration.
What are the requirements for renewal/reinstatement of licensure for a pharmacist who has not practiced for the preceding 12 months or longer?
40 intern hours for each 12mo out of practice, completion of additional CPE hrs, +/- an examination, or otherwise as determined by the BoP
What is the expiration date for an Rx for a CIII-V drug?
6 mo
What amount of time must pass after which a report of noncompliance with ID controlled substance laws become non-cumulative? (i.e., first offense -> second offense)
6 months after notice of prior offense (was sent)
Within how many days must a doctor provide a written prescription for an emergency CII drug order? What should be done if it is not received within that time period?
7 days Contact the BoP
What is the expiration date for an Rx for a CII drug?
90 days
What may a pharmacist initiate if allergic reaction to an immunization is suspected?
Administration of epinephrine, and IM/PO diphenhydramine per APhA guidelines
In which circumstances may a drug be dispensed from an ADS (automatic dispensing and storage) system without pharmacist review?
After-hours use, in an emergence and only in qs for immediate needs of patient, OR drug is a subsequent dose from a previously reviewed order
How often must a collaborative practice agreement be renewed?
Annually and if any changes are necessary or appropriate
When must a controlled substance inventory be performed?
Annually within 7 days of the prior year's inventory, in the event of a change of PIC by the first day of employment, or within 48hrs of the discovery of a theft of a controlled substance
Under what circumstance might CPE hrs carryover into next licensing period?
CPE hrs from June of licensing period, if... CPE hrs > requirements
What other information is required on a veterinary drug order?
Client name (not patient name) animal species license number of prescribing veterinarian
What additional qualifications are required for a pharmacist to be immunization certified?
Complete ACPE-accredited course, and hold a current certification for BLS. Annual completion of at least 1hr of ACPE approved immunization CPE
What must be done if a letter of "Discipline of First Offense" is received following non-compliance with ID BoP controlled substance law
Comply within 30 days, or the prescriber's licensing board will be notified and requested to initiate corrective disciplinary action
What is required in the EMR for each patient?
Demographics: name, addy, ph, DoB, gender Prospective drug review info Prescriber-provided info Other info at discression of pharmacist
What is required of a pharmacist in order to function as a PIC?
Designee must spend a substantial part of working time at the said pharmacy
What must a provider write on a CII prescription to extend it to 90 days from written date?
Earliest fill date
What are the Consulting Pharmacy or its PIC responsibilities regarding returns from an institution?
Ensure proper training of storage, use, and admin of drugs & devices Reviewing, approving, and enforcing written protocols that ensure compliance
Which controlled substance records may be stored at a central location? What must be done to allow this?
Financial and shipping records and invoices may be stored off site only if registrant has provided DEA notification
Under what circumstances may non pharmacy personnel enter the pharmacy?
For temporary legitimate business purposes, and only under the direct supervision of a pharmacist at all times
In what dosage(s) and formulation(s) may ephedrine sulfate containing no guaifenesin be sold without a prescription?
Hemorrhoidal ointment NTE 0.2% Ephedrine suppositories NTE 4mg/suppository
Through what system must administration of immunizations be reported?
IRIS (Idaho Reminder Information System)
What must a collaborative pharmacy practice agreement include?
Identification of the parties, scope of practice, the drug name, class or category and protocol or clinical guidelines that describe or limit practice, describe method to monitor compliance and intercede where necessary, document prescriber's right to override a decision, provide provision allowing cancellation of agreement, an effective date, and signatures
If located in a nursing home, what must be clearly marked on an ADS (automatic dispensing and storage) system?
Identity of supervising pharmacy and PIC who maintains the ADS (name, address, phone number)
What must be on the stocked drug documentation of an ADS (automatic dispensing and storage) record if demanded other than standard inventory list?
Identity of the ADS system, and name/initials of individual who filled the ADS and if applicable, the verifying pharmacist
Under what circumstances may a CII fax serve as the original rx pursuant to dispensing?
If compounded for direct admin via parenteral route for a resident of an LTCF, hospice patient, if so indicated on prescription drug order
When is positive ID presumed (not required) for a controlled substance?
If paid for by an insurer, patient is at an institution, or it is delivered to patient's residency
Under what circumstance may a CII be partially filled?
If unable to supply the full quantity ordered
Under what circumstance(s) may a pharmacist dispense a CII with a verbal prescription?
Immediate administration necessary No appropriate alternative available Not possible for prescriber to provide written rx limited quant only
Under what circumstance may a dispenser (pharmacy) act as a distributor to another dispenser (pharmacy)?
In an emergency where a quantity is needed without alternative source or normal distribution channel in sufficient time to prevent risk of harm that may be caused by delay
What is the significance of a "discipline of second offence?"
It means a prescriber's controlled substance registration will be suspended for 1 week, unless an explanation with plan of correction are submitted with payment of $100.
What is the significance of a "Discipline of Third Offence?"
It means a prescriber's controlled substance registration will be suspended for 30 days, unless an explanation with plan of correction are submitted with payment of $500.
What must be done, after properly receiving an acceptable donated drug, before it may be commingled with regular stock?
Label it to indicate it was obtained as a donation (from a nursing home) and must otherwise be segregated
Explain the specifics of appropriate expiration labeling
Lesser of: 1yr since dispensing date, or manufacturer's expiration date, or compounding exp date
What are some legal limitations of ADS (automatic dispensing and storage) systems?
May not be dispensed directly to patients, or in quantities exceeding that sufficient for 1 day No controlled substances
What are universal limitations to prescriptive authority for providers in Idaho?
May not prescribe controlled substances to self May not prescribe for family members if inconsistent with scope of practice
How are interns limited in ability to transfer?
May not transfer rx intern to intern
Explain process of verbal veterinary drug orders
Must be communicated directly from a veterinarian to a veterinary drug technician (VDT) Must be written on official, UNnumbered, ID Dept of Agriculture (DoAg) telephone drug order form Signed, numbered, official DoAg 3-part form must be delivered to veterinary drug outlet within 7 days
What are the recordkeeping requirements?
Must be electronic Must be capable of real-time Must maintain data for ≥ 15 months from entry Must be immediately retrievable Must have "audit trail" which identifies Rph/Cpt at each step Must be secure Must be routinely backed up
What restrictions apply to veterinary prescriptions?
Must be on official, numbered, ID Dept of Agr veterinary drug order forms. Each of 3 sheets or "copies" must be handled differently: "top sheet" being considered as original rx, and "copy 1" to be attached to prepared order, and "copy 2" is to be retained by Vet
What are the requirements for patient counseling according to Idaho Pharmacy Act?
Must document & retain evidence of offer to counsel
What conditions must be met in order for an ID licensed pharmacist to provide pharmaceutical care outside of a pharmacy or institutional facility, including across state lines?
Must have access to relevant PMH Must protect PMH from unauthorized use Must maintain PMH in electronic records
What's the most important thing to remember about the PMP (Prescription Monitoring Program)?
Must not be used outside scope of professional practice
What is the legal concentration limit of CV OTC cough syrup w/ codeine?
NTE 200mg codeine per 100mL or 100g (20%)
What is the legal maximum quantity of CV OTC cough syrup w/ codeine sale to one person?
NTE 200mg in 100mL in any 48 hr period
At what point after "change of status" such as a prescriber's death, or otherwise no longer treating a patient is the Rx valid?
NTE 90 days
What must be listed in a donation manifest to a qualifying charitable clinic?
Names of donating and receiving pharmacies, nursing homes, or clinics Drug: name, strength, exp, lot, quant
What documentation is required for a transfer?
Names of transfering Rph & receiving Rph Name of transfering pharmacy Date of transfer Number of refills transferred IF controlled, DEA of receiving pharmacy
May one qualifying charitable clinic trade or transfer donated drugs to another of the same?
No
Who may prescribe investigational drugs?
Not just any prescriber Only a principal physician-investigator in a legitamate trial, or an appointed clinician
What are the additional registration requirements for a sterile product drug outlet?
Onsite BoP inspection Floor plan approval Hood/etc device registration
What must be reported to the ID BoP?
PIC change w/in 10 days Annual personnel report on the renewal application Employment changes of pharmacists, techs, interns
What additional requirements must be included on a drug order for a controlled substance?
Patient's full name and address Prescriber's address and DEA registration number
What must be documented in collaborative practice patient care?
Pharmacist activities, in such a way that it may be readily available to other healthcare professionals
What is required for pharmacist licensure by reciprocity?
Pharmacist must be in good standing in another state Apply for transfer through NABP Must pass ID MPJE Inactivity requirements may apply
Who may dispense a Schedule V OTC?
Pharmacist must dispense, but staff may run the register after a pharmacist has fulfilled her professional and legal responsibilities
What are the requirements for telepharmacy?
Pharmacy must be registered with the ID BoP
Who is responsible for ADS (automatic dispensing and storage) unit system access, monitoring and control?
Prescriber, PIC, or director, or authorized designee
What must be attested to in a manifest of drugs to a qualified charitable clinic?
Proper storage, never been under custody of patient or unqualified individual, they are formulary drugs, any PHI has been removed
How are CV OTC sales documented?
Purchaser: name, addy, signature Purchase: drug, quant, date of sale Seller: initials
When are drug product substitutions allowed?
Pursuant to P&T approved hospital formulary, at the direction of skilled nursing facility with appropriate consultation and with consensus with TWO (2) other members of the nursing facilty, or in the case of of drug shortages a pharmacist may substitute alternative dosing to equate that which is prescribed
What is the legal term used to describe evidence that the amount of a controlled substance on hand differs from what is reported?
Rebuttal Presumption of Violation
What additional requirements are there for manufacturers (pharmacies) who ship/mail/deliver prescription drugs/devices to ID resident?
Registration by ID BoP
What is acceptable recordkeeping in the event of electronic system failure?
Retain hard copy/paperwork for rx 96hrs after system restoration
What ADDITIONAL documentation is required at the receiving pharmacy in a transfer of an Rx for a controlled substance?
Rx No. (and Rx No. for each pharmacy at which it had been filled if electronically transferred within pharmacies sharing a real-time online database) Dates and locations of each time the Rx had been dispensed Name, address, DEA of transferring pharmacy
Which sales of CV OTC are illegal?
Self purchase or sale to immediate family member Otherwise if undocumented, if purchaser is a minor, if exceeds quant/48h limits, or if dispensed by any persons other than pharmacist
How many days of medication are allowable per ID law for an emergency fill?
Sufficient quantity to maintain treatment until the earliest possible opportunity to contact the provider
What is the significance of a "Discipline of Fourth Offence?"
Suspention or revocation of controlled substance registration as determined by the Board, and administrative fees
How must adverse events in administration of an immunization be reported?
Through VAERS (Vaccine Adverse Event Reporting System)
How must a constrolled substance registrant dispose of expired, excess, or unwanted controlled substances?
Through the services of a DEA-registered reverse distributor or by another method permitted by federal law
What must be in place for ADS (automatic dispensing and storage) unit to be used?
Tools to modify, monitor, and safeguard access
What must documentation for Waste of Controlled Substances contain?
Transaction: date, time, drug, dose, wasted amount Identification: intended patient, person wasting, witness
In ID, may a student pharmacist administer immunizations?
Under supervision of qualified immunizing pharmacist, and with the proper training
What must a pharmacist, physician, PA, or NP do when receiving donated drugs for a authorized clinic?
Verify each donated drug against the donation manifest that each drug is what it is supposed to be, all PHI is removed, that it is not adulterated or misbranded, and that it is safe to use
Which entities are exempt from reporting dispensing of controlled substances to the ID BoP?
Veterinary (?), physicians providing drug samples
What are the requirements records maintenance for electronic prescription drug orders for controlled substances?
Whether on site or at registered location, records must be readily retrievable and capable of being sorted and printed
Who/what requires VAWD accreditation?
Wholesalers
When an institutional facility is preparing to bring returns to a pharmacy, and must store them temporarily, what must be done?
Write "Not Eligible for Return" on those drug products for which the conditions for return have not been met
May the remainder of a partial CII fill be dispensed? If so, what are the restrictions?
Yes, only within 72h of first filling, unless LTCF/hospice patient, in which case "terminally ill" or "LTCF pt" must be written on hard copy
What extra level of verification is required for controlled substance refills?
a documented must be kept in which each pharmacist involved in the dispensing of controlled substance refills signs a statement attesting to the fact that the refill information entered into the electronic recordkeeping system each day has been reviewed and is correct as shown
Which date(s) are illegal on a prescription? predate, antedate, postdate
antedate & postdate
What unique information is required on labels for parenteral admixtures?
date and TIME of addition or or of beyond use date and TIME
What must be documented in the case of pharmacy to pharmacy distribution of controlled substances?
date, name, address, and DEA of each dispenser drug name, strength, and quantity signature of each party
What must be documented for CII partial fills?
date, quant dispensed and remaining authorized quant, and identity of dispensing Rph.
What information is required for each refill?
date, quantity dispensed, identity of dispensing Rph (unless in a hospital), # of refills to date
What must be documented when generic substitution is made by a non-institutional pharmacy?
drug name and NDC
What are the forms of acceptable ID?
gov'nt issued photo ID w/ signature, make sure to document it (on permanent record such as on the hard copy)
Under what circumstance may the remainders of a CIII-V partial NOT be dispensed?
if quant exceedes total quant prescribed if dispensing occurs after 6mo from issue date
What is the pharmacist responsible for if he/she is unable to dispense the remainder of a partial CII?
informing provider
What type of gloves are approved for use in aseptic preparation?
non-latex
What are the regulations regarding flavoring?
ok at discretion of pharmacist or upon request
What must be documented if a controlled substance is dispensed to a patient if "personally and positively known by ..staff?"
recipient's name, notation by staff acknowleging that he/she is known to staff as well as staff member's name
Within what time frame must theft or loss of controlled substances be reported?
same day
What information must be recorded in the EMR for each original prescription drug order?
serial number (if any), date of issuance, date filled, identity of Rph/Cpt who processed&dispensed; drug details, sig., refills, name of prescriber (and addy & DEA registration number if controlled).
What are acceptable forms of transfer of prescriptions?
verbal, fax, electronic
How often must aseptic environmental control devices be certified?
≤ q12mo