ME MPJE flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Schedule II refills

A Schedule II prescription may not be refilled. The patient must obtain a new prescription from the prescriber for additional medication, except where federal or state law permits specific partial-fill exceptions.

Schedule III–V refills

May be refilled up to five times within six months of the date of issue. After that, a new prescription is required; the prescriber cannot authorize additional refills on the original order.

DEA Form 222

The order form used to transfer Schedule I and II controlled substances between DEA registrants. It must be completed accurately, retained, and matched to the substances received.

Biennial inventory

A complete count of controlled substances on hand, taken every two years on a date chosen by the registrant. It must be signed, dated, and retained for at least two years.

CII emergency oral order

In a genuine emergency a pharmacist may dispense a CII on an oral order, but the prescriber must provide a written or electronic prescription within seven days or the pharmacist must notify DEA.

Partial fill of CII

If the pharmacist cannot supply the full quantity, the remainder may be dispensed within 72 hours. If not completed in that window, the prescriber must be notified and a new prescription is needed.

Durham-Humphrey Amendment

The 1951 amendment that created the prescription-only drug category, requiring the legend "Rx only" and limiting dispensing of those drugs to a valid prescription.

Kefauver-Harris Amendment

The 1962 amendment requiring substantial evidence of effectiveness before approval and requiring informed consent in clinical investigations. It reshaped the modern FDA approval standard.

Combat Meth Act limits

Retail sales of ephedrine and pseudoephedrine are limited to 3.6 grams per day and 9 grams per 30 days per purchaser, with photo ID, a logbook, and behind-the-counter placement.

DSCSA transaction requirements

Prescription drug transfers require transaction information, transaction history, and a transaction statement. Suspect product must be verified and illegitimate product quarantined and reported.

EPCS requirements

Electronic prescribing of controlled substances requires identity proofing, two-factor authentication, and an audit trail. Pharmacies must confirm the prescriber's system meets DEA standards.

Ryan Haight Act

Generally requires an in-person medical evaluation before a controlled substance is prescribed via telemedicine, subject to limited exceptions and temporary federal flexibilities.

Class I recall

A recall involving a reasonable probability that use of the product will cause serious adverse health consequences or death. It is the most serious FDA recall classification.

Orphan Drug Act

A 1983 law providing incentives, including exclusivity, for drugs treating rare diseases affecting fewer than 200,000 patients in the United States.

HIPAA treatment exception

The Privacy Rule permits disclosure of protected health information for treatment, payment, and health care operations without patient authorization; other uses generally require authorization.

Valid prescription elements

A prescription must identify the patient, drug, strength, directions, date, and prescriber, and must be issued for a legitimate medical purpose in the usual course of practice.

Maine technician licensure

Maine requires pharmacy technicians to hold a Board of Pharmacy license before performing technician duties. Licensure is separate from pharmacist licensure and has its own renewal requirements.

Maine PMP query duty

Maine mandates that pharmacists query the prescription monitoring program before dispensing certain controlled substances, notably opioids, under specified circumstances, with defined exceptions.

Maine collaborative practice

Maine allows pharmacists to enter collaborative practice agreements with prescribers, and grants expanded authority for certain vaccines and hormonal contraception under defined protocols and age limits.

Maine generic substitution

Maine permits generic substitution unless the prescriber indicates dispense-as-written or the patient objects. The patient must be informed of the substitution and the choice documented.

Maine PSE logbook

Maine regulates retail sale of pseudoephedrine with quantity limits and logbook requirements consistent with the federal Combat Methamphetamine Epidemic Act, including photo identification.

State prescription age limit

State law sets the maximum age of a prescription for dispensing and the number of authorized renewals. A prescription beyond that age requires prescriber authorization before dispensing.

Prescription transfer rules

State rules allow limited transfers between pharmacies with documentation of transferring and receiving pharmacists, date, and refills remaining. Schedule II transfers are generally restricted.

State immunization authority

Many states allow pharmacists to administer vaccines under a protocol or standing order, with age thresholds and reporting requirements that vary by state and must be verified.

Counseling requirement

State law generally requires pharmacists to offer or provide counseling on new prescriptions and certain refills, with documentation of patient refusal where the state requires it.

Mandatory error reporting

Many states require pharmacists to report suspected prescription fraud, impaired practitioners, and dispensing errors to the Board or another authority within a defined timeframe.

Pharmacist-in-charge role

The PIC is responsible for pharmacy compliance, recordkeeping, and staff supervision, must be licensed in the state, and is the Board's primary contact for the permit.

Pharmacy permit changes

A pharmacy permit is location-specific. A change of location, ownership, or name generally requires a new permit or amendment, and an inspection before opening.

State CII expiration

Many states set shorter expiration periods for Schedule II prescriptions, often 30 days, than for non-controlled drugs. Verify the state-specific limit before dispensing.

State controlled scheduling

States may schedule substances more restrictively than federal law. A drug may be state-controlled even if not federally scheduled, and the stricter rule generally governs.

PMP confidentiality

Prescription monitoring program data is confidential. Disclosure is limited to authorized prescribers, dispensers, and law enforcement with legal process; unauthorized access is a violation.

State board discipline

Grounds include fraud, negligence, incompetence, impaired practice, and drug law violations. Sanctions range from reprimand and probation to suspension or revocation of licensure.