MD MPJE flashcards

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

Board of Pharmacy composition

The Maryland Board of Pharmacy has 12 members: 7 pharmacists, 2 pharmacy technicians, and 3 consumer members, all appointed by the Governor with Senate advice and consent.

Board member term limits

Board members serve 4-year terms and may serve no more than two consecutive full terms; a member appointed to fill a vacancy serves the remainder of the unexpired term.

Grounds for discipline

Grounds include fraud in obtaining a license, unprofessional conduct, incompetence, negligence, habitual intoxication, conviction of a crime involving moral turpitude, and violation of Board regulations.

Pharmacist CE requirement

Maryland pharmacists must complete 30 contact hours of continuing education per annual renewal cycle, including 2 hours of opioid-related CE and other Board-specified topics.

Pharmacy permit requirement

A pharmacy may not operate without a Maryland pharmacy permit issued by the Board; each physical location requires a separate permit, which is not transferable without Board approval.

Pharmacist-in-charge responsibility

The PIC is responsible for compliance with all laws and regulations at the pharmacy; a change of PIC must be reported to the Board within the time specified by regulation.

Nonresident pharmacy registration

A nonresident pharmacy dispensing to Maryland patients must obtain a Maryland registration and comply with Maryland labeling, recordkeeping, and patient counseling requirements, including a toll-free counseling number.

Technician registration and supervision

Pharmacy technicians must be registered with the Board and may perform only delegated tasks under pharmacist supervision; the pharmacist retains responsibility for the final product.

Prescription required elements

A prescription must include patient name and address, drug name, strength, dosage form, quantity, directions, prescriber name and address, DEA number for controlled substances, and date of issuance.

Prescription record retention

Prescription records must be maintained for at least 5 years and be readily retrievable for inspection by the Board and its agents.

Generic substitution rule

A pharmacist may substitute a therapeutically equivalent generic drug unless the prescriber writes "dispense as written" or the patient requests the brand; the substitution must be recorded.

Patient counseling requirement

Before dispensing, the pharmacist must offer to counsel the patient or caregiver on proper use, storage, and adverse effects; the patient may decline and the refusal must be documented.

Schedule II refill prohibition

Schedule II controlled substances require a written or electronic prescription and may not be refilled; a pharmacist may dispense only the quantity prescribed unless a partial fill is permitted.

Schedule III–V refill limit

Schedule III–V drugs may be refilled up to five times within six months of the date of issuance, unless the prescriber specifies otherwise.

Maryland PDMP reporting

Dispensers must report controlled substance dispensing to the Maryland Prescription Drug Monitoring Program within 24 hours, and pharmacists must review the PDMP before dispensing certain controlled substances.

CSOS ordering

CSOS allows electronic ordering of Schedule I and II controlled substances using a DEA-issued digital certificate; the order is transmitted to the supplier and a signed electronic record is retained.

Collaborative practice agreement

A CPA allows a pharmacist to initiate, modify, or discontinue drug therapy under a written protocol with a prescriber that specifies scope, conditions, and communication requirements.

Prospective drug utilization review

Before dispensing, a pharmacist must screen for therapeutic duplication, drug-drug interactions, drug-disease contraindications, incorrect dosage, and allergies.

Pharmacist delegation limits

A pharmacist may delegate tasks to technicians and interns but retains responsibility for accuracy and appropriateness of the final product and for patient counseling.

Vaccine administration authority

Maryland permits pharmacists to administer vaccines and certain medications under a statewide protocol or prescription, subject to Board regulations and training requirements.

Automated dispensing device rules

ADDs must be approved by the Board and maintained under pharmacist supervision; the pharmacist must establish policies for access, security, and accuracy and review transactions.

Sterile compounding standards

Sterile compounding must comply with USP <797>, requiring a designated clean room, environmental monitoring, personnel training, and records of equipment calibration and sterility testing.

Beyond-use date assignment

Repackaged and compounded drugs must be assigned a beyond-use date based on stability data, preservative efficacy, and storage conditions; the BUD may not exceed the manufacturer's expiration date.

Repackaging record requirements

Repackaging from bulk to unit-dose must be under pharmacist supervision with records of drug, lot number, expiration date, and repackager, and the product must be labeled accordingly.

DEA registration renewal

DEA registration is required for any pharmacy dispensing controlled substances, must be renewed every three years, and a separate registration is required for each location.

Drug recall classification

Recalls are classified as Class I, II, or III based on risk; pharmacies must check inventory, remove affected products, notify patients when required, and document the action.

HIPAA pharmacy obligations

Pharmacies must protect protected health information, provide a notice of privacy practices, and obtain patient authorization for certain uses; Maryland law may impose stricter confidentiality requirements.

DSCSA track-and-trace

Pharmacies must comply with the Drug Supply Chain Security Act by verifying transaction information and maintaining product tracing records for prescription drugs.

Medication error reporting

Medication errors must be reported to the pharmacy's quality improvement program and, when required, to the Board and other authorities; a pharmacist must not conceal an error.

Continuous quality improvement duty

A pharmacist must participate in CQI activities, including root cause analysis, error tracking, and implementation of preventive strategies to improve patient safety.

Impaired colleague reporting

A pharmacist must report an impaired colleague to the Board or a peer review organization when patient safety is at risk, in compliance with mandatory reporting laws.

Patient confidentiality duty

A pharmacist must maintain patient confidentiality and may disclose PHI only as permitted by HIPAA and Maryland law, such as for treatment, payment, or health care operations.