MI MPJE cheat sheet

Federal Controlled Substances Act scheduling criteria: Schedule I has no accepted medical use and high abuse potential; Schedule II has accepted medical use with severe psychological or physical dependence risk; Schedules III–V descend in abuse and dependence potential.

Federal legend requirement: a prescription drug may be dispensed only on a prescription of a practitioner licensed by law to administer the drug, and the label must carry the federal caution statement unless exempted by regulation.

Michigan Public Health Code Article 15 (MCL 333.17701 et seq.) governs pharmacy licensure, drug control, and discipline; the Board of Pharmacy adopts rules in the Michigan Administrative Code.

Michigan requires a prescription record to be retained for 5 years and made readily retrievable; federal law requires controlled substance records for at least 2 years, so the 5-year Michigan period controls in-state practice.

Federal CSA order-form rule: Schedule I and II substances are ordered on DEA Form 222 (or its electronic equivalent, CSOS); Schedule III–V substances are ordered on invoices that must show the supplier's DEA number.

Michigan's drug pedigree and anti-counterfeiting provisions apply to prescription drug distribution, requiring transaction documentation for drugs that leave and re-enter the normal distribution chain.

Federal HIPAA Privacy Rule permits disclosure of protected health information for treatment, payment, and health care operations without authorization; Michigan's medical records statute adds patient-access rights and confidentiality duties.

The federal Combat Methamphetamine Epidemic Act imposes daily and monthly sales limits and logbook, identification, and behind-the-counter storage requirements on ephedrine- and pseudoephedrine-containing products.

Michigan pharmacist licensure requires graduation from an accredited pharmacy program, passage of NAPLEX and the MPJE, and a criminal background check through the Board of Pharmacy.

A Michigan pharmacist license must be renewed every 2 years; Michigan requires 30 hours of continuing education per renewal cycle, including at least 5 hours on opioid and controlled substance prescribing and dispensing topics.

Pharmacy technician registration in Michigan requires application to the Board, payment of the fee, and renewal on the Board's cycle; technicians work under the direct supervision of a licensed pharmacist.

A Michigan pharmacy license is issued to a specific location and must be displayed; a change of location, ownership, or name requires Board notification and, for relocation, a new or amended license.

Nonresident pharmacies that ship prescription drugs into Michigan must register with the Michigan Board of Pharmacy and identify a Michigan-licensed pharmacist-in-charge.

Michigan requires a separate controlled substance license for a pharmacy that handles controlled substances; the license is issued by the state licensing agency and is distinct from the DEA registration.

DEA registration is site-specific and must be renewed every 3 years; a practitioner or pharmacy may hold only one DEA registration per location unless a separate registration is obtained for a distinct activity.

Michigan permits pharmacist licensure by reciprocity for licensees of other states who meet Michigan's requirements, including passing the MPJE and satisfying continuing education and background check standards.

A prescription must contain the patient's name and address, the drug name, strength, dosage form, quantity, directions, prescriber's name and address, and date of issue; missing elements must be obtained from the prescriber before dispensing.

Michigan allows a pharmacist to dispense a prescription drug pursuant to a valid prescription transmitted orally, in writing, or by electronic means; the pharmacist must reduce an oral prescription to a written record.

Substitution of a therapeutically equivalent generic drug is permitted unless the prescriber writes 'dispense as written' or the patient objects; the record must show the brand dispensed and the substitution.

The prescription label must include the pharmacy name and address, prescription number, date, patient name, directions for use, prescriber name, and any required cautionary statements.

A prescription may be refilled only if the prescriber authorizes refills; Schedule III–IV prescriptions may not be filled more than 6 months after issue and may not exceed 5 refills.

Michigan requires a prescription to be retained for 5 years and to be readily retrievable; a pharmacist must be able to produce the original or a copy on request of the Board or an authorized agent.

Patient records must document known allergies, drug interactions, and the pharmacist's interventions; a pharmacist must maintain a system for screening prescriptions for therapeutic duplication and interactions.

A pharmacist may dispense a prescription for a controlled substance only after verifying the prescriber's DEA registration and authority to prescribe that schedule.

Schedule II prescriptions must be written, signed, and dated by the prescriber, may not be refilled, and must be filled within a limited period; federal law requires a new prescription for each fill.

Michigan's prescription drug monitoring program (MAPS) requires dispensers to report controlled substance dispensing to the state database; pharmacists must review MAPS before dispensing certain controlled substances.

A pharmacist may dispense a Schedule II prescription only on the day it is written or within the period allowed by Michigan law; a prescription that is older may not be filled without prescriber confirmation.

Federal law permits a pharmacist to dispense a Schedule II drug on an oral emergency prescription if the quantity is limited and the prescriber delivers a written prescription within 7 days.

Schedule III–V prescriptions may be refilled up to 5 times within 6 months of the issue date; the prescriber must authorize each refill.

A pharmacy must report theft or significant loss of controlled substances to DEA and to the state licensing agency; the report must be made in writing and the circumstances documented.

A pharmacist must verify the identity of a person picking up a controlled substance and may require photo identification; the record of dispensing must show the date and quantity.

Schedule V substances may be dispensed without a prescription only when state law permits and the pharmacist complies with the identification, logbook, and quantity limits that apply.

A pharmacist must offer counseling to each patient receiving a new prescription; counseling may be declined, and the decline must be documented in the patient record.

Counseling must cover the drug name and description, dosage form, dose, route, duration, directions, special precautions, common adverse effects, interactions, and storage.

A pharmacist must perform a prospective drug utilization review before dispensing, screening for therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect dosage, and allergies.

Michigan requires a pharmacist to counsel on the proper use of devices and on the importance of adherence when dispensing a new medication or a changed dose.

Medication error and adverse drug event reporting is required for serious events; the pharmacy must maintain a quality assurance program that documents errors and corrective actions.

A pharmacist must provide the patient with a written patient package insert when federal regulations require one, such as for oral contraceptives and estrogen-containing products.

A pharmacist may not delegate counseling to a technician; technicians may perform data entry, counting, and labeling tasks under pharmacist supervision.

A pharmacist must maintain a system for identifying and resolving potential drug therapy problems and must document the resolution in the patient record.

A Michigan pharmacy must have a designated pharmacist-in-charge who is responsible for compliance with the Public Health Code and Board rules and for the pharmacy's day-to-day operations.

The pharmacy must have adequate space, equipment, and security to prevent unauthorized access; the prescription department must be enclosed and lockable when a pharmacist is not present.

A pharmacy must maintain a current policy and procedure manual covering dispensing, recordkeeping, security, and emergency procedures, and must review it periodically.

A pharmacy must be open only when a pharmacist is on duty; the pharmacy may not be operated without a licensed pharmacist present, except for limited activities permitted by rule.

Pharmacy technicians must be registered with the Board and must work under the direct supervision of a pharmacist; the pharmacist-to-technician ratio is set by Board rule.

A pharmacy must maintain a perpetual inventory of controlled substances and reconcile it at least every 2 years; discrepancies must be investigated and reported.

A pharmacy must have a written plan for handling recalls, returns, and disposal of drugs, including controlled substances, consistent with DEA and Michigan requirements.

A pharmacy must post required notices, including the pharmacy license, the name of the pharmacist-in-charge, and information on how to contact the Board with complaints.

Grounds for discipline in Michigan include fraud, deceit, negligence, incompetence, violation of the drug laws, and practicing beyond the scope of the license.

A pharmacist must report to the Board any knowledge of a violation of the Public Health Code by another licensee that poses a risk to patients.

A pharmacist may not dispense a drug for which the prescription was obtained by fraud, misrepresentation, or forgery, and must report suspected forgery to law enforcement.

A pharmacist may not have a financial interest in a prescriber's practice that creates a conflict of interest, and must avoid kickbacks and fee-splitting arrangements.

Michigan's disciplinary process includes an administrative complaint, a hearing before an administrative law judge, and sanctions ranging from reprimand to license revocation.

A pharmacist must maintain patient confidentiality and may not disclose protected health information except as permitted by law or authorized by the patient.

A pharmacist must not practice while impaired by alcohol or drugs and must report an impaired colleague to the Board or a designated program.

A pharmacist must maintain professional boundaries with patients and may not engage in sexual or exploitative relationships with patients.

Compounding must comply with USP General Chapter 795 for nonsterile preparations and USP 797 for sterile preparations, including facility, environmental monitoring, and personnel training requirements.

A pharmacy may not compound a copy of a commercially available drug product unless the prescriber documents a clinically significant difference for the patient.

A pharmacy that compounds sterile preparations must have a designated cleanroom, laminar airflow hood, and a program for monitoring air quality and personnel competency.

A pharmacy must maintain records of compounded preparations, including the formula, ingredients, lot numbers, and the identity of the person who compounded and verified the preparation.

A pharmacy may dispense a drug to a long-term care facility only pursuant to a prescription and must maintain records that identify the resident and the prescriber.

A pharmacist must provide counseling and written information to patients receiving drugs with a narrow therapeutic index or high risk of adverse effects, such as anticoagulants and insulin.

A pharmacy must have a plan for dispensing to special populations, including pediatric dosing, geriatric renal adjustment, and pregnancy and lactation precautions.

A pharmacy may not distribute drugs to another pharmacy without a valid wholesale license or a documented transfer permitted by law.