Are prescribers supposed to electronically transmit prescriptions to the pharmacy? What are the exceptions to this requirement?
ANSWER: A prescriber or his or her agent shall electronically transmit a prescription, including a prescription for a controlled substance, directly to a pharmacy of the patient’s choice. The requirement to transmit a prescription electronically does not apply under the following circumstances:
- If the prescription is issued by a veterinarian.
- If the prescription is issued during the event of a technological or electronic failure.
- If the prescription is issued by a prescriber who has received a waiver from the Michigan Department of Licensing and Regulatory Affairs (LARA).
- If the prescription is issued by a prescriber who reasonably believes that electronically transmitting the prescription would make it impractical for the patient due to a delay that would adversely affect the patient’s condition.
- If the prescription is orally prescribed.
- If the prescription is issued by a prescriber to be dispensed outside of Michigan.
- If the prescription is issued and dispensed in the same health care facility and the patient uses the drug exclusively in that health care facility.
- If the prescription is issued by a prescriber for a drug under a research protocol.
- If the prescription is dispensed by a dispensing prescriber.
- If the prescription is for a dialysis-related rug that is administered for home-based dialysis treatment.
REFERENCES: MCL 333.17754a
When do pharmacists and pharmacy technicians need to submit their continuing education (CE) for their licensure requirements?
ANSWER: Pharmacists and pharmacy technicians (pharmacy professionals) are not required to submit CE directly to the Board of Pharmacy as part of their licensing requirements. Pharmacy professionals must meet the CE requirements for their licensure at the time they submit their application to renew their license. They also must retain proof of credit in case they are audited (records stored in the CPE monitor meet this requirement). Pharmacy professionals will be required to submit this proof if subject to an audit.
REFERENCES: R 338.3044 (Pharmacists), R 338.3662 (Technicians)
How long should pharmacy records be kept for?
ANSWER: The Michigan Board of Pharmacy requires pharmacies to retain invoices, billing statements and Drug Enforcement Administration (DEA) 222 forms, etc. for two years. A pharmacy must keep and make available for inspection all acquisition and distribution records for five years. Prescription records must also be maintained for five years. Michigan Medicaid requires records to be kept for seven years and Medicare Part D regulations require all records to be kept for 10 years.
REFERENCES: 42 CFR § 422.504 (Medicare), R 338.3153 (Controlled Substances), R 338.583a (acquisition and distribution records), R 338.584 (Noncontrolled Prescriptions)
What are the rules pertaining to “returning to stock” medications that have not been picked up? Can the medication be added back into an open bottle, or must it remain in the prescription vial that was prepared for?
ANSWER: If the pharmacy “returns to stock” an open bottle of the medication with the same lot number and expiration date from which the drug was originally filled from, it is not misbranding. If the lot number and expiration dates are different, or if it is left in the vial without an expiration date or lot number, then it would be considered misbranding. It would also violate the rule of ensuring the strength, purity and quality of the medication dispensed.
REFERENCES: MCL 333.17762; R 338.571
What are the requirements for reporting a pharmacy theft or drug loss?
ANSWER: Michigan law requires that, within 15 days of completion of an investigation regarding a suspected theft or significant loss of a controlled substance, a licensee shall notify the department of the suspected theft or significant loss of a controlled substance and submit a copy of the DEA theft and loss report form 106, or equivalent document, to the department, whether or not the controlled substance is recovered or the responsible person is identified and action is taken against him or her, and whether or not it is also reported to the DEA.
Federal law requires notification of loss to the DEA within one business day of discovery (if the loss is significant). Significant loss is determined by the pharmacist. Regardless of whether the loss is significant, if it was either due to a break-in or armed robbery or reported to the local authorities you need to report the loss to the DEA.
REFERENCES: R 338.3141; CFR 1301.74
What must a pharmacy submit if patient records or prescription files are stolen?
ANSWER: There is a requirement to report this as a Health Insurance Portability and Accountability (HIPAA) Act breach to the U.S. Department of Health and Human Services (HHS). Information on how to file this report can be found on the HHS website. Theft is a classification of breach, and you can view some sample reports that have to do with paper theft on the HHS website. The pharmacy can also submit a letter to LARA along with any relevant documentation to be filed as part of the licensee’s record. They should also retain the documentation for their records.
REFERENCES: HHS website
What are the regulations regarding technician verification?
ANSWER: Michigan administrative rules grant pharmacy technicians the ability to provide technology-assisted final product verification, provided that the technician is using bar coding or another error prevention technology. This is subject to the following requirements:
- The licensed pharmacy technician holds a current full or limited pharmacy technician license in this state.
- Before performing final product verification the full or limited licensed pharmacy technician meets 1 of the following:
- Has accrued not less than 1,000 hours of pharmacy technician work experience in the same type of pharmacy practice site where the technology-assisted final product verification will be performed while the pharmacy technician holds a current full pharmacy technician license, a temporary license, a limited license, or is in training in this state.
- Has completed a final product verification training program that includes at least all of the following:
- The role of a pharmacy technician in the product verification process.
- The legal requirements and liabilities of a final verification technician.
- The use of technology assisted verification systems.
- The primary causes of medication errors and misfills.
- The identification and resolution of dispensing errors.
- The practice setting where a licensed pharmacy technician performs final product verification has in place policies and procedures including a quality assurance plan governing pharmacy technician technology-assisted final product verification.
- The technology enabled verification system must document and electronically record each step of the prescription process including which individuals complete each step.
- A licensed pharmacy technician shall not perform technology-assisted final product verification for sterile or nonsterile compounding.
- Technology-assisted final product verification by a licensed pharmacy technician is not limited to a practice setting.
- A pharmacist using professional judgment may choose to delegate technology-assisted final product verification after ensuring licensed pharmacy technicians have completed and documented relevant training or work experience.
REFERENCES: R 338.3665
What are the rules pertaining to emergency drug boxes?
ANSWER: According to the Board of Pharmacy General Rules (R 338.590), “a pharmacist shall routinely inspect the medications and, after use, shall verify the contents and replace the medications as necessary … The medications shall be approved and reviewed periodically as deemed necessary, but not less than once a year… in an area of limited access in a centralized area outside the pharmacy. Each medication shall be labeled to include the name of the medication, the strength, the expiration date, if dated, and the lot number.”
REFERENCES: R 338.590
What are the regulations regarding Expedited Partner Therapy (EPT)?
ANSWER: A physician may write a prescription to treat any sexual partners (within the last 60-days) of a patient who has a positive diagnosis for the following sexually transmitted diseases: chlamydia, gonorrhea or trichomoniasis. If the patient does not wish to supply the name of their partner(s), the prescription(s) may be issued with “Expedited Partner Therapy” under the “patient name” field. Note that third party payers are not required to cover the cost of the partner’s treatment.
REFERENCES: MCL 333.5110