When are prescribers supposed to electronically transmit prescriptions to the pharmacy?

ANSWER: Michigan statute (MCL 333.17754a) states that beginning October 1, 2021, or the implementation date set by the federal Centers for Medicare and Medicaid Services (CMS), whichever is later, 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 current implementation date set by CMS is January 1, 2022, therefore, implementation date in the state of Michigan is set for January 1, 2022.

When do pharmacy technicians need to submit their CE for their licensure requirements?

ANSWER: Pharmacy technicians are not required to submit CE directly to the Board of Pharmacy as part of their licensing requirements. Technicians 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).

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 222 forms, etc. for two years and pharmacy prescription records 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. Reference: 42 CFR § 422.504,  R 338.3153

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. Reference: MCL 333.17762; R 338.571

What are the requirements for reporting a pharmacy theft or drug loss?

ANSWER: Michigan law requires the reporting of all losses within 10 days of discovery; federal law requires notification of loss to the Drug Enforcement Administration (DEA) within one 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. Reference: 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 the Michigan Department of Licensing and Regulatory Affairs (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.* Reference: HHS website; *internal discussion with LARA.

Can the process of “tech-check-tech” be allowed in a hospital pharmacy? Would this fall under pharmacist delegation?

ANSWER: Pharmacy technicians are granted certain privileged tasks under their licenses which are listed in MCL 333.17739. The law also prohibits the delegation of any privileged tasks to pharmacy technicians outside of what is allowed in the law and administrative rules. Pharmacy technicians may “assist in the dispensing process,” which includes the preparation, compounding, packaging or labeling of a drug. R 338.3665 of the Board of Pharmacy Pharmacy Technician Rules states that in addition to performing the functions described in section 17739(1) of the code, a licensed pharmacy technician may also engage in reconstituting dosage forms as defined in 17702(4) of the code, under the delegation and supervision of a licensed pharmacist. The Board of Pharmacy rules have been undergoing edits to include “tech-check-tech” language, more to come! The functions of pharmacy technicians are not granted by the Michigan delegation doctrine, but all functions assigned to a pharmacy technician must be conducted under the supervision and personal charge of a pharmacist. The Board of Pharmacy administrative rules are interpreted to require final verification by a pharmacist, though this rule does not apply to inpatient medical institution services or telepharmacy practice. Reference: MCL 333.17703(3), 333.17739

Can a pharmacy technician or student pharmacist verify the work of another pharmacy technician?

ANSWER: Historically in the inpatient practice setting, there was no clear statement about who must complete the final verification step in the prescription dispensing process. R 338.586 implies that final verification will be completed by a pharmacist and must be initialed by that pharmacist, but this rule does not apply to inpatient medical institutions. Since the pharmacy technician law passed, however, MCL 333.17739(2)(b) restricts the privileged actions of pharmacy technicians to those that are listed in the act and in the rules (which only added reconstitution to the list). That being said, there is still debate as to whether or not verification is actually a privileged action, but the pharmacist always bares the responsibility for the integrity and accuracy of a dispensed prescription. Reference: MCL 333.17739; R 338.586, 338.589

What are the rules pertaining to emergency drug boxes?

ANSWER: According to the Board of Pharmacy General Rules (R338.590), “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.” Reference: MCL 333.17706; CFR 1305.03

What are the regulations regarding Expedited Partner Therapy (EPT)?

ANSWER: A physician may write a prescription to treat any sexual partners (within the last six months) 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. Reference: MCL 33.5110

What are the legal requirements pertaining to manual signatures on prescriptions?

ANSWER: A manual signature is required on all paper prescriptions presented to the pharmacy or on those prescriptions that were transmitted from a prescriber’s fax machine to the pharmacy’s fax machine. The prescriptions may be computer-generated; however, they must contain a manual or “wet” signature of the prescriber if they are printed out. The prescriber is required to sign a written prescription in the same manner as he would sign a check or legal document. Electronically generated signatures on these paper or fax-to-fax prescriptions are not valid. Reference: MCL 333.17708, 333.17709; CFR 1306.05

Is a stamped signature on a prescription a valid signature?

ANSWER: No. Reference: MCL 333.16106, 333.17708, 333.17709; R 338.3104, CFR 1306.05

What are the legal requirements pertaining to electronic signatures on prescriptions?

ANSWER: If the electronic prescriptions are created and signed using an application that has also been certified by a Drug Enforcement Administration (DEA)-approved vendor, electronically-communicated prescriptions are valid with electronic signatures for noncontrolled substances and for controlled substances. The electronic signature can be a sound, symbol or process attached to the record (may or may not be a digital version of the prescriber’s signature). A pharmacy’s software must also have been certified by a DEA-approved vendor to accept electronically-communicated prescriptions for controlled substances. Reference: MCL 333.17703, 333.17708, 333.17709; R 338.3162a, 338.3162b; CFR 1306.05, 1311.120

What is the limit on the number of medications that can be on a prescription?

ANSWER: There is a limit of six medications per computer-generated prescription, and a limit of four medications for a handwritten blank for non-institutional pharmacy practice. Reference: R 338.584

What are the rules pertaining to prescribers purchasing medications from a pharmacy for office use?

ANSWER: An authorized prescriber may purchase medication from a pharmacy for patients’ office use. If the pharmacy is distributing controlled substances to a practitioner, then the pharmacy must ensure that the practitioner has a valid Drug Enforcement Administration (DEA) registration. Medications distributed shall be recorded by the pharmacy and the practitioner via an invoice (in a similar manner as to how the pharmacy is invoiced from the wholesaler). The prescriber would be required to purchase schedule 2 substances via a 222 Form. A pharmacy cannot sell more than five percent of the total number of prescription medication dosage units distributed and dispensed by the pharmacy during a 12-month period to physicians or other persons. If they were to do so, they would be considered a wholesale distributor. That said, the five percent restriction applies individually to distributions of controlled substances as well as total medication sales. Reference: MCL 333.17706; R 338.551, 338.561, 338.3162, 338.3181; CFR 1305.03, 1305.22, 1307.11

How long is a schedule 2 CS prescription valid for?

ANSWER: A prescription for a schedule 2 controlled substance should not be filled more than 90 days after the date on which the prescription was issued. Reference: MCL 333.7333; CFR 1306.12

How long are schedule 3-5 CS prescriptions valid for?

ANSWER: Schedule 3 or 4 controlled substance prescriptions are valid six months from the date on which the prescription was written. In addition, no more than five refills can be granted within those six months. Prescriptions for schedule 5 controlled substances are valid for one year with no limitation on the number of refills within that year. Reference: MCL 333.7333; R 338.3168; CFR1306.22

What are the rules for issuance of multiple schedule 2 CS prescriptions?

ANSWER: Prescribers may issue as many schedule 2 controlled substance prescriptions as they deem appropriate, up to a 90-day supply, so long as each prescription complies with controlled substance prescription requirements and that doing so does not create undue risk of diversion or abuse. Each prescription must be dated and signed on the day the prescription is issued (the date the patient was seen by the prescriber) as well as the earliest permissible fill date, with the exception of the one intended for first fill. This “do not fill until” date is, by law, the earliest date on which the prescription may be filled. Each prescription expires 90 days from the date written. The prescriber is never allowed to post-date prescriptions for controlled substances. Reference: CFR 1306.12; MCL 333.7333

What are the legal requirements for transferring or receiving schedule 3-5 controlled substance prescriptions?

ANSWER: Schedule 3-5 controlled substances may be transferred once, if the pharmacies do not electronically share them on a real-time basis. The transfer of controlled substance prescriptions must be conducted between two licensed pharmacists, whether shared verbally or electronically on a real-time basis. However, pharmacies that electronically share on a real-time basis may transfer up to the maximum refills permitted by law and the prescriber’s authorization online.

Responsibility of the transferring pharmacist: The pharmacist completing a transfer must write the word “VOID” on the face of the invalidated prescription. On the back of the invalidated prescription, the pharmacist needs to document the name, address and Drug Enforcement Administration (DEA) registration number of the pharmacy to which it was transferred to and the name of the pharmacist receiving the prescription.

Responsibility of the receiving pharmacist: The pharmacist receiving the transfer must write the word “TRANSFER” on the face of the prescription and include all of the controlled substance prescription’s required elements in addition to the original prescription’s date of issuance, the original number of refills authorized, the remaining number of refills and the date of original dispensing. The pharmacist must also document the name of the transferring pharmacy, address, DEA number, the prescription number and the name of the transferring pharmacist. However, pharmacies that electronically share on a real-time basis may transfer up to the maximum refills permitted by law and the prescriber’s authorization online. A schedule 2 controlled substance prescription may not be copied from any pharmacy. Reference: CFR 1306.25

Does the DEA authorize the transfer of unfilled, “profiled” prescriptions?

ANSWER: Yes. According to the NABP clarification statement titled “Clarification on Transfer of Unfilled Controlled Substance Prescriptions,” which address the DEA’s policy, the DEA does authorize the transfer of unfilled, “profiled” prescriptions. The letter states that prescriptions can take the form of paper (including fax), call-in, or electronic prescription for controlled substances (EPCS). The DEA has addressed the forwarding of an EPCS prescription through published information in the preamble of the notice of proposed rulemaking (NPRM) on EPCS, 73 FR 36722, and the preamble of the interim final rule (IFR) on EPCS, 75 FR 16235. Note, because this was in the preamble and not in the EPCS regulations, it represents the DEA’s policy. As posted in the preambles of the NPRM and the IFR, an unfilled original EPCS prescription can be forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy, and this includes Schedule II controlled substances. Forwarded means transferred from one EPCS system to another. Thus, it must be maintained electronically and not verbally, for example.

Note that a pharmacy may have policies or producers in place prohibiting the transfer of unfilled prescriptions.

What information should a pharmacist submit to MAPS as a patient identifier on CS prescriptions?

ANSWER: Patient identifiers include the full name, date of birth and address (including zip code) along with an identification number such as a: a) Driver’s license number, b) State-issued identification number or c) the number zero. Zeros shall be entered if the patient is under 16 years of age. If the patient is an animal, the owner’s identification shall be used. Not that a social security number is no longer an allowable identifier. Reference: MCL 333.7333a; R 338.3102

Can a pharmacist fill a schedule 2 CS prescription prior to the “do not fill until” date?

ANSWER: No, the prescription cannot be filled until the date specified by the physician, not the date on which the prescription was written. Reference: CFR 1360.12

Can a pharmacist fill a faxed-in schedule 2 CS prescription for a long-term care (LTC) patient?

ANSWER: A schedule 2 controlled substance prescription for a resident of a long-term care (LTC) facility may be transmitted by the practitioner or by the practitioner’s agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription. LTC facilities need to have documented “agent of the prescriber” arrangements with each nurse acting as a practitioner’s agent. Facilities should utilize the approved Drug Enforcement Administration “agent of the prescriber” form for each nurse with every prescriber and have these forms updated routinely per facility protocol. Reference: CFR 1306.11

Can a pharmacist fill a schedule 2 CS prescription patients in partial quantities?

ANSWER: Yes. Schedule 2 controlled substance prescriptions can be partially filled and the remaining quantity shall be filled no later than 30 days after the date on which the prescription is written. Note that this new law does replace the partial filling of schedule 2 controlled substance for long-term care and terminally ill patients. The current law recognizes the partial filling of schedule 2 controlled substances, stating that the remaining quantity of a partially filled schedule 2 controlled substance shall be filled no later than 30-days after the date written. The previously referenced 60-day partial filling of schedule 2 controlled substances has been removed from the Public Health Code. Reference: CFR 1306.13(b); MCL 333.7333; 21 USC 829(f)

What are the rules pertaining to the ability for a pharmacist to dispense an emergency supply of a schedule 2 CS prescription for a patient?

ANSWER: A pharmacist may accept an oral prescription authorization from a prescribing practitioner in the case of an emergency situation, provided that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. Within seven days of authorizing an emergency oral prescription, the prescriber must provide to the dispensing pharmacist a signed written prescription for the schedule 2 medication. The prescription must have written on the front “Authorization for Emergency Dispensing”, and the date of the oral order. This needs to be attached to the oral order, and the prescription must be delivered in person or by mail. If delivered by mail, the postmark must be within the seven-day period. For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription, the original authorization and the date of the oral order in order to meet the Drug Enforcement Administration’s (DEA) approved certification standards. If the prescriber fails to deliver the written prescription to the pharmacist within seven days, the DEA office must be notified. Reference: CFR 1306.11(d)

Can a pharmacist provide a partial fill for schedule 3, 4 and 5 CS prescriptions?

ANSWER: Yes, according to the Code of Federal Regulations, providing a partial fill for a schedule 3-5 controlled substance is legal provided that: 1) each partial filling is recorded in the same manner as a refilling. The pharmacist should indicate in the appropriate National Council for Prescription Drug Programs (NCPDP) field the quantity written for and then, in the appropriate NCPDP field, the quantity dispensed, and likewise the appropriate number of refills. If the prescription is billed to a health insurance plan, then the pharmacist should document on the prescription the reason for dispensing less than prescribed (for example, the patient requested less than prescribed) to avoid audit issues; 2) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and 3) no dispensing occurs six months after the date on which the prescription was issued. If a patient requests less medication than the quantity prescribed, or if the insurance limits the quantity that is covered, the pharmacist may dispense fewer than the quantity written for. Dispensing less than the full amount written for does not constitute a refill and, therefore, does not count toward the five refills allowed on schedule 3 and 4 controlled substance prescriptions. Reference: R 338.3168; CFR 1306.22, 1306.23

Are technicians allowed to obtain orders for CS prescriptions, either orally from the prescriber’s office or to give or receive prescription transfers from another pharmacy?

ANSWER: No. A practitioner or the practitioner’s agent may convey a prescription orally to a pharmacist, who promptly reduces to writing all the required information. A pharmacist is defined as anyone licensed by a state to dispense controlled substances, and shall include any other person (e.g., pharmacist intern) authorized by a state to dispense controlled substances under the supervision of a pharmacist licensed by such state. Michigan Public Health Code defines “dispenser” as a person who dispenses medication and practitioner as a pharmacist permitted to distribute, dispense, etc. medication. Reference: MCL 333.7109, 333.7105; R 338.3162, 338.3153a; CFR 1306.05.

Is there a limit on the quantity a prescriber can write for CS prescriptions?

ANSWER: No. Neither the federal government nor the state of Michigan place a quantity limitation on the amount of controlled substance medications that can be prescribed and dispensed. There are, however, a few exceptions:

• If the prescriber is writing multiple prescriptions for a schedule 2 substance, then there is a 90-day limitation.
• Advanced Practice Registered Nurses (APRNs, including Nurse Practitioners, Nurse Midwives and Certified Nurse Specialists), may only write for up to a 90-day supply of a schedule 2 substance under the delegation of a physician.

Reference: CFR 1306.12; R338.2441, 338.119

Can an optometrist write a prescription for a hydrocodone-containing product?

ANSWER: Yes. In the Michigan Public Health Code, optometrists are given the ability to prescribe controlled substances in schedule 3, 4 and 5 as well as the ability to prescribe schedule 2 “hydrocodeinone” containing products (which is another name for hydrocodone-containing products). Reference: MCL 333.17401

Which schedules of CS are advanced practice registered nurses (e.g., nurse practitioners) allowed to prescribe under delegated authority by a MD or DO?

ANSWER: Advanced Practice Registered Nurses (APRNs) do not have limitations for prescribing controlled substances in schedules 3-5. They do, however, have limitations for the prescribing of schedule 2 controlled substances restricting them to a 90-day supply on a single prescription. APRNs prescribe controlled substances under delegation and must list the name and DEA number of their delegating provider. Reference: MCL 333.16215, 333.17211a

Can a Nurse Practitioner (NP) call a verbal emergency C2 if they follow up with a written prescription?

ANSWER: Yes, according to the federal regulations this is something that can be done for any individual who has the authorization to prescribe a schedule 2 controlled substance. Remember, however, that the script may only be valid for the duration of the emergency. Reference: CFR 1306.411

Which schedules of CS are physician assistants allowed to prescribe under delegated authority by a MD or DO?

ANSWER: Physician assistants (PAs) working under a practice agreement with an allopathic physician (MD) and/or osteopathic physician (DO) are allowed to prescribe controlled substance prescriptions, schedules 2-5, without limitations to the quantity or location of prescribing. For the purposes of prescribing, they are given prescriptive authority and do not need to list the name or DEA number of the delegating provider. Reference: MCL 333.17708, 333.17076.

Can Michigan pharmacies fill prescriptions written by out-of-state prescribers?

For noncontrolled prescriptions:

ANSWER: Yes. Pharmacies can fill noncontrolled prescriptions written by prescribers (MDs, DOs, podiatrists, dentists, licensed veterinarians), outside of Michigan (state, district, territory, commonwealth, or insular possession of the United States) as long as they fall within the prescriber’s scope of practice. Pharmacists may also accept prescriptions for noncontrolled medications written by Canadian MDs or DOs. Reference: MCL 333.16106, 333.17708, 333.17751(2)

For controlled substance prescriptions:

ANSWER: Controlled substance prescriptions can only be accepted if issued by a physician prescriber (MD or DO), veterinarian (DVM) or dentist (DDS) who is authorized under the laws of that state to practice dentistry, medicine or osteopathic medicine and surgery and is authorized to prescribe controlled substances. State, in this case, refers to states, districts, territories, commonwealths, and insular possessions of the U.S. Reference: MCL 333.7303, 333.7333, 333.17751, 333.17763

Can a pharmacist be delegated prescription authority and sign patient prescription orders?

ANSWER: There is nothing in the Public Health Code that prohibits a pharmacist from prescribing a noncontrolled substance under delegated authority. A pharmacist would need to identify on a prescription the name of the prescriber who granted them delegated authority to prescribe. A pharmacist, however, cannot prescribe controlled substances since a pharmacist does not have authorization by the Public Health Code or the Administrative Rules of the Boards of Medicine or Osteopathic Medicine and Surgery, nor are pharmacists able to obtain a Drug Enforcement Administration (DEA) registration number. The Public Health Code allows the delegation of prescribing controlled substances to an Advanced Practice Registered Nurse (APRN). Physician assistants prescribe controlled substances as independent practitioners provided they are operating under a practice agreement with a licensed MD or DO. Both are required by federal regulations to have their own DEA registration number. While pharmacists may be granted authority under delegation to prescribe noncontrolled substances, patients may have problems filling these prescriptions under their prescription health insurance coverage since many health plans do not recognize nor credential pharmacist prescribers. Reference: MCL 333.17708, 333.7109