Controlled Substance Administrative Rule Changes in Effect as of Jan. 4

In its continued effort to combat Michigan’s opioid epidemic, the Michigan Department of Licensing and Regulatory Affairs recently modified the Pharmacy Controlled Substance rules. Three significant changes went into effect on January 4, when the rules were filed with the Office of the Great Seal. Most significant of those is identification of five exceptions to the bona fide prescriber-patient relationship, which is required to prescribe Schedule 2 through 5 drugs. The revised rules also categorize gabapentin as a Schedule 5 drug and require all controlled substance licensees and their delegates to complete a one-time training in opioids and controlled substances awareness.

Exceptions to the Bona Fide Relationship Requirement

R 338.3161a provides the following exceptions to the bona fide prescriber-patient relationship that is required to prescribe Schedule 2 through 5 drugs:

  • When a prescriber is providing on-call coverage or cross-coverage for another prescriber who is not available and has established a bona fide prescriber-patient relationship with the patient, as long as the prescriber or an individual licensed under article 15 of the act, reviews the patient’s relevant medical or clinical records, medical history, and any change in medical condition, and provides documentation in the patient’s medical record.
  • When the prescriber is following or modifying the orders of a prescriber who has established a bona fide prescriber-patient relationship with a hospital in-patient, hospice patient, or nursing care facility resident and provides documentation in the patient’s medical record.
  • When the prescriber is prescribing for a patient that has been admitted to a licensed nursing care facility or a hospice and completes the tasks required in subrule (2)(a) and (2)(b) in accordance with the nursing care facility or hospice admitting rules and provides documentation in the patient’s medical record.
  • When the prescriber is prescribing for a patient, and the tasks required in subrule (2)(a) and (2)(b) are complied with by an individual licensed under article 15 of the Public Health Code and the prescriber provides documentation in the patient’s medical record.
  • When the prescriber is treating a patient in a medical emergency, as defined in the rule

Gabapentin a Schedule 5 Controlled Substance

R 338.3125 adds gabapentin to the Schedule 5 drug list as a controlled substance. Below are frequently asked questions drafted by the Michigan Pharmacists Association (MPA). The answers, published below with permission by MPA, are MPA’s interpretation and understanding of the new rule and are not to be considered legal advice as LARA may decide to enforce the rule differently.

What are prescription requirements now that gabapentin is a schedule V?
Pharmacists shall ensure that gabapentin prescriptions include the required information, as defined under the Board of Pharmacy Controlled Substance Rules (R 338.3161). Table 1 identifies the information required on all gabapentin prescriptions. Note that pharmacy law does not specify the maximum number of refills for a schedule V prescription. However, the DEA Pharmacist’s Manual states that refills for a schedule V are permitted, as authorized when the prescription is issued or if renewed by a practitioner. A prescription written for gabapentin expires in 12 months from the date written whereas a partially filled gabapentin prescription expires six months from the date written (R 338.3168).

Table 1: Gabapentin Prescription Required Information

Patient name and address

Prescriber name, address and professional designation

Prescriber DEA registration number1

Prescriber signature2

Prescriber telephone number2

Drug name

Drug dosage form

Drug strength

Drug quantity3

Directions for use

Date written

Refills authorized

  1. All gabapentin prescriptions written under delegated authority shall include the name and DEA number of the prescriber along with the name and DEA number of the delegating prescriber.
  2. Not required on oral prescriptions.
  3. Drug quantity for a written prescription (“hard-copy”) shall be written in numerical terms and spelled out on the prescription or a boxed shall be checked to indicate the quantity written.

A prescription phoned-in for gabapentin can only be carried out between the pharmacist on duty and a prescriber (or an agent acting on behalf of the prescriber). However, a pharmacist may delegate a student pharmacist (intern) the authority to receive prescriptions for controlled substances under his or her supervision. The prescription must include the identity of the receiving pharmacist (or intern) as well as the identity of the individual calling in the prescription. Note that Section 17739 of the Michigan Public Health Code prohibits pharmacy technicians from receiving verbal prescription for controlled substances; therefore, a pharmacist shall not delegate such activity to a pharmacy technician.
 
Do I have to void all prescriptions issued for gabapentin prior to the scheduling and obtain new ones?
The Department is yet to clarify on the validity of current prescriptions with authorized refills. The MPA suggests that pharmacists practice professional judgment during the next couple of days/weeks, until LARA issues further clarification. To minimize the likelihood of unforeseen violations, pharmacists may consider obtaining new prescriptions and thus avoiding the potential for problems. However, if a prescription meets all of the DEA requirements for a schedule V controlled substance and has valid refills, then an additional quantity can be dispensed. Pharmacists are encouraged to document all transactions.
 
Do I have to report my dispensing to MAPS?
Yes, the Board of Pharmacy Controlled Substance Rules (R 338.3162b) requires all dispensing practitioners, veterinarians and pharmacies to report dispensing of controlled substances schedule II through V to the Michigan Automated Prescription System (MAPS). MAPS reporting is done via the Prescription Monitoring Program Clearinghouse software (the current platform is Appriss Health’s PMP AWARxE software) by the end of the next business day.
 
When should I take inventory?
DEA registrants must inventory all gabapentin products on the effective date (R 338.3152). The initial inventory record is incorporated into the current controlled substance inventory. Thereafter, gabapentin shall be included in each annual controlled substance inventory. The controlled substance inventory is retained by the pharmacy and is not forwarded to LARA.
 
Why doesn’t the manufacturer’s label identify gabapentin as a schedule V controlled substance?
The scheduling of gabapentin occurred on a state level. Manufacturers are required to include scheduling only if the drug is scheduled on a federal level. Although the manufacturer’s label does not include scheduling, it is still considered as a schedule V in Michigan. All procedures established by the pharmacy when handling and storing controlled substances must now include gabapentin.
 

One-time Training Requirement

R 338.3135 requires all controlled substance licensees who prescribe or dispense controlled substances, and delegates who prescribe, administer, or dispense on behalf of a licensee, to complete a one-time training in opioid and other controlled substances awareness. The training must cover:

  • Use of opioids and other controlled substances
  • Integration of treatments
  • Alternative of treatments for pain management
  • Counseling patients on the effects and risks associated with using opioids and other controlled substances
  • The stigma of addiction
  • Utilizing the Michigan Automated Prescription system
  • State and federal laws regarding prescribing and dispensing controlled substances
  • Security features and proper disposal requirements for prescriptions.

This requirement takes effect September 1, 2019, for initial licenses and the first renewal cycle after the promulgation of this rule for controlled substance license renewals.

Click here for the new Board of Pharmacy's Controlled Substances rules in their entirety.

If you have questions, please contact the Bureau of Professional Licensing at 517.241.0199 or BPLHELP@michigan.gov