Michigan Department of Licensing & Regulatory Affairs Revises Controlled Substance Rules

1. Gabapentin is now added as a controlled substance to the Schedule 5 drug list.

2. Health care providers licensed to prescribe or dispense controlled substances must          complete a 1-time training in opioids and controlled substances awareness.  The training topics must include:

• Use of opioids and other controlled substances;
• Integration of treatments;
• Alternative 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 (MAPS);
• State and federal laws regarding prescribing and dispensing controlled substances; and
• Security features and the proper disposal requirements for prescriptions.

3. Acceptable training providers or methods of training include any of the following:

• Training by a nationally recognized or state recognized health related organization;
• Training offered by, or in conjunction with, a state or federal agency;
• Training offered by a continuing education program or activity that is accepted by a licensing board; or
• Training obtained in an educational program approved by a licensing board, or by a college or university.

The new rule specifies that a prescriber or dispenser shall not delegate or order the prescribing, dispensing, or administering of a controlled substance to an advanced practice registered nurse, registered professional nurse or licensed practical nurse unless the nurse complies with this rule.

In the event of an audit, the health care provider must provide proof of training, which may be either: (i) a completion certificate issued by the trainer or training program, or (ii) a self-attestation by the health care provider.  Both methods of training verification requires documentation of the date, training provider’s name, name of training and individual’s name.  Verification of training is required for controlled substance license renewals beginning with the next renewal cycle, and for initial controlled substance licenses issued after September 1, 2019.

Last year the Department of Licensing and Regulatory Affairs required a bona fide prescriber-patient relationship before controlled substances could be prescribed.  This requirement raised many issues when an in-person face-to-face interaction between a prescriber and patient was not possible.  The new rule specifies alternative ways to meet the bona fide prescriber-patient relationship requirement. The new rule specifies acceptable  compliance methods, such as:

• If a prescriber provides on-call coverage or cross-coverage for another prescriber who is not available and already has an established bona fide prescriber-patient relationship with the patient, it is acceptable for the on-call or cross-coverage prescriber to prescribe  controlled substances listed in schedules 2 to 5 if (i) he/she reviews the patient’s relevant medical or clinical records, medical history, and any change in medical condition prior to prescribing, and (ii) the prescriber provides documentation of such review in the patient’s medical record.

• If a prescriber is following or modifying the orders of another prescriber who has already established a bona fide prescriber-patient relationship with a hospital in-patient, hospice patient, or nursing care facility resident, such documentation of the bona-fide prescriber-patient relationship must be in the patient’s medical record, reviewed by the secondary prescriber, and the secondary prescriber should document his/her review of such information.

• If a prescriber is prescribing to a patient that has been admitted to a licensed nursing care  facility or a hospice and has reviewed relevant medical history and the current medical        condition of the patient in accordance with the nursing care facility or hospice                admitting rules and the prescriber provides documentation of such review in the patient’s    medical record, the prescriber may prescribe controlled substances for the patient.

• In the event of a  medical emergency, the prescriber may prescribe controlled substances.  The rule defines “medical emergency” as a situation when in the prescriber’s good faith professional judgment, there is an immediate threat of serious risk to the life or  health of the patient for whom the controlled substance is prescribed. Of course the nature of the medical emergency should be documented in the patient’s medical record.

This summary highlights the administrative rule changes to the prescribing of controlled subtances and is not meant to serve as legal advice, nor should be relied on as legal advice, regarding any particular set of circumstances.  Readers are encouraged to contact The Health Law Center for specific questions and circumstances related to the prescribing of controlled substances.