In response to growing concerns about misuse and abuse of opioid medications, Michigan has enacted three statutes amending the Public Health Code. The new statutes impose specific requirements on physicians, dentists, physician assistants, and nurse practitioners (“prescribers”) who prescribe controlled substances and on pharmacists who fill those prescriptions.
Any health professional must be aware of the legal requirements and standard of care when prescribing controlled substances in the care and treatment of patients. The Michigan Department of Licensing and Regulatory Affairs (LARA) has been actively investigating allegations that licensees did not comply with the standard of care when prescribing opioid and other medications to patients. Enforcement and disciplinary actions are becoming much more common.
Beginning March 31, 2018, a prescriber may not prescribe a Schedule 2 to 5 controlled substance unless there is a “bona fide prescriber-patient relationship” with the patient. To be a “bona fide” relationship, there must be a treatment or counseling relationship between the prescriber and patient. In addition, the prescriber (1) must review the patient's relevant medical or clinical records and complete a full assessment of the patient's medical history and current medical condition, including a relevant medical evaluation of the patient conducted in person or via telehealth, and (2) must create and maintain records of the patient's condition in accordance with medically accepted standards.
The statute authorizes LARA, in consultation with the licensing boards, to promulgate rules modifying the requirement of a bona fide prescriber-patient relationship. In the meantime, the statutory requirements apply to all prescribers.
There are several requirements when a prescriber writes a prescription for a Schedule 2 to 5 controlled substance:
- The controlled substance must be prescribed in “good faith,” which means the prescriber must act in regular course of professional treatment to an individual under treatment for a pathology or condition other than physical or psychological dependence upon or addiction to a controlled substance. There are separate requirements for treating patients for dependence or addiction.
- Before prescribing or dispensing a controlled substance to a patient, a prescriber must ask the patient about other controlled substances the patient may be using. The prescriber must record the patient's response in the patient's medical or clinical record. (Although not yet required by statute, a prescriber should check the Michigan Automated Prescription System whenever prescribing controlled substances for the first time and on a regular basis when continuing treatment with medications.)
- The prescriber must provide follow-up care to monitor the efficacy of using controlled substances as a treatment for the patient's medical condition.
- If the prescriber is unable to provide follow-up care, the patient must be referred to his or her primary care provider for follow-up care. If the patient does not have a primary care provider, the prescriber must refer the patient to another licensed prescriber who is geographically accessible to the patient for follow-up care.
- Prescription forms cannot be used for any purpose other than prescribing.
- A prescription must contain the quantity of the controlled substance prescribed in both written and numerical terms. More than one Schedule 2 controlled substance may be prescribed on a single form.
- A prescriber may not postdate a controlled substance prescription.
Beginning July 1, 2018, a prescriber treating a patient for acute pain may not prescribe more than a 7-day supply of an opioid within a 7-day period. “Acute pain” means “pain that is the normal, predicted physiological response to a noxious chemical or a thermal or mechanical stimulus and is typically associated with invasive procedures, trauma, and disease and usually lasts for a limited amount of time.”
Prescribers should be familiar with the current guidelines for prescribing controlled substances, such as the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. While there is some question as to whether these guidelines establish the standard of care, LARA and the licensing boards generally expect prescribers to follow the recommendations.
The new statute also imposes requirements on pharmacists when dispensing Schedule 2 to 5 controlled substances. A pharmacist must also in good faith, which means dispensing “pursuant to a prescriber's order which, in the professional judgment of the pharmacist, is lawful.” A pharmacist must follow nationally accepted professional standards in making a judgment and should consider:
- Lack of consistency in the doctor-patient relationship
- Frequency of prescriptions for the same drug by 1 prescriber for larger numbers of patients
- Quantities beyond those normally prescribed for the same drug
- Unusual dosages
- Unusual geographic distances between patient, pharmacist, and prescriber
The failure to comply with these requirements is a ground for taking disciplinary action against a prescriber’s or pharmacist’s license. Possible licensing sanctions include fines, probation, limitation, suspension, revocation, and permanent revocation.