MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes
to guide prescribers on gradual, individualized tapering

TOPIC: Opioid Pain Medicines: Drug Safety Communication - Harm to Patient Reported From Sudden Discontinuation of Opioid Pain Medicine
AUDIENCE: Patient, Health Professional, Pain Management, Pharmacy
ISSUE: FDA has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.

Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

Read FDA Recommendations

Revised FAQ on Michigan Opioid Laws

MARCH 6, 2019 – The Michigan Department of Health and Human Services (MDHHS) and the Michigan Licensing and Regulatory Affairs (LARA) have released an updated ‘Michigan Opioid Laws, Frequently Asked Questions’, document.

 Changes to the document include additional guidance specific to Health Profession Subfield Licensees and can be found in the following location in the PDF:

  • Page 7, FAQ #5
    • Subsection “c” added.
  • Page 13, FAQ #9
    • Subsections “c” and “d” added. Additionally, the links to Michigan statute that were previously broken have been fixed.

 Additionally, the links to Michigan statute that were previously broken have been fixed. Click on the button below to access the PDF file, Michigan Opioid Laws FAQ.

LARA Michigan Opioid Laws FAQ (PDF)

LARA Updated Regulations: Bona Fide Prescriber-Patient Relationship

Bona Fide Relationship Requirement Law. Public Act 247 of 2017, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance ("CS"). The Michigan legislature delayed the effective date of the bona fide prescriber-patient relationship requirement to the earlier of (a) March 31, 2019, or (b) the date administrative rules describing the exceptions to the requirement are promulgated. Public Act 247 also requires the prescriber to provider certain follow-up care to the patient to monitor the efficacy of the CS in treating the patient's medical condition. Failure to comply with the bona fide relationship requirement is considered professional misconduct and may subject the prescriber to professional discipline.

Effective Date. The Michigan Department of Licensing and Regulatory Affairs ("LARA") has now published a rule, effective January 4, 2019, describing exceptions to the bona fide prescriber-patient relationship requirement. Promulgation of this rule means that the bona fide prescriber-patient relationship requirement of MCL § 333.7303a is in effect as of January 4, 2019, for all practitioners who prescribe schedule 2-5 CS.
Link: LARA Updates: Bona Fide Prescriber-Patient Relationship

   

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Opioid Prescribers' Legislative Alert

On December 27, 2017, the Lieutenant Governor signed into law several new requirements aimed at combating the opioid epidemic. The MOA is part of a coalition that is working with the Department of Health and Human Services (MDHHS) to provide input from healthcare professionals in regards to the laws, regulations and systems used by prescribers. 

For MOA members, a page has been created with an overview, a link to a summary (PDF) and a link to a survey designed to get feedback from the MOA membership.

Opioid Alert page (MOA login page)
Michigan Automated Prescription System (MAPS) - User Support Manual