December 11, 2018

A Review of Opioid Prescription and Treatment Changes in 2017

By Bonnie P. Lane

With the declaration of a growing opioid crisis in Virginia, last year the Virginia Board of Medicine adopted regulations attempting to counteract the issue throughout the Commonwealth.

The regulations governing the prescribing of opioids and buprenorphine were initially enacted on March 15, 2017, with emergency regulations adopted on August 28, 2017, revising and replacing the March version. The August version replaced the term substance “abuse” with substance “misuse,” provided that pregnant women “may” be treated with buprenorphine mono-product, (as opposed to “shall”), and included a prohibition on the prescribing of buprenorphine mono-product in tablet form for chronic pain. Finally, with the treatment of addiction, “for patients who have a demonstrated intolerance to naloxone, such prescriptions for the mono-product shall not exceed 3% of the total prescriptions for buprenorphine written by the prescriber and the exception shall be clearly documented in the patient’s medical record” was added. The regulations do NOT apply to (1) the treatment of acute or chronic pain related to cancer or a patient in hospice or palliative care, (2) the treatment of acute or chronic pain during an inpatient hospital admission or in a nursing home or assisted living facility that uses a sole source pharmacy, or (3) a patient enrolled in a clinical trial as authorized by state or federal law.

Overall, these regulations apply to the evaluation and treatment of acute and chronic pain patients and to the prescribing of and treatment with buprenorphine for addiction treatment.  For both acute and chronic pain patients, non-opioid treatment must be considered prior to treatment with opioids, the PMP must be queried, and a history and physical examination must be conducted. For chronic pain patients, a mental status examination must also be conducted and documented, and the risks and benefits of opioid therapy must be discussed. Acute pain opioid prescription is limited to a seven day supply (fourteen days for treatment for a surgical procedure).  Opioid treatment for chronic pain patients must be reevaluated every three months and the rationale for continuation documented. Urine drug screen or serum medication levels must be conducted at the start of chronic pain management, at least every three months during the first year of treatment, and at least every six months thereafter. Buprenorphine without naloxone is restricted to pregnant patients or when converting patients from methadone or buprenorphine without naloxone to buprenorphine with naloxone for no longer than seven days. Additionally, practitioners engaged in office-based opioid addiction treatment with buprenorphine shall have obtained a SAMHSA waiver and the appropriate DEA registration.  As always, thorough and consistent documentation of evaluations and medical decisions related to opioid treatment is critical.

Looking forward, with a newly elected Governor and recent shake-up to the membership of the General Assembly, we can anticipate additional legislative changes. Several bills are currently proposed regarding the prescribing of opioids for treating pain and addiction. To read more on the proposed bills, please visit the “Crux of the Matter” blog on my firm’s website.

Reference: 18 VAC 85-21-10 et seq.

Bonnie P. Lane is an attorney at the Norfolk office of Goodman Allen Donnelly PLLC, and focuses her practice primarily on medical malpractice defense litigation and healthcare issues. www.goodmanallen.com