Sunday, May 1, 2011

Will Opioid Prescribers Comply with REMS?

Now that the FDA’s Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioid analgesics has been announced [see UPDATE here], an important question is: Will prescribers eagerly comply with requirements or will many choose instead to stop prescribing these analgesics for their patients with pain? Surveys conducted prior to the FDA’s recent action may offer some clues as to what might happen.

To assess the likely impact of REMS on opioid prescribing, researchers at the University of Pennsylvania conducted a survey sent via e-mail in January 2009 to members of the Pennsylvania Academy of Family Physicians [Slevin et al. 2011]. These clinicians were asked to respond to questions regarding their current opioid prescribing, and how various components of REMS might alter this practice in the future.

In the March/April 2011 edition of the Journal of Opioid Management, the researchers reported that a total of 259 surveys were completed (9.2% of the total sent). Most respondents (87%) said they were primary care providers and the others identified themselves as specialists. Almost all (96%) currently prescribed opioids for acute pain, 77% for cancer pain, and 83% for chronic nonmalignant pain. Nearly two-thirds (64%) required patients to sign opioid treatment agreements; although, only 40% reported using urine drug screening as part of ongoing opioid therapy, and 17.8% used periodic pill counts. Respondents were about evenly split between urban (52%) and rural (48%) practice settings.

Nearly half of all respondents (48%) reported their willingness to complete no more than 2 hours of mandatory training on opioid prescribing, if it were available locally. A similar proportion (50%) also said that they would encourage patient compliance with education and register their patients on an every 6-month basis, if required.

However, the following percentages of respondents said they would be likely to discontinue prescribing a long-acting opioid product (eg, MS-Contin, OxyContin, methadone) if mandated to comply with any of the following REMS requirements:

  • Complete 4-8 hours of training, followed by 2 hours of pain-related continuing medical education every 2 years thereafter — 31.2% would likely discontinue prescribing;

  • provide patient education on opioids at the point-of-care — 22.2%;

  • document ongoing outcomes of opioid therapy including efficacy, safety, and monitoring for aberrant drug-related behavior (eg, urine drug screens) — 18.2%;

  • register each patient in a patient registry, and have the patient re-registered every 6 months — 30.5%.

The percentage for each of the 4 points above encompasses ratings of 8 to 10 on a scale of 0 (no impact on willingness to prescribe) to 10 (would discontinue prescribing). However, the survey did not consider the cumulative impact of a combination of the items on willingness to prescribe opioids.

COMMENTARY: This survey has a number of limitations, especially the small percentage of participants. The results suggest that roughly half of the responding physicians would be willing to comply with education components of REMS, including the requirement to provide education to patients. However, the authors note, “this leaves a substantial proportion of physicians who would not be willing to prescribe opioids controlled by the new REMS, which could have the unintended effect of decreasing access to these medications for legitimate medical purposes.”

In the actual Opioid-REMS recently announced by the FDA there is no patient registry requirement, which about 31% of survey respondents found off-putting. And, at present, education requirements for prescribers and their patients as a part of REMS are voluntary. However, in the survey by Slevin and colleagues, it seems that 3 out of 10 prescribers might find even a half- to a full-day of opioid education to be an incentive to discontinue prescribing those analgesics, and roughly 1 in 5 might be deterred by a requirement to educate their patients and document progress.

A separate survey had been organized by the California Academy of Family Physicians (CAFP) and incorporated 9 state medical academies. When asked about a two-phase practitioner-education approach — with 4 CME credits on opioid prescribing over 3 years as Phase One, followed by a recurring requirement of 2 credits of CME to be taken during pre-specified intervals as Phase Two — roughly 39% of 690 respondents favored 2 CME credits every 3 years for Phase Two and 30% preferred 2 credits every 6 years instead [CAFP 2010].

At present it is not known what sort of voluntary opioid-education program will be developed for prescribers, including its length or timing — this was left rather open-ended by the FDA. However, judging from the two surveys, practitioners appear reluctant to devote any extensive amount of time to this activity, even though such efforts do contribute CME credits required as part of routine state medical license renewal.

As we have previously noted, federal agencies are working toward additional education being mandated as a part of DEA licensure to prescribe long-acting and extended-release opioids. In the CAFP survey, 79% of respondents said they would comply with this; however, nearly 11% said they would relinquish their DEA numbers and stop prescribing opioid analgesics altogether. And, as the survey by Slevin et al. suggests, if considerable education time is required by the DEA, many more might opt out of opioid prescribing.

Nota bene… the apparent reticence of some physicians to participate in opioid-related training is troublesome; especially, since they already are required to accumulate anywhere from 16 to 50 education credits per year for ongoing licensure renewals — depending on the state [see state requirements table here] — and opioid training could be a part of that. Therefore, considering the prevalence of pain among patients in most clinical settings, along with the appropriateness of long-acting/extended-release opioid therapy for certain chronic pain conditions, it seems reasonable to expect that prescribers would welcome a day (or more) of continuing medical education in proper and safe opioid prescribing to better serve their patients. If you believe otherwise… please comment below.

> CAFP (California Academy of Family Physicians). REMS Survey Report / March 2010. Unpublished.
> Slevin KA, Ashburn MA. Primary care physician opinion survey on FDA Opioid Risk Evaluation and Mitigation Strategies. J Opioid Manage. March/April 2011(Mar/Apr);7(2):109-115 [
abstract listed here].