The FDA Threatens to Remove Long Acting Opioids Unless the Benefits of these Medications Outweigh the Risks

FDA Requests Public Participation in the Development of a REMS Plan

The Issue

On February 6, 2009, the Food and Drug Administration (FDA) sent letters to 24 manufacturers of opioid analgesics (both long and short-acting) to let them know that that they would be required to develop a comprehensive Risk Evaluation and Mitigation Strategies (REMS) plan. According to the FDA, the purpose of the REMS would be to ensure that the benefits of the drugs continue to outweigh the risks (misuse, abuse and accidental overdose). Click here to view the entire document.

However, if the REMS for opioid painkillers increases the regulatory burden on physicians and patients, these changes will most likely cause enormous unintended negative consequences for palliative care and hospice care patients. We are urging the FDA to proceed cautiously.

The FDA is seeking input on the development of Risk Evaluation and Mitigation Strategies (REMS) for opioids. The FDA is accepting written or electronically submitted public comments on opioid REMS until June 30, 2009.

CAPC and the Hospice and Palliative Care Coalition (the Coalition), which includes AAHPM, NHPCO, HPNA, NPCRC and CAPC, request that you send a letter or an email to the FDA offering your opinions, comments and/or recommendations regarding efforts to develop and implement REMS for certain opioid medications. Now is the time to make your voices heard!

Recommendations for the FDA (based upon the Coalition Recommendations)

1. Certification Requirements: We are strongly opposed to the use of certification procedures.
There is no evidence that the use of a certification process will reduce abuse or diversion. Eighty percent of opioid prescriptions for medically ill patients in pain are written by generalist physicians who will be unwilling to go through a certification process. The risks of an overly burdensome REMS include less appropriate prescribing by physicians who are unwilling to go through the process, use of unregulated alternative and often riskier alternatives (such as steroids and non-steroidal anti-inflammatory drugs) to avoid the certification process and perhaps over-prescribing by physicians who develop a "false sense of security" about their skills.

2. Patient Registries: We urge you to reject the use of new patient registries.
Patient registries are expensive to maintain, stigmatizing and burdensome to patients and providers. There is no evidence to support the use of registries for reducing abuse or diversion. The FDA should instead build on existing Prescription Monitoring Programs, now functioning in 38 states.

3. The Coalition supports further educational requirements for providers and patient education through medication guides and package inserts.
The education of health professionals is the purview of the states, through respective professional boards. Educational programs aimed at the general public and focused on the risks of opioid diversion should also be developed.

4. Monitoring Impact: The FDA should develop mechanisms to monitor the effects of REMS on opioid access of "at-risk" populations (nursing home residents, children) and exacerbation of widespread and existing opioid shortages, across the country but especially in inner city and rural pharmacies.
The FDA should monitor specific changes in prescription practices in different clinical settings and minority populations and use existing systems (i.e. emergency departments) to monitor overdoses.

5. The FDA should form an advisory board tasked to review collated data on outcomes, intended and unintended, of the REMS.
Web-based population surveys involving prescribers such as hospice physicians, hospital-based palliative medicine physicians and oncologists should be conducted so that problems can be tracked and analyzed.

How to Submit

Submit written comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

Click here to submit electronic comments

All comments should be identified with the docket number
[Docket No. FDA-2009-N-0143]
Comment submission deadline is June 30, 2009.

About the Hospice and Palliative Care Coalition (Coalition)

The organizations that form the Coalition represent nearly 50,000 health care professionals who each year care for over 1.2 million patients with serious and life-limiting illnesses. Members include the American Academy of Hospice and Palliative Medicine, the National Hospice and Palliative Care Organization, the Hospice and Palliative Care Nurses Association, the National Palliative Care Research Center and the Center to Advance Palliative Care. We are committed to improving the quality of life of our patients and their families, including the delivery of timely and effective management of pain and other distressing symptoms.

The Coalition has continued over the past few months to actively collaborate with the FDA to help assure that implementation of the REMS occurs with the least disruption to managing pain and breathlessness in our vulnerable patient population. While we recognize the public health imperative to diminish abuse, misuse and diversion of opioids, we want to ensure that our patients will continue to have access to medications essential to their care.