BETHESDA, MD 19 April 2011—FDA today said the forthcoming risk evaluation and mitigation strategy (REMS) for long-acting and extended-release opioid products will entail education for prescribers and patients but no new responsibilities for pharmacists.
"This REMS is focused on the prescribers, on the patients," FDA's Janet Woodcock, director of the Center for Drug Evaluation and Research, told reporters during a briefing.
"We feel that prescribers are really critical in managing this," she said. "They really have to be able to determine the pain needs of the given patient."
The REMS, according to a letter (PDF) to pharmaceutical companies, will involve
- A medication guide for patients,
- Training of health care providers who prescribe the opioid product,
- Information that prescribers can use to educate patients in the safe use, storage, and disposal of opioid-containing products,
- Announcements to prescribers about the existence of the REMS and their need to complete the training, and
- Assessments, evaluations, and surveillance.
The agency has suggested the companies develop a "single, shared system."
Although Woodcock said the REMS will not put new responsibilities on pharmacists, this does not mean no involvement.
JoAnn Stubbings, manager of research and public policy for the ambulatory care pharmacy department at the University of Illinois at Chicago, said the REMS, "in the narrowest sense, means that the pharmacist will have to dispense med guides.
"But in the broadest sense, it means that pharmacists, being health care providers, should be educated on the appropriate prescribing and dispensing and counseling of long-acting opioids, as do all other health care providers."
Those pharmacists who can prescribe opioid products through collaborative drug therapy management agreements or standard-order sets may need to participate in the education programs, she noted.
And even though pharmacists, in their role as dispensers, will not have to participate in the education program, Stubbings said the program would be "very appropriate" for them.
Rita Shane, director of pharmacy services at Cedars-Sinai Medical Center in Los Angeles, said the REMS has less implications for pharmacists in the inpatient setting than in the outpatient situation.
Earlier this year, FDA announced its intention to use "enforcement discretion" in following up in the inpatient setting on the general requirement to distribute medication guides.
Whether hospital pharmacists at a facility should dispense a medication guide to inpatients receiving a long-acting or extended-release opioid product is a decision that needs to be made in a multidisciplinary venue, Shane said.
"These drugs are ubiquitously used in the postsurgical arena—OxyContin, for example," she said. "Some of them are specific to patients who have chronic pain, such as transdermal fentanyl, and those patients are on it prior to admission."
A hospital should examine each long-acting or extended-release opioid product, she said. Then a discussion should ensue as to whether the pharmacy will provide the medication guide to inpatients during the hospital stay, at the time of discharge, or not at all.
"Clearly, the focus of making sure that the population of prescribers is educated about this is really, really important so they understand what the safety issues are," Shane said.
Each company's proposal of a REMS must reach FDA within 120 days.
"We hope, after the back and forth over this, [the final REMS] will be completed by early 2012," Woodcock said.
FDA Commissioner Margaret A. Hamburg, during a press conference this morning, said the REMS will "support and act in concert with" the Obama administration's new Prescription Drug Abuse Prevention Plan.
Unveiled today, the plan calls for using education, monitoring, proper medication disposal, and enforcement to reduce Americans' abuse of prescription drugs.
Hamburg admitted that her agency lacks the authority to make education in long-acting and extended-release opioid products a prerequisite for licensure to prescribe those medications.
Tying education to licensure requires an amendment to the Controlled Substances Act, she said.
Michele M. Leonhart, who heads the Drug Enforcement Administration, said she expects "great interest" from members of Congress in providing such an amendment.