Opioid REMS may require pharmacist certification

The initiation of Risk Evaluation and Mitigation Strategies (REMS) for long-acting opioids is getting a sabbatical, as FDA extends its comment period until October 19, 2010. FDA can require the submission and implementation of a REMS if the agency determines that it is necessary to ensure that a drug's benefits outweigh its risks. The mandate for long-acting opioids will include more than 24 branded and generic drugs from 26 different manufacturers.

REMS for these opioids may present some tough challenges for pharmacists, who will be required to have special training, experience, and certification. The new rules also may limit prescriptions to certain doctors for patients, who must be enrolled in a registry and may be subject to monitoring, and limit distribution to certain pharmacies where drug quantities face limits on the quantities they fill.

The National Community Pharmacists Association (NCPA) asserts that pharmacy certification requirements for pharmacists dispensing certain opioid drugs are unnecessary and proper education already occurs through a rigorous pharmacy school curriculum and required continuing pharmacy education.

"The primary issues for retail pharmacists will revolve around extra work that is not compensated - calls to physicians to ensure compliance with REMS requirements, paperwork to document and demonstrate compliance with regulations and 'exception processing procedures - and access for the pharmacy (and patient)," said Robert Taketomo, president/CEO of Ventegra, a Glendale, Calif.-based pharmacy manager.

The access issue

"Access will become an issue because some REMS programs will require procurement of product from limited sources, usually by mail. This takes the local pharmacy out of the loop, and relegates it to a 'referral' role," he said. "Although REMS programs are being developed to ensure some level of safety, overall quality of care may be negatively impacted by this fragmentation of prescription processing. Unfortunately, there doesn't appear to be a standard REMS program for all drugs."

Heather Morel, vice president and general manager, Reimbursement and Access Services, McKesson Specialty Care Solutions, Scottsdale, Ariz., considers the introduction of REMS for opioids as aligning with three current trends: the recognition of pharmacists as skilled clinicians, the assignment to pharmacists of additional administrative tasks, and the necessity for pharmacists to obtain further education. Although new technology, certification, education, training, and registry processes may place some financial burden on pharmacists, Morel believes that riding on existing infrastructures will make the challenges easier.

She is concerned, however, that medication guides that convey risks to patients may present an additional task for pharmacists, who would be responsible for including the guides with prescriptions under certain REMS.

Last December, Kaiser Permanente, as America's largest private, integrated healthcare delivery system, submitted a citizen petition to FDA to revise REMS guidelines and the accompanying Elements to Assure Safe Use (ETASU) to guarantee that there is no "unduly" burden placed on patient access. The petition advocates increased input from stakeholders; availability to the public of summary data collected through REMS; regular evaluation of the effectiveness of ETASU; assurance that manufacturers not use requirements in programs that offer preferential treatment to certain healthcare providers; and the safeguarding of confidentiality of protected health information.

MARI EDLIN is a healthcare writer in Mill Valley, Calif.

This article was updated March 17, 2010.