FDA considers making changes to RiskMAPs

The medication may be administered only to patients enrolled in the risk management plan and prescribed, distributed, and infused only by providers registered with the program. That, according to Mary Willy, Ph.D., of FDA's Center for Drug Evaluation & Research (CDER), makes Tysabri another of the 30 or so drugs with some version of these restraints, called Risk Minimization Action Plans (RiskMAPs). And there are likely to be others as more is known about drugs' risks and benefits, and as genetic science helps develop more personalized drugs.

Current drugs with RiskMAPs include clozapine (Clozaril, Novartis; FazaClo, Alamo), thalidomide (Thalimid, Celgene), lindane, and isotretinoin (Accutane, Roche). The wide variety of RiskMAP protocols can in- clude patient screening; compliance documentation; drug information for physicians, R.Ph.s, and patients; participation agreements; patient training and assessment; registration of patients and providers; enhanced interaction precautions; mandated lab and other tests; and process measures.

"Pharmacists must deal with and manage the growing number of these tools and programs, each with different structures and often confusing requirements. This tends to focus pharmacists' interest and attention on administrative duties rather than on the appropriate medication use," Bough said. Rather than the current product-by-product approach in building RiskMAPs, "APhA recommends a system-based approach with use of standard tools based on the products' risk level."

APhA's testimony also called for RiskMAPs to be evaluated after they are implemented, at the practical level, by prescribers, pharmacists, and patients. Evaluations, Bough said, should include actual health outcomes as well as documentation of patient knowledge and compliance with the programs, and should look at how the programs would work in actual pharmacy practice.

Drug manufacturers should not be allowed to use RiskMAPs "as an opportunity for branding or for marketing advantage," said Mark Gregory, R.Ph., of Kerr Drug, representing the National Association of Chain Drug Stores and the National Community Pharmacists Association. He recommended that rather than have the manufacturers select the vendor for their RiskMAP development, FDA should contract with a central vendor. He noted that several current RiskMAPs restrict distribution to certain pharmacies. "Restricted distribution is not good for the patient and leads to fragmentation of care." Pharmacists, he said, are not reimbursed for the extra time needed to dispense drugs with RiskMAPs, and manufacturers or payers should fund a system to compensate pharmacies and other providers.

Nathan Thompson, R.Ph., of Johns Hopkins Home Care Group, representing ASHP, cautioned that if creation of RiskMAPs causes a delay in getting the drug to pharmacists, it could cause a critical delay in getting the medication to patients.

Said Sandra Kweder, M.D., deputy director of the office of new drugs at FDA's CDER, "As the agency engages more and more in this, we will see these taking a shape that better lends itself to the sort of transparency we all think would be a good thing."

FDA is accepting comments on the RiskMAPs through July 31. Further information is available at http:// http://www.fda.gov/cder/meeting/riskMAPs.htm.