By Edward Li, PharmD, BCOP, Drugs and Biologics Editor
On May 7, 2010, NCCN convened the NCCN Oncology Summit: Recommendations for REMS Stakeholders. At this meeting, NCCN highlighted some of the challenges with Risk Evaluation and Mitigation Strategies (REMS) in oncology and emphasized that, while drug safety should be ensured, REMS presents some significant challenges to provider workload and may have negative consequences regarding patient access to medications. Since that time, additional meetings were held by the Food and Drug Administration (FDA) and other stakeholders to address issues related to REMS. An overview of some of these meetings is provided below.
On July 27 and 28, 2010, the FDA held a public meeting to obtain input from stakeholders on the issues and challenges in the development and implementation of REMS. Over the course of this meeting, the FDA heard presentations from a variety of providers and stakeholder groups. The presenters represented providers (physicians, pharmacists, nurses), patients, and the pharmaceutical industry. There were six topics presented at this meeting:
1) Requirements for REMS
2) Establishing goals for REMS
3) Issues regarding elements to assure safe use (ETASU)
4) Evaluating the effectiveness of REMS
5) Effects of REMS on generics
6) Protection of patient information.
Overall, providers and provider groups agreed with the goal of REMS, which is to improve patient safety. However, there were major concerns in the areas of standardization, implementation, assessment, and provider burdens.
Among the topics discussed during the two-day meeting in July was the issue of Medication Guides, one aspect of REMS. The FDA recognized that there are currently limitations with Medication Guides (patient literacy, for example) and has decided to address patient medication information on a larger scale. The FDA convened a meeting on September 27 and 28, 2010, to obtain input about a new framework for developing and distributing a single patient medication information document. By doing so, the FDA seeks to consolidate the different types of information given to patients, including Medication Guides.
Most recently, on October 6 and 7, 2010, the American Pharmacists Association convened a stakeholder meeting with the overall goal of taking concrete steps towards designing a REMS system that is effective in mitigating medication risks, is efficient to providers, and maintains patient access to medications. Issues related to effective REMS tools, standardization of REMS, and business models for adequate financial compensation were discussed. The stakeholders at this meeting represented primarily pharmacists but included stakeholders from other provider groups (including NCCN), patients, and the health technology industry. Representatives from the FDA were present as observers. The outcome of the meeting will be a white paper containing consensus statements regarding the above issues.Much work still remains as to the proper implementation of REMS. The sole responsibility does not rest with the FDA but with multiple stakeholders as well. Changes to the system will not happen overnight, and much data still needs to be collected regarding the impact (from a monetary and workload standpoint) of REMS on providers. Furthermore, the science of risk mitigation must be further developed and refined such that REMS programs can be evaluated to assess whether they are effective in mitigating risk. Lastly, in a technologically-advanced society that has allowed us to pay bills and manage existing accounts online, it is hopeful that REMS processes could be similarly streamlined to minimize the inefficiencies that exist today.