Examples of Unintended Consequences in Other Clinical/Regulatory Areas We know from experience in other areas that restrictions for Schedule II products have led to physicians opting out of prescribing, reducing patient access to medically necessary drugs, and fostering a shift to Schedule III products.11 These effects were seen When New York mandated government‐issued serialized forms for benzodiazepines In states with PMPs that track only Schedule II substances In states that have ‘proactive’ vs ‘reactive’ PMPs When highly restrictive limitations were placed on solo and group practices equally for providing methadone maintenance and prescribing buprenorphine In all instances, the policy greatly limited patient access and physicians’ desire to provide opioid treatment and maintenance. Facilitators of Physician Compliance With REMS Factors facilitating physician compliance with REMS parallel some of the educational and system strategies and recommendations noted in a previous section on addressing gaps in pain treatment; they also contrast with some of the barriers mentioned above. Facilitators include: REMS Development Strategies7,10‐12,96,101 REMS should be standardized with general templates that drugs could be “slotted in to” Frontline healthcare providers (prescribers, pharmacists), as well as patients, should have input in the development of REMS Communication and awareness about REMS programs and requirements should be improved Achievable metrics should be developed to assess efficacy of REMS programs and modify the programs accordingly A clearinghouse should be developed for all REMS information Strategies should be piloted before nationwide implementation Education Strategies11,102,101,107 Pharmacists cite education (of prescribers, pharmacists, and patients) as a top element to incorporate into opioid REMS. Consistent with adult learning principles, education should be based on understanding how best to change prescribing behavior. It should be unique, creative, multifaceted, and allow for measurement of outcomes. Recommended strategies include Using interactive cases Academic detailing, in which nonindustry experts offer tailored instruction to clinicians1 Make education relevant to the providers’ practices Develop and implement physician/peer mentoring programs (eg, PCSS‐B), because physician behavior is most likely to change when prompted and assisted by other physicians Focus content on areas of greatest need and impact, such as factors contributing to overdoses, inappropriate patient selection or prescribing, and pathways to nonmedical use System Strategies6,7,11‐13,44,107 Without the support of systems, changes in behavior and outcomes are impeded. Systems recommendations include: Use PMPs Integrate REMS into the existing infrastructure of hospitals or long‐term care centers, including electronic medical record systems Modify workflow and staffing structures to facilitate implementation of REMS and ensure patient access to medications CO*RE Partners Copyright 2011 | Confidential/Not for Distribution
80