A look at the decision process that lead the Mayo Clinic to abandon the 80-mg dose of simvastatin
Through the use of its electronic health records (EHRs), a simvastatin prescribing guide was implemented at the Mayo Clinic in response to FDA's recommendation to limit the use of the 80-mg dose of the drug. A formulary decision process led to the Mayo Clinic abandoning the use of simvastatin 80 mg daily and developing conversion charts and case examples to help prescribers understand the options for individual patients, said R. Scott Wright, MD, at the American College of Cardiology's 61st Annual Scientific Session & Expo in Chicago.
Formulary decisions at the Mayo Clinic are made by physician-led task forces, with decisions based on efficacy and safety without regard to cost (unless several compounds with similar safety and efficacy exist). Each specialty within a therapeutic area has a task force chair, appointed by the formulary committee chair and approved by the Board.
In June 2011, FDA issued a drug safety communication about simvastatin that recommended limiting the use of the highest approved dose because of increased risk of muscle damage. The Cardiovascular Task Force convened a meeting within 48 hours of the FDA alert, beginning discussions about the impact of the alert on the Mayo Clinic practice.
"The use of a collaborative decision-making mechanism allowed colleagues to feel included and provided input and ultimately buy-in to the whole process about how to deal with a big issue like this when it comes from the FDA," Dr Wright said.
Using its purchasing records, the task force was able to determine how many "Mayo Clinic-covered lives" would be affected by issues surrounding the 80-mg dose of simvastatin (including potential interactions), and through EHRs, it identified how many patients were on appropriate simvastatin doses and concurrent medications. It identified about 1,400 patients who were taking the 80-mg dose and about 3,600 "who were on combinations that we needed to deal with," he said.
The task force recommended no further use of simvastatin, 80 mg daily, including those patients who had been receiving the drug for longer than 12 months, given the risk of myopathy. "We also recommended that all the physicians and providers, including the nurse practitioners and physician assistants in our practices, contact every patient who was on any combination of simvastatin and other medications where simvastatin needed to be down-titrated or perhaps eliminated," he said.
The task force then developed a prescribing guide for clinicians as an aid in managing patients on simvastatin who had new contraindications or restrictions. The guide was peer-reviewed across the prescriber community prior to its implementation.
The FDA dose conversion chart for statins (found on the website) was used to aid in switching patients from simvastatin to other agents.
Case examples were developed to help prescribers and case managers understand the options available for use with individual patients.
The recommendations were disseminated to Mayo Clinic colleagues via a "Dear Prescriber" letter signed by Dr Wright as the task force chair, the Mayo Clinic's internal website, a weekly employee newsletter, and a published list of contact names of key clinicians who were willing to answer questions. A "Dear Patient" letter was also drafted to alert patients to the potential interactions with simvastatin, 80 mg, and it encouraged them to contact their Mayo Clinic physician or primary care physician to talk about options to manage their dyslipidemia.
Processes were created in electronic orders to highlight the drug-drug interactions prior to any final printing or transmission of a prescription. Process rules were also created for pharmacists within the Mayo Clinic regarding the handling of prescription requests and possible denials, and a mechanism for adjudicating exceptions to the policy was developed.
"The electronic medical system that we all look to as probably the best and most user friendly...is the VA System. It seems to have the most complete dataset," said Dr Wright. "Our system was developed in collaboration with GE. Our health system has used the Cerner product and some of our sites use the Meditech product, so we have a heterogeneous system. We developed a software overlay that we call Synthesis that allows all of those systems to talk to each other, and have a single template that physicians can use to find information. Despite all of that, it was a challenge, and we had to use programming and information technology resources to gather these lists."