Covidien launched a patient safety organization – the Collaborating & Acting Responsibly to Ensure Safety (CARES) Alliance – today, featuring tools and resources for patients, physicians and pharmacists.
Located at CaresAlliance.org, the unbranded site offers tools and resources to combat misuse and abuse of opioids, and was developed in consultation with pain experts using a Failure Mode and Effect Analysis (FMEA) methodology, to “identify where problems occur in the use of pain medications, and the underlying causes of those problems,” according to a release. A listing of the current tools, which include wallet-sized safe opioid use and handling cards, interaction guides and FAQs for patients, an expert video series and risk assessment materials for physicians, and a DEA manual for pharmacists, can be found on the website (or here, in pdf).
The alliance, which was unveiled at Pain Week, a national conference for pain practitioners (September 8 – 11), is currently seeking further input from healthcare providers, advocacy groups and others, to develop additional resources, said JoAnna Schooler, a spokesperson at Covidien's pharmaceutical group. Visitors to the site can sign up for more information, and to offer their suggestions for the alliance, said Schooler.
Covidien is one of 18 manufacturers of long-acting opioid products, including 27 brand and generic drugs, and abuse rates have spiked in recent years. Although some opioid products, such as Covidien's Exalgo, have already been assigned a Risk Evaluation and Mitigation Strategy (REMS), FDA has not made final decisions on a class-wide REMS program for opioids, although the agency told WebMD's Medscape Medical News in August that it would approve such a program in 2011. In July, an FDA advisory committee voted against one a class-wide REMS proposal, over disagreements about how far the program should go, and what elements should be included.
Herbert Neuman, chief medical officer for Mallinckrodt, Covidien's pharmaceutical group, told MM&M in July that while opioid products are vital, they do have risks. “The key to success around this is embracing the risk and coming up with a valid scientific method for evaluating the tools that you use, or don't, and whether or not those tools are working,” said Neuman.
The FMEA-developed tools for the CARES Alliance “go beyond REMS requirements,” said Schooler. “They are created to supplement and expand on REMS, and to look at additional opportunities for providing responsible use [of opioids], and responsible prescribing practices,” she said. By the end of 2010, some 60 tools will be available through the CARES Alliance website, and a CME offering is also being considered, among other things, said Schooler.
According to information on the alliance's website, substance abuse treatment admissions associated with opioid pain relievers grew 400% between 1998 and 2008. Prescription drugs are second only to marijuana in terms of the most commonly abused drug types, according to the website.