Heads up! Risk Evaluation and Mitigation Strategies, or REMS, have been referenced in a number of recent industry discussions and could present significant challenges to the practice and business of pharmacy over the next several years.
Author: David J. Fong, PharmD
Here are the key headlines and highlights:
Growing number of REMS medications in marketplace
There is a growing number of medications for which the FDA has required pharmaceutical manufacturers to implement REMS before allowing them on the market. REMS accompany high-risk drugs with complex cautionary requirements and ongoing communication needs that present challenges to the reasonable access, consistent delivery, and execution of the drug therapy. They are required as part of the prescribing/dispensing process to help professionals ensure that the benefits of the drug outweigh its risks.
Components of REMS may include one or more of the following:
- Medication Guides
- Communication Plan
- Elements to Assure Safe Use (ETASU)
- Implementation System
Since 2007, there have been several hundred medications approved with REMS. With so many medications in the marketplace, the challenges include consistent access and guaranteeing high-quality patient care. Both the FDA and pharmaceutical manufacturers are on the hook for ensuring not just compliance, but also appropriate use and care.
FDA launched a website in mid-2015 to provide access to REMS@ FDA, a list of medications with REMS requirements. This was also important to ensure consistent access to the products by patients, providing safety information, pharmacy enrollment forms, and required actions for pharmacists who dispense the REMS medication.
Every practicing pharmacist can benefit from getting familiarized with REMS@ FDA.
Pharmacy’s growing responsibility
With the number of new products with REMS requirements entering the marketplace, pharmacy is positioned to expand its role in patient safety by assuming greater responsibility and authority in the management of products requiring REMS. Pharmacists are the most accessible, affordable, and trusted healthcare providers touching the patient in the community, so CMS and health plans are seeking pharmacy’s help to be the “gatekeeper” for assisting patients with appropriate monitoring, safe use, and utilization of high-risk medications.
Growing concern over opioids
REMS is being referenced in continued national public health discussions regarding growing rates of opioid overuse, misuse, and abuse. While the FDA determined that a REMS warning for extended-release and long-acting (ER/LA) opioids was necessary to ensure that the benefits of these analgesics continue to outweigh the risks, there are now very active discussions on applying REMS to short-acting opioid medications as well.
The four key pillar components in the REMS program are: education, monitoring, proper medication disposal, and enforcement. Along with the implementation of the opioid REMS, most states now have active and functional Prescription Drug Monitoring Programs, plus there are local, state, and federal efforts aimed at reducing questionable practices such as doctor shopping and so-called pill mills. Introduction of abuse-deterrent formulations of opioids, such as the transition of oxycodone in 2010, have been shown to decrease the popularity of their misuse.
Opioid overuse, abuse, and misuse are significant contributors to the growing healthcare spend and impact on payers. Pharmacists play an important role in reducing the risks of accidental overdose and opioid overutilization, which in turn help reduce the cost of healthcare. To help mitigate these risks, pharmacy is partnering with payers and working on potentially being reimbursed for case management and demonstrated documentation for the following:
- Verify that the prescription has met the prescriber responsibility required by the REMS product.
- Consult and manage patients with their initial therapy to closely and frequently assess the patients’ needs, their symptoms, and potential risk of misuse, diversion, and abuse.
- Check state Prescription Drug Monitoring Programs, as required, to identify behaviors that may represent abuse.
- Provide the Medication Guide to patients each time the medicine is dispensed and discuss the risks and side effects associated with buprenorphine products, including what to do if patients experience side effects.
- Remind patients who are picking up induction doses to return as directed to the doctor's office so that they can be supervised while taking the medication.
- Explain how to safely store the medication out of the reach of children.
- Provide appropriate patient counseling on safe use.
- Monitor ongoing compliance and adherence and communicate insight to the physician and payers.
Causing delays in generic launches
Some of these REMS requirements can actually end up delaying generic competition.
As the Generic Pharmaceutical Association (GPhA) said in a 2014 report: “Nearly 40% of new FDA approvals are subject to REMS, and brand manufacturers have also begun imposing distribution restrictions on non-REMS products. Government, consumers, and private payers are already missing out on sizeable healthcare savings from misuse of these programs. Specifically, REMS and non-REMS strategies to restrict access to brand drug samples represent lost savings on small-molecule drugs of at least $5.4 billion annually.”
The way the system works means brand manufacturers can prevent generic competitors from accessing their products because of certain REMS elements, so generic applicants cannot access what they need for bioequivalence testing and development.
In June 2016, Sen. Patrick Leahy (D-VT) and 11 bipartisan colleagues introduced a bill to try to help generic manufacturers facing delay tactics be able to bring action in federal court for injunctive relief. “Our bipartisan bill will allow more people to access generic alternatives by providing competition in the marketplace and removing unnecessary bureaucratic delays from the federal government,” he said. Closing this loophole would likely lead to lower pharmaceutical costs, particularly as companies abuse FDA safety programs by withholding access to drug samples for generic manufacturers, often resulting in increased costs.
Balancing the cost-quality equation
With the growing cost of healthcare, specifically prescription spend, pharmacy should continue to advocate for policies that can help consumers manage their out-of-pocket spend while optimizing the quality of care. Pharmacists continue to demonstrate our value and are positioned well to partner with other healthcare supply chain stakeholders to achieve success.
David J. Fong, PharmD, is president of Dave Fong Rx Consulting, Inc. A former senior retail pharmacy executive for Fortune 100 and Fortune 500 companies, he is recognized as one of the U.S. and Canada’s business and professional healthcare leaders, leveraging his knowledge and experience working with pharmaceutical manufacturers, distributors, retailers, payers, and healthcare technology companies to bring value to the industry and the consumer.
