Getting Involved with REMS

March 2011 - Vol.8 No. 3 - Page #12
Category: Specialty Wholesalers

Sixteen states now experience more prescription drug-related deaths than motor vehicle deaths per year according to the most recent CDC data and it is expected that this upward trend will continue. There is little doubt that the risks long associated with prescription drugs are becoming more acute as medications are both more powerful and more commonplace. As illicit abuse of these drugs has increased—including incidences of unintentional overdoses—the FDA has been well aware of these risks and we see the results of their efforts to curb such events in their risk evaluation and mitigation strategy (REMS) program. The goal of the REMS program is to ensure that patients and prescribers understand the risks associated with a listed product as well as the strategies to mitigate the chance of a serious adverse reaction.

Avoiding Adverse Events
Much like initial reactions to the introduction of USP General Chapter <797> a few years back, many in health care have been quick to protest another round of continually evolving regulated processes as unnecessarily burdensome. This argument certainly has been heard at the FDA and in her presentation at the ASHP Midyear Clinical Meeting in December, Kendra Worthy, PharmD, from the Division of Surveillance, Research, and Communication Support at the Food and Drug Administration not only acknowledged this, but also emphasized the importance of feedback on the effectiveness of these programs from the health care industry and from hospital pharmacists in particular. It is important that health care pharmacists, as front line providers of this safety information, become involved not only with ensuring compliance to these regulations but also in ensuring that the intent of these regulations is met in practice. In other words, pharmacy’s role is key in ensuring that REMS support informed decision-making, reduce poor outcomes, and verify that pre-evaluations are conducted as necessary.

The evaluation process of the new Joint Commission requirements for medication reconciliation, which will go into effect in July of this year, provides an opportunity to incorporate REMS into the process. Other opportunities for incorporating REMS and elements to assure safe use (ETASU) include indications on formulary request forms and CPOE forms; this is particularly key for products that require a certified provider for prescribing and/or dispensing. Additionally, the electronic medication administration record (eMAR) can be used to maintain attendant patient consent forms.

Opportunities in Reimbursement
Furthermore, it is important for pharmacy to become involved as the rules surrounding specialty pharmaceuticals continue to evolve rapidly. As ever-increasing restrictions are being placed on these products, the purchasing process is becoming more complex. In some cases, the hospital pharmacy is precluded from the purchasing and acquisition process altogether. In such cases, the specialty pharmacy exclusively manages these items and will ship only to the patient directly. Many agencies, including state Medicaid programs, are considering this approach to meet their cost containment goals. However, this leaves hospital pharmacists at a distinct disadvantage from the perspective of managing the chain of custody for a patient’s medications.

On the other hand, some hospitals operating as integrated service delivery networks have been able to augment their disease state management services with specialty pharmacy reimbursement systems, allowing for expansion into these new services. As specialty pharmacy continues to expand, there will be additional opportunities for hospital pharmacies to develop new services and exercise greater control over this area of medication use.

It is easy to get caught up in the attendant frustration that comes when additional responsibilities are suddenly added. This is particularly true when the requirements are still in flux and will continue to develop even after you are required to have established processes to meet them. Nonetheless, the goal of this program—to help patients avoid serious adverse events—is the same goal of every hospital pharmacy.


The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require a REMS from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.

A list of REMS that have been approved by the FDA is available online:

Medication Guides
Medication Guides address the issues that are specific to particular drugs and drug classes and they contain FDA-approved information that can help patients avoid serious adverse events. The FDA requires Medication Guides be issued for certain products when it determines that:

  • certain information is necessary to prevent serious adverse effects
  • patient decision-making should be informed by information about a known serious side effect with a product, or
  • patient adherence to directions for the use of a product are essential to its effectiveness.

A list of all Medication Guides is available online:


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