REMS: Reducing the risks

Written by: Roanne Weisman
Published: January 05, 2010
Reviewed by: Kevin Zacharoff, MD, December 2009

Julie was in a car accident during her senior year in college.  She was admitted to the hospital for evaluation and treatment, and was discharged with a physical therapy program and a prescription for long term opioid (narcotic) pain medication for her chronic pain related injuries. When she was ready to return to college she needed to bring her medication with her.  Most of Julie’s friends were worried about her, but a few wasted no time in asking her “what she got” for the pain.  These students even offered to pay Julie for some of her medication, and she found one friend searching through her drawers looking for pills.  Worried about theft, Julie visited the college office of health services, and asked if she could store her medication there.

A loaded gun

Although they come in small plastic bottles and look harmless, prescription opioid pain medications can be powerful, and have the same deadly potential as a loaded gun if not used as intended. If they are abused, not taken as directed, or taken by people for whom they are not prescribed, they can kill. In an ideal world, you don't give people guns without warning them of their deadly potential—and without making sure they understand the warning. The same should be true for prescription pain medications. Luckily, Julie was able to prevent the theft or misuse of her medication, but that is not always the case.  Some studies estimate that up two thirds of deaths relating to prescription pain medication in the U.S. are caused by medications that are legally obtained with a valid prescription, but were either not taken as directed, not taken by the person they were prescribed for, or that fell into the wrong hands.

The Food and Drug Administration (FDA) is trying to prevent deaths from misuse and abuse of prescription opioid pain medications through the development of a program called Risk Evaluation and Mitigation Strategies (REMS). Although it will only apply to some opioid medications, and may end up having many different pieces, a REMS program will likely have educational and evaluation sections for both health care providers and patients.  The education is to help be sure that health care providers and patients have the information that they need to understand the side effects and risks of prescription opioid medications.  Education might be needed even before prescriptions are filled.

REMS will be designed to be sure that everyone involved in the distribution and use of prescription opioid medications will be accountable. REMS will not just be optional guidelines; they will be a set of rules that everyone will be expected to agree to and follow.

A useful checklist

It may be helpful to think of REMS as a checklist, as it is a way to make sure nothing important is forgotten. There will be one list for you, one for your healthcare provider, and maybe even one for the pharmacist. Sticking to your checklist could go a long way towards making sure that your prescription medications don’t end up hurting anyone (including you). It might contain the following information:

• The dangers of sharing prescription medications
• The dangers of mixing alcohol (or illegal drugs) with your medications
• The best ways to safely store and dispose of prescription medications
• How to determine if anyone coming to your house is “high-risk” and might be inclined to take or misuse your prescriptions

Healthcare providers will have a REMS checklist with information including:

• How to decide who is—and who is not—a good candidate for prescription pain medications
• How to work with patients who have a history of abusing prescription pain medications or other substances, such as alcohol or street drugs
• How to help patients recognize side effects of prescribed medications
• How to develop a medication agreement to spell out patient and prescriber responsibilities when potentially dangerous or addictive medications are  being prescribed

The more everyone understands the risks and benefits of prescription pain medications, the safer we will be. The goal is to make sure that anyone who really needs a pain medication has access to it, while promoting the safety of all.