FDA Approves REMS for Transmucosal Immediate-Release Fentanyl Meds

Patient Expert

Since 2007, the FDA has been discussing and debating the development of Risk Evaluation and Mitigation Strategies (REMS) for opioid medications.   The purpose of these REMS is to make access to opioid drugs more difficult for drug abusers while still giving chronic pain patients the ability to fill their prescriptions without undue problems.   Of course, that is more easily said than done.

Needless to say, since the idea of REMS was first announced, chronic pain patients have been concerned about how the REMS would affect their ability to get the pain medications they need.   Many have already run into problems with doctors who are no longer willing to prescribe opioids and pharmacists who refuse to fill their prescriptions for various reasons.   It's a reasonable assumption that additional restrictions would only make getting their medications more difficult.

Although this first set of approved REMS for a class of drugs will not apply to most chronic patients, it does give us a peek at the direction in which the FDA is moving.   Transmucosal Immediate-Release Fentanyl (TIRF) is a group of medicines that are only approved to manage breakthrough pain in adults with cancer who are routinely taking other opioid pain medicines around-the-clock for pain.   Breakthrough pain is defined as "pain that comes on suddenly for short periods of time and is not alleviated by a patient's normal pain management plan."

TIRF medicines include:

  • Abstral (fentanyl) sublingual tablet
  • Actiq (fentanyl citrate) oral transmucosal lozenge and its generic equivalents (sometimes called "fentanyl lollipops")
  • Fentora (fentanyl citrate) buccal tablet
  • Lazanda (fentanyl) nasal spray
  • Onsolis (fentanyl) buccal

Despite the fact that they are just approved for breakthrough cancer pain, a few doctors have prescribed one or more of them - like Actiq - off label for severe breakthrough chronic pain.

The New TIRF Medication REMS

There are three parts to this REMS - one part applies to physicians, one to pharmacies and one to patients.

1.   Physicians - Physicians who prescribe TIRF medicines for outpatient use are required to enroll in the TIRF REMS Access program.   To enroll, prescribers must review the Education Program, successfully complete the Knowledge Assessment, and complete an enrollment form.   They will be required to re-enroll every two years.

2.   Pharmacies -   Both outpatient and inpatient pharmacies that dispense transmucosal immediate-release fentanyl (TIRF) medicines are required to enroll in the TIRF REMS Access program.   To enroll, a designated authorized pharmacist must review the Education Program, successfully complete the Knowledge Assessment, and complete an enrollment form.   Only then can the authorized pharmacist complete enrollment on behalf of the pharmacy.   The authorized pharmacist will then train other pharmacy staff in the appropriate dispensing of TIRF medicines according to the TIRF REMS Access program.

3.   Patients - Patients who are prescribed TIRF medicines on an outpatient basis must sign a Patient-Prescriber Agreement with their health care provider and will be asked to read the Medication Guide provided to them by their prescriber.   They can then take their prescription to an enrolled pharmacy to be filled.

The TIRF REMS Access Program will go into effect March 2012.   The Web site and phone number given out by the FDA will not "go live" until that time.

My Thoughts...

Because these are such powerful drugs and the misuse of them can be fatal, I don't have a big problem with making sure the doctors who prescribe them, the pharmacies who dispense them and the patients who take them be educated as to what they're dealing with.

The key to this program working is having enough physicians and pharmacists willing to go through the training and enrollment process so that the medication is available to the patients who need it.   The FDA says they do not expect this new class REMS will affect patient access to TIRF medications.   Since there are already individual REMS in place for each of these drugs, putting all of them under a single REMS program should be more efficient for all concerned.   At least that's what the FDA is anticipating.   I hope they're right.

U.S. Food and Drug Administration. Questions and Answers: FDA approves a class Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines.   Retreived 12/29/11.

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