Dispensing REMS medications is an excellent opportunity for many pharmacies to venture into new markets and expose revenue that they had not previously had access to. Furthermore, in the near future pharmacies may find themselves not able to dispense or purchase a drug they previously have had no issues with due to new REMS requirements.
If you’re interested in beginning to dispense medications that require a REMS program but aren’t sure of the requirements or how to go about it, the following information may help you along the way.
What You Need to Know about Dispensing REMS Medications
What is REMS?
REMS, or Risk Evaluation and Mitigation Strategy, programs were implemented by the FDA to monitor high-risk drugs and ensure the benefits of the medication outweigh the potentially harmful side effects.
Who can dispense REMS medications?
You cannot simply order a REMS drug from your wholesaler and begin dispensing it. Some REMS medications must be distributed by specialty or even inpatient pharmacists. Others can be distributed by a pharmacist that has been certified.
There are currently 80 drugs that the FDA has deemed necessary for a REMS program. There is no standard for REMS programs, and no two are exactly alike. Therefore, you must be certified for each medication that you would like to distribute.
How do I become certified to dispense REMS medications?
In the past the certification process was done manually, but thanks to innovations in the application program you can now complete it online. To become certified to dispense a medication you must register as an independent pharmacy on the drug manufacturer’s website, train with materials provided and test over the drug information.
Once you have passed the test, you can fill out an application to dispense this medication. However, if you’ve never filled a REMS medication before you may be required to send a series of test claims to verify that the claims make it to the switch.
Just because you trained and passed the test does not mean that you will receive certification for dispensing a REMS medication. As I stated earlier, some drugs may be available to specialty pharmacists or inpatient pharmacy systems only.
What does dispensing a REMS medication entail?
If not already completed by the prescriber, you will be required to enroll your patients in the REMS program by completing a patient enrollment form, which can be located on the drug manufacturer's website.
Each REMS program will have at least one of the following four elements required for a patient to take the medication. The one that is of most concern to pharmacists is the medication guide. However, you should be aware of all four.
- Medication Guide – Sometimes referred to as a patient package insert. Usually not required with REMS medication unless an ETASU is required. This guide is provided with the drug when it is received from your wholesaler. Also, many pharmacy software programs will print this guide when the medication is dispensed. It’s similar to the monograph, but contains more detail on the risks and side effects of the drug.
- Communication Plan – This is developed by the drugs sponsor and is set to inform you and the patient’s physician about the risks of the drug. This will most likely be included in the training material that you’re tested over.
- ETASU (Elements to Assure Safe Use) – ETASUs are special conditions under which the drugs can be prescribed or dispensed. This is why you must be certified to dispense the drug. Other ETASUs include dispensation with evidence of safe conditions (Med Guide) and mandatory patient monitoring, some of which can be done at home. For at home testing, you may be required to input lab information on the medication website.
- Implementation System – Reasonable steps the sponsor may be required to take to monitor and evaluate those in the healthcare system who are responsible for implementing ETASU measures.
Dispensing REMS medications takes a lot of time on the pharmacist’s part, so before you start dispensing you may want to research the medications you plan to dispense and see what will be required of you. I encourage you to visit the FDA website to learn more.