The US risk evaluation and mitigation strategy
In the United States, a manufacturer can be required to put a risk evaluation and mitigation strategy in place for a drug or biologic. The strategy is built from a set of elements, from a medication guide to elements to assure safe use, and it comes with a range of documents for the regulator and drug companies, for physicians and pharmacists, and for patients.
What a REMS is
The Food and Drug Administration Amendments Act of 2007 (FDAAA) gave the US Food and Drug Administration (FDA) the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biologic product outweigh its risks. The FDA can require a pharmaceutical company to include one or more of the elements of a REMS for any drug or biologic product for which it considers a REMS necessary. A REMS may be required as part of a New Drug Application (NDA) or Biologic License Application (BLA), or for products that have already been approved and marketed.
The elements of a REMS
The elements of a REMS are:
- a medication guide
- a communication plan
- elements to assure safe use (ETASU):
- health care providers who prescribe the drug must have particular training or experience, or be specially certified
- pharmacies, practitioners or health care settings that dispense the drug must be specially certified
- the drug must be dispensed to patients only in certain health care settings, such as hospitals
- the drug can only be dispensed to patients with evidence or other documentation of safe-use conditions, such as laboratory test results
- each patient using the drug must be subject to monitoring
- each patient using the drug must be enrolled in a registry
REMS have been approved for more than 150 drugs and biologics. For the majority of them only a medication guide was required, but 43 also required a communication plan, and 23 required one or more of the six elements to assure safe use.
The burden of the elements to assure safe use
The requirements of the elements to assure safe use can be extensive and can impose a substantial burden on patients and on health care organisations. For example, prescribers and store pharmacy representatives may need to be trained and enrolled in a training database; prescribers need to complete patient enrolment forms, review them with patients and send the forms to a REMS training database administrator; pharmacists at certified stores need to verify that the prescriber and the patient have been trained; and pharmaceutical companies need to build these databases and systems, and then report to the FDA on their effectiveness.
The documents of a REMS and who prepares them
The types of documents required for REMS include submission materials and reports for the FDA and drug companies; training materials, continuing education and surveys for physicians and pharmacists; and educational materials, agreement forms and surveys for patients.
Writers and editors with experience in these fields, as well as those with medical, clinical, regulatory, epidemiology and health statistics backgrounds, can all find an outlet for their skills in preparing REMS. Other related skills, such as programme management, web design and graphic design, are also valuable for medical writers working on REMS.