REMS stands for Risk Evaluation and Mitigation Strategy, and it is a concept that comes from a 2007 law giving the US Food and Drug Administration (FDA) new authorities and responsibilities. The purpose of REMS is to ensure that a drug or biological product’s benefits outweigh its risks. In some cases, a REMS is required by the FDA as part of the new product approval cycle, but sometimes it is necessary when new safety information comes to light later on. Ultimately, REMS is about enabling patients to have access to medications while effectively managing the safe use of those medications.
Every REMS is different, but often a REMS may include:
• A medication guide or package insert for patients
• A communication plan between drug suppliers and healthcare providers
• An “Elements to Assure Safe Use” (ETASU), which may require that a product be dispensed only in certified settings, with the use of a patient registry, or under other specific conditions
So far, REMS has been approved for over 200 products.
REMS and Pharmaceutical Sales Training
Pharmaceutical reps have to have a thorough understanding of REMS, both on a general level and specifically regarding products they represent that are subject to REMS. Manufacturers are required to develop educational materials for both prescribers and patients, but equally as important is internal training for account managers and pharma reps, so that they are prepared to respond to customers regarding these products appropriately.
Information on drugs with REMS is available in databases that can offer information on specific REMS requirements for each, and this information is valuable, but it’s not enough to ensure pharmaceutical sales training is up to scratch. Thorough understanding of the REMS requirements for the specific products they represent is only the baseline level of knowledge for the successful rep.
Addressing Customer Questions Through Multiple Channels
The advent of REMS corresponded with changes in the healthcare industry that have squeezed providers’ time and technological advances that have resulted in new product detailing methods. This is actually a good thing, since today’s rep has access to powerful apps and other mobile technology that puts a lot of valuable information right at their fingertips when they’re out in the field. It also provides a great opportunity for trainers to incorporate REMS training with overall pharmaceutical sales training programs.
Tele-detailing, e-detailing, and web portals for prescribers are just a few of the technological innovations that are improving how reps and prescribers work together. There’s no reason why REMS can’t be included as a core element in pharmaceutical sales training along with training on sales techniques, technology, and the products themselves. Multiple information channels give reps various options for ensuring they and prescribers adhere to all REMS requirements.
How Training Must Evolve With REMS and Other Influences
How can the pharmaceutical trainer keep up with REMS, technology, and changes wrought by legislation? The best option is to work with pharmaceutical sales training providers that make an effort to develop expertise on the latest industry requirements, trends, and preferences. A provider that thoroughly understands REMS and all its implications, and is ready to fold REMS training into relevant training modules can ensure that reps are fully trained and willing to represent REMS products effectively to prescribers.
REMS is a reality for many pharmaceutical companies, and pharmaceutical sales training must cover REMS and its implications for the products its reps speak for. CLD, Inc. is the industry leader in pharmaceutical sales training, remaining at the forefront of industry changes, legislation, and the technology used to deliver pharmaceutical product information. For over 35 years, CLD has helped trainers develop teams with the skills, confidence, and knowledge they need to reach and exceed their goals. If you’d like to learn more about how CLD can help you, contact us at any time. We are happy to answer your questions about REMS or any other aspect of pharmaceutical sales training.