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Ensuring Drug Safety with Risk Evaluation and Mitigation Strategies (REMS)

One of the pharmaceutical industry’s top priorities is to ensure the safe use of medications without compromising their efficacy. To facilitate achieving this goal, the U.S. Food and Drug Administration (FDA) requires manufacturers to provide a Risk Evaluation and Mitigation Strategy (REMS) for pharmaceutical products with serious safety concerns to help ensure that their therapeutic benefits outweigh their risks. In this article, we overview the main characteristics of REMS and explain the factors that influence its design.


What is a Risk Evaluation and Mitigation Strategy (REMS)?


A REMS aims to prevent, monitor, and manage risks by providing information and fostering educational activities that reduce the frequency or severity of adverse events related to the use of certain drugs. This program seeks to reduce the probability of misuse by promoting safe and responsible consumption. Thus, Risk Evaluation and Mitigation Strategies enable the commercialization of critical formulations that would otherwise not be approved for the market due to their inherent risks.


While non-prescription drugs do not need a REMS, generics from a brand name formulation with a REMS must also develop their program. To reduce costs and provide more precise information regarding a drug, often brand name manufacturers and generic producers develop and implement a joint Risk Evaluation and Mitigation Strategy, known as a shared system REMS. Alternatively, generic and brand-name drug companies might choose to have separate REMS, but they must share the same goals and requirements.


Although the FDA has the authority to request manufacturers to include specific actions within a REMS to ensure safe usage, the agency cannot demand that these requirements be implemented using specific methods or standards. Once Risk Evaluation and Mitigation Strategy programs are implemented, they can be updated as the relationships between different stakeholders evolve. 


The stakeholders of a REMS program


The FDA is responsible for determining if a particular formulation requires an REMS and subsequently monitors its creation and implementation. Still, the success of a specific REMS program lies in its stakeholders and their collaborative effort on risk mitigation. Below is a brief list of the actors usually involved:


Drug manufacturers are responsible for developing, implementing, and assessing Risk Evaluation and Mitigation Strategies. Once a REMS proposal is approved, manufacturers must submit reports to the FDA regarding whether the REMS is meeting its goals and determining if any change is needed.


Healthcare professionals can fulfill different roles depending on the requirements of a REMS. Usually, they will receive information about a certain formulation’s REMS, but in some cases, they might be required to complete certain training and receive additional documentation about safe drug usage, how to educate patients about the drug, and how to monitor them once they start using the formulation.


Patients have different roles according to the requirements of the REMS. Patients often receive information and counseling regarding the risks of using a specific formulation, how to detect adverse event symptoms, and what to report to their healthcare provider. Certain pharmaceuticals will also require patients to do lab tests periodically, enroll in a monitoring program, and sign a form to confirm that they have learned the risks associated with said medication.


Pharmacists usually receive information regarding the risks of a particular formulation. They might be required to complete additional training and become certified to dispense it. Pharmacists can also verify safe use conditions, counsel patients, and ensure that they receive the proper educational materials.


In addition to the aforementioned stakeholders, some REMS might assign distributors the task of ensuring that medications are delivered only to entities authorized to receive the product. While all stakeholders fulfill a variety of roles, the core priority is the same: ensuring that a REMS's policies and procedures are followed.


Latest updates on REMS


Ideally, the activities of a REMS would be aligned with the workflow of health care professionals. This alignment would require the industry to homogenize its data standards so that the information contained in a REMS flows smoothly between stakeholders. The CDER has already started to work on this challenge as well as on the improvement of compliance with REMS requirements, which has resulted in the Format and Content of a REMS Document Guidance for the Industry and the initiation of the REMS Structured Product Label (SPL) project. 


Since December 2022, all REMS must be in an SPL format. SPL allows stakeholders to easily access the REMS of a certain formulation and incorporate safe usage information or other needed procedures into patients' electronic health records and pharmacy information management systems.


In March 2023, the FDA opened a public request for feedback on how the agency should evaluate proposed REMS changes resulting from manufacturers switching REMS administrators and what should be considered before implementing changes such as system testing, success evaluation, and system failure prevention.


As mentioned before, creating a Risk Evaluation and Mitigation Strategy (REMS) requires stakeholders to play a more active role in the distribution of a pharmaceutical product. A REMS requires constant collaboration and communication from all sides involved in the supply chain, from manufacturer to patient, which in turn reduces the risk of adverse events and promotes the growth of a safer, more patient-centric pharmaceutical industry.


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