The problem of risks from taking certain insufficiently studied or incorrectly used drugs is acute in the modern world. To reduce such risks, a risk minimization program was developed, which immediately includes a set of tools to reduce the riskiness of taking new or existing drugs. The abbreviation REMS standing for Risk Evaluation and Mitigation Strategy refers to a category of drugs, which includes certain drugs that require certain precautions on the part of manufacturers and sellers. Implementation of the risk mitigation strategy should be FDA approved (Childs et al., 2012). To be FDA approved it can include: communication and safe use plans, as well as the implementation system which contains education of the clients on the risks.
However, when the REMS policy itself was presented to the market, it lacked any specificity, standardization of policies and actions. The article Risk evaluation and mitigation strategies: Assessment of a medical center’s policies and procedures provides a case study of this policy and brings it to the required format using the example of the specific clinic chosen for the study purposes. The number of FDA approved drugs was at 145 in 2010. It is possible to split it into two groups: for inpatients and outpatients. Out of 145 in total, only 22 were applicable for inpatients. 10 out of the 22 were used by the hospital providers within the study timeframe and became a subject of study (Childs et al., 2012).
Specific procedures were developed based on the lacking areas identified during the study, including the modifications of the drugs storage that were implemented with a separate section for REMS drugs. In addition, staff education programs, such as pharmacist knowledge regarding the uses and risks were suggested. The order-processing system was improved following the protocols and providing a warning during the order-entry roadmap for the REMS drugs (Childs et al., 2012). Summing up, instruments that were used in the study clinic using inpatient drugs to follow REMS were focused on the education of the staff, special storage, and development of the electronic order processing system.
Childs, L., Alexander, E., & Duong, M. T. (2012). Risk evaluation and mitigation strategies: Assessment of a medical center’s policies and procedures. American Journal of Health-System Pharmacy, 69(10), 885-889.