The case study provides an analysis of the challenges and possible solutions of implementing risk minimization measures of Product L in Taiwan. X Company is an international biopharmaceutical company which based in New Jersey, USA. Product L is one of X Company’s major product for the multiple myeloma patients, a type of blood cancer that has the death rate of 70% within 5 years of diagnosis. Product L shows significant improvement in the treatment of multiple myeloma patients; however, its well-known risk of fetus malformation, i.e. phocomelia, caused a dramatic tragedy to thousands of mothers who used this drug as sedative back in 1950s due to lack of the concept of drug safety.
To achieve the goal of ensuring patient safety on the medication use, the solutions are proposed with strategic imperatives. By reviewing the process and challenges on the actual operations, we could know what actions and resources are needed to deliver this objective, which is to execute the risk minimization measures smoothly so that all patients can receive the treatment without risk occurred in Taiwan. The recommendations are to keep having communication with Health authority and healthcare professionals as they are two major stakeholders in the risk minimization process implementation. Also, due to the unique healthcare system in Taiwan, X Company is willing to utilizing the advanced technology to help HCPs on diminishing the administrative work in the risk minimization process.

[1] World Health Organization, http://apps.who.int/medicinedocs/en/
[2] Taiwan Food and Drug Administration, https://adr.fda.gov.tw
[3] Ministry of Health and Welfare, https://www.mohw.gov.tw
[4] Taiwan Multiple Myeloma Research Room, www.tmmrr.com
[5] European Commission Press Release, http://europa.eu/rapid/press-release
[6] The New England Journal of Medicine, https://www.nejm.org/
[7] Morningstar Inc., http://www.morningstar.com/
[8] US Food and Drug Administration, https://www.fda.gov/