DRUGS WITH DISCONTINUED PRODUCTION- A DESCRIPTIVE ANALYSIS OF THE BRAZILIAN SCENARIUM
Author(s)
Dias L1, Pereira AC2, Alencar Junior FO1, Fernandes RA1
1Sense Company, Rio de Janeiro, Brazil, 2Sense Company, Rio de Janeiro, RJ, Brazil
Presentation Documents
OBJECTIVES Drugs with discontinued production by the manufacturers can cause drug shortage, a global problem that also affects the Brazilian healthcare system. Since 2014, Brazilian Health Regulatory Agency (ANVISA) obliges manufactures to communicate temporary or definitive discontinued production of drugs. Information on discontinued production is available as a database at ANVISA’s webpage and can be applied to predict potential drug shortages. This study aims to describe the profile of drugs with discontinued production by manufacturers in 2018. METHODS In this descriptive research, data on drugs with discontinued production in 2018 were collected from ANVISA’s webpage. The variables considered for the analysis were type of discontinuation (definitive or temporary), reason and therapeutic classification. Descriptive analyses were performed to evaluate these data. RESULTS In 2018, producers reported 1,963 discontinuations, 55.8% of them were temporary. The main reason for discontinuation was market interest (74.8%), and most of definitive discontinuations were motivated by this reason (94.5%). Changes in manufacture site or productions steps to other locations was the less frequent reason for discontinued production, accounting for 2.9% of reports. The most common therapeutic classes of discontinued drugs were nervous system (18.2%), general anti-infectives systemic (15.5%), cardiovascular system (14.5%), and alimentary tract and metabolism (11.6%). General anti-infectives systemic drugs and cardiovascular system presented the highest proportions of temporary and definitive discontinuations, with 263 (24.0%) and 191 (22.0%) cases, respectively. CONCLUSIONS The process of drug production discontinuation in Brazil is most frequently temporary, however, market interest is the main motivating reason. This procedure does not consider the availability of a similar technology to attend patients’ need. Although the World Health Organization defines that regulatory agencies cannot obligate a manufacturer to produce a drug, these data highlight the need of creating strategies to avoid impact on patients’ healthcare due to shortage.
Conference/Value in Health Info
2019-09, ISPOR Latin America 2019, Bogota, Colombia
Value in Health Regional, Volume 20S (October 2019)
Code
PDG10
Topic
Epidemiology & Public Health, Health Policy & Regulatory, Organizational Practices, Real World Data & Information Systems
Topic Subcategory
Coverage with Evidence Development & Adaptive Pathways, Health & Insurance Records Systems, Industry, Public Health
Disease
Drugs, No Specific Disease