Healthy Skepticism Library item: 10624

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Publication type: Journal Article

Tacco F, Taggiasco N, Broissand C.
Quality assurance in hospital pharmacies: Dispensation of thalidomide
Pharmacien Hospitalier 2002; 37:(151):219-226

Abstract:

Withdrawn in 1962 from the market related to the occurrence of serious teratogenic adverses events, thalidomide has been re-authorized in 1963 due to the evidence of new clinical particulars, such as efficacy in lupus erythematosis disseminated or leprosy. Since 1997, thalidomid has been available with a particular status, named French temporary authorization, which implicates hospital prescription and dispensation. These restricted conditions have been described by the French Health Authorities (Afssaps) in a written protocol, in collaboration with Laphal Laboratories. In our hospital pharmacy (D.P.H.E. -AP-HP-France), we have reviewed our dispensation process, according to ISO 9001 standard (version 2000), in order to take into account these restricted conditions. This study describes our dispensation process analysis. Inadequate prescriptions or medical supervising were the both main causes for dispensation refusals. Tight relationship between prescribers, hospital pharmacists and the company should improve prescription and dispensation quality, and, consequently, the thalidomide safety profile.