Drug and Device Shortages
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Drug and Device Shortages Our Experience in Bone Marrow Transplantation Drug or device shortages cause serious damage to patients.[1] Recently, shortage of the drug propofol has been reported.[2] Propofol is a fast-onset, short-acting sedative-hypnotic agent used for the induction and maintenance of anaesthesia or sedation, and the supply of this drug has become critically low due to manufacturing problems. We experienced a similar issue, in which the supply of bone marrow collection kits, for filtering bone marrow aspirate during transplantation, was abruptly disrupted. Shortage of the kit occurred as a result of the sale of its manufacturing rights during the global economic crisis in 2008. The problem was eventually resolved by the Japanese Government, which fasttracked the approval of an alternative kit without the conduct of clinical trials. However, as a result of the disruption, the number of bone marrow transplants involving non-related donors decreased by 22% when compared with the previous year,[3] and many patients were probably denied this life-saving procedure.[3] It took approximately 4 months to recover from the decrease. Shortage has also occurred with another drug. Production of thiotepa, an anti-cancer agent that is occasionally used in haematopoietic stem cell transplantation, was discontinued in 2009 due to the closure of its manufacturing facility. As a result,
some physicians had to switch to another treatment regimen that did not include thiotepa. These findings suggest that a shortage of medical products is an infrequent, but significant, problem. It is essential that international cooperation is received, and crisis management established, in order to resolve these critical shortages. Hiroto Narimatsu,1 Tomoko Matsumura2 and Masahiro Kami2 1 Advanced Molecular Epidemiology Research Institute, Faculty of Medicine, Yamagata University, Yamagata, Japan 2 Division of Social Communication System for Advanced Clinical Research, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan
Acknowledgements The authors have no conflicts of interest that are directly relevant to the content of this letter.
References 1. Steinbrook R. Drug shortages and public health. N Engl J Med 2009; 361 (16): 1525-7 2. Jensen V, Rappaport BA. The reality of drug shortages: the case of the injectable agent propofol. N Engl J Med 2010; 363 (9): 806-7 3. Narimatsu H, Takita M, Kodama Y, et al. Critical situation of bone marrow transplantation: information distribution regarding the problem of a shortage of bone marrow filters. Biol Blood Marrow Transplant 2010; 16 (1): 141-2
Correspondence: Dr Hiroto Narimatsu, Advanced Molecular Epidemiology Research Institute, Faculty of Medicine, Yamagata University, 2-2-2, Iidanishi, Yamagata, Yamagata, 990-9585, Japan. E-mail: [email protected]
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