Shortages of medicines: a complex global challenge.

Editorials 158 Shortages of essential medicines, among them generic injectable chemotherapy agents, are causing increasing concern in the United States of America (USA). However, the problem is far wider, affecting other classes of medicines including injectable anaesthetic agents, such as propofol, intravenous nutrition and elec-trolyte products, enzyme replacement products and radiopharmaceuticals. 3–5 Medicine shortages have also been noted in Australia and Canada. A recent commentary in a Belgian pharmacy journal claims that the problem is global – " from Afghanistan to Zimbabwe " – listing 21 countries affected by a variety of supply problems. 8 A shortage of the injectable antibiotic streptomycin was reported in 15 countries in 2010, with 11 more countries predicting their stocks would run out before they could be replenished. 9 This problem does not seem to be that new: concern about prescription medicine shortages was raised in the USA at least a decade ago. 10 The American Society of Health-System Pharmacists' web site (available at: http://www.ashp.org) shows 208 products were not available, with another 114 shortages resolved and 21 products removed from the market in the USA (as of 9 December 2011). A November 2011 report from the IMS Institute for Healthcare Informatics showed that medicine shortages in the USA were concentrated in just five disease areas (oncology, anti-infectives, cardiovascular, central nervous system and pain management) and that more than 80% involved generic injectables. 11 However, on a global scale, other markets may be particularly " fragile " , failing to meet demands for suitable products, such as paediatric dosage forms for HIV/AIDS and tuberculosis. 12 There is a wide range of causes for medicine supply shortages, some of which could be dealt with by government agencies. However, no medicines' regulatory agency can mandate that a manufacturer produce a specific product. Manufacturing quality problems have been implicated in shortages of products produced by a limited number of suppliers, such as propofol, 3 imiglucerase and agalsidase β and influenza vaccine. 10 Overall, 43% of 127 shortages investigated by the United States Food and Drug Administration were attributed to manufacturing quality problems. 13 Where manufacturing is dependent on a small number of facilities , shutdowns for various reasons may cause problems, as has been the case with some radiopharmaceuticals. 5 Changes in procurement practices (such as insistence on World Health Organization prequalifi-cation status or registration with a stringent regulatory authority) may invalidate a previous supplier, as happened …