Drugs shortages are finally being addressed

3 July 2015  •  Author(s): Dave Elder, GlaxoSmithKline and JPAG

David ElderMaintaining the security and quality of the manufacturing supply chain for drug products is a significant responsibility for all marketing authorisation holders (MAHs) to ensure the sustained availability of medicinal products for human use. There is clear proof that interruption of medicinal product supply can lead to treatment failures and the use of less appropriate, and often more expensive, alternative drugs. Disruptions to supply or delayed treatment also increases the potential for dispensing errors and lowers patient compliance. A rise in occurrences of largely preventable adverse events associated with alternative treatments is also seen.

Recent unanticipated interruptions to the pharmaceutical manu – facturing supply chain due to manufacturing/GMP compliance issues have resulted in both acute and chronic scarcities of important medicinal products across the EU and the US, necessitating modifications to prescribing information, and commencement of patient allocation programmes.

EU regulations require the compulsory pre-notification by MAHs of any disruption of supply caused by manufacturers of medicines in the case of any quality issues that could lead to an unexpected restriction in supply or when there are permanent or temporary cessations of supply. Similarly, the US Food and Drug Administration (FDA) has recently published a draft ‘Interim Rule’ regarding modified compulsory pre-notification requirements for manufacturers of medicines in case of potential drug shortages.


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