Written answers

Wednesday, 15 May 2013

Department of Health

Medicinal Products Availability

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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264. To ask the Minister for Health the plans that are in place to deal with the shortage of Augmentin which is currently being experienced by hospitals throughout the country; in view of this, and other medicine shortages in recent months, the actions that have been taken to ensure early notification of emerging medicine shortages to hospitals and patients to deal with such shortages and to ensure that there are alternative suppliers available to supply Irish patients; and if he will make a statement on the matter. [23249/13]

Photo of Alex WhiteAlex White (Dublin South, Labour)
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Over the last number of months hospitals have been experiencing a shortage of Augmentin intravenous products (Augmentin IV). This shortage is due to manufacturing capacity issues which the manufacturer, GlaxoSmithKline (GSK) is experiencing at its manufacturing site in the United Kingdom.

A number of measures are in place to deal with this shortage and minimise its impact on the delivery of essential health services. GSK, is closely monitoring supply and ensuring that product stocks are available for those considered most vulnerable and consequently the supply of Augmentin IV to hospitals has been and will continue to be rationed, with paediatric hospitals being prioritised.

For other hospitals there are two generic IV amoxicillin / clavulanic acid products currently authorised in Ireland. The Irish Medicines Board (IMB) has put in place measures to facilitate the continued supply of these alternative products until such time as normal supplies of Augmentin IV are resumed.

Clinical leadership within the HSE made clinical microbiologists, infectious diseases physicians and antimicrobial pharmacists aware of the potential issues in March 2013 and requested that individual hospitals consider preparation of contingency plans to guide clinicians on potential alternatives to Augmentin IV in the event that alternatives were required.

My Department works closely with the IMB and the HSE to identify and address medicines shortages so as to minimise their impact on patients. Shortages are a global issue and can arise for a variety of reasons, including, as in the case in Augmentin IV, production issues at a manufacturing facility. In the event of a particular shortage, priority is given to restoring supply as quickly as possible and to identifying and securing continued supply of alternative products. Manufacturers, wholesalers and pharmacies all have responsibility to work together to identify shortages and implement alternative arrangements to meet the needs of patients.

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