Dáil Éireann Debate, Tuesday - 25 September 2012
401. Deputy Paschal Donohoe asked the Minister for Health if his attention has been drawn to the difficulties that pharmacists are having in the procurement of cymbalta capsules which help stabilise individuals suffering from depressive illnesses; the actions he or the Health Service Executive will take to alleviate this problem; and if he will make a statement on the matter. [40123/12]
Amharc ar fhreagraThe Health Service Executive (HSE) and the Irish Medicines Board (IMB) have engaged regarding the availability of Cymbalta with the principal wholesaler responsible for placing it on the Irish market on behalf of the marketing authorisation holder. The HSE and IMB have been advised that there is sufficient availability of the product to meet the needs of patients within the State.
In order to ensure that stocks of this product are continuously maintained, it has been necessary for the principal wholesaler to introduce measures to manage the supply of this product to other wholesalers and pharmacies. These measures have been necessary to address the depletion of stocks on the Irish market for Irish patients because of export of the product from Ireland to other EU markets. is known as parallel distribution and is permitted under EU law. Parallel export has the potential to result in product shortages on the Irish market.
The measures introduced by the principal wholesaler to maintain a necessary stock of this product on the Irish market include limitations on the quantity of the product that can be ordered, in one transaction, by other wholesalers. The allocations from the principal wholesaler have been determined based on historical demand and, therefore should reflect current patient needs. There have been a small number of temporary shortages which have been quickly resolved. The HSE and the IMB will keep the situation under review.
My Department has been engaging with the IMB, the HSE and the Pharmaceutical Society of Ireland (PSI) to identify ways in which the Irish system can manage medicines shortages as effectively as possible in order to minimise the impact on patients. The IMB and HSE work closely with each other to operationally manage medicines shortages when they arise. The PSI has recently published guidance to registered pharmacists on managing medicines shortages. International efforts to effectively manage medicines shortages are also being considered.
