Dr. Caitríona Fisher:

The framework in place for managing shortages was implemented with stakeholders across the range dealing with medicines, including those who market medicines, wholesalers, distributors, manufacturers, healthcare professionals, patient organisations and the HSE. All these stakeholders came together to develop a framework where we in the HPRA co-ordinate the management of shortages. It is done with all these stakeholders.

We receive an average of 45 notifications per month. These come mainly from those who market the products. Some notifications might go to the HSE and we can share information on potential shortages. We ask that the company marketing the product would do some impact analysis and make proposals as to how to deal with the shortage. We then validate it, and as Dr. Nolan states, in some cases it would not be a shortage; there might be a shortage in one part of the country but there is no shortage of the medicine in the system. Of those notifications that are confirmed, they are designated as potential or actual shortages. A potential shortage is not happening but it is possible there would be a shortage. With an actual shortage, we would do a risk assessment on the impact on patients. We manage all of these shortages and the high-risk examples amount to between 10% and 12% of the total we get. Most of them are quite readily managed.

We would look at stock in wholesalers and get clinical advice if we need to help prescribers and pharmacists. We would also consider alternatives and the market share of other companies. We would see if there could be other strengths, formulations or generic products available. With the company in question we would communicate to healthcare professionals if required. If a shortage is confirmed as medium or high risk, a notice is put on our website. The page on the website describes ongoing shortages at any one time so pharmacists, doctors or patients can see what is short and when the product is likely to come back in. All the instances to date have been managed with alternative formulations or sources. In no case to date have we needed clinical guidance to be issued. There has been no change in the treatment options available to patients. There is no backlog and we deal with the 45 notifications per month. We have sufficient resources to deal with those.