My Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, therefore mitigating medicine shortages and strengthening security of supply is the subject of several workstreams in my Department, the wider health service and across Europe.
Unfortunately, medicine shortages are a feature of modern health systems worldwide. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; or product recalls due to potential quality issues.
Ireland has a multistakeholder Medicines Shortages Framework in place operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. This framework aims to help prevent potential shortages from occurring and to reduce the impact of shortages. Stakeholders include the HPRA, the Department, the HSE, healthcare professionals, manufacturers, wholesalers, patient representative groups and marketing authorisation holders.
In European law, pharmaceutical companies and wholesalers should ensure an appropriate and continuous supply of the medicines they market. Companies are required to notify the HPRA of medicines shortages or potential shortages impacting the Irish market. The HPRA maintains a list of current and resolved shortages on its website, such as:
Teva B.V., the company responsible for supplying Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution, has notified the HPRA of a shortage of Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution due to an unexpected increase in demand impacting globally. Teva B.V. are presently unable to advise of an exact date for resolution of the shortages of Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution.
To note, the recent shortage of Ipramol Salamol Steri-Neb 2.5mg/2.5 ml Nebuliser Solution has been resolved.
