‘Urgent need’ for a stronger national policy on medicine shortages, watchdog says

There is an “urgent need” for a stronger national policy to address and prevent medicine shortages, the medicines watchdog has said.

The Health Products Regulatory Authority (HPRA) maintains a list of medicine shortages affecting the Irish market. Companies are expected to notify the authority of existing or potential shortages.

Ireland has experienced record levels of shortages this year, with more than 300 medicines being in short supply as of mid-December. The HPRA said there has been a 30 per cent increase in medicine shortages in 2023 compared to 2022, though the rate has stabilised throughout the year.

The Department of Health sought to reassure patients in light of the shortages, stating “there are numerous alternatives available to ensure continuity of care”.

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At the end of August, the authority sent a briefing note to Minister for Health Stephen Donnelly detailing a proposal for the future management of medicine availability.

“There is an urgent need for a stronger national policy basis to enhance the means by which all stakeholders can collectively work to address three specific focus areas: building supply chain resilience to prevent shortages; managing high-impact shortages nationally; enhanced preparedness for crisis situations,” the briefing note says.

“The greatest strategic opportunity lies in having the capacity to take pre-emptive actions to prevent shortages by building greater resilience in the national medicines supply chain.”

The note, which was obtained under Freedom of Information laws, outlined a number of proposals by the HPRA.

It called for the establishment of a national forum for the management of medicine availability, describing it as a “priority to focus on the prevention of shortages for continuity of patient care”.

“While various parties in the broader health system are responsible for certain activities relating to medicine availability, there is no central mechanism for oversight and co-ordination,” it said.

The HPRA also called for digital infrastructure and enhanced transparency in this area.

The development of a national system for automated monitoring of medicine stock levels would “significantly enhance the ability of the health system to track the availability of medicines in the supply chain”, it said.

A spokesman for the Department of Health said it and the Minister are progressing “several work-streams” for management of medicine shortages, such as progressing primary legislative amendments to the Irish Medicines Board Act.

Under the amendments, the Minister is enabled to make regulations to enhance the security of medicine supply and for the better management of shortages and to legislate for the development of medicine substitution protocols.

“The department is continuing to assess and progress other policy proposals to best support the sustainability and security of medicines at a national level. This will continue to be a key strategic area for 2024,” the spokesman said.

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