Stephen Donnelly (Wicklow, Fianna Fail)
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The medicines regulator in Ireland is the Health Products Regulatory Authority (HPRA). The remit and regulatory functions of the HPRA include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products.

The Department of maintains regular contact with the HPRA regarding medicines shortages. Ireland has a multi-stakeholder Medicine Shortage Framework in place which aims to prevent, where possible, and mitigate the impact of medicines shortages through close collaboration with the Department, the HSE, industry and healthcare professionals. The Framework is operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health.

Pharmaceutical companies and wholesalers must ensure an appropriate and continuous supply of the medicines they market. Companies should notify the HPRA of medicines shortages or potential shortages impacting the Irish market. Any healthcare professional or member of the public may also report a shortage to the HPRA.

The HPRA publishes a list of medicines currently in short supply on its website (Medicines Shortages (hpra.ie)) with the reason for the shortage and expected dates for the return of supply. The information is available to assist healthcare professionals in managing medicine shortages when they arise and reduce their impact on patients. The information relating to shortages on the HPRA website is dynamic and changes depending on the current information.

Stephen Donnelly (Wicklow, Fianna Fail)
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Officials in my department report to me regarding medicines shortages and I am aware and fully up to date on medicine shortages.

The medicines regulator in Ireland is the Health Products Regulatory Authority (HPRA). The Department of Health maintains regular contact with the HPRA regarding medicines shortages. The HPRA publishes a list of medicines currently in short supply on its website (Medicines Shortages (hpra.ie)) with the reason for the shortage and expected dates for the return of supply. The information is available to assist healthcare professionals in managing medicine shortages when they arise and reduce their impact on patients. The information relating to shortages on the HPRA website is dynamic and changes depending on the current information.

Pharmaceutical companies and wholesalers must ensure an appropriate and continuous supply of the medicines they market in Ireland. Companies should notify shortages or potential shortages of medicines to the HPRA and the HSE.

Patients and healthcare professionals can also assist by reporting possible shortages not currently included on the HPRA shortages list.

All those in the medicines supply chain can play a role in preventing and effectively managing product shortages. This is a key goal of the multi-stakeholder medicine shortages framework.

Stephen Donnelly (Wicklow, Fianna Fail)
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In other jurisdictions outside of Ireland Serious Shortages Protocols (SSP) are used to facilitate community pharmacists to supply either an alternative quantity, strength, pharmaceutical form, or medicine. Legislation in Ireland already allows for generic substitution (alterative strengths, quantity and forms) but does not allow for therapeutic substitution.

Shortages protocols are product specific and are only used in very limited situations. For example, in the UK every draft SSP is reviewed by NHS England’s National Medical Director and Chief Pharmaceutical Officer, who can suggest amendments and raise any potential safety concerns, and Ministerial authorisation is necessary to give effect to the protocol. Each SSP is time limited.

The Department of Health is scoping the introduction of a similar framework, a limited stock supply framework (LSS) in Ireland which will only be used in certain emergency situations such as shortages. This is the case in all other countries that have a protocol in place. Legislative amendments will be required.

There are risks associated for both the pharmacist and patient with substituting prescriptions and the Department will need to be satisfied that these risks are addressed which will impact the timeframe for implementation. An initial proposal on implementation of this policy option is complete and work to develop the governance, legal, training and patient safety aspects of this proposal will be completed this year. The Department will engage with key stakeholders as this policy is developed.