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About medicines shortages

What is a medicines shortage?

The definition of a shortage is when the supply of a medicine is does not meet the needs of the patient. 

The World Health Organisation recognises medicine shortages are a global problem. They represent an increased focus for governments given their potential public health impact.

Why do medicines shortages occur?

A medicine shortage can occur for many reasons. Each shortage represents an individual set of circumstances. From industry information received by the HPRA, we know that:

  • Over 60% of shortages relate to delays or breakdowns during manufacturing or a product quality issue.
  • Manufacturing can also be delayed when an active substance or other ingredient is in short supply. Shortages in packaging materials can also lead to delays.
  • Unexpected demand can cause certain shortages. This could be due, for example, to an unanticipated increase in prescribing of a particular medicine. Greater than anticipated levels of seasonal illness can also result in shortages of medicines needed to treat those illnesses.

How are medicines shortages handled in Ireland?

The HPRA oversees a multi-stakeholder framework intended to address the issue of human medicine shortages in Ireland.

The aim of the framework is to:

  1. Help avoid potential shortages from occurring in the first place.
  2. Reduce the impact on patients when shortages do occur.

The framework sets out the roles of different stakeholder groups in managing shortages. Participants in the framework include:

  • Marketing authorisation holders (companies that have an authorisation to market a medicine in Ireland)
  • Manufacturers
  • Wholesale distributors
  • Healthcare professionals
  • The HSE
  • Patient representative groups

Representatives of the above stakeholders all participate in the framework. The HPRA co-ordinates and oversees its operation.

The framework outlines procedures for notification of shortages, their evaluation and communication. It also looks to further develop strategies that can help prevent shortages.

The framework does not cover commercial activities such as:

  • Pricing of medicines.
  • Sourcing of medicines from suppliers.
  • Clinical management of patients in the event of a shortage.

What is the role of the HPRA in medicines shortages?

Under the medicines shortages framework, the HPRA publishes a list of shortages currently affecting the Irish market. This regularly updated list, is published on our website. It includes information on shortages* notified to us, which may have a medium or high impact on patients.

Marketing authorisation holders should notify shortages or potential shortages of medicines to the HPRA and the HSE. Wholesalers, patients, and healthcare professionals can also assist by reporting possible shortages not currently included on the HPRA list.

*Where a product is not listed as a shortage on the HPRA website, availability may differ across wholesale supply. As a result, pharmacists may need to check with other distributors.

The HPRA also maintains a list of shortages resolved in the last six months.

Can the HPRA take regulatory actions to reduce the impact of a shortage?

Yes, where regulatory flexibility can ease a supply issue without impacting patient safety, we will be as practical as possible. In particular, we focus on actions to address acute and urgent patient needs.

For example, we can provide accelerated regulatory approval to supply a medicine to Ireland initially intended for another market. This may involve allowing flexibility on labelling or packaging to support the supply of interim stocks. We can also accelerate the approval of controlled drug licences in a shortage.

What is outside of the remit of the HPRA?

The HPRA cannot compel companies to supply or manufacture medicines.

We also have no role in:

  • The purchasing of medicines.
  • Commercial issues.
  • The provision of clinical advice and treatment to patients.

What can pharmaceutical companies do to minimise shortages?

In European law, pharmaceutical companies and wholesalers must ensure an appropriate and continuous supply of the medicines they market.

Companies can help prevent medicine shortages by continuing to reduce risk within their operations. When a potential shortage issue is identified, the HPRA should be notified as soon as possible. If the shortage cannot be prevented, then, where possible, the HPRA will work with other framework stakeholders to reduce the potential impact on patients.

Two-year review of the shortages framework

In November 2022, following consultation with stakeholders, we published a two-year review of the framework. This document includes a review of data gathered by the HPRA under the framework during 2019 and 2020. It also outlines the strategy for the next phase of the framework.

We continue to work closely with the Department of Health and our partners across the health system to improve further and develop the framework.

A shortages framework case study: Adrenaline auto-injectors

The framework aims to help prevent shortages and reduce patient impact by co-ordinating the management of potential or actual shortages as they arise. Our shortages case study on Adrenaline auto-injectors (AAIs) is an example of how the framework operates in practice. 

Shortages of veterinary medicines

Shortages of veterinary medicines are managed by the Department of Agriculture, Food and the Marine.