National side effect reporting information

In Ireland, the HPRA operates a reporting system through which suspected side effects (also known as adverse reactions) can be notified by healthcare professionals or members of the public (e.g. patients and carers).

All reports are carefully reviewed by our pharmacovigilance team and are recorded and stored in the HPRA's national adverse reactions database to enable further evaluation. In accordance with our legal obligations, the HPRA may share a copy of reports we receive with other organisations involved in the safety monitoring of medicines. Personal identifiers and contact details are removed before reports are shared. Please see the HPRA's privacy notice for full details of how your information is processed in line with GDPR.

Certain information on reports of suspected side effects notified to the HPRA is accessible as outlined below.

EudraVigilance

The EudraVigilance database is owned and administered by the EMA. Suspected side effect (adverse reaction) reports are pooled with data from other countries to provide information on global safety experience with medicines. Data from EudraVigilance together with additional safety data (e.g. from the scientific literature, cumulative safety data analysis, epidemiological studies, etc.) are assessed on an ongoing basis in conjunction with our EU counterparts to consider their impact on the known safety profile of the medicine in question and any need for regulatory changes.

Stakeholders, including marketing authorisation holders, regulatory authorities, academia, healthcare professionals, and patients, can access data held in the EudraVigilance database, based on the European Medicines Agency's (EMA) EudraVigilance access policy. The policy is designed to provide as much information as possible while meeting data protection obligations.

For healthcare professionals, patients and the general public, a restricted set of anonymised data from individual adverse reaction reports submitted to EudraVigilance, including those submitted by the HPRA, in line with GDPR, is publicly accessible through the European database of suspected adverse drug reaction reports.

HPRAs National Adverse Reaction Database

Online access to anonymised suspected side effect data is not currently available from the HPRA, other than through EudraVigilance. Additional information requests are considered in line with the HPRA access policy on request using our online contact form or in writing to Pharmacovigilance Section, Health Products Regulatory Authority, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, DO2 XP77.

Highlighted topics

The HPRA has published data on the national reporting experience for COVID-19 and HPV vaccines. These publications were made in light of the high public interest in these vaccines.

It is important, however, to understand the data provided and its limitations. Patients should not change their medication without consulting a healthcare professional. It is essential to always refer to the product information for details on the established safety profile of a medicine, including its known side effects. Product information will include advice on safe and appropriate use. This includes the Package Leaflet (for members of the public) and the Summary of Product Characteristics (for healthcare professionals).

Understanding data on suspected side effects received through the HPRA reporting system

Causation

• HPRA receives reports based on the suspicion that an adverse experience may be associated with a medicine. This does not mean the medicine caused the adverse experience. These are called 'suspected' side effects (also known as adverse reactions).
• Reports may describe coincidental events that occurred after a medicine was started but would have happened even if it had not been taken (e.g., due to an underlying medical condition or another illness).
• Whilst each report is carefully reviewed, the totality of data from all sources (e.g., clinical and epidemiological studies, literature) must be considered as part of ongoing safety monitoring to ensure evidence-based conclusions are drawn. Where necessary, the medicine’s product information will be updated to reflect any change in the known safety profile.

Number/Volume

• A single report may describe more than one suspected side effect in an individual (e.g., headache and nausea reported together); therefore, the number of side effects may exceed the total number of reports received.

Comparisons

• The type and number of reports for different medicines cannot be directly compared. Some medicines have been used for varying amounts of time and administered to different numbers of people with various health conditions in different settings. Each vaccine is authorised because its benefit-risk profile is and continues to be favourable.

Changes to data over time

• The description of suspected side effects reflects the information available at the time. These data may change as more information about individual reports becomes available through follow-up, and more data are reported and evaluated.

Product information

• Given the limitations of data on reports of suspected side effects, it is essential to always refer to the product information for details on the established safety profile of a medicine, including its known side effects. Product information will include advice on safe and appropriate use.
• This includes the Package Leaflet (for members of the public) and the Summary of Product Characteristics (for healthcare professionals).