Patient Reporting of Side Effects
The HPRA encourages patients, carers and other members of the public to report suspected adverse reactions (side effects) to us.
It is important that you also contact your doctor or pharmacist if you think you may have experienced a side effect after using a medicine. They will tell you if you need any medical care. They will also consider if you need to change your treatment or if you need a different treatment.
The HPRA has published an information leaflet for patients and other members of the public on side effects.
Reporting Suspected Adverse Reactions
Most of us will not experience any problems when using medicines. However, all medicines have some risks associated with their use and so a small number of people may experience an adverse reaction (also known as a side effect).
What is an adverse reaction (side effect)?
An adverse reaction is formally defined as a ‘response to a medicinal product which is noxious and unintended’. This definition includes any harm associated with the use of a medicine including use following overdose, misuse or error.
What should I do if I think I may have experienced an adverse reaction (side effect)?
If you are concerned that you have had a suspected adverse reaction to a medicine, you may need to contact your healthcare professional who can advise on any treatment that may be needed. They can also report the issue to the HPRA on your behalf.
If you wish to directly report an adverse reaction you can use the HPRA’s online reporting service. Anyone can report issues relating to the safety of medicines to the HPRA. This includes patients, carers, other members of the public and healthcare professionals.
How do I report an adverse reaction?
Reporting side effects during the COVID-19 response
In light of the ongoing temporary closure of the HPRA offices due to the COVID-19 public health measures, we ask that reports of side effects for medicines are submitted through our online reporting system. Alternatively, please e-mail firstname.lastname@example.org. Post and fax should be avoided during this time.
You can report a suspected side effect in a number of ways:
- To your doctor, pharmacist or nurse who can then notify the HPRA.
- By using our online form.
- By downloading a copy of our adverse reaction report form (Word version). You can e-mail completed forms to email@example.com
- By printing our adverse reaction report form (Word version) and posting a completed copy to the HPRA by freepost.
- By calling us on (01) 676 4971.
How do I fill in an adverse reaction report form?
Certain mandatory fields are required to successfully submit an adverse reaction report via the online systems. These include reporter details and a contact email address. The latter facilitates return of a unique report identifier number, as a confirmation of a successfully submitted report. The confirmation email from the HPRA will also contain a PDF version of the report submitted. In addition, the following minimum criteria must be included for a ‘valid’ adverse reaction report:
- An identifiable patient (i.e. patient initials/age/sex/record number)
- An identifiable medicinal product (i.e. product name or active substance if brand is unavailable)
- An identifiable reporter
- An identifiable reaction
While the above information reflects the minimum criteria needed for a ‘valid’ adverse reaction report, additional information regarding details relating to the reaction such as relevant medical history, other medication(s) being taken, action taken with the medicine, the outcome of the reaction and any other relevant information are extremely helpful in the evaluation of the suspected adverse reaction.
Once the report is reviewed by the HPRA, the reporter may be contacted for further follow up information that is considered to be significant to the evaluation of the suspected adverse reaction. Permission may also be requested to contact a healthcare professional directly for any further relevant information.
Why is it important for me to report suspected adverse reactions?
Patients are in an ideal position to identify the impact of medicines they have taken, particularly on their quality of life. Systems for patients/consumer reporting are an important tool to facilitate and encourage ‘spontaneous reporting’, which in turn contributes to the overall knowledge of the safety of a medicine and the patient experience. The patients’ role in reporting adverse drug reactions is a key element in building an improved system of pharmacovigilance and the participation of patients is now at the core of the new medicines safety monitoring in Europe.