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Health Products Regulatory Authority

Dáil Éireann Debate, Tuesday - 8 December 2020

Tuesday, 8 December 2020

Questions (646)

Carol Nolan

Question:

646. Deputy Carol Nolan asked the Minister for Health if the Health Products Regulatory Authority operates a national adverse reaction reporting system for all medications which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions to; if the Authority has been notified of any such adverse reactions with respect to mifepristone and or misoprostol in the context of early medical termination of pregnancy; and if he will make a statement on the matter. [41508/20]

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Written answers

The Health Products Regulatory Authority (HPRA) is responsible in Ireland for regulating medicines, medical devices and other healthcare products. The HPRA operates the national system for the reporting and recording suspected adverse reactions/events occurring in Ireland associated with the use of medicines. Anyone can report suspected issues relating to the safety of medicines to the HPRA via their online reporting service http://www.hpra.ie/homepage/medicines/safety-information/reporting-suspected-side-effects or alternatively via email at medsafety@HPRA.ie.

The HPRA encourages patients, carers and other members of the public to report suspected adverse reactions (side effects) to it. Healthcare professionals (including, but not limited to, doctors, dentists, pharmacists and nurses) are also encouraged and reminded to report suspected adverse reactions observed in their practice.

From the time of authorisation of Mifegyne products (which contains the active substance mifepristone) in late 2018, the HPRA has not received any reports of suspected adverse reactions associated with its use.

From the time of authorisation of MisoOne (which contains the active substance misoprostol) in November 2019, the HPRA received two reports of suspected adverse reactions associated with its use in the context of early medical termination of pregnancy. These reports described muscle spasms, chills, sore throat and asthenia (weakness), consistent with the types of side effects known to occur with misoprostol and described in the approved product information.

If individuals are concerned that they have suffered a suspected adverse reaction to any medicine, they are encouraged to contact their healthcare professional who can advise them if they will need any additional medical care or treatment. The healthcare professional may report the suspected issue to the HPRA on the patient’s behalf, or alternatively, the patient can report the suspected adverse reaction directly to the HPRA themselves.

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.

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