Written answers

Tuesday, 26 September 2017

Department of Health

Health Products Regulatory Authority

Photo of Mick WallaceMick Wallace (Wexford, Independent)
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334. To ask the Minister for Health if general practitioners and other professionals who have the authority to prescribe drugs are required to report their patients' experiences of adverse drug reactions to the HPRA; if this is a voluntary action on the part of the general practitioner; and if he will make a statement on the matter. [40437/17]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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General practitioners and other healthcare professionals that have the authority to prescribe drugs are encouraged to report their patients’ experiences of adverse drug reactions to the Health Products Regulatory Authority (HPRA); while this is a voluntary action on the part of these healthcare professionals, the HPRA proactively encourages and facilitates reporting of suspected adverse reactions by healthcare professionals and patients.

The national adverse reaction reporting programme in Ireland has been in place since 1968 and has continuously evolved over the years to encourage increased participation across healthcare professional groups as well as patients/consumers. A variety of methods are in place to facilitate reporting, such as online reporting tools, submitting a form by post or email, or reporting by telephone. The HPRA website includes a dedicated section on reporting of suspected adverse reactions which provides information for healthcare professionals as well as members of the public on the importance of reporting and the methods for doing so.

The HPRA regularly highlights reporting recommendations in its Drug Safety Newsletter, which is distributed to registered healthcare professionals, including doctors, nurses, pharmacists and dentists. The HPRA has also highlighted the reporting of suspected adverse reactions in its regular articles in MIMS Ireland (an independently edited publication designed as a prescribing guide primarily for general practitioners) and in the Irish Medicines Formulary (a non-promotional medicines reference source for Ireland).

In 2017, the HPRA collaborated on the development of an e-learning module for healthcare professionals to learn about the importance of reporting suspected adverse drug reactions. The availability of this e-learning module was communicated to healthcare professionals via the HPRA website and the HPRA Drug Safety Newsletter. In addition, a number of leaflets have been issued by the HPRA to highlight patient awareness around taking medicines safely and advising patients of reporting options. These leaflets have been distributed to the public through a number of channels, including being made available in GP surgeries.

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