Eugene Murphy (Roscommon-Galway, Fianna Fail)
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134. To ask the Minister for Health if there is a black triangle status on the 'flu vaccine for this season quadrivalent influenza vaccine split virion inactivated by a company (details supplied) and the HPV vaccine Gardasil 9 by another company; if so, the procedures put in place to advise healthcare professionals and members of the public of the black triangle status; the procedures in place for additional monitoring of the products; the procedures in place for the reporting of all adverse reactions to the vaccines, both serious and non-serious to the Health Products Regulatory Authority, HPRA, to allow quick identification of new safety information; and if he will make a statement on the matter. [43675/19]

Simon Harris (Wicklow, Fine Gael)
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Both Quadrivalent Influenza Vaccine (split virion, inactivated) and Gardasil 9 are subject to additional monitoring requirements as they are biological medicines.  Medicines subject to additional monitoring requirements carry a black symbol (inverted black triangle) on their product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)).  The purpose of this symbol is to actively encourage patients and healthcare professionals to report any suspected adverse reactions observed with their use, as well as letting healthcare professionals and patients know that these medicines are being closely monitored by European regulatory authorities.  The inclusion of the black symbol on product information does not mean that the product is unsafe but rather that, for example, the medicine contains an active substance that is new to the market, or that the medicine is a biological medicine.  All newly authorised biological medicines, including vaccines, are subject to additional monitoring requirements, usually for the first five years following authorisation.

In addition to the identification of these medicines via the black symbol, the product information also includes text indicating the status of the medicine and a request for reporting of any suspected adverse reactions observed with use.  Following the introduction of the concept of additional monitoring as part of legislative updates across the EU in 2012, the Health Products Regulatory Authority (HPRA) highlighted these updates in a special edition of its Drug Safety Newsletter (DSN) primarily intended for healthcare professionals and in a document describing the updates for patients and consumers, both of which were published on its website, following distribution.  Reminders about additional monitoring have been issued in the DSN on a number of occasions since then, most recently in December 2018 (91st edition).   

Ongoing monitoring of the safety of medicines, including those which are subject to additional monitoring is carried out in a number of ways.  This includes review and evaluation of suspected adverse reaction reports, published literature, epidemiological studies and any additional clinical trial/study results.  As part of this process, EU regulators continuously monitor safety, and routine ongoing pharmacovigilance activities are in place to review any new safety signals, should they arise from the EudraVigilance database of adverse reactions, published literature, or from any other source of information.  In addition, Periodic Safety Update Reports (PSURs) are reports providing regular evaluation of the benefit-risk balance of a medicinal product following authorisation, which marketing authorisation holders submit at regular intervals to the competent medicine’s regulatory authority in the EU as long as a medicine is available on the market.

As part of the system for monitoring the safety of medicines, the HPRA operates a spontaneous reporting system by which patients/consumers and healthcare professionals can report any suspected adverse reactions (serious/non-serious) through various reporting options, including an on-line option accessible via the HPRA website, downloadable and post-paid report cards, or by telephone.  All reports of suspected adverse reactions received by the HPRA, including those subject to additional monitoring requirements are routinely transmitted to the EMA’s EudraVigilance database, referred to above, within defined timelines for inclusion in ongoing monitoring activities, at EU level.