Seán Sherlock (Cork East, Labour)
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882. To ask the Minister for Health if consideration has been given to blood screening for severe and potentially fatal allergic reactions to a drug (details supplied). [19505/17]

Simon Harris (Wicklow, Fine Gael)
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There are no plans to introduce blood screening for severe allergic reactions to the chemotherapy drug Taxol (paclitaxel).

The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland. The HPRA highlights the fact that all medicines have some risks and a small number of people may develop side effects (also known as adverse reactions). The clinician treating the patient balances the risks associated with a medicine in the context of the overall benefit of the medicine to the health of the patient and the condition being treated.

Virtually all chemotherapeutic agents have the potential to initiate infusion or allergic reactions. Premedication can help to prevent and/or reduce the severity of infusion reactions, particularly infusion reactions. Generally, testing patients for allergy prior to receiving a chemotherapy is of limited value because the positive and negative predictive values are not known. Therefore, not all patients with positive results to these tests will develop reactions. Patients must be monitored closely both during and immediately after all chemotherapy infusions. Additional risk minimisation measures have been introduced to diminish the incidence and severity of infusion reactions (for example, prolonging the drug infusion, premedication, and antihistamines and glucocorticoids), and these measures have reduced the rate of severe reactions.

The packaging of all medicines placed on the market must include a Summary of Product Characteristics (SmPC) leaflet, which sets out detailed product information intended for healthcare professionals. This information is regularly updated as new data becomes available through various sources of post-marketing experience, including further studies, literature reviews, and evaluation of adverse reaction data. Section 4.2 of the Taxol SmPC provides detailed information on the premedication schedules and method and durations of administration which should be followed. It is advised in the SmPC that this chemotherapy should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents, and that appropriate supportive equipment should be available as hypersensitivity reactions are known to occur. The National Cancer Control Programme's published protocol on paclitaxel as monotherapy for breast and ovarian cancer states that facilities to treat anaphylaxis must be present when the drug is administered.

All medicines are also supplied with a packaging leaflet intended for the information of the patient/consumer. Product labels and package leaflets play an essential part in the safe and effective use of the medicine by both patient and healthcare professionals.

The HPRA, in conjunction with European counterparts, continues to review the safety of authorised medicines and takes appropriate regulatory action when necessary.