Dáil Éireann Debate, Wednesday - 4 November 2015
186. Deputy Michael Healy-Rae asked the Minister for Health if members of the Health Products Regulatory Authority know Roaccutane is a chemotherapy drug (details supplied); and if he will make a statement on the matter. [38634/15]
Amharc ar fhreagra187. Deputy Michael Healy-Rae asked the Minister for Health if he will address Dáil Éireann and inform the public that Roaccutane is a chemotherapy drug; and if he will make a statement on the matter. [38635/15]
Amharc ar fhreagra188. Deputy Michael Healy-Rae asked the Minister for Health if he will remove Roaccutane from the market in the interest of protecting the general public; and if he will make a statement on the matter. [38636/15]
Amharc ar fhreagra189. Deputy Michael Healy-Rae asked the Minister for Health if he will change the law so all prescribing doctors and all dispensers of Roaccutane inform their patients and customers by verbal or written notice on their premises that Roaccutane is a chemotherapy drug ; and if he will make a statement on the matter. [38637/15]
Amharc ar fhreagra195. Deputy Michael Healy-Rae asked the Minister for Health the reason Roaccutane has been permitted to be prescribed and dispensed since 1983 without informing the general public that it is a chemotherapy drug; and if he will make a statement on the matter. [38661/15]
Amharc ar fhreagra196. Deputy Michael Healy-Rae asked the Minister for Health the position regarding the drug Roaccutane and its side effects (details supplied); and if he will make a statement on the matter. [38662/15]
Amharc ar fhreagra198. Deputy Michael Healy-Rae asked the Minister for Health if Roche ever informed the Minister, the Health Products Regulatory Authority, the prescribing doctors and the dispensing pharmacies that Roaccutane is a chemotherapy drug; and if he will make a statement on the matter. [38687/15]
Amharc ar fhreagra199. Deputy Michael Healy-Rae asked the Minister for Health the number of adverse drug reaction reports Roche pharmaceutical has on its database on Roaccutane; if he will provide a chronological list of these reports, identifiable by age, gender and year since 1982 in the interest of protecting the general public; and if he will make a statement on the matter. [38689/15]
Amharc ar fhreagra200. Deputy Michael Healy-Rae asked the Minister for Health the reason the Health Products Regulatory Authority corresponded with the Food and Drug Administration concerning Roaccutane, prior to and post 1983; and if he will make a statement on the matter. [38690/15]
Amharc ar fhreagra201. Deputy Michael Healy-Rae asked the Minister for Health if he will ask Roche to publically state Roaccutane is a chemotherapy drug, and the reason Roche has not informed the general public in the interest of protection and safety before and since 1983; and if he will make a statement on the matter. [38691/15]
Amharc ar fhreagra202. Deputy Michael Healy-Rae asked the Minister for Health if he will change the law so that no limitation of information or otherwise in reporting of adverse drug reactions in association with Roaccutane is in place; and if he will make a statement on the matter. [38692/15]
Amharc ar fhreagra203. Deputy Michael Healy-Rae asked the Minister for Health as the Health Products Regulatory Authority, adverse drug reaction reports for Roaccutane are unclear, for example, in 239 of 289 reports there is no indication why Roaccutane was used, if he will confirm the reason Roaccutane was used in these 239 cases; and if he will make a statement on the matter. [38693/15]
Amharc ar fhreagra204. Deputy Michael Healy-Rae asked the Minister for Health the number of reports of patients requiring hospitalisation or a prolonged hospital stay in association with Roaccutane the Health Products Regulatory Authority has received since 1983; if he will identify these authority case numbers; and if he will make a statement on the matter. [38694/15]
Amharc ar fhreagra205. Deputy Michael Healy-Rae asked the Minister for Health the number of reports of persistent or substantial disability the Health Products Regulatory Authority received in association with Roaccutane since 1983; if he will identify these by the authority's case numbers; and if he will make a statement on the matter. [38695/15]
Amharc ar fhreagra206. Deputy Michael Healy-Rae asked the Minister for Health the number of reports of increased incapacity the Health Products Regulatory Authority received in association with Roaccutane since 1983; and if he will identify these by the authority's case number; and if he will make a statement on the matter. [38696/15]
Amharc ar fhreagra207. Deputy Michael Healy-Rae asked the Minister for Health for a chronological list of all adverse drug reactions (details supplied); and if he will make a statement on the matter. [38697/15]
Amharc ar fhreagra208. Deputy Michael Healy-Rae asked the Minister for Health the reason a chemotherapy drug, Roaccutane, is licensed here; and if he will make a statement on the matter. [38698/15]
Amharc ar fhreagraI propose to take Questions Nos. 186 to 189, inclusive, 195, 196 and 198 to 208, inclusive, together.
Roaccutane (isotretinoin) is authorised in Ireland for treating severe forms of acne which have been resistant to other standard therapies. In short, Roaccutane is prescribed when other acne treatments fail. Serious acne can be a physical and social burden for patients while severe acne if left untreated, may cause permanent scarring.
However as with all medicines there are side effects and these are documented in the product information. The product information also requires that Roaccutane should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements.
While there is a favourable benefit versus risk for patients for a specific indication there is no basis to justify removing a medicine from the market. Indeed such a removal could restrict access for a vulnerable group of patients to an effective treatment.
Roaccutane is not authorised in Ireland for the treatment of cancer and therefore this is not reflected in the product information. As stated above Roaccutane is authorised only for the treatment of severe forms of acne which have been resistant to other standard therapies.
I have, in response to previous parliamentary questions, provided the Deputy with extensive information on the authorisation process for a medicine and the safety monitoring which is undertaken once a medicine is placed on the market. Under EU legislation product information consists of the summary of product characteristics and the package leaflet. These documents include information on cumulative safety data and experience obtained with use of the product including reports of side effects. The product information makes no reference to Roaccutane as a treatment for cancer.
Information held by the Health Products Regulatory Authority (HPRA) on suspected adverse reactions has been forwarded to the Deputy in response to previous parliamentary questions. This information consists of a chronological list of adverse drug reactions and includes all the information available to the HPRA on age, gender and year. In many cases only limited information is provided in the reports submitted to the HPRA and the HPRA has made all the information it holds available to the Deputy. The HPRA will undertake a further review of individual reports to ascertain the number of patients requiring hospitalisation and reports of disability/increased incapacity. This review will take a number of weeks to complete and any additional information obtained from the review will be forwarded to the Deputy.
Requests for information on adverse drug reactions reports held by Roche Pharmaceuticals should be addressed directly to Roche.
The HPRA has no knowledge of correspondence with the Food and Drug Administration (FDA) concerning Roaccutane prior to or post 1983.
Under European and Irish legislation ongoing monitoring of the benefits and risks of a medicine includes review and evaluation of suspected adverse reaction reports at National and EU level. The national regulatory medicines authorities (in Ireland the HPRA) in each EU member state are responsible for gathering and evaluating national adverse reaction reports and in turn submitting these reports to the European Medicines Agency, which is responsible for the overall co-ordination of pharmacovigilance (measuring safety of medicines) activities across the EU. The minimum requirements, form and content of the information gathered under the pharmacovigilance system is determined at EU level and meets best international practice.
Information on reports of adverse drug reactions held by other EU member states is available directly from the European Medicines Agency (EMA). It is important to clarify however that while Roche Pharmaceutical has withdrawn its authorisations to market Roaccutane in a number of countries for commercial reasons, other isotretinoin-containing medicines remain authorised and marketed in those countries.
Information on individual Members of the Board of the HPRA and their qualifications is available on the HPRA website.
I am not aware of the knowledge held by Members of the Authority on specific marketing authorisations issued in respect of specific medicines. I am aware however that the acting Chief Executive Officer of the HPRA recently issued an invitation to the Deputy to meet with the HPRA so that they could clarify the authorisation process and address the Deputy’s specific concerns. I understand that the Deputy declined the invitation. Given the volume of questions the Deputy has on this product he may wish to reconsider the offer of a meeting with the HPRA.
