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Medicines Safety The New Zealand Pharmacovigilance Centre (NZPhvC) is the main body in New Zealand responsible for monitoring the safety of medicines and related products in New Zealand through voluntary reporting of adverse events. The NZPhvC oversees the Centre for Adverse Reactions Monitoring (CARM), the Medication Error Reporting Programme (MERP) and the Psychoactive Substances, Recreational Substances & Legal Highs reporting programme. Adverse Reactions Monitoring CARM collects and evaluates spontaneous reports of adverse reactions to medicines, vaccines, herbal products and dietary supplements sent in by health professionals, patients and pharmaceutical companies throughout New Zealand. These reports are routinely shared with Medsafe. Over 110,000 reports are currently held by the CARM database providing New Zealand-specific information that can help contribute to knowledge already known about the adverse reaction profiles of certain medicines or complementary therapies. This knowledge can help support clinical decision making. CARM also undertakes regular analysis of the database to identify any significant patterns of adverse reactions. These results may be considered by the Medicines Adverse Reactions Committee who may suggest to Medsafe that relevant prescribing advice for a particular product be emphasised or changed. This should result in the safer use of the medicine concerned. Information collected by CARM and other international monitoring centres is fed into the World Health Organization’s International Drug Monitoring Programme database, based in Uppsala, Sweden. This allows New Zealand and other countries to keep abreast of the latest concerns around drug safety as they emerge. New Zealand is the third highest reporting country globally, behind Singapore and the United States of America. What to report It is important to report any suspect reactions of clinical concern. This includes adverse reactions or interactions to all: •• medicines •• vaccines •• over the counter remedies or medicines •• herbal, traditional and alternative remedies. Reactions and interactions that are serious and medically significant should always be reported; however, if you are unsure of its significance, report it! It is also important to report ANY serious allergic reactions so that a danger warning can be entered against the patient’s name in the national health database, so re-exposure can be avoided for that individual. How to report Anybody can report an adverse event. An online reporting form is available on the NZ Pharmacovigilance Centre website (nzphvc.otago.ac.nz). A link to this site is also available through Medsafe (www.medsafe.govt.nz/profs/adverse/ reactions.asp). Alternatively, reports can be made to CARM by telephone (03 479 7247) or by downloading the ADR Reporting Card from nzphvc. otago.ac.nz/reporting-forms. Once completed, these can be either faxed (03 479 7150), emailed (nzphvc@otago.ac.nz), or posted back to: NZPhvC University of Otago Medical School PO Box 913 Dunedin 9054 NEW ZEALAND Medication Error Reporting Programme (MERP) MERP collects and analyses voluntary reports from healthcare professionals of actual and ‘near miss’ medication errors occurring in primary care. Its aim is to enhance the safety of medication use for New Zealanders by sharing information about medication errors to reduce and prevent other harmful medication errors. An online reporting form for MERP is available on the NZ Pharmacovigilance Centre website (nzphvc.otago.ac.nz/merp/report/). Psychoactive Substances, Recreational Substances & Legal Highs This programme aims to provide a way for health professionals and members of the public to report reactions to psychoactive substances. The programme was developed by CARM in response to a request by the Psychoactive Substances team at the Ministry of Health. Each individual report is anonymised for both patient and reporter and findings are used by the Ministry of Health as part of their ongoing safety review of products that are under review in terms of the Psychoactive Substances Act. An online reporting form is available on the NZ Pharmacovigilance Centre website (nzphvc.otago.ac.nz/substance/). The online form also links to a gallery of images of currently known psychoactive substances, which can be used to help identify the substance of concern. M 2 Medicines monitoring scheme M 2 is a medicines monitoring scheme which aims to: • • highlight safety concerns identified from reports of suspected adverse medicine reactions sent to CARM • • encourage further reports and increase the information on these potential safety concerns. This helps CARM and Medsafe to investigate these safety concerns and decide if any action needs to be taken. It is important to note that the appearance of a possible safety issue to a medicine does not mean that Medsafe and CARM have concluded that this medicine causes the reaction. Current medicines with safety concerns on the M 2 list at the time of going to print were: • • Viekira Pak and Viekira Pak-RBV – possible effects on blood glucose control when used in people with type 2 diabetes • • iodine-containing contrast agents – possible risk of hypothyroidism in infants exposed to these agents • • rivaroxaban, dabigatran, apixaban – possible risk of alopecia (hair loss). Medicines remain on the M 2 list for approximately six months and the list of medicines being monitored changes regularly. For more information see www. medsafe.govt.nz/safety/EWS/monitoring-communications.asp Page 183

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