{"id":4536,"date":"2021-06-02T11:16:00","date_gmt":"2021-06-02T11:16:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=4536"},"modified":"2025-12-03T05:05:34","modified_gmt":"2025-12-03T05:05:34","slug":"adverse-reaction-reporting-guide-for-new-zealand","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/adverse-reaction-reporting-guide-for-new-zealand\/","title":{"rendered":"Adverse Reaction Reporting Guide for New Zealand"},"content":{"rendered":"\n<p class=\"has-black-color has-text-color has-link-color wp-elements-6011ac135e293b218746496b4f5bdba7 wp-block-paragraph\">New Zealand maintains one of the highest global reporting rates for adverse reactions to medicines. The Centre for Adverse Reactions Monitoring (CARM) in Dunedin serves as the national repository for these reports, supporting international pharmacovigilance activities. The data collected plays a vital role in ensuring the continued safety and effective use of medicines within the country.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Contribution of Individual Reporting to Global Pharmacovigilance<\/strong><\/h2>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-0ef2e79c6a978a31826e21013d171415 wp-block-paragraph\">Despite New Zealand\u2019s world\u2011leading reporting rate\u2014measured both per 1,000 doctors and per million people\u2014it is estimated that only about 5% of adverse reactions are reported. CARM, contracted by Medsafe, collects voluntary reports on adverse reactions involving medicines, vaccines, herbal products, dietary supplements, and blood products. The database contains more than 48,000 reports, providing valuable insight into local patterns of medicine\u2011related adverse effects.<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-3e05b36c205d9485e65e7f2dba880ec2\">Identification of Potential Safety Issues and their Patterns in NZ<\/h2>\n\n\n\n<p style=\"color:#000\">Medical assessors are assigned with the duty to evaluate each report submitted to CARM. It helps them in deciphering the linkage between the reaction and the medicine.&nbsp;<strong><a style=\"color:#00bab9\" href=\"https:\/\/www.vistaar.ai\/\">The database is also used to support enquiries&nbsp;<\/a><\/strong>from health professionals regarding the possibility of adverse reactions as the cause of a diagnostic dilemma.<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-d02a2126868f30b6898c5d74740e7d3c\">Enhancing Patient Safety<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">When a serious adverse reaction is identified, CARM records a \u201cdanger\u201d (where re\u2011administration may be life\u2011threatening) or \u201cwarning\u201d (where re\u2011administration may cause a clinically significant reaction) flag in the National Health Index (NHI) database. Hospitals routinely access this database when patients seek care.&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The Medicines Adverse Reactions Committee (MARC) also reviews published data during quarterly meetings. Based on its assessments, MARC may recommend updates to pharmaceutical data sheets to strengthen safe medicine use.<\/li>\n\n\n\n<li><strong>Reporting Guidelines :-<\/strong> Anyone may submit an adverse reaction report to CARM. While reports from healthcare professionals are preferred, 65% of CARM\u2019s reports come from community doctors (mainly general practitioners), while hospital doctors contribute 17%. Pharmacists submit approximately 2.3% of reports.\u00a0Consumer reports are accepted but must involve the patient\u2019s practitioner, who may not otherwise be aware of the issue.<\/li>\n\n\n\n<li><strong>Yellow Reporting Form :-<\/strong> In June 2001, CARM reinstated the pale yellow version of its adverse reaction reporting form. A survey of trainee interns at Dunedin Hospital identified difficulty accessing the form as a barrier to reporting. Returning to the yellow colour was intended to make it easier for healthcare providers to locate the form. The updated form was included in the June 2001 issue of *Prescriber Update*.<\/li>\n\n\n\n<li><strong>How to Report in Three Steps<\/strong>\n<ul class=\"wp-block-list\">\n<li><strong>Patient Information :-\u00a0<\/strong>Patient details\u2014including name, address, date of birth, sex, and ethnicity\u2014are required when a danger or warning must be placed on the NHI database. CARM safeguards this information and uses it to identify duplicate reports.<\/li>\n\n\n\n<li><strong>Medicine or Suspected Product :- <\/strong>Provide the name of the suspected medicine (including brand name, if known), dosage, and the dates the medicine was started and stopped. This information helps assess causality.<\/li>\n\n\n\n<li><strong>Adverse Reaction Description :-<\/strong> Include the date the reaction began, along with detailed descriptions of symptoms, signs, laboratory results, and relevant medical history. It is also important to describe follow\u2011up events\u2014such as recovery after stopping the medicine (dechallenge), recurrence after re\u2011exposure (rechallenge), and severity of the outcome.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reporting IMMP Events :-<\/strong> Adverse events involving medicines listed in the Intensive Medicines Monitoring Program me (IMMP) may also be reported using the CARM form. The list of IMMP medicines is available in *Prescriber Update*, the CARM and Medsafe websites, and the New Ethicals Catalogue.<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-70e756bf597769ded1154f53f6854251 wp-block-paragraph\">MARC maintains a list of medicines associated with adverse reactions of current concern. Healthcare professionals are encouraged to report such reactions to CARM for causality assessment before MARC review. The list is available in each issue of *Prescriber Update* and on the Medsafe website.<\/p>\n\n\n<div style=\"color:#00bab9;font-size:16px\" class=\"taxonomy-post_tag has-link-color wp-elements-927c70617f5f183ae903ddc7892f010b wp-block-post-terms has-text-color\"><span class=\"wp-block-post-terms__prefix\"><mark style=\"background-color:#ffffff\" class=\"has-inline-color has-black-color\"><strong>Tags:<\/strong> <\/mark><\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/adverse-drug-reactions\/\" rel=\"tag\">adverse drug reactions<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/centre-for-adverse-reactions-monitoring\/\" rel=\"tag\">centre for Adverse Reactions monitoring<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/guide-for-adverse-reaction-reports\/\" rel=\"tag\">guide for adverse reaction reports<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/pharmacists\/\" rel=\"tag\">pharmacists.<\/a><\/div>","protected":false},"excerpt":{"rendered":"<p>New Zealand maintains one of the highest global reporting rates for adverse reactions to medicines. The Centre for Adverse Reactions Monitoring (CARM) in Dunedin serves as the national repository for these reports, supporting international pharmacovigilance activities. The data collected plays a vital role in ensuring the continued safety and effective use of medicines within the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1885,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[647],"tags":[537,535,538,539],"class_list":["post-4536","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-standards","tag-adverse-drug-reactions","tag-centre-for-adverse-reactions-monitoring","tag-guide-for-adverse-reaction-reports","tag-pharmacists"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>Adverse Reaction Reporting Guide for New Zealand<\/title>\r\n<meta name=\"description\" content=\"Adverse Reaction Reporting can help identify the contribution to the incidence of adverse events, resulting in increased healthcare costs, 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