Lucy T Perry1, Alice Bhasale1, Alice Fabbri1,2, Joel Lexchin3, Lorri Puil4, Maisah Joarder1, Barbara Mintzes1. 1. School of Pharmacy, Faculty of Medicine and Health, and Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia. 2. Centre for Evidence Based Medicine Odense, Odense University Hospital and University of Southern Denmark, Odense, Denmark. 3. School of Health Policy & Management, Faculty of Health, York University, Toronto, Ontario, Canada. 4. Department of Anaesthesiology, Pharmacology & Therapeutics, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Abstract
PURPOSE: To determine the frequency and characteristics of safety advisories issued by medicines regulatory agencies in Australia, Canada, United Kingdom (UK) and the United States (US). METHODS: This retrospective analysis examines medicines safety warnings issued by the US Food and Drug Administration (FDA), Health Canada (HC), the Australian Therapeutic Goods Administration (TGA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) from January 1, 2007 until December 31, 2016. A database of warnings obtained from regulators' websites was developed and warnings were classified by communication type, drug, or therapeutic class focus, and the risk discussed. Advisories identifying the same drug or therapeutic class and risk were combined into groups termed "drug-risk issues" for comparisons between regulators. RESULTS: Over this 10-year period, 1441 advisories were identified, with the MHRA issuing the most advisories (MHRA = 469, FDA = 382, HC = 370 TGA = 220). Seventy two percent focussed on single drugs (1034/1441) and 58.7% were alerts (846/1441) posted on the regulators' websites. Diabetes drugs, smoking cessation drugs and immunomodulatory agents were the individual drug types most often subject to safety advisories, while antidepressants, antipsychotics, and proton-pump inhibitors were the top three therapeutic classes. Of 680 identified drug-risk issues, 3.8% (26/680) described a risk of death. By body system, cardiac effects were the most frequent: 10.4% (71/680). CONCLUSION: We found considerable differences in the use of advisories including frequency, communication type, and focus. Disparities in communication about emergent evidence on risks may mean that clinicians and patients in some countries are less well informed about medicine safety concerns than others.
PURPOSE: To determine the frequency and characteristics of safety advisories issued by medicines regulatory agencies in Australia, Canada, United Kingdom (UK) and the United States (US). METHODS: This retrospective analysis examines medicines safety warnings issued by the US Food and Drug Administration (FDA), Health Canada (HC), the Australian Therapeutic Goods Administration (TGA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) from January 1, 2007 until December 31, 2016. A database of warnings obtained from regulators' websites was developed and warnings were classified by communication type, drug, or therapeutic class focus, and the risk discussed. Advisories identifying the same drug or therapeutic class and risk were combined into groups termed "drug-risk issues" for comparisons between regulators. RESULTS: Over this 10-year period, 1441 advisories were identified, with the MHRA issuing the most advisories (MHRA = 469, FDA = 382, HC = 370 TGA = 220). Seventy two percent focussed on single drugs (1034/1441) and 58.7% were alerts (846/1441) posted on the regulators' websites. Diabetes drugs, smoking cessation drugs and immunomodulatory agents were the individual drug types most often subject to safety advisories, while antidepressants, antipsychotics, and proton-pump inhibitors were the top three therapeutic classes. Of 680 identified drug-risk issues, 3.8% (26/680) described a risk of death. By body system, cardiac effects were the most frequent: 10.4% (71/680). CONCLUSION: We found considerable differences in the use of advisories including frequency, communication type, and focus. Disparities in communication about emergent evidence on risks may mean that clinicians and patients in some countries are less well informed about medicine safety concerns than others.
Keywords:
Australia; Canada; United Kingdom; United States; adverse reactions; drug-related side effects; pharmacoepidemiology; pharmacovigilance; risk communication
Authors: Ashleigh Hooimeyer; Alice Bhasale; Lucy Perry; Alice Fabbri; Annim Mohammad; Eliza McEwin; Barbara Mintzes Journal: Pharmacol Res Perspect Date: 2020-12
Authors: Richard L Morrow; Barbara Mintzes; Patrick C Souverein; Christine E Hallgreen; Bilal Ahmed; Elizabeth E Roughead; Marie L De Bruin; Sarah Brøgger Kristiansen; Joel Lexchin; Anna Kemp-Casey; Ingrid Sketris; Dee Mangin; Sallie-Anne Pearson; Lorri Puil; Ruth Lopert; Lisa Bero; Danijela Gnjidic; Ameet Sarpatwari; Colin R Dormuth Journal: Drug Saf Date: 2022-04-19 Impact factor: 5.228
Authors: Richard L Morrow; Barbara Mintzes; Patrick C Souverein; Marie L De Bruin; Elizabeth Ellen Roughead; Joel Lexchin; Anna Kemp-Casey; Lorri Puil; Ingrid Sketris; Dee Mangin; Christine E Hallgreen; Sallie-Anne Pearson; Ruth Lopert; Lisa Bero; Richard Ofori-Asenso; Danijela Gnjidic; Ameet Sarpatwari; Lucy T Perry; Colin R Dormuth Journal: BMJ Qual Saf Date: 2022-01-20 Impact factor: 7.035