Izyan A Wahab1, Nicole L Pratt2, Lisa Kalisch Ellett2, Elizabeth E Roughead2. 1. Faculty of Pharmacy, Cyberjaya University College of Medical Sciences, 3410, Jalan Teknokrat 3, Cyber 4, 63000, Cyberjaya, Selangor, Malaysia. izyan@cybermed.edu.my. 2. School of Pharmacy and Medical Sciences, Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute, University of South Australia, Adelaide, SA, Australia.
Abstract
INTRODUCTION: The potential for routine sequence symmetry analysis (SSA) signal detection in health claims databases to detect new safety signals of medicines is unknown. OBJECTIVE: Our objective was to assess the potential utility of SSA as a signal detection tool in health claims data for detecting medicines with potential heart failure (HF) adverse event signals. METHODS: We applied the SSA method to all subsidized single-ingredient medicines in Australia. The source of data was the Australian Government Department of Veterans' Affairs (DVA) administrative claims database using data collected between 2002 and 2011. We used first ever HF hospitalization and frusemide initiation as indicators for HF. A signal was considered to be present if the lower limit of the 95 % confidence interval for the adjusted sequence ratio was greater than one. To identify potential new signals of HF, we excluded medicines where HF or edema was listed in the product information (PI) of that medicine or for any other medicine in the same class. We also excluded medicines that were used in HF treatment and medicines indicated for diseases that may contribute to the development of HF. RESULTS: We tested 691 medicines. HF signals were detected for 12 % (80/691) using the hospitalization event and 22 % (153/691) using frusemide initiation. Among medicines that did not have HF listed in the PI, SSA found 11 % (44/397) associated with HF hospitalization and 15 % (60/397) associated with frusemide initiation. Of the medicines tested in which no other medicine in the same class had HF or edema in the PI, and where the medicine was not indicated for a disease that is a risk factor for HF, potential new signals were generated for 2-3 % of these medicines tested (12 of 397 medicines using HF hospitalization and 9 of 397 medicines using frusemide initiation). CONCLUSION: SSA generated potential new signals of HF for some anti-glaucoma and anti-dyspepsia medicines. For some of the potential signals, the event is biologically plausible and some have pre-marketing and post-marketing case reports to support the finding. Confirmation of these signals using cohort studies is required.
INTRODUCTION: The potential for routine sequence symmetry analysis (SSA) signal detection in health claims databases to detect new safety signals of medicines is unknown. OBJECTIVE: Our objective was to assess the potential utility of SSA as a signal detection tool in health claims data for detecting medicines with potential heart failure (HF) adverse event signals. METHODS: We applied the SSA method to all subsidized single-ingredient medicines in Australia. The source of data was the Australian Government Department of Veterans' Affairs (DVA) administrative claims database using data collected between 2002 and 2011. We used first ever HF hospitalization and frusemide initiation as indicators for HF. A signal was considered to be present if the lower limit of the 95 % confidence interval for the adjusted sequence ratio was greater than one. To identify potential new signals of HF, we excluded medicines where HF or edema was listed in the product information (PI) of that medicine or for any other medicine in the same class. We also excluded medicines that were used in HF treatment and medicines indicated for diseases that may contribute to the development of HF. RESULTS: We tested 691 medicines. HF signals were detected for 12 % (80/691) using the hospitalization event and 22 % (153/691) using frusemide initiation. Among medicines that did not have HF listed in the PI, SSA found 11 % (44/397) associated with HF hospitalization and 15 % (60/397) associated with frusemide initiation. Of the medicines tested in which no other medicine in the same class had HF or edema in the PI, and where the medicine was not indicated for a disease that is a risk factor for HF, potential new signals were generated for 2-3 % of these medicines tested (12 of 397 medicines using HF hospitalization and 9 of 397 medicines using frusemide initiation). CONCLUSION: SSA generated potential new signals of HF for some anti-glaucoma and anti-dyspepsia medicines. For some of the potential signals, the event is biologically plausible and some have pre-marketing and post-marketing case reports to support the finding. Confirmation of these signals using cohort studies is required.
Authors: Jeffrey S Brown; Martin Kulldorff; K Arnold Chan; Robert L Davis; David Graham; Parker T Pettus; Susan E Andrade; Marsha A Raebel; Lisa Herrinton; Douglas Roblin; Denise Boudreau; David Smith; Jerry H Gurwitz; Margaret J Gunter; Richard Platt Journal: Pharmacoepidemiol Drug Saf Date: 2007-12 Impact factor: 2.890
Authors: A Bate; M Lindquist; I R Edwards; S Olsson; R Orre; A Lansner; R M De Freitas Journal: Eur J Clin Pharmacol Date: 1998-06 Impact factor: 2.953
Authors: Padma Kaul; Justin A Ezekowitz; Paul W Armstrong; Becky K Leung; Anamaria Savu; Robert C Welsh; Hude Quan; Merril L Knudtson; Finlay A McAlister Journal: Am Heart J Date: 2013-01-22 Impact factor: 4.749
Authors: Preciosa M Coloma; Martijn J Schuemie; Gianluca Trifirò; Laura Furlong; Erik van Mulligen; Anna Bauer-Mehren; Paul Avillach; Jan Kors; Ferran Sanz; Jordi Mestres; José Luis Oliveira; Scott Boyer; Ernst Ahlberg Helgee; Mariam Molokhia; Justin Matthews; David Prieto-Merino; Rosa Gini; Ron Herings; Giampiero Mazzaglia; Gino Picelli; Lorenza Scotti; Lars Pedersen; Johan van der Lei; Miriam Sturkenboom Journal: PLoS One Date: 2013-08-28 Impact factor: 3.240
Authors: Ann S Doherty; Faiza Shahid; Frank Moriarty; Fiona Boland; Barbara Clyne; Tobias Dreischulte; Tom Fahey; Seán P Kennelly; Emma Wallace Journal: Pharmacol Res Perspect Date: 2022-10