Reactions 1664, p12 - 12 Aug 2017 Semi-automated pharmacoepidemiology studies Signals of medicine-related adverse events can be generated using semi-automated pharmacoepidemiology studies, according to results reported in Drug Safety, and "provides an opportunity for the rapid assessment of risk in post-marketing surveillance of medicine safety". Three national databases in New Zealand recording practice registers, hospital discharges and medicine use data were linked to include 5194 256 patients in 2007–2014, a total of 34 630 673 patient-years at risk. Using a newly developed semi-automated computer system, retrospective nested case-control designs evaluated risk for known drug class-adverse event pairs. Cases included patients with a hospital diagnosis recorded for the relevant study outcome. The 8274 cases hospitalised with upper gastrointestinal bleeding were matched with 41 365 controls. NSAIDs had been used by 26.1% of cases in the 3 months prior to hospitalisation, compared with 7.9% of controls (adjusted odds ratio [OR] 4.16; 95% CI 3.90, 4.43; p<0.001). SSRIs had been used by 8.5% of cases and 6.5% of controls (OR 1.39; 1.20, 1.62; p<0.001). Similarly, there was a significantly increased bleeding risk for patients who had received antiplatelets (OR 1.70), warfarin (OR 1.96) or dabigatran etexilate (OR 1.57). The 73 471 patients hospitalised with acute kidney failure (AKF) were compared with 348 075 controls. NSAIDs had been used by 13.6% of cases in the 3 months prior to hospitalisation, compared with 7.4% of controls (OR 1.78; 1.73, 1.83). Proton pump inhibitors had been used by 37.4% of cases and 20.3% of controls (OR 1.78; 1.72, 1.83; p<0.001). Similarly, there was a significantly increased AKF risk for patients who had received H2 antagonists (OR 1.65), diuretics (OR 1.95), ACE/A-II inhibitors (OR 2.00), or antibiotics (OR 2.27). The 17 323 patients with serious arrhythmia were compared with 86 549 controls. Antibiotics had been used by 32.7% of cases and 18.2% of controls (OR 1.72; 1.65, 1.79; p<0.001). There was a high risk for patients receiving fluoroquinolones (OR 1.38) or penicillins (OR 1.69). There was also a high risk for patients receiving antidepressants (OR 1.46) or anti-nausea and anti-vertigo agents (OR 1.30), and for antipsychotics prescribed within the previous 7 days (OR 1.27). Risks were generally higher among new medicine users, and when concomitant high-risk medicines were used. The estimates of risk were "consistent with findings from epidemiological studies conducted previously," note the authors. Study results were able to be generated within one day, although the authors note that "medical and pharmacological expertise and assessment is required in the interpretation of the results generated". The ability to analyse risks due to multiple drug therapy "could potentially inform prescribers of increased risk for their patients when prescribing additional medicines," note the authors. Tomlin AM, et al. A Pharmacoepidemiology Database System for Monitoring Risk Due to the Use of Medicines by New Zealand Primary Care Patients. Drug Safety : 1 Aug 2017. Available from: URL: http://dx.doi.org/10.1007/ s40264-017-0579-1 803263635 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664
Reactions Weekly – Springer Journals
Published: Aug 12, 2017
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