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Medication Safety, v3 CI 5.3: Warfarin – written drug information upon discharge (H) In 2011, there were 2,728 patients reported from 20 HCOs. The annual rate was 84.2 per 100 patients. The fitted rate deteriorated from 86.0 to 82.6, a change of 3.4 per 100 patients. In 2011, there were seven outlier submissions from seven HCOs whose combined excess was 128 fewer patients discharged on warfarin who received written drug information upon discharge. CI 5.4: Warfarin – dosage review following high INR result (H) In 2011, there were 280 patients reported from 23 HCOs. The annual rate was 96.8 per 100 patients. In 2011, there were two outlier submissions from two HCOs whose combined excess was six fewer patients whose dosage has been adjusted or reviewed prior to the next warfarin dose. CI 5.5: Warfarin – starting doses consistent with hospital approved protocol (H) In 2011, there were 85 patients reported from seven HCOs. The annual rate was 67.1 per 100 patients. Timely and appropriate monitoring of aminoglycoside antibiotics CI 6.1: Aminoglycoside toxicity – dosage adjustment prior to next dose (H) In 2011, there were 46 patients reported from three HCOs. The annual rate was 97.8 per 100 patients. * Australasian Clinical Indicator Report 2004–2011 Page 21 © ACHS. This work is copyright. Requests and inquiries concerning reproduction and rights should be addressed to pos@achs.org.au
Medication Safety, v3 Expert commentary Therapeutic Goods Administration (TGA) Reporting of adverse drug reactions to the TGA Although the number of adverse drug reaction (ADR) reports submitted to the TGA increased from almost 11,000 in 2004 to 14,500 in 2011, there has been a drop in reporting of CI 1.1 by HCOs from a peak of 3,010 in 2004 to 1,660 in 2011. This is contrary to international trends, where the number of hospital admissions, and hospital admissions extended by adverse drug reactions, is increasing. 1,2 Australia shares an ageing population and the tendency to increasing polypharmacy, suggesting a likely increase in the total number of adverse drug reactions (ADRs) experienced by consumers. 3,4 While the rate of reporting increased in 2011 to a rate of 0.12 reports per 100 separations, it is not clear why the number of reports and the number of reporting HCOs has dropped, particularly since there is a requirement for the clinical workforce in public hospitals to document patients’ previously known ADRs and report them to the TGA. The TGA seeks information from a variety of sources when monitoring the safety of medicines and vaccines on the market. One source of information is spontaneous adverse event reporting. The TGA encourages all hospitals to ensure that they have systems in place for reporting adverse events related to medicines. Adverse event reports from hospitals are particularly important to the TGA for a number of reasons: hospitals have early experience with new medicines and/or their use in people with comorbidities who would be excluded from clinical trials, and therefore may detect new signals; hospitals are encouraged to have in place systems to ensure that ADRs are identified and reported internally and to the TGA and patients may present to a hospital following a serious ADR. The TGA encourages all health professionals to report adverse events associated with medicines and thus contribute to the post-market detection and understanding of adverse drug reactions. The TGA supports the use of e-prescription forms to increase ADR reporting, and looks forward to the update of the software functionality. Medicines are just one clinical indicator data set. Equal consideration should be given to collecting CIs on medical device incident reports. The TGA also analyses reports of adverse reactions to medical devices to detect and investigate safety signals, and can provide comments on these. Australasian Clinical Indicator Report 2004–2011 Page 22 © ACHS. This work is copyright. Requests and inquiries concerning reproduction and rights should be addressed to pos@achs.org.au
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