Increasing the frequency, quality and breadth of adverse drug reaction reporting by consumers and health professionals

Moses, Geraldine (2005). Increasing the frequency, quality and breadth of adverse drug reaction reporting by consumers and health professionals Professional Doctorate, School of Pharmacy, The University of Queensland.

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Author Moses, Geraldine
Thesis Title Increasing the frequency, quality and breadth of adverse drug reaction reporting by consumers and health professionals
School, Centre or Institute School of Pharmacy
Institution The University of Queensland
Publication date 2005
Thesis type Professional Doctorate
Supervisor Lisa Nissen
Total pages 194
Total colour pages 5
Total black and white pages 189
Language eng
Subjects 111503 Clinical Pharmacy and Pharmacy Practice
Formatted abstract Background:
Since the 1960’s, a world-wide system of spontaneous adverse drug reaction (ADR) reporting has provided a centralised means for monitoring postmarketing drug safety. However, under-reporting to this system remains a major problem. In addition, whether consumers should participate is controversial and largely unexplored.

Aim:
This study investigated whether the intervention of a pharmacist-operated telephone helpline and/or an educational workshop could increase the number, quality and breadth of ADRs reported to the Australian Adverse Drug Reaction Advisory Committee (ADRAC) by consumers and health professionals (HPs) and how the results of each group would compare.

Method:
Two independent studies were conducted. In the HP study, 381 doctors, nurses, pharmacists, dentists and complementary medicine (CM) practitioners were recruited and randomly assigned to one of four intervention groups: 1) access to the ADR Reporting Hotline; 2) small-group workshop on ADR reporting; 3) access to the Hotline AND the workshop or 4) no intervention (controls). The number of ADRAC reports submitted by participants in the two years prior to the study (1999-2000) and during the study (2001-2002) was compared.

In the consumer study, a pharmacist-operated 1300 telephone helpline was established through which ADRs could be reported or enquired about. Marketing of the service was limited to the state of Queensland, and after 22 months, call data were audited.

Results:
The HP hotline received 108 calls over the study period, mostly from pharmacists (61%) and doctors (29.6%). Average call duration was 21.3 minutes. Fifty-two ADRAC reports were generated, resulting in a signal to noise ratio (SNR) for the hotline of 48.1% or 1:1. A further 52 reports were independently submitted by participants to ADRAC, giving a total of 104 reports for the study, 19% of which were serious. Data analysis confirmed that ADR reporting increased significantly (p<0.05) in all intervention groups, to three to four times pre-study rates whereas reporting in the control group fell slightly.

In contrast, the consumer helpline received 972 calls throughout the study period, with television and radio being the most effective forms of marketing. At 24.3 minutes, average call duration was not dissimilar from HP calls. Callers were predominantly female (79.5%) and middle aged (49.4% aged 51-70 years); 84.6% called regarding themselves and the remaining 15.4% calling on behalf of a significant, most frequently a spouse, parent or child. Of the 750 potential adverse drug events, only 13% were assessed by the helpline as being not medication-related. A total of 336 ADRAC reports were submitted, giving a SNR of 34.5% or 1:2.

Consumers reported a broad range of symptoms associated with a wide range of therapeutic drug classes. The novelty of consumer ADRAC reports was demonstrated by 13.4% being associated with CMs, 2% concerning recently marketed drugs and 15.6% of reactions not listed in the medicine’s product information. Training and protocols ensured that ADRAC reports submitted by helpline pharmacists were of consistently high quality, 62% of which were probable or certain, and 13.1% serious (involving hospitalisation).

Conclusions:
ADR reporting by HPs improved marginally with education and assistance to reduce the burden of reporting. The number, breadth and quality of ADRs reported by consumers via a pharmacist-operated helpline demonstrated that consumers can make a positive contribution to pharmacovigilance, which complements existing HP ADR reporting systems.
Keyword Drugs -- Side effects
Drugs -- Side effects -- Evaluation
Adverse drug reaction
Health professionals

 
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Created: Tue, 28 Aug 2012, 12:13:10 EST by Vanessa Lee King on behalf of School of Pharmacy