Comparison of Preventable Adverse Drug Reaction Evaluation Tools Between P Method and Schumock and Thornton Criteria

  • Cholticha Sonsupap Strategy and Planning Division, Food and Drug Administration
  • Rapeepun Chalongsuk Faculty of Pharmacy, Silpakorn University
Keywords: adverse drug reaction evaluation tools, preventable adverse drug reaction

Abstract

The purposes of this research were to compare the preventable adverse drug reactions
(pADRs) evaluation tools between P Method and Schumock and Thornton criteria and explore
the characteristics of pADRs from musculoskeletal system drugs that had reported by hospitals
where under the Office of the Permanent Secretary, Ministry of Public Health from 1 October 2014
to 30 September 2017 with causality assessment as certain and completeness score of Thai HPVC
at level 3. Data analysis using the percentage, the test of proportional differences in the number
of adverse drug reactions (ADRs) reported by Fisher's exact test and finding inter-observer reliability
of three observers by the Fleiss's Kappa Statistics. The results of this study showed that most of
the reports were female (65.93%) and aged between 15 and 59 years (56.04%) and 72.16% were
outpatients. All reviewers were the consensus for 3 reports that were scored as ‘preventable’
by using P Method and Schumock and Thornton criteria, two reports were related to therapeutic
duplication and one report was related to documented hypersensitivity to the administered drug.
The most common ADRs reported were from the skin and appendages disorders. The proportions
of the report when using different tools showed that there were significant differences in one
reviewer (P = 0.00). And when analyzing the inter-observer reliability by using Schumock and
Thontron criteria, it was moderate with a Fleiss’s Kappa 0.44 and slight with a Fleiss’s Kappa 0.15
when using P Method. The results of this study showed that the number of reports that reviewers'
consensus when using Schumock and Thornton criteria more than P Method. Moreover, most
reports were not assessable because the reports from Thai Vigibase could not provide some of
the related information. Therefore, the data in the ADRs reporting form should be containing
much more information for pADRs evaluation.

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Published
2020-03-18
Section
บทความวิจัย