Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal

Abstract

Analyzing the pattern and quality of scientific communications on pharmacovigilance can help the regional centers in Nepal and other developing countries to develop approaches for communicating effectively medicine safety issues. This kind of research is lacking in developing countries.Objectives:To analyze the pattern and quality of scientific communications on drug safety produced by the regional pharmacovigilance center at western Nepal.Methodology:Various conference abstracts and journal publications produced by the center during its initial four years of establishment (14th September 2004 till 13th September 2008) were identified. These communications were categorized in to case reports, review articles, conference presentations, short communications, newsletter and bulletin articles, original research and case series. In addition, the quality of the case reports were evaluated as per International Society of Pharmacovigilance/International Society of Pharmacoepidemiology (ISoP/ISPE) guidelines on the requirements for submitting case reports on adverse event reports in biomedical journals.Results:During the study period, 53 scientific communications were produced by the staff of the regional pharmacovigilance center in relation with drug safety. Among these, 18 (34%) were related to case reports and letters. The median (interquartile range) age of the patients described in the case reports was 46.5 (21.7-51.2) years. Among the total 18 ADRs, four were fixed drug eruptions, followed by contact dermatitis (n=2). Majority of the published case reports were related to skin (n=13; 72.2%). Antimicrobials were responsible for 27.8% (n=5) of the case reports. Among the 18 case reports published by the pharmacovigilance center, a majority followed the ISoP/ISPE guidelines. Few parameters like physical examination of the patient experiencing ADR, patient disposition, dosage and administration of the suspected drugs, and drug-reaction interface were missing in few of the cases.Conclusion:A high percentage of the scientific communications were ‘case reports’. A high proportion of the case reports produced by the center were of international standards. There were lacunae in ‘patient disposition’ in few of the reports.

Evaluation of completeness of adverse drug reaction case reports published in biomedical Journals: A preliminary analysis

“…In a study done by Routledge et al [14] this incidence was estimated at 80% of all ADRs occurring in an hospital, knowing the drug dose that is causing an ADR can help prevent it in the future by optimizing to a safe dose. Impicciatore & Mucci [8] and Palaian et al [11] showed that 15% & 22.2% researchers had failed to report suspect drug dosage, which is consistent to our study finding of 16%. Knowing about the doses leading to a particular ADR is of great importance because it can give a new range of dose leading to the ADR that might be useful in formulating new treatment guidelines e.g.…”

“…In our study we found that, amongst the required parameters, majority of the researchers have described most of the patient & ADR related details adequately (>90% reporting) (Table 1 & 3) and this finding is well supported by the studies done by Impicciatore & Mucci 8 and Palaian et al [11] . However, when it came to reporting drug related details in the ADR case report, we felt that the researchers largely fell short.…”

Bibliometric analysis of adverse drug reactions and pharmacovigilance research activities in Nepal

“…13 carried out a study that analyzed the pattern of literature in patient safety that suggests research directions for the future. The latter study showed the frequency of published articles and types of publications regarding PV and ADRs, 14 whereas our present study focuses on the impact of those published papers in different journals.…”