Key pharmacovigilance stakeholders' experiences of direct patient reporting of adverse drug reactions and their prospects of future development in the European Union

Inácio, Pedro; Cavaco, Afonso; Allan, Elaine; Airaksinen, Marja

doi:10.1016/j.puhe.2017.11.023

Cited by 11 publications

(7 citation statements)

References 34 publications

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“…The majority of respondents considered consumer pharmacovigilance necessary and this concurs with the responses of a survey conducted among consumers in Lalitpur, Nepal (Jha et al, 2017). Professionals from WHO, UMC and pharmacovigilance centers in the Netherlands and the UK considered patient reporting to be the future of pharmacovigilance (Inácio et al, 2018). Indeed, according to a survey conducted in fifty countries by Margraff and Bertram (2014) patient reporting-direct reporting, use of patient-specific reporting forms, and use of online forms were practiced in 44, 27, and 31 countries, respectively.…”

Section: Discussionsupporting

confidence: 75%

Knowledge, attitude and practice of pharmacovigilance among Nepalese health professionals

Shrestha¹,

Ghebremeskel²,

White³

et al. 2022

jpadr

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Introduction: Although Nepal joined the WHO program for International Drug Monitoring in 2006, published data about Nepalese health professionals’ understanding of pharmacovigilance and spontaneous reporting of adverse drug reactions (ADRs) is limited. Objectives: The purposes of this study were to: (1) investigate awareness, knowledge, attitude, and practice (KAP) of pharmacovigilance among health professionals and (2) gain insight into the ADRs reported for statins in Nepal. Methods: 125 health professionals (doctors, pharmacists/assistant pharmacists, and nurses) were recruited from health care institutions (hospitals, clinics, pharmacies) in Kathmandu, Nepal. Electronic and paper survey data were collected with the use of a validated questionnaire between April and December 2018. The multiple-choice questionnaire was structured to assess the KAP of pharmacovigilance, and ADRs associated with statins, and consisted of two open-ended questions for health professionals to give suggestions for the improvement of the pharmacovigilance system. Statistical Package for the Social Sciences (SPSS, version 25) was used to analyze the demographic and pharmacovigilance data. The main outcome measures were KAP of pharmacovigilance and ADRs reported for statins. Results:100 (80%) participants (44 doctors, 32 pharmacists / assistant pharmacists, 24 nurses) completed the self-administered questionnaire. Pharmacovigilance knowledge, attitude, and practice scores were 71%, 81%, and 53%, respectively. There was a significant difference between the number of knowledgeable health professionals (71 vs. 29%, p < 0.05) and had a favorable attitude (81 vs. 19%, p < 0.05) toward pharmacovigilance and ADR reporting compared with those who did not. The number of participants who did not report ADR was higher than those who did (90 vs. 10%, p < 0.05). The adverse reactions associated with statins were muscle symptoms (62%), elevated activity of liver enzymes (24%), and gastrointestinal symptoms (9%). Conclusion: Despite the knowledge and willingness of health professionals to report ADRs, the practice of pharmacovigilance remains low in Nepal. There is a need for clear and enforceable regulations for monitoring and reporting ADRs, and effective educational interventions to promote pharmacovigilance practices.

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Section: Discussionsupporting

confidence: 75%

Knowledge, attitude and practice of pharmacovigilance among Nepalese health professionals

Shrestha¹,

Ghebremeskel²,

White³

et al. 2022

jpadr

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“…Some of them suggest that better integration of work of EU regulators should be recommended because the number of patient reports varies between the member countries. In their reported outcomes, authors underline the urgency of additional human and financial resources to be used in order to grasp the benefits of patients reporting, as now their involvement is far from a desired level [ 30 ].The study which compared the tools used in promotion of patients engagement in pharmacovigilance in different European countries revealed that the webpage of National Competent Authority had been the most popular source of information on patients reports. Other sources indicated by the authors included leaflets, posters and social media websites.…”

Section: Resultsmentioning

confidence: 99%

The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process

Sienkiewicz

Burzyńska

Rydlewska-Liszkowska

et al. 2021

IJERPH

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All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems. The main role of the aforementioned system is to collect and analyze adverse drug reaction reports. Legislation introduced several years ago allowed patients, their legal representatives and caregivers to report adverse drug reactions, which caused them to be an additional source of safety data. This paper presents the analysis of EudraVigilance data related to adverse drug reactions provided by patients, their representatives, as well as those obtained from healthcare professionals related to medicines which belong to M01A anti-inflammatory and antirheumatic products, a non-steroid group. The objective of the study was to identify the changes in the number and structure of adverse reaction reporting after the introduction of pharmacovigilance (PV) obligations in EU. A review of scientific literature was also conducted to assess the differences in adverse reactions reported by patients or their representatives and by healthcare professionals. We also identified other factors which, according to literature review, influenced the number of adverse reaction reports provided by patients. Analysis of data collected from the EudraVigilance showed that from 2011 to 2013 the number of reports made by patients and their caregivers increased by approx. 24 percentage points, and then, from 2014, it constituted around 30% of the total of reported reactions every year, so patient reporting is an important part of pharmacovigilance system and a source of drugs’ safety information throughout their use in healthcare practice. Additionally, there was no interrelationship between the seriousness of reported adverse reactions and the overall number of patient reports when compared to reports form healthcare professionals.

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“…For this reason, our results can be interpreted with caution. That said, patients' reports are valid and reliable outcome measures in care or in estimating recent medication use [15,[46][47][48][49]. In addition, patients' reports are a recognized and reliable source of drug safety signal in pharmacovigilance.…”

Section: Discussionmentioning

confidence: 99%

Praziquantel and Upper Gastrointestinal Bleeding in Hepatic Schistosomiasis: A Quasi-Experimental Study

Opio

Kazibwe

Kabatereine

et al. 2020

Drugs - Real World Outcomes

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Background There is a general consensus that widespread use of praziquantel in populations where schistosomiasis is endemic prevents development of hepatic schistosomiasis and its complications. However, a few studies have reported discordant findings linking praziquantel to the occurrence of upper gastrointestinal bleeding (UGIB) in some patients with hepatic schistosomiasis and varices. Objective We explored if there was any causal association between recent praziquantel use (rPZQ) and upper gastrointestinal bleeding in hepatic schistosomiasis in rural Africa. Patients and Methods A quasi-experimental, retrospective case-controlled study was performed. It involved adult patients with past or acute UGIB, varices, periportal fibrosis, and/or cirrhosis. Cases had acute variceal bleeding while controls did not. The outcome was the frequency of lifetime episodes of UGIB and exposure was rPZQ (received praziquantel in the last 11 months from the date of enrollment). The data analysis included 2 × 2 tables, logistic regression, and propensity-score matching. Odds ratios (ORs), average treatment effects (ATEs), and their 95% confidence intervals (CIs) were used for inference. Results Over 6 weeks, we enrolled 19 cases with 92 lifetime episodes of UGIB, and 66 controls with 192 lifetime episodes of UGIB. Cases were more likely to experience UGIB than controls following rPZQ (92% vs. 62%; OR 7.6; 95% CI 3.4–17). Factors predictive of more lifetime episodes of UGIB at multivariable analysis included rPZQ (adjusted OR 13; 95% CI 2.9–53), relative leukocytosis (adjusted OR 26; 95% CI 7.6–89), large varices (adjusted OR 5.0; 95% CI 1.7–15), a family member with hepatosplenic schistosomiasis (adjusted OR 19; 95% CI 7.4–51), advanced periportal fibrosis (adjusted OR 8.0; 95% CI 2.6–22), ascites (adjusted OR 14; 95% CI 4.3–47), and jaundice (adjusted OR 32; 95% CI 7.8–128). While the ATE following rPZQ among the treated was 0.40 (95% CI 0.33–0.48). Conclusions Our findings suggest the presence of a plausible causal association between recent praziquantel use and increased frequency of UGIB in our study population. Supplementary Information The online version contains supplementary material available at 10.1007/s40801-020-00222-7.

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Key pharmacovigilance stakeholders' experiences of direct patient reporting of adverse drug reactions and their prospects of future development in the European Union

Cited by 11 publications

References 34 publications

Knowledge, attitude and practice of pharmacovigilance among Nepalese health professionals

Knowledge, attitude and practice of pharmacovigilance among Nepalese health professionals

The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process

Praziquantel and Upper Gastrointestinal Bleeding in Hepatic Schistosomiasis: A Quasi-Experimental Study

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