Impact of Safety Climate Perception and Barriers to Adverse Drug Reaction Reporting on Clinical Nurses' Monitoring Practice for Adverse Drug Reactions

ABSTRACT OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal) to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each), followed by first educational approach (265 reports, 20.31 €/report) and by the hyperlink approach (136 reports, 15.59 €/report). Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs). Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report), followed by first educational approach (38.79 €/report). CONCLUSIONS We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report.

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Factors Affecting Adverse Drug Reaction Reporting of Healthcare Professionals and Their Knowledge, Attitude, and Practice towards ADR Reporting in Nekemte Town, West Ethiopia

BioMed Research International ◽

10.1155/2016/5728462 ◽

2016 ◽

Vol 2016 ◽

pp. 1-6 ◽

Cited By ~ 12

Author(s):

Lense Temesgen Gurmesa ◽

Mohammed Gebre Dedefo

Keyword(s):

Health Care ◽

Adverse Drug Reaction ◽

Drug Reaction ◽

Adverse Drug Reactions ◽

Health Care Professionals ◽

Adverse Drug Reaction Reporting ◽

Drug Reactions ◽

Reaction Reporting ◽

Attitude And Practice ◽

Knowledge Attitude And Practice

Background. Adverse drug reactions are global problems of major concern. Adverse drug reaction reporting helps the drug monitoring system to detect the unwanted effects of those drugs which are already in the market. Aims. To assess the knowledge, attitude, and practice of health care professionals working in Nekemte town towards adverse drug reaction reporting. Methods and Materials. A cross-sectional study design was conducted on a total of 133 health care professionals by interview to assess their knowledge, attitude, and practice using structured questionnaire. Results. Of the total respondents, only 64 (48.2%), 56 (42.1%), and 13 (9.8%) health care professionals have correctly answered the knowledge, attitude, and practice assessment questions, respectively. Lack of awareness and knowledge on what, when, and to whom to report adverse drug reactions and lack of commitments of health care professionals were identified as the major discouraging factors against adverse drug reaction reporting. Conclusion. This study has revealed that the knowledge, attitude, and practice of the health care professionals working in Nekemte town towards spontaneous adverse drug reaction reporting were low that we would like to recommend the concerned bodies to strive on the improvement of the knowledge, attitude, and practice status of health care professionals.

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Physician reporting of adverse drug reactions. Results of the Rhode Island Adverse Drug Reaction Reporting Project

JAMA ◽

10.1001/jama.263.13.1785 ◽

1990 ◽

Vol 263 (13) ◽

pp. 1785-1788 ◽

Cited By ~ 13

Author(s):

H. D. Scott

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Rhode Island ◽

Adverse Drug Reactions ◽

Adverse Drug Reaction Reporting ◽

Drug Reactions ◽

Reaction Reporting

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Adverse Drug Reaction Reporting in Ethiopia: Systematic Review

BioMed Research International ◽

10.1155/2020/8569314 ◽

2020 ◽

Vol 2020 ◽

pp. 1-12

Author(s):

Abel Demerew Hailu ◽

Solomon Ahmed Mohammed

Keyword(s):

Health Care ◽

Adverse Drug Reaction ◽

Drug Reaction ◽

Adverse Drug Reactions ◽

Health Care Professionals ◽

Adverse Drug Reaction Reporting ◽

Drug Reactions ◽

Reaction Reporting ◽

Attitude And Practice ◽

Knowledge Attitude And Practice

Adverse drug reactions are major global public health problems and an important cause of mortality. Problems related to medicines safety can emerge from real-life medication use due to increasing access to complex treatment of concomitant infectious and noncommunicable diseases, hence leading to a higher prevalence of drug-related problems. The objective of this review was to assess the knowledge, attitude, and practice of adverse drug reaction reporting among health care professionals in Ethiopia. Relevant literatures were searched from Google Scholar, PubMed, Hinari, Web of Science, Scopus, and Science Direct using inclusion and exclusion criteria. From 133 searched studies, 13 studies were reviewed. The knowledge and attitude of health care professionals towards adverse drug reaction reporting ranged from 22.68% -60.33% and 47.22% -67.14%, with averages of 41.50% and 57.18%, respectively. While 46.93% encountered adverse drug reactions and 41.8% reported in the last 12 months. One-third (34.15%) of health care professionals do not know how to report adverse drug reactions. Fearing to report, uncertainty about the adverse drug reaction, concern about reporting generating extra work, thinking that one report does not make any difference, nonavailability of reporting forms, and lack of feedback from regulatory authority were the stated reasons for underreporting. We conclude that the knowledge, attitude, and practice of health care professionals towards spontaneous ADR reporting were low. Conducting awareness and educational training and implementation of electronic reporting can improve the ADR reporting practice.

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Legislation and current developments in adverse drug reaction reporting in Mongolia: how far are we?

Journal of Pharmaceutical Policy and Practice ◽

10.1186/s40545-021-00298-8 ◽

2021 ◽

Vol 14 (1) ◽

Author(s):

Zuzaan Zulzaga ◽

Erdenetuya Myagmarsuren ◽

Herman J. Woerdenbag ◽

Eugene P. van Puijenbroek

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Drug Safety ◽

Reporting System ◽

Adverse Drug Reaction Reporting ◽

Safety Data ◽

Regulatory System ◽

Basic Structure ◽

Reaction Reporting ◽

Adr Reporting

AbstractMonitoring adverse drug reactions is a vital issue to ensure drug safety and to protect the general public from medication-related harmful effects. In order to properly monitor drug safety, a regulatory system needs to be in place as well as an infrastructure that allows for analyzing national and international safety data. In Mongolia, adverse drug reaction (ADR) reporting activities have been implemented in the past decade. During this period, the basic structure and legal basis of an adverse drug reaction monitoring system was established. Because of the fragmented but growing healthcare system and the complexity of pharmaceutical issues in Mongolia, a sustainable process for the development of the adverse drug reaction reporting system is a key issue. The aim of this article is to disclose the Mongolian situation for the rest of the world and to share experiences on how an ADR reporting system can be developed towards a higher and more advanced level to contribute to both national and international drug safety issues. In this article, we review the features of the Mongolian health care and pharmaceutical systems, as well as the current development of the adverse drug reaction reporting system.

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