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

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.

scholarly journals A Qualitative Evaluation of Adverse Drug Reaction Reporting System in Pakistan: Findings from the Nurses’ Perspective

2020 ◽  
Vol 17 (9) ◽  
pp. 3039
Author(s):  
Rabia Hussain ◽  
Mohamed Azmi Hassali ◽  
Anees ur Rehman ◽  
Jaya Muneswarao ◽  
Muhammad Atif ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Healthcare Professionals ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Qualitative Interviews ◽  
Qualitative Evaluation ◽  
Adr Reporting ◽  
Willingness To Report ◽  
And Training

The contribution of all key healthcare professionals is vital to promote an efficient adverse drug reaction (ADR) reporting system. In this context, nurses are important as they are in a better position to observe a patient’s response regarding the drug therapy and to report an ADR. The aim of the study was to explore the perspectives of nurses about ADR reporting system in Lahore, Pakistan. A total of 21 nurses were interviewed. The thematic content analysis of the qualitative interviews yielded six major themes and eight subthemes. Major themes included: (1) Knowledge about the concept of the medication safety & the ADR; (2) Knowledge regarding pharmacovigilance activities; (3) Willingness to report; (4) Practices related to the ADR reporting; (5) Barriers to the ADR reporting; (6) Facilitators to the ADR reporting. The majority of the nurses were aware of medicine safety and ADRs, but in many cases, they were unable to report these ADRs. The study pointed out considerable concerns regarding the knowledge and practices of nurses about pharmacovigilance activities in their workplace, mainly due to increased workload, due to the absence of a reporting system and legal liability. The main challenges turned out to be the lack of knowledge and training, as well as the implementation of guidelines. Based on the findings, it is suggested that outcome of this study can serve as a guide to design policies that support ADR reporting by nurses in Pakistan.

Patient satisfaction with a hospital adverse drug reaction reporting system

2020 ◽  
Vol 50 (2) ◽  
pp. 152-159
Author(s):  
Matthew W. Scott ◽  
Michael McDonough ◽  
Grace O. Wong ◽  
Richard Summers ◽  
Marion Joy Spark
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Patient Satisfaction ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Reaction Reporting

scholarly journals Establishment of an Educational Program concerning Adverse Drug Reaction Reporting-System in Long-Term Practical Training at a Hospital

2012 ◽  
Vol 132 (6) ◽  
pp. 769-775
Author(s):  
Tomoka Yamamoto ◽  
Masayo Ueno ◽  
Miho Ueyama ◽  
Asami Okamura ◽  
Atsushi Washiyama ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Educational Program ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Practical Training ◽  
Reaction Reporting

scholarly journals Knowledge, Attitudes, and Practices of Health Care Professionals Toward Adverse Drug Reaction Reporting in Hiwot Fana Specialized University Hospital, Harar, Eastern Ethiopia: A Cross-sectional Study

2017 ◽  
Vol 53 (3) ◽  
pp. 177-187 ◽  
Author(s):  
Hussen Shanko ◽  
Jemal Abdela
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Healthcare Professionals ◽  
Adverse Drug Reaction Reporting ◽  
Cross Sectional Study ◽  
University Hospital ◽  
Sectional Study ◽  
Cross Sectional ◽  
Reaction Reporting ◽  
Adr Reporting

Aims: This study was designed to assess knowledge, attitude and practices of adverse drug reaction reporting among healthcare professionals in Hiwot Fana Specialized University Hospital (HFSUH). Method: Hospital based descriptive cross sectional study was conducted on healthcare professionals of HFSUH. Based on purposive sampling technique, all eligible healthcare professionals (nurses, physicians and pharmacists) were involved in the study. A pretested self-administered questionnaire was used to collect data. Data were coded, entered and analyzed using SPSS version 16. The test of association of selected categorical variables were done using cross tabulation and Pearson Chi-square test. Result: Our study indicated that about 297 participants provided their response to the distributed questionnaires which makes the response rate 91.4%. Of the total healthcare professionals involved in the study, 99 (33.6%) of them were able to understand the difference between adverse drug reaction (ADR) and side effects, of which pharmacists were significantly reported (95.24%, P<0.05). About 175(59.3%) of the respondents engaged in the study were reportedly knew the national ADR reporting system in Ethiopia. On the other hand, 181(61.36%) of the participants were recognized the presence of ADR reporting form while 114 (38.64%) of the respondents had no any information about its presence in the country. Conclusion: The study revealed that a gap in knowledge, awareness and practice of healthcare professionals on ADR reporting. Therefore, specific strategies should be designed in order to improve awareness, knowledge and practice of healthcare professionals to tackle issue related to under-reporting of ADR.

scholarly journals Awareness among consumers on adverse drug reaction reporting system in India - A cross-sectional questionnaire-based study

2021 ◽  
Vol 12 (2) ◽  
pp. 1276-1282
Author(s):  
Yamuna Devi M. S. ◽  
Saratha Muthukumar ◽  
Kaavya S.
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Side Effects ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Drug Effects ◽  
Indian Languages ◽  
Cross Sectional ◽  
Adr Reporting ◽  
The Government

The adverse drug reaction (ADR) reporting system in India came into existence in 2010 through an initiative by the Government, the Pharmacovigilance Programme of India (PvPI), considering the social and economic consequences of drug effects. Though the system is functioning effectively for almost a decade, there has been a lacuna in reporting due to the lack of awareness among the patients who are the direct consumers. Medicine side-effects reporting is the newest initiative started in 2014 by PvPI, and the forms for consumer reporting is made available in over 10 different Indian languages like Tamil, Hindi, etc. It is imperative to determine the level of awareness among the public regarding drug side-effects and the existence of a National Programme to monitor the same, especially in a country like India with a population of nearly 1.38 billion. The aim of this study was to determine the awareness among the general population about the ADR reporting system in India. This cross-sectional study was done over a period of one year amongst the general public in South India. Data was collected from about 338 participants using a standardized questionnaire and analyzed descriptively using SPSS statistical software version 24. The overall response rate was 93.8%, and the mean age was 35.62 ± 10.43 years. Though the respondents had sufficient knowledge (66%) about ADRs, their awareness about the reporting system was very poor (19%). Reporting through phone (78%) was preferred over-reporting through specific forms (10%). To conclude, our study emphasizes that public participation and awareness are crucial in strengthening the existing system of Pharmacovigilance.

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