Pharmacovigilance of COVID-19 vaccines in the context of Nepal: an assessment based on early adverse drug reaction reports

Abstract Objective The objective of this study was to assess the ongoing pharmacovigilance of coronavirus disease-19 (COVID-19) vaccines in the Nepalese context based on the available preliminary adverse drug reaction (ADR) reports and suggest approaches for strengthening pharmacovigilance mechanisms. Methods Currently, many COVID-19 vaccines are under advanced development and some have begun to be administered. In Nepal, the vaccination programme was initiated with Oxford/AstraZeneca COVID-19 AZD1222 (Covishield) vaccine on January 27th targeting frontline healthcare professionals, sanitary staff and security workers. Newspaper reports and ADR reports received at a regional pharmacovigilance centre in Nepal were analysed. Nepal initiated a national pharmacovigilance programme 15 years back and has 14 functioning regional pharmacovigilance centres. The authors examine the strengths and challenges facing the current pharmacovigilance system in ensuring the safety of COVID-19 vaccines. Key findings The news coverage has not mentioned any deaths till date with COVID-19 vaccination. Some patients reported vomiting, urticaria and sudden increase in blood pressure. Few people suffered from headache, fever and myalgia after being vaccinated. A vaccine, approved in an accelerated manner may have safety concerns. The vaccine may cause several types of reactions, but serious reactions have not been reported. Occurrence of adverse effects due to the vaccine is being studied. Conclusions Involving key stake holders, training health professionals and strengthening existing reporting procedures are important. Developing a system of reporting and analysing ADRs daily can help generate actionable intelligence to improve the safety of the vaccination programme. Establishing functioning communication channels between regulatory authorities and other stakeholders is crucial.

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Strengthening adverse drug reaction reporting in Nepal

Asian Journal of Medical Sciences ◽

10.3126/ajms.v6i4.11659 ◽

2015 ◽

Vol 6 (4) ◽

pp. 9-13 ◽

Cited By ~ 3

Author(s):

Nisha Jha ◽

Devendra Singh Rathore ◽

Pathiyil Ravi Shankar ◽

Sudesh Gyawali ◽

Mohamed Azmi Hassali ◽

...

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Healthcare Professionals ◽

Adverse Drug Reaction Reporting ◽

Community Pharmacists ◽

Current Status ◽

Pharmacovigilance Centre ◽

Adr Reporting ◽

National Pharmacovigilance Centre ◽

National Regulatory Authority

Pharmacovigilance in Nepal is still in infancy. Till date only healthcare professionals are involved and the problem of underreporting is seen. The national pharmacovigilance centre is located in the national regulatory authority of Nepal, i.e. Department of Drug Administration (DDA). Lack of adequate human resources for managing the pharmacovigilance program in Nepal has been a limitation for the growth of pharmacovigilance activities. Currently, there is neither any involvement of community pharmacists in Adverse Drug Reaction (ADR) reporting process nor any involvement of consumers for the same. This paper reviews the current status of pharmacovigilance and mentions possible benefits of involving consumers or patients in the existing pharmacovigilance program. A systematic review were conducted by searching different databases like PubMed, Google scholar, EMBASE, NepJOL, and Scopus. This study also describes the role of healthcare professionals in ADR reporting, possible reasons for underreporting of ADRs, regulatory perspectives and benefits of involving consumers in pharmacovigilance. DOI: http://dx.doi.org/10.3126/ajms.v6i4.11659Asian Journal of Medical Sciences Vol.6(4) 2015 9-13

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Bulgarian Experience with Adverse Drug Reaction Reports from Patients and Consumers – Retrospective Data-base Study

Folia Medica ◽

10.2478/folmed-2018-0016 ◽

2018 ◽

Vol 60 (3) ◽

pp. 447-453

Author(s):

Violeta I. Getova ◽

Stanislav R. Georgiev ◽

Assena H. Stoimenova ◽

Elina S. Petkova-Georgieva

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Data Base ◽

Healthcare Professionals ◽

Reporting System ◽

Safety Data ◽

Pharmacovigilance System ◽

Patient Reporting ◽

Post Marketing Surveillance ◽

Depth Analysis

Abstract Background: Since 2012, in compliance with the changes in the European legislation, the Bulgarian Drug Agency (BDA) has been receiving adverse drug reaction (ADR) reports directly from patients as well as from healthcare professionals and marketing authorization holders (MAH). Adverse reaction reports from patients and consumers have different characteristics from those sent by healthcare professionals. Moreover, they may require specific algorithm and assessment methods in order to be informative and beneficial to the pharmacovigilance system. Aim: The study aims to analyze the data-base of consumer reports in Bulgaria in order to distinguish and classify the main characteristics of the ADR reports from non-healthcare professionals. Materials and methods: In-depth analysis of the Bulgarian data-base of consumer ADR reports for 2012-2016 was conducted. The criteria include patient demographic characteristics, preferred method of reporting, seriousness and expectedness criteria and most frequently reported pharmacological groups. Results: The data showed the current trends in patient reporting in the country. It also marked new courses for development of the spontaneous reporting system and collection of safety data. The analysis of the data-base showed a rather stable level of patient reporting with a tendency for constant growth every year. Bulgaria follows the world tendencies for high number of reports for insufficiently studied ADRs which meet the seriousness criteria. The review of the most frequently reported ATC codes could lead to the conclusion that the current pharmacovigi-lance methods are not sensitive enough for specific groups of medicines. Conclusions: The results from the conducted study confirm the importance of patient reporting as a valuable source of information on adverse drug reactions. Moreover, it draws the attention to the lack of more sensitive methods for evaluation of drug safety in specific pharmacological groups. Maintenance of consumer-friendly ADR reporting system and innovative assessment algorithms should be the future directions for development in post-marketing surveillance.

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Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance

Journal of Health Sciences ◽

10.17532/jhsci.2014.183 ◽

2014 ◽

Vol 4 (2) ◽

pp. 120-125 ◽

Cited By ~ 3

Author(s):

Maša Amrain ◽

Fahir Bečić

Keyword(s):

Health Care ◽

Adverse Drug Reaction ◽

Drug Reaction ◽

Adverse Drug Reactions ◽

Bosnia And Herzegovina ◽

Health Care Professionals ◽

Healthcare Professionals ◽

Pharmacovigilance System ◽

Drug Reactions ◽

Adr Reporting

Introduction: Pharmacovigilance is an arm of patient care. No one wants to harm patients, but unfortunately any medicine will sometimes do just this. Underreporting of adverse drug reactions by healthcare professionals is a major problem in many countries. In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of health care professionals in adverse drug reaction (ADR) reporting was performed.Methods: A pretested questionnaire comprising of 20 questions was designed for assessment of knowledge, perceptions, practice and barriers toward ADR reporting on a random sample of 1000 healthcare professionals in Bosnia and Herzegovina.Results: Of the 1000 respondents, 870 (87%) completed the questionnaire. The survey showed that 62.9% health care professionals would report ADR to the Agency for Medicinal Products and Medical Device of Bosnia and Herzegovina (ALMBIH). Most of surveyed respondents has a positive perception towards ADR reporting, and believes that this is part of their professional and legal obligation, and they also recognize the importance of reporting adverse drug reactions. Only small percent (15.4%) of surveyed health care professionals reported adverse drug reaction.Conclusions: The knowledge of ADRs and how to report them is inadequate among health care professionals. Perception toward ADR reporting was positive, but it is not reflected in the actual practice of ADRs, probably because of little experience and knowledge regarding pharmacovigilance. Interventions such as education and training, focusing on the aims of pharmacovigilance, completing the ADR form and clarifying the reporting criteria are strongly recommended.

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

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17093039 ◽

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.

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Assessment of knowledge, attitude and practice of adverse drug reaction reporting among healthcare professionals in secondary and tertiary hospitals in the capital of Pakistan

Saudi Pharmaceutical Journal ◽

10.1016/j.jsps.2018.02.014 ◽

2018 ◽

Vol 26 (4) ◽

pp. 453-461 ◽

Cited By ~ 18

Author(s):

Zaka Un Nisa ◽

Ayesha Zafar ◽

Farooq Sher

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Healthcare Professionals ◽

Adverse Drug Reaction Reporting ◽

Reaction Reporting ◽

Attitude And Practice ◽

Tertiary Hospitals ◽

Knowledge Attitude And Practice

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The Knowledge and Attitude of the Healthcare Professionals towards Pharmacovigilance and Adverse Drug Reaction Reporting in Northern Cyprus

Journal of Pharmacovigilance ◽

10.4172/2329-6887.1000193 ◽

2016 ◽

Vol 04 (01) ◽

Cited By ~ 6

Author(s):

Hale Zerrin Toklu ◽

Mertdogan Soyalan

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Healthcare Professionals ◽

Adverse Drug Reaction Reporting ◽

Reaction Reporting ◽

Northern Cyprus ◽

Knowledge And Attitude

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Association between concomitant use of several systemic NSAIDs and an excess risk of adverse drug reaction. A case/non-case study from the French Pharmacovigilance system database

European Journal of Clinical Pharmacology ◽

10.1007/s00228-004-0761-0 ◽

2004 ◽

Vol 60 (4) ◽

Cited By ~ 11

Author(s):

Fran�ois Clinard ◽

Catherine Sgro ◽

Marc Bardou ◽

Patrick Hillon ◽

Monique Dumas ◽

...

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Excess Risk ◽

Pharmacovigilance System ◽

System Database

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Pharmacovigilance of suspected or confirmed therapeutic ineffectiveness of artemisinin-based combination therapies: extent, associated factors, challenges and solutions to reporting

10.21203/rs.3.rs-36571/v1 ◽

2020 ◽

Author(s):

Ronald Kiguba ◽

Helen Byomire Ndagije ◽

Victoria Nambasa ◽

Leonard Manirakiza ◽

Elijah Kirabira ◽

...

Keyword(s):

Associated Factors ◽

Healthcare Professionals ◽

Pharmacovigilance Centre ◽

Combination Therapies ◽

Public And Private ◽

Factors Associated ◽

Adr Reporting ◽

National Pharmacovigilance Centre ◽

Reporting Procedures

Abstract Background: This study aimed to determine the extent and associated factors of past 6-month reporting of artemisinin-based combination therapy (ACT)-failure by healthcare professionals (HCPs); and difficulties and solutions to the pharmacovigilance (PV) of ACT therapeutic ineffectiveness.Methods: Survey of 685 HCPs from June to July 2018 in purposively selected public and private health facilities in Uganda.Results: One in five [20%, 137/685; 95% confidence intervals (CI) 17% to 23%] HCPs reported ACT-failure to any authority in the previous 6-months. HCPs commonly reported ACT-failure to immediate supervisors (72%, 106/147), mostly verbally only (80%, 109/137); none had ever reported a written ACT-failure to Uganda’s National Pharmacovigilance Centre. Common difficulties to reporting ACT-failure were; unavailability of reporting procedures (31%, 129/421), poor follow-up of treated patients (22%, 93/421) and absence of reporting tools (16%, 68/421). Factors associated with reporting ACT-failure in past 6-months were: hospital-status (vs other; OR = 2.4, 95% CI, 1.41 to 4.21), HCPs aged under 25 years (OR = 2.2, 95% CI, 1.29 to 3.76), suspicion of ACT-failure in past 4-weeks (OR = 2.3, 95% CI, 1.29 to 3.92), receipt of patient-complaint(s) of ACT-failure in past 4-weeks (OR = 2.9, 95% CI, 1.62 to 5.12) and HCPs from northern (vs central; OR = 0.5, 95% CI, 0.28 to 0.93) and western (vs central; OR = 0.4, 95% CI, 0.17 to 0.77) parts of Uganda.Conclusion: One in five HCPs reported ACT-failure, mostly verbally to supervisors. The existing ADR-reporting infrastructure should be leveraged to promote the PV of ACT therapeutic ineffectiveness.

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