Current trends in pharmacovigilance: value and gaps of patient reporting

Inácio, Pedro; Cavaco, Afonso; Airaksinen, Marja

doi:10.1007/s11096-018-0689-6

Cited by 11 publications

(13 citation statements)

References 25 publications

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“…Pharmacovigilance is the science and activities relating to detecting, assessing, understanding, and preventing adverse effects or any other medicine/vaccine related problem. 9,10 With so many types of drug molecules and drug brands including generic drugs used in clinical practice, it is utmost important to have a robust system for recording and reporting any ADR suspected due to use of a drug. 11 To address this in India, pharmacovigilance program has been implemented since 2010.…”

Section: Discussionmentioning

confidence: 99%

A conceptual framework on health professionals' engagement towards pharmacovigilance: a qualitative exploration

Swain

Patel

Palo

et al. 2021

Int J Basic Clin Pharmacol

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Background: With the growing reliance on drug therapy in the recent era, the safety of medications is one of the vital parameters for the success of any medicine. Considering this, pharmacovigilance (PV) was developed to provide adequate identification, reporting, evaluation, and understanding of adverse drug reactions (ADR). The objective of this study was to understand the opinion of health care providers on PV, the current reporting mechanisms, identifying the causes for underreporting, and the existing process in clinical practice.Methods: A qualitative study using pretested interview guide was conducted among 20 different cadres of healthcare personnel (doctors, pharmacists, and staff nurses) from various hospitals such as government, private, corporate, and medical college of Odisha state. The data were analysed using a thematic analysis. The meaning units have been identified from the transcript and coded with MAXQDA software (MAXQDA Analytics Pro 2020, VERBI GmbH Berlin).Results: Participants showed a lack of awareness regarding the concept of PV. A cluster of challenges such as lack of ADR monitoring, non-conducive work atmosphere and lack of cooperation between staff, lack of knowledge among the health professionals, and fear of legal liability as major pitfalls causing poor ADR reporting. To enhance the pharmacovigilance practice, participants suggested context-specific strategies such as IEC activities, innovative ideas to improve ADR monitoring, regular monitoring.Conclusions: Capacity building through training, regular monitoring and supervision to strengthen the pharmacovigilance practices is the current need in India.

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Section: Discussionmentioning

confidence: 99%

A conceptual framework on health professionals' engagement towards pharmacovigilance: a qualitative exploration

Swain

Patel

Palo

et al. 2021

Int J Basic Clin Pharmacol

View full text Add to dashboard Cite

show abstract

“…scheduled visits and regular call meetings), adapting reporting systems to the needs of the institutions and respective units/services (e.g. simplified forms, adapted reporting flowchart and consensus meetings) [ 11 ] and engage social media as a potential promoter of patient reporting [ 12 ]. These active monitoring programs must transcend the different health services (e.g., pharmacies, nursing homes, family healthcare centres and, above all, hospitals) in order to increase the probability of detecting suspected drug incidents and accelerate the assessment of causality (or attribution of a degree of probability) of the events reported in COVID-19 patients.…”

Section: Guiding Axes For Drug Safety Management During the Covid-19 Pandemicmentioning

confidence: 99%

“…However, spontaneous reporting is a slow approach that does not promptly answer the needs of situations like the present COVID-19 pandemic, in which the scientific community and regulators need information on a near real-time point. As so, we advocate a multidimensional strategy that, together with the traditional pharmacovigilance methods, can promote active pharmacovigilance [ 12 ] and accelerate the process while optimising resources. This multidimensional strategy embraces six interrelated guiding axes.…”

Section: Guiding Axes For Drug Safety Management During the Covid-19 Pandemicmentioning

confidence: 99%

Guiding axes for drug safety management of pharmacovigilance centres during the COVID-19 era

et al. 2021

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The COVID-19 pandemic presents several challenges to the organisation and workflow of pharmacovigilance centres as a result of the massive increase in reports, the need for quick detection, processing and reporting of safety issues and the management of these within the context of lack of complete information on the disease. Pharmacovigilance centres permanently monitor the safety profile of medicines, ensuring risk management to evaluate the benefit-risk relationship. However, traditional pharmacovigilance approaches of spontaneous reporting, are not suitable in the context of a pandemic; the scientific community and regulators need information on a near real-time point. The aim of this commentary is to suggest six interrelated multidimensional guiding axes for drug safety management by pharmacovigilance centres during the COVID-19 pandemic. This working plan can increase knowledge on COVID-19 and associated therapeutic approaches, support decisions by the regulatory authorities, oppose fake news and promote more efficient public health protection.

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“…However, underreporting of ADRs is still a widespread problem in spontaneous reporting systems [7,11,12]. Therefore, countries encourage and require responsible stakeholders, including health care professionals (HCPs), regulatory authorities, and industry, as well as the public (consumers, patients) to participate in the spontaneous reporting system, for extensive reporting of ADRs [4,7,13]. The critical role of patients' participation in pharmacovigilance and direct reporting of ADRs has been increasingly recognized [8,[14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

A cross-sectional study: comparison of public perceptions of adverse drug reaction reporting and monitoring in eastern and western China

Ning-sheng

Chen

Ren

et al. 2022

BMC Health Serv Res

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Background Adverse drug reactions (ADRs) cause a substantial clinical and economic burden. Spontaneous reporting of ADRs by the public is crucial. In some developed countries like the United States, Canada, consumers have been allowed to directly report ADRs, however, convenient channels for direct ADR reporting by the public are lacking in China. Objective We aimed to compare the knowledge, attitudes, and practice(KAP) regarding monitoring and reporting of adverse drug reaction (ADR) among the general public in eastern and western China. Methods A questionnaire-guided cross-sectional study was administered to participants in Nanjing and Xi’an during April–July 2019. A descriptive statistical analysis was used to describe respondents’ demographic information and other results. The t-test and analysis of variance were used to test the differences in knowledge and attitudes among respondents with different demographic characteristics. P < 0.05 was considered statistically significant. Binary logistic regression analysis was used to examine factors associated with knowledge and attitudes. Results A total of 1085 questionnaires were distributed in this survey, 869 valid questionnaires were returned, the recovery rate was 80.09%. Respondents showed poor knowledge of the definition of ADRs and reporting criteria, with a significant difference in average knowledge scores according to education level, gender, and age group. Most respondents had positive attitudes toward ADR monitoring and reporting, with no significant differences in knowledge and attitude scores between the two cities. In total, 68.93% of respondents said they would feedback information to health care professionals, most (84.35%) would take the initiative to report ADRs if there were a convenient method. More than half (58.57%) of respondents were more likely to report ADRs by telephone. Conclusion The findings of our study indicated that health care professionals should encourage patients to actively report ADR. China should also explore ways to facilitate direct public reporting of ADRs by improving relevant laws and regulations.

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Current trends in pharmacovigilance: value and gaps of patient reporting

Cited by 11 publications

References 25 publications

A conceptual framework on health professionals' engagement towards pharmacovigilance: a qualitative exploration

A conceptual framework on health professionals' engagement towards pharmacovigilance: a qualitative exploration

Guiding axes for drug safety management of pharmacovigilance centres during the COVID-19 era

A cross-sectional study: comparison of public perceptions of adverse drug reaction reporting and monitoring in eastern and western China

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