Patient-centered pharmacovigilance: A review

Saleh, Hager Ali; Fourrier‐Réglat, Annie; Diogène, Eduard

doi:10.4314/tjpr.v17i1.24

Cited by 9 publications

(5 citation statements)

References 21 publications

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“…Our results indicating a longer median time to report among patients are consistent with a previous study [ 32 ] and suggest different awareness levels about ADR reporting. A review of patient-centered pharmacovigilance published in 2018 highlighted a need for patient education on ADR reporting [ 34 ]. Direct patient reporting in pharmacovigilance is still an unknown practice for most patients, basically because they do not know about it or do not feel they are capable of doing it properly [ 35 ].…”

Section: Discussionmentioning

confidence: 99%

Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France

Adopo¹,

Daynes

Benkebil

et al. 2022

Eur J Clin Pharmacol

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Introduction Because patients and patient organizations want to strengthen their role in the care pathway and drug evaluation and in order to improve pharmacovigilance activities, European competent authorities implemented regulations to allow direct reporting of adverse drug reactions related to medicinal products by patients in 2012. Objectives To describe evolution and analyze determinants of patient reporting activity in France in order to assess patient involvement in pharmacovigilance. Method Using the French national pharmacovigilance database, univariate and multivariate analyses were performed to compare the characteristics of adverse drug reaction (ADR) reports from patients and healthcare professionals (HCP) between 2011 and 2020. The relationship between regional patient ADR report activity and regional care provision and socio-professional characteristics was analyzed using the principal component analysis. Results A significant and higher increase in ADR reports over time from patients (r = 0.89, p < 0.001) compared to HCP (r = 0.27, p = 0.002) has been observed. Patient ADR report activities compared to HCP concerned more women (80% vs. 55%, p < 0.001), younger age classes (p < 0.001), reporting through web portal (83% vs. 17%, p < 0.001), and less serious events (26% vs. 63%, p < 0.001). In the principal component analysis, regional patient reporting activity was related to socio-professional categories, age classes, and densities of hospital beds and physicians. Conclusion Our results confirm an increasing involvement of patients in ADR report activities. The determinants of patient reporting activities are not only related to drug and medical factors but also to social factors. Digital tools may also play a role in health democracy in pharmacovigilance.

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Section: Discussionmentioning

confidence: 99%

Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France

Adopo¹,

Daynes

Benkebil

et al. 2022

Eur J Clin Pharmacol

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“…Upon a further review of past PV literature, and subsequent input from experts through brainstorming and nominal techniques, it was determined that patients in emerging economies play a much larger, and more critical role, in impacting the overall performance of their national PV system (AlHusaini and Al-Mubarak, 2018; Brown and Bahri, 2019;In acio et al, 2018;Jha et al, 2014;Saleh et al, 2018;Wilson and Amma, 2015). Consecutively, the "Patient PV KAP" barrier was divided into three distinct PV barriers: "Patient PV Knowledge", "Patient PV Attitudes", and "Patient PV Practices", which resulted in 15 key emerging economy-specific PV barriers altogether, which are summarized in Table 1.…”

Section: Jamr 195mentioning

confidence: 99%

“…Patient PV knowledge, along with pharmaceutical industry attributes, which in turn affected patient's attitude towards PV (barrier 12), ranged from socio-cultural beliefs (Eliasson, 2006) to cynicism towards PV reporting (Waring, 2005). These factors led to poor PV-related outcomes (barriers 14 and 15) (Saleh et al, 2018). Consequently, there was a resultant impact on Patient PV practices (barrier 13) (Desai et al, 2011;Wilson and Amma, 2015).…”

Section: Jamr 195mentioning

confidence: 99%

Pharmacovigilance in emerging economies: modeling interaction among barriers

Loomba

2022

JAMR

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PurposeThe main purpose of this paper is to identify and rank various barriers to pharmacovigilance (PV) in context of emerging economies and examine their interrelationships using the interpretive structural modeling (ISM) approach. The result is a model that offers insights about how to achieve rational and safe use of medicines and ensure patient safety as realized through robust national PV systems.Design/methodology/approachThe paper develops a model to analyze the interactions among PV barriers using the ISM approach. Based on input from clinical and medical product development experts, PV barriers in emerging economies were identified and reviewed. The hierarchical interrelationships among these PV barriers were analyzed in context of their driving/dependence powers.FindingsFindings of the study identify key PV barriers—lack of resources/infrastructure, weak legislation, unfair burden of disease, lack of PV capacity, training, and enforcement authority—that drive, or strongly influence, other barriers and thwart implementation of robust national PV systems in emerging economies. Pharmaceutical industry factors were PV barriers that were identified as autonomous, implying their relative disconnection from other barriers, and patient PV practices barrier was strongly dependent on other barriers.Research limitations/implicationsThe paper offers policy- and decision-makers alike with a framework to support further research into interdependencies among key PV barriers in emerging economies. It can serve as an impetus for further research with potential to broadening the understanding of how and why PV systems may be rendered ineffective. Future studies can be planned to apply the ISM approach to study PV barriers in the context of developed economies and draw lessons and implications for policy- and decision-makers by contrasting results from these studies.Practical implicationsThis paper contributes to the understanding of the multifaceted nature of PV and its barriers. The proposed approach gives public health decision-makers a better comprehension of driver PV barriers that have most influence on others versus dependent PV barriers, which are most influenced by others. Also, knowledge, attitude and practices of patients and caregivers can also be critical PV barriers in emerging economies. This information can be instrumental for public health policymakers, government entities, and health/PV practitioners to identify the PV barriers that they should prioritize for improvement and how to manage trade-offs between these barriers.Social implicationsPV barriers in emerging economies, as compared to developed economies, are inherently different and need to be examined in their specific context. The hierarchical ISM model suggests that resources and regulation initiatives by governments in emerging economies lead to through informed/enabled pharmaceutical supply chain players and eventually drive PV-specific knowledge, attitude, and practice outcomes improvements across their populace.Originality/valueThis paper highlights the deployment of ISM approach as a health policy decision support tool in the identifying and ranking barriers to effective PV systems in emerging economies, in terms of their contextual relationships, to achieve a better understanding as to how these interrelationships can affect national PV system outcomes.

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“…These results are comparable to other study (31) and suggest different awareness about ADR reporting. A review of patient-centered pharmacovigilance published in 2018 highlighted a need for patient education on ADR reporting (32). Direct patient reporting in pharmacovigilance is still an unknown practice for most patients, basically because they do not know about it or do not feel they are capable of doing it properly (33).…”

Section: Drugs' Descriptionmentioning

confidence: 99%

Patient engagement in Pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France

Adopo

Daynes

Benkebil

et al. 2022

Preprint

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Introduction: Because patients and patient organizations want to strengthen their role in the care pathway and drug evaluation and in order to improve pharmacovigilance activities, European competent authorities implemented regulations to allow direct reporting of adverse drug reactions related to medicinal products by patients in 2012. Objectives: Describe and study determinants and evolution of patient reporting activity in France to assess patient involvement in pharmacovigilance.Method: Using the French national pharmacovigilance database, univariate and multivariate analyses were performed to compare characteristics of patients and healthcare professionals (HCP) adverse drug reaction (ADR) report from 2011 to 2020. Then, we analyzed ADR report activities from patients according to regional demographics and economics characteristics.Results: We observed a significant and higher increase in ADR report over time from patient (r=0.89, p<0.001) compared to HCP reporting (r=0.27, p=0.002). Patient ADR report activities compared to HCP concerned more women (80% vs 55%, p<0.001), younger age classes (p<0.001) or reporting through web portal (83% vs 17%, p<0.001) and less serious events (26% vs 63%, p<0.001). In the principal component analysis, regional patient reporting activity was mainly related to socio-professional categories, age classes and densities of hospital beds and physicians. Conclusion: Our results confirm an increasing involvement of patients in ADR report activities. The determinants of patient reporting activities are not only related to drug and medical factors but also to social factors. Digital tools may also play a role in health democracy in pharmacovigilance.

show abstract

Patient-centered pharmacovigilance: A review

Cited by 9 publications

References 21 publications

Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France

Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France

Pharmacovigilance in emerging economies: modeling interaction among barriers

Patient engagement in Pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France

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