Exploring the factors and barriers of healthcare professionals in tertiary care hospitals toward pharmacovigilance: a multicenter study from Khyber Pakhtunkhwa, Pakistan

Sharif, Muhammad Junaid Hassan; Farrukh, Muhammad Junaid; Khan, Faiz Ullah; Khan, Qudrat; Ahmed, S.; Kousar, Rehana; Ahmad, Tawseef; Abid, Syed Mobasher Ali; Ashfaq, Muhammad; Khan, Shujaat Ali

doi:10.1080/03007995.2022.2042992

Cited by 2 publications

(2 citation statements)

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“…Fear of punitive action among all stakeholders surpasses all barriers to reporting ADRs. Several studies stated the same factors that contribute to hurdles related to ADRs reporting ( Al Dweik et al, 2017 ; Ali et al, 2021 ; Sharif et al, 2022 ). The quality of the language and completeness of reports can impede the understanding of the ADR ( Hazell and Shakir, 2006 ).…”

Section: Discussionmentioning

confidence: 99%

A Qualitative Study of Stakeholders’ Views on Pharmacovigilance System, Policy, and Coordination in Pakistan

et al. 2022

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Objectives:Due to the absence of necessary rules, poor coordination, and various challenges, the pharmacovigilance system of Pakistan is not optimally functional at all levels of the health system. The objective of the study was to assess the stakeholders’ perceptions of the current ADR reporting system and to identify the pharmacovigilance policy issues and problems of effective coordination.Methodology:Stakeholders from a broad range of disciplines, academia, regulatory authorities, the pharmaceutical industry, international health organizations, as well as pharmacovigilance experts, and healthcare professionals were included in the study. A total of 25 stakeholders throughout Pakistan were interviewed during exploratory semi-structured interviews. The interviews were recorded digitally, transcribed, coded, compared, and grouped according to their similarity of themes. Participants provided insights into gaps, limitations, and challenges of Pakistan’s current ADR reporting system, issues with proposed pharmacovigilance rules, and coordination difficulties.Results:The majority of the participants considered the ADR reporting system in Pakistan to be improving but in a nascent phase. The identified gaps, challenges, limitations of the system, and barriers to reporting were labeled as reasons for limited functioning. Almost all stakeholders were aware of the existence of draft pharmacovigilance rules; however, participants in the industry were familiar with the contents and context of draft pharmacovigilance rules. Bureaucratic red tape and lack of political will appeared to be the top reasons for delaying the approval of the pharmacovigilance rules. Wider consultation, advocacy, and awareness sessions of policymakers and HCPs were suggested for early approval of rules. Participants unanimously agreed that the approval of rules shall improve the quality of life and reduce the economic burden along with morbidity and mortality rates. The need for greater and collaborative coordination among the stakeholders in promoting medicines’ safety was highlighted. All participants suggested the use of media and celebrities to disseminate the safety information.Conclusion:Participants showed partial satisfaction with the way pharmacovigilance in Pakistan is moving forward. However, stakeholders believed that engagement of multi-stakeholders, approval of pharmacovigilance rules, and the establishment of pharmacovigilance centers in provinces, hospitals, and public health programs (PHPs) shall support in achieving the desired results.

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Section: Discussionmentioning

confidence: 99%

A Qualitative Study of Stakeholders’ Views on Pharmacovigilance System, Policy, and Coordination in Pakistan

et al. 2022

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“…Other barriers were also identified, such as unawareness of the ADR reporting process and non user-friendly ADR reporting form [ 22 ]. Knowledge about pharmacovigilance and the ADR reporting process among HCP still seems to be a very significant barrier, although less among pharmacists compared to physicians and nurses (73.5%, 18.7% and 13.8%, respectively) [ 23 ]. Other studies also report that community pharmacists, like general practitioners, have basic knowledge about ADR, although they are unfamiliar with the ADR report guidelines [ 24 , 25 ].…”

Section: Introductionmentioning

confidence: 99%

Motivation and Knowledge of Portuguese Community Pharmacists Towards the Reporting of Suspected Adverse Reactions to Medicines: A Cross-Sectional Survey

et al. 2022

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The close contact between patients and community pharmacists, along with the extensive geographical distribution of pharmacies in Portugal, offer exceptional conditions to detect and report adverse drug reactions (ADR). This study aimed to evaluate the motivation and knowledge of spontaneous reporting of ADR by community pharmacists of Porto, Portugal. Secondly, we aimed to generate real-world evidence on the main factors determining ADR report and at raising potential alternatives to the current reporting procedure in community pharmacy. We performed a descriptive, cross-sectional, observational, anonymous web survey-based study. Between April and July 2021, a web survey was implemented, targeting community pharmacists in the Porto district, Portugal. We validated 217 surveys from pharmacists. Regular notifiers seem to be more familiarised than non-regular notifiers with the Portuguese Pharmacovigilance System (PPS), with the Portal RAM for reporting suspected ADR, and with the update of the concept of ADR. Moreover, regular notifiers seem to be more proactive with their care in questioning patients about ADR and have more self-knowledge to identify suspected ADR. Conversely, non-regular notifiers, seem to be more reluctant to be judged by their ADR reporting activities. Respondents suggested to simplify and optimise the reporting process (31% of the suggestions), or to integrate a reporting platform into the pharmacy’s software (27%). This study identified opportunities to promote the ADR reporting process by community pharmacists, namely receiving feedback from the PPS on the reported case and its regulatory implications, implementing training programs in pharmacovigilance, and creating solutions to simplify the reporting process.

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Exploring the factors and barriers of healthcare professionals in tertiary care hospitals toward pharmacovigilance: a multicenter study from Khyber Pakhtunkhwa, Pakistan

Cited by 2 publications

References 37 publications

A Qualitative Study of Stakeholders’ Views on Pharmacovigilance System, Policy, and Coordination in Pakistan

A Qualitative Study of Stakeholders’ Views on Pharmacovigilance System, Policy, and Coordination in Pakistan

Motivation and Knowledge of Portuguese Community Pharmacists Towards the Reporting of Suspected Adverse Reactions to Medicines: A Cross-Sectional Survey

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