Adverse event reporting tools and regulatory measures in India through outcome of Pharmacovigilance Programme of India

Prakash, Jai; Sachdeva, Raghav; Shrivastava, Tarani Prakash; Jayachandran, C V; Sahu, Aseem

doi:10.4103/ijp.ijp_901_20

Cited by 12 publications

(2 citation statements)

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“…But the most convenient helpline (Toll-Free) system is set up in a way such that it could be easily remembered and recollected as 30 days and 24 hours ("3024"). The Helpline (Toll-Free) number helps in easy and quick reporting of ADRs and significantly improves the success of Pharmacovigilance systems 10,13 . PvPI encourages all types of suspected ADRs/AEs of known, unknown, serious, non-serious, frequent or rare, antibiotic resistance, medication errors, lack of efficacy, product quality defects, over-dose and off-label events due to medicines, vaccines and herbals products through the ADR reporting form.…”

Section: Resultsmentioning

confidence: 99%

Untitled

2023

IJPSR

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Background: Post-marketing surveillance via spontaneous Adverse drug reaction (ADR) monitoring and reporting method is in place, even though it is considered as one of the key challenge for under-reporting and establishing the quality of patient safety in the healthcare system. Objective: This study is intended to know the clinician's opinion (mindset) on the implementation of PvPI-Helpline (Helpline Number) and concise ADR form in In-patient case sheets at a tertiary care teaching hospital, Telangana India as they play a vital role for improving the reporting system of ADRs. Materials and Methods: A Cross-sectional Surveillance based study was carried out in Osmania medical college and affiliated hospitals, for 2-months duration among 160 Clinicians. The questionnaire consists of 4 questions and the participants were informed to provide their feedback. Data was collected and analyzed using SPSS version 25 software. Results: Only150 clinicians responded. 98.6% of Clinicians agreed to implement PvPI-Helpline (Toll-Free) number for quick reporting of ADRs.93.3% disagreed with creating a WhatsApp group for reporting ADRs as they taught it was not a secure platform to reveal patient details. Almost all Clinicians admitted that concise ADR form incorporation in In-patient case sheets helps easily identify ADRs along with the in-house set up of a smooth functioning Pv system. Conclusion: The results provided insight to clinicians on the importance of implementing Helpline Number and concise ADR form and the perception of Clinicians towards ADR reporting. The findings of our study highlighted the need to roll up quality care for patient safety.

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Section: Resultsmentioning

confidence: 99%

Untitled

2023

IJPSR

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“…Though PvPI has played a key role in establishing AMCs in the private sector, the quantity and quality of ICSRs reported by the public sector hospitals during the period 2011–2021 has been appreciably high ( 18 ). Aimed at fostering the culture of reporting by 3Ps, the PvPI has contributed by sending circulars, appreciation letters, feedback, etc.…”

Section: Discussionmentioning

confidence: 99%

Public-private partnership (3Ps) in ensuring safe use of medicines: An Indian experience

Kalaiselvan

Shukla

Arora

et al. 2022

Front. Public Health

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Adverse drug reactions (ADRs) are major concerns to the public health. To monitor ADRs and ensure patients' safety, the Pharmacovigilance Programme of India (PvPI) has been established by the Government of India in 2010. The programme is intact with the Public-Private Partnership (3Ps) in pharmacovigilance for quality services, better management of human resources and risk minimization. The present work is aimed at assessing the 3Ps engagement, performance and tangible outcomes in PvPI and also mapping of resources. The study was carried out for the period of 2011 to 2021 by assessing the various benchmarking tools such as 3Ps categorization, utilization of ADRs reporting tools, trainings, and the Individual Case Safety Reports' (ICSRs) quantity, quality and transmission for regulatory intervention (RI). Under PvPI, Central or State Government medical institutions/hospitals and consumers constitute public partners while private medical institutions/hospitals, pharmaceutical companies, corporate hospitals and professional bodies account for private partners. We observed that public partners extensively used ADR reporting form and toll-free helpline number while private partners used mobile based app and emails/post as preferred tools for reporting ADRs. Contribution of public sector in training programmes organized, stakeholders trained and sharing of resource materials was way higher than the private sector. The study revealed that 55.1 and 44.9% ICSRs were received from public and private partners, respectively during the study period. The quality completeness of data received from public partners was found to be 0.92/1 as compared to 0.46/1 from the private partners. The ICSRs data transmitted for RI process from the public and private partners (till 2018) was found to be 79 and 21%, respectively. In terms of sharing of resources for training and capacity building, the public sector played a major role. The 3Ps in India are enabled to establish a robust system for medicines' safety surveillance; however a more focused approach is required in mapping the resources.

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