Adverse Drug Reaction (ADRs) Reporting by NABH accredited Hospitals as Part of Pharmacovigilance Programme of India

An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the use of a drug/biologic/medical device/therapy or their combination under normal conditions of use and is suspected to be directly or indirectly related. An ADR will usually require the drug to be discontinued or the dose reduced. Adverse drug reactions (ADRs) have been reported to be among leading causes of morbidity and mortality In order to promote monitoring and reporting of Adverse Drug Reactions (ADRs) by NABH accredited Hospitals to Pharmacovigilance Programme of India (PvPI), around 600 National Accreditation Board for Hospitals and Healthcare providers (NABH) accredited hospitals have started reporting ADRs as part of their pharmacovigilance activities mandated by the government.

Indian Pharmacopoeia Commission (IPC) has recently trained healthcare professionals of NABH accredited hospitals in Telangana and Andhra Pradesh to promote monitoring and reporting of Adverse Drug Reactions (ADRs). This is followed by IPC signing a Memorandum of Understanding (MoU) with NABH. IPC is the National Coordination Centre (NCC) for PvPI.

Indian Pharmacopoeia Commission (IPC) conducted from January to October 2017 pharmacovigilance training program titled “Skill Development Programme on Basics and Regulatory Aspects of Pharmacovigilanceā€¯ to create general awareness regarding drug safety and the importance of a pharmacovigilance setup at all levels. The programme aimed to enhance the knowledge and skills of qualified Pharmacovigilance professionals working for ensuring better patient safety as per the requirement of Schedule Y of Drug and Cosmetics Act, 1940.

Young pharmacy, medical and paramedical professionals seeking career in Pharmacovigilance and existing professionals in Pharmacovigilance are being taught by renowned experts from government teaching and corporate hospitals, regulatory authority, WHO, pharmaceutical industries, academic and research institutions.

Skill development programs for pharmacovigilance will encourage process of creating a registry of skills, enable and mobilize a large number of healthcare professionals to take up training and acquire requisite skills for employment apart from capacity building and strengthening of Qualified Person for Pharmacovigilance (QPPv) as per the requirement of the schedule Y of D&C Act.

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Pharmacovigilance training is a much felt need throughout the world including fast developing countries. Training imparted online is sufficient for managing the pharmacovigilance system and is recommended for professionals at all levels, be it the hospitals, pharmaceutical companies, contract research organizations, or BPOs.

James Lind Institute offers robust and focused online pharmacovigilance training programs keeping in view the dynamic and changing regulatory landscape around the world and the interdependence of knowledge sharing which is required to understand the true adverse event profile of a drug.

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