Pharmacovigilance in NTEP

Pharmacovigilance is defined by the World Health Organisation (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

• It is a fundamental public health surveillance activity to ensure patient safety measures in healthcare.
• Good pharmacovigilance will identify the risks within the shortest possible time after medicines have been marketed and help establish or identify risk factors.

Importance of Pharmacovigilance

Pharmacovigilance allows for intelligent, evidence-based prescribing with the potential for preventing many Adverse Drug Reactions (ADRs). Pharmacovigilance will help in:

• Improving patient care by assessing both the harms and benefits received from drugs (anti-tubercular treatment).
• Strengthening patient safety, safeguarding the patient’s interests and ensuring adherence to prescribed drug regimens.
• Preventing antimicrobial resistance.

Pharmacovigilance ultimately helps each patient in receiving optimum therapy at a lower cost to the health system.

Conducting Pharmacovigilance under the National TB Elimination Programme (NTEP)

The Pharmacovigilance Programme of India (PvPI) was set up by the Ministry of Health and Family Welfare, Govt. of India, in July 2010. PvPI is India’s national programme for surveillance of ADR-related information.

NTEP in collaboration with PvPI, and with support from WHO India, developed the comprehensive active Drug Safety Monitoring and Management (aDSM) system for ADR monitoring. Pharmacovigilance is prioritised in Drug-resistant TB (DR-TB) centres for drug-resistant cases.

Adverse events reporting for pharmacovigilance is done as follows:

1. DR-TB centres are linked with ADR Monitoring Centres (AMC) established in medical colleges to initiate reporting of ADR in a systematic manner.
2. Serious adverse events are reported to AMCs and Central TB Division (CTD) within 24 hours. This is done via a standardized suspected ADR reporting form (Annexure-11) which is filled by the treating doctor.
3. The data is entered in Nikshay on a regular basis by statistical assistants at the nodal DR-TB centre and senior DR-TB TB-HIV supervisors at the district DR-TB centre.
4. From Nikshay, the information is directly communicated to PvPI through a connecting bridge called Vigiflow.
5. The ADR data submitted to Vigifloware is analysed by PvPI and shared with CTD on a regular basis.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
• Ready Reckoner for Medical Officer - Adverse Drug Reactions Associated with Anti-TB Drugs Identification and Management, 2019.
• Practical Handbook on the Pharmacovigilance of Medicines used in the Treatment of Tuberculosis, WHO, 2012.

Assessment