Challenges in implementing Pharmacovigilance Programme for ASU & H drugs

  • K Haseena Program Assistant
  • N Manojkumar Professor & HOD Dravyaguna, Program Co-ordinator, Peripheral Pharmacovigilance Centre, VPSV Ayurveda College Kottakkal, Kerala
Keywords: Adverse drug reaction, ASU & H Drugs, challenges, considerations, implementation, Pharmacovigilance programme.


Background: Pharmacovigilance deals with the Adverse Drug Reaction or any Drug related issues. Identification and reporting of Adverse Drug Reaction/ Adverse events and analysis of its consequences have a positive impact on the public health. Implementation of Pharmacovigilance programme for ASU & H drugs is not an easy task; it has come across with many challenges and barriers. This article highlights the challenges faced during the implementation of Pharmacovigilance Program for ASU & H drugs at Peripheral center.

Methods: It is an explorative study, wherein personal interviews of health care professionals and peer reviewed journals were collected and evaluated. Already published articles and books were also referred for compilation and interpretation of results.

Results: With the span of one year, the centre identifies certain obstacles like signal detection and reporting, collection of the details of the suspected drug, drug regulation etc

Discussion: Lack of awareness of ADR reporting among the healthcare professionals is considered as the major problem in implementing the programme. Hence certain considerations are made like Improvement in knowledge of Pharmacovigilance, communication with all sectors of health care system, patient education etc which will definitely help in implementing Pharmacovigilance programme.