Overview

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Objectives of Pharmacovigilance program in ASU & H Drugs

Though for centuries ASU & H drugs are considered as safe and innocuous drugs, this perception is likely to change in light of some recent incidences of ADRs during their use. This along with increased use of ASU & H drugs both at national and international levels is likely to lead to increased interaction of these drugs with diverse genomic profiles. This is likely to increase incidences of expression of unexpected effects, which may be useful or adverse in nature. Thus, it should be considered as the right time to evolve a mechanism to record ADR of ASU & H drugs. Since, there are considerable social and economic consequences of adverse drug reactions and the positive benefit / cost ratio of implementing appropriate risk management – there is a need to engage healthcare professionals and the public at large, in a well-structured programme to build synergies for monitoring adverse drug reactions of ASU & H medicines.

The Purpose of the Pharmacovigilance initiative for ASU & H drugs is to collect, collate and analyze data to establish evidence for clinical safety of ASU & H drugs and undertake surveillance of misleading advertisements of these drugs.

Raise your concern for any ADRs

The scheme aims at

  • Inculcating the reporting culture among the consumers as well as ASU & H practitioners to         facilitate documentation of Adverse Drug Reactions (ADRs)
  • Developing a system-wise database of Adverse Drug Reactions of ASU & H drugs and evolving evidence based recommendations regarding clinical safety
  • Reporting instances of misleading advertisements of ASU & H drugs and improper advertisements of ASU & H drugs for regulatory actions.

ASU & H systems of medicines have their own principles and have their own pharmacopoeia, but at times even are practised in the country as OTC drugs without any authentic prescription.

Considering the growing use of ASU & H products and medicines globally; inclusion of traditional medicines in Pharmacovigilance systems became equally important. Pharmacovigilance is defined as the detection, assessment and prevention of adverse drug reactions in humans.

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What to Report

This program for ASU & H drugs shall encourage reporting of all suspected drug related adverse events, including those suspected to have been caused by interaction with any other drugs or food incompatibilities using Suspected Adverse Drug Reaction Reporting Form for ASU & H Drugs. The reporting of seemingly insignificant or common adverse reactions would be important since they may highlight a widespread prescribing problem.

Who can Report

Any health care professional can report suspected adverse drug events to the concerned PPvCs / IPvCs using Suspected Adverse Reactions Reporting Form for ASU & H Drugs.

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Where to Report

The reporting on prescribed format can be submitted to the nearby / concerned PPvCs / IPvCs.

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What happens to the submitted Reports

The information in the form shall be handled in confidentiality. Peripheral Pharmacovigilance Centres shall forward the form to the respective Intermediary Pharmacovigilance Centres who will carry out the causality analysis. This information shall be forwarded to the National Pharmacovigilance Centre. The data will be analysed and forwarded to the Ministry of AYUSH, Govt. of India.

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