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Shardul Nautiyal, Mumbai November 18 , 2020
In order to enroll new adverse drug reactions (ADRs) monitoring centres (AMCs) in the country, the Ghaziabad-based Indian Pharmacopoeia Commission (IPC) has issued letter of intent (LoI) for prospective AMCs for voluntary reporting of ADRs due to COVID-19 drugs by healthcare professionals.

This is very much required as many drugs have been repurposed around treatment, prevention and management of COVID-19 pandemic. Therefore, more AMCs are enrolled for effective and comprehensive reporting of ADRs.

“As of today, there are 311 AMCs under Pharmacovigilance Programme of India (PvPI) and around 50 underthe Materiovigilance Programme of India (MvPI). There is a need to integrate both the flagship programmes of the Centre to optimally utilize the current capacity of AMCs in the interest of patient safety,” according to a senior official associated with the development.
 
As per the AMCs guidelines, a Pharmacovigilance Associate is supposed to report ADRs under the supervision of the coordinator of the respective AMCs, the official further informed.IPC last month had also rolled out a suspected ADR reporting form for voluntary reporting of ADRs by healthcare professionals to report ADRs for drugs used in prophylaxis for treatment of COVID-19.

The Ghaziabad-based IPC, which is the national coordination centre (NCC) for PvPI, has also rolled out medicine side effect reporting form to report ADR for consumers and patients. As a part of the roll out, a Toll Free PvPI Helpline -1800-180-3024 has been launched for public from Monday to Friday between 9:00 am to 5:30 pm.

Confidentiality is maintained to protect the patient's identity. Submission of an ADR report does not have any legal implication on the reporter. It has been recommended that all non-serious, known or unknown, frequent or rare ADRs need to be reported. A reaction is serious when the outcome is death, life-threatening, hospitalization (initial or prolonged). All clinicians, dentists, pharmacists and nurses etc. can report ADRs.

Duly filled in Suspected ADR Reporting Form can be sent to the nearest ADR Monitoring Centre (AMC) or directly to NCC for PvPI through helpline or mailed at pvpi.ipc@gov.in or pvpi.ipcindia@gmail.com.

The causality assessment is then carried out at AMCs by using WHO-UMC scale. The analyzed forms are forwarded to the NCC-PvPI through ADR database.  

Finally, the data is analyzed and forwarded to the global pharmacovigilance database managed by WHO Uppsala Monitoring Centre (UMC) in Sweden.

The reports are periodically reviewed by the NCC-PvPI. The information generated on the basis of these reports helps in continuous assessment of the benefit-risk ratio of medicines. The signal review panel of PvPI reviews the data and suggests any interventions that may be required.

Mandatory fields to be filled for ADR Reporting Form includes patient name with initials, age at onset of reaction, reaction term(s), date of onset of reaction, suspected medication(s) and reporter information.

NCC- PvPI has also developed an advanced version of the android mobile app which empowers all the healthcare professionals and consumers for ADR reporting. “Through this application, related images of ADR and lab investigation reports can be attached in a user-friendly manner for clinical assessment and signal detection,” said an official associated with the development.

The mobile application by the name “ADR PvPI” Android mobile app for ADR reporting has been developed to have administrative control of data with IPC, NCC-PvPI. This will empower all the healthcare professionals and consumers for ADR reporting with features like support source document and image attachment, healthcare professionals as well as consumer reporting, XML generation and auto filling of report details to save time.

CDSCO under the Union health ministry had initiated a nation-wide PvPI in July 2010. To strengthen ADR monitoring, IPC had also come out with guidelines focused on targeted drugs and events as a part of intensive ADR monitoring exercise under PvPI so that action could be taken on specific drugs involving adverse reactions.

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