Health ministry asks AMCs to report ADRs on priority from drugs used in treatment of Covid-19

Mumbai, June 23, 2021

The Union health ministry has asked adverse drug reaction (ADR) monitoring centres (AMCs) to report ADRs on priority from drugs used as prophylactic and in the treatment of Covid-19 through the new Suspected ADR Reporting Form.

The Indian Pharmacopoeia Commission (IPC) which is the National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (NCC-PvPI) has devised a new Suspected ADR Reporting Form for the drugs used as Prophylactic and in the treatment of Covid-19 and communicated it to all AMCs under PvPI.

PvPI recently extended its outreach in the country by enrolling around 35 new AMCs thereby enhancing the total number of AMCs from 311 to 346 so far and has also generated 4.7 lakh ADRs since its inception in 2010.

IPC has also rolled out a 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 the 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.

Duty 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 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.PharmaBiz