How to Report Adverse Events?

Last Updated on February 21, 2022

Adverse Events (AEs) are untoward medical occurrences in a patient to whom a therapeutic good is administered, and which does not necessarily have a causal relationship with the treatment. Examples of AEs are any unfavorable and unintended signs, symptoms, disease or abnormal laboratory findings associated with the use of a therapeutic good. However, an adverse event is not always essentially caused by the therapeutic good, it could be due to incorrect use, interactions or any other circumstances.

All stakeholders including consumers, patients, healthcare professionals and industry play their important role by reporting the AEs to the pharmacovigilance centers for continuance monitoring of the safety of therapeutic goods in Pakistan.

Methods of Adverse Events Reporting

National Pharmacovigilance Centre (NPC) has provided following methods for reporting of Adverse Events:-

1. Electronic Reporting System

Med Vigilance E Reporting System

Adverse Events can be reported to NPC, DRAP through our online Med Vigilance E Reporting System that is available on our official website. A telephone number of the reporter in the relevant field of the E-reporting system should be provided in case staff from NPC, DRAP intends to get further information from you in the form of follow-up. Healthcare professionals, patients/consumers or their caregivers can report through this platform.

Med Safety Mobile Application

The Med Safety App is available for download from App store (For iOS devices) and Google Play (For Android devices). This App has been developed for reporting of side effects or AEs, and adverse events following immunization (AEFI) by WEB-RADR in collaboration with the Medicine and Health Product Regulatory Agency (MHRA), United Kingdom and Uppsala Monitoring Centre (UMC), Sweden. Healthcare professionals, Patients/consumers of therapeutic goods can directly report adverse events or AEFIs to DRAP through this mobile application.

2. Manual Reporting

Yellow Reporting Form

Healthcare professionals can also report Adverse Events manually through filling of the Yellow Reporting Form, available for downloading on the DRAP website. The filled Yellow Form can be emailed to NPC at npc@dra.gov.pk or posted at our mailing address.

3.Reporting by Industry

E2B Reporting

Pharmaceutical companies can submit reports of adverse events in the E2B format to the National Pharmacovigilance Center of DRAP. Reporting through the CIOMS form is also acceptable.

Who Can Report?

Anyone can report an adverse event to the National Pharmacovigilance Center (NPC) of DRAP.

Consumers, Patients or Caregivers

Consumer, patients or their caregivers can report adverse events to the Pharmacovigilance centers. If you have experienced any side effect or adverse effect with the use of therapeutic goods and wish to report it, you are advised to discuss it with your doctor or pharmacist because they can perform first hand assessment and can report it on your behalf. Though, consumers or patients can also directly report using Medsafety mobile application or Med Vigilance E Reporting System . Detailed information on reporting is provided in the Guidance document for reporting of Adverse Events by consumer / patients, available on DRAP website.

Healthcare Professionals

Healthcare professionals including doctors, pharmacists, nurses, etc, are the key pillars for monitoring the safety of therapeutic goods. Adverse Events reporting generated by the healthcare professionals plays a vital role in the detection of potential risks related to safety of therapeutic goods and also help in continuous monitoring of benefit / risk ratio of all the available products. Healthcare professionals can directly report adverse events to National Pharmacovigilance Center using Medsafety mobile application or Med Vigilance E Reporting System or manually by filling out Yellow Reporting Form. A guidance documents on reporting of Adverse Events by Healthcare Professionals is also available on the DRAP website.

Companies

The therapeutic goods industry (product registration holders) have two options for submitting adverse events reports for their product to National Pharmacovigilance Center, DRAP:-

  • Electronic reporting using E2B xml format and send on the official email of PNPC: npc@dra.gov.pk.
  • Hard format on CIOMS Form-I on the postal address of National Pharmacovigilance Centre (NPC)

E2B submission is the routine procedure for all industry reporting; however, submission through CIOMS is allowed for those products registration holders who currently not generating E2B xml reports.