Methods for Pharmacovigilance Activity Reporting [aDSM​]

There are three methods for reporting pharmacovigilance activities (see figure below).

Figure: Three Methods for Reporting Pharmacovigilance Activities

1. Spontaneous Reporting
   • Spontaneous (or voluntary) reporting means that no active measures are taken to look for adverse effects other than the encouragement of health professionals and others to report safety concerns.
   • Reporting is entirely dependent on the initiative and motivation of the potential reporters.
   • This is the most common form of pharmacovigilance, sometimes termed passive reporting.
   • In some countries this form of reporting is mandatory.
   • Clinicians, pharmacists and community members should be trained on how, when, what and where to report.
2. Targeted Reporting
   • It focuses on capturing Adverse Drug Reactions (ADRs) in a well-defined group of patients on treatment. 
   • Health professionals in charge of the patients are sensitized to report specific safety concerns.
3.  Active Surveillance
   • It is a proactive effort made to elicit adverse events.
   • This is achieved by active follow-up after treatment and the events may be detected by asking patients directly or screening patient records. 
   • It is best done prospectively.
   • The most comprehensive method of active surveillance is Cohort Event Monitoring (CEM), which is an adaptable and powerful method of getting good comprehensive data.
   • Other methods of active monitoring include the use of registers, record linkage and screening of laboratory results in medical laboratories.
   • This is an important method of reporting under active Drug Safety Monitoring (aDSM) for Drug-resistant TB (DR-TB) patients.

Resources

• Training Modules (1-4) for Programme Managers & Medical Officers (NTEP), 2020.
• A Practical Handbook on the Pharmacovigilance of Medicines Used in the Treatment of Tuberculosis, 2012.
• Ready Reckoner for Medical Officer - Adverse Drug Reactions Associated with Anti-TB Drugs Identification and Management, 2019.

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