What?
The science and activities concerned with the detection, assessment , Understanding and prevention of adverse reaction to medicines or any other medicine related problems.
- Pharmaco = Medicine
- Vigilare = to watch
- Alert watchfulness
- For bearance of sleep : wakefulness
- Watchfulness in respect of danger : care : caution : circumspection
- The process of paying close and continuous attention
What?
Post marketing reasons
- To improve patient care and safety
- To improve public health and safety
- To contribute to the assessment of benefit, harm, effectiveness and risk of medicines.
- To promote understanding, education and clinical training
- Preventing patients from being affected unnecessarily
Databases
- The system should be structured in a way that allows reports of suspected adverse reactions to be validated in a timely manner and exchanged between competent authorities and MAH within legal expedited time frame.
- There are different types of databased used like Aris G, Argus, LSMV, AgXchange, IRT etc.
Objectives And Scope
- Unexpected adverse reactions
- Interactions
- Long-term efficacy, resistance
- Risk factors
- Quality(counterfeit)
- Cost assessment
- Adverse Drug Reactions are the 4th to 6th largest cause of mortality in US
- Percentage of hospital admissions due to drug related events in some countries is about or more than 10%
Valid ICSR
A Valid ICSR for expedited reporting shall include at least an identifiable reporter, an identifiable patient, at least one suspect adverse reaction and a suspect medicinal product.
Invalid ICSR with Drug and event with single/ multiple patients can be databased as invalid reports and stored in the database without reporting.
Seriousness Adverse events are considered to be serious which leads to any one of the seriousness criteria
- Death
- Life-threatening
- Hospitalization or prolongation of hospitalization
- Congenital anomaly
- Disability
- Medically significant – IME list
Steps In Pharmacovigilance
Pharmacovigilance involves various steps
- Collection of reports from various sources
- Intake / Book-in
- Triage
- Case processing
- Quality Review
- Medical review
- Finalisation and Reporting
Type of reports
- Clinical trial reports
- As per ICH-E2D guidelines, 2 types of reports in post-marketing phase, reports originating from unsolicited sources and those reported as solicited.
- Solicited reports – same intervention but for different indication
- Spontaneous reports – Voluntary reports submitted to MAH or any OHCP , physicians, pharmacist, nurse etc
Special situations
- Pregnancy / breastfeeding
- Overdose
- Off label use
- Medication error
- Lack of efficacy
Intake or bookin
It is the initial step for an ICSR where the validation of ICSR , detecting sender, seriousness, ICH detection , Duplicate search, Translations, etc takes place. as per Appendix 7 of GVP module 6 , all potential duplicates , linked cases and the outcome of all assessments should be recorded to avoid continually reassessing the same cases when further version arrives.
Triage
Aim: To prioritize the cases. In case of TRIAGE one should
- Check theIRD
- Seriousness
- Validity
- Duplicate search
Case processing
- Different kind of reports are processed in a different way based on the PVA agreements.
- Only valid ICSR`s should be reported.
- Various other criteria like Coding of adverse events, medicinl products with MedDRA, WHODD, Causality assessments, relatedness, writing narratives , assessing Dechallenge, rechallenge, action taken with medicinal product etc will be done in case processing.
- Before promoting any ICSR to next workflow validation of report should be checked, and if any note it should be recorded in the notepad based on the project requirement.
Quality review
Quality checks : is performed for all the ICSR information which is entered in the database. Validations are re-checked and corrected to move the case to next workflow.
Medical review : Medical assessment is performed for the entire ICSR and reassessing the narrative, causality and relatedness is checked.
Finalization and reporting : Validation of ICSR`s if any are cross checked and the complete ICSR is prepared for reporting based on seriousness.
