A case report in pharmacovigilance can be defined as : A notification relating to a patient with an adverse medical event (or laboratory test abnormality) suspected to be induced by a medicine.
A case report should (as a minimum to aim at) contain information on the following elements:
1. The patient: age, sex and brief medical history
2. Adverse event: description (nature, localization, severity, characteristics), results of investigations and lets, start date, course and outcome.
3. Suspected drug(s) : name (brand or ingredient name + manufacturer^ dose, route, start/stop date, indication for use.
4. All other drugs used (including self medication): names, doses, routes, start/stop dates.
5. Risk factors (e.g. impaired renal faction, previous exposure to suspected drug, previous allergies.
6. Name and address of reporter (to be considered confidential and to be used only for date verification, completion and case follow-up)
What to Report
The reporter should bear in mind that he will often be reporting only suspicions in his own mind that a drugs has caused particular adverse event. He should not wait until he feels certain that a causal link can be considered proven or disproven. In any case of doubt it is better to report than not to report.
He should report :
(a) Apparent ADRs previously unknown to the reporters
(b) Serious ADRs
(c) All suspected ADRs to new drugs
(d) Cases of suspected dependence
Who Should Report
Government/ Private Hospitals/ Clinics : Every hospitals and clinics must decide for itself how the reporting system should be operated and by whom. The arrangements will depend on the hospital's/clinics own organisation and traditions.
Generally the physicians themselves act as reporters, completing the reporting form, keeping a record and sending them to the ADRM Cell, Directorate of Drug Administration, 105-106, Motijheel Commercial Area, Dhaka-1000, Bangladesh. The hospital pharmacist may also act as a reporter, completing the forms in consultation with the reporting physician.
Collaboration with WHO
After evaluation of ADRs report by the Adverse Drug Reactions Advisory Committee (ADRAC), the ADRM Cell of Directorate of Drugs Administration, 105-106, Motijheel Commercial Area, Dhaka-1000, Bangladesh may provide the essential ADRs data to WHO collaborating center for International Drug Monitoring & Exchange of Drug Information.
NB : A Adverse Drug Reactions Reporting Form is available in this website, please download ADR Reporting Form.