Another biggest blunder has been committed by our pharmacists in regulatory sector with their poor or ill understood knowledge on the therapeutics and the issues thereon. [The earlier blunder was starting of pharmacy courses within 4 walls away from hospital and community environment with useless and baseless subjects and topics with no relevance to the field reality]
Here are my genuine concern on the pharmacovigilance program:
Weakness in the current pharmacovigilance program:
It has been started on a wrong note considering the export volume and potential instead of feasibility study and instances and magnitude of incidences of ADRs as could be seen in the proposal document submitted by the CDSCO to the Govt of India.
CDSCO cannot be an agency to start pharmacovigilance program as:
- ADR is not an offense under D&C Act and Rules.
- ADR monitoring is not a policing system
- CDSCO does not have the required clinical background or experience to understand the concept of Pharmacovigilance and ADRs
- CDSCO has proposed Pharmacovigilance program based not on the feasibility and need analysis but on the basis of the export volumed and potential, a clear indication that CDSCO do not know the subject matter at all.
- The committees and staff structures proposed in the policy / structure document is irrelevant and inconsistent.
Well, how it should done :
- Pharmacovigilance and ADR analysis is a clinical pharmacy subject and is a part and parcel of Clinical activity under Healthcare system.
- It should be managed by professionals who are familiar with both clinical and pharma knowledge Viz: Clinical pharmacists under Pharmacare program.
- Pharmaco-vigilance should be established under hospital based 'Pharmacare' program.
- Pharmacare program includes logistical pharmacy and Clinical pharmacy.
- Pharmacare department should be established in all the hospitals with 100 beds and above.
- There should be a network of Pharmacy Therapeutic committee with National, Zonal, State level and Hospital level therapeutic committee with a pharmacist as its member secretary.
- Pharmacovigilance program should involve the doctors, nurses and pharmacists in its activities.
- There should be an open channel for the doctors, nurses and patient / his attendant to report the AD events.
- The Pharmacovigilance and ADR analysis cannot happen effectively without a good network of Pharmacy Therapeutic Committee.
- Only the Pharmacy Therapeutic Committee can discuss and analyze the data and make recommendations
- The Pharmacy Therapeutic committee will get enriched with abundant data from the Pharmacare department and pharmacovigilance activity to promote competently the National Medication Policy.
- Pharmacy Therapeutic committee should remain as guardian for safe and effective medication.
- Therapeutic committee shall not involve collectively in any way in tender, tender evaluation and procurement process except in preparation of Essential Drugs List with specification for tender.