I am a fresh graduate in MD Clinical Pharmacology from Nepal, working in one of the medical colleges here.
Our department is interested in starting PVP in this college but we are uncertain about how to start. Some of our ideas are:
1. Do a baseline study to see how many reports can we generate in one year period.
2. Develop a SOP for ADR report collection
3. How to report the information to UMC. Here we have 2 options: obtain a Vigiflow account, OR be a part of the National PV reporting system.
So it would be really appreciable if you could share the experiences of your department for the same.
The biggest challenge with pvp centres in to get adrs from clinicians... there are two reasons for reluctance of clinicians to re adr:
1. Misconception that adr reporting can harm them .. they could be held responsible for occurrence of adr
2. They are busy and they dont think adr reporting is important
both these issues can be addressed by having frequent adr reporting sensitisation sessions.
other important thing that can help is to have good social repo witt clinicians
Dear Lumbini,
The first thing you can do is, contact the UMC on how to establish a Pv Centre. Get continued advise from them on the minimum requirements to establish a functional Pv Centre.
You need to develop an ADR reporting form that consists of the mandatory variables that need to collected. You can develop the form by adopting others and consult that UMC for further comments. Ask consultancy to train yourself and your staff on the basics of Pv and handling VigiFlow and data management like causality and preventability assessments.
Later on develop a training manual on basics of Pv and build national trainers. Moreover, advocate to Pv stakeholders on its importance with the WHO, public health program managers, Health facilities and higher officials.
Get money, train health professionals to report ADRs, assess them and submit them to the WHO global database.
I agree with the points mentioned by Dr Rimple and Mulugeta.
Once basics is developed as mentioned by Rimple, further can be taken care.
Yes, spontaneous reporting of adverse events is indeed a challenge. While starting a Pharmacovigilance Centre, the following points may be useful.
1. Initially use the WHO's CIOMS Form - Suspect Adverse Reaction Report, which is quite simple to fill in.
2. Develop Guidelines for filling the form and also SOPs
3. Impart PV training to the personnel involved.
4. As a "Pilot' Project", initiate the PV programme within the hospital, covering both outpatients and inpatients.
5. You can also include adverse events from clinical studies conducted by the instituition in this peliminary exercise.
6. To start with, the AEs can be reported to the National Pharmacovigilance Organisation.
7. After gaining experience with the initial efforts, the programme can be expanded to include spontaneous reporting by the practising doctors.
8. In parallel, awareness programmes can be conducted with the help of local medical bodies and pharmaceutical companies
First of all, constitute one pharmacovigilance committee at your setup and prepare SOP for its functioning.
Then arrange a meeting of above committee and fix agendas for its regular functioning.
Then sensitize health care providers regarding the importance ADR monitoring at your setup. You can arrange small group sensitization program at your setup.
Put display box ADR forms for health care providers and Patients.
Regularly visit dermatology and medicine OPDs and sensitize and request consultants for filling and reporting ADR.
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