How to Set Up a Pharmacovigilance (PV) Centre

Basic Steps in setting up a PV Centre

1. Contact relevant authorities to ensure approval for the centre by outlining the importance of the centre and its purpose.
2. Design an adverse events' reporting form and start collecting data by distributing it to hospital departments, family practitioners, etc.
3. Produce printed material to inform health professionals about definitions, aims and methods of the pharmacovigilance system.
4. Create the centre: staff, accommodation, phone, word processor, database management capability, bibliography etc.
5. Educate pharmacovigilance staff on:
   1. data collection and verification
   2. interpreting and coding of adverse reaction description
   3. coding of drugs
   4. case causality assessment
   5. signal detection
   6. risk management.
6. Establish a database for storage and retrieval of data
7. Organize routine meetings in hospitals, academia and professional associations, explaining the principles of pharmacovigilance and the importance of reporting.
8. Promote the importance of reporting adverse drug reactions through medical journals, other professional publications, and communications activities.
   

Reporting Adverse Events (AE)

To learn more about reporting please visit the PVG page "Tools and Innovations".

Logistics involved in the organization of a PV Centre

Staff

The expertise desirable in the routine of a PV Centre includes: clinical medicine, pharmacology, toxicology, epidemiology.

However, a new pharmacovigilance centre often starts with only a part-time expert (a physician or a pharmacist) and some secretarial support.

It may soon become necessary to have one expert who is responsible for pharmacovigilance for most of his/her time and for secretarial assistance to be expanded. When the reporting of adverse reactions increases, staff resource requirements may be calculated by assuming that the average assessment time per case report is about one hour.

Continuity

Continuity in accessibility and service is a basic feature of a successful PV centre. The centre therefore needs a permanent secretariat, for phone calls, mail, maintenance of the database, literature documentation, coordination of activities, etc. Secretarial continuity may be achieved through collaboration with related departments.

Advisory Committees

A multi-disciplinary advisory committee is desirable, to support the PV centre with regard to the quality of the procedures in: data collection and assessment, data interpretation, information publication.

A network of experienced advisors in various specializations is helpful.

Information service

The provision of a high quality information service to healthcare professionals is a basic task of a PV centre and a major instrument in the stimulation of reporting. For this purpose and for the assessment of case reports the centre should have access to a comprehensive and up-to-date literature source and information database.

Location of the centre in a large hospital usually has the advantage of a library within reach. National PV centres can have online access to the database of the UMC and be on the mailing lists of adverse events and bulletins produced by the World Health Organization and many national or regional centres through membership to PIDM.

Communications

A bulletin or newsletter distributed to all healthcare professionals or a regular column in reputed journals are good means for the dissemination of information. Prompt data-sheet amendments are important, but data-sheets may be printed infrequently and their educational impact may not be large.

Other useful collaborations

It is always ideal to look out for other organizations that may be able to collaborate with your PV Centre to reduce the financial and logistic burden. For example, poison control and drug information centres share similar PV interests. It may be useful to develop a PV system in conjunction with these centres.