Pharma gyan Pandit

Pharmacovigilance & health care

Public health is defined as the organized efforts of society to protect, promote and restore people’s health. It is the combination of science, skills and beliefs that is directed to the maintenance and improvement of the health of all the people through collective or social actions. The programmes, services and institutions involved focus on the prevention of disease and the health needs of the population as a whole. Public health activities change in response to variations in technology and social values, but the goals remain the same: to promote health and to reduce the amount of disease, premature death and disease related discomfort and disability in the population.

Pharmacovigilance is the science and activity relating to the detection, assessment, understanding and prevention of adverse effects or any other possible medicine related problems.

The aims of pharmacovigilance are to:

1.   To improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions.

2.      To improve public health and safety in relation to the use of medicines.

3.  To detect problems related to the use of medicines and communicate the findings in a timely manner.

4.  To contribute to the assessment of benefit, harm, effectiveness and risk of medicines, leading to the prevention of harm and maximization of benefit.

5.     To encourage the safe, rational and more effective (including cost-effective) use of medicines.

6.    To promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.

Good pharmacovigilance practice

To attain a coherent pharmacovigilance system it is vital that guidelines and standards are developed, which describe the practical details of the intended information flow.

Effective pharmacovigilance relies on contributions by many people with varying educational backgrounds. The concept of pharmacovigilance is normally not well understood, either by health professionals, patients or the general population. To attain a coherent pharmacovigilance system it is most important that guidelines and standards are developed, which describe the practical details of the intended information flow. Such standard operating procedures should include information on the following:

1.      What constitutes a reportable adverse reaction?

2.      Who is expected to report an observation of a suspected medicine-related problem?

3.      The availability and practicalities of filling in a reporting form.

4.      Procedures for submission or collection of reports.

5.      Routines for assessment, follow-up and processing of case reports at the pharmacovigilance centre.

6.      Procedures for analysis of aggregated information and options for action.

7.      Good communication practices.

8.      A description of indicators by which the progress of the monitoring system may be measured.