What things should be implemented for effective pharmacovigilance?

Close link is forged between pre-marketing and post-marketing pharmacovigilance activities, given the common aspects of the

two. Data monitor recommends that companies begin risk

management planning at the inception of Phase I and consider

consolidating both their pre- and post-marketing

pharmacovigilance activities in a single department.

It has become a necessity for companies to increase the

transparency of their activities and the communication of

information about drugs, triggered by the lawsuit that Spitzer filed

against GlaxoSmithKline in 2004, alleging that it withheld negative

information about the use of Paxil (paroxetine) in children. The

case has had repercussions across the industry, with the

reputation of the industry at an all-time low. Many companies

have taken things into their own hands, agreeing to voluntarily

register clinical trials and post all clinical trial data, whether

negative or positive, for marketed drugs on publicly accessible

websites.

Expecting few experts to know all is a difficult task. Community medicine advocates have to look at demographic data being presented by different companies and also understand the studies that are being submitted by medical practitioners for drugs and its effects. The forum of community medicine (can be at district level or at state level) need to analyze data pertaining to drug prescriptions, sale and the drugs effects. This can be the most effective way of pharmacovigilance.

India boasts of a highly developed IT sector. Since pharmacovigilance and pharmacoepidemiology deal with large numbers of ADRs, it would be wise for pharmacovigilance experts to collaborate with software professionals to develop and build a robust system. Software programmes developed can be used for collection and analyses of data sets, determining trends of drug usage in various disease areas, compliance, medication errors and drug interactions leading to ADRs. In specific areas where knowledge is inadequate, ie., pregnancy, paediatric population, patients with liver and renal dysfunction and the elderly, pharmacokinetic software programmes can help in optimising drug dosages in individuals in various diseased conditions. This will be useful not only in rational drug therapy but would also be an important asset in therapeutics.

Since adverse event management involves a lot of data, an advanced workflow that is in sync with differing case processing and one that is complaint with the reporting of all major regulatory agencies is important.

Regulatory authorities should be encouraged to establish databases of clinical information suitable for epidemiological studies to examine and quantify signals of possible emerging risk. The regulatory authorities should provide, upon request, technical advice and support to member states on the appropriateness of PMS plans submitted by sponsors when a medicine is being introduced to manage a specific public health campaign in that country.