Can New Media Improve the Output of Pharmacovigilance Data?
Shaloo Pandhi, Group Head of Pharmacovigilance Operation at Novartis Healthcare, shares his insights on pharmacovigilance in India.
Pharma IQ: There is an immense need to address all aspects of pharmacovigilance, what do you think are the main challenges that industry currently faces?
S Pandhi: We were into a preventative more and we are getting into more of a prophylactic safety management mode. I think that will be one of the biggest challenges; from being reactive to being proactive towards the safety of a drug.
Pharma IQ: And which stakeholders do you think are trying to set standards for proactive pharmacovigilance in India?
S Pandhi: From the Indian perspective, I don't think we are yet there. The challenges of industry that I was speaking to were more the overall challenges that, as a pharmaceutical industry, we are facing. India is still evolving in terms of pharmacovigilance systems. We currently have our government organisation, which is the DCGI and I think they are still involved in terms of their pharmacovigilance systems and practises. The current stakeholders, from the industry point of view, are more working in independent silos in terms of the pharmaceutical companies are taking it in a more individualistic way and developing the prophylactic approach from their perspective rather than from a wholesome common platform perspective.
Pharma IQ: How can we ensure the collection of high quality relevant data and the safety of medicines?
S Pandhi: I think it does involve a lot of uptrend work. If we stream right from the start, there are two aspects of it. Number one is when we are into development, the clinical trials, theses. If we train our site staff very nicely in terms of what data would be needed and if we really plan upfront, more from, as I said, a risk management perspective, and what are the key elements of the risks related to a particular drug and be upfront; ask the relevant questions, we would improve the safety data that is coming from our clinical trials, which may answer some of the questions later on. Number two is the post marketing collection. I think the chances of improving the data quality from where it is coming is a little better because it may vary from consumers to the investigators or the physicians who are using it. But I certainly think if we improve our data gathering tactics, in terms of providing more opportunities for people in terms of the new media. Use the new media, whether it's a mobile application or whether it is the internet applications. If we detail more information when people are really reporting the side effects or adverse events and that is the time we can improve, to a certain extent, the output of the data that we get.
Pharma IQ: Which strategies are pharmaceutical companies employing to optimise their drug safety teams?
S Pandhi: The pharmaceutical companies, in terms of the major strategies that pharmaceutical companies are using, I think, as I said, the definitions of what exactly is needed for, and I'm talking more of the products that are still in development and for which the safety data is limited, more of the products that are in development stages. For all those products, I think, as I mentioned earlier, we're going more into really a proactive approach. We are in the, kind of, establish early on in the drug development cycle in the form of safety profiling for a drug. Then still early on in this development field, we develop the safety profile plan. And thereon we, kind of, built up on the data and the data element, I mean, the risk that a drug may have are very well defined early on. And then it is as the drug passes through various stages of development, that data is built up in a systematic way. The new strategy does include a lot of proactive communications or trainings to the investigators in terms of what could be different ways of getting more information on the safety profile of the drug. What could be the relevant questions? So a questionnaire for the relevant risks of a drug is one of the ways in which we get relevant data for the risk that a product might show.