With the introduction of SafeTrack tool, Bayer Zydus Pharma takes a step further in enhancing pateint security. The tool allows patients, consumers, family, friends, caregivers and healthcare professionals to report side effects quickly. The company believes that good information is crucial for effective treatment. Manoj Saxena, Managing Director, Bayer Zydus Pharma discusses more about the web-based tool, SafeTrack, with Usha Sharma
Recently, Bayer has introduced the adverse event reporting tool for the public. Tell us the objective behind the launch?
At Bayer, we strive to learn from patients’ first-hand experience with our treatments. Any adverse event or reaction, or special circumstance, whether listed or not in the product information, should always be reported to the pharmaceutical company or to the national health authority according to the specific country’s requirement. This helps us to detect potential safety issues early and allows quick action to be taken, if needed, to protect the safety of both current and future patients. SafeTrack is part of our commitment to protecting patients. The web-based tool makes reporting side effects quick and easy for patients, consumers, family, friends or caregivers and healthcare professionals.
How do you ensure that Pharmacovigilance creates a steady stream of information?
Patient safety is our number one priority. It is the essence of our business and it is more than just an obligation. We work diligently at every stage of the product lifecycle to ensure that the benefits of our products outweigh the risks to contribute towards the best possible patient experience when taking our medicines. An important role of the Pharmacovigilance (PV) is timely updating the package leaflet, included with all medicinal products. It contains information on how to use medicinal products in the right way, how to store them, whether they can be used with existing medication, and whether there are any patients who should not use the product. Even long after products and treatments have become available, PV continues monitoring them to make sure the information is up to date. Therefore, in every country, PV continuously evaluates new studies, scientific publications, patient experiences and reports about side effects to gather new benefit-risk information.
The updated information is regularly shared with colleagues and reported to health authorities worldwide. Once the individual cases have been analysed and assessed, there is a review of the aggregated situation before new information is made available to healthcare professionals, patients, and users. This is how PV creates a steady stream of information, flowing from you to us, and from us to you. Because good information is crucial for effective treatment.
How does SafeTrack leverage different technologies?
SafeTrack is an easy, quick and convenient online platform that allows patients, their friends or family, caregivers and healthcare professionals to report adverse events.
We leverage advanced analytics such as AI for the processing of safety information. Bayer applies AI-related technologies to further improve and accelerate the processing of side effect reports. Additionally, AI-based systems have the potential to advance benefit-risk assessment through predictive capabilities. Once a risk is identified – for instance through incoming safety reports – predictive algorithms could estimate the burden on a population or sub-population. In this example, the AI-based system learns from historical data and integrates additional information to predict the effectiveness of risk-minimisation measures. In future, we expect to analyse patient safety data more quickly and detect trends within large data volumes. Faster detection of relevant safety signals contributes towards the optimum use of therapies and enhanced patient safety: risk minimisation measures can be initiated faster and thanks to increased accuracy, the scientific evidence can be even more robust.
What steps will be followed by the company to create awareness about the tech-enabled tool?
Bayer is continuously optimising opportunities to share knowledge and raise awareness among the HCP’s and patients in India. We will continue to use these awareness platforms to also communicate about the importance of ADR reporting and SafeTrack. On the occasion of International Patient Safety Day, Bayer announced the launch of the new tool in several countries including India. We have already promoted SafeTrack through the Bayer social media channels and it also accessible through our website. Bayer has also introduced the new web tool for reporting side effects globally in around 60 countries.
This year in Feb, Cipla (Indian Pharma) became the first company in APAC to upgrade to a cloud-based Pharmacovigilance solution. What is your strategy to cope with competition? And how are you strengthening your presence in the market?
As a key stakeholder in healthcare it is important that pharma companies feel responsible for the safety of their patients. Patient safety is our number one priority at Bayer and we are devoted to ensuring the safety of our current and future patients. Bayer is committed to advancing health literacy, as patients who are actively engaged in their own healthcare are more likely to stay healthy and manage their conditions while growing older than ever before. Bayer is committed to supporting patients to obtain and understand health information, ensuring best patient care now and in the future.
What is your perspective on the increasing focus of regulatory agencies for potential safety issues with marketed drugs and how do you address them?
Even long after products and treatments have become available, PV continues monitoring them to make sure the information is up to date. Therefore, in every country including India, PV continuously evaluates new studies, scientific publications, patient experiences and reports about side effects to gather new benefit-risk information.
Are there any collaboration talks with research/ academia institute to train pharma professionals?
Bayer is helping to optimise opportunities for good health through knowledge sharing and medical education to address the increase in average life span leading to a high-quality life that’s as active and independent as possible. Meanwhile, younger generations can make well-informed decisions to help prevent chronic diseases, so they’re encouraged to remain healthy well into their senior years. Therefore, we strive to enable patients to take informed healthcare decisions and work collaboratively with regulatory authorities, HCPs and patients to communicate up-to-date benefit-risk profiles of our products, resulting in access to improved product information on their safe and appropriate use.