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Role of pharmacovigilance in innovating and revolutionising healthcare accessibility in India

Dr Pramod Dhembare, Founder and Managing Partner, Fidelity Health Service, traces the role of pharmacovigilance in public healthcare

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Drug safety has been the new talking point in the global pharmaceutical industry in the last decade. The evaluation of any drug’s benefit-risk balance has been studied extensively by national and international researchers in the pharmaceuticals industry since the 80s and thus, the approval of new medicines and the withdrawal of medicines from the market have been done through a scientific inquiry of safety of drug use.

The usage of any medicine or vaccine or device may come up with a risk. It may be referred to as Adverse Drug Reaction (ADR). For drug safety, ADR must be monitored throughout the life of the drug, from its development, clinical trials and post-approval. Therefore, a new branch in pharmacology that concerns the detection, understanding, assessment and prevention of the ADRs emerged, is known as pharmacovigilance.

Pharmacovigilance in public health

Like every other developing country, India too bears the brunt of the health workforce crisis. Owing to the high doctor-patient ratio, grave issues like inaccessibility to treatment and insufficient treatment spring up, economic factors (cost of medicine) and dispensing of medicine without prescription (chemist dispensing) which leads to the prevalence of self-medication among patients. Self-medication, in turn, causes the side effects and ADRs of the medicines to go unreported and unobserved. Moreover, the effects of interactions of drugs with other drugs and food, would go unrecorded, and the information gathered during clinical trials would be missed, leading to jeopardy in reporting and collection of data that analyses serious health risks.

Reporting and collection of ADRs, especially serious from patients as well as the healthcare workers precede the data analysis in pharmacovigilance, following which, the steps in the process of a product/batch recall, intimation to the regulatory authority about the risk associated with drug usage and the preventive measures taken to eradicate drug-related problems take place. The process of giving systematic feedback to pharmaceutical scientists for better product planning stems from physicians, pharmacists, healthcare professionals, medical pharmacists, regulatory/industry officials and general mass feedback on the repercussions of medicinal drug usage.

The feedback may also be given by people within the structure set by the National Coordination Centre-Pharmacovigilance Programme of India, CDSCO, like the ADR monitoring centres, Safety Drug Advisory Committee, regulatory authority and industry health services. Side effects, including adverse effects, are reported and funneled into sets of useful data, which, when processed, helps in decision-making about the prevention of drug-related problems and the reduction of morbidity rates by medicine.

The practice of patient care is facilitated by the use of clinical training and education in pharmacovigilance, promotion of understanding of the procedure and its effective communication to professionals in the healthcare sector. Public confidence around the efficiency of pharmacovigilance builds by letting people have access to good-quality and safe medicines and a suitable system for the distribution of medicines that have cleared pharmacovigilance.

Breakthroughs in the pharmacovigilance system

Throughout the course of the years, the government of India is also emphasising on patient safety through quality medicine. The Indian Pharmacopoeia Commission (IPC) has been instrumental in addressing the issues related to the quality of medicines. To ensure the safety of medicines, an organisation of Pharmacovigilance Programme of India (PvPI) has been set up.

PvPI has designed an entire infrastructure to receive and evaluate the concerns about medicine for the patient safety of the Indian population. PvPI has formulated an ADR reporting form (for healthcare workers) in English and multiple regional languages. Further, it has set up a toll-free number for reporting ADRs across India (1800 180 3024). A mobile application (ADR PvPI) is developed for reporting ADRs via smartphones. PvPI is regularly arranging workshops and trainings to reach out to healthcare workers so that the objective of pharmacovigilance can be spread out which can, in turn, be helpful for the accessibility of healthcare in India.

The pharmacovigilance system and its process has been improvised backed by technological advances in smartphones and internet services. Mobile applications have been used to report adverse drug effects and notify safety alerts. These apps also make it easier for the patient to store their medical history digitally. Moreover, they plough the data to mitigate the limitations around effective reporting of ADRs, pushing the process of pharmacovigilance from reactive to a proactive approach.

The convergence of a robust digitised healthcare system, smart pharma and pharmacovigilance have brought innovations in the Indian medical industry. Faster and more comprehensive analysis of data have improved safety and efficacy, and incorporated the practice of proper use of medicines in health workers as well as patients. Pharma companies are increasingly using Robotic Process Automation (RPA)-based bots to smoothly extract data from documents, validate those and enter those into safety databases. Automation of data extraction also facilitates faster and better case creation for the contributors in pharmacovigilance to study and provide inputs in the quickest turnaround time with the highest quality.

Combined with the use of Artificial Intelligence (AI), effective monitoring of drug development and healthcare treatments has led to better patient outcomes with time. Advances in cloud computing and AI are also connecting the right dots and changing the landscape of healthcare treatments and drug developments by strengthening data analysis, monitoring risks on a broader level and accurately reporting patient events globally, ultimately improving the culture of patient satisfaction.

Processing and reporting activities have been automated by user-friendly IT systems. The use of technologies such as Natural Language Processing (NLP), RPA and Machine Learning (ML) can maneuver the entire process of data collection and analysis during pharmacovigilance. Therefore, the need for human intervention and the scope for human errors are much less. The trend of adopting the technology-based solution/services has been seen in companies performing the operations in pharmacovigilance India.

The emergence of pharmacovigilance has simplified the process of medical drug use and ensured transparency around the safety of medicines to the public. With the augmentation of pharmacovigilance as a science of improvised healthcare solutions, the pharmaceutical industry is sure to witness a paradigm shift towards safe and reliable medical care for all.

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