Express Pharma

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

1 983

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 worke