Pharmacovigilance – ensuring patient safety first

Medicines and vaccines used for the prevention and treatment of diseases may have unexpected side effects that are undesirable.

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Before the drug is introduced for general use in the market called Pre-market research and development stage and, once the drug is introduced into the market called post-market real-world use stage.

By Chinmaya P Chigateri  

Medicines and vaccines used for the prevention and treatment of diseases may have unexpected side effects that are undesirable. Although rigorous clinical trials are undertaken before any medicines/vaccines are authorized for use, since it uses a limited sample size for the drug trial, certain unknown side effects may emerge only at a later stage when it is used by a heterogeneous population over a long interval of time. It is imperative for pharmaceutical companies and regulators to constantly track such adverse events and to continuously notify the medical fraternity.. This is the fundamental principle behind a process called Pharmacovigilance, according to the WHO,” pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine-related problem.”

Pharmacovigilance can take place at two stages –

Before the drug is introduced for general use in the market called Pre-market research and development stage and, once the drug is introduced into the market called post-market real-world use stage. Pre-marketing pharmacovigilance is conducted during all 3 phases of clinical trials, during which all the adverse effects are monitored with at-most priority. Post-marketing pharmacovigilance is conducted in two ways –

Spontaneous reports – Health care professionals and patients send spontaneous reports to describe adverse drug reactions to the regulatory authority as part of passive monitoring.

Solicited reports – Targeted surveillance for certain events or medicines to completely determine the number of adverse drug reactions through a pre-planned process usually conducted by some pharmacy or some hospitals, or some physicians.

Traditional method of pharmacovigilance

The traditional manner of collecting data and processing in pharmacovigilance is a manual process where case data collected from patients spontaneously or via clinical trials, is registered in the Safety database and triaged based on the seriousness. Post triage, the case moves to data entry followed by Quality review and Medical review, finally submission to regulatory authorities.

 Role of automation in pharmacovigilance

Due to constraints of time and manpower, newer technologies are changing the Pharmacovigilance business, mainly driven by automation. It can range from Basic Automation, Robotic Process Automation to AI-driven technologies. There are multiple areas in pharmacovigilance where automation can help. Automation can change the way data is collected and analysed, which would speed up clinical trials. Electronic data capture (EDC) is a database that is used to store patient data during clinical trials. Using EDC-based tools for the collection and analysis of data during clinical trials and post-market observations is efficient. Cloud technology is perfect for providing a fully integrated database for all the stakeholders, which is crucial for the advancement of drug safety and pharmacovigilance.

Basic automation is needed in pharmacovigilance to provide automatic tracking, task monitoring, and collection of data. Robotic process automation (RPA) can eliminate manual tasks by providing automatic entry, processing, and analysis of data. A combination of RPA with cognitive automation via natural language processing can help in smarter decision-making. Artificial Intelligence and Machine Learning can help data analysts and data scientists to make predictions based on data analytics. This can improve the quality of the pharmacovigilance processes.

Automation in pharmacovigilance has several benefits which can improve the contribution of the sector to the pharma industry.

– The accuracy and quality of data are better.

– It eliminates human errors, minimizes cost and time.

– It ensures adherence to regulations.

– It helps to handle large volumes of data.

Pharmacovigilance in India:

National pharmacovigilance program (NPP) – India introduced an adverse drug reaction monitoring system in 1986 supervised by the Drug Controller of India. India joined the WHO Program for International Drug Monitoring in 1998, but this was not a successful arrangement. The NPP was launched by CDSCO, Ministry of Health and Family Welfare, Govt. of India in November 2004 and was renamed the Pharmacovigilance Program of India (PVPI) in 2010. The PVPI protects the health of the Indian population by maintaining strict vigilance on the medicines /vaccines produced in India. Over 250 drug monitoring centres have been established pan India by PVPI for the purpose of reporting Adverse Drug Reactions and training health care professionals. The PVPI is focused on building trust between the clinician fraternity and patients, leading to an increase in patient safety as well as raising the confidence of people in the country’s health system. The PVPI faces challenges like counterfeit drugs, antimicrobial resistance, and monitoring during mass vaccinations and other countrywide programs.

AyushSuraksha – There is separate pharmacovigilance set up for Ayurveda , Siddha, Unani and Homoeopathy (ASU&H) branches of medicine. They are generally considered safe drugs, but some recent cases of adverse drug reactions have prompted setting up a pharmacovigilance initiative for these categories of medicine. The increased use of ASU&H drugs in India and abroad is leading to exposure of these drugs to diverse genome profiles and this can lead to unanticipated adverse effects. There is a need to engage medical professionals and the public in a structured manner to build synergies to monitor adverse drug reactions of ASU&H drugs. The idea behind the pharmacovigilance initiative for ASU&H medicines is the collection, assimilation, and analysis of data to establish drug safety. For better pharmacovigilance in alternative medicines, it is important to strengthen education, awareness, training, and publicity. 

Pharmacovigilance is a continuous quality control process that is imperative for patient safety. It is essential to have a regulatory watchdog who can collect and analyse data and monitor irregularities to ensure a robust healthcare system. Technology is bound to improve the efficiency of pharmacovigilance. So there are going to be safer times ahead for healthcare.

(The author is the Director & CEO of HealthMinds. Prior to founding HealthMinds, he has consulted with various organizations in areas of medical publishing, healthcare IT and research advisory. Views expressed are personal and do not reflect the official position or policy of the Financial Express Online.)

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