Everything to know about Adverse Drug Reactions during COVID-19

Why do prescribed drugs have side-effects despite undergoing vigorous clinical trials? What led to adverse drug reactions during COVID-19 treatments? UPES School of Health Science’s conference on ‘Adverse Drug Reactions (ADR): Issues and Challenges during COVID-19’ attended by esteemed medical experts answered these questions and more…

Most of us have experienced or have heard someone suffer from the side-effects of a medicine. It could be a minor tingling in the ear, nausea, drowsiness, or skin rash. A severe side-effect, however, can have irreversible consequences and can also cause death.

Which is why, adverse drug reactions have become an acute healthcare concern.

Notably, 54 kinds of adverse drug events increased in frequency during the COVID-19 pandemic, according to a study published in Nature Computational Science that analysed patterns in adverse medication events before and during the pandemic.

In this regard, UPES School of Health Sciences (SoHS) organised a conference on ‘Adverse Drug Reactions (ADR): Issues and Challenges during COVID-19’ in collaboration with the National Coordination Centre-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopeia Commission, Ministry of Health and Family Welfare, Govt. of India. The event was held on 10th and 11th January 2022 (9:00 am – 5:00 pm).

The colloquium addressed the scenario of adverse events due to various medication errors, self-medication, and irrational use of medicines before and during the COVID-19 pandemic. The sessions covered the pharmacovigilance studies for COVID-19 vaccines to help understand and implement new strategies for preventing medication errors and adverse drug reactions in patients. The audience got an opportunity to understand the significance of reporting and monitoring of adverse drug reactions, especially in a pandemic.

The inaugural address was given by Dr. Neeraj Mahindroo, Dean, UPES SoHS, who highlighted the need for such a discussion. “In the context of COVID-19, there were accelerated approvals for several vaccines and drugs. They were tested without adequate scientific evidence being available because we needed them to manage the pandemic as early as possible. Because speed was required so data was collected, and emergency approvals were given. That means a lot still needs to be done to ensure that the designed interventions meet the safety guidelines.”

He said that there was an increased chance of ADR in countries like India where traditional systems are used and mixed with the allopathic systems. “Because those kinds of studies are usually not part of clinical trials for vaccines or the drugs which are tested for using in these conditions,” Dr. Mahindroo explained.

“One more thing which has been noticed during COVID is that patients with comorbidities and the elderly have been impacted more. That they have been taking drugs to manage the comorbidities, besides what they were prescribed for COVID-19 or the vaccines which were given to them, might have complicated the case,” he added, stating the need to ensure that this data is recorded properly for carrying out interventions or changes to make the usage of vaccines and drugs safer. “In this context, this conference is very timely,” Dr. Mahindroo said.

Welcoming the panellists, UPES Vice-Chancellor, Dr. Sunil Rai emphasised that awareness about the drugs was crucial to prevent side-effects. “Pandemic or not, the subject of Pharmacovigilance is crucial because prevention is better than cure. We should be aware of the effect of the drugs if not taken correctly or timely. There is an avalanche of solutions available. We have our medical system to guide us. Unfortunately, there is also a parallel healthcare system – the WhatsApp system – where we get unsolicited suggestions.”

“In such an environment, these conferences assume extra importance. It is a matter of human life. Rather than being a procedural aspect, this (Pharmacovigilance) should become a social movement,” he said.

The Pharmacovigilance Program of India has approved UPES SoHS to establish an ADR monitoring centre under PvPI. Joining the discussion, Dr. Jyoti Upadhyay, Assistant Professor, UPES SoHS, informed how an ADR centre functions. She said, “Pharmacovigilance plays an important role in our healthcare system through assessment, monitoring and discovery of interventions among drugs and their effects on humans. There are six ADR monitoring centres in Uttarakhand; over 500 in India. An ADR centre collects data of adverse events from across India and performs follow-ups to check the completeness of ADR reports as per standard operating procedures. The information is entered in a software called ‘Vigiflow’ and is sent to the National Coordination Centre PvPI.”

Current status of PvPI

Dr. Jai Prakash, Officer In-charge, National Coordination Centre – PvPI, appreciated UPES for conducting the seminar. He said, “I congratulate UPES for inviting us to this conference. My best wishes to SoHS for being recognised as an Adverse Drug Reaction Monitoring Centre (AMC). This AMC will be one of the important centres for collection of data, analysis, processing and sending it to the National Coordination Centre for PvPI at Ghaziabad.”

Shedding light on the current status of PvPI, he said, “The quality, safety and efficacy of vaccines are crucial determinants for the overall safety of patients. One important responsibility given to us is to track adverse drug reactions and collect it from all the stakeholders. We have over 5 lakh individual case safety reports in PvPI database. The National Coordination Centre for PvPI is now the ninth biggest ADR monitoring centres at the global level. India got enrolled as a member of the World Health Organisation (WHO) program of International Drug Monitoring in 1988. Since then, the adverse events data is being sent to the WHO.”

He added, “The healthcare professionals are sent messages from time to time to communicate the risks associated with the medicines. This builds confidence in the use of the medicines and ultimately boosts the public’s trust in the drugs being manufactured and marketed in the country. We have many channels for reporting ADR like the ADR PvPI mobile app, toll free helpline of PvPI that is 1800 180 3024, which is open for weekdays from 9 am to 5:30 pm. I hope this conference will be useful to the audience for understanding ADR.”

Risk-benefit assessment of a drug

Taking the conference forward, Dr. YK Gupta, President AIIMS Bhopal, gave the keynote session.

“First, I would like to congratulate UPES for taking this initiative. I am sure that SoHS will become one of the best ADR monitoring centres in the country,” he said.

Explaining why there is always a chance of an adverse drug reaction, Dr. Gupta said, “When a dossier on a drug is submitted, the Investigational New Drug (IND) experts conclude whether the drug has reasonable safety and efficacy for which it was planned. Therefore, it is permitted to be introduced into the market. Why reasonable? Because we have not tested an entire group; we have tested it in a clinical trial where there is a boundary covered by inclusion-exclusion criteria. It is a uniform situation; there is no liver or kidney disease, pregnancy is ruled out and extreme old age is not taken. And therefore, there is always a possibility of some adverse reaction happening later.”

“When there is repeated reasonable certainty, the only certainty is uncertainty,” he said. “That means, in the real-world situation, you may see ADR, which was not seen or anticipated during the clinical trial or an earlier stage. Once those drug reactions appear again and again, then you have to address the causality – whether it is because of this drug or other medicines or because of the disease progression and if it is related, how serious or how common it is. And then you do the risk-benefit assessment. The risk-benefit assessment of a drug is a continued process throughout the life of a medicine. When risk increases than the benefit and if an alternative medicine is available, the drug in use should be stopped or paused or given with caution or dose modification should be done. And that is Pharmacovigilance.”

Continuous vigil on the behaviour of a drug is called Pharmacovigilance.

Is the information obtained from datum (individual record) to data (collective record about adverse drug reactions) useful? “Not unless it is converted into knowledge and then wisdom that when I prescribe a drug, then I am careful about the possibility of this side-effect. If this side-effect happens, then how I will mitigate it. So, risk identification, risk assessment, risk minimisation and finally risk mitigation is key,” Dr. Gupta said.

Advances of the medical system

The Chief Guest of the session was Dr. Rajendra Dhobal, Director General, Uttarakhand State Council for Science and Technology, Government of Uttarakhand. He strongly expressed his trust in the medical system.

“I have faith in the experts working globally in the laboratories, giving services to the people to get us out of the pandemic. There was a time when Mahatma Gandhi was operated in the open under a tree. Today, our life expectancy has reached 70 years. See, what the medical system has achieved over the years.”

His message to students: “Work hard to give an easy solution to the society. I thank UPES for giving me the opportunity to be the Chief Guest. I wish to see the extended versions of this conference in the future.”

Watch the full session here:

(The excerpts have been edited for length and clarity.)