With 12% fully vaccinated for COVID-19, 40% of the Indian population has received at least one dose of the vaccine. The initiation of the vaccination program received great resistance in India. Many adverse effects (AEs)/adverse drug reactions (ADRs) were reported around the same. However, thanks to pharmacovigilance (PV), that infused confidence in the health authorities and the masses at large and made the extensive vaccination drive a possibility.

Vaccines, medicines, and various medicinal products have revolutionized the prevention, treatment, and cure of even deadly diseases. However, a constant vigil on the usage of these products is vital. These drugs might carry some unanticipated risks and side effects when used by the intended users. As stated by the World Health Organization (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.”

• Detection – recognition of the drug reported with adverse effects.
• Assessment – assessing if the risks associated with the drug surpass its established benefits.
• Understanding – understanding the severity and impact of the adverse effects.
• Prevention – taking measures to rectify the drug composition or prevent the occurrence of adverse effects in future.

In olden times, a drug manufactured successfully was deemed fit for use. However, it was only in 1995 when the European Medicines Agency (EMA) made the ‘approval for use’ of a manufactured drug by authorized health regulatory bodies mandatory.

All drugs and vaccines go through comprehensive testing and clinical trials for efficacy and safety of use before they are approved for use. The clinical trials are carried out in a phased approach – phases I, II, and III before applying for any new medicine’s market usage authorization. Nonetheless, these trials involve the examination and study of these products on some dummies or animals reserved for experimentation, followed by a small number of selected individuals or volunteers under close observation in a medical environment. The real-time situations are, in principle, quite different. Hence, it requires persistent monitoring of the product usage after it has been released for public use.

In India, the Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority chiefly responsible for conducting the clinical trial of drugs, laying down the drugs’ standards, and approval of drugs. It also performs pharmacovigilance under the Pharmacovigilance Programme of India (PvPI) through National Coordination Centre (NCC). The NCC-PvPI receives adverse drug reactions (ADRs) from the entire country and works on the same. It assists the CDSCO in making decisions based on these reports and investigations for drug safety and patient safety. It also works in coordination with the Sweden-based global ADR monitoring center, WHO-UMC, and contributes to the global ADRs data base.

All this highlights the criticality of the practice of pharmacovigilance (originated from the Greek word pharmakon meaning drug and Latin word vigilar meaning being vigilant). Besides underscoring the vital role played by the pharmacovigilance-performing bodies, the responsibility of reporting the ADRs is also very significant. Healthcare authorities, medical facilities, hospitals, and each individual need to report any such incident or occurrence of unwanted or unexpected adverse effects of any medicine, drug, or vaccine.

It is imperative to introduce and extend the awareness of PV, its need, and how every person can contribute. And what better tool these days than social media to spread knowledge on any subject?

Social media is indeed the most powerful, accessible, and affordable medium of broadcasting any information or discussing any topic. It was limited to a few some years back but now has reached almost every remote corner of India and the world at large. It gives a golden chance for pharmaceutical and allied companies to leverage the mounting growth of social media. It is a given that it was social media that ensured nearly everyone (including the uneducated or not-so-educated people) knew and understood the terms like lockdown, quarantine, isolation, infection, and distancing in the last two years; it is some information unknown to many prior to that. The ‘online’ outreach extends to the populace of all regions, religions, and languages. It would be only fair to exploit such resources to disseminate the understanding behind PV.

PV could also utilize social media to educate the public about the description, characteristics, usage, benefits, and the known side-effects of a product. It could also use it as a tool to interact with the customers, understand their feedback, listen to their complaints, take the required decision, and associated curative action. The ADRs collected through this approach could be monitored, analyzed, and remedied accordingly. The process would also require a proper connection with the reporter (if it’s a patient or a patient’s known) to understand their medical condition, medical history, response to the concerned drug, if they were on other medications as well, co-morbidities if any, and various relevant factors. Once identified, the anomaly is a must to be communicated to healthcare providers and all impacted. Social media again comes in a lot handy than other mediums for such communications.

The main points to social media-driven pharmacovigilance are:

• Analyze Study the minds of consumers (medical bodies/professionals and patients). Recognize the relevant social media keywords and trends that would help circulate the information to the right audience.
• Observe, listen, and connect Cautiously observe all interactions and mentions of the product. Monitor the content in real-time. Segregate the content based on positive and negative feedbacks (or benefits and side-effects of the product, respectively). Connect with the audience and address their concerns. Identify the users whose inputs would be beneficial in further investigation of the product. Try for an early resolution. Communication is the key – every milestone and conclusion should be communicated.
• DocumentationIt is significant to track, document, and report each observation and information reported.

Social media platforms enhance the consumer-producer connect and builds trust, all in a casual manner. The average time per day that users spend on social media platforms, including social networks like Facebook and Twitter, discussion forums like Quora and Reddit, media sharing networks like Instagram and Snapchat, or content curation networks like Pinterest, is on the rise. Healthcare providers and medical professionals are already using this media to spread information that helps in patient care, outbreak management, health education, symptom reporting, public health, and disease management. Many countries, including India, launched various mobile applications and used other social networks for the better management and reporting of the COVID-19 pandemic.

Health is a person’s best friend, which, if gone wrong, can disrupt the physical and mental balance. Once out of balance, anyone reaches out and trusts the doctors and healthcare professionals. They rely on the prescribed medicinal products to restore their healthy state.

How can ‘this’ person contribute to pharmacovigilance?

A person on any medication should

• Follow the medicines and schedule prescribed by the doctor.
• Go for the scheduled follow-ups with the doctor (even if they feel ok).
• Report the effects of the medicines and treatment.
  • Let the doctor know even if feeling better and results are positive, or
  • Not much impact (no benefit, no side-effect situation), and
  • Immediately reach out if any undesired effect is observed
• Ask the doctor to report the adverse effect or directly report it to the concerned pharmacovigilance team through social media or other available contacts, if any.

Reporting and addressing any health concern is as important as living a healthy life. Timely action will help prevent the spread of adverse effects and may save many other lives.

The persistency of pharmacovigilance ensures drug safety, and ultimately, patient safety. Therefore, it is crucial for the general public to learn about this through social media and other channels and contribute its part well.

In conclusion, it is vitally important for any pharmaceutical setup to adhere to and promote the concept of pharmacovigilance. There is a pressing need to fast pace the use of social media in the field of PV, as it is already being resourced in other healthcare sectors. This would, at a bare minimum, require

• Training the staff on the best practices for the usage of social media sites.
• Adopting a holistic social media strategy.
• Making social media monitoring a standard practice.
• Documenting, keeping track, and updating on any adverse outcome reported through respective social media forums.
• Analyzing the pros and cons of using various social media sites and revising the strategy accordingly for efficacy.
• Keeping appropriate checks on these sites and ensuring the credibility and validity of the reported adverse effects (patients would be direct reporters on social media, and hence appropriate checks are required to prevent spamming or ‘pseudo’ reporting). In addition, the data received via social media would be raw, unstructured, and some portion unnecessary. It would be required to structure and extract useful information.
• Ensuring the personal details and other patient-sensitive information are not revealed or misused.

Social media could thus become a significant enabler to drive better PV outcomes.