Speak up for the greater good if you suffer an adverse reaction from a medicine or vaccine

A couple of decades ago, Dr Vladimir Lepakhin, former head of health technology and pharmaceuticals at WHO had famously said that “Dying from a disease is sometimes unavoidable but dying from a medicine is unacceptable”.
In sync with this hypothesis, to coincide with the ‘National Pharmacovigilance Week’, the School of Pharmaceutical Sciences, Apeejay Stya University, hosted a webinar on “Pharmacovigilance: A step towards patient safety”, on September 18.

For the uninitiated, pharmacovigilance can be described as the science and activities concerned with the detection, assessment, understanding and prevention of adverse effects of any medicine/vaccine or any other related problem.

The lectures from the experts in the webinar covered the origin of pharmacovigilance, some new developments and the qualification and skills required for making a career in this field.  
Professor R.S. Dhankar, Vice Chancellor Apeejay Stya University, gave the opening address. He spoke to students about the importance of health care and general wellness.  He said, “In a nation with low per capita income, visiting a doctor is not a luxury, it is a crisis. Thus we must religiously follow a healthy lifestyle and avoid getting sick. Stay close to nature, it is a great healer.”

Mrs Navita Srinet, Senior Vice President, Soterius Life Sciences India, discussed the importance of pharmacovigilance and the latest technological developments in monitoring drug safety and adverse drug reactions (ADR). She stated that pharma companies are vigilant nowadays. They capture medicinal side-effects data from social media, mobile health apps and accordingly plan risk evaluation strategies and safety plans.   She further said, “Practical experience about pharmacovigilance in collaboration with the industry must be included in the syllabus for medical students to gain an insight about the industry. This is a relatively new and booming field. Pharmacovigliance departments are being set up in numerous companies and institutes, providing increasing career opportunities. ”

Mr Brijesh Singh, Head, Commercial Operations (India Business), Eisai Pharmaceuticals India, shared the history of pharmacovigilance with the students. It began with the first known clinical trials held by James Lind in 1747 to prove the efficacy of lemon juice in preventing scurvy. India joined the World Health Organisation (WHO) in 1997 in monitoring the ADR monitoring programme, added Singh. A year later, pharmacovigilance was initiated in India. “Pharmacovigilance is needed from a humanitarian perspective since there is insufficient evidence of safety despite clinical trials.”
There is little information on chronic toxicity in special groups such as children, elderly and pregnant women, Singh pointed out.  
He added that “an adverse reaction gets reported by a patient or a doctor or a medical representative to the pharmacovigilance team at the reporting portals of a company from where it finally reaches regulatory authorities. Because of these pharmacovigilance initiatives, there have been many success stories such as the diabetic drug Pioglitazone getting discontinued from market in 2013 upon reporting of ADRs

Dr Vivekanandan Kalaiselvan, Senior Principal Scientific Officer, Indian Pharmacopoeia Commission, recalled that the WHO established the International Drug Monitoring Programme to improve patient safety in 1961 following the Thalidomide tragedy. “Thalidomide was prescribed for morning sickness to pregnant women. But those women gave birth to children without limbs or extremely shortened limbs. This is medically known as Phocomelia. It was proven to be caused by Thalidomide, following which the medicine was removed from the market.” So, causality experiments make an integral part of pharmacovigilance, as they help identify the root cause of the adverse reaction.  

Dr Vishal Wahane, Senior Manager, Medical Services, Walter Bushnell Pvt Ltd, said one must encourage the reporting of adverse drug reactions. Under-reporting of adverse reactions is a major challenge in the field of pharmacovigilance, he said. Marketing authorisation holders must mention their website, email addresses on the products for patients and doctors to report ADRs. He also recommended training of employees at pharmaceutical companies for receiving reports on adverse reactions.  “We follow six categories while doing the causality assessment of an ADR.  It begins where the drug is identified as the cause of the reaction, to  probable, possible and further going down to unlikely, conditional and finally to unclassifiable where the link between the drug and the reaction is at the lowest value, ” added Wahane.  He said pharmacovigilance is a joint responsibility. Doctors, patients, companies, medical academics, everybody must participate in it vocally and actively.

Dr Sagar Salgaoncar, Executive Director, Genopharma Pvt Ltd, said adverse reactions are not reported actively due to societal taboos. The time-frame of reporting an adverse reaction is crucial. “A fatal adverse event must be reported within seven calendar days. A serious adverse event must be reported within 15 calendar days and a non-serious adverse event should be reported within 90 days of its occurrence.”

“The third largest manufacturer of medicine, India is at the ninth position when it comes to adverse drug reporting. Society has to be more vigilant in reporting adverse events on drug use. Not only in India but globally too. Let’s join hands to make all medical and paramedics in society at large aware of it. Organising such seminars and other events are true steps towards achieving this endeavour.”

-Dr Anupama Diwan, Dean, School of Pharmaceutical Sciences, Apeejay Stya University