18 Sep, 2020

Community Pharmacovigilance : Importance in COVID-19 Era

Community Pharmacovigilance : Importance in COVID-19 Era

Community pharmacovigilance has always been neglected area by researchers. Importance of drug knowledge and its side effects has never been thought from the school age. Drugs being important part of lifestyle, with so many commercials on over the counter drugs has increased awareness of general population on the drugs. With so many news on illicit drugs, it is even more important that we as a community know more about drugs and its side effects.

In second year pharmacology curriculum in MBBS, in one corner of K.D.Tripathi Textbook, there is definition of pharmacovigilance ” Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” and few pages regarding types of Adverse Drug Reactions. Period. It stops there. Why it is important, methodology, implications nothing is being explained to budding physicians. Why one should report adverse drug reactions as a patient or healthcare professional is not emphasised properly. Importance of data is negligible. Physicians not trying to adverse events due to busy schedules…pharmaceutical companies not bothering to have medical information centres…patients does not know where to report or even if they know neglect to report

Enters COVID-19. Deadly pandemic with no definitive treatments….Not known much about either disease, its complications or therapies….with no definitive treatment on our hand, we are trying everything which seems relatable…starting with chloroquine, hydroxychloroquine, remsedivir, famipravir, tocilizumab, dexamethasone, Vitamins, MMR vaccine and what not with no concrete evidence……And there comes reports of pulmonary fibrosis …..Irony is none of the reports have actually been reported as ADRs to either pharma companies or regulatory authorities…more to the lay press…..so no formal investigation…no lights on whether it is a natural course of the disease or drug side effect or drug-drug interaction……Until and unless healthcare professionals/patients are aware regarding importance of data analysis and reporting as suspected adverse events and regulators are more vigilant about emphasising on data reporting, we will not be able to know about risk benefit assessment of all these costly treatments and modes to deal with this deadly disease and its complications

Few thoughts on short term remedies:

 

  1. Follow-up all the patients with pneumonic patch in initial HRCT after 2-3 months of discharge to ascertain pulmonary fibrosis
  2. Report all these cases to at least CDSCO with all the details of treatment
  3. Causality assessment by treating physicians in lieu of patient characteristics

Few thoughts on long term measures for awareness of pharmacovigilance in community:

 

  1. Provide basic information regarding drugs, various over the counter drugs and their adverse events and importance of reporting adverse events from school age making appropriate accommodations in school curriculum
  2. Introduce pharmacovigilance as subject in medical and paramedical curriculum
  3. CPE credits compulsory for healthcare professionals to renew their credentials and make contribution in community pharmacovigilance efforts mandatory
  4. Proactive regulatory interventions by government agencies in the field of pharmacovigilance