Why Pharmacovigilance?

Why is #Pharmacovigilance important? To achieve the Utopian goal of #patientsafety ??

Well, we can’t understand the real significance of PV awareness until we experience the benefit in our own lives. So here are two personal stories where knowledge of pharmacovigilance helped me and my family:

1. Few years ago, my aunt developed a severe dry cough. She consulted many ENT specialists, tried different therapies but it did not resolve. Few weeks into the incessant cough that would keep her awake all night, she consulted another physician. He reviewed her regular medications, which included one for hypertension. He switched that medication to another salt, and her cough resolved! She was probably on an ACE inhibitor earlier that caused the cough.

Thankfully, the physician was well aware of PV and side effects and zeroed-in on the cause and ended her weeks long coughing woes.

2. During my pregnancy, I started experiencing severe constipation. I was put on laxatives by the Gyne, but it was recurrent and troubled a lot. I reviewed my medications and noticed that iron supplements in general, and the brand of iron I was taking in particular is highly associated with this event. Now you can’t stop iron during pregnancy, so I consulted with my gyne and requested her to switch me to another brand. That she did and the issue resolved in no time.

Being trained in PV – the dechallenge had worked, so I decided to rechallenge (after a few days) to establish causality – I took the older brand again, and the event reappeared within a day – establishing direct causality! I finally stopped that brand for good, and the issue never returned.
Iron supplements are usually associated with constipation, but some formulations make it more pronounced.

Reporting every event matters, serious or non-serious! Had these non-serious events not been reported – they would never have been added to the SmPCs and package inserts, and the knowledge would not have been there.

Therefore, the purpose of PV awareness is not to scare people about medications, it is about learning to be vigilant and judicious in the way we take them, thus ensuring patient safety.

  • Arshia Bhandari