This enlightening blog elaborates on:
- A Brief Account of My Introduction to Pharmacovigilance
- Defining Pharmacovigilance
- The Steps of the Process to Follow Within Pharmacovigilance Throughout.
Table of Contents:
- Exploring Awareness in Pharmacovigilance: A Discussion
- Overview of Pharmacovigilance
- Why Does Pharmacovigilance Matters?
- Overview of Pharmacovigilance Process
- Thoughts
- FAQ
Awareness to pharmacovigilance
If you’re a healthcare professional, often you’ve come across the term “Pharmacovigilance“. However, during my time studying bachelors in pharmacy, I was completely unaware of this profession until I pursued my Master’s degree.
From there, my journey into pharmacovigilance began, and now I’ve evolved into an entrepreneur, establishing my own pharmacovigilance service provider.
Recently, i see pharmacovigilance has gained significant popularity among healthcare professionals.
So Let’s dive in!
What is Pharmacovigilance?
Pharma + Vigilance= Pharmacovigilance. Pharmacovigilance is otherwise called Drug safety but little distinct.
The term “Pharmacovigilance” was first proposed in 1970s, has gradually gained traction to become one of the two common terms of art for the overall discipline, the other, older term being “drug safety.”
It is the reaction of a drug with its action of collection, detection, assessment, monitoring and prevention. It is simply the surveillance of drugs from the clinical trials report and followed up very closely under controlled conditions.
Etymology of the word:
The word Pharmacy is derived from the french word Farmacie, and directly from the Medieval Latin word pharmacia, from Greek pharmakeia “a healing or harmful medicine, a healing or poisonous herb.
The word Vigilance was first recorded in 1560–70; alteration (-ance for -ancy) of obsolete vigilancy, from Latin vigilantia; see vigilant, -ancy.
Why does Pharmacovigilance Matter?
Pharmacovigilance is an essential aspect of drug surveillance that is crucial to the field of pharmaceutical drug research.
Before a drug is approved for market, it undergoes clinical trials and research to determine its safety and effectiveness.
However, incidents like the thalidomide tragedy have shown that monitoring must continue even after a drug has been introduced to the market.
Considering Patient Safety
Post-Marketing Surveillance (PMS) is the process of monitoring a drug’s safety and effectiveness once it has been approved and made available to the public.
Patient safety is of utmost importance, as every drug has potential side effects, and it’s important to determine the severity and potential for new effects.
This surveillance is continuous and ongoing for as long as the drug remains on the market, and it’s also beneficial for pharmaceutical companies to maintain their business and reputation.
Ultimately, pharmacovigilance is vital in safeguarding the safety and well-being of patients by determining the risk and benefit analysis of every drug available in the market.
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Pharmacovigilance Processes to Follow
The pharmacovigilance process follows 5 steps mainly:
- Collection
- Detection
- Assessment
- Monitoring
- Prevention
Collection
Pharmacovigilance starts with the collection of data from the sources of reporting of events to the center of two variations solicited and unsolicited reporting.
Solicited are the reports from the designated data centers from the study, in otherwise unsolicited are spontaneous reports.
Detection
The second stage is to detect the events and confirm sources are valid. So here is the stage to triage the cases. Aftermath the valid cases are going forward to the next stage of assessment.
Assessment
Assessment is the very important stage of this process to assess whether the event does it have any causal relationship to the drug. This part done mostly by medics. Because some cases should upgrade to serious based on conditions decided by medics.
Monitoring
It involves data analysis and focuses more on risk management and signal detection. Professionals in this area can assist in the creation and review of reports relating to safety updates for drugs in clinical research and periodic risk-benefit evaluation reports.
Prevention
And finally, the importance of the pharmacovigilance process is to prevent people from disastrous events.
Conclusion
Many of us may think of how the future will be if we pursue pharmacovigilance as a career.
Many of my LinkedIn connections pinged me personally and asked for advice. I would say from my personal experience every field has its own ups and downs, it is everything about your skills.
So don’t worry just concentrate on developing your skills whatever your profession is. As for my concern, pharmacovigilance has a good future.
So good luck guys!
References:
FAQ:
Define pharmacovigilance
What are the 5 steps of process to follow in pharmacovigilance?
2. Detection
3. Assessment
4. Monitoring
5. Prevention
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