How Advanz Pharma digitally transformed to address data volume and complexity, to ensure drug safety.
From popular over-the-counter medications like paracetamol to more complicated drugs and vaccines, pharmacovigilance plays a crucial role in ensuring the safety of medical products before they are availed for public consumption.
If not identified, a single case of adverse effect (AE) may endanger hundreds of thousands of lives.
With numerous trials and results, data has been the tool for success in pharmacovigilance. However, the increasing data volume and data complexity are creating challenges in pharmacovigilance.
How are pharmaceutical organizations leveraging the latest technology and solutions to ensure drug safety and operational efficiencies?
DigiconAsia had the opportunity to draw out some insights from Dr Anju Agarwal, Director, Global Patient Safety, Advanz Pharma, surrounding Advanz Pharma’s previous challenges in pharmacovigilance, and how it has benefited from its digital transformation to improve processes both from the timeline and efficiency perspective, which help the company make faster and better safety decisions in pharmacovigilance within regulatory compliance requirements.
What is pharmacovigilance all about, and what are the challenges in managing complex drugs and vaccines in the pharmaceutical industry?
Dr Anju Agarwal (AA): Pharmacovigilance (PV, or PhV), also known as drug safety. The etymological roots for the word “pharmacovigilance” are: pharmakon (Greek for ‘drug’) and vigilare (Latin for ‘to keep watch’).
It is the pharmaceutical science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Pharmacovigilance is an important and integral part of clinical research.
Here are some of the key challenges in managing PV:
- Inconsistent reporting of adverse events
- Many healthcare professionals and patients are not willing to report
Inconsistent and incomplete data collection lead to false positives and false negatives while doing data analysis. Another concern is the misreporting and miscoding of adverse events. Integration between the various systems such as the clinical trial system, clinical data management system and many more.
The challenges increase when we talk about complex drugs where multiple scientific facts play a role. One example is managing the PV of biologics or vaccines or devices or drug-device combinations.
How did Advanz Pharma use technology innovations and cloud-based solutions to overcome these challenges?
AA: Advanz Pharma runs its safety database on Oracle cloud (Oracle Argus Enterprise Edition), which helps ensure that data is managed in accordance with Good Practices (GxP).
It’s easy to analyze a well-structured data. Safety database helps us retrieve the data faster and in structured format. The information received might be less or incomplete, but putting it in a structured way, using industry standard dictionaries and common rules for assessing the information, make it possible to use the analysis in the future.
What benefits has Advanz Pharma’s pharmacovigilance practice experienced as a result of moving to Oracle Argus Enterprise?
AA: The benefits of moving to Oracle cloud for Advanz Pharma are having better control of the company’s safety data, and retrieval of information in standard or customized way is much more convenient. It is cost-effective too.
How are you integrating advanced capabilities and emerging technologies (such as AI) into pharmacovigilance for next-generation advantages?
AA: Advanz Pharma’s pharmacovigilance (PV) system has lots of automation processes built in.
For example, while logging in a new case, there is an automated search for any duplicate case, auto report generation and scheduling both to agencies and partners, and validation checks at all crucial parameters.
We’re working closely with the Oracle team to bring in more next generation benefits and advantages.