This is the area in which IT can be leveraged to develop efficient operating models, whilst ensuring continued support for the implemented decisive safety applications. It is very important for the existing paper based process to be migrated to automated business process to increase accuracy and efficiency. However it is very important to have an in-depth understanding of the regulatory complexities so as to ensure that all the critical applications within the framework are compliant with FDA or EMEA regulatory norms. That is, the IT companies need to ensure that the automated processes, storage and distribution system are in compliance with FDA regulations (21 CFR Part 11) or EMEA (E2B) standards as well as industry standards. There is also the requirement of database management systems and data warehousing modules to consistently process, gather, store and retrieve adverse event data.
The IT companies need to evaluate the existing processes, drug safety systems and disparate technology platforms, aligning the various platforms and legacy processes to bring them within an integrated and efficient framework. This would help pharmaceutical companies to practice proactive pharmacovigilance. The integrated framework at the same time needs to be flexible so as to adapt to the frequent changes in the various business processes. These techniques would help the pharmaceutical companies switch over to a more efficient architectural platform in order to overcome the various challenges like increasing number of caseloads and reduced budgets, thus maintaining a sustainable growth model.
Pharmacovigilance is a constantly evolving science and it is in a phase of continuous changes to accommodate the growing amount of adverse drug events among the growing aging population. The backbone of pharmacovigilance is information and with the advent of revolutionary developments in pharmacovigilance solutions and the creation of database like ADROIT (ADR online tracking systems) the pharmaceutical industry is on the path to developing safer drugs for the larger masses.
The capabilities of data collection are still limited, as data needs to be collected from across thousands of centres across the world for each newly introduced drug. This is where IT can play a major role in integrating the various sources of information to see the broader spectrum of events that are happening. The advent of efficient pharmacovigilance solutions would have tremendous impact on the cost, services, quality and time constraints faced by the pharmaceutical companies. These solutions would help in pharmaceutical companies providing a higher level of patient safety and thereby promoting better quality of life for the patients.
Besides these, the quality of processes, data and products would increase thereby creating a greater value for the pharmaceutical companies. With the introduction of pharmacovigilance, solutions processes and systems could be streamlined so that resources could be allocated effectively. This would help in avoiding product withdrawals, fines, warnings and penalties for the pharmaceutical companies. At the same time the solutions help in reducing process cycle time and adherence to the regulatory reporting structures. In terms of services, the pharmaceutical companies would be able to provide accurate risk profiles of drugs and also maintain the company’s image and shareholder value.
Analyst’s estimate that the compound annual growth rate of pharmacovigilance solutions is about 10-12%5 till 2010. The IT industry is looked up to by the pharmaceutical companies around the globe to provide cost-effective solutions in pharmacovigilance so as to ease the financial and ethical burdens while at the same time providing better quality data analysis, process structures and compliance management.
However despite all these revolutionary trends happening in the pharmacovigilance arena there are several roadblocks in ensuring higher levels of drug safety. The drugs are now marketed around the globe and there is a definite awareness about drug safety and adverse events reporting among the medical fraternity in the developed nations. However, there is need to create more awareness among the doctors, pharmacists, nurses, hospitals and various stakeholders on the importance of reporting adverse drugs events.
There is also a need to make the doctors and other medical staff aware of the usage of IT solutions such as prescription event monitoring systems and other solutions in order to bring in more efficiency and accountability to the medical system. Gradually pharmacovigilance is becoming an integral part of drug safety risk management systems (DSRM) and this is a definite boon to bring in better compliance to patient safety.
With the advent of personalized medicine, pharmacogenomics and specialty drugs there are more and more drugs being introduced into the market and so IT companies and pharma companies need to gear up to meet the fast paced challenges in adverse drug events, changing compliance issues, generating more profits and providing better patient safety. The question is: Are the pharma companies ready to meet the challenges of Corporate Social Responsibility by promoting greater awareness among the medical fraternity in developing and non developed nations?
There is no “one-size-fits-all” solution currently in the market as different companies have different analytical techniques, reporting methods and varied platforms and this is where IT companies can definitely reap the benefits. The market is highly fragmented and there is scope for a lot of players to introduce better pharmacovigilance solutions in the market to promote a high level of drug safety and create better value for the shareholders of pharma companies.