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Pharmacovigilance technology systems are geared towards data entry and adverse reaction reporting, but they are also increasingly important in proactively managing risks and improving the level of safety for patients. The emphasis of today’s [link widoczny dla zalogowanych] pharmacovigilance industry is on prevention. Zhengwu Lu writes in the Drug Healthcare and Patient Safety journal:
The need for an integrated, powerful technology approach is clear. Oracle Health Sciences’ vice president, John Loucks, says that only a “‘structured signal management’ approach with defined workflow and integrated processes provides the framework required to turn reams of raw data into medication information.” Since the goal is to monitor and improve safety, enhanced data collection and processing is needed.
Pharmacovigilance technology systems can be effective in detecting what may be otherwise invisible to the human eye…[IT systems] are [link widoczny dla zalogowanych] less likely to miss important public health information hidden in “haystacks” of data. It is demonstrated that full product safety assessment can be conducted by such technologies in an efficient and effective manner.
Technology will also facilitate the shift in the industry from post-market safety monitoring to focusing on the entire life cycle of the drug. Pharmacovigilance needs to start at the beginning of a drug’s life cycle and follow it through. John Loucks predicts that “we will be begin to see pharmaceutical companies leverage technology to facilitate end-to-end monitoring and even gain the ability to monitor safety directly from electronic medical [link widoczny dla zalogowanych] records (EMR).”
November Research Group are premier pharmacovigilance solutions experts with extensive experience in Oracle Argus, ARISg and other commercial adverse event reporting systems.
While technology is not a cure-all for the pharmacovigilance field, it does present a viable solution to many of the issues facing the industry, and with continued development, it will help create a better framework for the management of risks. One example that illustrates how much technology can aid the process is in data collection. This is one weakness of pharmacovigilance efforts worldwide. ADR reports have to be collected from hundreds of thousands of locations around the world for each new drug. Automated systems not only facilitate greater rates of spontaneous reporting, it helps process and aggregate the data into useable information.
The World Health Organization’s pharmacovigilance database contains some 4.6 million reports, and that is growing by about a quarter million per year. The sheer volume of data calls for technical solutions – but so does the risk of underreporting. According to FDA estimates, only about 10 percent of adverse drug reactions are reported. Even with the low spontaneous reporting rate, pharmaceutical companies are overwhelmed by [link widoczny dla zalogowanych] reporting obligations and regulations.
One word you will hear again [link widoczny dla zalogowanych] and again in the pharmacovigilance industry is “proactive.” Companies need to be proactive, and innovative, in protecting the public’s safety. To do this effectively, IT solutions need to be integrated sooner rather than later.
As the pharmacovigilance industry grows, it becomes vastly more complex. Regulations and laws shift rapidly, and companies need to be able to keep pace. They increasingly [link widoczny dla zalogowanych] rely on IT solutions. An example: the European Medicines Agency (EMEA) requires that ADR reports to submitted electronically in specified formats, such as E2B. Other regulations can be met with the aid of software or web-based programs. Pharmacovigilance is only becoming more advanced, [link widoczny dla zalogowanych] and [link widoczny dla zalogowanych] the value of IT is not to be underestimated.
Cost is a great driver in the pharmacovigilance field, and until recently, it [link widoczny dla zalogowanych] has kept smaller firms from being able to provide effective aid in managing risks. These companies simply do not have the manpower or budget to devote to pharmacovigilance, but with technology, they find themselves on a more equal footing. IT also contributes to cost-saving initiatives by [link widoczny dla zalogowanych] allowing companies to assess risk much earlier and take potentially harmful products off the market before losses mount.
Pharmacovigilance has been indelibly changed by technology and new demands have been placed upon the industry as a whole. Technology, though, is also the solution to this massive undertaking. The simple reporting of adverse drug reactions has given way to a host of detection and prevention tasks. IT systems make fulfilling obligations, whether to regulatory bodies or to the patients themselves, more efficient. There is no doubt that pharamcovigilance faces immense challenges.
Pharmacovigilance has moved beyond the standard of merely reporting adverse drug events; today, consumers and government regulatory bodies demand that pharmaceutical companies and others have a more sophisticated system for recording, monitoring, and responding to risks, as well as managing long-term monitoring of specific drugs. Pharmacovigilance is increasingly dependent on information technology. While human input will always be vital to this discipline, it is imperative that new technologies be incorporated into efforts to increase effectiveness and efficiency. Pharmacovigilance IT [link widoczny dla zalogowanych] is an essential [link widoczny dla zalogowanych] part of the safety equation.
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