Big Data and Pharmacovigilance.
In the past few years the term ‘big data’ is buzzing around in different industries, and pharmacovigilance is not an exception.
Pharmacovigilance is a systematic process that in the majority of the time deals with large amount of data. For the longest time the data that is of paramount importance in the industry was collected and analyzed manually, depriving it of the benefits of digital development.
Today, pharmacovigilance is developing its methods of data collection and analysis to keep up with the trends and stay ahead of time.
What is Big Data and Why is it important?
Big data is a voluminous amount of data – structured or unstructured – that is mined for information in order to disclose patterns or trends of a specific industry.
Although big data does deal with ample amounts of data, it is not the amount that matters, but what people do with it. The data, however big it may be, acquires meaning only when used purposefully and analyzed properly. When it comes to the analysis, insights that are derived from the assay are the key value.
As a result of the analysis of big data, insights are gained that not only lead to better decision-making, but also to smart and strategic business moves.
Big data combined with effective analytics makes an unbeatable duo in any field, and healthcare is not an exception. In the last few years, this sector has largely been influenced by the use of big data, and medical professionals and HCPs (Health Care Professionals) do not fail to leverage the power of data.
Pharmacovigilance, playing a crucial role in the healthcare industry, is not an exception when it comes to using big data in the name of amending patient care and bettering its results.
Big data for pharmacovigilance is available in the form of
- electronic health records,
- medical claims data,
- registries monitoring diseases and drugs.
This data is collected from everybody in the medical field: from doctors to pharmacists, from patients to health care professionals.
What is Pharmacovigilance and How Does It Make Use of Big Data?
Pharmacovigilance, as defined by WHO (World Health Organization), covers the science behind detecting and assessing the harmful effects of medications and activities that aim at undertaking and preventing those effects. Pharmacovigilance (PV) aims ate minimizing and preventing adverse effects of medical products and drug related problems in general.
Medical products, before being placed in the market, undergo clinical trials to find out how safe and efficient they are. But clinical trials are different from natural settings, as in case of trials drugs are consumed by people and environment carefully selected. This is where pharmacovigilance comes into play!
Pharmacovigilance monitors drug safety after the marketing of the medical products – once they are released into the market. The primary role of pharmacovigilance is monitoring ADEs (Adverse Drug Events).
The information about ADEs is collected based on medical literature, adverse event records, electronic health records, clinical trial results, pre-clinical studies, as well as social media. So, due to high amount of data traditional methods may not work anymore.
The digital revolution of the 21st century resulted in the improvements connected with the usage of data for drug safety surveillance. And the industry, in the recent years, is making the most use of its collected data, and ‘big data’ can be seen as an approach for data mining for drug safety reasons.
Before the concept of big data was introduced to pharmacovigilance, the clinical data was reviewed manually. As the volume and clinical data increased through the years, it has become unreasonable and unreliable to analyze it manually.
The big data in pharmacovigilance, and health care industry in general, is represented in the form of multiple health databases. The usage of more than one health databases simultaneously to evaluate how effective and safe a drug is, is much more reliable than using a single source.
Big data for pharmacovigilance deals with innovative electronic methods that are used to analyze data, the volume of which constantly grows. The information is collected in spontaneous reporting systems (SRS), as well as in other digital sources. Reporting systems deal with spontaneous reports of Adverse Drug Events and is made by health care professionals (HCPs), average consumers, pharmacists, companies releasing medical products and numerous other sources that in some way or form are connected with the medical industry. In contrast to manual search that was used for years before big data ‘came into the life of pharmacovigilance’, novel methods let the researchers identify the data points needed in the blink of an eye. With traditional manual research this was nearly impossible.
The methods used in big data assist in the identification of adverse drug events, risk factors and new associations among medications. As this is the purpose pharmacovigilance serves, the interest in big data and its methods was to be expected since the early years of big data taking over industries.
The advantages of using big data in pharmacovigilance are numerous. One of the most outstanding benefits big data ensures for pharmacovigilance is that it gives it an opportunity to analyze diverse information as far medical history goes. The information includes both in-patient data, which includes everything that has to do with the hospital stay of a patient, and out-patient data, which covers prescriptions, medical history of registries of rare diseases, etc.
The use of big data in pharmacovigilance has resulted in the improvement of research efficiency and creation of new tools for health care professionals, as well using innovation for the benefit of improving the quality of drug safety research.
Big data with its databases and registries constantly being filled up with information has made it possible to analyze and draw information from multiple medical databases and registries. It allows researchers and HCPs make use of the medical history of patients from all over the world. In pharmacovigilance, which is responsible for drug safety and efficiency, this is a huge revolution that is going to change many things for the better in the protection of public health.
The opportunity to use the case of every patient in history is a possibility that awaits us in the healthcare industry.
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