Monitoring Drug Safety in the Age of Big Data

Healthcare databases may allow for greater access to real-world medical data, but they can become a risk to patients and healthcare systems if they are not considered carefully, according to a study published in Current Epidemiology Reports.

The researchers studied healthcare databases used in pharmacovigilance for quantifying adverse outcomes, methods to improve research quality, and best practices for pharmacoepidemiologic studies. They found many sources do not include information on potential risk factors affecting health outcomes, such as smoking and adherence to the medication.

Another challenge the authors encountered was the fact that some long-term outcomes, such as cancer, are difficult to study because many databases contain relatively short-term follow-up.

"The monitoring of drug safety cannot yet be delegated to smart algorithms applied to healthcare databases," Elizabeth Andrews, PhD, vice president of pharmacoepidemiology and risk management at RTI Health Solutions and co-author of the paper, said in a statement. "With all the fervor around the potential for big data, it's critical to keep in mind the substantial differences across databases in content, coding systems and practices, duration of available medical history and follow-up time, quality of outcome information, and clinical practice patterns."

The authors found that healthcare databases tend to include real-world evidence instead of data from clinical trials. This real-world data used in healthcare databases are often not verified against source records or controlled, which has both pros and cons.

"A drawback of clinical trials is that they are highly controlled and highly monitored to ensure strict adherence to protocol; however, that's not how people take drugs in the real world," Andrea V. Margulis, MD, ScD, senior research epidemiologist and co-author of the paper, said. "Real world data have problems too because they are so uncontrolled. With this report, we wanted to explore the pros and cons of working with real world data."

They concluded that using healthcare databases for some activities may not be advisable until these applications can be better targeted to “the right data sources appropriate for specific exposures and outcomes.” Unfortunately, the increasing amount of healthcare records from multiple sources increases the difficulty of targeting.

“Without appropriate care, we risk finding an overabundance of false signals and false assurance from the absence of signals, with associated consequences for patients and the healthcare system,” the authors concluded.