The opioid epidemic in drug safety reporting systems

Last week, the founder of Insys Therapeutics, John Kapoor (76), was sentenced to 66 months in prison for orchestrating a scheme to bribe physicians to prescribe Subsys, a highly addictive form of fentanyl, to patients who did not need this drug. Five corporate executives, including Kapoor, were convicted of racketeering conspiracy. Under his leadership, John Kapoor exercised tight control over all decisions within Insys. At dinner parties, disguised as peer-to-peer educational lunches, prescribers received bribes and kickbacks for Subsys prescriptions

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The impact of data breaches in healthcare on research

In the U.S., summary details of private health information breaches that involved more than 500 individuals are available at the HHS OCR portal called Wall of Shame for the public to view [1]. In Europe, EU-level legislation on data privacy has to be transposed into national law. National regulators are also responsible for implementation and enforcement. Unlike in the U.S., information on data breaches and the nature of the incidents is not available in Europe. There is no one place

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Balancing patient privacy and research in care delivery

Balancing patient privacy and research in care delivery, including the use of electronic health records (EHRs) for screening and research, is an ongoing challenge. Registries that contain information that is sensitive and confidential represent a unique set of challenges that impact patient populations enrolled in clinical trials. In an “honest-broker” model, the registry shares only de-identified data with investigators. For example, the Brain Health Registry asks the potential participants to complete a series of online tests, allows access to medical

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Patient trust is key to successful clinical trial recruitment

Health research cannot be done without the active participation of patients, and without access to their medical records to determine the safety and efficacy of treatments. Validation of assumptions from clinical studies conducted before the drugs reache the market depends on the availability of relevant treatment data and methodical comparison of multiple interventions under real-life conditions. When patients lose trust in the system, they may eventually decline to participate by refusing to make their health records available to researchers. Medical

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Patient trust as the most precious prerequisite in health research

Health research cannot be done without the active participation of patients. This especially concerns those who suffer from an incurable disease, should it be common plagues of today such as cancer, Alzheimer’s, or rare and complex disorders. Data collected for monitoring the safety and efficacy of drugs are analyzed for patterns that reveal more information about the products’ benefit: risk profile. Electronic health records are mined for associations and potentially causal links between medications and adverse and unexpected outcomes. Active

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The unbearable cost of pharmacovigilance

“Making more informed drug choices using comprehensive and actionable adverse drug events data leads to improved patient safety and outcomes and reduced costs.” Becker’s Hospital Review, 2015 According to Institute of Medicine (IoM) study To Err Is Human (IoM, 2007), adverse drug events are the largest single category of adverse events in hospitalized patients that account for 19% of all injuries. According to this study, the number of preventable adverse drug events that occur annually in U.S. hospitals ranges from

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Drug diversion – issues and identification

Section 505-1 of the FDCA authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS) if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks. Spotting drug diversion within the current reporting system is a major challenge due to limited information on the offending product. Close surveillance of drugs that could be used criminally to immobilize victims is particularly crucial. Drug-facilitated sexual assault (DFSA) is a

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Biases in pharmacovigilance reporting

The FDA Adverse Event Reporting System (FAERS) database is often taken as the “gold standard’ to which data gathered from social media is compared. This practice, although useful in a practical sense, has some limitations that need to be considered. Disproportionality calculations rely on comparator incidence as a valid and reliable control. The use of FAERS as the gold standard in social media monitoring The database is meant to support the post-market surveillance efforts and contains information on adverse events,

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Detection and annotation of data from social media

Manual annotation of vast amounts of data obtained from social media is a costly commitment because the work must be done by experts with domain knowledge. The amount of data required to train the algorithm is in the tens of thousands of records. Extraction of ADRs from generic platforms such as Twitter is more difficult than from platforms that are highly specialized. Twitter users generate over 400 million posts daily, of which most have no relevance in drug safety. According

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Twitter and Facebook as a source of pharmacovigilance data

Social media use has substantially expanded over the last decade, with 321 million monthly users and 126 million daily users on Twitter. This year, Twitter made a few tweaks to its own user metric: instead of daily users, they count monetizable daily active users. This figure might not be directly comparable to other social networks such as Instagram (500 million daily users) and Snapchat (186 million daily users). Because Twitter cracked down on bots, fake profiles, and spam users, its

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