2021 Virtual Workshop – Innovative Approaches to Drug Safety
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Will pharmacogenomic testing become a routine part of clinical care?
Veracuity Blog Will pharmacogenomic testing become a routine part of clinical care? Some adverse drug events are a predictable consequence of therapeutic, especially dosing failures. Idiosyncratic toxicities, on the other hand, are much less predictable and much more insidious. Pharmacogenomics is a powerful tool that can reveal some of these vulnerabilities before toxicity occurs or, if performed after the fact, can explain the cause of an adverse drug event that has already happened. Clinical trials cannot detect all adverse drug events due to the limited population in which the drugs…
Utilizing pharmacogenomic testing to ensure effective therapy
Veracuity Blog Will pharmacogenomic testing become a routine part of clinical care? Some medications are administered as prodrugs that need to be metabolized in the active form by the body. An example of such a drug is codeine. It undergoes biotransformation into morphine by CYP2D6. Patients who transform codeine faster who are referred to as ultrarapid metabolizers, transform codeine into morphine so fast that they can develop opioid toxicity. On the other hand, poor metabolizers would not be able to produce enough active moiety, thereby making the drug ineffective. One…
Adverse incidents of medical devices
Veracuity Blog Adverse incidents of medical devices Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746 The new European legislation places numerous new obligations on manufacturers of medical devices marketed in Europe. The current requirements for reporting adverse incidents of medical devices in Europe are detailed in the Medical Devices Directive (MDD) [1], Active Implantable Medical Devices Directive (AIMD) [2] and In-Vitro Diagnostic Devices Directive (IVDD) [3]. The current procedures are described in Guidelines on a medical devices vigilance system [4]. The manufacturer is obliged to report…
Veracuity’s platform GoDiva will transform medical device surveillance
Veracuity Blog Veracuity’s platform GoDiva will transform medical device surveillance
Meeting reporting obligations for medical devices
Veracuity Blog Meeting reporting obligations for medical devices Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746 U.S. manufacturers of medical devices who are placing their devices on the European market have been facing many challenges relating to the new coming European legislation. The deadline for implementing the European Medical Devices Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746) was postponed from May 2020 to May 2021 due to the COVID-19 outbreak, giving manufacturers more time to prepare. Manufacturers are required…
Publication: The value of real-world evidence for clinicians and clinical researchers in the coronavirus crisis
Veracuity Blog Publication: The value of real-world evidence for clinicians and clinical researchers in the coronavirus crisis
Supervised learning approach a necessary and important step in monitoring drug-related social media posts
Veracuity Blog Supervised learning approach a necessary and important step in monitoring drug-related social media posts Social media, such as Facebook and Twitter, provides many users with an outlet to share opinions online among a broad audience. Some of these discussions concern their experiences with prescription and over-the-counter (OTC) medications. These conversations can have an outsized influence on the public perception of the products they discuss. The sentiment of individual posts regarding the efficacy and side effects of medications can be either positive or negative. Consumers may also disclose misuse…
COVID-19 Survey is now available in Spanish and Italian
Veracuity Blog COVID-19 Survey is now available in Spanish and Italian To increase the reach, Veracuity LLC and Alliance for Clinical Research Excellence and Safety (ACRES) now offer the survey in multiple languages, including Italian and Spanish. TransPerfect Life Sciences, a leading provider for global development and commercialization of drugs, treatments, and devices, has generously donated translation services in support of these efforts. Healthcare providers or hospitals interested in completing the survey or contributing data to the initiative can do so at https://www.acresglobal.net/covid-19. The target audience for the survey is any healthcare…
Veracuity joins COVID-19 Evidence Accelerator
Veracuity Blog Veracuity joins COVID-19 Evidence Accelerator In April 2020, the Veracuity team developed a survey tool for the collection of data from hospitalized COVID19 patients. This initiative was implemented and widely distributed by the Alliance for Clinical Research Excellence and Safety (ACRES). At the recommendation of the Principal Deputy Commissioner of Food and Drugs, Amy P. Abernethy, M.D., Ph.D., Veracuity joined the COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research. The scarcity of evidence and ambiguity concerning the spread of…
ACRES and Veracuity Launch COVID-19 Real World Evidence Initiative
Veracuity Blog ACRES and Veracuity Launch COVID-19 Real World Evidence Initiative The Alliance for Clinical Research Excellence and Safety (ACRES), a Massachusetts-based global non-profit collaborative, is distributing a simple online tool for collection and analysis of real-world data on predisposing conditions, treatment strategies, outcomes and side effects experienced by COVID-19 patients. This survey tool, designed by Veracuity LLC, expands data collection from providers and hospitals in near-real-time to enhance understanding of the COVID-19 pandemic, including risk-factor identification, triage, treatment management and outcome predictors to gain insight into the safety and efficacy of traditional,…
Benchmarking AI in healthcare
Veracuity Blog Benchmarking AI in healthcare Artificial intelligence (AI) models are becoming an indispensable part of healthcare delivery due to the ever-growing volumes of data the sector produces. The technology supports countless operations, from pattern recognition and classification of disease entities to clinical decision-making. The purpose of AI is to decrease the burden of repetitive tasks on staff and provide information support. Exploration of the applications of AI in health has attracted considerable investment. Despite the significant potential, there are numerous unresolved issues in AI applications in the healthcare sector,…
A New Approach at Conducting Post-Market Drug Safety Surveillance
Veracuity Blog A New Approach at Conducting Post-Market Drug Safety Surveillance The early foundation of Veracuity’s platform eVERA tracks back to a series of works by Dr Veronika Valdova in collaboration with Dr Jonathan Fishbein. The works describe the shortcomings of the current post-market drug safety surveillance and outline ways the process can be optimized. The material was ultimately organized in the form of a working paper. A New Approach at Conducting Post-MarketDrug Safety Surveillance describes the production of real-world evidence at the hospital level to provide accurate and timely insight…
The opioid epidemic in drug safety reporting systems
Veracuity Blog 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…
The impact of data breaches in healthcare on research
Veracuity Blog 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…
Balancing patient privacy and research in care delivery
Veracuity Blog 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…
Patient trust is key to successful clinical trial recruitment
Veracuity Blog 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.…
Patient trust as the most precious prerequisite in health research
Veracuity Blog 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…
The unbearable cost of pharmacovigilance
Veracuity Blog 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 380,000 to 450,000…
Drug diversion – issues and identification
Veracuity Blog 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 sexual activity…
Biases in pharmacovigilance reporting
Veracuity Blog 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 monitoringThe database is meant to support the post-market surveillance efforts and contains information on adverse events, medication errors and product quality…
Detection and annotation of data from social media
Veracuity Blog 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…
Twitter and Facebook as a source of pharmacovigilance data
Veracuity Blog 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,…
Quality of evidence in pharmacovigilance
Veracuity Blog Quality of evidence in pharmacovigilance Database WITHDRAWN lists 578 drugs that were pulled out of global markets due to safety reasons. Most importantly, the database contains information about therapeutic targets, off-targets, underlying mechanisms of toxicity involved, and biological pathways. In addition, the database maps single nucleotide polymorphism (SNPs), genetic variations that are associated with toxicity in some people [1]. Post-market safety withdrawals occur for a variety of reasons, from lack of efficacy to manufacturing and business reasons. Yet, for approximately half of the drugs in the database, safety concerns were…
The right drug at the right dose to the right patient: the value of pharmacogenomic information
Veracuity Blog The right drug at the right dose to the right patient: the value of pharmacogenomic information In April 2019, Mozilla internet health report published an article “23 reasons not to reveal your DNA” [1]. The primary reasons why people should worry about sharing their DNA with strangers are quite obvious – privacy concerns, the potential for abuse and limited validity of the findings top the report’s list of reasons. While there are good motives why one should stay away from universal wavers that allow the use of DNA…
Social media as a source of adverse drug effects
Veracuity Blog Social media as a source of adverse drug effects People increasingly turn to online sources to search for health-related information, investigate options they have, and only then decide whether it is worth investing time and money to get the qualified opinion of a healthcare professional. Pew Research Center asked U.S. adults about their behavior online when it comes to health-related questions. The results were astonishing: 35% of U.S. adults went online to figure out a medical condition they or people around them might have. Of these online diagnosers,…
Digital epidemiology in pharmacovigilance
Veracuity Blog Digital epidemiology in pharmacovigilance One of the most important shortcomings of the current pharmacovigilance data collection system is the fact that the FDA Adverse Drug Event Reporting System (FAERS) does not provide any insight into the incidence, prevalence, and rates of occurrence of adverse drug events in the post-approval period [1]. To improve the ability to detect trends and rates, data collection systems need to be modified to incorporate less traditional data points. The utilization of patient-generated data such as search engine logs, social media posts, Wikipedia access…
Pharmacovigilance at a crossroads
Veracuity Blog Pharmacovigilance at a crossroads The global pharmacovigilance market is growing and is still expected to grow. In 2013, post-market safety surveillance accounted for 60% of the global pharmacovigilance market and should reach $6 billion by 2020. Main drivers for increased reporting of adverse drug reactions include compliance requirements and liability resulting from high-profile product failures. Implementation of a reporting system to comply with regulatory requirements for a Phase I study can cost about $100,000, before the first serious adverse event (SAE) even occurs [1]. The reporting system collects…
The compliance trap
Veracuity Blog The compliance trap Pharmaceutical industry is a tightly regulated business, especially in the U.S. and in Europe. Before medicines reach the market, they must undergo extensive clinical testing. Upon reaching the market, approved drugs can be prescribed to any patient if the physician can reasonably expect therapeutic benefit for the specific patient. Clinical research on human subjects can be sponsored by the industry, academic institutions, hospitals and even by individuals. A sponsor is the organization or person who initiates the study and who has authority and control over the study,…
The cost of patient harm
Veracuity Blog The cost of patient harm U.S. health care spending reached $3.5 trillion in 2017, of which hospital care was $1.1 trillion and physician and clinical services was $694 billion. Retail prescription drugs cost $333.4 billion [1]. The cost of drug-related patient injury, referred to adverse drug events (ADEs) in the U.S. is estimated at $528 billion in 2016 [2]. Costs associated with ADEs include new hospital admissions, readmissions, prolonged length of inpatient stay and additional therapeutic interventions. According to a decade old research published by the Institute of…
Pharmacovigilance history, importance and current status
Veracuity Blog Pharmacovigilance history, importance and current status Pharmacovigilance, a science that studies the adverse effects of medicines, has come a long way since its inception in the 1960’s when the thalidomide disaster occurred. Manufacturers of medicinal products must prove the safety and efficacy of their products to obtain regulatory approval and place their product on the market. Side effects of medicines identified in clinical trials are now included in the drug label, along with indications, contraindications, interactions with other drugs and conditions of use. Specific population subgroups such as…
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