Thanks to everyone on the great feedback we have received on this blog series focused on pharmacovigilance best practices for clinical and early post-approval biopharma companies. We've discussed discussed the importance of understanding reporting and submission to FDA, taking control of your pharmacovigilance software and creating a shared services model with your CRO.Read More
The idea of selecting, implementing, and deploying pharmacovigilance software is overwhelming for smaller companies. At larger pharma companies, teams of people, vendors, and consultants are dedicated to implement the software and keep it running. Smaller clinical and early post-approval stage biopharma companies have to make do with significantly fewer resources and they are understandably quick to look for outside help.Read More
Traditionally, safety related meta-analyses have been costly, taken significant time to produce and can often miss relevant studies. Further, there has been no efficient way to test the outcome of those studies prior to initiation. This has led to a lot of unnecessarily wasted resources.
Luckily, Advera Health with the help of machine learning, artificial intelligence, and data science is solving this problem for drug safety, epidemiology, and medical affairs departments of all sizes.
Last week we announced the launch of Clinical Meta-Analysis in Evidex capability and we have provided a walkthrough with screen shots is below. This new analytical tool provides the capability to perform meta-analyses of safety issues using a cloud-based software-as-a-service platform.Read More
It's been a busy week in the world of pharmacovigilance software. Major players are being acquired, new players are coming into the market, and there is more and more talk of the "next generation of PV" emerging.
First, this week it was the Wall Street Journal reporting that Nordic Capital has agreed to purchase a majority stake in ArisGlobal at a valuation of ~$700 million. On the heels of Medidata being acquired by Dassault Systemes, the WSJ opines that both deals are bets on the "...increasing adoption of software by the broader pharmaceutical industry".
The SaaS model has become so commonplace that even Salesforce itself had to clarify back in 2015 that “No Software” really meant, “No legacy software, just cloud software.” SaaS and software are now synonymous, in all but a few cases. Pharmacovigilance software is one of those few cases.Read More
We work with biopharma companies across the size spectrum. When small and medium sized companies with marketed products first approach us, many of them have not implemented a software solution for signal management. Why? Many feel their case volumes are not high enough. Others believe they don’t have the right in-house resources. Still others have “a great spreadsheet that works just fine”. All of these excuses, err, reasons boil down to one thing: FEAR.Read More
We founded Advera with the goal of designing a pharmacovigilance platform that provided a modern user interface and next generation data and analytics. The FDA Adverse Event Reporting System (FAERS) was the first dataset we integrated into our Evidex platform. In those early days, we strived to create an optimal FAERS experience, which meant finding a way to quickly ingest, standardize, and de-duplicate the very messy raw FAERS data.Read More
Every year I use the DIA Pharmacovigilance and Risk Management Strategies Conference (DIA-PVRMS) as a barometer to help better understand where the pharmacovigilance and drug safety industry is at and where it is heading in the coming year.
Now that the 2019 session is behind us, I thought I’d summarize my thoughts.Read More
We have a tradition in the RxView blog of starting each new year by asking if the year ahead will be “The Year of Drug Safety” or “The Year of Healthcare Technology”. We typically lay out a few thoughts on why the year ahead has the potential to be a big year.Read More
I recently wrote an article for PharmExec called Pharmacovigilance Software is Having its “Salesforce” Moment. It discusses how the market for pharmacovigilance software is starting to catch up to other verticals through disruption by technological innovation. I argue that the barriers that were in place such as drug safety’s role as a cost center and the difficulty of accessing data are breaking down. And the result is that there are now choices in the pharmacovigilance software market that weren’t available just a few years ago.
After re-reading the article, I think there is an important, key point that got lost and could use further definition. The concept of the evolution of software from a “system of record”, to a “system of engagement”, to a “system of intelligence”, and why that evolution is so important.Read More
Over the course of the last blog posts, the requirements of the four stages of the GVP Module IX Signal Management (GVP IX) process were discussed in great detail, along with specific ways in which Evidex Signal Management can help an organization to efficiently meet GVP IX requirements in a single, user-friendly, easy to implement platform built on a foundation of safety data and analytics.Read More
After an initial review, a determination is made whether the signal is non-validated or that it is in fact a validated signal that needs prioritization and further assessment.Read More
Advera Health has long embraced the fact that safety signals can arise from a wide variety of data sources. The authors of GVP IX agree. The module specifies that common datasets include spontaneous reporting (MAH’s own database, national databases such as FDA Adverse Event Reporting System (FAERS), EudraVigilance, and VigiBase), active surveillance, studies, and scientific literature. All of these data sources should be considered depending on characteristics of the product and based on clinical judgement.Read More
Good Pharmacovigilance Practices (GVP) are a set of measures put into practice in 2012 to facilitate the performance of pharmacovigilance in the European Union (EU). GVP is broken out into several modules that govern different aspects of pharmacovigilance processes. GVP Module IX - Signal Management (GVP IX) provides general guidance and requirements on scientific and quality aspects of signal management.
The guidelines apply to Marketing Authorization Holders (MAH) for medicines authorized by the European Medicines Agency (EMA) and EU Member States. However, in the absence of formal regulation on the process of signal management by other health authorities, such as FDA, these guidelines have become the de facto global standard.
There are several aspects of the GVP IX process:Read More
In addition to asking questions around the value and validity of using social media monitoring for pharmacovigilance, we also often get questions around our thoughts on whether social media data are inherently biased. When I brought this question to the Booz Allen Epidemico data team, they educated me on the three dimensions of bias that come from different drug safety datasets: Patient reported outcomes, seriousness, and completeness. The graphic below shows how those three dimensions differ across social media, clinical trials, spontaneous reports, and EHR records.Read More
One of the biggest fears that pharmacovigilance professionals have when it comes to using social media is that amount of work that it will create. How will you be able to take the time needed to "clean" the data and get it fit for analysis? Machines can be trained to identify posts with drug-adverse event combinations, but it is more difficult for them to be able to ensure the post is an accurate representation of an adverse event. Thus, Booz Allen's Epidemico team uses human curation to provide the most accurate data.Read More
In recent years, the rapid development of “big data analytics” has created a surge within pharmaceutical companies to leverage data from the entire value chain to drive actionable insights. Although other departments within pharmaceutical companies have long been focused on utilizing data driven insights, modern pharmacovigilance departments are just starting to fully incorporate a data-and-analytics-first approach to signal detection, validation, and management.Read More
In talking with current and prospective clients around Advera Health's partnership with Booz Allen's Epidemico social media monitoring data, we get asked a lot about not only the validity of the process Booz Allen goes through to cut through the "noise", but also about the value social media monitoring has for post-marketing drug safety surveillance and pharmacovigilance. In addition to highlighting the primer we put together, we also refer those interested to the numerous academic publications on the topic. Three core publications that Booz Allen has conducted in collaboration with regulators and industry serve as a starting point, and below is a summary of key points and links to the full publications.Read More
A study published Tuesday in the Journal of the American Medical Association found that people who take at least one of the 200 drugs that list depression as a side-effect are, in fact, more likely to be depressed. The study, which included 26,192 adults who participated in the National Health and Nutrition Examination Survey, does not prove a causal effect, but the association is striking.Read More
Modern pharmacovigilance departments today do more than process and review ICSRs. They are involved in the entire lifecycle of a drug, providing vital data points and analysis that inform everything from clinical trial design to commercial planning to post-market safety surveillance. In order to perform well, pharmacovigilance and safety science teams require access to an array of data and the analytics to make sense of those data. The insights gained from unique combinations of clinical and real world data drive signal detection, epidemiological research, and evidence generation, all of which support organization-wide decisions.
The problem is that drug safety insights are hard to obtain and teams often get caught in a "paralysis by analysis" trap.Read More
Wow, it’s the end of February. I’m sure I’m not the only one who feels that the first two months of 2018 have flown by. Advera Health’s engineering, product, and analyst teams have been hard at work. Evidex’s back-end data architecture has been enhanced to keep up with our growing library of datasets and to ensure the analytics layered on all of the data are efficient and fast to meet client demands.Read More
It is now well established that the rapid expansions of the internet and computing power have opened up the use of social media and Internet forums for pharmacovigilance. These sources contain untapped, albeit noisy, safety and benefit information. As noted in Social Media Listening for Routine Post-Marketing Safety Surveillance, published in the journal Drug Safety, methods exist to reduce noise and make the data suitable for post-marketing safety surveillance. However, the use of these data to date have been constrained by limitations in how to best implement novel methods without disrupting traditional signal detection management and evaluation work flow.Read More
We have a tradition in the RxView blog of starting each new year by asking if the year ahead will be “The Year of Drug Safety” or “The Year of Healthcare Technology”. We typically lay out a few thoughts on why the year ahead has the potential to be a big year.
This year feels different. Maybe it’s the incredible bull market that has inflated our confidence or the fact that my colleague Jim Davis feels that it is a foregone conclusion that the Philadelphia Eagles will finally win the Super Bowl (sorry Jim, that’s ridiculous!). Or perhaps it’s the fact that our client roster keeps growing, Evidex keeps getting more valuable to our users every day, and key industry opinion leaders are confirming that our vision is THE path forward. Whatever the reason, I’m willing to be a bit bolder this year.
2018 WILL BE the year that the pharmacovigilance industry embraces the next generation of drug safety data, analytics, and software; What we call Pharmacovigilance 2.0.Read More
Recently the FDA published the Q2 2017 version of Potential Signals of Serious Risks / New Safety Information as identified by the FDA Adverse Event Reporting System (FAERS).Read More
Last week we announced the addition of VigiBase global safety data to the Evidex platform. VigiBase is the unique global database of individual safety reports collected from over 110 countries by the World Health Organization. It totals over 15 million adverse event reports since 1968 and is administered by the Uppsala Monitoring Centre in Sweden.
This is an exciting development for our company, for our clients, and for the drug safety community at large.Read More
Advera Health released a new functionality framework in Evidex this week called Custom Analytics. The goal of Custom Analytics is to provide Evidex users an easy way to perform complex queries across all of the clinical, spontaneous and other real-world data included in the Evidex platform and to return a filtered set of specific information.
We have launched Custom Analytics with a Custom Drug-Adverse Event Analysis search function. With the Custom Drug-Adverse Event Analysis, users can easily filter case reports by specific drug combinations, demographic, and descriptive information, create customized MedDRA queries with multiple preferred terms, and calculate Reporting Odds Ratios (RORs).
The best part? It's simple to use.
Let's demonstrate the power of Custom Analytics through a case study, analyzing adverse events associated with endothelin receptor antagonists (ERAs) using the FDA Adverse Event Reporting System (FAERS) data.Read More
Santa Rosa, California in Sonoma County is where we live and work. It's probably best known for its world class wines, restaurants, and hotels.
Last week, we made global news for a much different reason.
Starting early in the morning on Monday Oct 9, a series of wildfires tore through the city of Santa Rosa and the surrounding areas. By the end of the week, thousands of homes and commercial buildings had burned, more than 40 people had died, and another 50+ remained missing. For a county with a total population less than 500,000 and fewer than 200,000 housing units, the effect on our home town has been devastating.Read More
It’s been an exciting week in the normally staid world of drug safety.
Last Thursday, FDA launched a public dashboard for FAERS (the FDA Adverse Event Reporting System). We’ve been calling on FDA to do this for years, so we were quite excited to read the news and take the new dashboard out for a spin.
Apparently, a lot of others were just as excited. The site almost immediately stopped working and stayed that way for most of Friday.Read More
Most pharmacovigilance departments are resource constrained. Whether its human capital, budget, or both, the drug safety specialists within pharmaceutical companies are being asked to do a whole lot with very little.Read More
One of the key benefits of a drug safety evidence aggregation platform is the data source flexibility it provides. Historically, smaller organizations have put off automating aggregate signal detection on FDA Adverse Event Reporting System (FAERS) data to avoid the cost and time commitment needed to implement traditional signal detection software. And those organizations that do have traditional software installed, have typically limited use to specific functional areas within drug safety and “expert” users, making FAERS data and analytics hard to access. An evidence aggregation platform makes these data and the related analytics easy and provides for a robust source of insight.Read More
Last month, FDA released their quarterly watch list of ongoing drug safety concerns. My colleague Jim wrote a blog post on some of the major talking points around the update, not on the drugs or the risks themselves, but general pharmacovigilance themes. Our post this week focuses on one of the risks that was specifically discussed by FDA on the SGLT-2 class of diabetes drugs. The SGLT-2's had triggered a safety signal for nephrolithiasis (aka kidney stones). Evidex RxSignal analysis had also predicted this safety signal for most of these SGLT-2 drugs, with many of the signals being triggered more than a year prior to this alert.
However, unlike the 12 other safety issues in this same alert, the FDA quickly determined that despite the safety signal shown in the postmarketing data, “no action is necessary at this time, based on available information”. In other words, the FDA does not believe that kidney stones should be disclosed as a risk to the labels of these medications.
Why did the FDA make this determination so quickly? What information did the FDA use?Read More
Earlier this month FDA quietly published a quarterly update to their publicly available “watch list” of ongoing drug safety concerns. The updates are based on Q1 2017 FDA Adverse Event Reporting System (FAERS) data. You can download a copy of our recent Evidex Alert, covering the new additions, clarifications, and “all clears” so I won’t get into the details in this post. However, it is worth noting that there were fourteen unique drugs, or in some cases entire classes of drugs, that were included in the update. Many of the drugs have been on market for quite a long time and otherwise would be considered to have a well established safety profile. For 8 of the 11 alerts that could be signaled for (3 of the alerts were AEs that were already labeled for), Advera Health’s RxSignal early warning system did its job and picked up on the signal. The remaining alerts either weren't on a RxSignal eligible adverse event, meaning it wasn't a serious event that the FDA typical takes action on, but there was noticable elevated reporting as defined by reporting odds ratios (ROR).Read More
Canada has long had a more open system for reporting and searching adverse drug events. They provide an easy to use online form for healthcare providers and consumers to make direct reports, which contrasts significantly to the cumbersome reporting form provided by FDA here in the U.S. They provide a web-based search tool that enables anyone to search through adverse event reports submitted to Health Canada. Nothing like that exists from FDA in the U.S.
Now comes word that Canada is taking a step toward something that we’ve long believed to be a crucial factor in improving and increasing adverse event reporting – requiring reporting from healthcare providers.Read More
It’s been a very busy week for many of us. School’s finishing up for the kids here in California (no snow days here!), the annual ACSO conference was in full swing, the Warriors are up 3-0 in the NBA finals, and the media coverage of the Comey hearing has been non-stop.
With everything else going on, we wanted to make sure to draw your attention to some significant drug safety reporting over the past week, as we wouldn’t want to be accused of “failing to warn”!Read More
If you read this blog, you probably follow the world of drug safety closely. So I’m sure you saw the JAMA article, and the resulting coverage by the main stream media, that was authored by Downing, et al., Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.
If you haven’t had a chance to read the study yet, the results demonstrated that a third of every drug approved from 2001-2010 was subject to post-marketing action by FDA. Even more alarming was the finding that drugs with accelerated approval by FDA during this period were twice as likely to be subject to label changes or warnings after approval.Read More
Next week, May 3rd and 4th, will mark a big moment for Advera Health. Our Chief Product Officer Bob Kyle and I will be attending the World Drug Safety Congress in Philadelphia. The moment will be big, not because we are exhibiting for the first time (we are), or because we are demonstrating significant advances in drug safety data (we are), or even because I’m a huge fan of the Philadelphia Eagles (I am) and Bob has always dreamed of imitating Rocky and running the 72 stone steps before the entrance of the Philadelphia Museum of Art (he hasn’t).Read More
FDA released the fourth quarter of Adverse Event Reporting System (FAERS) data on Thursday March 16th. By Monday March 20th, our team had run the data through our proprietary RxFiler optimization process and the de-duplicated, cleaned, and properly cataloged data were onto our Evidex platform and ready for use by our clients.
For the fourth quarter, we processed 310,222 new unique case reports, which brought the total new unique case reports for 2016 to 1,253,464.
While a full analysis of our Q4 findings is still pending, it’s clear that the sheer volume of case reports continues to grow rapidly.
Our infographic below provides some key details:
We're happy to have a guest writer on the RxView blog this week, Alan Lukazewski, RPh – Director of Clinical Pharmacy at WEA Trust.
WEA Trust is a not-for-profit health insurer serving Wisconsin public employers, their staffs and families. In my role as Director of Clinical Pharmacy, I manage pharmacy benefits for WEA Trust, including prior authorization management, clinical program design, and specialty pharmacy management. Within those areas, I focus attention on adverse drug event detection and prevention, especially in older adults.
Last year, we partnered with Advera Health on a unique project to determine whether we could use data from theFDA Adverse Event Reporting System (FAERS) to determine total medical costs for a particular class of medicines. Previously, Advera Health published a study detailing their methodology for calculating medical costs from FAERS data, but this would be the first study to pair FAERS data with specific claims data to determine downstream medical costs.Read More
It’s been an exciting week for drug safety with articles in both USA Today and FiercePharma examining the five-fold rise in reporting of serious adverse events into FDA’s Adverse Event Reporting System over the past twelve years. We were thrilled to see Advera Health featured prominently in both of those articles.
Despite the significant reporting increase, limitations in the use of FAERS data for post-market surveillance remain. One of the biggest limitations is that not all adverse events are reported. As a spontaneous (i.e., voluntary) reporting system, it’s simply not possible for every adverse event to be recorded. This is different from a controlled clinical trial where all adverse events and outcomes are recorded.Read More
I'm pleased to introduce Jill Notte, Director of Global Marketing, APCER Life Sciences, who authored this week's post.
As a marketing communications professional in the pharmaceutical industry, I try to choose my words carefully in everything I write. The field of drug safety, where I have spent the past 15 years of my career, is particularly choosy about its terms. Words have precise definitions, and so we say, for example, that an event is “suspected” when we haven’t yet confirmed whether it is “unexpected” or “serious.”Read More
This week marked the annual HIMSS Conference. HIMSS, Healthcare Information and Management Systems Society, is the big annual gathering of IT firms trying to market their wares into healthcare systems, pharmaceutical companies, and health insurers.
While usually a time for big partnerships, acquisitions, deployments, and new client wins, this year’s HIMSS kicked off in a rather inglorious manner. On Sunday news broke that world-renowned cancer center MD Anderson had discontinued their partnership with IBM Watson. After a string of big wins by the Watson team, this appeared to be the first – and certainly the largest – setback.Read More
A few weeks ago, I published a post in this blog, Drug Safety Progressives - The Rise of the Pharmacovigilante. I was blown away by the positive response and resulting discussions. I even received a few requests for the t-shirt shown in the picture, but I’m sorry to say that our business model is based on software-as-a-service, not retail. But I digress… back to the Pharmacovigilantes…Read More
The United States is a polarized place right now. Democrats vs. Republicans. Liberals vs. Conservatives. President Trump vs. the world. The divide runs deep and battle lines have been drawn. And while there is no escaping this highly publicized political chasm, there is another fight being played out in the shadows… The Drug Safety Progressives vs. the Drug Safety Conservatives.
I was at the DIA Pharmacovigilance and Risk Management conference last week, fittingly taking place in Washington D.C right after the inauguration and the women’s march. The division was obvious.Read More
In November 2016, I was honored to be asked to join the Board of Directors of the Foundation for Sarcoidosis Research (FSR). The foundation began in 1999 as a grassroots organization, and now has expanded their efforts and impact to become the leader in supporting sarcoidosis research. I'm looking forward to using my experiences both as a sarcoidosis patient and in drug safety to contribute to the mission. Please visit www.stopsarcoidosis.org for more information.
I originally wrote the post below for the FSR blog. The original can be seen here.Read More
Seventy two hours after 2016 Q2 FDA Adverse Event Reporting System (FAERS) data were publicly released by FDA, our RxFilter® process had it standardized and loaded into the Evidex platform. Based on the volume of data in Q2, it looks like we’re well on the way to yet another record year of adverse events reported into FAERS.
Here is a chart of new case reports (including our estimate for full year 2016). Note that these numbers are based on a clean dataset; de-duplicated, primary suspect cases only).Read More
This post was originally published on the BBK Worldwide Blog.
Big Data was a Big Topic at this year’s DIA Annual Meeting, and continues to be an area of interest and investment across the life sciences and healthcare industries as organizations seek to further integrate new data streams and real-time analysis into clinical R&D. Data collection, management and analysis are at the crux of everything we do here at BBK, and our clients are keenly interested in how to manage and optimize Big Data. We interviewed Brian Overstreet, CEO of Advera Health Analytics, a leading healthcare informatics company, to get their take and to see how access to meaningful data is helping to push healthcare forward.
We are pleased to report that our latest major publication, “A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports” was released this week in the esteemed journal “Drug Safety.” It was published as an online-first feature and will also appear in the April copy of the print version of Drug Safety.Read More
One year after its birth, the ultimate data parasite has come of age by latching on to a $3 billion host. It is big, blue, pretty good at Jeopardy, and if you were to believe the data detractors, utterly useless.
We are proud to announce after months of hard work and dedication from everyone on the Advera Health development team that we have launched the newest version of RxSignal. RxSignal is our proprietary tool which identifies serious adverse events which are most likely to be added to a drug’s label in the future. This latest version produces more accurate signals that lead to label changes involving more important medical events while producing a lower number of signals that do not lead to label changes or actions by the FDA.
A recent article by Pharmacy Times titled, “Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training” made me really angry.
I’m angry at the pharmacists, I’m angry at FDA, I’m angry at the academic institutions, I’m angry at the whole damn system.
Why? – go read the article. Here’s the link again.
Indifference, insecurity, ignorance, guilt, fear, complacency, and lack of training. Those were the main factors the authors of the underlying study cited for why pharmacists fail to report adverse drug events. It’s like the 10 plagues on Passover, except worse.Read More
The use of the FDA’s Adverse Event Reporting System (FAERS) for broad post-approval drug safety studies has long been curtailed due to three assumed limitations of the dataset. AdverseEvents has systematically set out to debunk all three of these myths through the use of peer-reviewed studies in major academic journals. This blog article summarizes our findings and we invite you to review our complete journal articles for more details.
On June 3rd, the FDA launched OpenFDA, in an attempt to take large internal datasets and make them more accessible and usable by the developer and business community.
OpenFDA is delivered in a search-based API that should enable software developers to more easily build applications based on adverse event data from the FDA Adverse Event Reporting System (FAERS) dataset for the period 1/1/2004 to 6/30/3013. The FDA has announced plans to add device and food adverse events data to the framework, along with structured product labeling and recall data (update: drug and device recall data was added on July 16).
The launch was heralded with the sort of buzz and hoopla usually reserved for a major product launch from a Silicon Valley startup. I decided to hold off on any analysis and opinion until now to give our team the needed time to look through the system thoroughly.Read More
Creating actionable analytics around the big data set provided through the FDA Adverse Event Reporting System (FAERS) is the backbone of the AdverseEvents Explorer software. Given the infrequency of releases in 2013, you can imagine how excited we were when we heard the news that Q1 2013 data were finally posted for download. While probably not surprising, self-described data geeks do get excited about data.
The centralized computerized information database for post-marketing drug safety surveillance is the FDA Adverse Event Reporting System (FAERS), which is currently growing by approximately 800,000 new cases per year. In 1993, FAERS (then referred to as AERS) launched with a simple, and worthy, goal: facilitate the reporting of post-approval ADEs. For healthcare professionals and consumers reporting is voluntary, but drug manufacturers must report all known ADEs to the FDA. In 2007, in order to enhance post-approval drug safety analysis even further, the FDA began to require drug companies to enact Risk Evaluation and Mitigation Strategies (REMS) to better manage, track, and report ADEs.