January 13, 2014 Issue
The Most Powerful Name In Corporate News and Information
Integrating Drug Safety Information for Pharmacists and Physicians
Drug side effects can cause substantial harm. They result in serious injury to more than 2 million people in the United States each year, including more than 100,000 fatalities. The costs of preventable hospital re-admissions, where at least one third are related to medications, tops 12 billion dollars a year. Unfortunately, the challenge of drug safety is worsening. 30 million Americans now take 5 or more medications, a statistic that will increase 7% over the next decade as more baby boomers retire. In addition, the science of drug safety is complex. There are more than 15,000 different adverse drug events as well as thousands more drug-drug and drug-clinical interactions. For patients taking 10 or even 20 medications, the amount of information is currently unmanageable.
data refinement process employs complex algorithms and hands-on analysis by
pharmacists and physicians to integrate drug safety information from
thousands of product labels and millions of aftermarket case reports.
ScopiaRx compares this proprietary database to a consumer’s entire
medication regimen including brand name products, generics, and
over-the-counter medications and supplements. Our unique algorithm then
sifts through the hundreds of safety warnings and precautions that may apply
to one patient and generates a one-page summary. Patients no longer have to
compare safety information from stacks of information for 5, 10, or more
medications. ScopiaRx does this automatically in seconds, and generates a
list of the most important side effects for the complete mixture of
medications. It’s quick, easy and complete. When a patient or family
caregiver observes early signs of a side effect, the ScopiaRx provider
report shows doctors and pharmacists all of the evidence so that they can
recommend the best change.
30 W. Third Street
Cincinnati, OH 45202
Interview conducted by: Lynn Fosse,
Senior Editor, CEOCFO Magazine, Published: January 13, 2014
CEOCFO: Dr. Huth, what is the concept for ScopiaRx?
Dr. Huth: ScopiaRx is a software company that solves the problem of managing hundreds of safety precautions when someone takes 5, 10 or even 20 medications. Because no good tools to manage this information have been available for doctors and pharmacists, thousands of patients have been injured. Three distinguishing features of ScopiaRx have allowed us to develop a product that successfully addresses this information management problem: personalization of the safety information based on medical, demographic, and lifestyle information; a careful application of aftermarket drug safety data to highlight commonly observed side effects; and creation of composite alerts that pull together safety information just as an expert pharmacist or doctor would do if they had an hour to analyze your case.
CEOCFO: Why is there a need for an independent service? Are doctors not doing what they should?
Dr. Huth: That is a good question! When someone is taking multiple medications the amount of safety information is pretty much overwhelming. A number of side affects can and do occur when someone takes 5 or 10 medications. The challenge is to balance the risks and benefits. Unfortunately, the bottom line is that doctors have a couple of minutes, the pharmacists have maybe a couple of minutes and when someone takes ten medications the amount of safety information can take hours to retrieve and analyze. However, you want to do it properly with the tools at hand. Therefore, what ScopiaRx does is we act as an automated PharmD to look up all of this information related to, not only the medications, but the characteristics of the patient; the demographic information, the clinical information, the lifestyle information; such that you can take that vast network of safety information and condense it down into what is the most important information for this particular person.
CEOCFO: Often in my experience, when you are prescribed a medication, the pharmacy will alert you to a possible conflict. How superficial is that? Could you explain some of the levels that you are able to reach in considering potential problems?
Dr. Huth: We have a comprehensive view of the product label information that comes with every approved medication and we layer on top of that aftermarket information. These are case reports that are submitted to the FDA after a drug is on the market. There are millions of those case reports. Therefore, when you look at two questions; what was observed in clinical trials when hundreds or thousands of patients took a medication, and what was observed after the drug approval with use by thousands to millions of patients, we answer both. We can comprehensively retrieve all of this information and put it together in such a way that this knowledge now becomes enlightening about the risks most important for you.
CEOCFO: Who is using your services today?
Dr. Huth: Right now, we are offering this direct to the public using our web based app for tablets and PCs and an iPhone app that can be downloaded from the Apple store. We are also doing pilot studies with healthcare institutions. We are just getting going with offering this through homecare organizations, assisted living facilities, and employers which I am really excited about. Meeting the needs of seniors in their homes is an area where there is a huge need for medication safety. Many of these seniors have a number of serious conditions and monitoring them is very challenging. This burden usually falls on the shoulders of family caregivers and aids from home health organizations, neither of whom are medically trained. Resources are simply not available for close oversight by nurses and doctors. The potential to get information like ScopiaRx into the hands of these caregivers is just a great thing. The owners of the companies that we have talked to so far are thrilled with the idea of providing better services to their clients by acting as the watchdog for side affects and identifying problems before clients end up in the emergency room. We think that by offering ScopiaRx through employers, even more caregivers will get access to this important tool.
CEOCFO: Has the concept been tried by other organizations?
Dr. Huth: No. We are the first who has taken this approach of analyzing all of the medications together considering both the clinical trial and aftermarket data. And then distilling this information down, not only for the doctors or pharmacists, but actually getting information into the hands of the patients and their caregivers, no one has ever done that before.
CEOCFO: You will see a commercial or you will read an ad for a medication and they have to list all of the potential side effects, however unlikely they might be. How do you weigh each potential problem when making an assessment?
Dr. Huth: What we do is personalize the information and walk people through the process of finding out what is most important for them. A good example is just as you said, when you hear an ad for a drug they will rattle off at least ten side affects. Those are typically the warnings that come in the product insert. However, these warnings usually apply to people with certain conditions. What we do is handle the information is a smart way. We organize all of the drug label information and produce a customized questionnaire that allows people and their providers to quickly go through and identify which of those scary warnings even applies to them. Then we also do something called composite risk assessment where we look and say, “Is there more than one reason why I should be concerned about a side effect, such as hurting my kidneys. ”Patients assume hundreds of minor medication risks every day. Most of them should be ignored because the drug benefits far outweigh these risks. But when several minor risks for the same outcome start to stack up, the scale can tip to the other side and the risks are greater than the benefits. That is a composite risk that we bring up to the top of the list, and is how we “get through the weeds”, so to speak.
CEOCFO: There is a trend towards more accountability and there is a trend towards prevention.
Dr. Huth: Absolutely, these trends are even more important in the age of the Accountable Care Act. The introduction of better information technology into healthcare is going to make it easier to satisfy these goals. Organizations and the physicians themselves will be able to keep track of more information in an easier way and make better decisions about not only population health issues, but also what is best for this particular patient in my office. There are growing pains now because many institutions are just completing major upgrades to collect data and have not yet implemented great tools to use the information. ScopiaRx is in a position to be the kind of tool that takes advantage of all of the data that is being collected in the health systems and use it in a smart way. That is one of the reasons why we are excited to be offering this to more health systems when they are in a position to take a breath and tackle polypharmacy safety.
CEOCFO: You mentioned that the homecare people are interested. Are the other parties showing interest? Because there is so much going on and so much information that is bombarding everyone, particularly in healthcare these days, how do you get attention?
Dr. Huth: We have talked to doctors, pharmacists, nursing home administrators, family caregivers and patients. The feedback has been tremendously positive about the need for a service like ScopiaRx that helps patients manage complex medication therapies. At the end of the day we need to make businesses more successful. For pharmacies I think the answer is a resounding yes. This is something that they do better than anyone else already. They are the go to provider for medication safety. Therefore, the opportunity to do that in a better way just fits with their business. The pharmacy benefit management companies are similar in that regard in that they are providing drug safety information to employers and to Medicare plans, so there is a natural fit there as well.
CEOCFO: How do you reach the various parties? What doors do you need to knock on?
Dr. Huth: We try and get in at the level of the Chief Medical Officer or the VP of pharmacy at health care institutions, or HR directors at self-insured employers to talk to them about our new service, and get them excited about the potential for better health care at lower costs.
CEOCFO: What have you learned in your previous ventures and your previous experience that has been helpful in one, developing the product and two, getting recognition?
Dr. Huth: Personally, my background includes a scientific view point of medications; I spent a decade working for a drug company designing new medications, but also working in an environment where we were very comfortable with using a lot of information and using information technology to answer questions. When I transitioned to medical school and that healthcare environment, what I saw was that they were just starting to learn how to use sophisticated IT tools. We all carry our suitcases from one job to another and I would say that in my case learning how to use data and information technology to answer questions is something that I am trying to bring to the problem of medication safety. On the other hand, having training in medicine has been very important for getting recognized first by investors and now by clients as an expert in clinical pharmacology and medication safety. This blend of pharmacology, medicine, and IT has been the recipe for guiding ScopiaRx to a large unmet need.
CEOCFO: Aside from the medical knowledge, what did you learn in medical school that is able to contribute to what you are doing as CEO?
Dr. Huth: There is a lot of training and exposure to the real world experience of healthcare when you go through medical school and residency. You do not get that perspective when you are designing a drug in the lab. When someone is being treated and they are trusting in you, there is a person behind that. There is personal fear and uncertainty, not just an unanswered question. You also have to convince people to do things. It is a whole other level of need that a health care product like ours needs to address. I think it comes out when we are trying to design our reports for patients and caregivers. ScopiaRx information needs to be presented in such a way that they are going to appreciate it and use it. Having experience as a provider helps to address that market need.
CEOCFO: Do you see the individual consumer as a big part of your constituency or does it remain to be seen?
Dr. Huth: I think, like any new venture you are going to have to see it to believe it. However, I would say, not only for ScopiaRx, but for almost any product and service in healthcare these days, the consumer is the playing a much bigger role. The patient is not just “that other person in the room.” They are putting pressure on the system to make changes. Just like the pharmaceutical companies are selling medications directly to the consumers, much of healthcare will be going down that path, in part because the consumers are having to make choices based on cost and quality more and more. Therefore, I think the consumers are, and will continue to become, smarter buyers of healthcare. For that reason we view the individual consumer not only as a purchaser of ScopiaRx, but also as a partner in using the technology to promote safer therapies.
CEOCFO: Development and commercialization are almost always a costly process. Are you funded for the next steps? Will you be seeking partnerships or funding?
Dr. Huth: Yes. We have individual investors that have been instrumental in getting this going. We see the next steps being larger capital firms that typically fund ventures like us. We are also open to corporate partnerships, if that makes sense for synergizing implementation and new product development.
CEOCFO: Why should people pay attention to ScopiaRx?
ScopiaRx is the only solution available that solves the safety problem of
people taking many medications; five, ten, fifteen even twenty. If you are
serious about assessing the risks from taking this many medications,
ScopiaRx is the software that you need.
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