Pharma Manufacturer Collaboration Seeks to Improve Drug Transparency
New medical information website provides pharmacists and other providers with both in-label and potential off-label medication information.
The medical information (MI) departments of pharmaceutical manufacturers provides both scientific and clinical information regarding their products, including details of clinical trials and information on ingredients and formulation. Unfortunately, finding this information can be difficult to navigate, and some are unaware of its existence.
To combat this issue, phactMI was created to provide a one-stop-shop to easily access crucial and accurate information, as well as quickly provide answers to any questions that arise. PhactMI is a free, non-profit medical information website that helps health care professionals provide their patients with the best possible care.
In an exclusive interview, phactMI CEO Patrick Reilly, and Evelyn Hermes-DeSantis, PharmD, BCPS, spoke with Specialty Pharmacy Times to dive into what phactMI is all about, what prompted its creation, and the value it holds from a user perspective.
SPT: What is phactMI?
Reilly: phactMI is a collaboration across the industry that stands for Pharma Collaboration for Transparent Medical Information. It came about 3 and a half years ago where several of us that were heads—–I was at BMS (Bristol-Myers Squibb) for 30 years––of medical information organizations.
We were having conversations about the plethora of information out there, specifically drug information. There’s a lot of third party sources, some of which are better than others. I'll just use Wikipedia to pick on somebody and say, you know it’s good information but good gosh, we're the ones that are the source of all this information, particularly from the clinical data that we generate and the information that we have as part of our label. So, would it make sense as an industry that we step up and take charge of a situation? If we’re not THE source, we should certainly be ONE of the sources for this information. We have very robust organizations with any one of the companies that really provide excellent, credible, evidence-based, timely information, for our health care providers, and a lot of them aren't even aware of it. That was kind of the genesis of [phactMI], where we all just decided it’s time we come together and create this collaboration.
I hosted the first meeting at BMS, and we had 19 companies agree to attend. Seventeen were on site and 2 of them did it by teleconference. It was a 5- to 6-hour meeting and they were there the entire time, so it was really impressive. Honestly, we didn't know what to expect, we just felt like it was something that we should try; we had nothing to lose. When we all got together, it was better than any of us would have considered in terms of the level of collaboration, the energy, the conversations that took place, and opportunities for next steps to start to already thinking about creating some committees to concentrate on certain aspects of conversations that we had during that day.
Hermes-DeSantis: From an outside perspective, I first heard about this at a meeting. I think it was probably just around the time that you guys were starting to form. I still remember writing a note during the meeting to the person sitting next to me and I'm like, “Oh my gosh, this sounds wonderful. We have to figure out a way of helping out.”
My area of specialty is drug information, clinically evaluating literature, and applying it to questions at hand. Being able to access the information in the easiest way possible, I think that's what health care providers need and this is one way of getting it. When [Patrick] mentioned Wikipedia, a shiver went down my spine because that is one of—–I know people use it––but time and time again we've looked at studies that have shown how poor of a site that is.
SPT: Could you describe how the phactMI site works?
Reilly: I want to exercise upfront that for the purposes of thinking about phactMI, yes we have a website, yes it was one of the projects that brought us together that we felt like we could have a true deliverable, one-stop shop where people could go and get information, but phactMi is so much more than that.
The website is essentially a landing page where anybody can go to. You typically identify yourself as a health care provider, but then as you go to the site you'll see that all you need to do is start to type in either a drug or a company and it will automatically pull up that company or the drug, and it will associate that drug to a particular company. I call it a landing page or a portal simply because its then mapped to the member's company website. If a member company doesn't happen to have a website that it's mapped to, then it would be mapped to contact information, numbers, and other information; email for instance, you could email your questions or requests for information. At that point, you have full access to all their products and information that is both in-label and potential off-label information. I say potential because the way it works is it's highly regulated, you can only provide information from a pharmaceutical perspective, from a company's perspective, if you have a very specific question. You're not allowed to share additional information unless it is unsolicited information you are providing to the question. There are specific questions being asked.
SPT: What prompted the creation of phactMI?
Reilly: Some of us go to these meetings on a regular basis and we're a part of panel discussions, and we've done a little bit of research ourselves, where we were just trying to evaluate where people were going for information. One study that we did back in 2014 was a survey and we pulled about 100 physicians across multiple specialties. We discovered that almost 40% of physicians seeking information, even knew about pharmaceutical companies having this resource. They didn't even know it. There were 60% who did.
When you ask the follow up question to that 60%, “would you use this information?” then you were dealing with issues around how much can I trust this information, it's coming from pharmaceutical companies so on and so forth. We clearly saw the opportunity to provide something that's easily accessible so you don't have to think about multiple websites and their URLs and their locations—–you could go to one place and you could get the information.
We also show a huge opportunity to create greater awareness around this very capable and credible resource that the pharmaceutical companies do, as just a cost of doing business. We are obligated to do this, it's just part of us providing information relevant to our products. They are requirements in the FDA to have this particular resource available to practicing physicians and patients.
Hermes-DeSantis: I'm on the outside of it, but from a user perspective, I think the website, again, just gives you access to that level of information. It helps direct you to where to find the information. As a pharmacist, as a drug information specialist, I can find the telephone numbers for most MI departments in the industry relatively easily, finding their websites is not easy. Being only one part of what phactMI is about, the website gets me to the company, that info department site, much easier. But as Patrick had eluded to, phactMI is much more than just the website.
SPT: Why is transparency so important in the health care community?
Hermes-DeSantis: I think transparency is so important because it allows the practitioner to see what's going on and where this information is coming from. When it's just, “oh, because someone said so” or it's that hidden, not sure where things are from or what's going on, it makes a practitioner a little bit warier about using the information. Knowing the background and knowing where stuff is coming from and having that level of transparency gives us a bit more confidence of being able to use that information and how it would apply to my specific patient. We realize that the pharmaceutical industry has those limitations, and can only respond to a specific request, can only say certain things, and then it’s the clinician who needs to then be able to apply it to their specific patient and make that final recommendation. But knowing where that information is coming from and the level of transparency behind that is so critical to give us the confidence in the information.
Reilly: When we were thinking about the name that was very purposeful. We could have used a lot of other names to describe what we're providing, accurate information [and] relevant information, but transparency was important to everyone who was a part of this because we're not hiding anything here. This is evidence-based information, you can trust this information because it's coming from a group of professionals that have been trained specifically to pull together this information and make it accessible and relevant for practitioners to make decisions, often at point of care.
SPT: In general, how is technology changing the future of health care?
Reilly: Having access to this information anyway [and] anywhere that you can get it is important. I know the last 4 or 5 years I was at BMS that was what we said, it’s been a motto. Everybody has different ways of trying to get information, some people are fine with a telephone while others want to go online. You have to take that into consideration depending on who the end user is. Technology is only going to continue to help us provide easily accessible information. This is not about providing more information, this is about providing the best information we possibly can and consolidate that information so that at point of care, health care providers and physicians can make [not only] quick decisions, but very informed decisions.
Hermes-DeSantis: I think where health care is going—–as with everything else––is it’s going to be more and more on that technology side in terms of how we are consuming information, how we are providing information, and how we provide information to our patients. Just look at the explosion of Twitter and other social media aspects. How many physicians are getting their information and what's being published through the Twitter feed of the journals? We're consuming information at a much higher rate in that much more electronic space. So, I think technology is changing the way we consume information and how we are providing the information to others.
SPT: Could you expand on why phactMI is so much more than just the website?
Reilly: If you're going to talk about websites, technology, and getting information these days, there are a lot of different sources; and I get that. I’ve used Google myself, I’ve used Wikipedia; although, I wouldn’t use it for drug information, but I can find uses for other things.
What differentiates us is the resource on the other end of that phone or on the other end of that website. What we provide is access—–and not just to information––but to highly, credentialed professionals that are more often than not trained for 6 to 7 years within the medical affairs space, that are experts when it comes to understanding data, being able to interpret data, being able to provide information, and can have those conversations above and beyond the printed word. For example, you have the opportunity to not only get the information if you request it, but once you're done, you then have the opportunity to have a contact person, whether it's one of the medical information specialists or somebody in their medical affairs organization at BMS or Pfizer, or a field-based person to be able to follow-up on that––to be able to provide the answer to the question behind the question, because often times it's not a simple question.
It's not necessarily about providing the information, it's the ability to have that additional information that we can provide that will help them make better decisions. We're not going to tell them what to do, but we will provide all the necessary information we possibly can to make those decisions.
SPT: Some of the core features of the website include the ability pull down package inserts (PIs) for products from the companies, the resources tab for each company that lists their contact information, as well as the different programs that the medical information department offers without visiting their site, and the ability to submit an inquiry directly from the website for any of the products. Why are these important?
Hermes-DeSantis: Those are really the things that as the end user are so important for us. Finding the most current package insert is always important to be able to see what's there, to be able to see what other resources are available. As I always said, I can find the phone numbers but finding the med info department website at times can be a challenge.
One example we had a few years ago, was we had what should have been a relatively simple question wasn't in the package insert, but I knew it was information that the medical information department of the company would have. Unfortunately, we got the question at 8 o'clock in the morning, east coast time. The company was in California and they didn't open until 9 o'clock west coast time. So, we couldn't respond to this question until closer to noon our time because the company wasn't open. If I had access to their medical information website, and they happen to have the information in a database like some of them do of their standard response letters, I could have found the information and been able to respond with the company information to my caller by 8:15 instead of waiting till closer to 1 o'clock when the company finally got back to me. Just that little bit of a time-lag, depending upon what the question, could be very important for the patient we're dealing with.
By having access to the med info websites, I can get access to other tools that even I, who knows that med info is out there, can't always remember all the websites for all the different companies. [With phactMI] I can get into their database very easily. I can find out, I can submit a question, I can get their telephone number, and I can figure out who the MSL [medical science liaison] in my area is so I can contact them for more of that face to face discussion and conversation and additional information. It really does bolster what we can do in responding to inquiries from the physicians, and allowing me the clinical tools necessary to practice to the highest level of pharmacy standards.
SPT: How does the inquiry function work on the website? Do all companies have ready responses that would come back quickly?
Reilly: Yes, they typically do. You can access the information through search criteria and try to get the information without any assistance whatsoever. You can submit a question, and typically how it works—–even after hours––is that goes into the queue. A lot of these systems now are sophisticated … and can be turned around within 24 hours. I think most companies, I know we did this at Bristol, was strong criteria. We wanted to turn around anything, any question that came in within 24 hours. In the instances where the information wasn't readily available, the specialists get to work on it right away and start scouring the databases of other sources where they can compile an accurate answer to that question.
SPT: What else do you want people to know?
Reilly: I keep referencing it, but at the meeting they focused on 2 things, collaboration was just the word of the day. You have to understand that traditionally, it has been more of a commercial focus meeting, but this year was the first time they had a medical affairs track. They focused on collaboration, they talked about breaking down silos and walls within organizations to provide—–at the end of the day––what the patient needs, what the health care provider needs, but ultimately what the patient needs.
I think what we represent within the industry is the opportunity for us to collaborate beyond the brand, beyond the company, and start to think about what is the patient needs and [if] we’re providing. It may sound altruistic, and it is, but at the end of the day the medical professionals that wake up every day, that work for any of these companies, that's where their focus is. It's providing information for the patient. The patient could be your mother, your father, your grandparents, your uncles, your aunts, your brothers, your sisters, and that is critical in terms of what we believe is important to make that decision worthwhile.
I think there are other things that I envision as CEO I’m starting to tackle, they are more political in terms of having a voice for medical information in the industry. I think industry had a reputation in the past of not being as trustworthy as they possibly can or not providing information as they should, in fact there's a commercial interest there.
But what we feel as medical information specialists and medical affairs specialists is there's more to it than that, that they need to hear and understand. We have programs and we're working with Evelyn, just as an example, to create outreach around this greater awareness, even at the student level. We will be focusing on pharmacy students, we will be focusing on medical students and residents to educate them about this resource that's so important to them when they start to get out to clinical practice. There are other opportunities as well, as part of phactMI that are starting to pop up as we meet 4 times a year. We have an opportunity as a 26-member company to start talking about best practices. The benefit of this is we are not approaching any of these things as challenges indecently. As an example, we look at the globalization of our companies and our medical information functions, and now we're collaborating on what that looks like and sharing that information as part of a publication that we'll put out in the upcoming months.
[This is a huge] benefit in terms of raising the awareness around medical information and that resource, huge benefit in terms of starting to address the needs of our end users as it relates to this information, ease access, consolidate information, so they can make decisions at point of care. And hopefully much more to come in terms of any kind of partnerships that we'll have with other like-minded organizations that are out there that want to provide the best information we possibly can for our health care providers.