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Linda Elsegood: Welcome to the LDN Radio show brought to you by the LDN Research Trust. I'm your host Linda Elsegood. Today we're joined by pharmacist Mark Filosi from Family Care Compounding Pharmacy in Florida. Thank you for joining us today, Mark. We'd like to find out more about who is Mark Filosi.
Mark Filosi: I grew up in pharmacy. My very first job was in a pharmacy when I was 14 years old. I began compounding even back then. This is before computerization, typing on a manual typewriter, filling capsules, one at a time on a torsion balance on Saturdays in support of compounding. Fast forwarding to 2023 where we've got really a state-of-the-art very high-tech pharmacy this is very very different.
Linda Elsegood: So are you the manager? The owner? What's your role?
Mark Filosi: I own two pharmacies. I own Family Care Compounding. I also own Live and Learn Pharmacy. I've done a brief stint as a PCAP ACHC Surveyor or accreditation and compounding both sterile and non-sterile. I also sit on the board of directors for the Alliance for Pharmacy Compounding. It's really the only advocacy group that I know of in the United States in support of what we do and allows us to be able to compound things like low dose naltrexone and bioidentical hormones. I'm a preceptor for four different universities in America. I'm a career coach for young pharmacists. I also teach educational programs for continuing education for pharmacists through the parent company that's sponsoring me on Medisca and LP3 Network. I'm a senior facilitator for them. I've worked teaching sterile and non-sterile, advanced non-sterile business for pharmacists for the last 15 years.
I've taken on a very new role on basically off the bench now as a pharmacist, even though I still work in my stores. I'm a success partner with Medisca Pharmacy Compounding Coaching Services. That is something that's very new. When my son was younger, I was a Boy Scout leader for him and horseback riding with my daughter and all kinds of fun stuff with my wife. Now we have a a lot of hobbies and projects.
Linda Elsegood: You are a very busy man obviously. Please tell us about your pharmacies.
Mark Filosi: We've been in business for 27 years. I started way back when there really wasn't much support for compounding pharmacies, back when there was just a publication called the Secundum Artem.
I would learn everything then that Mark Erickson talked about in that particular publication. I learned how to compound a progesterone suppository. Then I would go out land market that one thing to physicians and practitioners in Florida. I became so impassioned with that that I wanted to learn more. I've taken flagship programs from Medisca Sterile Compounding, non-sterile and I've really expanded the scope of what we do to the point where I would say compounding has really eclipsed all the other things that I do in pharmacy, but I've probably done just about everything you could think of as a pharmacist. My most passionate and exciting thing that I do at my pharmacy is non-sterile compounding. I just love it.
Linda Elsegood: What forms do you compound LDN into?
Mark Filosi: Right now we compound rapid dissolve tablets, trochees, which are just basically lozenges that you dissolve in your mouth. Capsules of course are probably our number one, but one of the exciting things that you might not know about is something called Nova film from Medisca. It can bypass down the hatch, into the stomach, then to the liver, then to the blood, then to the biological side of action. We've got a new product called Nova film which is sublingual but the unique thing about it is it's also mucoadhesive so it gives your body much more opportunity for absorption in the tiny blood vessels inside your mouth. It is similar to a Listerine strip or some of the commercial products that are like that right now. The mucosal lining is kind of a moving target. There's a turnover rate with it and this really makes it bind to that and we're really looking forward to using low dose naltrexone in that type of delivery system. It is very novel, very unique.
Linda Elsegood: Do you make low dose naltrexone (LDN) in a nasal spray?
Mark Filosi: It's my feeling and the feeling that the folks that support me at Medisca and LP3 that that should probably start as a sterile compounded preparation as it doesn't have direct access to the body like an injection or intramuscular, but it's still something that you wouldn't want to introduce a pathogen into somebody's body. I don't really focus on sterile compounding anymore. That's not something that I do.
Linda Elsegood: You mentioned two pharmacies. Are they run very similar?
Mark Filosi: Yes they are. Live and Learn Pharmacy, a pharmacy I just purchased a few months ago, was nothing but compounding, and my pharmacy was a hybrid of just about everything; DNA, retail and of course compounding.
Linda Elsegood: What kind of doctors do you deal with in Florida? I know West Coast is mainly naturopathic doctors. Do you have MDs and DOs and physician assistants, etc.
Mark Filosi: NDs would not be the primary here because they don't have prescriptive authority in Florida. It is interesting, I could take a prescription from an ND in California because they do legally have prescriptive authority and the right to prescribe low dose naltrexone in California, so if one called to here I could fill it, but an ND in Florida, I would not be able to. It is very interesting but I would say the primary prescribers that I see here in Florida would be MDs and probably nurse practitioners. Especially because nurse practitioners here in Florida can be autonomous. They can open up their own practices and this is really kind of a niche market that's very well supported with nurse practitioners. It's something that's really within their power to do that.
Linda Elsegood: We find that there are many nurse practitioners who seem to have more time to spend with patients than a doctor.
Mark Filosi: Although I've got some really wonderful prescribing MDs I will say that in my experience nurse practitioners do give you more of their time and because of that it can be a very powerful experience for a lot of people
Linda Elsegood: Now in Scotland, and we're going to start having them in England – Pharmacy Consultant Prescribers. Something so new in Scotland, I think they had it before COVID. It will mean you can go to your doctor or your pharmacist with minor things. In Scotland they could prescribe LDN as well. In England I think it's going to be minor things to begin with. Do you have that already in place?
Mark Filosi: It depends on the state because each state is run like a small country. We have different rules within the state versus Federal law standards and guidelines. In Florida we've got two programs. We've got something called Test To Treat where a pharmacist could do a CLIA approved test and then from that we would be able to prescribe certain limited things like you're describing in Scotland. We also have something called a Collaborative Practice Model where we could create a collaborative practice agreement with a practitioner and then prescribe things within that agreement. I would think that prescribing LDN could be one of those collaborative things that we could do moving forward.
Linda Elsegood: It is really exciting.
Mark Filosi: I am excited for that and I think that the world has recognized that pharmacists have a great place within healthcare and that we should be recognized as practitioners and we're probably one of the best suited professions, and that we would be able to prescribe because we know the drug.
Linda Elsegood: Doctors only do a certain amount of drug interactions because that's not their wheel house that's yours. It's the pharmacy, that's the nurse, prescribers are like doctors to a point you know. Why wouldn't you have a pharmacist prescribing like you have a nurse prescriber? I don’t see what the difference is.
Mark Filosi: That's very true and it's funny that the lobbying groups and the association surrounding nurses and doctors are strong but historically those types of groups surrounding pharmacists have been weak. We haven't been a cohesive body. That's one of the reasons why I sit on the board of directors for APC is to give that voice
Linda Elsegood: Because in England there's a crisis that we are short of medical professionals, doctors, nurses, etc and I'm sure it must be similar to the US. It would be so much easier for patients who have access to medical care if all those pharmacists that were ready and willing and able to become prescribers. Surely that would take a lot of pressure off your health system.
Mark Filosi: Yeah, and I think that it's a partnership with those people. It's not like we're taking power away from a practitioner. We're sharing the process. I think we make them more effective. If a physician only has five or ten minutes to meet with a patient we can work behind the scenes and write suggested prescriptions. We can measure outcomes with prescribers and patients and it's that triad. It's the relationship between a pharmacist, a patient and a practitioner that really rounds out that whole process.
Linda Elsegood: It is all for the good of the patient.
Mark Filosi: Of course, it works best if you have that kind of time. That's something that APC, an independent group, they have a new product called Outcomes MD. It is a platform available to both pharmacists and providers. It interfaces with electronic healthcare records and they have a very new platform specific to naltrexone that I can text a survey to my patient. Once they receive their prescription it will establish a baseline of symptoms with that patient associated with naltrexone and then I can start to measure and monitor outcomes. The measures are to prove that it's either working or if there's some sort of gap in therapy, or is there something that I can go back and now recognize because the beauty of compounding is it something that we can modulate, fix and make better, because it's personalized medicine.
Linda Elsegood: It is always good to start with a baseline. For people sitting in that survey initially before they take the first pill, capsule, whatever it may be, you then got the baseline which makes such a big difference.
Mark Filosi: I would say to the pharmacist in the United States that might hear this that the data that's being collected by Outcomes MD will become redacted and shared back to the Alliance for Pharmacy Compounding. This is something that we can show evidence to the FDA that compounding is valid and that the works of pharmacy are true. We've been doing this as a privilege for thousands of years. With a stroke of a pen the Federal regulatory bodies could take that away from us. I think it's important if we want to preserve really valuable and powerful things like LDN and BHRT and all those things that go with it then we have to be proactive.
Linda Elsegood: I believe you are quite big in the hormone community.
Mark Filosi: With the community of everything that's possible within non-sterile compounding and sterile compounding. Yes, I've got a new role. In addition to being a facilitator for educational programs I also teach. I have been teaching compounding for 15 years. I've been advocating for colleges of pharmacy and so on. When you take a program like that then people don't know what to do on Monday morning after the program, after they get home. They've taken a course, they've gone to college but they still need somebody to hold their hand through the process and Medisca, now the parent company, the global leader in compounding, really has allowed me to open this channel and I become what's called a success partner. I have two other people that are working with me. I've got another coach that's working as a coach and remote patient monitoring and clinical services. I have another coach that's specializing in pharmacy operations, CEO mindset leadership. When somebody wants to open the niche market of non-sterile compounding or maybe they already are a fantastic non-sterile compounder but they want to open the niche market of LDN I can walk them through that process and really this whole team would guide them on that effort. Something that's very new and this is what we're going to kind of splash at the LDN conference.
Linda Elsegood: Third party testing is very important and pharmacists hold that in very high regard because as a pharmacist you can say there is definitely 4.5 milligrams in my capsule.
Mark Filosi: You know I have what I affectionately call pharmacists that behave more like bartenders. They're dabblers in non-sterile compounding. Then I have pharmacists that are truly professional, personalized compounding pharmacists and they're very different. It's different than just crushing a 50 milligram tablet and dividing it in some way to make a capsule or some other preparation. If you used an FDA grade, USP grade, active pharmaceutical ingredient from somebody like Medisca and you learn how to manipulate that.
If I have five milligrams of Naltrexone, and 50 milligrams of Naltrexone it is very difficult for somebody to weigh that precisely. You have to learn how to weigh the unweighable. You need to learn how to do mixtures that if I was making a capsule, even if every one of my capsules the finished product weighed exactly 300 milligrams but the finished powders in there. If I make a hundred capsules at a time, if they all just by chance weigh 300 milligrams, my theoretical weight, how would I really know 4.5 milligrams or 1.5 milligrams on the titration was really in those capsules? That predicates itself on homogeneity and content uniformity when we make that mixture powder blend to start with. We would need devices like the Mazerustar, that's an inverse planetary mixer. We would need testing facilities to confirm and validate repeatedly that when I make a mixture in service of making a 1.5 milligram capsule or a 3 or 4.5 or what have you that I do have a homogeneous blend. When I make those capsules and they weigh the correct amount the finished preparation is correct. I believe that all pharmacists should operate by the family rule. If I was making that for my mom, I was making that for my wife, if it's not good enough to dispense to any of those people then I shouldn't be doing this. If you're just dropping a tablet into a glass of water, are you thinking about the fact that naltrexone is the salt of a strong acid and it could be either more dissociated or less dissociated in the presence of an acid or a base. It could undergo hydrolysis in water. It's not stable. What happens if a lot of the excipient ingredients have grabbed onto that drug and it's at the bottom of the glass and you're supposed to drink one tenth of this glass to give you the five milligrams which is going to be nearly impossible. At the beginning of that glass maybe you get a light dose, at the bottom of the glass maybe get a heavy dose and you're looking at a narrow therapeutic index drug where we're telling people that 1.5 milligrams in increments is what you need to do. If we're giving people instructions that are that precise. If we're doing very low low dose naltrexone, an ultra low dose naltrexone how is that possible without this committed validated process?
Linda Elsegood: Please share your website so that people can go and find out more.
Mark Filosi: Yes uh I would tell them to go on to Medisca.com and they can look at pharmacy success partners. They can look at our services. They can look at formulation development. We have everything. Really a need from LP3 education it's a one stop shop really to get somebody up to speed and able to do something like this. Which really is something that you really need to pay close attention to. If you don't do it right we can cause patient harm instead of patient good. I think that if you really want to do things correctly you want to work with somebody like this company Medisca.
Linda Elsegood: Any questions or comments you may have please email me Linda@ldnrt.org. I look forward to hearing from you.