The Rise of the Compounding Pharmacist and Patient-Specific Medicine

QmedRx Vice President of Formulations Scott Karolchyk discusses the resurgence of compounding pharmacies.

Earlier this month, QmedRx, a compounding pharmacy that serves patients in over 40 states through in-home delivery, named former President of the International Academy of Compounding Pharmacists Scott Karolchyk as its Vice President of Formulations. In an interview with Specialty Pharmacy Times, Karolchyk discussed the future of compounding pharmacy and the increasing prevalence of patient-specific medicine.

SPT: What is the role of the compounding pharmacist?

Karolchyk: Compounding medicine is an integral part of patient therapy and the practice of pharmacy. Compounding is something every pharmacist learned in college, and before the 1950s every medicine was made by a compounding pharmacist. It wasn’t until pharmaceutical companies started producing medicine that took care of 95% of the population that compounding took on a lesser role. Since the 1980s, that role has started to increase. There are a lot of patients who aren’t being helped by conventional medications. Some medicines that worked really well for them in the past are no longer available and, most recently in the past 7 years, there has been massive drug shortages. There is at least at any point in time, anywhere from 350 to 450 drugs off the market. A lot of these are injections, sterile preparations, and antibiotic chemotherapy, so these medicines are needed but unavailable. Compounding has filled that role.

SPT: What kind of services does QmedRx offer?

Karolchyk: Everything in compounding revolves around the new law that is the Drug Quality and Security Act. What the FDA wants is for compounding to be patient specific. Every prescription on the human side has to be patient-specific. So they don’t want these gigantic pharmacies, or entities calling themselves pharmacies, just becoming like little manufacturers where there is limited oversight, limited quality, and things like that. So a lot of pharmacists go back to the intent of the law and it should be one prescription, one doctor, and one patient. That’s the philosophy of Qmed. Qmed is patient-specific and services patients in over 40 different states. Every prescription on the human side is patient-specific. We work with their physicians, we brainstorm, and formulate specific customized formulas for them to treat the condition they have and then talk to the patient, explain what it is and why we’re doing it, and we deliver the medicine to them.

SPT: What are the benefits of patient specific medicine and how does it contribute to better outcomes?

Karolchyk: There’s roughly 5% of patients who aren’t getting the treatment they really need. Maybe the medicine works but the side effects are too high, they can’t tolerate the dose, or they don’t like the way they feel. So that medicine isn’t used or the patient doesn’t take it on a regular basis. The medicine might not be available in a form they can take. If it’s a child who needs a smaller dose form of the medicine, it has to be customized and formulated in a manner where not only will the patient take it, but it’s also stable. It has to work, it has to be usable, and it has to have benefits. One of the drawbacks of commercial medicine is that it may not be available for children, but a child needs it. A compounder working with a child’s physician can come up with a stable formula that is specifically customized for the patient. The pediatric needs are huge, but also the other spectrum is geriatric needs. A lot of patients can’t tolerate the side effects. They might be combining a few medicines or using something that a doctor wants but isn’t available commercially. That’s something a compounding pharmacist can help with.

SPT: How can patient specific medicine solve the problem of adherence?

Karolchyk: If the side effects of commercial medicine is too great orally that they won’t take their medication, we might be able to change that into a transdermal gel so the drug is absorbed through the skin in gel form and the patient gets the relief they need without the side effects. Since we’re customizing it for the patient, it’s not one size fits all. It’s a little more involved, it’s not just saying “I hope this formula works and we’ll see you in 30 days.” We’re going to find out what the person is on, work with the doctor, find out what works, what they have tried, and what they haven’t tried in the past. We’re going to find out a little more about the physiology of the patient and why the pain is there. Based on the current research and studying, the pharmacists will work with the doctor, find the research, start with lower transdermal doses, and titrate up so the patient gets pain relief. It doesn’t take very long. It takes 3 to 4 weeks of working with patients and they can get great relief without other problems.

SPT: Do you see patient specific medicine becoming more prevalent as we look into the future?

Karolchyk: I do. Some of the new biotech drugs, some of the new biologics and new immunotherapy medications with all these new forms, there’s very few pills. We’re getting into gene therapy, getting into pharmacogenomics, we’re getting into microbiome. If you have an infection, we don’t just guess on the infection and do a culture anymore. They’re actually doing DNA analysis using a microbiome and within 3 days we know exactly what the DNA of the active bacteria is. So there are some really hi-tech things going on right now. The specialty pharmacist and the compounders, if they follow this, are going to be necessary to titrate these very potent biological drugs that only come in one size and are so expensive. We’ll be able to work with that patient to get multiple doses or a tailored dose for that patient that the drug companies won’t be able to do. They’re going to rely on specialty pharmacies or their own pharmacies. Ones that can work with the doctor, understand lab results coming back, and formulate something specific for that patient. So the bottom line is the insurance companies are happy, the patient is happy, and the doctor, because they helped that patient, is happy. That’s something only a specialty pharmacist can do.