Board Review General Medicine

Custom Therapy Options in the Modern Podiatry Practice

Emil Haldey, PharmD

Emil Haldey, PharmD gives a brief overview of what a compounding pharmacist is and what types of medication they are capable of creating. Mr Hadley reviews many different conditions that can be treated by compounding medication not only in podiatry, but in all areas of medicine. Additionally he discusses the advantages of compounding medications and different forms of medication administration available.

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Goals and Objectives
  1. Define compounding and Discuss the advantages of compounding
  2. Highlight the conditions in which custom therapies can be utilized
  3. Review methods of administration for compounding preparations
  4. Discuss common conditions and compounding considerations
  5. Discuss clinical case studies
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  • CPME (Credits: 0.75)

    PRESENT eLearning Systems, LLC is approved by the Council on Podiatric Medical Education as a provider of continuing education in podiatric medicine.

    PRESENT eLearning Systems, LLC has approved this activity for a maximum of 0.75 continuing education contact hours.

    Release Date: 03/16/2018 Expiration Date: 12/31/2018

  • Author
  • Emil Haldey, PharmD

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    Emil Haldey has nothing to disclose.

  • Lecture Transcript
  • Male Speaker: It's becoming a little more popular in our profession and one that we need a lot of education on is compounding. Compounding materials that are usually applied topically for various conditions that can promote some type of medication, whether it's reduction of pain, inflammation, et cetera. Obviously, we need to go to a specialist outside of our profession to assist us in this educational process. Our next talk is going to be given by two physicians, one is Dr. Haldey, who is a pharmacist who knows the profession of pharmacy very well. He has worked for numerous companies, including Parke-Davis Pfizer and Boehringer Ingelheim Pharmaceuticals. In addition, we will be hearing from Dr. Akhtar, who is a practicing podiatric physician, dealing in wound care and specializing in trauma. He is working at the Hyperbaric and Wound Care Center at Saint Joseph in Paterson in Wayne New Jersey. So, please welcome Dr. Haldey and Dr. Akhtar.


    Dr. Emil Haldey: Good morning everyone. Thank you so much for having us here. My commitment to you is this. We're going to have fun today. We're going to learn about compounding. But also, regardless of your familiarity with compounding, I guarantee you, you will walk away with a few pearls of information that you'll be ready to use comes Monday or Tuesday in your clinical practices. Are you guys seeing the slide on the screen here? Great, thank you. Today, what are our objectives? We'll define compounding. We’ll discuss advantages of compounding. In addition, we'll highlight various conditions and disease states in which custom therapies can be used. I will review methods of administration for compounding. We'll also talk about the common conditions and various compounding consideration. Lastly, Dr. Akhtar will finish with some clinical case studies. First, let's talk about compounding and what it is. Got it. Thank you. Let's go to the definition of compounding. It's an art and science of preparing customized medications. Let’s dissect it. Art and science, just like medicine, science because everything a good compounding pharmacist does is evidence-based, very, very important. Customized medications for individual patients based on the prescriber’s specifications. A very key element here is individual patients based on doctor specifications. We'll talk more about it. It’s important as we learn about compounding, we dissect it and realize what it is. How many of the doctors here speak or read Russian? We have some? This is a copy of a prescription that I found in my family files written by my grandfather physician back in the Soviet Russia from 30 plus years ago. The reason I show it to you, number one, this is near and dear to my heart. Number two, compounding has been around for ages. Just like medicine, it's been around as a scientific tool for many, many years. In early 1900s, as pharmaceutical industries started getting momentum, compounding started taking a nose dive. But the last 20 years or so, compounding has seen resurgence due to the technology, and also a number of patients asking and requesting information about it. What is a compounding pharmacist? Who is a compounding pharmacist? Every time you talk to one of us, we make it a point to specify it to you, we are a compounding pharmacist. We're not just a regular pharmacist, we are compounder. Why do we do that? Why are we so proud? Well, we look at ourselves as innovators, as solution, as problem solvers. As I go through this presentation, I will share a lot of examples with you throughout various fields of medicines. Not to educate you about dentistry or gynecology, but rather to impress upon you the possibilities of compounding, because the possibilities are endless. What's the difference between compounding and manufacturing? Well, with manufacturing, you have no specific patient in mind when the drug is produced. Doctors matching patients to their product available. With compounding, we’re making the formula to match the patient. That's the key difference.


    If you remember back to the definition that I shared with you, individual patient, individual prescriber. That's the key difference between compounding and manufacturing. A well-trained compounding pharmacist always functions within the triad of care where you have a patient, a doctor and a pharmacist. What's the goal in compounding? Well, the goal is really to solve the problem and to improve therapeutic outcomes. I always tell doctors when I speak to doctors, the goal is to deliver the right drug to the right place of action. If you need a different dose, dosage form or medication that's not commercially available, we can do it. For example, if you have a child who cannot swallow a pill, we can deliver that medication to them in the liquid form. If you have a medication that's available in tablet form but you’re looking to deliver it to your patient in suppository form, a compounding pharmacist can do that. If you need a combination product or sustained-release product, we can do that as well. For example, many of you may be familiar with transdermal formulations, combining various drugs from different therapeutic classes, obviously done by a company pharmacist. If your patient needs to avoid dyes or preservatives, a few months ago, I got a call from a pain management doctor telling me that my patient is allergic to parabens. The patient has been responsive to Lidoderm, Lidoderm patches, but now has developed an allergic reaction. Can you compound something similar to that? First of all, I said, “Thank you doctor. I didn’t know Lidoderm had parabens, so I learned something.” We went back to the data and looked at the cream basis that had no parabens. I compounded something for that particular patient, so the patient could tolerate the medicine and get the clinical benefits. What are the service areas? I'll make it easy for you. Virtually, every field of medicine, starting from podiatry, pain management, physical medicine and rehab, all the way down to neurologist sports medicine, even dentistry. We'll discuss some of the therapeutic areas and go through this presentation. Let's talk about pain management first. Well, it offers you alternative routes of administration. A lot of times, when you talk to pain management doctors, they also work within hospice care. I'll throw some examples out to you from hospice care. Let's see how a patient who is nauseous and experiencing vomiting. One of the common drugs used for nausea and vomiting is compazine or prochlorperazine. What happens if you have a patient who has nausea and vomiting and you administer an oral medication to them. A lot of times they can't hold it, they can't tolerate it, so they’ll give it right back to us. A well-trained compounding pharmacist can take prochlorperazine, put on transdermal gel or cream base, and patient would apply it transdermally to the wrist area or behind the ear to get systemic absorption. The reason you apply it on your wrist or behind the ear, because the tissue concentration is quite thin here, so you get systemic absorption. In pain management who also do what we call individualized pain management. As I talk more about transdermal therapeutic approaches, we'll talk about combining various classes of drugs into one product to help your patients with the compliance and improve efficacy. Dermatology, a very common field in our practice where we create medications for acne, various fungal infections, psoriasis, for scars, vitiligo, eczema and warts. We’ll touch some of these as we go through the presentation. Exercise and sports medicine, a huge part of our practice where a lot of solutions that we offer are transdermal pain creams and gels that combine nonsteroidal anti-inflammatories with muscle relaxants, various neuropathic agents. Bioidentical hormones, a very big part of many compounding practices, has gained a lot of momentum over the last several years, especially as Oprah and Dr. Oz bring onto a lot of patients, where we take the same biodentical hormones that we have in our bodies. They diminish with age. We introduce it back to our patients through natural sources with the physicians, making sure those hormones are within normal levels. Quite often, I'm asked, "How do you know how to dose these medications?" Well, first of all, remember as I told you, everything a well-trained compounding pharmacist does has evidence to support it. We also use something called applied science in the field of compounding. What does that mean? Well, if we know that something is indicated or works for a need, let's say transdermal formulation that works for applications that in need, we can derive that, it probably works on other joints as well.


    I'll give you an example of progesterone, and this is an example of applied science we use quite a bit in our hormone practice. Progesterone is available commercially in 100 milligram capsules and 200 milligram capsules. Brand name is Prometrium. Are you guys familiar with that? If you look at the package insert, FDA-approved package insert, it tells you that only 10% of orally administered product is bioavailable. If your patient takes 400 milligrams, which is the maximum approved FDA dose, they’re getting 4 milligrams in the system. If I'm asked as a compounding pharmacist to formulate a progesterone cream for a patient, I'm going to assume that if I do a transdermal application, 40 milligrams or 4% cream is the maximum we can administer to the patient. You talk to well-trained compounding pharmacists when you use the concept of applied science to explain dosing and other considerations. Dental needs, we work quite a bit with dentists as well, and I'll give you a few examples. What happens if you have a patient who’s on warfarin, who needs a major dental surgery? Generally, what happens, an oral surgeon picks up the phone and calls primary care physician and tells them, "I'm going to do a dental surgery, a major surgery in a week or a few days from now. I want the patient to stop taking warfarin so they don’t bleed to death.” Of course, there is discussion. Well, what if I tell you that there is a substance that I’ve put in solution called tranexamic acid, and there is plenty of data to show that if patients rinse with that solution before, during and after surgery, you could have your patient on warfarin and go on with the surgery. The data suggest that there are no complications. The solution is compounded by a compounding pharmacist, tranexamic acid 5%. There is also data to show that if you use tranexamic acid intravenously during surgery, it’s been used for knee and hip replacements, that there is no bleeding complications. There's also some studies with tranexamic acid for used topically during surgery, but it's too early to say whether it's totally safe. Then, there is a physician, a podiatrist, a lower extremity doctor. It's a medical group within one physician, because you are a surgeon, you are a plastic surgeon, you're a dermatologist, you're a rheumatologist, you're a neurologist and many other specialties. So, compounding pharmacist offers a number of solution to the podiatrist for fungal infections, for wound care, diabetic neuropathy, for vascular issues, warts, calluses, even excessive perspiration. What are the dosage forms that a compounding pharmacist can formulate? Well, I'll make it very simple again. Every dosage form that's available commercially, a compounding pharmacist can formulate for you, whether it's oral capsules and liquids. We’ll talk more about transdermal gels. We could even formulate lollipops for kids, putting medications and flavoring. Flavor them, basically any flavor the kid wants. We could develop suppositories, enemas, rapid dissolve tablets, nasal and otic preparations. I’ll give you an example of creative solution. How many of you are familiar with trigeminal neuralgia? A very tough condition to treat, but basically one of the possible solutions is in lidocaine nasal spray, a very simple solution but quite effective. Where a compounding pharmacist formulates 8% lidocaine spray, patient sprays upon attack and there is decreased incidents and severity of attacks. I'm sure many of you are familiar with transdermal drug delivery. We have a number of commercial products that use transdermally and also a number of compounded preparations that are very popular, your transdermal drug delivery. They are effective in number of conditions, starting from arthritis to sports injuries, musculoskeletal pain, neuropathies, cancer pain and various physical therapy conditions. Many patients with rheumatoid and osteoarthritis can benefit from those transdermal formulations. Here is an example of transdermal formulation using a nonsteroidal and anesthetic. By working with a compounding pharmacist, you're not limited to a particular nonsteroidal. You could choose a number of them. You could start with ketoprofen. You could go to ibuprofen, piroxicam, indomethacin.


    You have a number of choices. I work closely with a pain management physician who always tells his residents and other physicians he is teaching said, “A doctor should know three nonsteroidals.” Why is that? Well, if you had 100 patients and you put them on the first nonsteroidal, 30 of them will come back to you and say, "Doc, it does not work." You take the second group of 30 patients, put them on the second nonsteroidal, 30% of that group will come back to say it does not work. So, you’re left with 10 patients. Third group, you put on third nonsteroidal and three of them will come back. Those three, you send to pain management. With compound, they give options. If your patient doesn't response to diclofenac, you could switch to indomethacin. You could switch to the ketoprofen. We can combine different nonsteroidals to get synergistic effect. Sports injuries is a huge part of our practice. Guafenesin, how many of you know what that is? It's an expectorant, right? Well, it's not just an expectorant. At 10% and above transdermally, it becomes a muscle relaxant. We use it quite a bit in our sports management formulations. The key there is to put a 10% in the transdermal gel base. Neuropathic pain, a very common condition, I'm sure all of you see regularly in your clinical practices. Many pathologists leading to it, starting from shingles to postherpetic neuralgia, diabetic neuropathy, even vitamin deficiencies. I want to read a definition to you, not to teach you about neuropathic pain but rather to drive a point home. Some neuropathic pain arises as a result of a primary lesion or dysfunction of the nervous system, which leads to the loss of the capacity to conduct information. The nervous system is, in a sense, short circuited and action potential generation becomes out of control. Essentially, you get abnormal wiring. You have connections, neurotransmitters and receptors not working properly together. But what's key here is that single pharmacological approach often is not as effective as multiple approaches. Well, we know that but let me drive it on further. This is a list of products of chemicals that you now have in your clinical toolbox, whether they are available commercially, or whether they are not available commercially, and maybe available through a compounding pharmacist. You have a product, NMD antagonist, glutamate antagonist, tricyclic antidepressants, GABA agonist. Dextromethorphan, do you guys remember what that is? It's a cough suppressant. We talked about a guaifenesin, an expectorant, now, we're talking about dextromethorphan. Well, about cough medicines here, right? Well, dextromethorphan, at 10% and above, if you put on a transdermal cream or base, that becomes an NMD antagonist, similar to ketamine, similar to methadone. Loperamide, can someone tell me what that is? Loperamide is Imodium, an antidiarrheal product. Why am I talking to you about loperamide, antidiarrheal product in compounding and neuropathic pain? Well, the way loperamide works for diarrhea, it hits the neuroreceptors in the gut. By hitting the neuroreceptors in the gut, it slows GI motility. Well, we have new receptors peripherally in our skin and tissues, so we routinely use loperamide to get the opioid-like effect without giving our patients opioids. That's a clinical option that you have available. If your patient has circulation or vascular issues, we could add nifedipine to the formulation. All of these products are now available in your clinical toolbox by working with a compounding pharmacist. Where do you apply transdermal gels and creams? Well, obviously, you could apply to where it hurts. You could apply to original site of injury. But what's interesting, and there is data to support it, you could instruct your patients to apply it to a dermatome. And to practice, very common if you look podiatry, where doctor points out to the caregiver most likely the right place to apply dorsally and to the site of pain. Of course, you could apply to the trigger point. How does transdermal drug delivery work? Well, a number of years ago, a new technology was developed, PLO technology, pluronic lecithin organogel. What’s really cool about that technology, that it has a lipid phase and it has a water soluble phase. That particular technology is able to combine lipid soluble drugs and water soluble drugs in one cream or gel.


    That's how we're able to deliver those medications together to the patient. What are the advantages of the transdermal drug delivery? Well, we avoid systemic side effects. Most of the transdermal drugs that are delivered achieve high tissue concentrations but very low systemic levels. It will bypass liver and kidneys. It generally have no GI irritation. It is cost affective. As I mentioned before, you get low plasma concentrations for most drugs, not for all but for most. The disadvantages are very minor. In my practice, on occasion, I hear a possible skin irritation. Most likely, it's a reaction to the inactive drug or inactive filler or cream base. These are some sample neuropathic pain formulations that are requested frequently in our practice. For example, the first one combines amitriptyline and tricylic antidepressant, gabapentin, ketoprofen and lidocaine and a transdermal cream base. It's important to let your patients know to apply it for up to 10 days to reach high tissue concentrations. If after 10 days your patients come back to you and says, "Well doc, it doesn't work as well as I wanted to.” We could adjust this formula to anything you want. If you look at the second formulation, we increase gabapentin to 10%, add some ketamine, keep the ketoprofen and lidocaine. That's a step up from the first formula. Let's say after 10 days of therapy or a month of therapy, your patient is requesting some additional support. You have an option to bump it up to even more complex formulation. The possibilities are endless here. This is an example of some formulas that are commonly requested in our practice for arthritic patients. Very simple formulas, some of them combine a couple of nonsteroidals. The idea is to get synergy, which with the two products. Also, give you clinical options. If your patient doesn’t respond to indomethacin, you could put them on diclofenac or ketoprofen or even Celebrex, or Celecoxib transdermally. Wound care and skin infections is an important part of many podiatrist practices. I'll introduce a couple of agents to you that you may or may not be familiar with. Phenytoin is an old anti-epileptic drug. One thing we know that patients who are taking phenytoin, they have to go quite often to the dentist to trim their gums, because phenytoin causes something called gingival hyperplasia. From that, we learn that it promotes granulation. It also inhibits formation of collagenase, and therefore increases collagen synthesis. Misoprostol is a product we see commercially in Arthrotec, which combined with diclofenac, is a PGE1 analogue that helps your mucosal stomach lining. If it helps regenerate mucosal stomach lining, it helps regenerate tissues and wound care as well. Hyperhydrosis, a common condition I'm sure many of you see regularly in your practices, with limited commercial options. Now, we have a few other options. We could do glycol paraloid deodorant. We could increase the aluminum concentrations in your patient's deodorants to 20%. We could do formaldehyde solution, a number of clinical options. Plantar warts, a difficult to treat condition, sometimes frustrating for many doctors. But once again, we have a number additional options here that you could use in your clinical toolboxes. The first formulation on the slide is a combination of cream product that a patient applies at home for about four to eight weeks. The second product is a combination of cantharidin, podophyllin and salicylic acid. It's a combination of [indecipherable] [23:58] agents, where it must be administered in a physician's office under doctor's supervision. Onychomycosis, a very common condition with limited commercial options. I know it's a frustrating condition to treat sometimes for many podiatrists. Here, I'm listing a few other options that exist through compounding pharmacist. Dermatitis, we heard a very nice lecture earlier about dermatitis. Generally, the mainstay of therapy is corticosteroids. What if you don't want to go with corticosteroids? Well, you have a couple other options here. Cromolyn sodium is an old asthma medicine, not available in the US commercially, but you can get it through a compounding pharmacist. It's a mast cell stabilizer and decreases pruritus intensity, erythema and severity. You also have an option with tranilast, which is also a mast cell stabilizer, but it also inhibits collagen synthesis, which makes it a very useful product in dermatitis but also in scar therapy.


    I know we are tight on time here, so I'm going to zoom some of these slides. These are some of the examples of the scar formulations that are prescribed commonly by physicians we work with. Tamoxifen, you could see it in the second formulation. Do you guys remember what that is? It's an antiestrogen product used by breast cancer survivors. Well, at 0.1%, tamoxifen inhibits collagen synthesis, making it a very useful product in scar therapy. The key in the scar formulation is to have the right base that you deliver your drugs in and most often, we deliver that in a silicon-based gel. Picture is worth a thousand words as they say, so this is an example of a scar formulation used for an ankle scar and you could see the results that are pretty dramatic I think, day one and day 14. This is an example of a child who's got a facial burn and you could see the results there day one and day eight of a scar formulation using a silicon-based gel. Plantar fasciitis, condition seen by many of you but now we have more option and many more options actually. This is just an example of one more option. This is a formula requested often from our compounding pharmacy by podiatrists. It combines a nonsteroidal baclofen verapamil and bupivacaine, very useful and therapeutically efficacious formulation. I talked to you about a lot of concepts but this concept is only as effective as the working clinical practice. We are fortunate to have a good collaborative relationship with Dr. Akhtar who is a friend and a colleague and Dr. Akhtar is going to share with you a few of the clinical studies, clinical case studies from his practice.

    Dr. Akhtar: Hello everyone. Yeah, with all of the formulations that Emil has talked about is a lot of medications that I've actually prescribed and used with a great deal of success. I've been using compound medications now for about five to six years and partly because it's a form of therapy that other practitioners necessarily offer but primarily because of the results. First, I will just give you two brief examples of patients. One is a retired peace officer who with diabetes and the obvious onset of neuropathy had severe symptoms, moderate to severe symptoms of your classic neuropathic burning, pain, tingling and all of the above. Initially, everything was effectively I treated for a number of years with Metanx and Lyrica. But as the years progressed, unfortunately, he developed prostate cancer and was then initially started, obviously started on chemotherapy. So, he came in to the office multiple times complaining of just exaggerated pain and we increased the dosage of various oral medications and I was left with no choice but to give him some opioids. Even with that, obviously we couldn’t maintain him long term. As a result, I gave him a formulation. This formulation is the one that you see over here. Without the medication, the patient is having severe significant symptoms. With the medication, he is essentially pain free. Another case that I have is a male that's initially presented to a vascular surgeon over a decade ago. He's still in his 40s. He was basically treated for venous stasis ulcerations. When the failed treatment consisting of all the above coming from just conservative management, topical treatments, compressor dressings, multiple, multiple vascular interventions, after graft applications, the works, with everything failing. Do we have any slides of the --

    Dr. Emil Haldey: Yes, we have a slide.

    Dr. Akhtar: Okay, actually this picture we have over here is actually an after effect of what I use in terms of a particular formulation and that formulation being this. That, again going back to a previous picture. This previous picture here. This large geographical area is an area that was essentially open for multiple years. He would call me at odd hours at night and we’re talking about two or three in the morning, stating he's got profuse bleeding and the area is extremely painful.


    And as a result again, we have to do, we did it at that time, we just constantly applying compressor dressings and hope for the best. Intervention with the dermatologist prove to be truthful either but after doing maybe a fifth soft tissue biopsy and essentially came back as a necrobiosis lipoidica. So what do we do different? Well, nothing major, other than the fact that I went to that’s a formulation and as a result, what you see there is not brilliant but highly, highly effective in terms of him going for a swim, and having a bath, having a shower and for the last two years, he hasn't has had any constant or consistent episodes of cellulitis.

    Dr. Emil Hadley: Thank you Dr. Akhtar. Also as we discussed the patient earlier, you had a patient on oral Trental pentoxifylline. Was it this particular patient? This particular patient was also treated with oral pentoxifylline, Trental and another option that’s available to doctors is to deliver pentoxifylline transdermally. You can redeliver it together with the rest of the wound care products. Once again, more clinical options available for you and your toolboxes. So to conclude, to me, a podiatrist is a physician that sees it all and does it all. You are a multispecialty physician group in one doctor. You are the dermatologist, the neurologist, the rheumatologist, the plastic surgeon, the regular surgeon, you do it all. And you have a lot of conditions that you treat and by partnering with a compounding pharmacist, you have many more clinical tools available to you for various conditions starting from pain, and fungal infections, to wound care, dermatitis, warts and calluses, hyperhydrosis and many other conditions. I shared a lot of concepts with you. These concepts are only as good as concepts and they say knowledge is not power, it's only potential power that becomes real through use. So I challenge you all to ask us questions. I also know that I presented a lot of concepts and formulas. I want to welcome you to speak to me through questions now but also we'll be around throughout the conference. You could find us at our booth, we have special materials presented to be shared with you where we capture all of these concepts and formulas and we can share that with you physically. Once again, I challenge you to work with your compounding pharmacist, put those clinical tools to use to help your patients. Thank you.


    Dr. Emil Hadley: Are there any questions or comments? Thank you all.