What is Methylene Blue:

In the world of medical research, certain compounds often take center stage due to their versatile applications. Methylene Blue (MB), a synthetic dye with a long history in various industries, has recently emerged as a potential therapeutic powerhouse. From neurological disorders to infectious diseases, the latest research is shedding light on its diverse medical applications. However, it is crucial to recognize the importance of obtaining methylene blue through a prescription and from accredited compounding pharmacies that prioritize pharmaceutical-grade ingredients.

The Rediscovery of Methylene Blue:

Originally synthesized in the late 19th century, methylene blue found its place in textile and dyeing industries. However, over the years, researchers began exploring its potential in the medical field, leading to a resurgence of interest in its pharmacological properties.

Can Methylene Blue be used for Neurological Disorders:

Recent studies have shown promising results regarding methylene blue's efficacy in neurological disorders. Alzheimer's disease, Parkinson's disease, and traumatic brain injuries are among the conditions where MB has demonstrated neuroprotective effects. Research suggests that MB may help mitigate oxidative stress, reduce neuroinflammation, and enhance mitochondrial function, contributing to improved cognitive outcomes.

Can Methylene Blue be used for Infectious Diseases:

Methylene blue's antimicrobial properties have been extensively studied, revealing its potential in the fight against infectious diseases. Studies have explored its effectiveness against various bacteria, viruses, and even parasites. In particular, MB has shown promise in the treatment of malaria, showcasing its versatility in combating a range of pathogens.

Can Methylene Blue be used for Cardiovascular Health:

The cardiovascular benefits of methylene blue have also been a subject of recent research. Studies indicate that MB may improve vascular function, enhance blood flow, and protect against endothelial dysfunction. These findings suggest potential applications in managing conditions like hypertension and cardiovascular diseases.

Can Methylene Blue be used for Cancer Therapy:

Methylene blue's role in cancer therapy has sparked interest as well. Some studies suggest that MB may have antitumor effects, making it a potential adjunctive treatment in certain cancers. While more research is needed, early findings point to the compound's ability to inhibit cancer cell growth and induce apoptosis.

Prescription and Quality Sourcing:

Despite the promising research surrounding methylene blue, it is essential to emphasize the significance of obtaining it with a prescription and from accredited compounding pharmacies. Pharmaceutical-grade ingredients of the highest quality ensure the purity and safety of the compound, minimizing the risk of contamination or impurities.

Methylene blue is a potent compound, and its therapeutic use should be under the guidance of a qualified healthcare professional. A prescription ensures that the dosage is tailored to the patient's specific needs, reducing the likelihood of adverse effects and ensuring optimal therapeutic benefits.

PCAB Accredited Compounding Pharmacies:

Choosing an accredited compounding pharmacy is equally crucial. These pharmacies adhere to strict quality standards, using pharmaceutical-grade ingredients that meet rigorous purity and potency criteria. This ensures that the methylene blue obtained is of the highest quality, enhancing its safety and effectiveness.

Methylene blue's journey from a textile dye to a potential medical marvel is a testament to the ever-evolving landscape of medical research. The latest studies suggest a myriad of therapeutic applications, ranging from neurological disorders to infectious diseases and cancer. However, the responsible and safe use of methylene blue requires a prescription and a commitment to obtaining it from accredited compounding pharmacies. The Medicine Center Pharmacy in New Philadelpiha, Ohio is. your local resource for quality compounding solutions for patients and providers. Give the Medicine Center a call at 330-339-4466 or send us an email if you would like to learn more about Methylene Blue or other compounded prescription solutions. At the Medicine Center Pharmacy, we prioritize pharmaceutical-grade ingredients and quality sourcing, so we can unlock the full potential of methylene blue in advancing medical therapies.

Autoimmune diseases are a complex group of conditions in which the immune system mistakenly attacks healthy cells and tissues. While treatment options exist to manage symptoms, there is no known cure for autoimmune diseases. However, recent research has shed light on the potential benefits of Low Dose Naltrexone (LDN) in managing these conditions. In this blog post, we'll explore some of the latest research findings on the use of LDN in autoimmune diseases.

1. The Basics of Low Dose Naltrexone (LDN)

Low Dose Naltrexone (LDN) is an FDA-approved medication typically used in higher doses to treat opioid addiction. However, in low doses (usually 1-4.5 mg per day), it has shown promise in addressing autoimmune diseases. LDN works by modulating the immune system and may help reduce inflammation and promote self-tolerance.

2. Promising Research on Multiple Sclerosis (MS)

Recent studies have examined LDN's potential in treating Multiple Sclerosis (MS), an autoimmune disorder affecting the central nervous system. LDN appears to have a positive impact on MS patients by reducing the frequency and severity of relapses and improving overall quality of life. It may work by inhibiting the activation of microglia cells, which are implicated in neuroinflammation.

3. LDN and Rheumatoid Arthritis

In Rheumatoid Arthritis (RA), LDN has shown potential as an adjunct treatment. A study published in the Journal of Translational Medicine in 2014 suggested that LDN can reduce disease activity and pain levels in RA patients, along with improving sleep quality. LDN's mechanism of action may involve its ability to modulate the immune response and reduce inflammation in the joints.

4. Crohn's Disease and LDN

Crohn's Disease, an inflammatory bowel disease, has also been the focus of LDN research. Several studies have reported that LDN may help reduce disease activity, improve quality of life, and reduce the need for other medications. The anti-inflammatory properties of LDN could be instrumental in providing relief to Crohn's patients.

5. The Immune Modulation Effect

LDN's ability to modulate the immune system is a key feature that makes it relevant for autoimmune diseases. It appears to promote the release of endorphins, which, in turn, influence immune function. By balancing immune responses and reducing inflammation, LDN may be a valuable complementary therapy for a range of autoimmune conditions.

6. Safety and Side Effects

Low Dose Naltrexone is generally well-tolerated, and side effects are typically mild and transient. However, it's essential to work closely with a healthcare provider when considering LDN as part of your treatment plan. Dosage and monitoring should be tailored to individual needs.

Conclusion

While Low Dose Naltrexone is not a guaranteed cure for autoimmune diseases, the recent research findings are promising. LDN's potential to modulate the immune system and reduce inflammation has drawn attention from both patients and healthcare professionals. Nevertheless, it's essential to approach LDN as part of a comprehensive treatment plan, under the guidance of a qualified healthcare provider.

Autoimmune diseases are highly individual, and what works for one person may not work for another. It's crucial to discuss the use of LDN with your doctor to determine whether it's a suitable option for you. With continued research and clinical trials, LDN may play a more significant role in managing autoimmune diseases in the future, offering hope for improved quality of life for those who are affected by these conditions.

Health Matters is a weekly radio show sponsored by the Medicine Center Pharmacy on WHBC 1480 AM in Canton, Ohio. This episode pharmacists Brad White and Paul White discuss common skin conditions with Dr Garcia-Zuazaga from Apex Dermatology.

Your skin is your protection. It’s the very first line of defense for anything you come into contact with. For this reason, you should be adamant about maintaining its health. Whether it be skin cancer, acne, eczema or aesthetic concerns, you should never neglect the health of your skin.  Today we will talk with Dr. Garcia-Zuazaga about Apex Dermatology and their approach to treating skin conditions.

Listen to the episode on Apple Podcasts, Spotify, Castro, Stitcher, Amazon Music, or on your favorite podcast platform.

Tune in to this episode of Health Matters to learn answers to the following questions:

1. It seems like getting into a dermatologist as a new patient requires months of waiting, How can you get patients in the same day?

2. How common is it and what are some of the risk factors that make it more likely to get skin cancer?

3. If I am looking at a mole and am concerned by its appearance, what should I look for?

4. How often should someone be screened for skin cancer?

5. What does the acronym ABCDE mean?

6. Other than skin cancer, what are some common medical conditions treated at Apex?

Thanks for listening today! We’d like to remind our listeners, if you suspect you have a medical issue, please contact your healthcare provider. Thanks to our sponsors Studio Arts & Glass and Jenior Appraisals and LIquidations. As always, we thank our listeners for joining us on Health Matters with the Medicine Center Pharmacy. Have a healthy week and we’ll see you again next Friday right here on News Talk 1480 WHBC.

There has never been a time to be more aware of your personal health and wellbeing. Complementary therapies may yield significant positive effects on both the physical and mental health of patients. In this webinar, which is open to everybody, we will talk about options that may help in modulating patients' immune system, as therapies researched to offer antiviral and antibacterial properties, and how it can have a profound impact on their lives by helping them in achieving the most optimal well-being.

Hosted By:
Brad White, RPh
Medicine Center Pharmacy Pharmacist, Brad White, RPh will discuss all about the potential effects of natural therapies in maintaining good health. He regularly hosts webinars on health related topics and therapies and how they may impact one’s overall health positively.

Chris Jurist
Chris Jurist is the Vice President and Owner of im·bue botanicals and will talk all about the positive impact of alternative therapies on one’s health, providing information on the possible benefits of using natural therapies to improve the health of patients everywhere.

Zoom Video Archive Here:

If you have questions about health and wellness therapies then I encourage you to speak with one of our pharmacists. You can schedule a one on one consultation by clicking here or call the Medicine Center Pharmacy nearest you.

Naltrexone is commonly known as an opiate antagonist. This means this drug competes for the same receptors in the body as opioids, like oxycodone or morphine. In doing this, naltrexone makes it so opioid drugs do not work like they normally would. Basically, it reverses their effects and eliminates the feelings of well-being . It is very useful in accidental or intentional overdose and short or long term toxicity. However, these effects are only seen at the higher doses of Naltrexone. High doses include anything 50 mg or higher. At lower doses, Naltrexone has many different effects. Low Dose Naltrexone (LDN) is usually 1 to 5 mg, but can vary slightly. It still keeps its opioid blocking effects, but for a temporary effect. It’s main effect is working on the immune system. This gives LDN the capability to work in a lot of different areas including autoimmune diseases like rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and so much more.

Chemical Structure of Naltrexone

There are two different main types of inflammatory bowel disease; ulcerative colitis and crohn’s disease (as pictured below). Crohn’s disease is complex and mysterious because the cause of it is unknown. It’s thought that many things contribute such as environmental, genetic, infectious, immune, and non-immune factors. What we do know is that it has a distinct characteristic of life-long inflammation that comes and goes most commonly in the colon and last parts of the small intestine. Crohn’s disease is not limited to these areas, it may affect the whole digestive tract in one area or many areas at once. Crohn’s disease is most commonly diagnosed in young adults, before age thirty. Common complications can include extensive bowel wall injury, fistulas, narrowed intestinal lumen, small bowel strictures, and nutritional deficiencies. Some common treatments are medicines, bowel rest, and sometimes surgery. No one treatment regimen will work for everyone with crohn’s disease, but the goal is to decrease the inflammation in the intestines, to prevent flare-ups of symptoms, and to keep the disease in remission.

For Crohn’s specifically, the mechanism of LDN ties into the distinct life-long inflammation that comes and goes in the gastrointestinal tract. Toll-like receptors (TLR) are a class of proteins in the body that play a key role when dealing with the immune system. Overactivation of TLRs has been linked to various infectious and inflammatory diseases. LDN has been shown to reduce inflammatory response by controlling these TLRs and their signalling. In addition, LDN increases endogenous endorphin signaling through the whole body by short term opioid-receptor blockade. In other words, endogenous (internal) opioid signalling can mimic the effects of opioids because endorphins can cause an analgesic effect. Further, this can promote healing, inhibit cell growth, and reduce inflammation. LDN may even stimulate the body’s own production of endorphins, even after the LDN is no longer in the system. A recommended dosing pattern for LDN in crohn’s disease starts at 1.5 mg per week and can be increased by 1.5 mg per week up to 4.5 mg until symptoms have been reduced.

LDN is unique in the sense that it is not made by a manufacturer like other traditional prescriptions. It is only made in compounding pharmacies, making the dosage and formulation type unique to each prescription. LDN can be compounded into come in liquid, capsules, sublingual drops, cream or tablets. A LDN prescription will require working with both a physician and pharmacist. In almost every recorded trial where LDN is used for the treatment or improvement of crohn’s symptoms, there was a positive effect on the outcome. It has shown to improve crohn’s disease activity index, remission after failing multiple standard regimens, clinical improvement, and reduction in use of anti-inflammatory medications. It is also important to note that the improvement of these outcomes does not come at a price.

LDN very rarely has been associated with side effects during trials and has been well tolerated. Some of the most common side effects reported with its use in trials for inflammatory bowel disease were vivid dreams, drowsiness or insomnia, and headache. These side effects do not affect the effectiveness of LDN. The LDN Research Trust states that in inflammatory bowel disease,

LDN is expected to be successful 78 - 84% of the time according to patient’s reports. The first time LDN was used for inflammatory bowel disease in clinical trials was published in 2007. This refers to a study that used compounded 4.5 mg capsules of LDN daily for three months in addition to their regular medications. LDN was used to determine if it’s use helped enrolled patient’s symptoms related to crohn’s disease. To assess LDN’s effect on disease activity, patients recorded their symptoms in a Crohn’s symptom diary recording things like frequency of diarrhea, abdominal pain, and general well-being. This was used to calculate a Crohn’s disease activity index (CDAI). The index scores can range from 0 to about 600. A CDAI of less than 150 is a marker of remission of Crohn’s disease and a score of greater than 450 is a marker of severe Crohn's disease. Their study results indicated that out of the seventeen patients enrolled, 89% of the patients had a response to the LDN and 67% achieved remission according to their CDAI score.

More recently, in 2018 another study evaluated LDN in patients both not in remission and not responding to the usual therapy for treatment of inflammatory bowel disease. Including more patients than ever before, this study’s goal was to assess LDN’s effects for inflammatory bowel disease treatment of actual patients rather than theoretically or in the lab. Forty-seven patients with inflammatory bowel disease used 4.5 mg of LDN daily for 12 weeks. Clinical improvement was measured by patient self-assessments and outpatient assessments. Of the enrolled patients, 74.5% achieved a clinical response overall. Of those patients who achieved a clinical response, 25.5% of patients had a response of at least 3 months whereas the rest were seen between four and twelve weeks. The biggest difference between this study and the previous study mentioned is this study takes into account both ulcerative colitis and crohn’s disease. However, the results did not show any significant differences between the two types of inflammatory bowel disease. Overall, all studies have shown LDN in crohn’s disease to help in either remission of symptoms or clinical improvement in a well tolerated manner. More and bigger studies are needed to prove it’s place in practice, but it continues to show benefits as a safe add on treatment for the complicated gastrointestinal disease known as crohn’s disease.

The Medicine Center Pharmacy in New Philadelphia specializes in custom compounded medications in custom dosage forms. The pharmacists are trained experts in low dose naltrexone therapy. LDN therapies can be customized across 23 different dosage forms for 15 different disease state protocols. If you would like to learn more about low dose naltrexone or would like to schedule a phone call or video conference please contact us.

Key Articles

★ LDN Rx Consultants (July 2019). Inflammatory bowel disease (IBD) [PDF

file]. Retrieved from: ldnrx.com.

★ Lie MRKL, Giessen JV, Fuhler GM, et al. Low dose Naltrexone for induction

of remission in inflammatory bowel disease patients. J Transl Med

2018;16(55):1-11.

★ Pradeep Chopra (2014). Mechanism of action of low dose naltrexone (ldn)

[PowerPoint slides]. Pain Management Center, RI. Retrieved from:

https://www.ldnresearchtrust.org/sites/default/files/LDN_Mechanism_Of_

Action_Pradeep_Chopra_MD.pdf .

★ Revia® (naltrexone hydrochloride tablets USP) [package insert]. Pomona,

NY: Duramed Pharmaceuticals, Inc.; issued Oct 2013.

★ Smith JP, Stock H, Bingaman S, et al. Low dose naltrexone therapy

improves active crohn’s disease pilot study. Am J Gastroenterol

2007;102:820-28.

★ Toljan K and Vrooman B. Low-dose naltrexone (ldn)-review of therapeutic

utilization. Med Sci 2018;6(82):1-18.

Physiology of the Disease

Cancer is a condition in which cells within your body divide at an uncontrolled rate. Our body's natural defense against these cells are known as tumor suppressor genes. However, mutations can occur leading to the formation of oncogenes that promote cell growth and reproduction, or suppression of tumor suppressor genes. When this occurs, the cells divide rapidly leading to tumors or large masses and cause your bodies other healthy cells to die. These cancerous cells can then travel to other parts of your body through the bloodstream via a process known as metastasis. When this occurs, the cancer can continue to grow in these areas making it much more difficult to treat.

LDN – How it Works

At its intended doses of 50-100 mg, naltrexone is an opioid antagonist used in the treatment of addiction. However, when used at much lower doses, naltrexone is known to act as an anti-inflammatory agent. As we used LDN more and more, and involve it in animal and human studies, we have found it to be useful in many other conditions such as cancer. Although we do not know the full mechanism of action for benefit in cancer patients, here are some proposed mechanisms:

●      Intermittent dosing significantly reduced cancer cell development, in contrast to a constant blockade that accelerated tumor growth

●      May enhance natural killer cells, T-Cell, IL-2, and TH-2 activity via the mu receptor and also by binding to receptors on cancer cells themselves. These cells are the major players in our body’s natural immune system

●      LDN causes increased cell death in certain cancers and potentially increases patient response to chemotherapy agents

●      Cells that are treated with LDN up-regulate BAD and BIK1 genes that aid in cell death

●      Some cancer patients treated with intermittent LDN, experienced greater benefit by chemotherapy drugs

o   Example: Priming HCT116 with LDN before treatment with oxaliplatin significantly increased cell ki

Effectiveness

            Naltrexone’s potential for cancer prevention and treatment began mainly from the work of Penn State investigators Ian Zagon and his colleagues. They initially studied and published evidence that a dose of 0.1mg/kg in mice reduced neuroblastoma tumor incidence by 66%, slowed tumor growth by 98% and increased survival by 36% over controls.

            More recent publications include that from Liu et al in 2016 who published that cells treated with LDN followed by chemotherapy always resulted in a greater reduction in cell number and viability when compared to cells cultured with LDN after chemotherapy treatment. However, in cells treated with standard NTX, treatment with any of the cytotoxic drugs did not generally result in dramatic reductions in cell number or viability.

            Another researcher, Dr.Bernard Bihari has reported he has treated about 450 cancer patients with LDN, and he reports that over 270 patients had significant benefits from LDN. Of those patients, 86 of them had shown objective signs of decreased tumor size of at least 75%. Another 125 patients were stabilizing or on a path toward remission.

Dosing

Starting doses can be anywhere from 0.5 mg to 1.5 mg, and is increased up to 4.5 mg; which is the maximum dose for Low Dose Naltrexone. Specifically for cancer patients, the dose should be a goal daily for at least 7 days before starting an "on/off cycle"

●      An "on/off cycle" consists of 3 days on and 3 days off LDN

●      The 3 days off should fall directly before chemotherapy treatment. Although there are no known contraindications with chemotherapy, it is recommended to avoid use together until further research is completed

It has been seen in some cancer patients, that taking a CBD product on the 3 days off increases the anti-tumor effect of LDN

Side Effects

LDN is well tolerated in most patients and limited further when a patient is started on a start low and go-slow method. This means the patient should be started at a low dose and titrated up slowly. When side effects occur, they are usually mild and include:

●      Sleep disturbances

●      Mild headache

●      Mild agitation

●      Nausea/GI effects - consider switching to liquid sublingual LDN to bypass GI tract

It has been found in patients that experienced side effects, that they can be stopped by decreasing the dose by half for 2-3 days, and then continuing with titration again.

Formulations

●      Oral liquid: 1 mg/1 mL daily

●      Capsules or tablets

●      Sublingual drops

o   Drops are placed under the tongue from a dropper bottle

●      Creams: 0.5 mg/mL

o   Useful for children who you have difficulty administering the other formulations, or those who are allergic to additives in other formulations of LDN

Key Resources

Boundless. Overview of Cancer [Internet]. Lumen: Boundless Anatomy and Physiology. Available from: https://courses.lumenlearning.com/boundless-ap/chapter/overview-of-cancer/

Brown N, Panksepp J. Low-dose naltrexone for disease prevention and quality of life. Medical Hypotheses. 2009;72(3):333–7.

How Low Dose Naltrexone Works [Internet]. How does Low Dose Naltrexone Work | LDN Research Trust - Low Dose Naltrexone. Available from: https://www.ldnresearchtrust.org/how-naltrexone-works

Low Dose Naltrexone [Internet]. The Low Dose Naltrexone Homepage. Available from: http://www.ldninfo.org/

Toljan K, Vrooman B. Low-Dose Naltrexone (LDN)—Review of Therapeutic Utilization. Medical Sciences. 2018;6(4):82.

Hydroxychloroquine (Plaquenil), a popular anti-malaria drug is also used as a primary treatment for Rheumatoid Arthritis and Lupus. In light of the COVID-19 crisis, we have been getting calls from patients that are concerned about maintaining drug therapy due to the nationwide shortage of hydroxychloroquine. Disease flare ups are a common concern with patients of any condition when vital medication is on the FDA shortage list or in limited supply.

What is the Medicine Center Pharmacy’s Role in Hydroxychloroquine Supply Chain?

We received a shipment of bulk powder of the active ingredient hydroxychloroquine. If a patient is having difficulty maintaining their current therapy we can consult with their provider to obtain a prescription to compound capsules or a liquid formulation if necessary. 

Compounding pharmacies use bulk chemical ingredients to formulate patient specific medications. Alternatively, hydroxychloroquine tablet are mass manufactured by large drug companies. You can have confidence in the Medicine Center Pharmacy process as we are a PCAB Accredited Non-Sterile Compounding Facility.

There are treatment options to consider outside of hydroxychloroquine.  Low Dose Naltrexone (LDN) has the potential to be a therapeutic alternative as it has been documented to be effective in many autoimmune conditions. 

Medicine Center Pharmacy accepts most insurance plans. Often insurance companies exclude compounded medications from coverage which has been a very frustrating for patients that depend on insurance for care. In many cases, the cost for a compounded medication is very affordable and often is comparable to insurance copays.

Low-Dose Naltrexone

Patients with autoimmune conditions are finding relief with Low Dose Naltrexone (LDN). The Medicine Center Pharmacy is part of national network of pharmacists that is dedicated to educating patients and providers about alternative treatment therapies and specializes in using LDN for autoimmune and pain conditions.

We have additional resources for Low Dose Naltrexone Education:

**Updated: the New Closing Date for public comments is October 15th, 2020.

Protect your access to customized compounded medications for your pets.

The FDA has released a Guidance for Industry #256 that if approved as is and enforced will directly affect how your veterinarian can provide care for your favorite pet or animal. Below we have outlined some facts with the assistance of PCCA and Alliance for Pharmacy Compounding that are listed to demonstrate the far reaching scope of this prepared to submit to the FDA so that we can share what challenges this will cause for veterinarians, pharmacists, owners, and animals if this guidance document is enforced in its current form.

The policy requires compounded animal medications to be prepared from FDA-approved products with the idea that these deliver better quality active ingredients and better quality to the final compound. FDA currently regulates manufacturers of active ingredients, making the reliance on approved products an unnecessary burden. Further, no evidence is available that compounds made from approved products are of higher quality. In fact, USP has shown failures of compounds using approved products. The end-result is a more expensive compound that is not proven to have higher quality. This unnecessary stipulation will lead to fewer animals being able to receive their needed medications, or sadly, euthanized.  

The Draft Guidance fails to recognize that pharmacists generally lack access to approved animal products to be able to compound with them. Further, the Guidance does not recognize the need for compounds to be made in cases of shortages of animal drugs.  Human drug shortages are no secret in the marketplace.  Products as simple as sodium bicarbonate and cyanocobalamin were in short supply for a considerable amount of time, there is no reason to assume that this is not possible in the animal space.

The Draft Guidance attempts to enter into the practice of veterinary medicine and single out these animal health professionals as the only ones required to document their rationale for their prescription, as opposed to the prescription itself being the expression of their best choice for that individual patient based on their education, training and experience.

The Agency has previously registered its concerns with splitting tablets for the purpose of creating fractional doses; yet, somehow recommends this practice for animal patients rather than compound an appropriate dose. 

The policy on patient specific animal compounds requires that the medication be prepared in compliance with applicable “USP monographs for a compounded finished product.” These formulations are not appropriate for all species and force some animals to be exposed to ingredients that can be detrimental to their health.

USP monographs for compounded formulations do not consistently use FDA-approved products as a source of active ingredients, instead, favoring bulk pharmaceutical ingredients. This directly contradicts the FDA’s other requirement to use approved products as the source of active ingredients.   

The FDA does not have statutory authority to regulate animal compounding from bulk ingredients. Federal law discusses the application of the Agency’s extralabel use provisions to drugs with an approved application as an animal drug. Further, the scope of the Agency’s own regulations state that they apply to “the extralabel use in an animal of any approved new animal drug or approved new human drug” (emphasis added).  

The FDA has no ability to create a positive or negative list of bulk ingredients related to office use of compounded medications for animals. Further, this appears that FDA is once again attempting to apply provisions from DQSA to animal compounding. Congress has chosen for compounding from bulk ingredients to be available for human patients and it is illogical to conclude that they would prohibit or limit this for animal patients in the ways that the Draft Guidance proposes.

Animal owners, Veterinary providers, and pharmacy staff members are encouraged to submit comments to the FDA during this draft period before June 17th, 2020**. You can download a template here and customize it to share your views and make it unique.

**Updated: the New Closing Date is October 15th, 2020.

Submissions can be made on the FDA website at” https://www.regulations.gov/

A recent article published by NPR does a fantastic job of providing legitimacy to a therapy that has been very popular at our compounding pharmacy, low dose naltrexone (LDN). The volume of scientific information is expanding at an enormous pace, and as a result it is challenge to be aware of all the cutting edge therapies, so it is great when the press helps to raise awareness.

The good news is that the research is there, but often takes time to trickle into the mainstream standard of care. This NPR article relays the experience of living with chronic pain from the “other side" of the story, the non-research side, from the point of view of patients.

The article tells the history of LDN, why it's so promising, and the fact that ONLY compounding pharmacies have the ability to prepare this medication in custom dosage forms to meet patients needs.

Patients and providers can quickly read (or listen) to this news story and understand now low dose naltrexone works and it provides legitimacy in coming from a national news source such as NRP

Dr. Bruce Vrooman, an associate professor at Dartmouth's Geisel School of Medicine, was an author of a recent review of low-dose naltrexone research.

The full text of the NPR News story can be found here: In Tiny Doses, An Addiction Medication Moonlights As A Treatment For Chronic Pain

The compounding pharmacists can assist you with your questions about LDN, for more information contact the pharmacy here or call us at 330-339-4466.

Our next public information session on LDN will be October 3rd, 2019 at 6:30pm at the Hampton Inn Meeting Room 1299 West High Avenue New Philadelphia, Ohio 44663.

Do you have experience with LDN you would like to share?