by Eugene Papantoniou | Nov 18, 2019 | Uncategorized
Throughout the years the regulations surrounding pharmacy compounding have changed rapidly and generated the most questions outweighing all other topics by far. In an attempt to demystify and shed light on the current regulatory landscape surrounding pharmacy compounding, compounded medications, and patient access, I have written this post. Pharmacy regulations allow compounding of unique, novel, or one-of-a-kind combinations or version of medications prescribed by a physician. The major distinction between manufactured prescription medications one-size fits all approach is that compounded medications are individually tailored to an individual patient’s needs (e.g. flavor, dosage form, route of administration, dosage, and dosage combinations). Federal and state regulations allow for compounding any medications as long as the FDA has not removed, restricted, or banned that particular medication from the marketplace. In recent years, the Drug Quality and Safety Act (2013) gave regulatory authority to the FDA over compounded medications which was a major shift in the regulatory landscape for pharmacies. While the driving factor for this change is patient safety, what has ultimately occurred is decreased patient access to compounded medications vital for patient health. I believe there is a responsible balance between patient safety and patient access that can be achieved; however the restrictive nature of current regulatory environment has created confusion for patients, prescribers, pharmacists, and pharmacies. As a premier pharmacy that offers quality compounded medications Trinova Health is committed to meeting all your health care needs which included access to vital compounded medication while adhering to the strict regulations. If you have any questions contact us today! Silas Raymond,...
by Eugene Papantoniou | Feb 23, 2017 | Compounded Medications
As a pharmacist, I have often found that many patients that are new to LDN (low dose naltrexone) therapy tend to have many questions about it. This isn’t surprising, given that LDN is not a mass-marketed medication and there is a lack of good, reliable information online available. The following is an FAQ for LDN therapy that I hope will help answer many common questions I receive about LDN. What are the side effects? In general, most patients tend to have few, if any side effects when starting low dose naltrexone therapy. The most common side effect that can occur from LDN therapy is sleep interference. Some patients sleep better and more deeply, some have difficulty staying asleep. It seems to be a flip of the coin. I would say I tend to see about 5% of patients have either side effect. Most patients have no issues at all with their sleep while taking LDN. I recommend to patients that if LDN is causing them difficulty sleeping, to simply take their LDN in the morning vs at night. I firmly believe that they will still reap the benefits of LDN, without the sleep difficulties. Is LDN expensive? No – at Trinova Health, it is less than $1 per day. Does my insurance cover it? As a rule of thumb, the general answer is no. I always advise patients to check with their plan to see if their health plan provides coverage for compounded medications, but in general, many insurance plans do not cover compounded medications. The usual cost per month often ends up being less expensive than a typical monthly...
by Eugene Papantoniou | Nov 17, 2015 | Uncategorized
Are you interested in taking Low Dose Naltrexone, but not sure where to turn to? Maybe you’ve read about the possible benefits for patients with fibromyalgia, Crohn’s, rheumatoid arthritis (RA), Hashimoto’s, chronic pain, depression, or many other conditions? Discover what thousands of other patients already have – the benefits of Low Dose Naltrexone! LDN has been shown to help improve and address the root cause of Hashimoto’s disease by balancing the immune system and restoring it to healthy function. Many patents have been able to reduce or even eliminate the need for synthetic thyroid replacement medications through LDN! Do you suffer from fibromyalgia, chronic fatigue, or chronic pain? Discover what thousands of patients have – LDN! Trinova Health has partnered with some of the nation’s leading doctors to provide low cost consultations for patients wishing to use his revolutionary new therapy. Using the power of telehealth, a licensed physician is able to evaluate you from the comfort of your own home. Simply fill out our confidential contact form below, and a representative will contact you right away! You can also reach us toll free at 844-219-2139 – help is just a phone call away! Name(required) Email(required) Telephone Number Comment(required) DISCLAIMER Trinova Health is a licensed pharmacy located in Tampa, Florida that only engages in compounding in response to a practitioners prescription. A written prescription from a licensed practitioner is required for compounded medication from our pharmacy. The information on the site is general in nature and is only intended for use as an educational tool. You should consult your physician or a Trinova Health pharmacist if you have any specific questions...
by Eugene Papantoniou | Nov 5, 2015 | Uncategorized
Do you struggle with any of the following – scars, skin irritation, eczema, or psoriasis? Trinova Health is now offering a revolutionary new product that is designed to address many common skin issues that patients struggle with. If you suffer from scars, you know that there are very few options available to help reduce or eliminate the appearance of scars. Whether your scar may be from an injury, surgery, or pregnancy – Trinova Health offers solutions! Even better – this product is typically covered under most prescription drug insurance plans! Call us at 844-219-2139 today, or simply fill out the form below and we’ll reply within 24 business hours! Name(required) Email(required) Phone Number Comment(required) DISCLAIMER Trinova Health is a licensed pharmacy that only dispenses prescription medication in response to a practitioners prescription. A written prescription from a licensed practitioner is required for any medication. The information on the site is general in nature and is only intended for use as an educational tool. You should consult your physician or a Trinova Health pharmacist if you have any specific questions relating to the diagnosis and treatment of any health problems. Information and statements about products and health conditions have not been evaluated by the Food and Drugs Administration (FDA), nor has the FDA approved the products to diagnose, cure or prevent...
by Eugene Papantoniou | Aug 3, 2015 | Compounded Medications
Feeling out of balance? Trinova Health can help! We are leading experts in the compounding of bioidentical hormone replacement therapy. Whether you’re a man or a woman, Trinova Health has solutions that can restore you so that you’ll feel “like yourself again”! By utilizing natural, plant derived hormones, we can make aging feel optional – not mandatory! Possible symptoms of unbalanced hormones include fatigue, lack of energy, mental fogginess, decreased libido/sex-drive, disturbed sleep or insomnia, and depression. By replacing hormones using bioidentical hormone replacement therapy, we can often reduce or eliminate the symptoms described above. Hormone replacement therapy is the process of replacing the bodies natural hormones that have decreased through the process of aging. We can help! Call us at 844-219-2139 today, or simply fill out the secure contact form below and we’ll get back to you within 24 business hours! Name(required) Email(required) Phone Number Comment(required) DISCLAIMER Trinova Health is a licensed pharmacy located in Tampa, Florida that only engages in compounding in response to a practitioners prescription. A written prescription from a licensed practitioner is required for compounded medication. The information on the site is general in nature and is only intended for use as an educational tool. You should consult your physician or a Trinova Health pharmacist if you have any specific questions relating to the diagnosis and treatment of any health problems, including hormone replacement therapy. Information and statements about products and health conditions have not been evaluated by the Food and Drugs Administration (FDA), nor has the FDA approved the products to diagnose, cure or prevent...
by Eugene Papantoniou | Jul 15, 2015 | Compounded Medications
Do you currently struggle with pain? Tired of taking pills that may cause organ damage and could be addictive? Would you like pain relief that goes to work immediately, applied right where it hurts? Trinova Health has many different options to meet nearly any budget! Are you on Medicare? We have affordable out of pocket pain cream solutions for you too! Simply fill out the form below, and a representative will contact you within 24 hours! Name(required) Email(required) Telephone Number(required) Comment DISCLAIMER Trinova Health is a licensed pharmacy that only engages in compounding in response to a practitioners prescription. A written prescription from a licensed practitioner is required for compounded medication. The information on the site is general in nature and is only intended for use as an educational tool. You should consult your physician or a Trinova Health pharmacist if you have any specific questions relating to the diagnosis and treatment of any health problems. Information and statements about products and health conditions have not been evaluated by the Food and Drugs Administration (FDA), nor has the FDA approved the products to diagnose, cure or prevent...
by Eugene Papantoniou | Jun 25, 2015 | Uncategorized
Given that research has shown that low dose naltrexone (LDN) can have powerful immune modulating effects, it would seem worthwhile to examine the use of low dose naltrexone in patients who are afflicted with IBS and IBD, or inflammatory bowel disease. The two main types of IBD, Crohn’s and Ulcerative Colitis, can lead to debilitating complications and often leave patients with a lowered quality of life. While certain prescription medications can often lead to decreased symptoms and improved quality of life for patients, they may do so at the cost of side effects that can be intolerable to come patients. While the use of low dose naltrexone in Crohn’s and UC is not meant in any way to replace traditional prescription medications that are approved to treat these conditions, some patients may benefit from LDN therapy. One open-label pilot study published in The American Journal of Gastroenterology found that Crohn’s patients who received 4.5mg of low dose naltrexone once daily at bedtime. In this study, 89% of patients responded to therapy, while 67% achieved a remission in symptoms. It should be noted that in this study, low dose naltrexone was added on to a patients current medication therapy. Another recent systematic review looked at 2 different studies – one in adults and one in pediatric patients with Crohn’s disease. In both studies, both adult and pediatric patients received a dose of 4.5mg of naltrexone, which as we’ve discussed before is often considered the “gold standard” in terms of dose for low dose naltrexone. Each study produced outcomes that appear promising concerning the use of low dose naltrexone in helping...
by Eugene Papantoniou | Jun 9, 2015 | Compounded Medications
Veterinary Compounding: Anti-Seizure Therapy Does your pet struggle with seizures? Is your pet having a difficult time taking their seizure medication? Is your pet’s medication is available in an appropriate strength for their size and weight? Do they have intolerable side effects to their current seizure medication? Does your pet has other health concerns (liver issues)? If so, your veterinarian may have a narrowed set of anti-seizure treatment choices available for your pet. Don’t fear! It is in moments like this that veterinary compounding can help. What commonly prescribed anti-seizure options are available for pets? Phenobarbital – Has to be given twice a day and over time may cause liver damage (WebMD). Also this medication is a controlled substance and not all veterinarians can prescribe it. Neurontin (gabapentin) – Only available as large tablets or capsules in high doses meant for humans. Lyrica (pregabalin) – Only available in limited strengths in capsules and is a controlled substance as well. Typically used for humans. So how can veterinary compounding help my pet? Neurontin (gabapentin) – We can mix it in a liquid with an appropriate flavor; paying close attention to your pet’s dosing needs. Also we can place your pet’s specific dose into a single capsule simplifying your pet’s regimen. Potassium Bromide – We can mix it in a liquid with an appropriate flavor; paying close attention to your pet’s dosing needs. Also we can place your pet’s specific dose into a single capsule simplifying your pet’s regimen. Also, potassium bromide is not processed through your pet’s liver making it an ideal choice for young pet and long term use (WebMD)....
by Eugene Papantoniou | Jun 3, 2015 | Compounded Medications
Just in case you didn’t have the chance to read it yet, be sure to check out Part 1 of our series on Low Dose Naltrexone (LDN)! Picking up right where we left off last time, researchers have discovered that naltrexone, when given in a dose of 4.5 mg each night at bedtime, appears to work via “boosting” or “priming” the immune system. Upon the discovery that immune cells throughout the body have opioid receptors (the receptors that naltrexone bind to), it was theorized that by taking naltrexone each night at bedtime, an interesting thing might occur – it’s believed that certain elements of the immune system will be “boosted”, such as endorphins and enkephalins. These elements are critical in the regulation of pain and immune function, and are believed to be key in how low dose naltrexone may be helpful in certain conditions such as fibromyalgia. One study conducted in normal volunteers, for example, showed a marked increase in beta-endorphin blood levels in the days following taking low dose naltrexone as described above. Given that low dose naltrexone appears to work via altering and enhancing the immune system, it would follow that it may be helpful in conditions where the immune system plays a vital role in that condition. For example, low dose naltrexone appears to help reduce some symptoms of fibromyalgia, as demonstrated in small scale clinical trials. In one trial, for example, 60% of patients reported a reduction in fibromyalgia symptoms. Encouragingly, no serious side effects were reported during the study, although a small number of participants reported vivid dreams. Another small study in women found...
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