Prescribers often re-purpose medications to treat conditions that fall outside those originally approved by FDA (Food & Drug Administration).
Medications used this way are considered to be used “off-label” from their original FDA approval. For example, a blood pressure medication may be used (off-label) to treat anxiety before public speaking. In the realm of compounded medications, pharmacists use medications approved by FDA for use in humans. Often, physicians request custom compounded medications in order to create a solution to a medical condition that is not being well met by a commercial product. Compounding pharmacists are creating innovative, ‘off-label’ medications every day with the goal of improving clinical outcomes, versus another commercially available therapy that may have been tried and failed.
“off-label” isn’t necessarily what you think
The Food and Drug Administration has a pretty broad definition of what constitutes “off-label” use of medication. They often refer to it as “unapproved”. Because of this definition, changing the form of delivery for a medication (e.g. taking a medication only commercially available as a pill and making it a flavored suspension) constitutes an “off-label” or “unapproved” use of the medication. Any time a drug is changed from its approved form or dosage, it becomes an off-label use.
Compounding pharmacists work with healthcare professionals to find innovative answers for hard-to-treat conditions. Together they develop personalized pharmaceutical care not available with formally approved medications. Personalizing medication can mean different dosing levels or combining medications in a way not commercially available. Often, compounding pharmacists are taking out non-essential ingredients that a patient cannot tolerate. It can also include those times when doctors have seen success in treating one illness, with a different (usually lower) dosage of a medication approved for another use. An example of this is the use of an extremely low dose of Naltrexone (referred to as Low Dose Naltrexone or LDN) for the treatment of chronic pain associated with illnesses such as Fibromyalgia. Naltrexone in its approved form and (higher) dosage is used to combat opioid addiction.
Expanding the patient treatment toolbox
From common illnesses where patient adherence is an issue, to using different drugs to combat rare diseases, the off-label use of medications by healthcare professionals increases the accessibility of successful treatments. Working with skilled and safety-minded compounding pharmacists expands the use of available medications in a safe, controlled setting with patient safety and treatment success in mind.
By definition, a custom compounded Rx is “off-label” or “unapproved” by the FDA. Just as when a commercial product is used off-label, doctors and patients everywhere are receiving the benefits of custom therapies compounded by a skilled professional pharmacy for a unique need. The list of success stories grows daily where the individual needs and requirements of patients are met with new and innovative pharmaceutical care prescribed by doctors and crafted by compounding pharmacists.
Health Dimensions Clinical Pharmacy has been providing pharmaceutical solutions to doctors and their patients since 1996. Locally owned and based in southern Michigan, Health Dimensions Clinical Pharmacy was among the first compounding pharmacies to earn accreditation by the Pharmacy Compounding Accreditation Board (PCAB) of the Accreditation for Healthcare Commission. Our mission is to partner with physicians to provide service excellence, accuracy, and rapid response to patient needs. To learn more about building a partnership, call Health Dimensions Clinical Pharmacy at (800) 836-2303.