Last week's article drew some attention on social media from both individuals open to the information presented and others who were not in favor of it.
If the information gave you heartburn, my apologies, as that was never the intention. In writing these articles, I aim to provide not mainstream information but more outside-the-box information. Thinking outside the box is to think differently, unconventionally, or from a new perspective and to explore creative and unusual ideas.
If you were to come to my pharmacy and had a consultation about whatever issue or condition you are looking for help with, you will likely walk away with potential solutions to your problem that are often outside the box ideas. We like to think of ourselves as problem solvers.
The good news is, patients who choose to seek out our services are exposed to multiple tools, including conventional medications, compounded medications, and dietary supplements.
Conventional medications
are FDA-approved drugs that have passed the FDA's approval process, rendering them safe and effective for their intended uses.
Compounded medications are FDA-approved drugs prescribed for off-label use.
Off-label use refers to prescribing a medication for a different purpose than those formally approved by the FDA and found in the drug's package labeling. Providers might prescribe medications off-label for a medical condition because the use is well-known and has been done for many years without concerns, or there is a lack of safe or effective alternatives.
An example of off-labeled prescribing is the drug Trazodone, an FDA-approved anti-depressant that has a side effect of drowsiness. Trazodone is often prescribed off-label for insomnia.
In the compounding world, the majority of medications that we make fall into the off-label use category. An example of a compounded medication is taking a commercially available tablet like carvedilol a cardiovascular drug, crushing the tablets, and making a liquid suspension for a small child. The drug is only available in tablet form, yet the provider would like the child to have the drug in a much lower pediatric dosage. The child cannot swallow a tablet, so a suspension is formulated based on the provider's prescription.
One off-labeled medication that has evolved since we first started investigating its use is naltrexone. Fifteen years ago, a handful of studies looked at the benefits of using low doses of naltrexone to treat pain. Research has mapped out naltrexone's effect on different receptors in the body, which have multiple mechanisms of action. When looking at different disease states, you can see which receptors are associated with the disease state and then work backward to consider prescribing the medication for a specific specific condition.
There are no large-scale studies to prove effectiveness of naltrexone for specific conditions, but theoretically, the medications could benefit a multitude of conditions. For some who prescribe compounded medications, this may be a sticking point or an area they may not feel comfortable venturing into, and we respect that opinion.
When compounding a specific medication, we ensure that the product is safe at the prescribed doses. The tenant of "first do no harm"
is an important part of the process that goes into a compounded medication. If we are uncomfortable with a dose of a particular medication, we will visit with the prescriber to ensure dosage is appropriate. On some occasions, new information has come out to warrant a dose we may not have seen previously. Learning is a big part of what we do as we try to provide the best therapies for our patients.
Once we have received a prescription for a compounded medication, if it is something we have not made previously, we begin the formulation process. In the case of carvedilol that was previously referenced, how will we best make a liquid suspension for a child? Choosing the right liquid base has us looking at studies and formulas for the best preparation. After formulation, the medication needs to be compounded, which requires another set of education and equipment to make that happen.
Both FDA-approved and compounded medications need to be prescribed by a licensed provider for an individual patient. The exceptions to this rule are when pharmacists have limited prescriptive authority, such as with naloxone, an opioid antagonist, vaccines, and smoking cessation medications.
The third tool, dietary supplements, fall into a different category of regulation by the FDA. The FDA has established good manufacturing practices (GMPs) that companies must follow to help ensure their dietary supplements' identity, purity, strength, and composition, and they periodically inspect manufacturing facilities. Supplement companies are responsible for having evidence that their products are safe and that the label claims are truthful and not misleading. The FDA does not determine whether dietary supplements are effective before marketing.
The title of this article is Living Outside the Box. It is truly the direction my team and I have chosen to help our patients differently.
We are helping both patients and prescribers in our community and beyond, with difficult medication problems. There are many great pharmacists in our community who can fill your prescriptions and provide consultative services to help you with conventional medications, however not many have the tools we have to offer.
Irsfeld Pharmacy is on the path least traveled, and at times, that can be a rocky path that many don't want to venture on.
It is a path that has been helpful to so many in our community while being professionally rewarding. My hope is that most of you won't need to utilize our services but know that if you do, our team is committed to helping you on your journey to optimal health.
If you want help with outside-the-box options in your health journey, please call the pharmacy @ 701-483-4858 or stop in to schedule a consultation. Please visit my website at
www.irsfeldpharmacy.com
to find this and other archived articles in the blog section.
Until next time, be vigilant about your health!!!
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