We know compounds help our patients. Here's how we can prove it.
We all see how our compounded medications help our patients on a daily basis, especially those taking compounded hormone replacements.
We are also aware of the NASEM “study” that was released in 2020. We believe that FDA may act on conclusions of this “study” sometime in the near future. We do not know what action the agency may take, but at worst case, it could conclude that compounding of bio-identical hormones is “demonstrably difficult” and thereby make compounding them a violation of section 503 of the Food, Drug and Cosmetic Act.
In order to make a strong case for compounded HRT to the FDA, we must demonstrate safety and efficacy.
Are compounded hormones safe? Although we cannot definitively claim that yet, there is an increasing body of evidence that demonstrates the safety of compounded hormone replacement therapy. Again, we cannot claim our compounds are safe as the agency has very specific requirements to qualify safety.
Does compounded hormone replacement therapy do what it is supposed to do? So far, we only have largely subjective data. But now we have hope via a tool I recently started using called OutcomeMD.
OutcomeMD has created scientifically validated clinical outcomes assessments that your patients can complete at the beginning of therapy and then again at one-, three- and six-month intervals. This platform objectively measures the patient’s change in symptoms from baseline. By asking your patients to submit their results, you can help APC obtain vast amounts of HIPAA-compliant data to demonstrate to the FDA and other stakeholders that compounded HRT really, truly improves our patients' health.
By helping to provide APC this data, you help your patients, and you stay in business.
Will you join me in helping APC collect your patients’ objective, clinical outcomes? Oh, I should also mention that as an APC member, you receive special pricing.
Learn more about OutcomeMD here or contact Lorraine Kaiser at firstname.lastname@example.org.
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David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at email@example.com.