Compounding pharmacists know they make a significant difference to patient care. From hormone replacement therapy to modified dosage forms that benefit children and the elderly, customized medication supports patient wellbeing.
But too much of the evidence in this field is anecdotal. Because validated, standardized data about the effects of compounding medications does not exist, the FDA has issued clear, declarative warnings against pharmacy compounding. These warnings have led Congress to consider tighter restrictions on compounded medication that could limit patient access to the high-quality, customized drug products that they need.
Current restrictions have already hampered compounding pharmacists’ ability to grow their pharmacy and have led to a chilling effect for patients who could benefit from customized medications.
To protect patients’ medication needs — and to gather the medically validated data that the FDA requires — compounding pharmacies are starting to rely upon patient-reported outcomes measures (PROMs). PROMs are objective reports of the effects of supplements, creams and other compounded medications and dosage forms on patient health and wellness.
The Alliance for Pharmacy Compounding (APC), for instance, is using the OutcomeMD platform to collect, track and engage patients about how compounded formulations are addressing their specific needs. This gives pharmacists the insight and data they need to validate their customized medication formulations.
“The OutcomeMD platform is something long-needed in compounding: a means of collecting and aggregating patient outcomes data in a way that’s not just useful to the pharmacy but useful to the profession,” APC CEO Scott Brunner, CAE, said.
The way it works: compounding services send medically validated questions to their patients via a secure smartphone app. Patients respond, and both the patient and the pharmacist receive clear data about how the customized medication is working. This allows pharmacists to be able to adjust formulations quickly if they are not working. It also helps compounding pharmacies collect large-scale aggregated data that could demonstrate the effectiveness of compounded medications to the FDA.
People who use customized medications can monitor their progress through a fitness tracker-like experience, while compounding pharmacists can receive invaluable information about their formulations, allowing them to better serve individual patients and improve their messaging to prescribers.
Data wins the day. In making their case to Congress and the Food and Drug Administration, compounding pharmacists are relying on peer-reviewed studies, like the one recently published in the journal Menopause that highlight the safety and efficacy of compounded drugs. The Pharmacy Compounding Accreditation Board promotes the collection of data to measure quality and compliance with USP standards.
The more data independent pharmacies and compounding pharmacists can gather about how their formulations meet patient needs, the better positioned they will be to promote this critical avenue of care to patients who could most benefit from it.
Testimonials and anecdotal information can only take compounding pharmacies so far. PROMs provide the medically validated data that state boards of pharmacy, the FDA and, most importantly, patients need to feel confident in the compounded drugs and formulations that individual patients receive.
|OutcomeMD Blog Team|