Recent recalls, enforcement actions and reports challenging dietary supplement quality has prompted many pharmacists to look for ways to ensure the quality of products they recommend. One of the key roles of pharmacists is optimizing a patient’s therapy. They have access to a wealth of information as well as extensive training into the effects of medications and their interactions with both drugs and foods.
Pharmacists are familiar with USP’s role ensuring the quality of prescription and over-the-counter medications, and as such they rely on the USP Verified Mark when it comes to choosing a quality supplement. Not only does the USP Mark offer assurance that “what’s on the label is in the bottle”, it also offers assurance of product consistency regardless of the manufacturer.
Under the current regulatory framework, dietary supplement manufacturers can follow public standards like USP’s or they can set their own private standards. The allowance for private standards increases product variability in the marketplace.
Two companies can both make an Echinacea supplement for example, but they may make it to very different specifications, using different varieties of the Echinacea plant or different processing techniques. Both products may be “quality” products, but they may have very different effects or potency.
A third Echinacea product may be less potent than the other two as it may contain a diluted amount of the active constituent or include material from other plants not listed on the label. Unfortunately, it is impossible for even a trained pharmacist to distinguish one from the other.
Earlier this year, tests on several botanical products raised questions about supplement quality. “Multiple products were found to contain wheat matter that was undisclosed on the labeling or, worse, was found on products specifically labeled as gluten-free,” explained Cydney McQueen, PharmD in a guest editorial published in the March 2016 issue of the journal Hospital Pharmacy. “Those small amounts may indeed be a small matter for individuals going gluten-free by choice, but they pose much more serious consequences for patients with celiac disease or gluten intolerance.” She adds that “many severe adverse events with herbal medications have been methodically traced to accidental or purposeful substitution of toxic plants for the intended herbs….Proof of low quality, whether through contamination or insufficient potency, abounds in academic studies and reports from consumer organizations.”
That’s why Dr. McQueen recommends consumers, pharmacists and practitioners look for the USP Verified Mark on dietary supplements as an assurance of product quality and consistency.