Pharmacists must guard vulnerable patients against inactive ingredients in medications

June 10, 2015

After you've tracked wheat-derived ingredients through a vulnerable patient's scripts, you realize the problem.

Joel ClaycombOn any given day in any given pharmacy, a typical scenario unfolds: A patient requests a generic medication made by a specific manufacturer. Early on in my career, I patiently handled these request from patients, if at times mentally rolling my eyes. I had been taught that generic medications were fundamentally the same, and while I understood that people differ physiologically, these requests often struck me as clinically unnecessary, if not just plain overly fussy.

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More questions

Several years ago, a pleasant older patient finally got me to see the issue in a different light. Having been recently diagnosed with celiac disease, she requested that I confirm which of her medications (if any) contained gluten or gluten-like ingredients.

Identifying the ingredients in her medication was only the beginning, however. After tracking down the package insert information to determine the ingredients in her medications, I was left with more questions. Gluten was not specifically listed in any of the ingredient lists I reviewed, but what about pregelatinized starch?

I spent the better part of a weekend identifying each of the inactive ingredients in her medications and determining whether they would have an impact on her celiac disease. Upon hearing my suggestions, the patient decided to change manufacturers for several of her medications, and she has let our pharmacy staff know that she appreciates our continued support.

Needle in a haystack

The topic of gluten intolerance is the first one I mention, but patients can have intolerances or allergies to myriad other ingredients. Many patients indicate intolerance to tree nuts, lactose, soy coloring agents, or any number of other ingredients found in their medications. As with my example above, determining which specific inactive ingredients might trigger an allergic response in an individual can be a daunting task.

There are currently tens of thousands of prescription medications available in the United States, and thousands of potential ingredients found within them. At present, few resources allow the patient or pharmacist easy access to information about the active and inactive ingredients contained in prescription and over-the-counter medications. One can contact the manufacturers directly or sift through the fine print in package inserts to obtain this information, but either way, the search for answers is a time-consuming and tedious process.

Online option

An excellent website run by a clinical pharmacist is Glutenfreedrugs.com. This particular website offers a comprehensive list of common Rx and OTC products and notes whether specific drugs contain gluten, soy, or lactose. Other websites, such as Drugs.com, allow searches for specific medication ingredients, but unless the user knows exactly what to look for in connection with specific intolerances, this can be futile, as with the pregelatinized starch ingredient I mentioned above.

 

The next step

FDA is evaluating different approaches to help patients with celiac disease avoid gluten in their medications. One approach seeks to determine whether such ingredients are necessary and whether it might be possible to discontinue the use of glutens or other wheat-derived ingredients in the making of pharmaceutical products. As many of these ingredients have been used as excipients in medications for decades, this may take some time. In some cases, manufacturers of generic medications are taking the initiative and already avoiding the use of gluten in drugs.

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Celiac disease in the United States is estimated to affect about 1% of the population, or roughly 3 million individuals. In addition, every year, hundreds of thousands of individuals discover new allergen triggers in their lives.

Ultimately it is the responsibility of the pharmacist to handle specific requests and concerns about inactive ingredients in medications. While many individuals have already devoted considerable time to aiding pharmacists in this regard, there is still much work to be done.

Joel Claycombis currently working with 3JC Solutions to improve ease of access in searches for inactive ingredients in Rx medications. For more information, e-mail him at jcclaycomb@gmail.com.