MedicalResearch.com: What is the background for this study?
Response: We started thinking more about this topic following a clinical experience five years ago that Dr. Traverso was involved in where a patient suffering form Celiac disease received a prescription of a drug which potentially had gluten. This experience really opened our eyes for how little we knew about the inactive ingredients and how clinical workflows do not currently accommodate for such scenarios.
We therefore set up a large scale analysis to better understand the complexity of the inactive ingredient portion in a medication as well as how frequently critical ingredients are included that could potential affect sensitive patients.
MedicalResearch.com: What are the main findings?
Response: The main findings are that, on average, around two-thirds of the mass of a pill/capsule corresponds to the inactive ingredient portion and this is frequently made up of multiple different inactive ingredients. Interestingly, not all versions of a medication contain the same inactive ingredients, which indicates that alternative versions exist that avoid certain critical inactive ingredients. However, overall almost all pills or capsules contain at least one critical ingredient that could trigger a reaction in a sensitive patient (these are rare events).
MedicalResearch.com: What should readers take away from your report?
Response: Included quantities of inactive ingredients are small, so most patients might not be affected by such results. However, if readers are
aware of having extreme sensitivities, such effects could impact them. Pharmacists and doctors will be able to assist them in navigating the different ingredients and what medication formulations will be free of ingredients known to induce adverse effects in the patient.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Multiple avenues of future work are important. We need to better understand the exact quantities of specific inactive ingredients as well as the tolerated levels before sensitivities manifest. Only then will we be able to study which ingredients are most critical. Furthermore, we are currently exploring whether healthcare professionals are usually aware of such effects and what kind of technologies can best assist them and their patients to navigate the inactive ingredient portion of medications.
Daniel Reker, Steven M. Blum, Christoph Steiger, Kevin E. Anger, Jamie M. Sommer, John Fanikos and Giovanni Traverso. Inactive” ingredients in oral medications.Science Translational Medicine, 2019 DOI: 10.1126/scitranslmed.aau6753