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Historical Evolution and Provider Awareness of Inactive Ingredients in Oral Medications

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Abstract

Purpose

A multitude of different versions of the same medication with different inactive ingredients are currently available. It has not been quantified how this has evolved historically. Furthermore, it is unknown whether healthcare professionals consider the inactive ingredient portion when prescribing medications to patients.

Methods

We used data mining to track the number of available formulations for the same medication over time and correlate the number of available versions in 2019 to the number of manufacturers, the years since first approval, and the number of prescriptions. A focused survey among healthcare professionals was conducted to query their consideration of the inactive ingredient portion of a medication when writing prescriptions.

Results

The number of available versions of a single medication have dramatically increased in the last 40 years. The number of available, different versions of medications are largely determined by the number of manufacturers producing this medication. Healthcare providers commonly do not consider the inactive ingredient portion when prescribing a medication.

Conclusions

A multitude of available versions of the same medications provides a potentially under-recognized opportunity to prescribe the most suitable formulation to a patient as a step towards personalized medicine and mitigate potential adverse events from inactive ingredients.

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Abbreviations

API:

Active Pharmaceutical Ingredient

FDA:

Food and Drug Administration

IRB:

Institutional Review Board

NDC:

National Drug Code

NIH:

National Institute of Health

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ACKNOWLEDGMENTS AND DISCLOSURES

This work was funded in part by: Swiss National Science Foundation Fellowships P2EZP3_168827 and P300P2_177833 (DR), the Department of Medicine Residency Program (SB), MGH Cancer Center T32 2T32CA071345-21A1 (SB), the Alexander von Humboldt Foundation Feodor Lynen Fellowship (CS), the NIH grant EB000244 (GT), the Division of Gastroenterology at Brigham and Women’s Hospital, the Department of Mechanical Engineering at MIT and Karl van Tassel (1925) Career Development Professorship (GT), and the MIT-IBM Watson AI Lab (DR, CS, GT). We are grateful to Professor R. Langer for invaluable guidance and comments on this work. Complete details of all relationships for profit and not for profit for G.T. can be found at the following link: www.dropbox.com/sh/szi7vnr4a2ajb56/AABs5N5i0q9AfT1IqIJAE-T5a?dl=0. S.M.B. has a consulting relationship with Two River Consulting, Third Rock Ventures and is an equity holder in Kronos Bio Inc. C.S. is employed by Bayer AG, Berlin, Germany. D.R. acts as a consultant for the pharmaceutical and biotechnology industry and a mentor for the German Accelerator Life Sciences. D.R., S.B., and G.T. are co-inventors on a provisional patent application 62/811, 502 encompassing systems and algorithms capable of quantifying and providing inactive ingredient burden in medications.

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Author notes

  1. Daniel Reker

    Present address: Department of Biomedical Engineering , Duke University , Durham, North Carolina, 27708, USA

  2. Daniel Reker and Steven M. Blum contributed equally to this work.

Authors and Affiliations

  1. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, 02139, USA

    Daniel Reker, Steven M. Blum, Peter Wade, Christoph Steiger & Giovanni Traverso

  2. Division of Gastroenterology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, 02115, USA

    Daniel Reker, Christoph Steiger & Giovanni Traverso

  3. MIT-IBM Watson AI Lab, Massachusetts Institute of Technology, Cambridge, Massachusetts, 02139, USA

    Daniel Reker, Christoph Steiger & Giovanni Traverso

  4. Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, 02115, USA

    Steven M. Blum

  5. Department of Medical Oncology, Dana-Farber Cancer Institute/Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, 02115, USA

    Steven M. Blum

  6. Cancer Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, 02114, USA

    Steven M. Blum

  7. Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts, 02139, USA

    Giovanni Traverso

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  1. Daniel Reker
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  2. Steven M. Blum
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Corresponding author

Correspondence to Giovanni Traverso.

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Reker, D., Blum, S.M., Wade, P. et al. Historical Evolution and Provider Awareness of Inactive Ingredients in Oral Medications. Pharm Res 37, 234 (2020). https://doi.org/10.1007/s11095-020-02953-2

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