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Diabetes groups, Helmsley Trust to fund investigation of insulin quality across pharmacies

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The American Diabetes Association, JDRF International and The Leona M. and Harry B. Helmsley Charitable Trust will fund a 1-year study to investigate the consistency and potency of insulin available at retail pharmacies across the United States, the organizations announced in a press release.

An investigation team based at the University of Florida will examine eight insulin formulations that vary on time-action profiles, across five U.S. regions for 12 months, using multiple potency testing methodologies. The results work will be published by mid-2019, according to the release.

“Insulin activity is of utmost importance to the diabetes community,’’ Timothy Garrett, PhD, of the pathology laboratory at the University of Florida, who will lead the new study, said in the release. “In collaboration with Insulin for Life, we have designed a comprehensive measurement approach that incorporates standard methods for quality assessment, along with new methods that taken together will provide the best assessment of insulin activity for the patient.”

The effort was prompted by a small study published in the December 2017 edition of the Journal of Diabetes Science and Technology. The study, which was not initiated or supported by JDRF, the ADA or Helmsley, suggested there was a wide variation in the level of activity in insulin available at U.S. pharmacies.

In the study, researchers examined 18 10-mL vials of NPH and regular insulin produced by two major manufacturers and randomly purchased in U.S. pharmacies. It found an average dosage of 40.2 U/mL with levels ranging from 13.9 to 94.2 U/mL. None of the vials met the 95-U/mL standard at the time of testing. The U.S. Pharmacopeia and the FDA require insulin vials and cartridges to contain a minimum of 95% intact insulin (95 U/mL).

Their report raised concerns among people with diabetes and health care providers, and controversy among manufacturers, clinicians and biochemists because the study’s findings were inconsistent with data from previous regulatory audits, as well as detailed checks and balances from manufacturers. The new study is designed to help identify and assess the potential for insulin degradation across a wide range of formulas.

“The December 2017 study shed light on an issue that affects millions of insulin-dependent Americans,” Sanjoy Dutta, JDRF assistant vice president of research, said in the release. “Along with our partners at the ADA and the Helmsley Charitable Trust, we are confident that Dr. Garrett and his team will help to accurately analyze the quality of insulin at the point of sale to ease the concerns of our community.”

In a statement, William T. Cefalu, MD, chief scientific, medical and mission officer for the ADA, said the study should bring peace of mind to the millions of people with diabetes.

“Patients and their loved ones should not have to worry about whether or not the insulin at their local pharmacies will be effective,” Cefalu said in the release. “The ADA is grateful for the collaboration and support of JDRF and Helmsley to help make this research possible.”