For years, shortages of both over the counter and prescription drugs have troubled both patients and providers.
It’s an issue that has made its way to halls of Congress, where both chambers are taking steps to address the issue.
In December Inma Hernandez, PharmD., PhD (HPM ’16), a professor in the Division of Clinical Pharmacy at University of California-San Diego’s Skaggs School of Pharmacy, testified to the U.S. Senate Committee on Finance as part of its ongoing investigation into drug shortages around the country.
“Drug shortages are an ongoing public health concern that threatens patients’ access to essential medications. Drug shortages have devastating consequences, leading to delays or omission in the use of life-saving treatments or substitution with less effective drugs, all of which contribute to adverse health effects,” Hernandez told lawmakers.
The biggest issues are in the generic market, which accounted for 84% of the shortages between 2017 and 2023 due to several factors, including the fact that generic drugs are generally not high profit products for makers, so companies often aren’t interested in making them. That means much of the generic drug market leans on international suppliers.
“The recent hearing in the [U.S. House of Representatives] have been focused on the outsourcing of generic drugs. The Senate committee was focused on economic drivers of the drug shortage and how things like reforming Medicare reimbursement models would help” Hernandez says. “The were a lot of technical discussions, about the issue, including who and what influenced drug prices.”
Citing a study published in JAMA, Hernandez told Senators that pharmacy benefit managers (PBMs) can hinder access to lifesaving medication.
“My colleagues and I identified 16 generic drugs that were reimbursed in 2021 at a mark-up of 1000% or higher by at least one of the leading Part D sponsors,” said Hernandez. “As patient co-insurance is based on the point-of-sale reimbursement, this practice likely results in increased out-of-pocket expenses for patients.”
Senator Maria Cantwell (D-WA), a member of the committee, has introduced legislation calling for transparency by PBMs and their pricing models.
Another solution, says Hernandez, is using value-based payments to incentivize large buyers of generics like pharmacies and hospital systems to purchase medicine from manufacturers with more dependable supply chains.
Research conducted by Dr. Hernandez alongside HPM professor and chair, Julie Donohue and HPM associate professor Tina Hershey, published in JAMA in March 2020, regarding drug pricing and shortages was heavily cited by the committee during the hearing, and in the white paper it released in January with policy suggestions that could help solve the problem.
“I am grateful to have worked with Drs. Donohue and Hershey on that research,” says Hernandez. “This issue is tied very closely to the work that has been done and is being done at Pitt.”
To watch Dr. Hernandez's entire testimony, click here.
- Mike Friend