Panel: ’Every link on the chain’ must change to end drug shortages
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A National Comprehensive Cancer Network Annual Conference plenary session examined the impact of drug shortages on oncology care, as well as potential solutions.
The discussion focused on drug shortages from the perspectives of pharmacists, physicians, payers, policymakers and patient advocates.
“We’re the wealthiest country in the world with the greatest per-capita aggregate spending on health care, and supposedly the most innovative and productive life sciences industry on the planet. Why in the world are there drug shortages?” moderator Clifford Goodman, PhD, an independent consultant in health care technology and policy, said when introducing the session. “We’re going to talk with our panelists about why we are in this mess and how we can get out of it.”
‘An incredibly cruel thing’
The clinical community is facing the largest number of ongoing and active shortages in more than 20 years, according to Erin R. Fox, PharmD, MHA, BCPS, FASHP, associate chief pharmacy officer at University of Utah Health.
“There are 323 active and ongoing shortages, and that is not individual National Drug Codes or individual formulations, Fox said. “Those are drug molecules. This problem is the worst it has ever been.”
There is no “early warning” system in place to alert pharmacists of impending shortages, Fox added
“Many times, you figure this out when you open your pharmacy order and your tote is empty. You don’t have the drug you need,” she said. “That starts an emergency process inside the pharmacy that is invisible to other parts of the health care system.”
Fox cited further challenges in relying on cisplatin produced in China, which may not be compatible with safety systems used in the U.S.
“One of the complications when you have to use a new product, even if it’s the same drug molecules, is that our safety systems — like barcode scanning and safety pumps — don’t work, so you have to re-do that,” Fox said. “Often, you have to dilute it differently and mix it up differently. It’s a point of frustration, additional waste and risk for error.”
Rondeep Brar, MD, a hematologist at Stanford Cancer Institute, explored the situation through the lens of clinicians.
Barr discussed the extensive “intellectual, operational and emotional capital” involved in discussing and formulating an initial plan with a patient.
This process might involve parsing data, choosing a drug, providing patient education, coordinating appointments with surgeons and radiation oncologists, getting authorization, placing central lines and other additional steps.
“When plan A — poof! — just goes away, it’s not just about what drug you can swap in,” Brar said. “Once the first domino falls, the rest are right in place, and that’s all assuming that plan B is just as good as plan A.”
Drug shortages also impact clinical trial participants and potentially raise ethical questions, Brar said. Patients participating in clinical trials are taking a risk that might contribute valuable evidence for the research and clinical communities.
“Do we have a reciprocity-based obligation to these individuals?” Brar asked. “On the other hand, if you’re allowing access to a scarce resource by participation in investigational research, that might be viewed as coercion.”
Lalan S. Wilfong, MD, senior vice president of payer and care transformation at US Oncology Network, said the shortages created a challenge of equitably distributing drugs to patients. The issue sparked considerable debates within the network’s pharmacy and therapeutics committee.
“For example, with the cisplatin shortage, our first thought was of patients with testicular cancer. This is the curative therapy for these patients,” he said. “Then we started debating a lot as far as head and neck cancers and gynecologic malignancies. We had very significant debates as the shortage got worse about who we could switch to alternative therapies.”
Christina Barrington, PharmD, vice president and chief pharmacy officer for Priority Health, shared insights from the payers’ standpoint.
When drug shortages require a switch to an alternative therapy, payers must consider whether the new drug will deliver the expected outcomes and whether the drug will be tolerable enough for the patient to continue treatment, Barrington said. Financially, a shift to an alternative agent is often quite problematic for both patients and payers.
“Many times, we are going from a generic agent to a branded alternative agent, and that may increase the costs from $30,000 to $70,000 for a patient,” Barrington said. “From the payers’ perspective, if the costs of these drugs are doubling or tripling, that puts a financial impact on us. Premiums go up, and it’s a spiral effect.”
Panelist Laura Bray, MBA — founder and chief change maker at Angels for Change, a global volunteer nonprofit dedicated to ensuring access to lifesaving drugs — experienced the drug shortage from the most harrowing angle.
She recalled the day her 9-year-old daughter asked her if she was going to die without her medicine — the only targeted drug suitable for her disease.
“We told her she would have to endure this protocol for 3 years but that, in the end, it would be OK,” Bray said. “We told her this on days she couldn’t walk into the hospital and we had to carry her in. So, what do you say to her when the medication isn’t there and she’s asking if she’s going to die? It was an incredibly cruel thing to do to a family in crisis.”
‘Boots on the ground’
Panelists discussed the efforts they are making at various levels to address oncology drug shortages.
One of the priorities of McKesson, which supports the US Oncology Network, is to multisource drugs so as not to be too reliant on one manufacturer, Wilfong said. He also discussed efforts to mitigate potential hoarding.
“We allocate drugs based on historical spends so, when someone has a spike in orders, they don’t get all the drugs,” he said.
Wilfong cited the US Oncology Network’s Fair Share Distribution Program, which develops protocols regarding which patients should be prioritized for drugs during a shortage.
“We were able to make sure that patients with the greatest need for those drugs were prioritized,” he said. “We really had to do a lot of boots-on-the-ground type work to make sure all of our physicians, nurses and pharmacists understood exactly what we were dealing with and how serious it was, so we could all agree to work together.”
Brar said his practice focuses on having a multidisciplinary group of team members at the table, including a bioethicist and a patient advocate,.
As a pharmacist, Fox said she often finds it helpful to store a few months’ supply of drugs that are frequently in low supply.
“It’s worth it to have 2 to 3 months on hand for products that are always on shortage,” she said. “This enables us to have a bit of a runway, and we go and talk to our ethicist about who is going to get this.”
Fox also emphasized the need for greater transparency around the oncology drug supply chain.
“Congress needs to pass laws mandating more transparency around the supply chain of oncology drugs,” she said. “If we’re going to solve this, lawmakers need to act.”
‘This is real action’
Panelists discussed recent efforts at the legislative level to address drug shortages.
Bray, who played a role in HHS’ recent white paper on the causes of drug shortages and potential solutions, said it is important to recognize that the problem is not limited to one side of the supply chain or another.
“This supply chain has both demand- and supply-side challenges, and all of these challenges are very inefficient and hurt a lot of patients,” she said. “Any work that isn’t looking at connecting the supply chain and the supply-and-demand side is not going to solve this problem.”
Bray mentioned a white paper the Senate Finance Committee published in January.
“Both papers look at the root causes of drug shortages, specifically the sterile injectable marketplace, and the economics of why it is so broken,” she said.
“These conversations are happening. ... This is real action.”
Bray encouraged clinicians to read both white papers, which emphasize the need to incentivize resiliency in the drug supply chain.
“Our supply chain is lacking in reliability. It breaks too often,” she said. “It’s also lacking in resiliency, which means when it breaks, it can’t recover quickly.”
Panelist Stephen Colvill, MBA, assistant research director at Duke-Margolis Institute for Health Policy, described the white papers as “the first time I have seen a comprehensive plan that could make a real difference” ending drug shortages in a few years.
“The major proposal is a manufacturing resiliency assessment program and a hospital resiliency assessment program,” he said. “It would identify manufacturers who are taking steps to invest in reliability and tie incentives into that through payment programs from CMS.”
Colvill also emphasized the importance of a committed contracting model with real financial penalties if a manufacturer doesn’t supply the product they committed to, or if the purchaser does not purchase the amount they committed to.
“We need to give more assurance to both manufacturers and providers that the manufacturer is going to get the demand they expect and the provider is going to get the level of product they expect so they can have peace of mind,” he said.
Some change will be needed to successfully end drug shortages in the U.S., Bray said. However, these relatively small changes will make a big difference, she said.
“Every link on the chain will have to make changes to end the ongoing crisis of dangerous and heartbreaking drug shortages,” she said. “But if we do this right, everyone will only need to change a little bit in order to prevent drug shortages and save lives.”
References:
- Reducing the impact of drug shortages. Presented at: National Comprehensive Cancer Network Annual Conference; April 5-7, 2024; Orlando..
- Senate Committee on Finance. Preventing and mitigating generic drug shortages: policy options under federal health programs. Available at: https://www.finance.senate.gov/imo/media/doc/white_paper_preventing_drug_shortages.pdf. Published Jan. 25, 2024. Accessed May 7, 2024.
- U.S. Department of Health and Human Services. Policy considerations to prevent drug shortages and mitigate supply chain vulnerabilities in the United States. Available at: https://aspe.hhs.gov/sites/default/files/documents/3a9df8acf50e7fda2e443f025d51d038/HHS-White-Paper-Preventing-Shortages-Supply-Chain-Vulnerabilities.pdf. Published April 2, 2024. Accessed May 7, 2024.
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Reducing the impact of drug shortages. Presented at: National Comprehensive Cancer Network Annual Conference; April 5-7, 2024; Orlando.
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