By building strategic partnerships, hospitals can improve care, cut costs, strengthen compliance and optimize workflows.
Every hospital’s mission is to provide patients with the best possible care, and today’s most highly rated health systems focus closely on their patients’ experiences and outcomes. How their pharmacies operate can be a make-or-break factor.
The role of the hospital pharmacist has evolved, and pharmacists are now closely involved in helping nurses and doctors ensure patients get the right medications at the right dosage while counseling patients on how to use medications correctly, says Varsha Gaitonde, vice president of pharmacy services for QuVa Pharma, a 503B outsourcing organization registered with the U.S. Food and Drug Administration (FDA) that supplies sterile, ready-to-administer drug products to many leading health systems. Gaitonde worked as a hospital pharmacist for years before coming to QuVa and saw the shift firsthand.
“Traditionally, pharmacists were essentially part of the distribution only—we made our drugs and gave them to patients, or we gave them to the nurses to administer to patients,” Gaitonde says. “But today we have more collaborative care, where the pharmacist has direct involvement with making decisions around patients’ medication needs.”
That means pharmacists spend more time at patients’ bedsides with clinicians—a very positive trend in terms of improving patient outcomes—but it ultimately means they have less time to oversee in-pharmacy tasks like the compounding of drugs.
“A pharmacist’s primary goal should be to be an asset to the physician and nurses so they can provide better care to patients,” she adds. “That can’t happen if pharmacists are spending the bulk of their time putting together IV bags or checking to ensure the technicians are doing so correctly.”
Answering Complex Challenges
Hospital pharmacy leaders also grapple with other patient-care issues that make compounding drugs onsite less attractive and viable. For one, many large hospital pharmacies contend with high turnover rates of pharmacy technicians and other personnel. That puts a strain on their onsite compounding operations, further limiting the time pharmacists can spend with patients, says Peter Jenkins, co-founder and chief development officer at QuVa Pharma.
Treatment mistakes can also be more common when drugs are compounded on site, Jenkins says. Due to the regulations that hospital pharmacies must comply with, drugs compounded on site are sometimes prepared quickly right before a patient needs them—increasing the chance of error. They also may not be as clearly labeled as they would be coming from a 503B facility, such as QuVa Pharma, which uses color-coding and other labeling techniques to greatly reduce the odds of a drug mixup.
“As a patient, I want to make sure the nurse or clinician is dispensing the right drug for me,” Jenkins says. “At QuVa, we spend a lot of time—and have very open ears—to the labeling of our products to make sure they’re as useful as possible to the doctors and nurses.”
Susan Jackson, executive director of pharmacy operations at Wellstar, one of Georgia’s largest and most integrated healthcare systems and also a QuVa partner, says clear labeling and standardization helps ensure high-quality patient care. “There are a lot of patient safety benefits of using 503B products,” she says. “A key benefit is the barcode or chip in them that helps to ensure the patient is getting the proper medication.”
Moreover, because 503B products are ready-to-administer, clinicians can use them to treat patients quickly, without the delay you might see if they have to be compounded on site at the hospital, says Mark Hendrickson, director of the Compounding Quality Coalition, a Washington, D.C., organization that promotes higher industry standards. “In an emergency situation, the 503B product is ready to go at a quick notice—you’re not holding up treatment of the patient.”
Adding to this complex issue is the fact that hospitals increasingly rely on compounded drugs to address challenges like drug shortages, which have become widespread in recent years. A 2019 survey by Vizient Inc., which negotiates contracts for products and services on behalf of 3,100 health systems nationwide, found that drug shortages cost health systems a total of 8.6 million labor hours annually as their providers try to solve those shortages. Those labor hours add up to a $360 million financial cost annually.
Beyond the high cost, shortages also mean that patient care suffers. “If you can’t get the drugs, you might have to cancel or delay surgeries or elective procedures, or you might have to switch to an alternative therapy that may not be as desirable,” says Mittal Sutaria, vice president of contracting and program services for Vizient.
Scalable Solutions
Many healthcare systems have turned to 503B compounding facilities, such as QuVa Pharma, to answer patient-care challenges like drug shortages while also maximizing key resources—like their pharmacists’ time.
Such partnerships allow hospitals to more ably source drugs in short supply, because 503Bs are given the ability to manufacture drugs on the FDA’s drug shortage list. Moreover, 503Bs can develop new drug products that hospitals can’t logistically or affordably produce in-house. For example, a few years ago a Houston, Texas, hospital asked QuVa if it could manufacture an epinephrine-based pain medication called R.E.C.K. that combines four non-opioid molecules. The hospital wanted to use the medication in orthopedic procedures, such as knee surgeries, to reduce their reliance on opioids. While the hospital could have made the drug in-house, it would have been challenging, Jenkins says.
“It’s a product that a hospital could do on its own, but it would struggle with the stability of the product,” he says. “It’s something we can do—and have done with a number of other products—because we have a technical skill for manufacturing drugs that hospitals generally don’t have.”
QuVa was approved for a patent for R.E.C.K. and now distributes thousands of units of it a month to about 250 hospitals nationwide. “So by turning to us, the hospital was able to get an answer for a problem it wanted to solve—and now we’re able to solve that same problem for other hospitals,” Jenkins adds.
Another advantage to working with a 503B like QuVa is that the products are ready-to-administer—meaning the pharmacists and technicians don’t have to spend time preparing for their use. Doctors and clinicians can quickly administer them to the patient if the need arises suddenly.
“There is a core value proposition for our partners: We efficiently deliver large-volume products in a high-quality cGMP [current good manufacturing practice] fashion—validated by a strong testing regime—with a great use-by date that they would have a hard time replicating in-house,” Jenkins shares. “And by us providing this, they can spend time focused on their patients.”
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