By Adolfo Espitia, Jr., undergraduate public affairs intern
Hurricanes Irma and Maria struck back-to-back in Puerto Rico on Sept. 6 and 20, 2017, destroying pharmaceutical manufacturing plants that long supplied Mayo Clinic. Puerto Rico-based factories were the clinic’s single source of an amino acid solution required for preparation of liquid nutrition administered intravenously (called "parenteral nutrition," or PN) necessary for some of Mayo Clinic’s most vulnerable patients.
With patients of all ages needing the amino solution to meet nutrition requirements, Erin Nystrom, Pharm.D., a clinical pharmacist specialist in Nutrition Support at Mayo Clinic, recognized the need to act quickly to protect patients. Working together with Dr. Nystrom was Whitney Bergquist, Pharm.D., senior clinical pharmacy manager, and Molly McMahon, M.D., endocrinology consultant and Hospital Nutrition Core Group chair. The team began responding to the crisis by brainstorming operational needs, including who should be involved in the plan to safely meet patient needs.
The unexpected shortage required a collaborative effort combining administration, pharmacy technicians, pharmacists, physicians, nurses and staff from other disciplines. Most importantly, Dr. Nystrom says, “We needed to ensure that no PN-dependent patient went without PN.”
She and her colleagues recently published a paper on their experience in rapid change management, “Parental Nutrition Drug Shortages: A Single-Center Experience With Rapid Process Change,” in the Journal of Parenteral and Enteral Nutrition.
Before the disaster, PN solutions were customized for each patient, to provide daily requirements for calories, protein, fat, and electrolytes for individuals. Mayo Clinic pharmacy staff compounded (mixed) each patient’s PN in custom preparations, as ordered by the care team, to meet individual needs based on clinical status and lab test results.
With the base amino acid solution supply suddenly rationed across the country and dwindling rapidly, Drs. Bergquist and Nystrom realized an alternative would be needed quickly.
Collaborating for a quick and safe solution
Working with Supply Chain Management, a potential substitute product from another supplier was identified. “Our Supply Chain team was critical to identifying an alternative, and did so in an environment where available options were rapidly dwindling,” says Dr. Nystrom.
This alternative was a commercially-prepared multi-chamber bag of parenteral nutrition (MCB-PN), from a new supplier. As the PN source supply became compromised, Dr. Nystrom and her colleagues defined criteria to conserve limited remaining supplies for use in custom compounded PN for children and adult patients with the most critical need. They established new clinical ordering criteria and pharmacy preparation processes incorporating the MCB-PN for patients who were metabolically stable and considered lower risk. These new criteria were communicated to providers from top leadership.
After establishing MCB-PN as a safe alternative, nursing staff—in particular—were trained on the new product and associated processes through presentations, group training and hands-on demonstrations. Talking with affected departments helped the team discover gaps and identify solutions. Within two weeks, Mayo Clinic had started the substitute processes.
“Within the first day, the use of custom PN dropped to our target of 25% of usual” Dr. Nystrom says. As the product was incorporated into clinical practice, additional feedback from providers involved in the process helped refine MCB-PN pharmacy preparation and clinical use.
As hurricane season fast approaches, Dr. Nystrom says reviewing this scenario encourages a discussion of future disasters and how the downstream effects could possibly wreak havoc among medications, medical devices and other critical components of patient care. “Drug shortages are becoming much more common,” she says, necessitating preplanning and ongoing discussions about potential mitigation strategies.
In publishing the article, the team hopes other hospitals take time to consider how to address future drug shortages. Dr. Nystrom highlights the “well-oiled” team that assisted in addressing the compounded PN shortage, researching alternatives and determining how to effectively use MCB-PN among patients.
Communication was critical
“Our communication was done in a way that basically said if you are experiencing a shortage here is a tool kit for how you would need to address this,” Dr. Nystrom says. “These are the criteria for patients who would qualify for MCB-PN and these are the things you would need to provide the nurse to give your patient MCB-PN. It wasn’t prescriptive for them, but supportive.”
Dr. Nystrom applauds Dr. Bergquist as well as Dr. McMahon and others up and down the organization, for allotting time to handle the shortage. “Dr. McMahon was a tireless champion not only locally but at national level,” says Dr. Nystrom. “She recognized the value of including all disciplines and engaging practice leadership to actively communicate and educate.”