As drug shortages continue to affect day-to-day pharmacy operations and patient care, pharmacy leaders are turning to several strategies to help manage supply and mitigate impacts.
From centralized pharmacy operations and prediction technology to data transparency and advocacy efforts, among others, strategies vary by institution but are consistent in their aim to identify, assess and address shortages.
To provide insights into this critical issue, we gathered five industry leaders for a panel at the Becker's 14th Annual Meeting. The panel—sponsored by McKesson, a distribution and healthcare services leader—was comprised of the following pharmacy experts who deal with drug shortages each day, including:
- Nilesh Desai, chief pharmacy officer, Baptist Health System (Louisville, Ky.)
- Michelle Holm, PharmD, senior manager, pharmaceutical contract portfolio and supply chain management, Mayo Clinic (Rochester, Minn.)
- Melanie Massiah-White, vice president and chief pharmacy officer, Inova Health System (Falls Church, Va.)
- Gerald Rebo, PharmD, director, pharmacy value and outcomes, Novant Health (Winston-Salem, N.C.)
- Stephen Stalker, vice president, drug shortages, McKesson
Below are four key takeaways from their conversation.
Factors contributing to drug shortages
Product availability ebbs and flows based on a variety of factors like the prescribing or patient demand pattern changes, sourcing or manufacturer limitations, natural disasters, market economics or product discontinuations, and more.
"When new shortages begin, they typically last for a while," Mr. Stalker said. “That’s why we are continually improving our processes, building redundancy and contingency-planning to proactively predict, identify, and mitigate drug shortages.”
When we last experienced widespread drug shortages over a decade ago, there was a significant increase in new drug applications (ANDAs). While this increased options across generics, it also led to some companies exiting in the long term and limiting supply.
"If you pinpoint a resource to one or two suppliers, that further constrains the supply system," Dr. Rebo said. "If there's a natural disaster, raw material shortage and the single manufacturer can't produce, you end up in a drug shortage again."
In response, pharmacy leaders are adopting multiple supply chain strategies
As a long-term solution, Mayo Clinic suggests new contracting practices that emphasize redundancy in supply, whereas traditional models focus on financials. “If there was more than one sole award given, especially in the generic injectable space, we wouldn't have this issue,” said Dr. Holm. “If we awarded dual and multi-source awards especially in the group purchasing organization category… we would have more drug manufacturers in supply chain and we wouldn't be dealing with this.”
To increase control and improve inventory visibility, Inova Health System is opening a centralized pharmacy service center. Baptist Health System is also centralizing its pharmacy operations to provide better utilization tracking and ultimately better forecasting.
Technology and data can improve visibility into the pharmaceutical supply chain
Innova Health System and Novant Health developed data dashboards to monitor drug shortages. “We're all creating our own internal database, leveraging AI and various systems to improve visibility across the system,” Ms. Massiah-White said. “I think if we could work together across the industry to improve it, we would move much faster.”
Panelists agreed on the need for collaboration and data sharing across the supply chain and beyond. "We need to get that kind of information out nationally," Dr. Rebo said. "Sharing data would be huge in moving beyond reactive to more proactive management of drug shortages."
Each week, the distribution community collaborates in sharing inventory and order data with the U.S. Department of Health & Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR). This collaboration emerged from the COVID-19 pandemic and continues to provide valuable insights on a subset of products critical to public health emergency preparedness.
"At McKesson, we continue to support efforts to improve data collection from manufacturers to improve our understanding of potential supply chain vulnerabilities,” Mr. Stalker said. “Our big focus is using AI and machine learning to help predict potential shortages looking three to six months ahead so we can situate inventory appropriately."
Potential solutions to drug shortages include standardization, ready-to-use products and advocacy.
Industry standardization of drug formulations is one approach that could help reduce drug shortages.
"Everyone thinks they are special, and there are hundreds of different concentrations of drugs," Mr. Desai said. "Data sharing and partnering with pharma will be crucial so they can identify the right concentrations to use across the country and plan their manufacturing accordingly."
Given the persistent workforce shortages in healthcare, the pharmaceutical sector also needs to think about manufacturing ready-to-use products. "If an ANDA takes over 30 months to develop, are we putting in resources to manufacture ready-to-use products? We may not have the resources to draw drugs out of vials and into syringes. We need to think through the total cost of care for a drug," Dr. Holm said.
To address drug shortages, building relationships and working collaboratively across stakeholder groups will continue to be immensely important. "Advocacy and policy change at the local, state and national levels are critical," Dr. Rebo said.