An Active Response to Cardiac Drug Shortages

 

The American Society of Health-System Pharmacists (ASHP), the United States’ largest association of pharmacy professionals, maintains the most extensive database of drug shortages available. As of August, ASHP reports there are more than 240 drug shortages, including a number of cardiac drugs. These shortages are more than an inconvenience for pharmacists, physicians, nurses and patients. They cause real-world issues and present several challenges to care teams and individuals doing their best to manage cardiac conditions. Additionally, they provide opportunities for improving care and communication on personal and systemic levels.

How Did We Get Here?

Drug shortages are nothing new. However, active and ongoing drug shortages are currently at their highest point in a decade. The effects of the COVID-19 pandemic, market influences and recent supply chain issues have exacerbated long-standing problems and created new ones. 

Still, the direct cause of individual cardiac drug shortages varies depending on the product and manufacturer. For example:

• Adenosine, used to treat supraventricular tachycardia, is no longer made by two major manufacturers.

• Manufacturers of dofetilide, a drug to treat atrial fibrillation and atrial flutter, are having difficulty obtaining the active ingredient. 

• Lidocaine, used to treat ventricular arrhythmias and in surgical procedures, faces a shortage due to decreased manufacturing and increased demand. 

In some cases, branded versions of generic drugs are available. However, branded options bring their own additional access and cost issues.

Communication About Cardiac Drug Shortages Is Crucial

Patients, prescribing physicians, drug manufacturers and wholesalers each approach the issue of cardiac drug shortages from distinct perspectives with disparate pieces of information and differing goals in mind. Each stakeholder has valid aims and needs. However, they’re not always aligned, leaving pharmacists in the middle of the fray. 

Patient Concerns

Patients with cardiac conditions typically know little about drug shortages or their causes. Understandably, their primary concern is receiving high-quality, appropriate treatment to decrease symptoms, prevent future cardiac events and improve quality of life. They trust their physician to choose the right drug for them. If their doctor suggests a medication that’s currently unavailable, it may cause the patient undue stress or worry about whether they’re receiving proper treatment. 

Drug shortages may also lead to delays in cardiac treatment or rationing of medication. Additionally, rising costs or supply issues due to drug shortages may disproportionately affect patients with limited incomes or who live in rural areas.

Physician Perspectives

While physicians are well-versed in cardiac drugs and their appropriate use, they generally know less about the processes and systems involved in ordering and procuring drugs. Again, this knowledge gap is reasonable and understandable but may cause tension between teams. Physicians may feel they are the last to hear of drug shortages facing pharmacy departments. This can be frustrating for physicians and nurses who recognize acute cardiac intervention needs, develop a care plan and then find they need to pivot quickly in response to a shortage. 

The Pharmacist’s Role

Of the health care team, the pharmacist has the expertise to track and understand the complexity and volatility of the drug shortage environment. Because of this, it’s vital for pharmacists to take the lead in communicating shortages and updates, as well as in developing predictable, ongoing methods to disseminate information. What works for one team may not work for another. However, it’s crucial to find an effective communication strategy for your team. Communication is the most effective tool available to mitigate and prevent team or system-wide issues that arise due to cardiac drug shortages.

A Need for Nationwide Solutions

Drug shortage issues extend well beyond the walls of a particular clinic, hospital or pharmacy. It’s truly a nationwide concern that affects a wide range of stakeholders. Given the scale, nationwide solutions are needed to address the issues. 

Under current U.S. law, drug manufacturers must notify the U.S. Food and Drug Administration (FDA) six months in advance of pauses in manufacturing or permanent discontinuations. This is a good start. However, it isn’t enough. 

In 2023, several bipartisan legislative bills were introduced to address drug shortages, including:

• The Drug Shortage Prevention Act (S. 2362). This bill would require drug manufacturers to notify the FDA of: 

  1. Active pharmaceutical ingredients and other essential items needed for manufacture and distribution

  2. Circumstances that may lead to supply delays or shortfalls of over-the-counter drugs

  3. Increased demand that may affect the manufacturer’s ability to keep up 

• The Mapping America’s Pharmaceutical Supply (MAPS) Act (S. 2364). Under the MAPS Act, the Secretary of the Department of Health and Human Services (HHS) would create a federal database that maps drug origin and manufacturers, as well as risks affecting drug supplies, such as recalls.

• The Pharmaceutical Supply Chain Risk Assessment Act (S. 1961). This bill would require an assessment of drug supply chain vulnerabilities by the Department of Defense, HHS and the Department of Homeland Security.

• The Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S. 2510). The RAPID Reserve Act would allow contacts between HHS and quality drug manufacturers of certain critical generic drugs to build a reserve of these drugs and their essential ingredients. 

All of these bills are supported by the American Hospital Association and have the potential to make a difference. The Drug Shortage Prevention Act, in particular, has the potential to become the gold standard for manufacturer behavior. 

What We’re Doing at St. Luke’s Health

As a part of a larger health care system, St. Luke’s Health (SLH) is well-positioned to respond to cardiac drug shortages due to access advantages and enhanced buying power often not afforded to smaller health care systems or pharmacies. Still, the effects of cardiac drug shortages are felt daily within the walls of SLH clinics and hospitals and our patients’ homes. Furthermore, improving access to high-quality care, including appropriate cardiac drugs, and advancing social justice in health care are essential components of our mission.

SLH is implementing a multi-faceted approach to respond to cardiac drug shortages and act in line with our values, including:

• Collaborating with cardiologists and other physicians to explore alternate medications

• Maintaining effective communication between health care teams

• Sourcing cardiac drugs from alternate suppliers

The current state of cardiac drug shortages is a complex situation that has become more concerning over time. Still, we have the power to make a difference by keeping communication open, staying up to date on drug shortage issues and actively advocating for the rights of our patients.