Plan ahead: Best practices in an era of drug shortages

Most healthcare organizations are not immune to drug shortages. In fact, 90% of hospitals say they’ve experienced at least one shortage in the past six months that affected patient safety, and 99% said a shortage forced them to purchase a more expensive alternative.¹

See also: Progress made on drug shortages although manufacturing issues persist

Rising shortages

The U.S. Government Accountability Office reports that the total number of active shortages has increased since 2007.² As of June 30, 2015, there were 219 active drug shortages in the United States, according to figures from the University of Utah Drug Information Service. While this represents a decline from the more than 300 shortages reported at the end of 2014, it is still a 44% increase over the 152 active drug shortages reported in 2010.

It is estimated that more than 80% of the drugs in short supply are generics, and of those, 80% are injectables that treat cancer, cardiovascular disease, infection, central nervous system conditions, and pain.³

See also: Generic shortages complicating pharmacists' duties

Early notification

 “Permanent discontinuance or interruption in manufacturing of certain drug or biological products” (RIN 0910-AG88), the final ruling issued by the FDA, went into effect this month.  The ruling requires all manufacturers of certain medically important drug and biologic products to give the FDA early notification of potential drug shortages and to report the reasons for potential shortages. 

While this ruling may help FDA to identify potential drug shortages and to mitigate the impact on providers and patients, it will not eliminate shortages altogether. To truly help your hospital or health system mitigate these outcomes, it is important to understand not only the underlying causes of drug shortages but also the proactive measures that you can take, along with the resources that are available to help you.

Underlying causes

Determining the causes of drug shortages is difficult. In fact, the reason for nearly half of all shortages reported in 2013 was unknown. When shortages can be explained, they often fall into these categories: manufacturing problems (25%), supply-and-demand issues (17%), and raw material problems (2%).⁴

•  Manufacturing problems: More than half of the drugs on the shortage lists are manufactured by just one or two companies. This means there is little cushion when a production or quality problem develops during the complex manufacturing process.³

• Supply-and-demand issues: Demand for drugs can be challenging to predict. For example, an unexpected spike in flu cases in January 2014 caused a shortage in IV saline solution.⁵ Because manufacturers typically run production lines at maximum capacity, it is difficult to quickly switch production schedules and stem a shortage of just-in-time products.

• Raw material problems: Of the active ingredients used by drug manufacturers, 80% originate from outside the United States; of the finished drugs that Americans take, 40% are manufactured overseas.⁶ When there is an issue with quality control or a raw materials shortage, the repercussions are felt far and wide. The pharmaceutical industry truly is a global business, and its players are interconnected and dependent on one another.

What is being done?

To help reduce drug shortages over the long term, FDA has implemented several initiatives, including the FDA Safety and Innovation Act, and the Strategic Plan for Preventing and Mitigating Drug Shortages. According to FDA, these efforts helped prevent 170 new shortages in 2013.⁷ In addition, the pharmaceutical industry has launched its own initiatives to better prevent and forecast shortages.

How can your health system best manage shortages?

According to Yen Nguyen, PharmD, senior product manager, Pharmacy Solutions, McKesson Health Systems, “receiving and communicating accurate and complete information is critical to managing a drug shortage.” More than 80% of healthcare practitioners surveyed reported a lack of advance warning and information about the duration and/or cause of a drug shortage.⁸

Nguyen suggests health system pharmacies can better prepare for a drug shortage by considering the following best practices:

Have a plan. The director of pharmacy should consider developing a plan for managing drug shortages. According to the American Society of Health-System Pharmacists (ASHP), the plan should include three phases: assessment, preparation, and contingency.⁹ The plan should outline responsibilities, communications, and decision-making during each phase. Additionally, pharmacies should identify a point person to take the lead in implementation, coordination, and monitoring during a shortage.

Implement structured communications. Next, understand how your distributor communicates drug shortages. Shortage information may be available through reports and messages in your online ordering platform, and your account representative should also be able to help.

After arming yourself with the right information, the next step is to provide timely communications to your team about potential shortages so they can act quickly to manage the risk to your organization and patients.

Ask the right questions.A manufacturer with only a limited supply of a drug may not be able to support a high-volume order from a distributor. As a result, you may not receive the product. To learn about the status of a particular drug, consider contacting the manufacturer directly and asking them the following questions:

• Are you shipping your purchase orders to my distributor in full?

• Are any shipments delayed?

• Are you reducing shipment quantities to my distributor?

• If you have a limited supply, can you ship drugs directly to my facility?

Don’t feed the gray market. Purchasing products from unofficial supply channels not only puts your patients at risk, as products may be contaminated and stored improperly; it perpetuates the problem by keeping gray-market wholesalers in business.

Keep it balanced. Having the right amount of inventory is a true balancing act. Keeping inventory too lean can cause issues, but stockpiling a formerly scarce product once it becomes available is not a good practice either. Talk to your distributor about inventory optimization technologies and programs that can help you find the right solution for your needs.

Additional resources

ASHP has a host of information to help your hospital or health system effectively respond to and manage drug shortages. Other resources that you may find helpful include:

• Industry Rx Backorder News

• FDA List of Drug Shortages

• FDA Safety and Innovation Act

• FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages

• Verify Wholesale Drug Distributor Licenses

A complex issue

Drug shortages are a complex global issue. To better equip your hospital or health system, consider the resources that you currently have at your disposal, including your pharmacy and supply-chain leadership, your distribution partner, and industry associations. They can help you find accurate and timely information on drug shortages to ensure that your actions are as effective as possible.

References

1. Drug shortages 2014: A Premier healthcare alliance update. Premier, February 2014. http://bit.ly/PremierUpdate. Accessed September 22, 2015.

2. Drug shortages: Public health threat continues, despite efforts to help ensure product availability. U.S. Government Accountability Office. February 10, 2014. http://www.gao.gov/products/GAO-14-194. Accessed September 22, 2015.

3. IMS study reveals drug shortages in U.S. disruptive yet narrowly concentrated. IMS Institute for Healthcare Informatics. November 14, 2011. http://bit.ly/PremierUpdate. Accessed September 22, 2015.

4. National drug shortages: Annual new shortages by year, January 2001 to December 31, 2014. University of Utah Drug Information Service. Accessed February 1, 2015. http://bit.ly/UUdruginfo. Accessed September 22, 2015.

5. Jaimy Lee. Growing IV saline shortage has providers scrambling during bad flu season. Modern Healthcare. January 23, 2014. http://bit.ly/IVsaline. Accessed September 22, 2015.

6. FDA globalization. U.S. Food and Drug Administration. http://bit.ly/FDAglobal. Accessed September 22, 2015.

7. Douglas C. Throckmorton, M.D. Examining drug shortages and recent efforts to address them. U.S. Food and Drug Administration. February 10, 2014. http://bit.ly/ExaminingShortages. Accessed September 22, 2015.

8. Drug shortages: National survey reveals high level of frustration, low level of safety. Institute for Safe Medication Practices. September 23, 2010. http://bit.ly/ShortageSurvey. Accessed September 22, 2015.

9. ASHP guidelines on managing drug product shortages in hospitals and health systems. American Society of Health-System Pharmacists. August 1, 2009. http://bit.ly/ASHPguidelines. Accessed September 22, 2015.

Heather Cooleyis the director of supply chain services at McKesson.Cathy Leventisis a managing pharmacy consultant at McKesson.