Providers ramp up preparation for drug shortages

But after Hurricane Maria crippled the primary manufacturer of small-volume saline bags, that process hit overdrive as they convened daily, if not hourly. They brainstormed how they could repackage what they already had, potential substitutes and how to best ration their three-week supply of saline—one of the most widely used drugs in hospitals.

Cleveland Clinic is much better prepared for the next disaster, now that it had to navigate the worst drug shortage it has ever seen, said Chris Snyder, a Cleveland Clinic pharmacist and drug shortage specialist.

"It has a cascade effect," he said. "You have to have these committees ready to act because a lot of these shortages repeat."

Having a drug product shortage team that can access data involved in purchasing alternatives; changing storage, preparation and dispensing procedures; and altering electronic health record processes is a crucial element of preparing for shortages, according to new guidelines published Tuesday by the American Society of Health-System Pharmacists. That team, led by a designated point person, should develop a list of stakeholders to consult for specific shortages.

Providers should also have a resource allocation committee, according to the guidelines. It should include unbiased representatives from the pharmacy, nursing, social work and medicine departments; a patient representative; and a member from the organization's ethics team.

The committee should carefully determine which patients should be prioritized, and allow feedback and changes as the situation evolves. Standardizing the ethics framework could simplify the decisionmaking process, which can place a heavy burden on clinicians.

If the drugs affected by shortages are in a clinical trial, providers should inform study sponsors and lead investigators that they may have to halt trial enrollment or continue patients on the standard-of-care treatment only as necessary until the shortage subsides.

The U.S. healthcare system spent an estimated $209 million in 2013 for purchasing more expensive substitutes alone, according to Erin Fox, the senior director of drug information at University of Utah Health who wrote the guidelines. University of Utah Health provides data to the American Society of Health-System Pharmacists for the shortage list. That cost does not include the added labor expense that providers take on as they work overtime to find alternatives and change operations accordingly.

The healthcare industry has been dealing with drug shortages for decades, but they have become more acute as of late. They can stem from a lack of information regarding manufacturers or manufacturing sites; quality issues; production delays and a minimal number of suppliers; the thin margins involved in generic-drug manufacturing; shortages of raw materials; inventory reductions; and restricted distribution networks.

Cleveland Clinic plans to build a 503B-compliant compounding facility that would allow it to sell drugs to other hospitals. While the system has the luxury of a full-time drug shortage specialist and an informatics analyst who regularly changes EHR order sets during a shortage, it's important to develop a strong relationship with internal hospital networks and know each hospital's inventory, said Scott Knoer, chief pharmacy officer at Cleveland Clinic.

"Somebody may have a certain drug, and we can move it from one of hospital to another," he said. "Getting everyone involved is important."

Hospitals should adopt a standardized process for identifying and approving alternative therapies, according to the American Society of Health-System Pharmacists guidelines. It should involve representatives of medicine, nursing, pharmacy and other affected disciplines, and those decisions should be approved by the appropriate medical committees as quickly as possible.

There will be situations when it is difficult or impossible to simply substitute an alternative. There should be a transparent and fair ethical process that weighs who will receive the drug in short supply and who gets an alternative.

In the midst of a drug shortage, the shortage team should assess the procedural and financial effects that could impact patient care. An institution's success typically depends on how well the system can change drug products in their system under normal conditions, according to the guidelines.

Ultimately, ongoing discussions with clinicians is key.

"You have to have good relationships with medical staff so you can call them and rely on them when needed," Snyder said.