Thursday April 27th 2017

Supply and demand

Health care professionals share information, strategies on drug shortages 

It is deeply ingrained in RNs to focus on the “Rs” — as in right patient, right dose, right route and so on — when administering medications.  But there’s another factor surrounding medications and patient care that’s demanding the attention of nurses and other health care professionals: ongoing drug shortages.

“It’s a bigger issue than many people realize, and it’s getting worse,” said Eileen Handberg, PhD, ARNP-BC, FACC, a board member of the Preventive Cardiovascular Nurses Association, an organizational affiliate of the American Nurses Association, and Florida Nurses Association member. “This is something more worrisome to providers, because patients [just] expect that they will be given the right therapy, so they can get well or back to some reasonable level of function. But what happens to your critically ill patient when there is no heparin available? Or if a drug is in short supply, do you give less than the optimal level or not do a procedure? It can become an ethical dilemma.”

Even clinicians may not appreciate the entire picture of drug shortages, because they tend to be more aware of the unavailability of medications in their practice area, such as oncology or cardiovascular nursing, according to Handberg, research professor of Medicine and director of the Clinical Trials Program at the University of Florida.

But Mike Bonck, RPh, pharmacy manager at CHI Franciscan Health-St Joseph Medical Center in Tacoma, WA, knows firsthand the extent of ongoing drug shortages, describing it as “a fact of life.”  It has been an ongoing issue now for more than five years and overall has not improved that much despite the Food and Drug Administration requiring manufacturers to report when they will not be able to produce sufficient product to meet patient needs, he said.

Affected medications run the gamut, from antibiotics and chemotherapy to the “bread and butter drugs,” such as antihypertensives, diuretics and anesthesia reversal agents that are given to patients every day, Bonck said.

In their May 2016 article published in American Heart Journal called “The Impact of Drug Shortages on Patients with Cardiovascular Disease: Causes, Consequences, and a Call to Action,” Brent Reed, PharmD, FAHA, and his co-authors reported that the increasingly common shortage of cardiovascular drugs, including those used with critically ill patients, represents an “ongoing public health crisis.”

“We’ve had shortages of code drugs — calcium chloride, epinephrine,  sodium bicarb syringes,” said Bonck, adding how critical it is for nurses and others to be aware of any medication shortages and substitutions. “In some cases we have had to provide alternative packaging of code syringes such as epinephrine.”

So Bonck and other health care clinicians in Tacoma and at facilities nationwide are working diligently to stay on top of all drug shortages by employing several key strategies, and all with patient safety as the top priority.

Behind the missing meds

The FDA maintains a database that lists current shortages, resolved issues and discontinued drugs. Among the many medications and solutions listed as current shortages in October were: calcium gluconate injection, lidocaine hydrochloride injection, peritoneal dialysis solutions, dextrose 5 percent solution bags and penicillin G procaine injection.

Reasons for shortages of drugs vary with problems ranging from a missing ingredient, contamination and other manufacturing issues to shipping delays to companies no longer making a medication, according to additional research cited by Reed. Many drugs also are manufactured in other countries, which adds to the complexity of the issue.

“Drug manufacturing seems to be based on supply and demand, and there is little excess,” noted Mary Zellinger, MN, APRN-CCNS, ANP-BC, CCRN-CSC, a clinical nurse specialist in cardiovascular critical care at Emory University Hospital in Atlanta, GA, and former member of the national board of the American Association of Critical-Care Nurses, an organizational affiliate of ANA. “If three manufacturers make normal saline and one stops production for reasons such as industry consolidation or a lack of needed raw materials, the other two companies may not immediately increase supply, if at all.”

She noted that often hospitals have little warning of shortages, and pharmacy personnel spend a great deal of time trying to track down supplies from other sources.

“When there was a shortage of normal saline, many staff switched to using lactated ringer’s, which led to that being in short supply as well,” Zellinger said. “Another problem is when there is a new demand for an older drug, such as Narcan in response to the opioid epidemic, and the manufacturer greatly increases the price. Also when shortages occur, some hospitals may stockpile the drugs, which makes it more difficult for others to obtain them. In this situation, larger health care systems tend to have an advantage over smaller ones.”

Escalating costs — including on many long-standing generic drugs — is another major concern among health care professionals and creates a lot of scrambling for potential substitutes in pharmacy and purchasing departments.

Communicating and educating

Renae Battié, MN, RN, CNOR, past president of another ANA organizational affiliate, the Association of periOperative Registered Nurses, was part of a team that met regularly with representatives from pharmacy (including Mike Bonck), anesthesia services and nursing to mitigate the impact of drug shortages at the eight-hospital system CHI Franciscan Health in Tacoma.

“For me, pharmacy’s communications with other members of the health care team can make or break how drug shortages are managed,” said Battié, who now works with CHI Health in Omaha, NE. There are many critical drugs used in surgery, like hemostatics, that the team closely monitors in addition to anesthesia and pain-reducing medications.

Bonck agrees that having an infrastructure in place and ongoing communication are vital to effectively addressing medication shortages. Besides the team meeting with anesthesia services, pharmacy conveys information to other health care team members on drug shortages and appropriate substitutes through daily safety huddles, just-in-time online posts, newsletters and other key meetings throughout the system.

Ensuring substitute medications are in place is a complex process, he noted. For example, they must be entered into the electronic health record system and stocked in the medication delivery cabinets.

Pharmacist Alan Mader, PharmD, BCPS, and Medical-Surgical Nurse Educator Jennifer Kennedy, MSN, RN-BC, also are well aware of drug shortage challenges at Centegra Health System in McHenry, IL.

Mader is continually monitoring supplies in both the pharmacy department and on nursing units, developing projections on how long supplies will last, and how to effectively manage shortages through medication substitutions – such as oral versus IV prednisone – or other strategies.

“I provide a weekly alert to nursing, pharmacy and physicians about new drug shortages and what other medications might be problematic in the future,” Mader said. “For example, there was a recent shortage of IV methylprednisone. In addition to a continued search for purchase opportunities, our department promoted the use of oral prednisone through written communication to physicians, and verbally when our pharmacists rounded on the nursing units.”

Noted Kennedy, “Because we have such a good system in place to communicate drug shortages and substitute medications, nurses aren’t shocked or worried [by drugs not being available].  Nurses just want to give the best care they possibly can.”

That said, they sometimes are concerned about potential delays in medication administration, such as if a nurse has to find another nurse to witness wasting one milligram of a two-mg vial of Dilaudid, because one-mg vials are suddenly unavailable, explained Kennedy, a board member of the Academy of Medical-Surgical Nurses, an organizational affiliate of ANA, and member of ANA-Illinois.

She also said pharmacy, nurse educators and RNs work closely to ensure that any differences between substitute medications and the shortage drugs are understood.

Reflecting on the wider problem, Kennedy said, “I’ve heard, for example, that other hospitals in our area have run out of normal stocked dosages of meds on their crash carts.  When nurses have to work quickly and their adrenaline is pumping, it’s important that they are familiar with any substitutes.”

Zellinger agrees that staff education is vitally important.

“When there was a limited supply of Epi Abbojects, for instance, hospitals started using epinephrine vials,” Zellinger said. “This required education regarding changes in preparation and the dosage or concentration of the drug to ensure the correct amount of drug was being delivered to the patient.”

Other safety steps might include re-programming smart pumps and using scanning, she added.

Zellinger also had some concerns about suitable replacements.

“For the most part, we can substitute drugs that work or have efficacy, however the alternative medication might be less studied for that purpose.”

And both she and Kennedy also emphasized nurses’ role in monitoring and communicating with the health care team any side effects of substitute medications.

Advocating for change

“The solution is all about regulation and enforcement by the FDA,” Zellinger said.

Handberg stressed that nurses and other stakeholders must advocate Congress for more funding for the FDA so agency staff have the resources needed to monitor potential and ongoing shortages.

Battié and Kennedy emphasized the importance of developing and maintaining strong partnerships among nursing, pharmacy and other members of the health care team to manage drug shortages effectively to ensure safe patient care.

And nurses and other health care professionals are urged to alert key personnel in-house, as well as the FDA when they encounter a drug shortage.

“Clinicians can harness their power and desire to do the best for their patients by holding manufacturers responsible for safe, adequate [and affordable] supplies of drugs,” added Handberg. “This is such a fundamental issue to people’s health and well-being.”

— Susan Trossman is a writer-editor for the American Nurses Association.

Resources

Third Annual Report on Drug Shortages for Calendar Year 2015:
www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM488353.pdf

This report summarizes significant actions taken by the Food and Drug Administration to prevent or mitigate drug shortages, which the agency has said are helping to reduce the threat and impact of scarcities. It notes that the FDA will continue to prioritize addressing drug shortages, which the agency termed a public health issue.

FDA list of shortages: www.accessdata.fda.gov/scripts/drugshortages/

American Society of Health-System Pharmacists list of shortages:
www.ashp.org/drugshortages/current/

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