Drug Shortages

by
  • Pauker, Kenneth, MD
| May 30, 2011

Drug shortages? Are you kidding me? This must be somebody else’s problem. Their hospital must be mismanaged and must not have anticipated its needs, or it must belong to the wrong purchasing group. Our multi-hospital, multi-system supply chain is just too large and powerful to fail to procure essential supplies. Well, think again! Welcome to the brave new world of rolling shortages of essential drugs. 90% of anesthesiologists are, according to a recent ASA survey, in the same boat!

This issue first popped up in my hospital when our custom combined spinal epidural (CSE) trays were “back ordered.” I used to think that “back ordered” simply meant someone didn’t pay the bills, and that we would not be getting new shipments until they did. Instead, it means one of many possible things: supplies are low or have run out, raw materials are scarce and the end product cannot be produced, manufacturing is derailed by contaminated items, or perhaps plants have been retooled to make different items which are more profitable.

With the custom CSE trays in my hospital, sterile bupivicaine 0.5% in 30 ml glass vials could not be found by the manufacturer, so they sent various iterations of a replacement kit containing a wide variety of problematic substitutions—the wrong epidural catheter, a spinal needle which was the wrong length for the Tuohy needle, a plastic, instead of glass syringe for loss of resistance, and a previous version of the epidural catheter with a stiff tip. In addition, since there was no bupivicaine in the kit, anesthesiologists had to draw it up from an external source. Of course, each iteration was usable, with appropriate modifications in technique, but such distractions are not welcome when one has to place a CSE on an uncomfortable, laboring patient. The tray manufacturer, of course, blamed the substitutions on the specific shortage of sterile bupivicaine.

Flash forward to the propofol shortage. As anesthesiologists, we all use propofol commonly for induction, for total intravenous anesthesia (TIVA), as a low-dose background infusion with volatile agents, with neuraxial anesthesia as a sedating agent, and for garden variety sedation—mild, moderate and deep. Originally, we had brand name Diprivan, then propofol with metabisulfite, then big bottles or just small bottles, and then none available at all. Later, we had Propoven from Germany, then Diprivan again, and now we use propofol with EDTA.

This series of changes and substitutions was all very frustrating and stimulated me to wonder why, after so many years of reliable drug supplies, we were seeing these kinds of “back orders.” Then one day, succinylcholine or “sux,” was unavailable. The pharmacy and also certain areas within the hospital, like the Labor and Delivery (L&D) area, were holding supplies in reserve for dire airway emergencies. Of course many anesthesiologists no longer use sux, but I do, and I believe it is a very useful drug when you need it. No other drug is an effective substitute. On one occasion, when our hospital was facing a shortage of succinylcholine, I raided the hidden stockpile in L&D for an emergent case in our OR. Fortunately, sux came back into supply.

Next came an announcement that supplies of neostigmine would be very limited, and it then disappeared from our anesthesia carts. I had to adjust my technique, by using low dosage cis-atracurium, or no relaxant at all. There was an instance however, where I had a case which finished more quickly than anticipated, and I had to sit and wait for the relaxant to wear off. The patient had a difficult airway, was morbidly obese, and had sleep apnea and asthma, so I was not simply going to put her on a “blower.” Instead, I waited and used tincture of time instead of tincture of a reversal agent. Not only was there no neostigmine, but no edrophonium, and also no pyridostigmine. I heard about a Department Chair at a prominent academic institution amassing a closetful of neostigmine vials, in reaction to the shortage. There was physostigmine, which one of my partners used, but the potential for too many side effects kept me from trying it in my population of geriatric patients.

During this time of shortages, health care professionals may sometimes let their guard down when drugs reappear. I know of a situation in a prestigious hospital in Orange County where succinylcholine 100 mg/ml got stocked on an anesthesia cart, but it looked just like the usual 20 mg/ml vial, which had been previously supplied. The stronger concentration never was administered to a patient because an alert anesthesiologist caught the error, but consider what might have happened, and how many people overlooked the substitution in order for the drug to get to the anesthesia cart at all. Changing routine is not good for patient safety, and these shortages force anesthesiologists, on short notice, to employ techniques they have put aside for years. Sux drip anyone?

ASA co-convened a drug shortage summit of stakeholders in November 2010. It was determined that there are multiple factors contributing to drug shortages: raw material and supply chain problems, contamination issues and patent and profitability issues, to name a few. As a result, there are now FDA and hospital pharmacists’ web pages listing drugs in short supply. There is a Government Accountability Office (GAO) investigation underway. The ASA put the issue of drug shortages on the agenda for the ASA Legislative Conference, in part perhaps because our own Dr. Paul Yost pushed to have the issue raised there. Bill SB 296, the "Preserving Access to Life-Saving Medications Act," introduced by Minnesota Senator Amy Klobuchar, intends to improve the FDA’s ability to prevent drug product shortages by establishing requirements for notification and contingency plans by drug manufacturers. The CSA and ASA have taken concerns to the Hill and asked for relief, perhaps by regulation, perhaps by legislation. This problem is ongoing. Talk to the pharmacists at your hospital. Ask questions and stay informed.

For more information, a comprehensive ASA web page with relevant links pertaining to drug shortages can be found here.

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