According to a special article in the December issue of Anesthesia & Analgesia, the official journal of the International Anesthesia Research Society (IARS), the United States is facing ongoing shortages of several critical anesthesia medications, which could have a potentially serious impact on patient care and safety.
Dr Gildasio S. De Oliveira, Jr, of Northwestern University, Evanston, Ill writes, “Anesthesiologists should be actively involved in the steps necessary to provide a fast resolution [to drug shortages] and that can minimize adverse effects to patient care.”
Shortages of Perioperative Drugs – Causes and Safety Impact
Dr. Oliveira and his team decided to review key factors for national shortages of important drugs used before, during and after surgery (perioperative period). Over the past 10 years, medication shortages have become more and more frequent, and last year the American Society of Health-System Pharmacists (ASHP) reported 140 medications to be in short supply. An even bigger concern is that this shortage also applies to alternative medications in several categories.
Product recalls and shortages of raw materials are just a couple of factors that contribute to medication shortages. Even when manufacturing and supply remain unaffected, a sudden rise in demand can lead to bottlenecks. Sterile injectable medications are particularly affected, as the manufacture of these drugs is very complex, consisting of several production steps. Another factor is current inventory management practices, for example by cutting fine production schedules by leaving orders to the last minute, or having too short inventories.
The impact of drug shortages on patient care can be ‘devastating’, especially when alternative drugs are also unavailable, with patients likely to encounter delays in treatment, have their procedures canceled, or being administered with alternative, less effective drugs or drugs with more side effects. The researchers established that “Drug shortages can therefore increase risks to patients, and can also have a negative impact on institutions.”
Anesthesiologists face a particular problem regarding the shortage of Propofol, a drug that is commonly used for anesthesia, but also as a sedative. Also in short supply is Naloxone, which is essential for managing an overdose of morphine-like drugs, with other reported shortages consisting of medications for paralyzing patients during surgery, and drugs that are used to reverse muscle paralysis.
Call for Anesthesiologists to Play an Active Role
Dr De Oliveira and his team press anesthesiologists to actively tackle the shortage problem, declaring that, “proactive measures must be taken to identify, resolve, and possibly prevent a medication shortage before patient care and safety are jeopardized.” Anesthesiologists must adhere to SHP guidelines when dealing with medication shortages and take on a pro-active role to develop and implement the response at local hospitals.
The FDA also takes note on information provided by health care professionals in terms of potential drug shortages and depending on the cause, it may intervene to alleviate shortages by helping to obtain raw materials or permitting to import alternative medications.
Dr De Oliveira and his team write:
“As anesthesiologists, we have an obligation to report shortages, especially the ones that cause deviations from the best practices of patient care.”
According to Oliveira and his team preventative measures should be taken now to avoid shortages of anesthesia drugs from becoming a public health issue. These could consist of implementing policies and legislation to increase drug production, increasing inventories, and regulatory changes in terms of drug manufacturing.
Drs Richard P. Dutton and Jerry A. Cohen warn anesthesiologists to use caution in using substitutes during shortages or non-availability of the desired drug. In an accompanying editorial, they state:
“We must not continue to expose patients to these risks, when we know that proper action on the part of industry, our policy makers, and ourselves, can reduce it.”
Written by Petra Rattue