Steps Urged to Maintain Supplies and Prevent Harmful Effects from Shortages of Key Drugs

Newswise — San Francisco, CA. (November 23, 2011) – The United States is facing ongoing shortages of several critical anesthesia medications—shortages with potentially serious effects on patient care and safety, according to a special article in the December issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

"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," writes Dr Gildasio S. De Oliveira, Jr, of Northwestern University, Evanston, Ill.

Shortages of Perioperative Drugs—Causes and Safety ImpactDr. Oliveira and colleagues reviewed key issues related to national shortages of important drugs used in the perioperative period (before, during, and after surgery). Medication shortages have become increasingly frequent over the past decade. In 2010, the American Society of Health-System Pharmacists (ASHP) listed 140 medications in short supply. Even more alarming, shortages are also reported for alternative drugs in several categories.

Many factors contribute to medication shortages, such as product recalls and shortages of raw materials. A surge in demand can cause shortages even when manufacturing and supply are unaffected. Shortages are especially acute for sterile injectable medications because of the many complex steps involved in their manufacture. Current inventory management practices, such as short inventories and "just in time" production schedules, also play a role.

Drug shortages can have a "devastating" impact on patient care—particularly if alternative drugs are not available. Patients may face treatment delays, have procedures canceled, or receive alternative drugs that are less effective or have more side effects. The study noted that "Drug shortages can therefore increase risks to patients, and can also have a negative impact on institutions."

Of special concern to anesthesiologists is the shortage of propofol—a drug that is widely used not only for anesthesia but also as a sedative. Naloxone, an essential drug for managing an overdose of morphine-like drugs, is also in short supply. Shortages have also been reported for medications used to paralyze patients during surgery, as well as the drugs used to reverse muscle paralysis.

Call for Anesthesiologists to Play an Active RoleDr De Oliveira and colleagues urge anesthesiologists to take the lead in dealing with the problem of shortages, noting that "proactive measures must be taken to identify, resolve, and possibly prevent a medication shortage before patient care and safety are jeopardized." Anesthesiologists need to be aware of ASHP guidelines for dealing with medication shortages and play an active role in developing and implementing the response at local hospitals.

Health care professionals can also inform the FDA about potential drug shortages. Depending on the cause, the FDA may take steps to alleviate shortages—for example, by helping to obtain raw materials or allowing important of alternative medications.

"[A]s anesthesiologists, we have an obligation to report shortages, especially the ones that cause deviations from the best practices of patient care," Dr De Oliveira and coauthors write. They believe that steps should be taken now to prevent shortages of anesthesia drugs from becoming a public health issue. These may include increasing inventories, implementing policies and legislation to increase drug production, and regulatory changes affecting drug manufacturing.

An accompanying editorial by Drs Richard P. Dutton and Jerry A. Cohen urges anesthesiologists to use caution in using substitutes when a desired drug is not available. They conclude "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."

Read the full articles in Anesthesia & Analgesia

About the IARSThe International Anesthesia Research Society is a nonpolitical, not-for-profit medical society founded in 1922 to advance and support scientific research and education related to anesthesia, and to improve patient care through basic research. The IARS contributes nearly $1 million annually to fund anesthesia research; sponsors an annual forum for anesthesiology leaders to share information and ideas; maintains a worldwide membership of more 15,000 physicians, physician residents, and others with doctoral degrees, as well as health professionals in anesthesia-related practice; sponsors the SmartTots initiative in conjunction with the FDA; and publishes the journal Anesthesia & Analgesia. Additional information about the society and the journal may be found at the IARS website.

About Anesthesia & AnalgesiaAnesthesia & Analgesia was founded in 1922 and was issued bi-monthly until 1980, when it became a monthly publication. A&A is the leading journal for anesthesia clinicians and researchers and includes more than 500 articles annually in all areas related to anesthesia and analgesia, such as cardiovascular anesthesiology, patient safety, anesthetic pharmacology, and pain management. The journal is published on behalf of the IARS by Lippincott Williams & Wilkins (LWW), a division of Wolters Kluwer Health.