Volume 25, Issue 1
PARACHUTES FOR THE PHARMACEUTICAL FREE FALL
Policy and Practical Solutions for Medication
N. Martin Giesecke, MD, TSA President
As Anesthesiologists, each of us is acutely aware of the impact of medication shortages. We have witnessed, over the past decade, how the lack of medications we use every day can affect an anesthetic plan on one hand, and patient safety on the other. There are numerous causes of these shortfalls. Some medications, such as sodium thiopental, are pulled off the market for sociopolitical reasons.
Hospira’s Italian manufacturing plant, the sole producer of sodium thiopental, pulled the sedative ‐ hypnotic off the market in response to concerns of its use for U.S. Capital Punishment. Many other medications leave the market due to compromises in some manufacturing quality, such as metal filings finding their way into medication vials.
Many of you participated in the March 2012 ASA survey on drug shortages with 3063 respondents nationally. Major findings: 97.6 percent of respondents reported they were experiencing a shortage of at least one anesthesia drug.
In July 2012, the U.S. Congress passed, and President Obama signed into law, S.3187, the Food and Drug Administration Safety and Innovation Act. This legislation received significant advocacy efforts supported by the American Society of Anesthesiologists. The Safety and Innovation Act accomplished several things. First, it reauthorized and modernized the programs which enable medications to come to market sooner than if the FDA were to rely solely on its
Please join me in welcoming Mr. Clayton Stewart to the TSA family.
limited review budget. More importantly for our patients, the law addresses the widespread problem of medication shortages. The law requires drug manufacturers to give the FDA advanced warning of likely shortages. This lead time will allow the FDA to implement contingencies to the medication shortage, such as requesting other manufacturers to take up production. The law also includes incentives for the development of nextgeneration antimicrobials.
Despite the passage of the Safety and Innovation Act, we still face medication shortages. In my practice alone, we recently were told that not only would propofol and etomidate be in short supply, but also that fentanyl, morphine and hydromorphone would be scarce.
Thus, it is imperative that each of you solo practitioners and each anesthesiology practice, develop in collaboration with your institutional pharmacy associates, a plan to address the issue of medication shortages. Such a plan should allow you to foresee when a shortage of a particular medication will occur. Some rationing techniques used in multiple Texas facilities include having the pharmacy prepare ten milliliter doses of propofol, so that wastage is decreased. The same technique can be applied to opioids, succinylcholine and reversal to decrease wastage. Please encourage your pharmacists in this time of pharmaceutical famine to acquire, and not strike from the formulary, older analgesics like meperidine and antiemetics like inapsine. The options
Continued on page 5
