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December 1, 2013 Volume 77, Number 12
Committee News: Practical Considerations With Drug Shortages Jeffrey S. Jacobs, M.D., Chair
Committee on Ethics



Anesthetic drug shortages have become widespread, and these shortages have impacted nearly every practicing physician at one time or another. The causes of drug shortages have been explained by everything from a lack of raw materials to misguided legislation leading to a failed market. Whether the cause is either of these, both of them, or due to factors completely unrelated, most physicians are only concerned with, “how do I deal with these shortages?” The ASA Committee on Ethics discussed this topic and developed statements that address these profound questions:

 

Is it the burden of anesthesiologists to deal with shortages?

Drug shortages affect the way we care for our patients to such an extent that some may refer to shortages as a public health crisis. In many situations, we are forced to use medications with which we are not accustomed, and in some circumstances, we need to use medications that may result in less-than-optimal outcomes for our patients. There is no question that anesthesiologists have an ethical responsibility to participate in the development of solutions to this societal problem.

 

Do we always have to provide an anesthetic if a drug shortage might negatively impact the patient’s outcome?

Of course not. Part of our duty as a physician is to protect the patient by using sound medical judgment to decide appropriateness of care. As an extreme example, suppose the facility in which one practiced was out of oxygen. There would be no question that business as usual would stop until the situation was rectified. The effects of some drug shortages can be mitigated with alternative medications, but some medications do not have a suitable substitute. It’s up to each individual provider, working with the surgeon or proceduralist, and taking into account the patient’s planned procedure and health status to decide what’s safe. Anesthesiologists, as well as surgeons and other proceduralists, should consider postponing an elective procedure when the risks of proceeding might outweigh the risks of using medications that are alternative to those in short supply or unavailable.

 

Assuming there are drug shortages in my operating room, do I need to tell the patient about this?

Some medication shortages may have a definite and profound impact on the patient’s experience. For example, some medications are associated with an increased risk of postoperative nausea and vomiting as compared with others. Some medications have a longer half-life, which might lead to greater than normal effects. On the other hand, some medications may be seamless substitutes for the usual drug. In general, if the anesthesiologist judges the risk of increased morbidity or mortality by using alternative medications to be negligible, then there is no need to discuss this issue when obtaining informed consent. However, if the anesthesiologist judges the added risk to be significant, then the discussion of alternative plans should be part of the informed consent process.

 

If my patient suffers as the result of a medication shortage, should I keep it to myself?

Part of the solution to drug shortages comes from the ability to track bad outcomes and complications due to the lack of a medication or from the use of a substitute. If nobody reported bad outcomes, there may be a misperception that the shortages were having no impact on patient safety. One such place to report is to the Anesthesia Quality Institute (AQI), which is a Federally Designated Patient Safety Organization. This means anything reported to the AQI is anonymous, confidential and not discoverable based on federal law (www.aqihq.org/airs/airsIntro.aspx). In addition, we encourage members to notify the FDA of new and ongoing drug shortages at drugshortages@fda.hhs.gov. In general, the collection of adverse events occurring as a result of drug shortages provides important information useful in the pursuit of a solution. Anesthesiologists should report these events to the appropriate entities for this purpose.

 

Is there anything I can do to make my supply last longer?

The first thing every anesthesiologist should evaluate is his/her normal pattern for medication usage. In the face of shortages, it may be reasonable to question whether all possible emergency drugs need to be drawn into syringes (as opposed to having them available in their original packages). It may be reasonable to use smaller vials of medications, when available, to minimize wastage. It is never reasonable, however, to create your own rules when it comes to dividing ampules or bottles of medications in order to share the drugs among multiple patients. There are strict guidelines for how this should be accomplished, and if the rules do not make sense, anesthesiologists should advocate for amending them. Of note, ASA supports the CDC’s position on single-dose vials and has adopted its position for safe injection practices, which can be found at www.asahq.org/For-Members/Advocacy/Washington-Alerts/CDC-Releases-Report-on-Infection-Transmission-from-Single-Dose-Vial-Use-for-Multiple-Patients.aspx. In summary, in the face of specific drug shortages, anesthesiologists should reassess customary practice patterns of drug usage to minimize drug wastage and safely maximize any limited supply.

 

Could I have contributed to the problem?

Theoretically, yes. Because of the training an anesthesiologist undergoes, we have the understanding and ability to develop suitable and safe alternative plans when a medication has limited availability. While this is appreciated by the institution and allows for safe patient care, it downplays the actual problem. For example, if drug x is in short supply, and anesthesiologists decide to substitute drug y, eventually drug y could undergo a shortage. What if there is no substitute for y? Therefore, flexibility and adaptability in patient care may obscure the reality of potential harm created by drug shortages and should not be a substitute for pursuing a permanent solution.

 

Must I deal with this issue alone?

Of course not. You should work in partnership with all involved stakeholders to develop safe plans within your institution as well as discuss solutions with your professional society and your elected officials. Anesthesiologists should collaborate with colleagues, pharmacists, appropriate committees, institutional administrators, professional societies and government agencies to manage issues, policies and procedures related to drug shortages.

 

Is it O.K. to order lots of extra medications that are in short supply so my facility has enough?

Probably not. While having plenty of medication x is great for one institution, if that drug is in short supply, then it follows that other facilities will have less, which could potentially inconvenience or harm their patients. The distinction between preparedness and hoarding with regard to medications is unclear. In general, if you have cases of a medication stored away while your competitor has none, it’s unethical. Some might say that’s good business, but because this particular business involves peoples’ health, it crosses a line. In summary, while stockpiling medications may be beneficial for a given institution, excessive accumulation and storage of drugs can result in shortages to other institutions and may be unethical.

 

Should my medical societies be doing anything about this?

Yes. Because of the complexity of the issue and the widespread affect drug shortages have, professional societies are in the unique position to identify and advocate for statutory and legislative changes that will ameliorate this problem. For example, ASA recently worked behind the scenes strongly supporting the incorporation of Title X (solely devoted to shortages) in the recently passed FDASIA legislation. ASA has also hosted and been part of drug shortage summits. One significant issue is there are current rules that, while likely well-intended, are not evidence-based. Because of the intellectual capital a professional society holds, rational alterations in rules and laws may be possible. In general, professional medical organizations should identify statutes, regulations and guidelines that impact the adequate supply of medications, and to advocate for appropriate evidenced-based changes that would optimize their availability.

 

There is no doubt that in the face of perioperative drug shortages, anesthesiologists can play a critical role, wearing many different hats, to make the patient experience a safe one. This is the chance to show our leadership skills not just in the operating room, but in society. Let’s not squander it!



Jeffrey S. Jacobs, M.D. is a staff anesthesiologist, Cleveland Clinic Florida. He is ASA Alternate Director from Florida.

 

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