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Anesthesia Drug Shortage: An Ever-Changing Problem

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Drug shortages across disciplines of medicine are not uncommon and can occur for many reasons, including difficulties in obtaining raw materials, shifts in manufacturing companies, government regulations, and more. However, a few years into the 21st century, the United States began to suffer from a prolonged drug shortage, especially in anesthesia. In response, in 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA), which gave the FDA more authority to act on the issue. FDASIA mandated manufacturers to notify the FDA of almost any potential issues that may affect their production output. Shortly after, in 2013, the FDA released its Strategic Plan for Preventing and Mitigating Drug Shortages, which had two goals: 1) to mitigate drug shortages and 2) to develop strategies for long-term prevention.

Despite governmental action, anesthesiology remains one of the most affected areas of practice. A 2014 report released by the Government Accountability Office (GAO) found anesthetic and central nervous system drugs to be among the class of drugs that accounted for 17 percent of all shortages in the United States. The shortages resulted in anesthesiologists citing less than optimal anesthetic outcomes, an increase in minor complications, and prolonged surgical and recovery times.

Anesthesia Drug

When brands and concentrations of available drugs continuously change, the burden on anesthesiologists to develop and adhere to new protocols without jeopardizing patient safety significantly increases. As a result, some facilities and personnel hoard drugs that are susceptible to shortages. In turn, this causes many potential shortages to swiftly become actual, nation-wide shortages.2

Today, the 2017 nationwide shortage of lidocaine with epinephrine persists, as there continues to be an epinephrine shortage and only 2 pharmaceutical companies (Pfizer and Fresnius Kabi USA) still produce it. Additionally, over the past several months, several medication shortages in North America have been exacerbated by Hurricane Maria and its effect on Puerto Rican manufacturing plants. The shortages are now affecting health care facilities in new ways, as this is an issue whose landscape changes on a weekly basis. Care facilities are now receiving drugs in varying volumes and concentrations (including that of epinephrine), which further complicates standard anesthesia protocols.

Now more than ever, with no imminent solution in sight, increased public and governmental attention and action is critical to resolving the issue and ensuring patient safety. Furthermore, anesthesiologists and other care providers must collaborate to develop a new school of thought when it comes to developing adaptive drug administration protocols.

 

References

Orlovich, D. S., & Kelly, R. J. (2015, February). Drug Shortages in the U.S. ­ A Balanced Perspective. Retrieved May 15, 2018, from https://www.apsf.org/article/drug-shortages-in-the-u-s-%C2%AD-a-balanced-perspective/

Vaidya, A. (2014, October 16). Anesthesia drug shortages are a reality: 5 options for ASCs. Retrieved May 15, 2018, from https://www.beckersasc.com/anesthesia/anesthesia-drug-shortages-are-a-reality-5-options-for-ascs.html

Bodie, B., Brodell, R. T., & Helms, S. E. (2018). Shortage of lidocaine with epinephrine: Causes and solutions. Journal of the American Academy of Dermatology.

Carniol, E. T., Gantous, A., & Adamson, P. A. (2018). Local Anesthesia Shortages—Adapting to a New Way of Life. JAMA Facial Plastic Surgery.

 

Dosing of Neuraxial Anesthesia Blocks for Obese Patients

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Obesity is a nationwide epidemic, affecting over 30% of Americans. Over 50% of pregnant women in the United States are overweight or obese. Neuraxial anesthesia is often a good choice for this population for appropriate surgeries as well as for labor, avoiding airway instrumentation and complications of general anesthesia that are often exacerbated by obesity.

It remains a topic of debate whether the dosage of local anesthetics for neuraxial blocks needs to be adjusted for obese patients. Traditional teaching based on earlier studies recommends decreasing the dose of local anesthetics for spinal and epidural blocks, citing a positive correlation between cephalad spread of sensory blockade and BMI. However newer data calls this correlation into question.

MRI studies demonstrate a smaller cerebrospinal fluid volume in the lumbar subarachnoid space of obese patients, as well as an inverse relationship between lumbar CSF volume and cephalad block extension. The epidural space in these patients is also smaller. The mechanism is thought to be compression and increased abdominal pressure by abdominal fat, which causes caval compression, epidural vein engorgement, and displacement of soft tissue through the intervertebral foramina.

Despite these confirmed physiological differences between obese and non-obese patients, several recent clinical studies have shown no significant difference in the ED50 and ED95 of hyperbaric spinal bupivacaine in obese parturients and those with normal BMI when undergoing cesarean section. There is little data on super-obese patients (BMI >50 kg/m2). Some argue based on these studies that intrathecal dosing of local anesthetics need not be reduced for obese patients, however there is no expert consensus on the topic.

Less controversy exists in the epidural dosing of obese patients, with most studies showing a decreased requirement for local anesthetics in this population.

The fact that block overdose, block failure and inadequate block duration in obese patients may lead to undesirable emergency airway instrumentation in a population with increased incidence of difficult airway raises the stakes of accurate dosing. Options such as combined spinal epidurals allow for dosage reduction in the initial intrathecal component, with the ability to titrate together with the epidural component. This and intrathecal catheters both guard against the possibility of longer surgical duration in patients with high BMI.

While it remains unclear whether obesity warrants a reduction in local anesthetic dosing for neuraxial anesthesia, a prudent approach may be to start on the side of safety and begin with smaller dosages while employing a catheter-based technique.

 

References

Brodsky JB, Lemmens HJ. Regional anesthesia and obesity. Obes Surg. 2007 Sep;17(9):1146-9.

Lamon AM, Habib AS. Managing anesthesia for cesarean section in obese patients: current perspectives. Local Reg Anesth. 2016 Asug 16;9:45-57. doi: 10.2147/LRA.S64279.

Panni MK, Columb MO. Obese parturients have lower epidural local anaesthetic requirements for analgesia in labour. Br J Anaesth. 2006 Jan;96(1):106-10.

Guides to Preventing Medical Malpractice

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Medical malpractice claims are increasingly a prominent issue in the United States healthcare system. By the historical legal definition, medical malpractice refers to a legal suit which centers on a healthcare practitioner’s alleged breach of his/her professional medical duty to the patient. Furthermore, the person who brings forth the suit must be able to prove that this breach caused more than negligible harm, including proof of significant injury that led to damages.

Across the spectrum of healthcare providers, anesthesiologists and certified registered nurse anesthetists (CRNAs) are among the specialists with the highest number of malpractice claims nationwide. Research shows that approximately a third of anesthesiologists will encounter at least one medical malpractice suit resulting in an indemnity payment, over a six-year time period. Furthermore, indemnity payments related to anesthesiology-based medical malpractice claims are often high-cost. Anesthesiologists comprise the third largest bucket of physicians that are held liable to pay higher than a million dollars in one medical malpractice claim. The significance of the financial burden incurred to the practitioner, along with the trickle effects that influence the professional reputation of the physician, underlines the critical nature of this issue to anesthesiologists and CRNAs that practice in the United States.

So, which types of medical episodes are most likely to result in medical malpractice claims against anesthesia healthcare providers? The Advanced Institute for Anesthesia Practice Management reports that nearly half of all anesthesia medical malpractice suits are associated with anesthesia for dental procedures. The next highest number of claims result from deaths that occurred due to or as a result of improper anesthesia administration. Lastly, a small proportion of claims result from issues such as nerve damage, tissue injury, infection, surgical complications, extended pain, burns, or errors in medication administration.

Medical malpracticeTo prevent the onset of medical malpractice claims, anesthesia providers such as anesthesiologists and CRNAs should follow the below guidance, based on advice from experts in the field:

  1. Informed, holistic consent is necessary to prevent future claims. If a patient does not feel comprehensively informed about the procedure, including the potential symptoms during recovery time, he/she is much more likely to feel a sense of betrayal and confusion after the procedure. To ensure informed consent, anesthesiology practitioners should maintain that support staff such as research coordinators, registered nurses, and even physicians are trained on how to deliver ethical, culturally sensitive, informed consent to every patient who walks in the door before the procedure.
  2. Focus on increased documentation pre, during, and post-surgery. While documentation requirements are already heavy, it is essential that anesthesiologists and CRNAs have extensive records at their disposal in order to prepare for any potential outcome during the procedure. Moreover, extensive documentation is the best practice from the management perspective as well, for analyzing past medical episodes to determine patterns of care or potential factors that may influence the outcomes of surgeries. In this field, information is essential.
  3. If a mistake is made, consider mediation. Even in a highly fixed setting such as the operating room, mistakes occur because of sleep deprivation or human error. If a mistake was undeniably made by a practitioner in the OR, it is useful to remain open to mediation with an independent third-party mediator. Mediation is a modern conflict resolution practice that is rising in relevance as physicians and patients begin to realize the negative spiral of engaging in endless arbitration. With mediation, the two parties can settle on a financial payment that both believe is fair for the claim. Moreover, if the practitioner is willing, in the mediation setting patients have the option to receive an apology, a practice that is nearly impossible in the arbitration setting.

Errors can happen, even in the most controlled of circumstances such as an OR. However, anesthesia professionals and healthcare administrators can use tools such as the above to circumvent the onset of medical malpractice claims, allowing practitioners and patients to work together towards a peaceful and healthy future.

 

Sources

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2628513/
  2. https://www.nejm.org/doi/full/10.1056/NEJMsa1012370
  3. https://www.everyusb.com/ebooks/tulane/#627/z

Safety of Anesthesia for Children Under Three

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Children who require anesthesia services before the age of three represent a broad range of medical diagnoses and circumstances. Regardless of how serious a child’s situation may be, there has been a longstanding concern in clinical medicine around the potential risks of receiving anesthesia at such a young age. Much of this concern has stemmed from animal studies where drugs used in general anesthesia show neurological consequences for young subjects. Some observational studies of humans who were exposed to anesthesia drugs at a very young age also report correlations with behavioral and neurodevelopmental issues. The questions raised in these studies are deeply troubling: are children who require anesthesia at a young age at risk of lifelong neurological setbacks? This is a troubling price to pay for safe and painless medical interventions in a highly vulnerable population.

A groundbreaking study released recently from researchers at the Mayo clinic shows results that should be encouraging for patients, their families, and the anesthesiologists who care for them. Dr. David Warner led a team of researchers in evaluating Minnesotan children via the Mayo Anesthesia Safety in Kids (MASK) study. The basic question this study aimed to answer was: do children who require multiple procedures facilitated by general anesthesia have a higher risk of adverse neurodevelopmental outcomes?

Anesthesia for Children

Much to the relief of researchers and clinicians alike, this rigorous cohort study suggests that the answer is no. The study mainly tracked children for differences in IQ, a useful barometer for adverse neurological impact. Also, it used screening and parental reporting to identify any behavioral or learning-related issues. This provided a holistic picture of many possible risks to the mental well-being of children who receive anesthesia before the age of 3. Results indicated that children with such exposure to anesthesia were not associated with lower IQs compared to children who had no anesthesia before age 3. With regard to the behavioral and learning issues, children with a single anesthesia experience also had no increased risk. However, children with multiple anesthesia experiences had slightly more reported learning and reading difficulties from parent accounts.

In studies like these, it is always difficult to know for certain whether potentially confounding factors have been appropriately accounted for. On a basic level, children who require medical interventions multiple times at a very young age likely have other differences from children who do not beyond their anesthesia exposure. It is nearly impossible to say whether the anesthesia are the determinant of the slight delay in reading, for example, or whether it is on account of an early childhood disrupted by medical challenges.

This research could have useful implications for hospital and larger-scale policies. Follow-up and coordination of services for medically complex child