Joint position statement educates policymakers on safe in-office preparation of buffered lidocaine by dermatologists
The scrutiny dermatology continues to face when it comes to the safe in-office preparation of buffered lidocaine (and other in-office preparations) is daunting for the specialty-at-large. To help advocate for the continued practice of safe in-office preparation of buffered lidocaine without unreasonable, burdensome restrictions that may impede patient care, a new joint position statement on Safe In-office Preparation of Buffered Lidocaine as a Local Anesthetic was approved by the AAD/A. While the position statement, which was also adopted by the American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery, outlines how to safely prepare buffered lidocaine on a daily basis in practice, it also can serve as an educational tool to demonstrate to policymakers, who, without specialty knowledge or skill, are not familiar with the step-by-step approach dermatologists take to safely and effectively prepare buffered lidocaine in a clinical setting.
AAD Board of Directors member Seemal R. Desai, MD, chair of the AADA Compounding Workgroup shares more with Dermatology World Weekly.
DWW: Why is this position statement important?
Dr. Desai: As board-certified dermatologists, there’s no question as to why we support and rally behind the safe practices we routinely follow to administer anesthetics like buffered lidocaine in the office environment. We know what we do is safe, effective, and improves patient care and access. However, these sentiments haven’t necessarily been spelled out, in black and white, for policymakers, who are not dermatologists or physicians. We, as experts of the specialty, must advocate and educate them on our day-to-day practice and what trivial blanket rules and regulations mean for our role in providing superior and compassionate patient care. The joint position statement was created by the AADA and sister societies as a unified strategy to advocate to and inform policymakers with a written, highly detailed document that captures a step-by-step approach to how we safely buffer and prepare lidocaine in an office environment.
DWW: What advocacy efforts remain in front of the AADA on this topic, and how can members support them?
Dr. Desai: The compounding battle has been ongoing and continues — and so do AADA advocacy efforts. I think mostly everyone is aware of the scrutiny dermatology has faced over the past several years when it comes to in-office preparations. As a result of strong advocacy and intense discussions with the FDA, it later released documents that stated they do not intend to consider physician offices the same as a compounding pharmacy. This was certainly a win.
Since that time, however, we’ve continued to lead staunch advocacy efforts alongside the American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery and other groups to address the United States Pharmacopoeial Convention (USP) as it prepares to finalize the Chapter 797 standards, which proposed only a one-hour exemption from preparation to administration and are now considering a four-hour exemption. Considering many dermatology practices prepare buffered lidocaine syringes daily ahead of patient visits and procedures, the AADA and fellow sister societies provided input to the USP to advocate for at least a 12-hour window, which is the minimum threshold for beyond-use date (BUD) established in the new position statement.
Advocacy doesn’t just stop with the USP. We’re going to need continued advocacy at the state level, and this is where members can get involved. Ultimately, it’s the state pharmacy boards that implement the regulation. While the USP is a non-governmental body, its standards are frequently adopted by state pharmacy boards. If finalized as proposed, this federal guidance would leave it to the states to regulate physician in-office preparations. We are advocating so that when the USP standard becomes enforceable at the state level, we won’t have problems there.
DWW: With a very detailed synopsis of preparing buffered lidocaine outlined in the position statement, what should the takeaways be for members?
Dr. Desai: The statement is strategically worded to offer principles on personnel qualifications, personnel hygiene and garbing, facilities, cleaning and disinfecting, beyond-use dates, labeling, documentation, and preparation process. It is not intended to make our lives as physicians difficult. These principles streamline and standardize this preparation process and educate policymakers on the safe preparation process that dermatologists have used for decades without incident.
DWW: How can members simplify the position statement to make it applicable and more transparent for in-office staff?
Dr. Desai: The content in the position statement is “spelled out” for policymakers who aren’t as familiar to the safe in-office practices dermatologists routinely follow when preparing and administering buffered lidocaine. However, for those who live and breathe the specialty, I can reassure you that there is nothing in the position statement that is new, overwhelming, or outside of the sphere of how in-office staff operate day-to-day. In fact, the language in the step-by-step protocol is what most of us have been doing throughout our dermatology career. It simply reinforces, in words, best practices that we know are safe and effective when preparing and buffering lidocaine. The position statement was adopted by the AADA, ASDSA, ASMS, and ACMS to collectively show the best way to make this less restrictive and onerous on dermatologists.
DWW: Allison Vidimos, MD, RPh, is serving as an expert consultant to the USP Compounding Expert Committee to represent the dermatology community and explain the importance and safety of in-office preparations in dermatology. To further AADA advocacy efforts on safe in-office preparation practices, Dr. Vidimos recently presented the position statement to the USP. What was the result?
Dr. Desai: The USP has agreed to facilitate the testing process for what will hopefully be a compounded preparation monograph that will include safety standards so that dermatologists do not have to comply with all of the requirements outlined in Chapter 797. Assuming the USP 51 testing goes well, there will also need to be stability testing performed as USP determined that currently published peer-reviewed journal articles are not sufficient for a new monograph.
