Lidocaine shortage
Ask the Expert
By Victoria Houghton, Managing Editor, January 1, 2023
DermWorld spoke to Eric Millican, MD, FAAD, chair of the AADA Regulatory Policy Committee and Drug Shortage Workgroup, about the AADA’s advocacy efforts on the lidocaine and lidocaine with epinephrine shortage.
DermWorld: Dermatologists are currently struggling to get access to lidocaine and lidocaine with epinephrine. Why are these so hard to get from manufacturers right now?
DermWorld: What role has the COVID-19 pandemic played in the lidocaine shortage?
Dr. Millican: We don’t have hard data from the manufacturers, but in part we know that the supply chain shifted to prioritize the manufacture and distribution of the COVID-19 vaccine. In addition, the broader supply chain and staffing disruptions related to COVID may be contributing. We may also be seeing a snap-back issue where production decreased in response to lower demand during COVID restrictions and the supply has struggled to keep up as demand has briskly returned.
DermWorld: Do we have a sense as to how long the shortage will last?
Dr. Millican: Manufacturers are unsure how long this shortage will last but predict extended difficulties of at least 6-12 months. Manufacturers are updating the FDA on a dose and delivery availability in almost real-time. The ASHP also has an up-to-date listing from the University of Utah’s Drug Information Service.
DermWorld: What is the AADA doing to improve lidocaine supplies?
Dr. Millican: We’ve been active on this issue for quite a while. In June, AADA Compounding Workgroup Chair Seemal R. Desai, MD, FAAD, and AADA Past President George Hruza, MD, MBA, FAAD, representing ASDSA, participated in an FDA compounding workgroup listening session. They took the opportunity to clearly outline the consequences for patients of the escalating problem with shortage of generic injectable medication.
In August, the AADA sent a joint letter with ACMS, ASDSA, and ASMS to the FDA expressing our concern about the critical national shortage of lidocaine with epinephrine, lidocaine, and other local anesthetics. The societies urged the FDA to take immediate action by adding lidocaine and lidocaine with epinephrine to the “List of Extended Use Dates to Assist with Drug Shortages.”
On the legislative front, the AADA has expressed its support for H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act, which would improve access to compounded drugs for in-office use and improve access to medications during drug shortages. In October, the AADA also formed a Drug Shortage Workgroup to identify the root causes of the shortage and strategize on advocacy efforts to mitigate the ongoing problem.
DermWorld: Is the Academy aware of a supplier that currently has stock? How can dermatologists avoid being price gouged by distributors when shopping around for lidocaine?
Dr. Millican: We have connected with the Alliance for Pharmacy Compounding (APC) to assist members in finding a local pharmacy (both 503A and 503B facilities) that is licensed and compounds lidocaine products. You can visit APC’s find a compounder resource page.
In light of the national lidocaine shortage, the best option is for dermatologists to continue to work closely with their current supplier and secondary distributor/supplier. If they do not have a trusted supplier currently, we encourage our members to utilize the AAD Member Buying Program, a member benefit designed to lower medical and office supply costs. It can allow members to place lidocaine orders with existing manufacturers and distributors at a potentially lower price and can help minimize the risk of price gouging. Members are also encouraged to work with a reputable national supplier/distributor; the member buying program cautions that some suppliers may charge five to six times more, but these suppliers do not have a long-term supply.
Stay tuned
Keep current on the AADA’s advocacy efforts on the lidocaine shortage.
DermWorld: What other strategies does the Drug Shortage Workgroup have planned?
Dr. Millican: The Academy is continuing to advocate to federal agencies for assistance to alleviate regulatory burdens to increase supply. We are also working to meet with the manufacturers to get more detailed information about the specific causes of the current shortage and a realistic timeframe for a return to normal availability. We all share the same frustrations with the shortage and the same concern about the impact on our practices and our patients. Ultimately, the solution will come from increasing production until it meets demand. We have limited direct control over that process, but we are searching for all of the levers that we have available to ease the supply crunch in the near term.
As members know all too well, patients suffer the most, and the workgroup suggested members and their patients reach out to their federal legislators to help raise awareness of the shortage with policymakers. To help members with their outreach, AADA has a sample letter for members and their patients. To download the letter, visit AADA’s Drug Shortage page.
Eric Millican, MD, FAAD, is chair of the AADA Regulatory Policy Committee and its Drug Shortage Workgroup.
