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Lidocaine shortage update


What’s driving the ongoing shortage — and when can dermatologists expect it to end?

Feature

By Emily Margosian, Assistant Editor, January 1, 2024

Banner for lidocaine shortage update

A new year has arrived, but America continues to face a familiar problem. According to the American Society for Health-System Pharmacists, there are more than 300 drugs in shortage — the highest number since 2014.

Among these, several dermatology drugs remain difficult to come by. However, ongoing scarcity of injectable lidocaine and lidocaine with epinephrine has posed an escalating challenge for the many dermatologists who rely on them for over 100 diagnostic, reconstructive, and therapeutic procedures.

While the ongoing lidocaine shortage has undeniably disrupted care — frustrating physicians and patients alike — hope may be on the horizon according to manufacturer and regulator projections.

This month, DermWorld digs into what factors have contributed to the shortage — and when it’s expected to end.


Short on time?

Key takeaways from this article:

  • Several dermatology drugs remain in shortage, but among these, lidocaine and lidocaine with epinephrine are of most acute concern for dermatologists and their patients.

  • The shortage can be attributed to several factors, including increased demand, strict quality control requirements for manufacturers, and supply chain issues caused by the COVID-19 pandemic and other natural disasters.

  • Manufacturers and regulators project that the shortage will abate by early 2024.

  • In the meantime, the AADA has taken multiple steps to address the shortage, including partnership with regulators, legislators, and other key stakeholders.

Why is lidocaine so hard to get right now?

“It definitely is a frustrating problem, because we all want there to be something we can do — just tweak this or get over this one hurdle — but it really is a systemic issue,” said Eric Millican, MD, FAAD, chair of the AADA Regulatory Policy Committee and Drug Shortage Workgroup.

While the exact cause of the shortage is opaque, experts say multiple factors are likely at play, including increased demand, shortages of raw ingredients or containers, and disruptions of manufacturing facilities, due to quality concerns and staffing shortages.

“The strict quality control requirements of the FDA often make it difficult to quickly add new manufacturing capacity when a drug shortage occurs,” explained Allison Vidimos, MD, RPh, FAAD, registered pharmacist and member of the AAD Drug Shortage Work Group.

The nature of lidocaine itself also presents a more difficult supply chain problem to address compared to other drugs. “With lidocaine with epinephrine in particular, the manufacturing process is just that much more of a challenge to get up and running. If there’s a persistent shortage of a medication in pill form, you can get a new manufacturing line for a tablet or capsule set up reasonably quickly at a relatively lower cost in comparison to a sterile injectable,” said Dr. Millican.

“The problem with projections is that they’re rough estimates. Sometimes it’s a rolling target, but manufacturers have been fairly consistent, even after the tornado, that they expect things to be substantially better in the first quarter of 2024.”

In addition to manufacturing difficulties, supply chain issues due to the COVID-19 pandemic and recent natural disasters have also worsened the ongoing lidocaine shortage.

“There was increased demand for local anesthetics during the COVID-19 pandemic, which depleted existing supplies of lidocaine,” said Dr. Vidimos. “In addition, the supply chain shifted to prioritize manufacture and distribution of the COVID-19 vaccine during that time.”

In July 2023, the Pfizer Rocky Mount facility in North Carolina was impacted by a tornado. The facility produces nearly a quarter of all of Pfizer’s sterile injectables, and accounts for 8% of the overall U.S. market.

One month after the tornado, the End Drug Shortages Alliance (ESDA), a coalition of stakeholders which includes the AADA, released a report evaluating the impact of the incident on drug supply chain issues. The report determined that several drugs, including lidocaine and lidocaine with epinephrine, are likely to experience further supply chain disruptions due to damage at the facility.

“It was originally projected that things would be getting better in the fourth quarter of 2023. The tornado that hit Pfizer’s manufacturing facility in North Carolina delayed things slightly because unfortunately, that is one of the plants where they manufacture lidocaine with epinephrine,” said Dr. Millican. “Fortunately, it didn’t hit the manufacturing line itself. So, the ultimate impact of the storm should be more of just a blip rather than a fundamental problem.”

When will the shortage end?

Based on current manufacturer reports, the FDA estimates the shortage may abate by early this year. “In meetings with the FDA, the agency indicated that AADA members should expect relief from the lidocaine shortage by early 2024,” said Dr. Vidimos. “AADA staff and leaders have also met with lidocaine manufacturers, Pfizer and Fresenius Kabi, who indicated that they expect to see relief in 2024.” AADA President Terrence Cronin Jr., MD, FAAD, is in regular contact with manufacturers and continues to share the impact drug shortages have on our members and patients.

“That’s still the best projection, but the problem with projections on shortages is that they are rough estimates,” said Dr. Millican. “Sometimes it’s a rolling target, but manufacturers have been fairly consistent, even after the tornado, that they expect things to be substantially better in the first quarter of 2024.”

“We’re talking to everyone there is to talk to. We’re continuing to put pressure and keep it top of mind with legislators, regulators, and drug companies.”

For physicians seeking real-time information on where things stand with dermatology drugs in shortage, the FDA reports on drug shortage information submitted by manufacturers on its Drug Shortages webpage. The American Society of Health-System Pharmacists (ASHP) also publishes drug shortage bulletins.

“Help should be around the corner if those projections continue to stay true,” said Dr. Millican. “One complicating factor is that there is a great deal of built-up demand, and some of that is based on the knowledge that lidocaine is in shortage. Right now, people want to get as much as they can, and will place a big order even if that’s not necessarily their normal month-to-month need for lidocaine with epinephrine. So, from the manufacturer’s side, they end up with a very large backlog of demand, but it’s hard to know if that’s real demand or demand that is going to very quickly get back toward normal levels once supply becomes more reasonable. I think that’s partly why the projections of when things will get better are not always perfectly accurate.”


Dermatologist use of dental supplies of lidocaine

Amid the ongoing lidocaine shortage, dermatologists feeling the pinch may look to other supply chains for help.

While medications from veterinarian supply chains are not approved for human use and should not be used, lidocaine products sold for dental use are approved and can be used by physicians in the same manner as lidocaine from regular suppliers. “We have been able to confirm that the dental supply of lidocaine with epinephrine is much more robust and seems to have a fairly reliable supply,” said Dr. Millican.

As with any situation using medication from a new supplier, it is important to be aware of any differences with these products — including medication concentrations, preservatives, and packaging in individual versus multi-use vials. “Dental lidocaine is sold in different formulations in terms of the packaging itself,” said Dr. Millican. “It comes in glass carpules more geared for dental syringes than our normal glass vials, but it’s usable in a pinch. There are some workarounds to make its use more efficient, and it can be a stopgap if regular supply is just really not there for a given dermatology clinic.”

Members utilizing dental lidocaine for use in their practice are urged to check the package insert before using alternative sources to verify the concentration, presence/absence of preservatives, and indicated uses. Be aware that using some alternative sources for dermatologic procedures may be considered off-label use.

Learn more about dermatologist use of dental supplies of lidocaine.

What is the AADA doing to improve lidocaine supplies?

Working with regulators:

The AADA continues to work with the FDA on multiple strategies to address the lidocaine shortage, including importation. “As far as importation, the FDA has asked if we are aware of international manufacturers of lidocaine that they could reach out to and the Academy shared information on a European lidocaine manufacturer,” said Chad Appel, JD, AADA director of regulatory & payment policy. “The AADA supports the legalized importation of prescription drugs by wholesalers and pharmacies only if all drug products meet all FDA requirements and other United States laws and regulations, and the drug distribution chain is ‘closed,’ meaning all drugs imported can be electronically tracked. We are also supportive of Congress granting additional funding and resources to the FDA to ensure imported drugs are safe and effective.”

For more information, read the Academy’s position statement on Access to Affordable Treatments.

Under current FDA rules, physicians and others may not import lidocaine directly from Canada for purposes of administering to patients. Learn more about rules regarding the importation of lidocaine.

In August 2022, the AADA sent a joint letter to the FDA expressing concerns about the critical national shortage of lidocaine with epinephrine, lidocaine, and other local anesthetics. The Academy also met with FDA drug shortage staff in March 2023 to get a status update on the lidocaine and lidocaine with epinephrine shortages. “We’re continuing to sign joint specialty letters. We’re continuing to advocate with the FDA. We’re keeping pressure on both the FDA and manufacturers to push them to improve supply as best they can,” said Dr. Millican.

This past June, AADA President-Elect Seemal R. Desai, MD, FAAD, presented before the FDA and urged the agency to expand regulatory flexibilities for compounding facilities, pharmacies, and physicians to help increase the supply of lidocaine.

Engaging with legislators:

The Academy also continues to champion this issue with members of Congress. In May 2023, the AADA submitted a statement to the House Oversight Subcommittee following a hearing on drug shortages. “The purpose of the hearing was to explore why drug shortages have become commonplace, and how the U.S. can improve the resiliency of its drug supply chain,” said Appel.

The following month, U.S. Senate Majority Leader Charles Schumer (D-NY) held a press conference demanding that manufacturers and regulators end drug shortages affecting patients. “Sen. Schumer wants Congress to pursue importation from other countries to help address drug shortages, expedite the FDA’s safety and quality reviews, and assess the nation’s drug supply chain to locate potential surplus. At the urging of AADA and dermatology leaders, Sen. Schumer called attention to the lidocaine shortage’s impact on dermatology patients,” said Appel.

The AADA has also expressed support for H.R. 167, 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.

As the AADA is engaging Congress on drug shortages, you can help! Visit the AADA Action Center to urge Congress to work with stakeholders to address the national drug shortage. Dermatologists can also encourage their patients and members of the public to urge Congress to act on drug shortages and the lidocaine issue.

Partnering with stakeholders:

The AADA has collaborated 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. The APC has a find a compounder page.

This year, the AADA also joined the EDSA to partner with other key stakeholders on identifying solutions to resolving the supply chain shortages and ending drug shortages. “The EDSA is an alliance of health system, supply chain, industry, and other stakeholders dedicated to solving pharmaceutical supply challenges by collaborating to increase visibility, access, and advocacy,” said Appel.

“I think the biggest thing to highlight is that we’re talking to everyone there is to talk to. We’re continuing to put pressure and keep it top of mind with legislators, regulators, and drug companies,” said Dr. Millican. “Progress is slow — not for lack of trying — but because there’s not a quick solution that can be rolled out tomorrow. When we talk to regulatory bodies, they’re open to suggestions, but they don’t have a great lever to force supply back in the market any faster than it’s already trying to get there. Adding new manufacturing is just something that’s slow. We’re continuing to push on all sides, but there’s still an inherent lag as to when things will improve.”

AAD Member Buying Program

If members do not currently have a trusted lidocaine supplier, they are encouraged to utilize the AAD Member Buying Program, a member benefit designed to lower medical and office supply costs. The program can allow members to place lidocaine orders with existing manufacturers and distributors at a potentially lower price and help minimize the risk of price gouging. Learn more.

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