Academy pushes FDA action on resolving shortages of sodium bicarbonate and buffered lidocaine

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By Colby Evans, MD
Chair of the AAD Drug Pricing and Transparency Task Force and a member of the Patient Advocate Task Force

National drug shortages continue to greatly impact dermatologists. Sodium bicarbonate and lidocaine with epinephrine are now both experiencing national shortages, and are listed on the Food and Drug Administration (FDA) shortage webpage.

As part of our ongoing advocacy efforts, several members of the Drug Pricing and Transparency Task Force highlighted the importance of these drugs to the FDA's Office of Generic Drugs on a recent call. The Task Force emphasized how the shortage is forcing dermatologists to use these drugs sparingly, disrupting workflows, and even causing surgeries to be delayed. We also highlighted how patients – especially those in the pediatric population – are forced to endure painful injections of lidocaine without buffering. The Task Force members encouraged the FDA to continue working with the manufacturers to resolve the shortages. Additional topics we covered on the call included:

  • the rising prices of dermatologic generic drugs and the impact on access to necessary treatments;
  • the significance of eliminating the backlog of generic drug applications to increase competition; and
  • and the importance of generic topicals, as they often serve as the first line of defense to prevent a recurrence of a disease or a flare-up and can frequently be used to avoid costly surgeries in the case of topical chemotherapies.

Update on drug availability from Pfizer

Additionally, the AADA recently spoke with Pfizer, one of the manufacturers of sodium bicarbonate and lidocaine with epinephrine. To help keep track of expected supply dates, Pfizer updates expected shipments and resupply dates daily. Download a PDF with drug availability information.

Pfizer indicated sodium bicarbonate is on track to be restocked by November 2017, with backorders currently in the process of being filled. They plan to stock the backorders using historical records of drug usage in order to ensure stakeholders are receiving the shipments.

According to Pfizer, an increase in demand has led to the lidocaine with epinephrine shortage. Pfizer is continuing to ship out as much lidocaine with epinephrine as they can, but they do not expect to be fully restocked until the second quarter of 2018. They also noted that others manufacture lidocaine with epinephrine as well.

Physicians and pharmacists can prepare lidocaine with epinephrine (which is generally considered essentially copies of commercially available drugs) due to shortage. However, they must comply with the prescription requirement. To obtain compounded drugs from a traditional compounding pharmacy, physicians must provide a patient-specific prescription prior to distribution. For in-office preparations, currently, under the FDA prescription requirement final guidance, physicians can compound anticipatorily without a patient-specific prescription up to a 30-day supply of compounded medications. This final guidance requires the prescription to be noted in the patient chart before administration.

The following resources in JAAD provide an overview of the available anesthesia options:

Advocacy efforts

The AADA continues to advocate on behalf of dermatologists to preserve access to necessary drugs. In response to a recent FDA request for input on how to help ensure the intended balance is maintained between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs, AADA plans to include in its comment letter information on how these shortages are impacting access.

AADA will continue to encourage FDA to prioritize its efforts to help with the shortages of these important drugs. Several of the issues highlighted in the letter will be consistent with AADA’s position statement and advocacy efforts.

The AADA was also successful in advocating for language to be included in the FDA Reauthorization Act of 2017 to create an expedited review process for the FDA to approve generic drug applications, which could increase access to generic medications. This language was one of the primary asks at the AADA 2016 Legislative Conference. President Trump signed the bill that reauthorizes the FDA user fee programs for another five years into law in August of 2017.