Navigating drug shortages and more: Strategies and solutions

By Olivia Barry, Manager, Practice Management, February 1, 2024

Each month, DermWorld tackles issues “in practice” for dermatologists. This month, practice management staff explains how to navigate drugs shortages and more.

Prescription drug shortages are a persistent and complex challenge across dermatology. What is the major cause of drug shortages? There are several factors that contribute to drug shortages including availability of raw materials, manufacturing issues, regulatory requirements, and discontinuations or approval delays. An Academy survey found that 4 in 10 dermatologists experience drug shortages daily and 9 in 10 experience it at least monthly. These shortages not only regularly disrupt dermatologists’ workflow, but also impose an administrative burden and compromise patient care. This article delves into the major causes of drug shortages and provides actionable steps to mitigate the impact of these shortages, offering valuable resources and guidance.

Lidocaine shortage

Dermatologists are facing shortages of lidocaine, leading to delays in patient procedures and creating a panic to access replacements before depletion of their current supply. An Academy survey found that 9 in 10 dermatologists believe that drug shortages have negatively impacted patient outcomes — even directly causing patient harm. Drug shortages have forced dermatologists to delay patient procedures or refer patients to an ambulatory or hospital setting to receive proper anesthesia. In turn, patients are unable to receive a timely diagnosis and may be hit with an increased cost of care.

As predicted by the FDA, the lidocaine shortage is anticipated to wind down by early 2024. Until then, use the lidocaine guidance and resources below to enhance your practice’s operations around the shortage.

• Use these strategies on how to extend your current lidocaine supply.

• Find a licensed local pharmacy that compounds lidocaine products.

• Visit the lidocaine shortage FAQs page to learn more about the cause of the shortage and how to minimize the risk of price gouging.

In addition to providing the above resources, the Academy is also working diligently with policymakers, the FDA, manufacturers, and medical societies to address the shortage of lidocaine and lidocaine with epinephrine. The most recent efforts include the establishment of the Drug Shortage Workgroup to pinpoint the causes and strategize on advocacy efforts to mitigate the impact. Further, the AADA discussed the lidocaine shortage with Fresenius Kabi and Pfizer (two major manufacturers of lidocaine), voicing members’ concerns. Learn more about the AADA’s advocacy efforts regarding lidocaine.

Compounding medication

Compounding medication serves as a crucial response to drug shortages, providing customized formulations or alternative medications when commercially available options are scarce. Dermatologists already perform in-office compounding regularly to tailor medications specific to a patient’s needs so this can be leveraged further during time of shortages. You can continue to compound medications in-office. However, ensure you are following federal and state regulations including the Drug Quality and Security Act of 2013, prohibiting compounded drugs that are a replica of a commercially available drug.

Use the AADA’s Compounding Decision Tool at staging.aad.org/compounding-tool to determine whether the type of compounding you are performing complies with FDA regulations. Additionally, uncover ways to access the drug product if compounding in your office is not feasible.

As reported from the International Journal of Dermatology, 94.7% of dermatologists use compounding pharmacies. However, did you know that the FDA no longer permits traditional compounding pharmacies to distribute office-use compounded medications to practices without patient-specific prescriptions? Ensure you are ordering medication through a pharmacy that is compliant with FDA requirements, including compliance with current good manufacturing practice (CGMP) and reporting adverse events. If you’re looking for a facility to order office-use compounded medication without a prescription, review the list of FDA-designated outsourcing facilities.

Visit our advocacy page on compounding for more information on in-office preparations and assistance with obtaining a compounded medication for office use.

Drug pricing assistance

Drug shortages have not only created challenges with accessibility but have led to increased cost of medications for both physicians and patients. According to an Academy survey, 73% of dermatologists reported increased practice costs due to shortages and necessary medication substitutions. Medication costs can be an obstacle for patients, especially those who do not have insurance or those who need prescriptions that are not included in their insurance plans. Help patients overcome the obstacle and explore GoodRx — a tool that aids in finding cost-effective local prescriptions. Gain insights into patient programs that provide assistance with prescription drugs, including no-cost medications for those without insurance coverage, as well as prescription coupons.

Learn more about the issues driving the cost of medication and the advocacy initiatives of the AADA, which include price transparency, generic drugs, price fluctuations, pharmacy benefit managers (PBMs), and drug importation.

Step therapy guidance

Step therapy is a process employed by health plans that may require patients to try less-expensive alternative medications before allowing access to a drug that may be preferred by the physician. Insurers view this as an effort to manage health care expenses. However, step therapy — also referred to as “fail first” — has proven to have a negative impact on patients. Step therapy can result in treatment delays, disease progression, limited shared decision-making, physician burden, and increased medication costs. Does the state you practice in have step therapy laws? Are you familiar with your state’s step therapy legislation? Check out your state’s step therapy provisions, exceptions, and which insurers the legislation applies.

Due to AADA’s advocacy, numerous states have implemented laws reforming step therapy practices. Learn more about the AADA’s advocacy efforts for state step therapy reform.

Prior authorizations

Prior authorization remains one of the top administrative burdens for dermatologists. The process can be drawn out due to the follow-up with patient and insurer, patient tracking, appeals letters, and much more. Add to that the frustration of drug shortages, and it becomes an even bigger headache. In addition to employing the aforementioned resources, save your practice time and use the Academy’s prior authorization appeal tool at staging.aad.org/pa-tool. The tool provides over 60 appeal letters that are customizable and clinically specific, allowing your practice to easily download a letter based on drug name or diagnosis.

Are you interested in learning about how to set up an efficient prior authorization workflow? Learn more about prior authorization best practices.

While the inevitability of drug shortages and their effect on dermatologists persists, you can utilize the guidance outlined in this article to reduce the negative impact on patient care, prevent increased practice costs, ensure pharmaceutical compliance, and keep current on the AADA’s advocacy efforts.

Additional DermWorld Resources