Partnering to Increase Access to Tuberculosis Medications

August 19, 2024 | Amelia Poulin-Obregon, Donna Hope Wegener, Kelly White

In recent years, a variety of factors, including supply chain interruptions, a loss of manufacturers, and erratic drug supplies, have resulted in tuberculosis (TB) drug shortages nationwide. Policy across all levels of government—international, federal, state, territorial, tribal, and local—can help improve the availability and administration of medication and access to ancillary supplies. By developing effective partnerships, health agency leadership and TB programs can tap into existing efforts to address drug shortages, as well as support coordination around emerging strategies.

Background 

There are highly effective treatments for both active TB disease and latent TB infection. In fact, medication can almost always cure TB disease, resulting in improved outcomes for the patient and ensuring the infection does not become transmissible. Unfortunately, however, first line TB medications have been in shortage or difficult to access over the last decade. For example, CDC recommends rifampin, isoniazid, and rifapentine to treat active and latent TB, but they are in short supply, as declared by FDA as early as 2020 (rifapentine since 2020, rifampin since 2021, and isoniazid since 2023).

Despite drug shortages, health agency leadership and program managers have been able to leverage a variety of strategies and program adaptations to ensure access to TB medications. This includes prioritizing medication for those with active TB disease, identifying flexibilities in contracting and procurement mechanisms, and developing reserved drug inventories—all of which strong partnerships are critical to.

Strategic Partnerships

Routine monitoring and communication with partners before a supply issue exists can help programs plan and conserve supply before it impacts patients directly. Health agency leadership and program managers can strategically leverage the following partners to address challenges with fluctuating TB medication availability: 

National Organizations

National organizations focusing on medication supply challenges, (e.g., End Drug Shortages Alliance and Angels for Change) can help educate public health program staff and providers about the medication supply issues, investigate the root causes of the issues, and advocate for a resilient supply chain. Other national organizations representing governmental public health can serve as a resource for TB programs by maintaining awareness of medication availability and supporting information sharing, namely:

• ASTHO: State and territorial health agencies (S/THAs) can leverage ASTHO as a partner when looking to understand peer experiences, seeking program documents or materials, sharing best practices, and more. ASTHO’s Health Security Unit houses committees focused on both infectious disease policy and public health preparedness policy, staffed by experts who were able to weigh in on related topics areas.
• National TB Coalition of America (NTCA): NTCA can support health agencies and other TB program staff in accessing information and resources for improved TB health outcomes. It has developed an online drug availability reporting mechanism to systematically collect timely data on challenges procuring TB medications.

Additionally, federal organizations like CDC may help public health programs acquire medication, such as through the Division of TB Elimination’s drug stockpile. The stockpile can release TB drug supply when there is an FDA-declared shortages, or when drugs in the stockpile are going out of date. Finally, both national and international organizations can support availability of TB medications by adding them to essential or priority medication lists (e.g., rifampin is on the WHO Model List of Essential Medicines), which signify the critical nature of this issue for policy makers and can reduce access barriers.

FDA

FDA monitors the availability of medications, including those used to treat TB, and has mechanisms in place to collect information around medication supply disruptions, which may include changes in provider ordering behaviors. Likewise, FDA may have information about a potential or existing disruption to the availability of certain medications. Health agency staff can check the FDA Drug Shortages webpage or send questions to drugshortages@fda.hhs.gov. 

Manufacturers and Distributors

Manufacturers and distributors often communicate with health agencies and other entities offering clinical services when there are anticipated supply challenges. The earlier these communications, the better partners can plan for and mitigate downstream effects. By keeping in regular contact with manufacturers, health agency programs can stay up to date on drug availability and take appropriate steps to maintain adequate supply or plan for alternatives. It can be advantageous for public health programs to partner with multiple manufacturers and distributors to have alternate access to medications in case of distribution disruption.

Pharmacists

Pharmacists have a unique understanding of supply chain disruptions and can provide valuable perspectives to workgroups or convenings focused on drug shortages. This may include both large commercial pharmacies as well as smaller compounding pharmacies, which may play a role in compounding pediatric and other TB drugs. Pharmacists often have access to information on drug supply availability outside the scope of a public health program.

Health agency programs may consider defined or routine communication efforts with pharmacies on drug availability to monitor trends. During a medication supply disruption, pharmacists can serve as integral partners with public health programs and providers to mitigate the impact to the patient.

Other S/THA Programs

Other S/THA programs, both internal to the health agency as well as across jurisdictions, can consult on the best practices their unit has identified. Challenges such as drug shortages affect nearly all disease areas, and other public health programs may have innovative approaches that others can leverage in new contexts. Public health programs can also work with each other to identify if drug supply issues are localized or regional, collaborate on solutions, and even share supply. Agency leadership can also facilitate partnerships with additional manufacturers and suppliers and conduct outreach to providers, who may rely on assistance from agency personnel outside the immediate programs.

Healthcare Providers

Healthcare providers can remain aware of drug shortages and collaborate with local, state, and federal partners to identify additional procurement or treatment options. Health agency programs should also share with providers any FDA-approved alternative treatment regimens and other considerations when prescribing medication, and offer additional support when possible. For example, listing information about drug shortages and medication availability on the health agency’s webpage in an easy-to-find location (e.g., the Indiana Department of Health’s webpage) can assist providers in identifying changes in availability and alternate treatment regimens early on.

When providers are aware of drug shortages, they can take action to mitigate downstream effects, such as contacting pharmacists to ensure patients are getting the medications they need or prescribing alternate treatment regimens to ensure patients successfully complete treatment.

Community Members

Community members rely on health agency programs to produce communications about what to expect. Community members interested in TB control (e.g., people living with latent TB infection, their friends or family, public officials) may also be interested in participating in workgroups or providing qualitative data for health department communication initiatives. 

Departments of Corrections Facilities

Departments of Corrections Facilities are at increased risk of TB transmission due to overcrowding, poor ventilation, and the presence of other risk factors like substance use. Health agencies may work with departments of corrections to implement TB screening programs for diagnosis as well as treatment (e.g., reviewing chest x-rays or lab orders, writing medication prescriptions, reviewing progress for active and latent cases) or even offer support by providing medications to patients.

Universities

Universities may offer capacity building through training programs, providing an evidence-base for health agency strategies (i.e., improving medication adherence), conducting community outreach, developing and implementing data collection tools, and more. Once a relationship is formed, health agencies may provide medications for the university to dispense through an established program.

Conclusion 

Understanding and addressing ongoing drug shortages and other medication availability challenges can be time-consuming and costly for public health programs and other key partners. The uncertainty of a robust and affordable drug supply has implications for patient care, health equity, and, ultimately, health outcomes. Efforts to eliminate infectious diseases like TB become compromised when the appropriate medications are not available or affordable. Partnerships to address these challenges are essential. This document provides insights into those critical partnerships and identifies specific partnerships for health agency leadership and public health program staff to consider.