Improving Access to Critical Medications: A Policy Toolkit for Health Agency Program Leadership
September 30, 2024 | Amelia Poulin
While outside forces (e.g., manufacturer delays) affect the availability of medications, state and territorial health agencies (S/THAs) can mitigate the impact of drug shortages by implementing three main strategies:
- Prepare for Drug Shortages. The strategies in this section support health agency efforts to prepare for drug shortages by managing existing supply through tactics such as tracking, monitoring, and educating key partners.
- Develop and Maintain Partnerships. This section shares opportunities to leverage policy options related to HRSA’s 340B drug pricing program and other policy partnerships health agencies may use to address drug shortages, including through contracts and funding policies.
- Communicate to Support Coordination. This section focuses on the diverse set of individuals, organizations, and other partners with unique perspectives and partnerships to contribute valuable insights to coordination efforts.
Note: In this toolkit, “drug shortage” is an umbrella term that refers to lack of access to a drug, regardless of the reason, be it a global lack of inventory or a local procurement challenge. This contrasts with how FDA defines drug shortage, who examines this issue nationally: “We consider a drug to be in shortage when the total supply of all versions of a commercially available product cannot meet the current demand, and a registered alternative manufacturer will not meet the current and/or projected demands for the potentially medically necessary use(s) at the patient level.”
Health agency programs may face challenges far in advance of an FDA-declared drug shortage; however, sometimes this action is a required policy trigger to access additional resources, which presents a challenge to S/THAs that need additional support.
On This Page
Introduction
Drug shortages both directly and indirectly impact patient and public health outcomes. Most apparently, when there is disrupted access to critical medications (e.g., for sexually transmitted infections (STI) or tuberculosis (TB)), patients go without treatment, increasing transmission risk and worsening health outcomes including death. Further, some challenges with medication access stem not from actual low supply but from navigating complex policies that govern drug pricing, management, and distribution.
“We don't know if it's a national drug shortage, [or] if it's just that our distributor can't get it from their network of vendors.”
At the organizational level, health agency prevention programs face ripple effects of treatment challenges. For example, STI and TB testing programs face issues related to communication, and ultimately trust, when public health teams enter communities testing priority populations without medication available to treat the serious infections being identified.
Toolkit Development
ASTHO, with support from CDC, conducted five interviews with health agency staff and select public health partners to better understand the biggest opportunities for S/THAs to address drug shortages and other medication availability challenges. ASTHO also held informal conversations with members and partners to collect additional context. This toolkit outlines the resulting recommended strategies and how to implement them, with select quotes from the interviews to provide insight into key issues.
Note: Domestic and international manufacturers, distributors, and other actors have authority and influence over policies, programs, and resources available to S/THAs. As a result, while this toolkit focuses on policy actions that S/THAs may take to address drug shortages, they are one piece of a much larger puzzle.
Important Policy Note
Policy levers can range from unilateral action from a public official (e.g., a public health order) to a deliberative process involving multiple branches of government (e.g., legislation being enacted into law). For any public health policy issue, there are often several policy levers operating simultaneously to create a broader policy landscape.
Health agency program staff should consult their organization’s attorneys with questions about implementing any of the policy options described in this toolkit. Health agency attorneys may have more information about authority and influence, and identify key decision-makers.
How To Use This Toolkit
This toolkit helps S/THA’s STI, TB, and other programs develop an action plan for addressing drug shortages and other medication access challenges (focusing on what is available to health agency programs offering/ensuring clinical services), providing practical considerations for implementation and case examples.
Before a drug shortage becomes apparent, jurisdictions may benefit from understanding the existing policy landscape, as well as proactively identifying, prioritizing, and implementing policy options to mitigate effects. As you move through the toolkit, use this policy action plan template (Word download), making note of policy options that may be helpful in your jurisdiction. Consider also checking out ASTHO’s Policy Academy On-Demand to further increase these skillsets.
There are many other decision-making frameworks and analyses that may support S/THAs in uncovering root causes and key impacts of drug shortages. The American Society of Hospital Pharmacists presents a decision-making framework which includes conducting operational and therapeutic assessments and short term impact analyses to inform S/THA efforts.
Prepare for Drug Shortages
Health agencies face challenges preparing for drug shortages for a variety of reasons. Interviews with health agency staff reveal challenges around unreliable supplier projections and that efforts to monitor supply can be time-consuming. Maintaining up-to-date information on drug availability during an outbreak, public health emergency, or drug shortage may require daily communication with suppliers, as stock levels can change rapidly. Suppliers also may face region-specific supply issues, which may make the cause of the shortage unclear.
Additionally, by working with a single supplier, any interruption in the supply chain can leave the agency at risk of a drug shortage, with existing contracts potentially prohibiting agencies from obtaining additional suppliers. Further, the unpredictable nature of disease outbreaks complicates projections.
“It just takes one outbreak with higher numbers or an MDR [multi-drug resistant TB] patient that is not predictable, not forecastable, and it blows totally out of the water any kind of stock or inventory… For TB, ultimately, the forecasting of how much meds you're going to need for the active cases or LTBI [latent TB infection] is incredibly challenging and very unpredictable.”
Policy and Program Approaches
Managing Existing Supply
It is vital for health agencies to manage existing supply through tracking, monitoring, and educating key partners, in order to address drug shortages:
Track and Monitor Inventory
Programs that have a large throughput may need to learn best practices for stock management, which can help prevent an accumulation of expired medication. Tracking inventory routinely allows health agencies to monitor drug supply in their jurisdictions, both of medications purchased by the health department as well as broader inventory availability. Health agencies can employ predictive analytics and data-driven approaches to anticipate potential shortages based on factors like demand trends, manufacturing issues, or regulatory changes. By leveraging this information, it is easier to allocate existing drug supplies, ensuring equitable distribution.
Download the Considerations for Tracking and Monitoring Inventory.
Communicate With Suppliers
For programs purchasing medication, maintaining constant communication with suppliers is essential for staying informed about drug availability. Health agencies should consider establishing daily check-ins with suppliers to get real-time updates. This continuous communication ensures that agencies are aware of sudden changes in availability and can take immediate action to secure necessary medications.
Procure Medication From Multiple Suppliers
Health agency program leadership may work with their contracts and procurement teams to ensure a thorough understanding of their agency’s processes and support necessary flexibility to contract with multiple suppliers. This may include reviewing existing or future contracts for language limiting vendors. There may also be manufacturers that offer indigent patient care programs for certain medications that health agencies may be able to leverage or direct patients to.
Explore Contracting Strategies
Health agencies may also be able to set up “framework agreements,” which outline terms for future contracts, and can improve timeliness and cost of obtaining inventory. Health agencies may establish a supplier list that is pre-approved to meet known requirements, to reference when needed.
Educate Healthcare Providers
Healthcare providers, including pharmacists, play a unique role in the supply chain as they are involved in ordering medications, managing inventory, distributing and dispensing medications, and more. In particular, providers in fast-paced clinical settings (e.g., emergency departments) may benefit from education from health agencies on disease presentation to support accurate diagnosis and encourage appropriate use of medications, such as antibiotics.
Supporting Efforts to Research Alternative Treatments
Health agency programs can support researchers by providing subject matter expertise and networks that may have an interest in weighing in on considerations for new treatment regimens. Once new medications or regimens are ready for implementation, health agencies can provide educational materials.
Enrolling in HRSA’s 340b Drug Pricing Program
If your health agency has not already, consider enrolling in HRSA’s 340B Drug Pricing Program.
Understand Program Purpose
HRSA administers the 340B Drug Pricing Program, which refers to Section 340B(a)(4) of the Public Health Service Act specifying details of the program. Entities like federally qualified health centers, those receiving section 318 funds to address STIs, and/or 317 funds to address tuberculosis are eligible to participate in the 340B drug pricing program. Participation in the 340B drug pricing program prohibits recipients from receiving duplicate discounts or rebates for medication and requires the entity be certified by HHS prior to participating. Interested entities should consult their legal counsel to determine the potential benefits and risks of joining the program.
Understand Program Benefits and Challenges
Some potential benefits of 340B cost savings include:
- Health centers that are working to address gaps in social determinants of health among the patient population by supporting family therapists and addiction counselors, or by using savings to expand care coordination and case management services, likely participate in the 340B program.
- Health centers directly pass along 340B discounts to their low-income and uninsured patients, via in-house and contract pharmacies.
While the 340B program may be beneficial to entities, there are administrative and regulatory requirements to participation that may make it challenging for a public health agency. For example, federal law prohibits entities from reselling or transferring medications to people who are not patients of a covered entity. Public health and healthcare leaders have found this restriction challenging when responding to fluctuations in medication availability, including during drug shortages. For example, if a jurisdiction accidentally over-orders a critical medication under the 340B program they would only be able to provide that medication to patients of their clinic and would not be able to transfer or share the medications to another clinic to treat patients in need.
Consider the 340B Program in the Context of Drug Shortages, Cost, and Equity
The 340B program helps qualifying healthcare providers reduce costs by providing medications at a discount, which can be critical for serving low-income and underserved populations. However, during drug shortages, providers may struggle to secure discounted medications and might have to purchase at higher prices from the open market, potentially impacting their ability to care for patients effectively.
The 340B Program requires documentation and medication tracking to ensure compliance which can be time-consuming and pose a significant challenge for covered entities. This administrative burden is compounded during drug shortages, as providers face increased complexity in managing both medication scarcity and compliance with 340B rules. These challenges can strain resources, increase the risk of non-compliance, and further impact the delivery of care to vulnerable populations. These requirements are complex. The “resources” section of this toolkit shares links to more information.
Case Examples
California Department of Public Health
CDPH manages requests for TPOXX (for treatment of mpox infection) that come in from providers via local health jurisdictions. The CDPH Warehouse team manages the stockpiled TPOXX received from ASPR at the onset of the mpox emergency response. Since the provision of TPOXX from ASPR ended, the CDPH team still manages the remaining oral TPOXX at the warehouse but preferentially points providers towards the STOMP clinical trial. CDPH refers providers and local health jurisdictions to CDC for IV TPOXX use, and serves as a stopgap with its remaining <20 doses of IV TPOXX.
Texas Department of State Health Services
The Texas Department of State Health Services prepares a weekly inventory report of TB medications available for distribution to regional and local health department TB programs. Inventory falling below established thresholds are monitored closely and prompts additional public health action such as prioritizing use of medications in limited supply.
Resources
340B Resources
- Apexus: Apexus Answers - 340B Support
- HRSA: 340B Drug Pricing Program
- NASTAD: 340B for Viral Hepatitis Programs: 340B Drug Pricing Program Guidance & Webinar Series
- NCSD: 340B Basics and Beyond
- NCSD: The ABCs of 340B: A 101 Webinar on the 340B Drug Discount Program
- NCSD: The 340B Drug Pricing Program: Frequently Asked Questions
- Medicaid.gov: 340B Drug Pricing Program
- HRSA: Sec. 340B of the Public Health Service Act
Additional Resources
- ASHP: Drug Shortage Recommendations
- ASHP: Current Drug Shortages
- ASTHO: Health Equity Policy Toolkit
- CDC: STD PCHD Funding Guidance (automatic PDF download)—page 15 shares how recipients can use funds to purchase STI medications
- FDA: Drug Shortages
- FDA: Drug Shortages | Additional News and Information
- FDA: Frequently Asked Questions about Drug Shortages
- NCSD: Bicillin Forecasting and Inventory
- HHS: Policy Considerations to Prevent Drug Shortages and Mitigate Supply
- Chain Vulnerabilities in the United States Develop and Maintain Partnerships
- HHS: Strategic National Stockpile (SNS)
- WHO: Addressing the Global Shortage of, and Access to, Medicines and Vaccines
- NASHP: State Initiatives Using Purchasing Power to Achieve Drug Cost Containment
Develop and Maintain Partnerships
Partnerships are a powerful tool to implement any policy option, regardless of disease area, and each partner has a unique role in supporting health agency needs. Agencies should analyze opportunities to leverage policy options related to HRSA’s 340B drug pricing program and other steps to address drug shortages, including through contracts and funding policies.
Leveraging Purchasing Power to Contain Drug Costs
The National Association for State Health Policy outlines two models for using purchasing power to achieve drug cost containment:
- Intrastate models: A payer approach consists of state agencies coordinating to purchase for their own programs, while a purchaser approach entails the state directly buying and dispensing drugs for facilities such as prisons. Another component of intrastate models is group purchasing organizations (GPO): entities that help agencies pool their purchasing power to obtain discounted prices. Health agency programs can use this strategy for purchasing medications so that the GPO may negotiate discounts for their members. While this may be more expensive than purchasing drugs through the 340B program, health agencies have noted greater flexibility.
- Interstate models: A payer approach includes multi-state rebate pools (e.g., the National Medicaid Pooling Initiative) that negotiate rebates from drug manufacturers. A purchaser approach includes when entities negotiate bulk discounts on behalf of various government agencies.
Developing and Accessing Mechanisms to Store Reserve Supplies
Health agencies may develop reserve supplies of medication in coordination with partners and access the reserve supply when needed. One health agency asked their pharmacist to order more medication and ended up with a small backstock that they were able to use.
Multiple state health departments are considering developing a reserve supply of pharmaceuticals managed by a commercial supplier, which aims to improve access to short-term critical care drug shortages not covered by the Strategic National Stockpile (SNS) formulary. In this structure, state health departments identify the pharmaceuticals to be managed in the reserve supply, and the wholesaler procures the selected pharmaceuticals to create a bolus within their supply chain. The states allocate funding for the additional staff and infrastructure required to manage and rotate the pharmaceuticals. Rotation of the stockpile through the wholesaler’s regular business operations minimizes waste due to expiration. States are currently examining funding options and support for these plans.
CDC’s Division of Tuberculosis Elimination manages a limited supply of anti-TB drugs in the TB Drug Stockpile. Upon availability, units of drugs can be released to TB programs when there is a national shortage (as defined by FDA) or when drugs in the stockpile are approaching the expiration date.
Understanding Health Agency Processes for Drug Procurement, Contracts, and Administration
Health agencies may explore internal procurement, or other, processes that may be available in their unique context (e.g., emergencies). It may also be helpful to use contractual language that is specific enough to fit the project constraints but broad enough as to allow for small changes, to minimize the administrative burden that accompanies an amendment.
“One of the biggest barriers to rapidly being able to respond to the drug shortage has been limitations on contracting… not to be able to be nimble and agile when you are facing... a full shortage or just the supply challenges, is a challenge for us.”
Utilizing 340B Policies to Enhance Flexibility in Program Planning for Enrolled Grantees
Under this program, there are unique policy considerations that eligible grantees may use to support flexibility in program planning to address drug shortages. These include opportunities to leverage 340B program savings, and the combined purchasing and distribution model. The benefits of reduced administrative burden, and flexibility in medication distribution support S/THAs to effectively respond to drug shortages in a timely manner.
Strategically Leverage 340B Program Savings
340B enrolled programs may experience significant cost savings. Programs can use these resources to fill service gaps in patient care as there are not the same requirements for patient-level documentations and other regulations governing spending of 340B savings. For example, programs have used 340B savings to care for uninsured patients, offer free vaccines, and provide medication management services. Notably, some state prisons purchase HIV and hepatitis B medications through the 340B program. The number of people requiring these medications is relatively small, which ensures the administrative requirements are manageable. The prison may then use the 340B savings to purchase medication for hepatitis C, which affects a much greater population, without being required to abide by stringent regulations for this larger population.
This flexibility supports an equitable, syndemic approach as entities are able to assess population needs and disparities, and implement targeted interventions to improve the health of the whole person.
Consider the Combined Purchasing and Distribution Model
Each 340B covered entity receives a unique ID by HRSA and is generally unable to share medication with other 340B providers unless HRSA grants approval. HRSA developed a process for grantees to implement a combined purchasing and distribution model where a 340B provider can be approved to purchase medication and share inventory within an established structure with other entities holding separate 340B IDs. Grantees requesting this model should consider how they would meet 340B program compliance and maintain auditable records for medications purchased.
Case Examples
Indiana Department of Health
The Indiana Department of Health (IDOH) worked with the state Medicaid program to add bedaquiline (a TB medication) to the formulary, which would have cost tens of thousands of dollars if IDOH paid full price. Indiana does not bill or ask for insurance information for TB patients. In addition, IDOH shared medication with nearby states and large cities after examining applicable regulations, and identified a special procurement request process for critical medication available with additional justification. This greatly reduced the 6-month procurement process that follows a request for proposals.
California Affordable Drug Manufacturing Act of 2020
The California Affordable Drug Manufacturing Act of 2020, known as CalRx, empowers the State of California to form partnerships to produce, procure, and distribute generic prescription drugs. CalRx’s initial project focuses on supporting the development of a biosimilar version of the three most popular insulin medications. The CalRx Biosimilar Insulin Initiative will lay the groundwork for future drug projects addressing additional medications that have become a financial burden for patients. While this type of program may not be feasible to implement in all states, collaboration between states could create a regional program or focus on single drugs.
California Intrastate Model
California utilizes an intrastate model to pool its purchasing power across all state programs to lower prescription drug costs. For some purchasing agreements, such as for condoms, local governments within California can access the state price negotiated by California’s Department of General Services. Other states may utilize an interstate model, which leverages multi-state programs such as Medicaid.
Resources
340B Resources
- HRSA: Tips and Tools for a Combined Purchasing and Distribution (CPD) Models
- HRSA: Can the receipt of in-kind contributions through section 317 or 318 of the Public Health Service Act (PHSA) qualify an entity for participation in the 340B Drug Pricing Program? What are in-kind contributions for purposes of 340B Program eligibility?
- NCSD: Demystifying 340B: What Providers Need to Know
- NCSD: Injectable Syphilis Treatment Delivery: Considerations for STD Programs
Communicate to Support Coordination
Agencies must tap into the diverse individuals, organizations, and other partners that have unique perspectives and valuable insights into coordination efforts. Partner coordination may include both internal and external partners, and range from a working group or committee to informal communications.
Communicating with Internal Partners
It is important to meet with other staff within the health department, and present information about the infectious disease program at a very foundational level. Internal partners may include other programmatic areas, as well as health agency finance or legal teams. Telling the program story with data that shows the patient impact can underscore the importance of the program and highlight challenges. Once internal partners understand the program area, it may be easier to communicate program outcomes, impacts, and needs, or the potential patient impacts from continued lack of medication access.
Communicating with External Partners
Communication with external partners may help health agencies stay informed about national perspectives and trends, share information, and more effectively collaborate with state and local partners. Health agencies may consider identifying liaisons at federal and state organizations to remain up to date on medication supply and drug shortage information.
Healthcare Providers
Health agencies play a critical role in communicating with healthcare providers, including sharing guidance. It’s important for health agencies to be familiar with available federal guidance to be able to quickly develop and disseminate communications. When providers are familiar with nuances in treatment regimens among priority populations, they can prescribe medications more effectively.
It's also important to consider social factors that may affect adherence to treatment regimens, and communicate these considerations to healthcare partners so that they can best help treat the patient. For example, a provider may need to think about if the patient is unstably housed and how they may affect adherence to a lengthy or difficult alternative treatment regimen
When medication is in short supply, health agencies have shared guidance to providers about prioritizing the medication for populations that are at increased risk for infections or severe disease.
“We often prioritize infectious TB over latent TB, because infectious TB is transmissible and that person has disease. But we don't want it to be an either-or, because every person with latent TB infection has some risk to go on to develop active disease.”
Additionally, evidence should inform any public health program, and so it’s important for health departments to have an up-to-date understanding of how disease epidemiology looks within their community. Demographic changes incidence may inform outreach strategies and information shared.
Correctional Facilities
Correctional facilities have an increased infectious disease burden, and there are opportunities for testing and treatment. The high-throughput, entrance, release, and return pattern of priority populations in correctional facilities serves as a unique opportunity to reach those most impacted through maintaining health agency partnerships.
Medicaid
Medicaid programs may be able to help ensure priority medications are covered in their formulary. Making critical medications more affordable for priority populations can help to mitigate the inequitable effects of drug shortages.
Pharmacies
Pharmacies have oversight on parts of drug procurement that clinicians and health departments do not typically see. Pharmacies may also be able to share stock among one another.
National Partners
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 able to weigh in on related topic areas.
Some health agencies utilize the National Tuberculosis Coalition of America (NTCA) to support communications around TB drug shortages and other medication availability challenges. NTCA has supported its members, including S/THA staff, with accessing medication that is about to expire and communicating TB drug price and availability changes. Learn more about partnerships to address medication availability in ASTHOBlog “Partnering to Increase Access to Tuberculosis Medications.”
“On the national level, I think programs are informed by the NTCA reporting of drug shortages, which is real-time.”
Additionally, the National Coalition of STD Directors offers resources that may be helpful for health agencies addressing STI treatment shortages, including several throughout this toolkit.
Other Non-Profit Organizations
Health agencies can direct nonprofit clinics, charitable pharmacies and health centers to non-profit organizations which may be able to offer support. For example, the Direct Relief ReplenishRx program may support smaller, short-term drug shortages through ensuring safety net providers have a consistent supply of medicines donated by leading biotechnology, pharmaceutical, and healthcare companies for eligible patients.
Case Examples
California Department of Public Health (CDPH)
CDPH’s TB program established a network of local health jurisdictions to monitor price and availability among major distributors. When a local health jurisdiction identifies and shares an issue of concern with the program liaison, the program liaison can take additional action (e.g., contacting the manufacturer directly to obtain a drop shipment or attempting to troubleshoot the issue). The state program also shared surveys to understand which distributors programs are purchasing from to determine distributor-specific issues.
CDPH released a Health Advisory to alert healthcare providers of the Bicillin® L-A (Benzathine Penicillin G) shortage. This Health Alert included clinical guidelines for the prioritization and conservation of shortage drugs, and alternative treatment options.
California TB Controllers Association
The California TB Controllers Association utilizes a working group that has representation from jurisdictions across the state in addition to state health agency staff. This working group has been helpful for health agency staff to monitor and communicate between programs when actionable information becomes available. CDPH staff also described a medical mutual aid system for sharing, supplies, medication, and information among local and regional level organizations.
Texas Department of State Health Services
Texas Department of State Health Services created and updates the TB Medication Availability Notice, which provides clinical guidance and alternative regimens for medications in limited supply.
Resources
Partner Coordination Resources
- ASTHO: Partnering to Increase Access to Tuberculosis Medications
- CDC: Availability of STI Testing and Treatment Products
- CDC: Clinical Testing Guidance for Tuberculosis: Health Care Personnel
- CDC: Latent Tuberculosis Infection: A Guide for Primary Health Care Providers
- CDC: Sexually Transmitted Infections Treatment Guidelines, 2021
- CDC: Tuberculosis Drug Supply Interruptions and Shortages
- CDC: TB Clinical Guidelines
Policy Menus
Tables 1, 2, and 3 detail some of the policy options (broken up by the content areas of this toolkit) available to S/THA leadership, S/THA programs offering clinical services, and those that are 340B-enrolled to address drug shortages. These are not exhaustive lists but rather a starting place for improving access to critical medications, like those to treat STIs and TB.
| Theme | Policy Option | S/THA Programs Specified |
|---|---|---|
| Prepare | Collect data from providers and pharmacies around medication distribution to better understand impact of treatment efforts. | |
| Prepare | Evaluate and improve of inventory management practices. | |
| Prepare | Educate healthcare providers about disease presentation to support accurate diagnoses and disease staging, and encourage appropriate use of medications, especially in fast-paced clinical settings. | |
| Partner | Ensure accuracy of surveillance data and communicate trends with affected communities. | TB |
| Partner | Access national stockpiles, such as the one maintained by CDC's Division of TB Elimination. | TB |
| Partner | Partner with correctional facilities to facilitate testing for syphilis, HIV, TB, and viral hepatitis upon entry and exit from correctional facilities. Health agencies may also partner with correctional facilities to support contingency planning. | TB, STI |
| Partner | Connect pharmacies experiencing shortages with alternative suppliers. | |
| Partner | Collaborate with other states' programs to leverage expertise and established systems. | |
| Communicate | Assess demographic changes in disease incidence, and communicate findings to key parties to ensure treatment is provided equitably. | |
| Communicate | Share guidance with healthcare providers in line with CDC's STI Treatment Guidance. | STI |
| Communicate | Share guidance with healthcare providers to prioritize treatment of individuals with infectious TB over those with latent TB. | TB |
| Communicate | Increase communication with pharmacy distribution centers to remain informed. | |
| Communicate | Engage with program leadership outside of disease area within the health department to share best practices and identify areas for collaboration and enhanced coordination. | |
| Communicate | Communicate with healthcare providers about medication availability. | |
| Communicate | Communicate with federal contacts about medication availability and associated challenges. | |
| Communicate | Develop a network of local health partners to support monitoring of medication availability and cost among various distributors. S/THAs may collect information from local health partners to better understand root causes, as well as share information among local health departments to support coordination. | |
| Communicate | Develop a state-level working group of infectious disease public health and healthcare professionals. This may support streamlined communications and coordination between pharmacies, state authorities, and the CDC to expedite the delivery of essential medications. | |
| Communicate | Communicate with health department general counsel and other policymakers to better understand, and overcome, challenges and ensure program compliance with applicable regulations. | |
| Communicate | Work with Medicaid to have priority medications added to the formulary. | |
| Communicate | Educate providers about factors that may impact adherence to treatment regimens and strategies to minimize nonadherence. |
| Theme | Policy Option | S/THA Programs Specified |
|---|---|---|
| Prepare | Increase staff time dedicated to ordering, monitoring, and allocating drug stock. | |
| Partner | Use PCHD funds to purchase and dispense STI medications as per page 15 of PCHD Notice of Funding (automatic PDF download) | STI |
| Partner | Provide billing staff guidance for appropriate diagnosis, procedure, and medication codes to support accurate charging. | |
| Partner | Work with other jurisdictions to identify strategies for medication transfer. This may include developing a medical mutual aid system, and communicating with regional and local medical systems and developing a resource request process. | |
| Partner | Develop and implement protocols for establishing reserve supplies. | |
| Partner | Diversify contracts with suppliers to mitigate risk of limited suppliers. | |
| Partner | Diversify contracts with manufacturers to mitigate risk of limited manufacturers. | |
| Partner | Explore opportunities to partner with retail pharmacies (i.e., Walgreens, CVS) to support flexibility in medication distribution. |
| Theme | Policy Option | Considerations |
|---|---|---|
| Prepare | Understand the health agency's drug procurement practices, particularly through programs such as 340B or state drug assistance programs. | Health agency staff may benefit from understanding program eligibility and compliance regulations from relevant programs supporting drug access, including HRSA's 340B drug pricing program and the jurisdiction's disease-specific drug assistance programs. By understanding and following applicable regulations, program enrollees can prevent potential penalties or lapses in coverage. |
| Prepare | Enroll in 340B program to purchase medication at a discounted rate. | The choice of a eligible program to enroll in HRSA's 340B program is dependent on the unique factors of that program. The program offers substantial savings on drug costs, which programs are able to use to address community needs. On the other hand, some programs find the administrative components of the program to be overwhelming, including 340B documentation requirements and limitations on drug sharing. |
| Partner | Under the 340B program, use the combined purchasing and distribution model for drug purchasing due to flexibilities in supply distribution. | Under this model, entities such as an eligible state grantee may purchase a drug, and then provide that drug to other entities, such as locals, nonprofits, and other partnering organizations. There is an approval process to participate in this strategy, and this model may not be feasible in every jurisdiction. 340B-covered entities are responsible for preventing diversion of 340B medications to ineligible patients, which may be resource-intensive with a centralized purchasing and distribution model. |
| Partner | As financially viable, purchase mediation outside of 340B program at full price to support administrative flexibilities, such as transferring the medication. | If administrative barriers offset the benefits of participating in the 340B program, health agency programs may choose to purchase medications outside of the program. |
| Partner | Strategically leverage 340B program savings to increase administrative flexibility in medication administration. | Leverage 340B savings to purchase medications that can be distributed, without the same requirements for patient-level documentation and auditable records-keeping. This method supports flexibility in medication purchasing and distribution. |
Review your action plan. Are there policy options where you’d like additional information or support? Contact ask@astho.org to request technical assistance.
Thank you to health agency staff, partners, and committees who contributed to this toolkit including ASTHO’s Infectious Disease Policy Committee and Public Health Preparedness Policy Committee; CDC; California Department of Public Health, Indiana Department of Health, Massachusetts Department of Public Health, Missouri Department of Health and Senior Services, and Texas Department of State Health Services; and National Coalition of STD Directors and National TB Coalition of America.
This project is supported by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award (NOFO OT18-1802, titled Strengthening Public Health Systems and Services through National Partnerships to Improve and Protect the Nation’s Health) totaling $205,000 with 100 percent funded by CDC/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, CDC/HHS or the U.S. Government.