Dispensing Book 1

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Under section 564A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA may allow emergency dispensing (including mass dispensing at a point of dispensing (POD)) of approved MCMs during an actual CBRN emergency, without requiring an individual prescription for each recipient of the MCM, if (1) permitted by state law or (2) in accordance with an order issued by FDA.

Emergency dispensing orders issued by FDA also may include waivers of Current Good Manufacturing Practice (CGMP) requirements, when appropriate. Section 564A(c) of the FD&C Act permits FDA to waive otherwise applicable CGMP requirements, such as storage or handling, to accommodate emergency response needs. In addition, when feasible, FDA and the Centers for Disease Control and Prevention (CDC) will coordinate issuance of an emergency dispensing order and Emergency Use Instructions (EUI) for an MCM.

Note: The issuance of the Doxycycline Emergency Dispensing Order and Doxycycline Emergency Use Instructions (EUI) replace the need for an Emergency Use Authorization (EUA) for doxycycline mass dispensing for post-exposure prophylaxis (PEP) of inhalational anthrax.

Note: The issuance of the Ciprofloxacin Emergency Dispensing Order and Ciprofloxacin EUI replace the need for an EUA for ciprofloxacin mass dispensing for post-exposure prophylaxis (PEP) of inhalational anthrax.

The EUI authority allows CDC to facilitate the availability of streamlined information about the use of eligible, approved MCMs needed during public health emergencies without FDA needing to issue an Emergency Use Authorization.

Under section 564A(e) of the FD&C Act, CDC may create and issue, and government stakeholders may disseminate, EUI (also referred to as fact sheets for recipients of an MCM and for health care professionals) about the FDA-approved conditions of use for such MCMs before or during a CBRN event. When feasible, FDA and CDC will coordinate issuance of an emergency dispensing order and EUI for an MCM. To facilitate creation of EUI, FDA and CDC entered into a Memorandum of Understanding. The HHS Secretary delegated the EUI authority to the Director of CDC in 2013.

Despite the increase in the number of oral antivirals dispensed during the study period, population-adjusted dispensing rates in high-vulnerability zip codes were substantially lower than those in medium- and low-vulnerability zip codes, even though high-vulnerability zip codes had the most dispensing sites. Oral antivirals, particularly Paxlovid, provide an essential tool that can prevent hospitalization and death from COVID-19 (5). The findings in this report highlight an ongoing need to identify and eliminate barriers to oral antiviral access, particularly within socially and economically disadvantaged communities.

1CDC COVID-19 Emergency Response Team; 2Palantir Technologies, Palo Alto, California; 3Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, Washington, DC.

* The week ending December 25, 2021, is not shown because no oral antiviral dispensing was reported during that week. Zip codes were classified as having low, medium, or high social vulnerability based on ranking within the lower, middle, and upper tertiles of the Equitable Distribution Index score.

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Naloxone dispensing from retail pharmacies increased from 2012 to 2018, with substantial increases in recent years. Despite increases, in 2018, only one naloxone prescription was dispensed for every 69 high-dose opioid prescriptions. The lowest rates of naloxone dispensing were observed in the most rural counties.

Additional efforts are needed to improve naloxone access at the local level, including prescribing and pharmacy dispensing. Distribution of naloxone is a critical component of the public health response to the opioid overdose epidemic.

Results: The number of naloxone prescriptions dispensed from retail pharmacies increased substantially from 2012 to 2018, including a 106% increase from 2017 to 2018 alone. Nationally, in 2018, one naloxone prescription was dispensed for every 69 high-dose opioid prescriptions. Substantial regional variation in naloxone dispensing was found, including a twenty-fivefold variation across counties, with lowest rates in the most rural counties. A wide variation was also noted by prescriber specialty. Compared with naloxone prescriptions paid for with Medicaid and commercial insurance, a larger percentage of prescriptions paid for with Medicare required out-of-pocket costs.

Conclusion: Despite substantial increases in naloxone dispensing, the rate of naloxone prescriptions dispensed per high-dose opioid prescription remains low, and overall naloxone dispensing varies substantially across the country. Naloxone distribution is an important component of the public health response to the opioid overdose epidemic. Health care providers can prescribe or dispense naloxone when overdose risk factors are present and counsel patients on how to use it. Efforts to improve naloxone access and distribution work most effectively with efforts to improve opioid prescribing, implement other harm-reduction strategies, promote linkage to medications for opioid use disorder treatment, and enhance public health and public safety partnerships.

For decades, emergency medical service (EMS) providers, first responders, and emergency department clinicians have administered naloxone in cases of suspected drug overdose, and community-based organizations have offered naloxone through education and distribution programs. Recent efforts have focused on expanding naloxone access through clinician prescribing and pharmacy dispensing. All 50 states and the District of Columbia have enacted laws permitting pharmacy-based naloxone dispensing (6). Laws allowing providers to prescribe naloxone to any persons in a position to assist another with an overdose (i.e., third-party prescriptions) and standing orders for pharmacists to dispense naloxone have been associated with increases in naloxone dispensing from retail pharmacies (7). Several states have mandated that clinicians coprescribe naloxone when overdose risk factors (e.g., high opioid dosages) are present, a recommendation for consideration in the CDC Guideline for Prescribing Opioids for Chronic Pain (4); such laws have been associated with substantial increases in naloxone dispensing (8). Many of these states have only recently implemented these laws; thus, sufficient time has not passed to examine their full impact at the state or county level.

Recent analyses examining the extent and characteristics of pharmacy-based naloxone dispensing are lacking. Also unknown is the extent to which naloxone dispensing varies by county and by other factors (e.g., prescriber specialty and patient insurance coverage). Understanding variation could help identify the need for tailored approaches to improve prescribing and dispensing, similar to those that have been indicated for opioid prescribing (9). To address this gap and to inform future overdose prevention and response efforts, CDC examined trends in, and characteristics of, naloxone dispensing from retail pharmacies at the national and county levels in the United States.

Data on naloxone dispensing came from IQVIA, which maintains information on prescriptions from approximately 50,400 retail pharmacies, representing 92% of all prescriptions in the United States. Changes in naloxone dispensing from 2012 to 2018 were examined nationally, by U.S. Census region, and by county urban/rural status (i.e., metropolitan, micropolitan, and rural) (10). Annual dispensing rates were calculated by dividing the number of naloxone prescriptions by U.S. Census population estimates per 100,000 persons. CDC analyzed naloxone dispensing in 2018 by age group, sex, out-of-pocket costs, and method of payment.

Across U.S. counties, the rate of naloxone prescriptions dispensed varied substantially, from an average of 16.2 per 100,000 population in the lowest quartile to 410.0 in the highest quartile (Figure). The rate of naloxone prescriptions per 100 high-dose opioid prescriptions also varied across counties, from an average of 0.2 in the lowest quartile to 2.9 in the highest quartile (Figure). In 2018, the rate of naloxone prescriptions per 100 high-dose opioid prescriptions ranged from 1.5 in metropolitan counties and 1.6 in the Northeast to 1.2 in rural counties and 1.3 in the Midwest; the largest increase in 2018 was in the Midwest (Table 2). In 2018, 236 counties (8.3% of counties with available data), dispensed high-dose opioid prescriptions but did not dispense any naloxone prescriptions.

After adjusting for all county characteristics in the multivariable logistic regression models, high naloxone-dispensing counties had higher high-dose opioid dispensing rates, higher drug overdose deaths rates, higher potential buprenorphine treatment capacity, lower percentages of non-Hispanic white residents, higher disability prevalence, and higher rates of Medicaid enrollment (Table 3). Compared with metropolitan counties, micropolitan and rural counties had lower odds of being a high-dispensing county.

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