These results describe the data obtained from LHD staff through the web-based survey.
Sixty-one LHDs were invited to participate in this study. Forty-four local health departments completed the survey, resulting in a 72% response rate. These counties represent 74% of the population of California. Participating agencies did not statistically differ from non-participating agencies with respect to the size of population served by the health department (chi-square with two degrees of freedom = 5.64, p
= 0.35) or median household income (t = 0, p
= 0.60). There was a borderline significant difference in the geographic distribution of responding counties (chi-square with two degrees of freedom = 5.64, p
= 0.06), with the lowest participation in the southern region (46%) compared to the inland region (81%) and the coastal region (76%) [16
The most widely represented functional role for respondents was SNS coordinators, with 55% identifying themselves as such. Other common functional roles were Emergency Preparedness Coordinator/Director and Health Officer with 25% and 27%, respectively (respondents could choose more than one functional role). Ninety eight percent of respondents stated that they were very knowledgeable about their LHD's antiviral activities during 2009 H1N1 response and 2% reported being somewhat knowledgeable about their LHD's response. Survey respondents who indicated that they knew only "a little" about their LHD's antiviral response were not allowed to complete the survey. Two respondents fell into this category and were not included in the overall response rate.
Acquiring, distributing and allocating antivirals
All LHDs received antivirals from state or federal stockpiles, with a few LHDs receiving antivirals from a local cache or purchasing antivirals directly from the commercial or retail market as well. In this report, those antivirals purchased by state or federal government agencies for public use will be referred to as "publicly purchased antivirals" or "state and federal stockpiles."
Twenty-eight LHDs reported distributing publicly purchased antivirals to other organizations for dispensing to the public, which accounts for 64% of respondents. The organizations and agencies that received antiviral drugs from LHDs are presented in Table . Among those most frequently cited were clinics, hospitals, and pharmacies (71%, 64%, and 54%, respectively). While many LHDs distributed antivirals to hospitals, others found that hospital pharmacies were unable to accept publicly purchased antivirals, as described by one participant,
Number of LHDs that distributed antivirals to other organizations for dispensing to public (n = 28).
"We contracted with [chain retail pharmacy] for this service since hospitals could not accept public antivirals into their pharmacies."
Receiving organizations classified under "Other" include HIV care providers, addiction programs, homeless centers and children's homes.
LHDs selected organizations to dispense publicly purchased antivirals for the following reasons: to reach the uninsured or underinsured (89%), to reach severely ill persons (61%), to reach medically at-risk persons such as pregnant women (57%), and/or because the organization was well-known in the community (61%). LHDs also noted that dispensing sites were chosen based on storage capacity or the ability of a pharmacy to correctly reconstitute antiviral suspension for children.
The number of antivirals allocated to these dispensing sites was determined based on the characteristics of the patient population served (41%), requests for antivirals (37%), number of persons served by a medical or treatment facility (33%), and/or epidemiologic data and patient volume (26%).
Eight of the 28 LHDs that distributed antivirals to other organizations for dispensing to the public reported that they required facilities to show that antivirals were not commercially available before they could receive publicly purchased antivirals (28%). This strategy was based on the rationale that publicly purchased antivirals should be used only as a last resort after the commercial and retail markets had been depleted.
Antiviral dispensing, use and shortages
Thirty-one LHDs reported that publicly purchased antivirals were dispensed for patient use in their jurisdiction (70%). Of these LHDs, approximately 90% dispensed fewer than 250 doses of antivirals (ranging from less than 100 doses to more than 10,000 doses). On average, the reported number of antiviral doses dispensed in a community increased with population size. For small LHDs serving fewer than 50,000 residents, the modal number of antiviral doses dispensed was 0 doses (ranging from 0 to 250 doses); for medium LHDs serving a population of 50,000-499,999, the modal number of antiviral doses dispensed was less than 250 doses (ranging from 0 to 1,000 doses); and for large LHDs serving a population of 500,000 and more, the modal number was less than 250 doses (ranging from 0 to more than 10,000 doses). For those LHDs reporting that publicly stockpiled antivirals were not dispensed in their jurisdiction, many reported that they had few influenza cases and demand for antivirals was low. Others indicated that their strategy was to use publicly purchased antivirals when shortages were reported in the local commercial market, which did not occur in their communities.
All LHDs that distributed publicly purchased antivirals to dispensing sites required those organizations to agree to certain terms of dispensing. Eighty six percent of these 28 LHDs required dispensing sites to track antiviral utilization and report it to the health department. Providing antivirals free of charge to the uninsured or underinsured and providing antivirals free of charge to all were required by 61% and 50% of these LHDs, respectively. Other requirements noted by respondents included: returning unused antivirals to the LHD, following current recommendations for use, requesting documentation from recipients to ensure eligibility, and the use of temperature-controlled storage.
Potential uses of antiviral drugs include treatment, pre-exposure prophylaxis, and post-exposure prophylaxis. LHDs were asked about allowable uses for publicly purchased antivirals in their community and the target groups for each allowable use (Tables , and ). In addition to the target groups presented in Tables 3 and 4, several LHDs further specified that restrictions on populations eligible for publicly purchased antivirals for treatment were lifted when antivirals were not commercially available. Regarding prophylaxis, LHDs noted that publicly purchased antivirals were dispensed to uninsured or underinsured persons, children, and household members of ill persons early in the pandemic in order to slow transmission of the virus.
Allowable uses for publicly purchased antivirals (n = 31).
Target groups for treatment with publicly purchased antivirals (n = 28).
Target groups for prophylaxis with publicly purchased antivirals (n = 25).
In order to determine eligibility to receive publicly purchased antivirals, 24 of the 31 LHDs reporting that publicly purchased antivirals were dispensed for patient use in their jurisdiction instituted verification procedures. Fifty four percent of theses LHDs reported using pharmacists or dispensing sites to determine eligibility status, 46% reported that physicians provided proof of eligibility, and 25% indicated that patients self-reported their eligibility status. Six LHDs did not require any eligibility verification.
Among all LHD respondents, 26 indicated that their communities experienced shortages of at least one type of antiviral drug (60%). Shortages were primarily of pediatric formulation of oseltamivir, followed by adult formulation of oseltamivir (reported by 96% and 38% of LHDs with shortages, respectively). No shortages of zanamivir or peramivir were reported.
Antiviral tracking and monitoring
LHDs were asked about their ability to track the movement of antivirals from stockpile sites to recipients. Of the 28 health departments that distributed antivirals, nearly all were able to track the federal/state stockpile to their health department (93%), and from the health department to dispensing sites (100%). Most LHDs were able to track from dispensing sites to recipients (71%).
Twenty-four LHDs received antiviral utilization data from dispensing sites with varying degrees of frequency. Half of these LHDs received antiviral utilization reports weekly or more frequently. Some health departments received basic utilization data, such as number of courses dispensed or lot numbers, while others received more specific data, including demographic information, intended use of antivirals (e.g. treatment, PEP), or reason that public stockpiles were utilized (e.g. shortages, uninsured recipient). These data were primarily used for making allocation decisions, surveillance, future antiviral planning, reaching target populations, and providing data to other agencies. Utilization data were received primarily by fax, but also by email, phone calls, face-to-face meetings, and mail.
The most common mechanisms LHDs used for communicating with other organizations participating in the antiviral response were to following: email (56%), blast-fax (53%), phone (49%), and in-person/face-to-face meetings (42%). Other commonly cited communications mechanisms were teleconference (33%), websites (30%), and the California Health Alert Network, known as CAHAN (21%). The remaining LHDs indicated that communication with other agencies around antivirals did not occur in their jurisdiction or was not applicable to their health department's response.
LHDs also used various mechanisms to inform the public about where eligible persons could obtain antivirals. Around half of LHDs indicated that the health department (57%) or the clinician (45%) were the source of information for these individuals. Others relied on pharmacists (32%), the media (16%), or employers (7%). The remaining LHDs did not communicate with the public because they perceived antiviral need to be low.
Only six LHDs found that there were stakeholder groups with whom they had to establish communications for the antiviral response that had not been originally planned. These stakeholder groups included: smaller clinics, retail pharmacies, certain minority populations, community clinics, local school districts, community based organizations, state correctional facilities, and indigent populations.
Antiviral challenges for LHDs
LHDs were asked about antiviral challenges faced and feedback received during the H1N1 influenza response. In terms of challenges, LHDs were asked to identify issues that were problematic early and later during the pandemic response. "Early" was defined as April to June 2009 and "Later" was defined as July 2009 onward. These challenges are presented in Figure .
Figure 1 Antiviral challenges reported by Local Health Departments, by time period (n = 44). Proportion of LHDs reporting each antiviral challenge, by time period (April to June 2009 and June 2009 onward). Among those LHDs reporting a challenge, those issues reported (more ...)
Changes in antiviral guidance and multiple sources of information about antivirals presented a serious challenge to LHDs. This was the most widely cited issue both early and late in the pandemic, and was described as 'very challenging' by more than a third of health departments. One LHD noted, "Changing guidance made it difficult to determine appropriate recipients." Other participants indicated that state and federal antiviral guidance during H1N1 differed from what they had anticipated, particularly with respect to the target population for stockpiled antivirals. This discrepancy required their health departments to revise their planned activities to support this strategy. As several respondents indicated,
"The drugs from the SNS were originally intended to [be] used only when the drugs were no longer available through the commercial market. During the H1N1 epidemic the state required that we make the drugs available to people who were unable to afford the meds."
"The state's late decision to make the SNS antivirals available on a compassionate basis...created a great deal of trouble for my department."
"....had this event been more widespread, guidance from the state could have caused considerable issues related to the first responder community."
Shortages of pediatric antivirals and staffing issues also remained significant challenges for LHDs throughout the pandemic. The staffing issues were highlighted by one respondent,
"H1N1 served as a 'dry run' for a more severe pandemic. Had we been faced with the need to distribute antiviral drugs to multiple health care and other venues, to a large percentage of our population, over a prolonged period of time, we would have been severely challenged to do so in a secure, accountable, consistent, and equitable manner. Given decreasing public health resources, I do not foresee an improvement in our capacity to do this anytime in the near future."
Early in the pandemic, the main challenges centered on ramping up response efforts, such as: determining uses and target groups for antivirals, ascertaining information about antiviral availability in the commercial market, finding temperature-appropriate storage, and managing confusion about the use of public versus private stockpile antivirals. All challenges were cited less frequently during the later time period, with the exception of relabeling antivirals, which was mentioned twice as frequently in the later time period.
For those LHDs experiencing each challenge, the issues most likely to be reported as 'very challenging' were staffing and personnel issues, changing antiviral guidance and multiple sources of information, and administrative hurdles (these "very challenging" issues are marked with an asterisk in Figure ). An example of the type of administrative hurdles faced by LHDs was illustrated by one respondent,
"We [the LHD] were advised [by the county] ...that the county would need to consider rapid purchase of antivirals for protection of essential county workers and possibly health care workers. We were asked to develop a special agreement to have local pharmacies make the purchase investment and guarantee them employee utilization and billing of insurance. At the start of the pandemic, this additional administrative task to avoid a sizeable county expenditure in antivirals for ongoing prophylaxis was an added task for our small health department."
Feedback from community partners
LHDs reported receiving negative feedback from community partners regarding a number of issues related to antivirals (Table ). The most frequently mentioned issues centered on confusion around appropriate uses and target groups for antivirals and especially publicly purchased antivirals.
Negative feedback received by LHDs from community partners (n = 44)
Private clinicians and hospital/healthcare facilities were the most frequently cited sources of negative feedback, reported by 30% and 16% of LHDs respectively. LHDs that received negative feedback from these entities commonly also reported negative feedback in the following areas: confusion regarding clinical guidance for antiviral use, dissatisfaction regarding which patients should receive publicly purchased antivirals, and confusion regarding the use of the public versus private sources of antivirals. Medium sized health departments (those serving populations between 50,000-499,999 persons) were more likely to report hearing negative feedback regarding antiviral availability (Fisher's Exact test, p < 0.05).
Only five LHDs reported difficulties or concerns in providing antivirals to specific populations. The populations noted by respondents included homeless/transient populations, undocumented persons, and pregnant women. One respondent described how reimbursement issues in Medi-Cal (California's state Medicaid insurance program for the poor and underserved) made it difficult to reach pregnant women early in the pandemic,
"...We had issues in the beginning with Medi-Cal patients namely pregnant women that did not get access to the stockpiled antivirals because Medi-Cal took so long to change their formulary and a communication (or other) issue related to getting the women to a location with the antivirals existed. This was remedied when Medi-Cal changed their formulary."
LHDs also noted positive experiences working with the state health departments, including,
"The antiviral acquisition, allocation, distribution, and dispensing was probably the smoothest [part of the] response during the H1N1 campaign. State did a great job getting them out to the LHD's as well as retrieving them."