Published online October 1, 2008
PEDIATRICS
Vol. 122
No. 4
October 2008, pp.
e835-e840
(doi:10.1542/peds.2008-1092)
Temporary Vaccine Recommendations and Provider Compliance: A Survey of Pediatric Practices During the 2003–2004 Pneumococcal Conjugate Vaccine Shortage
Holly Groom, MPH,
Achal Bhatt, PhD,
Michael L. Washington, PhD and
Jeanne Santoli, MD
Immunization Services Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
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ABSTRACT
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OBJECTIVE. Heptavalent pneumococcal conjugate vaccine was in short supply from December 2003 to August 2004. The Centers for Disease Control and Prevention with the American Academy of Pediatrics and the American Academy of Family Physicians made recommendations to providers to withhold third and fourth doses of heptavalent pneumococcal conjugate vaccine to ensure availability for those at highest risk. Previous studies of vaccine shortages have demonstrated that provider compliance with temporary recommendations is low. The objective of this study was to collect timely data about awareness and adherence to temporary recommendations and current supply status of heptavalent pneumococcal conjugate vaccine in pediatric practices.
METHODS. A 2-phase telephone survey of pediatric practices was conducted during a 10-week period during the 2003–2004 heptavalent pneumococcal conjugate vaccine shortage. Immunization nurses at randomly selected sites with physician-members of the American Academy of Pediatrics were asked a series of questions.
RESULTS. In both study phases, >90% of participating practices were aware of the recommendations and reported adhering to the recommendations. In phase 1, practices with insufficient supply were more likely to implement recommendations than practices with sufficient supply. Participants identified health departments and Wyeth Vaccines as the most common sources of information. At least 65% of the practices in each phase reported use of tracking systems for children who missed doses.
CONCLUSIONS. Most pediatric practices surveyed were aware of the shortage and were implementing the heptavalent pneumococcal conjugate vaccine recommendations. Simplified recommendations and collaborative efforts to develop and widely disseminate interim recommendations may result in increased compliance by providers.
Key Words: immunization • compliance • pneumococcal conjugate vaccine • shortage
Abbreviations: CDC—Centers for Disease Control and Prevention • AAP—American Academy of Pediatrics • PCV7—heptavalent pneumococcal conjugate vaccine • DTaP—diphtheria-tetanus-acellular pertussis
National-level vaccine shortages have been a challenge for parents, health care providers, and public health agencies in recent years. Since 2000, 7 vaccines recommended by the Advisory Committee on Immunization Practices as part of the routine schedule for children and adolescents experienced short supply, causing delays in up-to-date status for many age-eligible children and teens.1–3 To help providers prioritize limited vaccine supplies, the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians work together to develop temporary, revised vaccination recommendations to target vaccines toward populations at highest risk for disease.
Because the duration and severity of shortages is difficult to predict, recommendations have been released in phased and oftentimes complex formats. Previous studies that assessed provider compliance with the temporary recommendations that were in place during the 2001–2003 heptavalent pneumococcal conjugate vaccine (PCV7) shortage have shown variable compliance. Stokley et al4 reported that 29% of providers implemented the revised recommendations, whereas Broder et al1 found that, contrary to the recommendations, 49% of pediatricians were administering the fourth dose of PCV7 to healthy children, and Fairbrother et al5 reported 62% compliance with the recommendation to withhold the fourth dose of PCV7 for healthy children. Meanwhile, Stokley et al4 found that 16% of providers complied with the temporary diphtheria-tetanus-acellular pertussis (DTaP) recommendations issued in 2001, and Zun et al6 found that, during the tetanus-diphtheria shortage of 2001, 88% of surveyed emergency department medical directors were aware of temporary recommendations but <2% were able to outline correctly the temporary prioritization plan. These studies demonstrate that temporary recommendations have had limited impact on prioritization of existing vaccine supplies.
In response to the PCV7 shortage that occurred from December 2003 through September 2004, specific efforts were made to increase compliance among health care professionals. These efforts included (1) simplification of the temporary recommendations, (2) timely release of recommendations, (3) collaboration with key partners with frequent communication and information-sharing, and (4) provision of data that supported the temporary recommendations (eg, information on the efficacy of a reduced schedule).
As a result of these efforts, the CDC released a series of 5 notices about the PCV7 supply situation between December 2003 and September 2004. The first notice, from December 2003, warned providers that a limited supply was anticipated.7 The second and third notices, published in February and March 2004, recommended that health care providers temporarily suspend routine use of the fourth dose and third dose, respectively, among healthy children to conserve vaccine. These notices also included information on the short-term efficacy of receiving 2 and 3 doses of the vaccine.8,9 The fourth notice, published in July 2004, recommended reinstatement of the third dose of vaccine to healthy children,10 and the fifth notice, from September 2004, announced that the vaccine shortage was resolved and to reinstate the routine schedule.11 The third, fourth, and fifth notices recommended use of systems to track children who had missed doses of the vaccine series and to notify them once the vaccine shortage resolved (Table 1).
In addition to publishing the temporary recommendations, the CDC worked closely with state and city health department immunization programs to get the updated information passed on to practices in an efficient manner. The AAP, the American Academy of Family Physicians, and Wyeth Vaccines also disseminated the recommendations directly to pediatric practices.
Given the CDC's role of crafting and disseminating temporary vaccine recommendations for providers during times of limited vaccine supply, studies that measure the adoption of recommendations provide critical feedback to improve the management of future shortages. The objectives of this study, therefore, were to examine provider experiences with PCV7 during the 2003–2004 shortage and to determine provider compliance with the temporary recommendations. These data can assist the CDC in understanding whether efforts to improve on the content and dissemination of PCV7 temporary recommendations were effective in increasing implementation.
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METHODS
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This study was reviewed by the human subjects coordinator at the CDC and was determined to be exempt from institutional review board review. We conducted a national, cross-sectional, 2-phase telephone survey of pediatric practices. To expedite the survey, we randomly sampled physician-members of the AAP from a printed list, published in 2001. Phase 1 was conducted over 7 weeks (March 9 to April 27, 2004) when the recommendation was to withhold the third and fourth doses of PCV7 for healthy children. Phase 2 was conducted over 3 weeks (August 2–24, 2004) when the recommendation was modified to reinstate the third dose but continue deferring the fourth dose of PCV7 for healthy children. Different practices were contacted during phase 1 and phase 2 of the survey.
Eligible respondents included unique practices in the United States where a physician-member of the AAP was actively delivering primary care. Practices were defined as ineligible in the study when the sampled physician-member of the AAP was not practicing at the site; the practice was not routinely administering vaccines, including PCV7, to children who were younger than 5 years; or the contact information of the physician-member could not be verified. Practices were considered to have unknown eligibility when the listed telephone number was incorrect or disconnected with no updated information available, there was no answer after at least 5 contact attempts, no information was provided for the physician-member, or the telephone number listed was a home number. Follow-up was done on practices with outdated contact information through various Internet search engines.
The survey was administered to the clinician who was most knowledgeable about vaccine delivery in the practice and took approximately 5 minutes to complete. The phase 1 survey instrument included 19 questions related to practice demographics, how the practice was made aware of the PCV7 recommendations, whether the practice was implementing current recommendations, the current status of the PCV7 supply, and whether limited supplies had affected the practice's ability to administer the recommended doses of PCV7. Vaccine supply was characterized as sufficient when the practice had enough vaccine to administer at least 3 doses of PCV7 to each healthy child from both their public and private vaccine supplies and insufficient when the practice was not able to administer at least 3 doses of the PCV7 to all children from either their public or private vaccine supply. A severe vaccine-supply limitation was defined as needing to defer the first or second dose of PCV7 to any child. In addition, providers were asked whether a tracking system was being used to document children who had missed any doses of the PCV7 series (this question was added to the survey on March 23, 2004, 2 weeks after phase 1 began). During phase 2, in addition to asking whether the practice had followed the initial recommendation to withhold the third and fourth doses, a question was added to determine whether the practice had adopted the modified recommendation to reinstate the third dose but to continue deferring the fourth dose.
The data were clean and analyzed by using SAS 9.1 (SAS Institute, Inc, Cary, NC). Questions with missing and "don't know" responses were excluded from analysis. Descriptive statistics were calculated to obtain general information about providers, and 
2 tests for significance (P < .05 level) were performed to examine factors that contributed to providers' being more or less likely to adhere to recommendations.
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RESULTS
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A total of 536 completed surveys were collected (399 from phase 1 and 137 from phase 2). Combining phases, the survey was conducted in a mean of 8 practices per 1000 physician-members of the AAP in 49 of 50 states and Washington, DC.
Phase 1: Deferral of the Third and Fourth Doses of PCV7
As diagrammed in Fig 1, telephone contact was attempted with 1791 practices in phase 1. Of these, 772 (43%) were ineligible and 611 (34%) had unknown eligibility. Of the 408 eligible respondents, 9 refused to participate in the survey. On the basis of the Council of American Survey Research Organizations response rate formula,12 which assumes that a proportion of individuals of unknown eligibility are truly eligible, the survey response rate for phase 1 was 50%; the refusal rate was 2%.
The majority of respondents (n = 285 [71%]) indicated that between 2 and 10 medical doctors practiced at their site, and 192 (50%) practices reported that >25% of their patient population were enrolled in Medicaid or other public insurance (Table 2).
Of the 399 completed surveys, 385 (96%) practices were aware of the most current recommendations, 348 (90%) of whom reported fully implementing them. As shown in Fig 2, Wyeth Vaccines and state or local health departments were the most common sources of recommendation information. Providers with an insufficient supply of vaccine were significantly more likely to implement the recommendations than providers with a sufficient supply of vaccine (98% vs 88%; P = .0006; Fig 3). One quarter of practices surveyed (n = 104 [26%]) experienced a severe vaccine-supply limitation, all of whom were aware of the most current temporary recommendations. Practices were more likely to report sufficiency in their public versus private supply of vaccine (85% vs 73%, respectively, had sufficient supply for 2-dose schedule; P < .05; data not shown). Among the 278 practices who were asked about the use of a tracking system, 178 (64%; Fig 4) reported having a system in place with the intent to recall patients who had been deferred doses.
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FIGURE 2 Four most commonly reported sources of recommendation updates: percentage of respondents who mentioned these sources, according to phase. a Phase 1 surveys were administered between March 9 and April 27, 2004. b Phase 2 surveys were administered between August 2 and 24, 2004. c State and local health departments are collapsed into health departments. Respondents were able to cite multiple sources of information; therefore, percentages exceed 100%.
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FIGURE 3 Implementation of recommendation according to vaccine-supply status. a Phase 1 surveys were administered between March 9 and April 27, 2004. b Phase 2 surveys were administered between August 2 and 24, 2004. c Vaccine supply was sufficient to administer at least 3 doses of PCV7 to each healthy child from both public and private vaccine supplies. d Vaccine supply was insufficient to administer at least 3 doses of PCV7 to any child from either public or private vaccine supplies.
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FIGURE 4 Reported tracking system that pediatric practices used for children with missed PCV7 doses: phases 1 and 2 combined.
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Phase 2: Reinstatement of the Third Dose of PCV7
During phase 2, telephone contact was attempted with 856 practices. Of these, 417 (49%) were ineligible and 298 (35%) had unknown eligibility. Of the 141 eligible respondents, 4 refused to participate in the survey (Fig 5). Using the Council of American Survey Research Organizations response rate formula, the survey response rate for phase 2 was 43%; the refusal rate was 3%.12
The majority of respondents (n = 123 [90%]) indicated that between 2 and 10 medical doctors practiced at their site, and 64 (49%) practices reported that >25% of their patient population were enrolled in Medicaid or other public insurance (Table 2).
Of the 137 completed surveys, 131 (95%) practices were aware of the most current temporary recommendation to reinstate dose 3 of PCV7 but to continue withholding the fourth dose of the vaccine, and 118 (90%) of 131 reported adhering to the current recommendation. As shown in Fig 2, health departments were the most frequently cited source of the updated recommendations. Practices with a public supply of PCV7, either as a sole supply or in addition to a private supply of the vaccine, were more likely to adhere to the current recommendation than practices with only a private supply of PCV7 (95% public only, 93% both supplies, 74% private only; P < .05; data not shown). There were no differences in implementation between practices with sufficient versus insufficient vaccine supply (Fig 3). Eighty-five (69%; Fig 4) practices reported having a tracking system for children who had deferred any dose of PCV7.
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DISCUSSION
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In this 2-phase survey of pediatricians, the majority of practices were aware of and reported adhering to each of the temporary recommendations for vaccine administration. These findings suggest that efforts to disseminate broadly temporary recommendations in a timely manner were successful. In addition, even practices with sufficient vaccine supply during the shortage reported implementing recommendations, indicating that many providers were willing to withhold vaccine that was in ready supply.13 Finally, just over two thirds of providers surveyed in both phases reported having in place systems to track children for whom vaccination was deferred as a result of the shortage.
In comparison with what has been published in previous studies, we found high levels of self-reported compliance with temporary recommendations.1,4–6 This high compliance is consistent with the actual vaccination patterns observed in 2 other studies that assessed the 2003–2004 PCV7 shortage.14,15
Focusing on the 2 PCV7 shortages that occurred during 2001–2003 and 2003–2004, there is a notable difference in reported compliance rates (ranging from 29% to 62% in 2001–2003, compared with 90% in 2003–2004). Explanations offered for low compliance include (1) the complex strategies for allocating vaccine within a practice, (2) the delayed release of recommendations, and (3) provider reluctance to withhold vaccine from children when local supplies were available.1,4,13 The strategy for developing and disseminating the recommendations for the most recent PCV7 shortage was designed to address each of these barriers.
The content of the recommendations for the 2001–2003 PCV7 shortage was more complex than the content of the 2003–2004 PCV7 shortage recommendations. During the PCV7 shortage of 2001–2003, providers were recommended to withhold vaccine from healthy children who were older than 2 years and to defer some doses to healthy children who were younger than 24 months, depending on the "basis of age at which vaccination was initiated and the estimated amount of vaccine available to the... practice."16 This recommendation was in effect from December 2001 until the shortage was officially resolved in May 2003. Thus, implementing these recommendations required providers to reevaluate continually their vaccine supply for 16 months to tailor vaccine administration according to both the current local supply and the vaccination history of each child. The effort that this involved may have discouraged some practices from implementing the temporary recommendations.
In contrast, the recommendations made during the 2003–2004 PCV7 shortage were issued in staggered intervals, according to the most current national shortage situation, and did not require providers to factor in the practice's current supply. Another study that compared adherence to temporary recommendations between the first and second PCV7 shortages also suggested that improved adherence during the 2003–2004 shortage may be a result of increased clarity in published recommendations.5
The timing of the recommendations also likely affected the differences in uptake of recommendations during these 2 PCV7 shortages. During the first PCV7 shortage, a notice was published and disseminated to providers in September 2001, 1 month after many practices had already started experiencing shortages in their PCV7 supplies. Stokley et al4 looked at provider compliance with the temporary recommendations for this first PCV7 shortage and revealed that 21% of surveyed providers stopped administering all doses of PCV7 as a result of their depleted supplies without knowing that a national shortage was in effect. A study conducted by Freed et al13 found that >50% of respondents from practices who experienced short supply of PCV7 during 2001–2003 were not even aware that a national shortage was occurring until their practice was affected. These 2 studies suggest that awareness of the temporary recommendations was not high and that implementation of the recommendations occurred only by default. During the 2003–2004 shortage, a notice was issued and broadly disseminated in December 2003, as soon as the CDC received notice from Wyeth Vaccines that local shortages might occur. This notice prepared practices for the possibility of a shortage and let them know that revised recommendations on administration of PCV7 would be forthcoming.
A third factor that may have played a role in increasing uptake of recommendations was the inclusion of statements on the efficacy of 2 and 3 doses of PCV7, as compared with the full 4-dose series. During the 2001–2003 PCV7 shortage, the information on vaccine efficacy did not clearly state whether withholding doses would have an impact on the susceptibility of children. In 2004, a clear statement indicating that the "effectiveness, at least for the short-term, is not compromised by delaying administration of the fourth dose"6 was included in the text. This statement was further supported by the finding that 3 doses were 90% effective, compared with 96% efficacy of the 4-dose series. Providing this information within the recommendation may have helped providers weigh the added risks to their patient population of deferring doses.
Two other study findings are worthy of note. First, in phase 1, practices were more likely to report a sufficiency of public supply than private supply. A previous study that measured the differential impact of the 2001 DTaP and measles-mumps-rubella shortages on children who received immunizations in public versus private provider offices was published by Santibanez et al.17 The study found that private providers may have been preferentially given DTaP vaccine over public practices, resulting in a greater reduction in coverage with the fourth dose of DTaP among children who were vaccinated only at public clinics. No such inequities have been found during assessments of the 2001–2002 PCV7 shortage.1,4,13 Second, the majority of providers surveyed reported having tracking systems to recall children who had missed doses. Such systems are recommended by the Task Force on Community Preventive Services as an evidence-based strategy for increasing immunization coverage.18
The study had 3 important limitations. Because of the nature of the sampling frame listed, a large number of providers originally sampled were ineligible or had unknown eligibility, resulting in a low response rate in comparison with other published telephone surveys (50% in phase 1, 43% in phase 2); however, the extremely low refusal rate (2% in phase 1, 3% in phase 2) means that nearly all contacted practices agreed to participate, which suggests that the results were not biased by differences between providers who agreed or refused to participate in the study. Second, information on compliance with recommendations and vaccine-supply status was self-reported and no independent verification was obtained. Third, as a result of having a small sample size in phase 2, we may have limited our power to detect differences.
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CONCLUSIONS
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In 2003, the National Vaccine Advisory Committee reviewed the confluence of shortages of vaccines that occurred in the United States between 2000 and 2003 and made a number of recommendations for preventing and minimizing the impact of vaccine shortages. One recommendation addressed the importance of "improved communication among stakeholders" and "increased availability of public information"19 as a strategy to enhance implementation of temporary recommendations during a vaccine shortage. The process used to develop and disseminate temporary recommendations for the 2003–2004 PCV7 shortage was responsive to this recommendation. Results from this national survey of pediatric offices suggest that provider awareness of and compliance with those recommendations were high.
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ACKNOWLEDGMENTS
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We are grateful to those who contributed to this study, including Larry Pickering, MD, Lance Rodewald, MD, Paul Gangarosa, MPH, Karen Lees, PhD, Edith Gary, MTASCP, Rodrigo Silva, MPH, and Henry Roberts, PhD.
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FOOTNOTES
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Accepted Jun 20, 2008.
Address correspondence to Holly Groom, MPH, 1600 Clifton Rd, NE, Mail Stop E-52, Atlanta, GA 30329. E-mail: hgroom{at}cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily reflect the views of the funding agency.
The authors have indicated they have no financial relationships relevant to this article to disclose.
| What's Known on This Subject
Published studies on previous vaccine shortages have shown limited provider compliance with temporary vaccine recommendations. Explanations for low compliance include complexity of recommendations and delayed dissemination of vaccine-supply information.
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| What This Study Adds
This study reports provider compliance with temporary vaccine recommendations after a concerted effort to improve clarity and timeliness of vaccine-supply status information. Specific efforts to partner with key organizations and vaccine manufacturers to disseminate recommendations resulted in improved provider compliance.
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PEDIATRICS (ISSN 1098-4275). ©2008 by the American Academy of Pediatrics
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ABSTRACT
METHODS
