Occurrence of home-based record stock-outs-A quiet problem for national immunization programmes continues.

Home-based records (HBRs) provide an effective, inexpensive mechanism for recording and tracking infant vaccinations, yet stock-outs prevent HBRs from fulfilling their intended function. We describe the annual occurrence of HBR stock-outs during 2014-2016 reported by national immunization programmes to the WHO and UNICEF on the Joint Reporting Form on Immunization. During 2014-16, 48 countries reported at least one HBR stock-out. Thirteen countries reported HBR stock-outs for two of the three years. Forty-four countries reported two or more HBR funding sources in 2016. Challenges persist in ensuring continuous availability of HBRs. HBR stock-outs have important implications as they may impact continuity-of-care, increase inefficiencies at the point-of-care and reduce the ability of caregivers to be effective health advocates. Identifying mechanisms for preventing stock-outs should be a focus of attention for programmes and development partners. Expanded efforts are required to better understand the underlying causes of HBR stock-outs and identify solutions.

Introduction

Vaccination cards and child health books, also known as home-based records (HBRs), play an important role in documenting immunization and other primary care services [1]. HBRs complement facility-based recording and monitoring systems that provide the information necessary to inform frontline clinical decision making that may ultimately reduce the inefficiencies and improve care [2], [3]. HBRs offer a simple and relatively inexpensive means of fostering coordination and continuity-of-care, facilitating communication between providers and caregivers and improving caregiver understanding and expectations about health services [1]. HBRs can help stimulate demand for vaccination services by raising caregivers’ awareness of the benefits of vaccines, the recommended vaccination schedule and the date of the child’s next vaccination visit.

In order to meet these critical needs, a well-designed, durable HBR must be readily available in adequate quantities for field-level health workers to distribute. HBRs are often underutilized, in part, due to insufficient supplies. As with stock-outs of other vaccine delivery supplies, HBR stock-outs are avoidable with appropriate attention to strengthening supply chains and logistics. We recently highlighted the occurrence of national-level HBR stock-outs [4] reported to the World Health Organization (WHO) and United Nations Children’s Fund (UNICEF) for 2014 and 2015. This report provides an update on HBR stock-outs that occurred during 2016.

Methods

Since 1998, the World Health Organization (WHO) and United Nations Children’s Fund (UNICEF) have collaborated annually to collect global information on national immunization programme performance using a standardized data collection form, the Joint Reporting Form on Immunization (JRF). Most often, national immunization managers complete the questionnaire. A detailed description of the JRF, including questions on immunization system indicators and data collection process is described elsewhere [4]. The information collected by the JRF serves as a critical resource for tracking implementation of the Global Vaccine Action Plan (GVAP) [5], and the Regional Vaccine Action Plans (RVAPs). These initiatives serve as key frameworks to guide immunization strategies at the global and regional levels. The JRF began collecting data on the occurrence of HBR stock-outs in 2015 for events occurring the prior calendar year.

During the first quarter of 2017, national immunization programmes reported immunization system performance data for 2016 to the WHO and UNICEF on the JRF. During 2014–16, the JRF included the following questions related to HBRs:

Was there a stock-out of home-based vaccination records for children (no remaining home-based records for any period of time) at the national level during 201(4/5/6)? (Yes-No or No Response [NR]).

Which organization is responsible for financing the home-based records for children in your country? (Multiple Choice, Multi-Select question allowing the respondent to select any combination of the following: (i) immunization programme or Ministry of Health (EPI/MOH), (ii) other government agency (iii) development partner and (iv) other) (Yes-No or NR).

Is the printing of home-based vaccination records for children the responsibility of the national programme (EPI or MOH)? (EPI/MOH-Other).

Respondents were asked to provide clarifying details for each response.

Results were tallied at the global level and by WHO operational region, World Bank income classification and eligibility for Phase 2 financial support from Gavi, the Vaccine Alliance (i.e., Gavi 73 countries) (N.B.: In Gavi Phase 2, country eligibility was based on the World Bank Gross National Income estimates for 2003 against an eligibility threshold of US$1000. A total of 72 countries were eligible at the time plus the addition of South Sudan which was recognized as an independent member state of the World Health Assembly in 2011). For the most recent reporting period, reflecting the situation in 2016, 97% (189/194) of Member States to the World Health Assembly reported data on the JRF, an improvement from 68% (131/192) of countries in 2000.

Results

In 2016, 29 (15%) countries reported a national-level HBR stock-out, an increase from that reported in 2014 (n = 19); 16 of the 29 were located in the WHO Africa Region. While stock-outs occurred in countries of all income groups, middle-income countries reported stock-outs most frequently. Stock-outs were reported in 18 middle-income countries, 9 of which are countries who were among the Gavi 73 countries. More than half of the countries reporting a HBR stock-out in 2016 were Gavi 73 countries, an increase from 2014. For the current year, 104 (54%) countries reported no HBR stock-out and 59 (30%) countries did not report data on the occurrence of HBR stock-outs (Table 1). In 2013, two countries, Norway and Belarus, reported [6] that they do not use HBRs.

Table 1

Occurrence of national level home-based record stock-outs during 2014–16 reported by national immunization programmes by WHO region, Gavi-eligibility and World Bank income classification.

	2014			2015			2016
	Yes	No	NR	Yes	No	NR	Yes	No	NR
WHO Region
AFR (n = 47)	11 (23)	26 (55)	10 (21)	13 (28)	30 (64)	4	16 (34)	24 (51)	7 (15)
AMR (n = 35)	4	25 (71)	6 (17)	3	27 (77)	5 (14)	4	25 (71)	6 (17)
EMR (n = 21)	1	12 (57)	8 (38)	1	14 (67)	6 (29)	1	13 (62)	7 (33)
EUR* (n = 53)	0	24 (47)	27 (53)	0	26 (51)	25 (49)	1	23 (45)	27 (53)
SEAR (n = 11)	0	9 (82)	2	1	8 (73)	2	3	7 (64)	1
WPR (n = 27)	3 (11)	13 (48)	11 (41)	5 (19)	15 (56)	7 (26)	4	12 (44)	11 (41)
Gavi 73 (n = 73)	10 (14)	44 (60)	19 (26)	16 (12)	47 (63)	10 (26)	19 (26)	39 (53)	15 (21)
Income group
Low (n = 31)	7 (23)	17 (55)	7 (23)	7 (23)	22 (71)	2	10 (32)	17 (55)	4
Middle (n = 105)	12 (12)	63 (61)	29 (28)	16 (15)	67 (64)	21 (20)	18 (17)	61 (59)	25 (24)
Gavi (n = 42)	3	27 (64)	12 (29)	9 (21)	25 (60)	8 (19)	9 (21)	22 (52)	11 (26)
non-Gavi (n = 63)	9 (15)	36 (58)	17 (27)	7 (11)	42 (68)	13 (21)	9 (15)	39 (63)	14 (23)
High (n = 56)	0	28 (51)	27 (49)	0	29 (53)	26 (47)	1	25 (45)	29 (53)
Not classified	0	1	1	0	2	0	0	1	1
Totalsa (n = 194)	19 (10)	109(57)	64 (33)	23 (12)	120(63)	49 (26)	29 (15)	104(54)	59 (31)

Data reported as n (%). Percentages are not reported for cells with less than 5 countries.

NR, no response.

Two countries, Norway and Belarus, reported to WHO in 2013 that they do not use home-based records.

Across a three-year period, 2014–2016, 48 (25%) countries reported at least one national-level HBR stock-out, including 31 Gavi 73 countries. Five countries (Belize, Cameroon, DRC, Guinea-Bissau, Venezuela) reported national-level HBR stock-outs for all three years, 13 countries (Botswana, Burundi, Cambodia, Chad, Dominican Republic, Equatorial Guinea, Ghana, Kenya, Lao People’s Democratic Republic, Namibia, Philippines, Somalia, Timor-Leste) reported HBR stock-outs for two of the three years, and 30 countries reported a national-level HBR stock-out for one year during the three-year period. Sixty-nine (35%) countries reported no HBR stock-outs for any of the three years (Fig. 1). Seventy-five countries did not report any information on the occurrence of HBR stock-outs for at least one year during 2014–16; 31 countries did not report data for all years during 2014–16 and 44 countries did not report data on HBR stock-out for one or two years during 2014–16.

Fig. 1

Occurrence of national-level home-based record stock-outs reported by national immunization programmes (2014–16). Map Data Source: Nationally reported immunization system performance data for calendar year 2016 submitted on the Joint Reporting Form on Immunization.

In 2016, reported funding sources for HBRs included the national immunization programme in 111 countries, other government agency in 25 countries, non-governmental partners in 37 countries and other sources (e.g., private health providers) in 25 countries (Fig. 2). Forty-four countries reported two or more HBR funding sources in 2016. Forty-one percent (12/29) of countries reporting a HBR stock-out in 2016 noted two or more HBR funding sources compared to 28% (29/104) of countries that did not report a HBR stock-out. Among the remaining 59 countries that did not report data on HBR stock-outs (recall that two countries reported that they do not use HBRs), only three countries noted two or more HBR funding sources.

Fig. 2

Funding source for home-based records reported by national immunization programmes (2016). Map Data Source: Nationally reported immunization system performance data for calendar year 2016 submitted on the Joint Reporting Form on Immunization.

Among the 29 countries reporting national-level HBR stock-outs in 2016, 27 provided information on the funding sources for HBRs (Appendix A Table). Sixteen countries reported a single source, eight countries reported two sources, two countries reported three sources and one country reported four sources of HBR funding. The most frequently reported funding sources included the national immunization programme (n = 18 countries) and non-governmental partners (n = 16). Of the 36 countries that reported detailed information on the partner, UNICEF (n = 23) was the most frequently noted partner followed by the WHO (n = 18) and Gavi, the Vaccine Alliance (n = 11).

In 2016, national immunization programmes were solely responsible for printing HBRs in 93 countries and jointly responsible with other partners in 22 countries; other partners (e.g., UNICEF, Gavi) had sole responsibility for printing HBRs in 21 countries. National immunization programmes and other partners shared responsibility for HBR printing in 22 countries. HBR stock-outs were reported by 20% (23/115) of countries where the immunization programme was responsible for printing, by 14% (6/43) of countries where other partners were responsible for printing and by 18% (4/22) of countries reporting a shared responsibility for printing.

Discussion

Maintaining sufficient quantities of HBRs at the national level remains a challenge. More countries reported national-level HBR stock-outs in 2016 than in 2015 or 2014. Several countries have had considerable difficulty sustaining HBR stocks, reporting annual stock-outs multiple times during the three-year period. Taking into consideration results from an assessment of national-level HBR stock-outs in 2013 collected using a similar approach [6], national-level HBR stock-outs were reported by the Democratic Republic of Congo, Guinea-Bissau and Venezuela each of the past four years (2013–16).

Research has shown that a primary reason for missed opportunities for immunization is a caregiver being inadequately informed about the benefits of vaccines, recommended vaccination schedule and the child’s next vaccination visit [1]. When HBRs are not available for distribution, a critical opportunity to educate caregivers about the role of vaccination in protecting the health of their child is missed. Repeated or extended gaps in HBR availability further decrease the likelihood that instructional scaffolding—or the structured interaction between health worker and caregiver around the importance of immunization—is implemented and may impact the timely administration of the full infant immunization series.

Overall, monitoring of HBR supply chain systems remains inadequate. In 2016, roughly one-third of countries and 21% of Gavi 73 countries failed to report whether a stock-out did or did not occur at the national level. Across 2014–16, 75 countries failed to report data on HBR stock-outs for at least one year. Thus, the 48 countries reporting at least one HBR stock-outs during 2014–16 reflects a minimum number; in a worst-case scenario, 75 additional countries could have had a HBR stock-out if each of the countries with no reported data noted one or more years with an HBR stock-out. In addition, a number of programmes failed to provide information on the number of HBRs printed regardless of whether a stock-out occurred: 12 of 29 countries reporting a HBR stock-out and 51 of 104 countries reporting no HRB stock-out. Whether countries lack this information; have the information, but not in a readily accessible form for reporting; or are choosing not to report information on supply levels when information exists is unclear. We previously highlighted [4] that the absence of information on whether HBR stock-outs occur in a country may serve as a signal of more broad problems in a country’s recording and reporting system, not unlike the situation with stock-outs of vaccines and injection supplies [7]. Regardless, in some countries it appears that no one organization is responsible for monitoring HBR supply chains. Improving monitoring systems to track the quantity of HBRs available at national and subnational levels is critical for accurately managing current stock, forecasting future needs and averting stock-outs or unnecessary overstocks where excessive inventory is retained. Monitoring systems should allow for timely, uncomplicated access to this critical information. Countries are encouraged to critically examine the roles and responsibilities around HBR supply chains and take action to ensure that one organization maintains monitoring responsibilities.

In addition to overall increases in reported stock-outs, the number of Gavi 73 countries reporting a HBR stock-out increased, from 10 countries in 2014 to 19 in 2016. We previously highlighted the need for further examination of HBR stock-outs among Gavi-eligible countries. Given that two-thirds of countries reporting HBR stock-outs in 2016 are Gavi 73 countries, we encourage the Gavi Secretariat to include HBR system indicators, such as those collected in the JRF, in their monitoring of country programmes. Further to this, the Gavi Secretariat could increase country attention on the importance of ensuring high levels of HBR availability and ownership. One way to accomplish this would be to place greater importance on improving the proportionate contribution of documented evidence of vaccination history found in HBRs towards coverage estimates as part of the current requirements for periodic vaccination coverage surveys to monitor programme performance [8]. For example, in most vaccination coverage surveys, coverage is based on information from the combination of documented evidence observed in the HBR and caregiver recall if no HBR is available. If coverage by HBR is 45% and coverage by recall is 30%, then coverage by the combination of HBR or recall is equal to the sum of these values, or 75%. The proportionate contribution of documented evidence of vaccination history in HBRs in this case is 45/75 or 0.60. The closer this value is to 1.0, the more the survey coverage estimate is based on documented evidence.

The information provided by the JRF, only identifies stock-outs at the national level and may not reflect disruptions in HBR supply at district levels or in the private sector. In countries where HBR printing responsibility resides with the national programme, district-level HBR stock-outs likely follow national stock-outs given that subnational stock-outs of vaccine are extremely common when a national-level stock-out occurs [7]. The reported data also do not provide any indication of HBR stock-out duration; prior information suggests national-level HBR stock-outs may last as long as seven months on average [6].

Financing and printing of HBRs reflect complex arrangements between a national immunization programme and its partners. In 2016, 44 countries reported two or more HBR funding sources and 22 countries shared responsibility for printing HBRs. Complex financing arrangements appear to be associated with the occurrence of HBR stock-outs. As noted elsewhere [4], further work is necessary to better understand the complex financing mechanisms currently being used by national immunization programmes and their contribution to the occurrence of disruptions in HBR availability. Similar to the challenges of single-source procurement of vaccines for supply shortages, scenarios where countries rely solely on a single external funding partner may be equally challenging. Ideally, countries will maintain a dedicated budget line item for HBR printing and distribution as part of sustainable immunization financing through annual government budgets.

These results update the occurrence of HBR stock-outs reported by national immunization programmes as of 2016 and highlight the persistent challenge in ensuring continuous availability of HBRs. An increasing number of countries reported HBR stock-out during each of the last three years. Opportunities to better understand and improve supply side disruptions in HBR systems exist alongside efforts to improve immunization supply chains and health information systems. Taking advantage of these opportunities will require a dedicated focus on HBRs, particularly by Gavi-eligible countries. National immunization programmes, and the development partners supporting them, are encouraged to consider HBRs an essential component of the immunization delivery system. HBR availability should be monitored and adopted among other programme indicators to leverage existing investment opportunities [2] for exploring sustainable solutions that minimize mistakes in ordering, demand forecasting and supply chain to ensure a sustained, uninterrupted supply of HBR at the national and subnational levels moving forward.

Authors’ disclaimer

The findings and views expressed herein are those of the authors alone and do not necessarily reflect those of their respective institutions.

	Reported Financing Sources for HBRs
Country	EPI			Other Gov’t			Partner			Other			No Data Reported
	One financing source
Angola		◆
Belize		◆
Cambodia		◆
Cameroon		◆
Rwanda		◆
Swaziland		◆
Tunisia		◆
Venezuela		◆
Estonia					◆
Democratic Republic of Congo								◆
Guinea-Bissau								◆
Madagascar								◆
Myanmar								◆
Sierra Leone								◆
Zambia								◆
	Two financing sources
Bangladesh		◆						◆
Burundi		◆						◆
Ghana		◆						◆
Guinea		◆						◆
Samoa		◆						◆
Ecuador		◆									◆
Namibia		◆									◆
South Sudan					◆			◆
Comoros								◆			◆
	Three financing sources
Gambia		◆			◆			◆
Philippines		◆			◆			◆
	Four financing sources
Dominican Republic		◆			◆			◆			◆
	No reported data
Papua New Guinea														◆
Timor-Leste														◆