Improving the availability of vaccines in primary healthcare facilities in South Africa: is the time right for a system redesign process?

An uninterrupted supply of vaccines at different supply chain levels is a basic component of a functional immunization programme and care service. There can be no progress toward achieving universal health coverage and sustainable development without continuous availability of essential medicines and vaccines in healthcare facilities. Shortages of vaccines, particularly at health facility level is an issue of grave concern that requires urgent attention in South Africa. The causes of vaccine stock-outs are multifactorial and may be linked to a broader systems issue. These factors include challenges at higher levels such as delays in the delivery of stock from the pharmaceutical depot; health facility level factors, which include a lack of commitment from healthcare workers and managers; human resource factors, such as, staff shortages, and lack of skilled personnel. Therefore, there is a compelling need to address the factors associated with shortages of vaccines in health facilities. This paper highlights the challenges of vaccine availability in South Africa, the associated factors, the available interventions, and recommended interventions for the expanded programme on immunization in South Africa. We propose a system redesign approach as a potentially useful intervention.

Country-Level Assessment of Missed Opportunities for Vaccination in South Africa: Protocol for Multilevel Analysis.

BACKGROUND: Vaccination is one of the greatest public health interventions of all time. Vaccination coverage in South Africa has shown a steady improvement in reaching the national target. However, while there is progress nationally, there are districts within the country that are below the set target for vaccination coverage. One of the main drivers of suboptimal vaccination coverage is thought to be missed opportunities for vaccination. OBJECTIVE: This study aims to understand the magnitude and determinants of missed opportunities for vaccination in South Africa. METHODS: The 2016 South African Demographic and Health Survey will be used to conduct multilevel regression analyses to determine individual and contextual factors associated with missed opportunities for vaccination in South Africa. The perspectives of parents attending health care facilities in South Africa will be explored through exit interviews and focus group discussions. Similarly, perspectives of the health care providers will be sought to understand enablers and barriers to vaccination coverage at the facility level. Insights to such factors will aid in designing tailor-made interventions to improve vaccination coverage in South Africa. RESULTS: Ethical review submission is planned for October 2020. Data collection is expected to be underway in January 2021. CONCLUSIONS: The extent of missed opportunities in South Africa coupled with the associated factors presents an opportunity for efforts to increase uptake in districts where vaccination coverage is below the national target. Population-level data such as those from the 2016 South African Demographic Health Survey will provide an idea of the magnitude of missed opportunities for vaccination in South Africa at the national and subnational levels. The findings of the study will inform national and subnational policy implementation on vaccinations and help to find context-specific interventions to improve vaccination coverage. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16672.

Contextualised strategies to increase childhood and adolescent vaccination coverage in South Africa: a mixed-methods study.

INTRODUCTION: Despite the unparalleled success of immunisation in the control of vaccine preventable diseases, immunisation coverage in South Africa remains suboptimal. While many evidence-based interventions have successfully improved vaccination coverage in other countries, they are not necessarily appropriate to the immunisation needs, barriers and facilitators of South Africa. The aim of this research is to investigate barriers and facilitators to optimal vaccination uptake, and develop contextualised strategies and implementation plans to increase childhood and adolescent vaccination coverage in South Africa. METHODS: The study will employ a mixed-methods research design. It will be conducted over three iterative phases and use the Adopt, Contextualise or Adapt (ACA) model as an overarching conceptual framework. Phase 1 will identify, and develop a sampling frame of, immunisation stakeholders involved in the design, planning and implementation of childhood and human papillomavirus immunisation programmes in South Africa. Phase 2 will identify the main barriers and facilitators to, and solutions for, increasing vaccination coverage. This phase will comprise exploratory qualitative research with stakeholders and a review of existing systematic reviews on interventions for improving vaccination coverage. Using the findings from Phase 2 and the ACA model, Phase 3 will develop a set of proposed interventions and implementation action plans for improving immunisation coverage in South Africa. These plans will be discussed, revised and finalised through a series of participatory stakeholder workshops and an online questionnaire, conducted as part of Phase 3. ETHICS: Ethical approval was obtained from the South African Medical Research Council (EC018-11/2018). No risks to participants are expected. Various steps will be taken to ensure the anonymity and confidentiality of participants. DISSEMINATION: The study findings will be shared at stakeholder workshops, the website of Cochrane South Africa and academic publications and conferences.

Vaccine stock management in primary health care facilities in OR Tambo District, Eastern Cape, South Africa.

BACKGROUND: Poor stock management has been identified as one of the causes of vaccine stock-outs in health facilities. This study assessed the occurrence of vaccine stock-outs and vaccine stock management practices in primary health care facilities in OR Tambo district of the Eastern Cape province, South Africa. METHODS: Descriptive cross-sectional study design was used in this study to assess both the stock management practices and the availability of vaccines in the facilities. The study was conducted in 64 primary health care facilities across all sub-districts in OR Tambo. Data were collected using a questionnaire administered by the researcher, record checks and through observation. The occurrence of stock-outs of six tracer vaccines on the day of the visit and in the preceding 24 months were assessed. The data were captured into REDCap tool and analysed using STATA version 14. RESULTS: Most standard stock management procedures were not adhered to, as these procedures were mostly handled by health care workers who either required formal training or refresher training on vaccine management. Cold chain capacity was not adequate and some vaccines were exposed to freezing. Both stock cards and the stock visibility solution (SVS) device were used in all the facilities for vaccine stock management. Less than half of the facilities visited 27 (44%) filled their stock cards regularly. Delays in receiving supplies from the pharmaceutical depot were commonly reported by facilities, which contributed to stock-outs. A total of 49 (77%) health facilities had at least one stockout for at least one vaccine on the day of the visit. Furthermore, BCG and OPV were the most affected vaccines in 37 (58%) and 28 (44%) of facilities, respectively. CONCLUSION: Interventions for improving vaccine availability should be considered, especially those targeting human resources and the entire stock management system.

Mobile reporting of vaccine stock-levels in primary health care facilities in the Eastern Cape Province of South Africa: perceptions and experiences of health care workers.

The use of mobile and wireless digital technologies - mobile health (mhealth)- is increasingly been adopted in low- and middle-income countries (LMICs) to improve data visibility, improve decision-making, and consequently help ensure availability of health commodities in health facilities. In a bid to improve availability of medicines in primary health care facilities, the South African department of Health launched the Stock Visibility Solution (SVS), a mobile application developed for the purpose of capturing and monitoring stock levels of medicines including vaccines using mobile phones. The stock levels of medicines in facilities are usually uploaded to the central stock management system so that managers can act promptly to address stock-out situations. Pilot studies show that the SVS has the potential to reduce stock-outs from occurring. This study aimed to explore the perceptions and experiences of the SVS system amongst healthcare workers (HCWs) who are involved with managing stock levels of medicines in primary health care facilities in the Eastern Cape Province. This will help identify potential barriers and facilitators to implementation of the system and contribute to the development of strategies to improve its efficiency and effectiveness. A qualitative research design was employed, including semi-structured interviews with 64 HCWs working in primary health care facilities in the OR Tambo district, Eastern Cape Province in South Africa. Data was transcribed verbatim and analyzed using thematic analysis. Most HCWs understood the SVS as a system for reporting stock levels to managers and conveyed commitment to ensuring the system works. However, they highlighted a number of factors that demotivated efficient usage of the system: inadequate training, staff shortages and high staff turnover, lack of responses from the managers, the extra workload that comes with the system, amongst others. HCWs made various suggestions for how the system might be improved, most pertinently the need for more pharmacists and pharmacy assistants and for these cadres to be primarily in-charge of stock management and the use of the SVS. While HCWs are committed to addressing vaccine stock-outs, they face various barriers to an effective and efficient implementation of the SVS system. We make various recommendations for how these barriers might be addressed.

A global review of seasonal influenza vaccine introduction: analysis of the WHO/UNICEF Joint Reporting Form.

Background: Influenza is a highly contagious disease that affects the upper and lower respiratory tract caused by several subtypes of influenza viruses. While vaccination remains the mainstay strategy to protect populations against influenza, there is a global shortage and inequitable access to influenza vaccines. Although influenza vaccine production capacity increased from 500 million doses in 2006 to 1.5 billion doses in 2013, little is known about the global distribution of these vaccines albeit its introduction. We assessed the global status of influenza vaccine introduction. Research design and methods: We analyzed data from the World Health Organization (WHO) Joint Reporting Form, a publicly available source of immunization data from 194 countries of all six WHO regions. We used 2017 data, available as of July 2018. Results: By December 2017, 117 of 194 (60%) WHO Member States had introduced the seasonal influenza vaccine. European and American regions accounted for 70% (82/117) of the total number of countries that had introduced influenza vaccine. The other four regions account for only 30%. Ninety-four percent (50/53) of countries in the European region and 91% (32/35) in the American region had introduced influenza vaccine. In the Eastern Mediterranean and Western Pacific regions, 67% (14/21) and 52% (14/27), respectively, had introduced the vaccine. Yet only 27% (3/11) and 9% (4/47) in the Southeast Asian and African regions, respectively, had introduced the vaccine. Among countries (n = 117) that had introduced the vaccine, children (56%), older adults (87%), and risk groups (99%) were prioritized and given the vaccines. Conclusions: Introduction of influenza vaccine in the African and Southeast Asian regions remains suboptimal. This critically underscores the need for financing mechanisms and having countries in the regions that are lagging behind to prioritize seasonal influenza vaccine.

New vaccine introductions in Africa before and during the decade of vaccines - Are we making progress?

Vaccines are excellent investments with far-reaching rewards beyond individual and population health, but their introduction into national programs has been historically slow in Africa. We provide an overview of the introduction of new and underutilized vaccines in countries of the WHO African Region by 2017, using data from the WHO-UNICEF Joint Reporting Form. By 2017, all 47 countries had introduced vaccines containing hepatitis B (compared to 11% in 2000 and 98% in 2010) and Haemophilus influenzae type b (Hib) (compared to 4% in 2000 and 91% in 2010). The proportion of countries that had introduced other vaccines by 2017 was 83% for pneumococcal conjugate vaccine (PCV) from 7% in 2010, 72% for rotavirus vaccine from 2% in 2010, 55% for the second dose of a measles-containing vaccine (MCV2) (compared to 11% in 2000 and 17% in 2010), and 45% for rubella-containing vaccines (RCV) (compared to 4% in 2000 and 7% in 2010). From 2000 to 2010, there was no significant difference between countries eligible (N = 36) and those not eligible (N = 10) for Gavi support in the introduction of hepatitis B and PCV. However, Gavi eligible countries were more likely to introduce Hib and non-Gavi eligible countries were more likely to introduce MCV2 and RCV. From 2010 to 2017, the only significant differences that remained between the two groups of countries were with mumps, inactivated polio and seasonal influenza vaccines; which non-Gavi eligible countries were more likely to have introduced. There has been significant progress in the introduction of new childhood vaccines in Africa, mostly driven by Gavi support. As many countries are expected to transition out of Gavi support soon, there is need for countries in the region to identify predictable, reliable and sustainable immunization funding mechanisms. This requires commitments and actions that go beyond the purchase of vaccines.

A scoping review of interventions for vaccine stock management in primary health-care facilities.

One of the challenges facing the success of immunization programs is shortages of vaccines at health facilities, which could result from inadequate vaccine stock management. Several approaches have been designed by countries to improve vaccine stock management. This review summarizes currently available information on interventions for vaccine stock management.We considered both randomized trials and non-randomized studies eligible for inclusion in this review. The following databases were searched: PubMed, Embase, Cochrane Central Register of Controlled Trials, World Health Organization Library Information System, Web of Science, and PDQ-Evidence. We searched the websites of the World Health Organization, Global Alliance for Vaccine and Immunization, PATH's Vaccine Resources Library, and United Nations Children's Fund. The reference lists of all the included studies were also searched. Two authors independently screened search outputs, reviewed full texts of potentially eligible articles, evaluated risk of bias, and extracted data; resolving disagreements through consensus.Four studies met our inclusion criteria (three before-after studies and one randomized trial). Three studies were conducted in low- and middle-income countries while one was conducted in Canada (a high-income country). All the studies had various limitations and were classified as having a high risk of bias. Study findings suggest that the use of digital information systems to improve information and stock visibility, coupled with other interventions (such as training of health-care workers on the use of innovative tools and redesign of the supply chain to tackle certain bottlenecks), has the potential to increase vaccine availability, reduce response times, and improve the quality of vaccine records.

Protocol for a systematic review of the effects of interventions for vaccine stock management.

BACKGROUND: Inadequate vaccine stock management in health facilities leads to vaccine stock-outs. The latter threatens the success of immunisation programmes. Countries have used various approaches to reduce stock-outs and improve vaccine availability, but we are not aware of a systematic review of these interventions. This protocol describes the methods we will use to assess the effects of existing approaches for improving vaccine stock management. METHODS: We include randomised and non-randomised studies identified through a compehensive search of peer-reviewed and grey literature databases. We will search PubMed, Cochrane Central Register of Controlled Trials, Embase, Web of Science, PDQ-Evidence and Scopus. We will also search websites of the World Health Organisation (WHO), Global Alliance for Vaccine and Immunisation, PATH Vaccine Resources Library and United Nations Children's Fund. In addition, we will search the WHO International Clinical Trials Registry Platform and reference lists of included studies and relevant reviews. Finally, we plan to do a citation search for included studies. We will use Cochrane recommended methods to screen search outputs, assess study eligibility and risk of bias, extract and analyse study results. We will use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool to assess the certainty of the evidence on the effects of the interventions. DISCUSSION: We believe that the findings of this review will serve as valuable information for policy makers on ways to improve vaccine stock management and vaccine availability. When vaccine availability is improved, those who need them, especially children, will be adequately protected from vaccine-preventable diseases. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018092215.

Impact of vaccine stock-outs on infant vaccination coverage: a hospital-based survey from South Africa.

Introduction: National population-based immunization coverage surveys provide data for validating official administrative coverage figures. However, these costly and logistically challenging surveys are conducted infrequently. This hospital-based records review determined coverage of birth-dose vaccines, fully immunized under 1-y-old coverage (FIC) of 12- to 59-mo-old children; and the reasons for missed vaccinations. Methods: Rotavirus surveillance in South Africa is based on under-5-y-old children being treated for diarrhoea, and includes photocopying the official vaccination document and collecting data on reasons for missed vaccinations. These data were captured from all 508 records collected from 2011 to 2014, and subjected to descriptive statistical analysis. Results: Bacille Calmette Guérin coverage was 99%; oral polio vaccine birth dose (OPV(0)) coverage was 99%. Coverage for 12- to 59-mo-olds ranged from 75% for the pneumococcal conjugate vaccine third dose to 99% for OPV(0). Several instances of subsequent doses being recorded without prior doses being received resulted in a FIC of 55%. In total, 207 vaccinations were missed by 88 children. Vaccine stock-outs were responsible for 62% of missed vaccinations. Conclusions: Efforts to improve vaccine stock management at facility and district levels should be implemented, and should include vaccinator training and supervision to eliminate vaccine stock-outs and missed vaccination opportunities.

Existence and functionality of national immunisation technical advisory groups in Africa from 2010 to 2016.

We describe the existence and functionality of National Immunisation Technical Advisory Groups (NITAGs) in Africa between 2010 and 2016, using data from the WHO-UNICEF Joint Reporting Form. The number of African countries with NITAGs increased from 15 (28%) in 2010 to 26 (48%) in 2016. Countries with a functioning NITAG increased from 5(9%) in 2010 to 16 (30%) in 2016. In 2016, 13 of the 27 (48%) low-income African countries reported having a NITAG; seven (54%) of them functional. Thirteen of the 26 (50%) middle-income countries reported having a NITAG; nine (69%) of them functional. In 2016, six of the seven African countries (86%) in the WHO Eastern Mediterranean Region had a NITAG, with three (50%) functional. In the WHO African Region, 20 of the 47 countries (43%) had NITAGs; 13 (65%) of them functional. Substantial investments should be made to ensure that every African country has a functional NITAG.

The status of vaccine availability and associated factors in Tshwane government clinics.

BACKGROUND: Vaccines have greatly contributed to the control of vaccine-preventable diseases and to human development. Efforts by many countries to introduce new vaccines are a significant move towards achieving the sustainable development goal for health. However, effective vaccine supply chains that ensure an uninterrupted supply of vaccines are pivotal to attaining universal access to life-saving vaccines and sustainable development. The introduction of new vaccines puts a strain on supply chains; South Africa (SA) is no exception, as there are indications of vaccine stock-outs in clinics. OBJECTIVE: To establish the status of vaccine availability and associated factors in government health facilities of Tshwane Health District in Gauteng Province, SA. METHODS: A cross-sectional study was conducted in a sample of randomly selected government clinics in the Tshwane health district of Gauteng Province. Data were collected using a structured measurement instrument in participating clinics. Data were analysed using Excel-based software (Microsoft, USA). RESULTS: A total of 31 clinics participated. In the preceding 12 months, clinics had experienced vaccine stock-outs, especially of the three newer vaccines: pneumococcal conjugate vaccine, rotavirus and Pentaxim. These were also out of stock for a long duration; for over 2 weeks in a majority of clinics. The causes of vaccine stock-outs were: poor management of stock, district depot out of stock, unreliable deliveries, lack of pharmacy assistants and limited fridge capacity. Further burdening the situation is the ineffective emergency-ordering system. CONCLUSION: Significant shortages of vaccines, which are essential drugs, occur in Tshwane government clinics. Vaccine supply chain issues and vaccine shortages should be treated as a priority at all levels of the healthcare system; therefore, a similar study should be conducted at national level. It is recommended that the vaccine supply chain should be restructured and overhauled with the use of advances in technology and could be linked with current initiatives such as MomConnect.

HIV prevention counseling intervention delivered during routine clinical care reduces HIV risk behavior in HIV-infected South Africans receiving antiretroviral therapy: the Izindlela Zokuphila/Options for Health randomized trial.

CONTEXT: Sustainable interventions are needed to minimize HIV risk behavior among people living with HIV (PLWH) in South Africa on antiretroviral therapy (ART), a significant proportion of whom do not achieve viral suppression. OBJECTIVE: To determine whether a brief lay counselor delivered intervention implemented during routine care can reduce risky sex among PLWH on ART. DESIGN: Cluster-randomized 16 HIV clinical care sites in KwaZulu Natal, South Africa, to intervention or standard of care. SETTING: Publicly funded HIV clinical care sites. PATIENTS: One thousand eight hundred ninety-one PLWH on ART received the HIV prevention counseling intervention (n = 967) or standard-of-care counseling (n = 924). INTERVENTION: Lay counselors delivered a brief intervention using motivational interviewing strategies based on the Information-Motivation-Behavioral (IMB) Skills model during routine clinical care. MAIN OUTCOME MEASURES: Number of sexual events without a condom in the past 4 weeks with partners of any HIV status, and with partners perceived to be HIV negative or HIV-status unknown, assessed at baseline, 6, 12, and 18 months. RESULTS: Intervention participants reported significantly greater reductions in HIV risk behavior on both primary outcomes, compared with standard-of-care participants. Differences in sexually transmitted infection incidence between arms were not observed. CONCLUSIONS: Effective behavioral interventions, delivered by lay counselors within the clinical care setting, are consistent with the strategy of linking HIV care and HIV prevention and integrating biomedical and behavioral approaches to stemming the HIV epidemic. TRIAL REGISTRATION: Not applicable.

Evaluating the acute flaccid paralysis surveillance system in South Africa, 2005-2009--an analysis of secondary data.

INTRODUCTION: Acute Flaccid Paralysis (AFP) surveillance was adopted by World Health Organization (WHO) to monitor progress towards poliomyelitis eradication. South Africa Department of Health (DoH) routinely collects AFP surveillance data but has no documented evidence of its epidemiological use. The study discusses the epidemiology of AFP in South Africa from 2005-9, evaluates performance of the AFP surveillance system, and identifies components that require strengthening. METHODS: A retrospective descriptive analysis was conducted on secondary AFP surveillance data for South Africa for the period 2005-2009, consisting of all children. RESULTS: South Africa reported 1501 AFP cases between 2005 and 2009. Of these, 67.2% were <5 years of age, and 54.3% were male. None of the cases were confirmed poliomyelitis, and ten (0.7%) were classified as polio-compatible. The national annualized non-polio AFP detection rate increased from 1.6 in 2005 to 2.1 non-polio AFP cases/100,000 children <15 years in 2008-9. All performance indicators met the WHO-specified targets except two. Between 2007 and 2009, 51.5%, 55.3% and 65% of specimens, respectively, reached the laboratory within 72 hours of being sent (WHO target is ≥80%). Proportion of stool specimens where non-polio enterovirus was isolated decreased from 22.5% in 2006 to <1% in 2008 and 2009 (WHO target is ≥10%). CONCLUSION: The AFP surveillance system met most WHO-specified epidemiological and laboratory performance standards. The surveillance programme needs to address problems of delayed specimen arrival to the laboratory and incomplete documentation of laboratory findings in the national AFP surveillance database.

The decision making process on new vaccines introduction in South Africa.

South Africa has a functional decision making process for the introduction of new vaccines; with an established National Immunisation Technical Advisory Group (NITAG), referred to as National Advisory Group on Immunisation (NAGI). South Africa has played a leadership role in the African continent with introduction of new vaccines, which dates back to 1995 with the introduction of hepatitis B, followed by the Haemophilus influenzae type b in 1999 and recently the national roll out of the pneumococcal conjugate and rotavirus vaccines in 2009. NAGI has the responsibility to deliberate on key policy issues as part of the process for decision making on the introduction of new vaccines. In developing recommendations NAGI considers: disease burden, cost effectiveness, and the impact on the Expanded Programme on Immunisation (EPI). Although guidance and recommendations from WHO are considered, the decision to introduce a new vaccine in South Africa is based on local data. NAGI recommendations are presented to the National Department of Health (NDOH). The NDOH pursues the matter further through the involvement of provinces. When an agreement has been reached to accept the NAGI recommendations, the NDOH seeks funding from the Ministry of Finance (MOF). Once funds are available, the new vaccines are implemented by the immunisation programme. Although there is an established functional system for decision making in South Africa, some areas need to be addressed. A system should be developed to allow the NDOH, NAGI and the MOF to engage in the deliberations on financial and economic impact of new vaccines. It is further recommended that a committee be established that will assess the programmatic issues to weigh the potential benefits of a new vaccine. Furthermore, political commitment should support the immunisation programme and strengthen it so that it can make an impact in the achievement of the Millennium Development Goal no. 4 of reducing child mortality.

The National Advisory Group on Immunization (NAGI) of the Republic of South Africa.

The National Immunization Technical Advisory Group (NITAG) in South Africa, known as the National Advisory Group on Immunization (NAGI), was established in 1993 to advise the National Department of Health (DoH) on issues related to vaccination. Meetings are held as needed but at least twice a year. The scope includes vaccines and immunization and other relevant infectious disease issues. NAGI also makes recommendations on vaccine schedules and formulations. Agendas are set by DoH and the Chairman of NAGI. NAGI brings together experts from a range of different fields relevant to vaccines and vaccinations and has been an important resource for guiding the Expanded Program of Immunization (EPI) in South Africa.

First 5 years of measles elimination in southern Africa: 1996-2000.

BACKGROUND: Measles is the leading cause of vaccine-preventable death in Africa. Regional measles elimination is considered feasible using current vaccines and a series of WHO-recommended strategies. We aimed to interrupt transmission of measles, and to use case-based surveillance to show the effect of such interruption. METHODS: In southern Africa from 1996, seven countries with a total population of approximately 70 million and with relatively high routine vaccination coverage implemented measles elimination strategies. In addition to routine measles immunisation at 9 months of age, these included nationwide catch-up campaigns among children aged 9 months to 14 years, then follow-up campaigns every 3-4 years among children aged 9-59 months, and the establishment of case-based measles surveillance with serological diagnostic confirmation. RESULTS: Nearly 24 million children aged 9 months to 14 years were vaccinated, with overall vaccination coverage of 91%. Reported clinical measles cases declined from 60000 in 1996 to 117 laboratory-confirmed measles cases in 2000. Reported measles deaths declined from 166 in 1996 to zero in 2000. No increase in adverse events was noted after the measles vaccination campaign. CONCLUSION: A reduction in measles mortality and morbidity can be achieved in very low-income countries, in countries that split their vaccination campaigns by geographical area or by age-group of the target population, and where initial routine measles vaccination coverage among infants was <90%, even when prevalence of HIV/AIDS was extremely high. Continued high-level national commitment will be crucial to implementation and maintenance of proven strategies in southern Africa.