Study design

This study was anchored on an exploratory research design to acquire qualitative data from purposively selected participants in Nigeria. Key informant interviews were conducted at the national and sub-national (state) levels to understand the perspectives of AEFI surveillance stakeholders on the challenges of e-reporting at the national and state levels and the ways by which e-reporting can be optimized. Participants were recruited and interviewed between September 12 and October 27, 2022. The recruitment period took about seven weeks due to competing priorities on the part of the health administrators, particularly at the national level.

Study settings

The study was conducted in twelve (12) states across the six geopolitical zones in Nigeria at the sub-national level, and the federal capital territory at the national level. Nigeria is a multinational country with almost 230 million people, spread across 250 ethnic groups, speaking 500 different languages and identifying with a wide range of cultural lives. Nigeria is the sixth most populous country in the world and the most populated country in Africa. Nigeria is divided into six geopolitical zones, including Northwest, north-central, northeast, south-south, southwest, and southeast.

One of Nigeria’s six geopolitical zones, which collectively make up the Middle Belt, is the North Central one. It consists of Nigeria’s Federal Capital Territory as well as the six states of Benue, Kogi, Kwara, Nasarawa, Niger, and Plateau. From the border with Cameroon to the border with Benin, the North Central region spans the whole breadth of the nation. Approximately 20 million people live in the region, making up 11% of the nation’s overall population.

Geographically, the Northeast represents the largest geopolitical zone in the country, making up almost one-third of all of Nigeria. It is made up of the states of Taraba, Yobe, Borno, Bauchi, Adamawa, and Gombe. With a population of over 26 million, the region makes up 12% of the nation’s total population. It is well-known for its cattle and its abundant crop development, both of which have a significant impact on the national economy. When compared to the country’s southern portion, the area is not as heavily populated.

Nigeria’s northwest is referred to as the Northwest both politically and geographically. It is made up of the following seven states: Zamfara, Jigawa, Kaduna, Kano, Katsina, Kebbi, and Sokoto. Culturally speaking, the majority of the zone is contained inside Hausaland, the ancestral territory of the Hausa people, who comprise the majority of the population in the northwest. Significant minorities of Fulani people and other ethnic groups do exist, mostly on the zone’s edges.

The Southeast, which includes the five states of Abia, Anambra, Ebonyi, Enugu, and Imo, also denotes the political and geographic region of inland southeast Nigeria. It is the smallest geopolitical zone, but it makes a significant economic contribution to the country because the majority of its territory is Igboland, the indigenous cultural homeland of the Igbo people, who make up the majority of the ethnic population in the southeast.

The six states that make up the South-South are Rivers, Edo, Delta, Cross River, Akwa Ibom, and Bayelsa. A large portion of the Niger Delta, which is essential to the region’s ecology and economic growth, is enclosed by the zone. Despite making up just around 5% of Nigeria’s total area, the South-South’s substantial oil and natural gas deposits enable it to make a significant economic contribution to the country. With over 26 million residents, the zone makes up 12% of the nation’s total population.

The states of Ekiti, Lagos, Ogun, Ondo, Osun, and Oyo make up the Southwest. The majority of the zone is culturally part of Yorubaland, the native country of the Yoruba people, who comprise the largest ethnic group in the southwest. The Yoruba kingdom also extends in part to some areas in Kwara and Kogi states, and together they make up the Nigerian Yorubaland. Nigeria’s economy benefits considerably from the economic contributions of the Southwest’s urban centers, primarily Lagos and Ibadan. Over 50 million people live in the region, slightly over one-fifth of the nation’s population. Lagos is the most populated city in Africa, the Southwest, and Nigeria (Please see Table 1).

Download:

• PPT
  PowerPoint slide
• PNG
  larger image
• TIFF
  original image

Table 1. State selection across the geo-political zones of Nigeria.

https://doi.org/10.1371/journal.pone.0331093.t001

The study participants are health administrators within the primary healthcare system and include those at the national and sub-national levels. The health administrators at the state level are particularly incorporated into the Nigerian Centre for Disease Control (NCDC) and are often members of the disease outbreak response team at the sub-national or state level. The health administrators at the national level include the director and deputy director of disease control and immunization. The healthcare workers at the state level, participants include the State epidemiologist, the state disease surveillance and notification officer (DSNO), the state Immunization Officer (SIO), the State monitoring and evaluation (M&E) officer, and the State Health Education Officer (SHEO)

However, this study does not include the category of healthcare workers who directly report AEFI at the facility level. The categories of healthcare workers who are often faced with this responsibility are the routine immunization officers (RIOs), recorders, and, in a few cases, nurses in the facilities (as a backstop for RIOs). If recorded manually, data is often submitted to the local government area Monitoring and Evaluation Officer (LGA-M&E), who subsequently reports to the state level, and that is eventually submitted to DHIS2 by the state M&E officer. Electronic reporting often involves direct data uploading into DHIS2 and is verified by the state M&E officer

Sampling

For this study, state-level participants were purposively selected from 12 states, plus the purposive selection of the Federal Capital Territory, covering the 6 geopolitical zones. Two states were chosen from each geopolitical zone based on

1. (i) High/low reporting of COVID-19 AEFIs
2. (ii) Availability of uninterrupted network services

Inclusion and exclusion criteria for study participants

The participants at the sub-national level were purposively identified and selected based on their job positions and roles in the AEFI surveillance system in their respective states. At the national level, members of the AEFI technical working group (TWG) who were also involved in coordinating disease surveillance at the state levels were selected for the interview (based on availability and consent). On the other hand, participants were excluded at the sub-national level if their job titles did not fit into those responsible for disease surveillance. Also, participants who were not involved in the technical working group at the national level were excluded.

The DSNO, State Epidemiologist, state M&E officer, and SIO made up the subnational stakeholders. There were two national stakeholders interviewed. Six (6) of the intended thirty-six (36) participants at the sub-national levels were absent at the time of the study due to certain constraints (Please see Table 2).

Download:

• PPT
  PowerPoint slide
• PNG
  larger image
• TIFF
  original image

Table 2. Participants Selection across the study locations.

https://doi.org/10.1371/journal.pone.0331093.t002

Ethical approval and consent to participate

The study adhered to the ethical guidelines outlined in the Helsinki Declaration for research involving human subjects. Prior to the key informant interviews (KIIs), participants provided both written and verbal consent. Strict measures were implemented to ensure confidentiality of information, and the discussions were conducted anonymously. Furthermore, the study protocol received approval from the National Health Research Ethics Committee (NHREC) of the Federal Ministry of Health (FMoH) in Abuja, with approval number NHREC/01/01/2007–19/08/2022.

Data collection

A semi-structured interview guide, based on the study objective, was developed for the study respondents to generate the data needed for this study. Participants were invited for interview sessions via electronic mail and a letter of introduction from the National AEFI TWG of the National Primary Healthcare Development Agency (NPHCDA). Physical interview sessions were held with respondents at the national level, while respondents across the selected states were interviewed virtually through the Zoom platform. Specifically, the study assessed participants’ perceptions of the challenges facing healthcare workers in the process of reporting AEFIs. This was focused on the need to understand and gather insights into the reality of the AEFI reporting system in Nigeria. The findings from the acquired data were used to design tailored interventions to strengthen the AEFI surveillance system thereafter. Participants were asked questions such as “Tell me briefly about yourself, your work, and your role in the AEFI Surveillance structure. In your opinion, do you think it is possible to integrate AEFI surveillance with other existing state health programs? What are your thoughts on the current AEFI data electronic reporting methodology? And What are your thoughts on the utility of the AEFI electronic data management system?”.

Data collection procedure

A total of thirty (30) interviews were conducted at the sub-national level, while two (2) interviews were conducted at the national level. Written Consent (for national level participants), and Verbal consent (for sub-national level participants) were obtained from the respondents before all the interviews were conducted. All interviews were conducted in English Language to facilitate easy communication. The interviews, which lasted between 18 and 23 minutes, were recorded and stored on a local audio device.

Data analysis

All recorded interviews were conducted in English, and the recorded files were transcribed verbatim in English language by professional transcribers. Transcripts from interviews were triangulated with notes taken by data assistants during data collection to ensure that the transcripts accurately captured all points.

A hybrid approach (inductive and deductive) to thematic analysis, described by Swain [22] was used to analyze the transcripts. Firstly, a codebook was developed using a framework of barriers to electronic pharmacovigilance systems defined by Agoro et al [23]. The Pharmacovigilance system is the scientific interpretation of detecting, assessing, understanding, and preventing adverse drug or vaccine events (post-usage). Following transcription, two members of the research team read through the transcripts to identify emerging themes, and the codebook was then refined based on emerging themes from the transcripts. Using the revised codebook, all transcripts were coded deductively using the Dedoose software (Version 9) by a team of 4 professional coders. Data synthesis was conducted thematically based on the pattern identified in the participants’ responses. Four thematic and sub-thematic areas were generated from the observed pattern of responses.

Socio-demographics of the study participants

A total of 32 respondents were interviewed. Two respondents were officials from the NPHCDA, and 30 were members of the state AEFI committee. No respondent withdrew from the study.

Following the interview sessions held with the study participants, the study adapted Agoro et al [23] thematized framework of reporting the barriers to electronic reporting of the pharmacovigilance system. Therefore, this study developed and categorized the participants’ responses into four main themes (please see Fig 1). The thematic areas are (i) healthcare workers’ knowledge deficiency and fear, (ii) technical infrastructural challenges, (iii) poor reporting systems, and (iv) inconsistency in government commitment. Responses were discussed across various perspectives using the participants’ expressions on various issues that contributed to the challenges that apply to reporting AEFI on COVID-19 vaccination and routine immunization in Nigeria.

Download:

• PPT
  PowerPoint slide
• PNG
  larger image
• TIFF
  original image

Fig 1. Thematic structure analysis.

https://doi.org/10.1371/journal.pone.0331093.g001

Healthcare workers’ knowledge deficiency and fear

Technical infrastructural challenges

Following subsequent discussions with the participants, the study revealed that the second major barrier identified was outside the control of healthcare workers, and this revolved around technological issues in health facilities. These technological issues include the unavailability of mobile phones, and mobile data shortages

Poor reporting system

This alludes to barriers that revolve around the functionality of the e-reporting portal and the modality of reporting. The study participants aired their perceptions of limitations to the reporting system or structure in place, and this was evident in the emphasis made by some participants that:

You know, before we were not reporting AEFI electronically because it was paper-based. But now, different people have been complaining about the portal that it will not load sometimes. Some will tell you that they cannot login, and so because of that they were unable to appropriately report it. The DSNOs often complain that they do not receive any data from the facilities because they keep having different complains(KII/ State Level/2022).

Now, that recently we are using electronic data collection tools, what I realized is that the link or the platform can’t be accessed to report AEFI from COVID-19 and especially other vaccination exercises (KII/ State Level/2022).

Inconsistency in government commitment

This is the fourth theme identified in the study based on the participants’ responses. Findings from the study revealed that participants are of the notion that the government and health authority are not entirely playing their roles as expected, to enhance an effective and efficient electronic reporting system within the immunization sector. Some participants were able to shed light on this when they emphasized that:

Like now, some health facilities are very far from other health facilities, and we have to go there to get data from them, so we can report to the state level. We complained to the state people, and they said they would provide small money for us to buy petrol in our machines, but we did not hear anything again (KII/ State Level/2022)

A big problem is that the government keeps promising that they will provide logistics, but we have not seen that since they said it. But if there are logistics for us at the state level to move around and to sensitize them and tell them the importance of reporting, I think our reporting method will be improved (KII/ State Level/2022).

Implications of study findings

Findings from our study have established salient points integral to the understanding of the challenges affecting electronic pharmacovigilance reporting on Adverse Events Following Immunization (AEFI) based on stakeholders’ perspectives. On this note, participants’ perception of knowledge deficiency and fear among healthcare workers implies that the knowledge gap among healthcare workers regarding AEFI reporting is a severe challenge. Specifically, the lack of reporting knowledge has significant implications for the lives of many individuals who may be affected by adverse events following their immunization exercises. Additionally, the lack of knowledge of reporting on the part of healthcare workers has indirect implications on policies associated with adverse events following immunizations, as only limited data will be available, which may not be sufficient to inform appropriate decisions.

Furthermore, the search for greener pastures, which is highly prevalent among Nigerians, especially in the healthcare industry, is preponderantly responsible for the lack of knowledge on AEFI reporting within health facilities in the country. This implies that training of healthcare workers representing health facilities cannot be limited to a one-off event, as recruitment, replacement, and reshuffling because of attrition would translate to the need for routinized training. By extension, fear among healthcare workers raise concerns about how their work and competency will be perceived should they report AEFI events that were presented in their health facilities. This may be hinged on the belief held by healthcare workers that reporting AEFI is a negative outcome of their hard work toward vaccination exercises. In other words, healthcare workers may perceive reporting AEFI as tarnishing their reputation or undermining their immunization efforts. However, conducting sensitization (informative and educative) programs about AEFI and AEFI reporting at the state level and emphasizing the importance of reporting can help improve the reporting culture. It is therefore pertinent to address the concern of fear amongst healthcare workers and promote a supportive environment that would encourage healthcare workers to report AEFI cases without concerns over judgment or negative consequences.

Consequently, the lack of mobile phones dedicated to health facilities significantly impacts the reporting rate of AEFIs. This challenge limits healthcare workers’ reporting capacity, leading to underreporting and incomplete data on AEFIs. Delayed reporting and response sometimes compromise the timely investigation and risk assessment. This challenge increases the risk of data inaccuracies and inconsistencies, impacting on the reliability of AEFI data and compromising effective analysis and decision-making

Participants highlighted that in some cases, especially in situations where the AEFI event is presented to them in their respective facilities, they are usually confronted with the challenge of mobile data shortages to synchronize and send out the reported data. In other words, the provision of mobile network data to healthcare workers for reporting AEFI electronically will not only serve as a tool for executing their responsibilities, but also as an agent of extrinsic motivation to the healthcare workers. As such, mobile data could help them reach out to their co-workers, especially the DSNOs, via social media pages such as WhatsApp, especially when such platforms are adopted for official purposes, including but not limited to check-in meetings, and communication and social mobilization.

The study participants exuded their expectations of the government‘s commitment towards their welfare, with particular reference to logistics to encourage their visits to the various health facilities, not only for data evaluation but also for supervision and on-the-job mentoring support. This implies that the government not reneging but rather committing to their promises to the healthcare workers will significantly influence the execution of job responsibilities among healthcare workers, which in turn will improve the efficiency of the reporting system at the grassroots level to the pinnacle of the reporting system. This will also play an indirect role in the decision-making process of managing and controlling adverse events following immunization and/or drug administration. Additionally, the government’s commitment can also be strengthened through improved counterpart funding and ownership of health program implementation. This is because of the limited political interest in health program interventions, especially when it require the collaboration of the national and subnational levels.

Study strengths and limitations

This study has successfully illuminated the perspective of health administrators across two key levels: the Federal and State levels. On the other hand, the lack of assessing the experiences of facility health workers who primarily deal with AEFI reporting (direct experiences) is a major limitation of the study. Consequently, our findings may have been affected by social desirability bias, as many of our respondents might have answered the questions in a way that they believed was socially acceptable or desirable, rather than reporting their true opinion

Recommendation

Based on findings from this study, we recommend that stakeholders, particularly at the state level, engage in frequent sensitization of healthcare workers on the benefits of reporting AEFI cases through all appropriately established channels (paper-based and electronic) to ensure that comprehensive data are available to make decisions at the right time, and in the right way. Additionally, stakeholders at the state level should also take responsibility for refresher training, and the provision of necessary tools for healthcare workers. Furthermore, training for healthcare workers (beyond AEFI reporting) should be institutionalized through policy and support from the national government with adequate resources across all health interventions. Stakeholders at the national level can support the sub-national, while also providing guidance and oversight functions to facilitate and ensure appropriate conduct.

Beyond healthcare workers’ training, there is a need for the government to initiate multisectoral collaborations, especially with network providers, that can create a pathway for addressing network service provision challenges. Such a partnership would not only be beneficial to health workers, but also to community members in the vicinity of the facility. This partnership can also be leveraged to provide internet services at a limited cost for special phone numbers that can be registered to facilities only. There is also a need for the government to create a routine diagnosis for the AEFI reporting platforms that are controlled by the government (such as Med Safety App) and also connect such to other global databases that may be in use (like DHIS2). Finally, it is imperative on the part of the government to keep to the promises made to the public, including the healthcare workers, as this would foster political trust between the people and the government.