2.1 The Côte d’Ivoire Health Care System

The health care system in Côte d'Ivoire is under the responsibility of the Ministry of Health and Public Hygiene (MHPH) and constitutes the public sector, private sector, and traditional medicine. The public sector comprises administrative and medical components, each with three levels. The administrative component contains a central level that includes, among others, the Ministerial Cabinet and related services, an intermediate level currently made up of 33 regional offices, and a peripheral or operational level composed of 86 health districts responsible for the implementation of primary health care. The medical component of the public sector is primarily supported by the state and classified according to primary (urban and rural health care centres), secondary (regional and general hospitals), and tertiary care. The tertiary health care facilities (HCFs) include four university teaching hospitals (Centre Hospitalier Universitaire, CHU), five specialised national institutes, and four other national public institutions [16]. The private sector includes clinics, hospitals, specialist practitioners, infirmaries, and pharmacies.

2.2 The PV Enhancement Project in Côte d’Ivoire

The objectives of the project in Côte d’Ivoire were to improve post-marketing safety monitoring of medicinal products through PV training and mentoring of HCPs, and increase AE reporting in selected HCFs in the Abidjan region. Ethical approval was therefore not required. The national PV stakeholders agreed to implement the project in the Abidjan region, which has a population of five million inhabitants. This region was identified as lacking both PV focal point training and trained HCPs.

The project was implemented from the end of August 2018 to February 2020. The main stages of the project are presented in Fig. 1.

Fig. 1

Project roadmap showing the main phases of the PV enhancement project in Côte d’Ivoire. AE adverse event, HCF health care facility, HCP health care provider, KPI key performance indicator, PV pharmacovigilance

2.3 Project Initiation and Planning

After submitting a letter of intent to the MHPH in September 2016, an initiation meeting was held from 28 November to 1 December 2016 to endorse the project. This brought together representatives from GSK, PATH, MHPH, WHO country office, Expanded Programme on Immunisation (EPI), national PV experts, and the DPML (currently known as AIRP, but referred to in this manuscript as the DPML because the Vigilance Unit was under the DPML at the time of project implementation).

The initiation meeting was followed by a planning meeting on 22 February 2017 with the national PV stakeholders, GSK, and PATH to discuss project implementation and to define key performance indicators (KPIs) for monitoring and evaluating progress. A collaboration agreement was signed between the Côte d’Ivoire DPML and GSK before the start of project implementation on 27 August 2018.

2.3.1 Selection of HCFs

The HCFs selected for this project were district referral hospitals (general hospitals) and other HCFs, based on patient consultation rates. Ninety-one HCFs were selected within the two health care regions of Abidjan: Abidjan 1 Grands Ponts (37 HCFs) and Abidjan 2 (54 HCFs). In Abidjan 1 Grands Ponts, there were 29 HCFs in six health districts, six general hospitals, one private clinic, and one private pharmacy, and in the Abidjan 2 region, 44 HCFs in six health districts, seven general hospitals, and three private clinics (Table 1; Supplementary Table S1).

Table 1 Summary of PV trainings provided to HCPs in Abidjan, Côte d’Ivoire, and numbers of AE reports received centrally by the Vigilance Unit2.3.2 Critical PV Personnel

Personnel important for project delivery included PV focal points, the national PV coordinator, and the PV data manager. No new positions were created; instead, existing infrastructure and personnel were engaged for sustainability. Forty focal points (20 per health care region) were identified, trained and engaged in training HCPs at their facilities: 12 for the 12 health districts, 13 for the 13 general hospitals, and two for the five private facilities, as well as 11 focal points for monitoring AEs following immunisation (AEFI) for each district (apart from the Marcory-Treichville district, which had instead a focal point at each of the two district general hospitals), and one for each of the two Abidjan health care regions in order to establish two regional PV hubs. Of the 40 focal points, 26 were pharmacists, 10 were clinicians, and four were pharmacy assistants. The EPI and health district focal points were based at the health district offices and were responsible for the HCFs within their district, while the focal points for the general hospitals and private facilities were based within their respective facilities.

A pharmacist from the Vigilance Unit of the DPML was designated as PV coordinator to lead and coordinate PV activities as part of this project and nationally. The PV coordinator had prior experience in national PV initiatives and partnerships, including PV training in conjunction with AEFI monitoring associated with vaccination programmes. To support effective data management, a dedicated data manager role was established at the Vigilance Unit, with responsibility for data entry into the Vigilance Unit’s PV database (Excel spreadsheet) and the global PV database (VigiBase). However, VigiBase data entry did not occur until the end of 2019.

2.3.3 Key Performance Indicators

Various KPIs were discussed and validated by the national PV experts to ensure systematic evaluation of the project’s performance in the Abidjan region. No baseline AE reporting data were available specifically from this region, only national data showing 20 and 74 AE reports were received at the Vigilance Unit in 2015 and 2016, respectively, and 10% of identified AEs underwent causality assessment by the Vigilance Unit in 2016. Four categories of KPIs were proposed: (A) volume of AE reports; (B) efficiency of AE report transmission and data entry; (C) quality of the AE reports; and (D) quality of the central response to the AE reports received. Expected proportions were set for each KPI where possible, based partly on experience from the pilot project in Malawi [10].

A.

Volume of AE reports

KPI 1.

The number of AE reports received at the Vigilance Unit.

KPI 2.

Proportion of AE reports received at the Vigilance Unit, calculated as the number of AE notifications drawn up and sent by HCPs, and received centrally by the Vigilance Unit, divided by the number of notifications expected to be received centrally during the implementation period (since it was expected that all AE reports that were made by HCPs would be received by the Vigilance Unit eventually, the expected proportion was 100%).

KPI 3.

Proportion of serious AEs, as identified from all AE reports received and reviewed at the Vigilance Unit (no expected proportion set because of lack of previous data from Côte d’Ivoire). A serious AE was defined as standard, i.e., as an AE that results in death, is life-threatening, requires hospitalisation or prolongation of hospitalisation, or results in persistent or significant disability or a birth defect.

B

Efficiency of AE report transmission and data entry

KPI 4.

Proportion of AE reports delivered to the Vigilance Unit within 72 h, calculated as the number of reports transmitted by the focal point or HCP within 72 h of when the HCP completed the AE notification divided by the total number of AE reports received centrally at the Vigilance Unit (expected proportion, 50%). Proportion of AE reports delivered to the Vigilance Unit within 30 days (expected proportion, 100%) was evaluated as a supplementary analysis.

KPI 5.

Proportion of AE reports received, examined, and entered into the Vigilance Unit’s PV database (Excel spreadsheet) within 48 h (expected proportion, 100%).

KPI 6.

Proportion of AE reports received, examined, and entered into VigiBase (expected proportion, 90%).

C

Quality of AE reports

KPI 7.

Proportion of AE reports received that were complete, i.e., contained information considered mandatory for a valid AE case report: the reporter, event, patient, and suspected medicinal product (expected proportion, 80%).

D.

Quality of central response to AE reports received

KPI 8.

Proportion of AE reports for which causality assessment was performed for identified AEs by the Vigilance Unit (no expected proportion set because of few previous data from Côte d’Ivoire).

KPI 9.

Proportion of AE reports for which feedback was provided to the reporter. Feedback (at the least, acknowledgement of receipt) was expected for all AE reports received (expected proportion, 100%).

The KPIs were to be evaluated by the national stakeholders and GSK/PATH every six months and at the end of the project.

2.4 Project Implementation2.4.1 PV Trainings

Project implementation began with a “Training of Trainers” workshop for the focal points, held in Grand-Bassam, Côte d’Ivoire, 27–30 August 2018. The sessions included trainings on AEFI and ADR classification, sensitisation on the importance and impact of vaccination, case studies on how to notify an AE, group presentations, and sharing of real-life experiences of the challenges of AE reporting. Interactive sessions encouraged the active participation of all attendees. On Day 2 of the workshop, a roundtable discussion allowed focal points to share what they had learned from the previous day’s training and how they could impart PV sensitisation within their HCFs. All participants received a certificate of attendance, reinforcing the value of the training. The trainers were recognised as country PV experts: a clinical pharmacologist from the University of Bouaké, a vaccinologist from the EPI, and a pharmacist from the Vigilance Unit (also the national PV coordinator).

Trained focal points delivered 1- to 2-h abridged PV trainings to HCPs at the selected HCFs, with the aim of raising awareness among HCPs of the importance of spontaneous AE notification and explaining how to report AEs. The trainings covered topics such as the importance of detecting and reporting suspected AEs to the national PV office, the process of reporting AEs, the minimum and essential information required, and a case study on AE reporting. Trainings were provided every two to three months. The first two rounds of training were provided by the national PV coordinator and subsequent rounds by trained focal points, with new HCPs trained during each session.

2.4.2 PV Mentoring

The national PV coordinator visited the selected HCFs every three months to supervise and mentor the PV activities of the focal points and to participate in the HCP training sessions. Mentoring was done through supervision visits, telephone calls, short message service (SMS) messages, WhatsApp group reminders, email, and hand delivery of material during face-to-face meetings. Additionally, during each sensitisation visit, focal points of selected general hospitals mentored at least seven previously trained HCPs, while the district and AEFI focal points mentored at least five HCPs per HCF. Each focal point received a monthly airtime award, which enabled them to communicate freely with HCPs in the HCFs under their responsibility during the sensitisation and mentoring phases.

2.4.3 AE Report Form Completion, Transmission, and Data Entry

The national AE reporting form was the primary tool for AE notification. The HCPs were encouraged to report ADRs, AEFIs, traditional medicine-suspected AEs, and any incidents in newborns, whether or not medicinal products were prescribed, including information on where the medicinal product was purchased (pharmacy, drug store, or roadside vendor). The original AE reporting form (Supplementary Material S2 and S4) was revised in April 2019 to include essential information facilitating causality assessment, such as information on risk factors, medical history, batch number, etc. (see Supplementary Material S3 and S5).

The AE report transmission scheme in place in Côte d’Ivoire is shown in Fig. 2. However, the focal points and HCPs were encouraged to use all possible means for transmitting completed AE report forms directly to the Vigilance Unit, including email, SMS, postage, and hand delivery, for prompt data entry and assessment of the reports. Because Côte d’Ivoire had no national AE database, an Excel spreadsheet was used to collate the AE data, and this information was entered later into VigiBase.

Fig. 2

Official route for flow of information on AEs in Côte d’Ivoire: the transmission pathway for reporting AEs (mostly adverse drug reactions) to the AIRP (previously DPML) Vigilance Unit followed by data entry into the WHO global database (VigiBase). Dotted lines indicate causality assessment by the Clinical Pharmacology Department of University Félix Houphouet-Boigny. E-notification refers to data entry via the Med Safety medical mobile app (used since 2020). AEs adverse events, AIRP Ivorian Pharmaceutical and Regulatory Authority, DPML Department of Pharmacy, Medicine and Laboratories, HCF health care facility, MHPH Ministry of Health and Public Hygiene, UTH University teaching hospital, WHO World Health Organization

Weekly accountability sessions were to be held internally by the Vigilance Unit to classify the quality of the reports and detect any signal requiring causality assessment for discussion and assessment by the Clinical Pharmacology Department of U-FHB, the reference centre of the NCP.

2.4.4 Project Communication

The PV coordinator regularly communicated project updates to the focal points. Posters were developed by the DPML and displayed in sensitised HCFs and other HCFs across the country to raise awareness and remind patients and HCPs of the importance of spontaneous AE reporting.

National PV stakeholder meetings were organised within 12 months of project implementation to update the PV experts on project progression. Two technical committee meetings were held during the 18-month implementation period to discuss the progress of the project, including successes and challenges. During HCP trainings and mentoring visits, challenges were discussed, along with proposals on how to improve reporting. Due to the COVID-19 pandemic, the end-of-project meeting planned in March 2020 with national stakeholders, GSK, and PATH could not be held.

2.4.5 Funding

GlaxoSmithKline Biologicals SA provided financial support for the PV trainings and mentoring visits, and acquisition of office equipment (such as laptops, hard disks, printers, antivirus software, etc.). Allowances for the PV coordinator and data manager were also funded.