Stakeholder perspectives on the demand and supply factors driving substandard and falsified blood pressure lowering medications in Nigeria: A qualitative study

OBJECTIVES: Although substandard and falsified (SF) blood pressure (BP) lowering medications are a global problem, qualitative research exploring factors driving this in Nigeria has not been reported. This study provides information on factors driving demand for and supply of low-quality BP lowering medications in Nigeria and potential strategies to address these factors. METHODS: This was a cross-sectional qualitative study. Between August 2020 and September 2020, we conducted 11 in-depth interviews and 7 focus group discussions with administrators of health facilities, major manufacturers and distributors of BP lowering medications, pharmacists, drug regulators, patients and primary care physicians purposively sampled from the Federal Capital Territory, Nigeria. Data were analysed using directed content analysis, with the aid of Dedoose. RESULTS: We found that demand for SF BP lowering medications in Nigeria was driven by high out-of-pocket expenditure and stockouts of quality-assured BP lowering medications. Supply of low-quality BP lowering medications was driven by limited in-country manufacturing capacity, non-adherence to good manufacturing and distribution practices, under-resourced drug regulatory systems, ineffective healthcare facility operations, poor distribution practices, limited number of trained pharmacists and the COVID-19 pandemic which led to stockouts. Central medicine store procurement procedures, active pharmaceutical ingredient quality check and availability of trained pharmacists were existing strategies perceived to lower the risk of supply and demand of SF BP lowering medications. CONCLUSION: Our findings suggest that demand for and supply of SF BP lowering medications in Nigeria are driven by multi-level, interrelated factors. Multi-pronged strategies need to target stakeholders and systems involved in drug production, distribution, prescription, consumption, regulation and pricing

Clinical characteristics and treatment patterns of pregnant women with hypertension in primary care in the Federal Capital Territory of Nigeria: Cross-sectional results from the Hypertension Treatment in Nigeria Program

BACKGROUND: Hypertensive disorders of pregnancy, including hypertension, are a leading cause of maternal mortality in Nigeria. However, there is a paucity of data on pregnant women with hypertension who receive care in primary health care facilities. This study presents the results from a cross-sectional analysis of pregnant women enrolled in the Hypertension Treatment in Nigeria Program which is aimed at integrating and strengthening hypertension care in primary health care centres. METHODS: A descriptive analysis of the baseline results from the Hypertension Treatment in Nigeria Program was performed. Baseline blood pressures, treatment and control rates of pregnant women were analysed and compared to other adult women of reproductive age. A complete case analysis was performed, and a two-sided p value \u3c 0.05 was considered statistically significant. RESULTS: Between January 2020 to October 2022, 5972 women of reproductive age were enrolled in the 60 primary healthcare centres participating in the Hypertension Treatment in Nigeria Program and 112 (2%) were pregnant. Overall mean age (SD) was 39.6 years (6.3). Co-morbidities were rare in both groups, and blood pressures were similar amongst pregnant and non-pregnant women (overall mean (SD) first systolic and diastolic blood pressures were 157.4 (20.6)/100.7 (13.6) mm Hg and overall mean (SD) second systolic and diastolic blood pressures were 151.7 (20.1)/98.4 (13.5) mm Hg). However, compared to non-pregnant women, pregnant women had a higher rate of newly diagnosed hypertension (65.2% versus 54.4% p = 0.02) and lower baseline walk-in treatment (32.1% versus 42.1%, p = 0.03). The control rate was numerically lower among pregnant patients (6.3% versus 10.2%, p = 0.17), but was not statistically significant. Some pregnant patients (8.3%) were on medications contraindicated in pregnancy, and none of the pregnant women were on aspirin for primary prevention of preeclampsia. CONCLUSIONS: These findings indicate significant gaps in care and important areas for future studies to improve the quality of care and outcomes for pregnant women with hypertension in Nigeria, a country with the highest burden of maternal mortality globally

Formative evaluation and adaptation of a hypertension Extension for Community Health Outcomes program for healthcare workers within the Federal Capital Territory, Nigeria

BACKGROUND: The Extension for Community Health Outcomes (ECHO) model has been used extensively to link care providers in rural communities with experts with the aim of improving local patient care. OBJECTIVE: The aim of this qualitative research study was to assess the feasibility, acceptability, perceived needs, and contextual factors to guide implementation of a hypertension focused ECHO program for Community Health Extension Workers (CHEWs) in the Federal Capital Territory, Nigeria. METHODS: From September 2020 to December 2020, key informant interviews were performed with seven global organizations (hubs) providing ECHO training focused on cardiovascular disease or nephrology to identify contextual factors and implementation strategies used by each hub. In February 2022, seven focus group discussions were performed with 42 frontline healthcare workers in the Federal Capital Territory to inform local adaptation of a hypertension ECHO program. Directed content analysis identified major themes which were mapped to the Consolidated Framework for Implementation Research. Qualitative analyses were performed using Dedoose, and results were synthesized using the Implementation Research Logic Model. RESULTS: We found both barriers and facilitators across the Consolidated Framework for Implementation Research domains that mapped to a number of constructs in each one. The results of these analyses confirmed that the core components of the ECHO model are a feasible and appropriate intervention for hypertension education of healthcare workers. However, implementing the ECHO program within the Federal Capital Territory may require strategies such as utilizing communications resources effectively, developing incentives to motivate initial participation, and providing rewards or recognition for ongoing engagement. CONCLUSIONS: These results provide valuable formative insights to guide implementation of our proposed hypertension ECHO program for CHEWs in the Federal Capital Territory, Nigeria. This information was used for key decisions around: 1) scope and content of training, 2) format and frequency, 3) selection of implementation strategies, and 4) building a community of practice

Effect of Patient-Centered Care on Medication Adherence among Hypertensive Patients attending General Outpatient Clinic at University of Abuja Teaching Hospital, Abuja Nigeria

BackgroundAdherence to medication is poor among adult hypertensive patients and is a factor that influences the control of hypertension. The objective of this study is to assess the effects of patient centered clinical care [PCC] on adherence to antihypertensive medications among adult patients at the general outpatient clinic, University of Abuja Teaching Hospital, Nigeria.MethodsThe study was a single-blinded randomized controlled trial involving 64 hypertensive adults. Participants were assigned using simple random sampling technique into an intervention and a control group. The intervention offered was patient centered clinical care. The control group received the traditional biomedical care for hypertension. Medication adherence was assessed using the Morisky Medication Adherence Scale (MMAS-8) at baseline and after twelve weeks of follow up. Data was analyzed using SPSS software and t-test and Chi square test were used to assess significant statistical differences between variables and proportions at 5% significance level. ResultsAt baseline, 15.6% of participants in the intervention group and 25.0% of participants in the control group had high medication adherence. At baseline, the difference was not statistically significant (p-value 0.351). However, after twelve weeks of intervention, 75.0% of participants in the intervention group were adherent while only 37.5% in the control group were adherent and this difference was statistically significant (p-value 0.002).ConclusionPatient centered care improved medication adherence among adult hypertensive patients. Therefore the use of patient-cared care is recommended in this setting to reduce the risk of cardiovascular events and death

A differential response to antihypertensive therapy in African men and women: Insights from the CREOLE Trial

Background: We sought to address the paucity of data to support the evidence-based management of hypertension to achieve optimal blood pressure (BP) control on a sex-specific basis in Africa. Methods: We undertook a post hoc analysis of the multicenter, randomized CREOLE (Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans) Trial to test the hypothesis that there would be clinically important differences in office BP control between African men and women. We compared the BP levels of 397 and 238 hypertensive women (63%, 50.9 ± 10.5 years) and men (51.2 ± 11.3 years) from 10 sites across sub-Saharan Africa who completed baseline and 6-month profiling according to their randomly allocated antihypertensive treatment. Results: Overall, 442/635 (69.6%) participants achieved an office BP target of \u3c140/90 mm Hg at 6 months; comprising more women (286/72.0%) than men (156/65.5%) (adjusted odds ratio [OR] 1.59, 95% confidence interval [CI] 1.07–2.39; P = 0.023). Women randomized to amlodipine–hydrochlorothiazide (HCTZ) (adjusted OR 3.03, 95% CI 1.71–5.35; P \u3c 0.001) or amlodipine–perindopril (adjusted OR 2.62, 95% CI 1.49–4.58; P = 0.01) were more likely to achieve this target compared with perindopril–HCTZ. Among men, there were no equivalent treatment differences—amlodipine–HCTZ (OR 1.54, 95% CI 0.76–3.12; P = 0.23) or amlodipine–perindopril (OR 1.32, 95% CI 0.65–2.67; P = 0.44) vs. perindopril–HCTZ. Among the 613 participants (97%) with 24-hour ambulatory BP monitoring, women had significantly lower systolic (124.1 ± 18.1 vs. 127.3 ± 16.9; P = 0.028) and diastolic (72.7 ± 10.4 vs. 75.1 ± 10.5; P = 0.007) BP levels at 6 months compared with men. Conclusions: These data suggest clinically important differences in the therapeutic response to antihypertensive combination therapy among African women compared with African men

Fixed‐dose combination therapy‐based protocol compared with free pill combination protocol: Results of a cluster randomized trial

Abstract Fixed‐dose combination (FDC) therapy is recommended for hypertension management in Nigeria based on randomized trials at the individual level. This cluster‐randomized trial evaluates effectiveness and safety of a treatment protocol that used two‐drug FDC therapy as the second and third steps for hypertension control compared with a protocol that used free pill combinations. From January 2021 to June 2021, 60 primary healthcare centers in the Federal Capital Territory of Nigeria were randomized to a protocol using FDC therapy as second and third steps compared with a protocol that used the same medications in free pill combination therapy for these steps. Eligible patients were adults (≥18 years) with hypertension. The primary outcome was the odds of a patient being controlled at their last visit between baseline to 6‐month follow‐up in the FDC group compared to the free pill group. 4427 patients (mean [SD] age: 49.0 [12.4] years, 70.5% female) were registered with mean (SD) baseline systolic/diastolic blood pressure 155 (20.6)/96 (13.1) mm Hg. Baseline characteristics of groups were similar. After 6‐months, hypertension control rate improved in the two treatment protocols, but there were no differences between the groups after adjustment (FDC = 53.9% versus free pill combination = 47.9%, cluster‐adjusted p = .29). Adverse events were similarly low (<1%) in both groups. Both protocols improved hypertension control rates at 6‐months in comparison to baseline, though no differences were observed between groups. Further work is needed to determine if upfront FDC therapy is more effective and efficient to improve hypertension control rates

Assets for integrating task-sharing strategies for hypertension within HIV clinics: Stakeholder's perspectives using the PEN-3 cultural model.

BackgroundAccess to antiretroviral therapy has increased life expectancy and survival among people living with HIV (PLWH) in African countries like Nigeria. Unfortunately, non-communicable diseases such as cardiovascular diseases are on the rise as important drivers of morbidity and mortality rates among this group. The aim of this study was to explore the perspectives of key stakeholders in Nigeria on the integration of evidence-based task-sharing strategies for hypertension care (TASSH) within existing HIV clinics in Nigeria.MethodsStakeholders representing PLWH, patient advocates, health care professionals (i.e. community health nurses, physicians and chief medical officers), as well as policymakers, completed in-depth qualitative interviews. Stakeholders were asked to discuss facilitators and barriers likely to influence the integration of TASSH within HIV clinics in Akwa Ibom, Nigeria. The interviews were transcribed, keywords and phrases were coded using the PEN-3 cultural model as a guide. Framework thematic analysis guided by the PEN-3 cultural model was used to identify emergent themes.ResultsTwenty-four stakeholders participated in the interviews. Analysis of the transcribed data using the PEN-3 cultural model as a guide yielded three emergent themes as assets for the integration of TASSH in existing HIV clinics. The themes identified are: 1) extending continuity of care among PLWH; 2) empowering health care professionals and 3) enhancing existing workflow, staff motivation, and stakeholder advocacy to strengthen the capacity of HIV clinics to integrate TASSH.ConclusionThese findings advance the field by providing key stakeholders with knowledge of assets within HIV clinics that can be harnessed to enhance the integration of TASSH for PLWH in Nigeria. Future studies should evaluate the effect of these assets on the implementation of TASSH within HIV clinics as well as their effect on patient-level outcomes over time

Organizational readiness to implement task-strengthening strategy for hypertension management among people living with HIV in Nigeria

Abstract Background Hypertension (HTN) is highly prevalent among people living with HIV (PLHIV), but there is limited access to standardized HTN management strategies in public primary healthcare facilities in Nigeria. The shortage of trained healthcare providers in Nigeria is an important contributor to the increased unmet need for HTN management among PLHIV. Evidence-based TAsk-Strengthening Strategies for HTN control (TASSH) have shown promise to address this gap in other resource-constrained settings. However, little is known regarding primary health care facilities’ capacity to implement this strategy. The objective of this study was to determine primary healthcare facilities’ readiness to implement TASSH among PLHIV in Nigeria. Methods This study was conducted with purposively selected healthcare providers at fifty-nine primary healthcare facilities in Akwa-Ibom State, Nigeria. Healthcare facility readiness data were measured using the Organizational Readiness to Change Assessment (ORCA) tool. ORCA is based on the Promoting Action on Research Implementation in Health Services (PARIHS) framework that identifies evidence, context, and facilitation as the key factors for effective knowledge translation. Quantitative data were analyzed using descriptive statistics (including mean ORCA subscales). We focused on the ORCA context domain, and responses were scored on a 5-point Likert scale, with 1 corresponding to disagree strongly. Findings Fifty-nine healthcare providers (mean age 45; standard deviation [SD]: 7.4, 88% female, 68% with technical training, 56% nurses, 56% with 1–5 years providing HIV care) participated in the study. Most healthcare providers provide care to 11–30 patients living with HIV per month in their health facility, with about 42% of providers reporting that they see between 1 and 10 patients with HTN each month. Overall, staff culture (mean 4.9 [0.4]), leadership support (mean 4.9 [0.4]), and measurement/evidence-assessment (mean 4.6 [0.5]) were the topped-scored ORCA subscales, while scores on facility resources (mean 3.6 [0.8]) were the lowest. Conclusion Findings show organizational support for innovation and the health providers at the participating health facilities. However, a concerted effort is needed to promote training capabilities and resources to deliver services within these primary healthcare facilities. These results are invaluable in developing future strategies to improve the integration, adoption, and sustainability of TASSH in primary healthcare facilities in Nigeria. Trial registration NCT05031819

Stakeholder perspectives on Nigeria's national sodium reduction program: Lessons for implementation and scale-up.

BackgroundTo reduce excess dietary sodium consumption, Nigeria's 2019 National Multi-sectoral Action Plan (NMSAP) for the Prevention and Control of Non-communicable Diseases includes policies based on the World Health Organization SHAKE package. Priority actions and strategies include mandatory sodium limits in processed foods, advertising restrictions, mass-media campaigns, school-based interventions, and improved front-of-package labeling. We conducted a formative qualitative evaluation of stakeholders' knowledge, and potential barriers as well as effective strategies to implement these NMSAP priority actions.MethodsFrom January 2021 to February 2021, key informant interviews (n = 23) and focus group discussions (n = 5) were conducted with regulators, food producers, consumers, food retailers and restaurant managers, academia, and healthcare workers in Nigeria. Building on RE-AIM and the Consolidated Framework for Implementation Research, we conducted directed content qualitative analysis to identify anticipated implementation outcomes, barriers, and facilitators to implementation of the NMSAP sodium reduction priority actions.ResultsMost stakeholders reported high appropriateness of the NMSAP because excess dietary sodium consumption is common in Nigeria and associated with high hypertension prevalence. Participants identified multiple barriers to adoption and acceptability of implementing the priority actions (e.g., poor population knowledge on the impact of excess salt intake on health, potential profit loss, resistance to change in taste) as well as facilitators to implementation (e.g., learning from favorable existing smoking reduction and advertising strategies). Key strategies to strengthen NMSAP implementation included consumer education, mandatory and improved front-of-package labeling, legislative initiatives to establish maximum sodium content limits in foods and ingredients, strengthening regulation and enforcement of food advertising restrictions, and integrating nutrition education into school curriculum.ConclusionWe found that implementation and scale-up of the Nigeria NMSAP priority actions are feasible and will require several implementation strategies ranging from community-focused education to strengthening current and planned regulation and enforcement, and improvement of front-of-package labeling quality, consistency, and use