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Objective: Antimicrobial resistance (AMR) is a global health crisis that threatens to undermine the achievement of Sustainable Development Goal 3, which calls for promoting the health and well-being of all people. AMR prevention and healthcare innovation are essential to Kenya's healthcare system. This study examined the incorporation of transformative elements in interventions that facilitate the implementation of Antimicrobial Stewardship (AMS) in Kenya's decentralised healthcare system. Materials and Methods: The authors conducted a systematic review of technical documents to identify six transformative elements of AMR interventions: directionality, societal goals, impact on the healthcare system, learning versus reflection, conflict resolution and consensus building, and inclusiveness. Results: Kenya's healthcare regulations are strategically in line with its constitution, national development goals, and international commitments. A multidisciplinary approach is guaranteed by the coordination of initiatives across ministries, research institutes, academia, and civil society through several inter-agency committees. The development of healthcare networks and the integration of traditional medicine into conventional healthcare are two factors that support innovative practices. Conclusion: Kenya's healthcare system has made significant progress in implementing AMR prevention and healthcare innovation policies and programs. Active stakeholder participation, particularly from marginalized communities, promotes inclusivity and system-wide impact. However, challenges remain, including resource allocation, policy coordination, and innovation barriers. Continuous learning, reflection, and adaptation are essential for successful AMR stewardship and dispute resolution caused by restrictive regulations. [ABSTRACT FROM AUTHOR]

The change from natural forest cover to tea and Eucalyptus is rampant in protected areas of western Uganda. The objectives were; to examine the trend in land-use /cover change and determine the effect of these changes on the physico-chemical properties of soils around Kibale National Park. The trend in land use/cover change was assessed by analyzing a series of landsat images. Focused group discussions and key informant interviews were used for land-use/cover reconstruction. Three major land uses were included; woodlot (Eucalyptus grandis; 5 years old) ), tea (57 years old) and natural forest used as a control. Each of these land-uses were selected at two different North facing landscape positions and were replicated three times. A total of 36 composite soil samples were taken at 0-15 and 15-30 cm depth from natural forest, Tea plantation and eucalyptus on three ridges. Results showed that small scale farming, tea and eucalyptus plantation and built up area have increased over time, to the expense of woodlot and forest cover. Tea and Eucalyptus have induced changes in: exchangeable Mg and Ca, available P, SOM, pH, and bulk density of sub soil (P < .05). Landscape positions within land use also significantly influenced most soil properties (P < .05). Similar findings were observed by Wang et al. (2006) in commercial tea plantations in China that received nitrogen fertilizers. [ABSTRACT FROM AUTHOR]

Background: In 2018, Kenya introduced triple-drug therapy with ivermectin, diethylcarbamazine, albendazole (IDA) through mass drug administration (MDA) to accelerate the elimination of lymphatic filariasis (LF). This community-based surveillance study assessed the safety and effectiveness of IDA-MDA in reducing LF-antigenemia prevalence and circulating filarial antigens (CFA) clearance among LF infected individuals., Methods: A total of 8928 residents in Mombasa, Kenya, were screened for CFA using the Filarial Test Strip: 3464 were screened in 2018 and 5464 in 2021 after two annual IDA-MDA rounds. CFA-positive individuals in 2021 were re-tested at two and four months of post-MDA for CFA-clearance rates. Adverse events (AEs) associated with IDA-MDA were monitored via door-to-door visits on days 1, 2, and 7 post-MDA to document the incidence, type and risk factors. Efficacy outcomes included post-MDA LF-antigenemia prevalence reduction after two rounds of annual MDA and CFA clearance rate. Chi-square test compared proportions, and logistic regression analysis identified AE predictors., Results: LF antigenemia prevalence significantly decreased from 1.39% (n = 48) in 2018 to 0.66% (n = 36) in 2021 [P < 0.001; 95% confidence interval (CI) for difference in proportions: 0.003-0.012]. CFA clearance rates were 63.2% (12/19, 95% CI: 41.0-80.1%) at 2 months and 68.4% (13/19, 95% CI: 46.0-86.6%) at 4 months post-MDA. Among 53 CFA-positive individuals monitored, the cumulative 7-day AE incidence was 37.7% (95% CI: 25.6-51.7), higher than the general population's 27.3% (95% CI: 26.4-28.2). Common AEs included nausea (11.3%), diarrhea (11.3%), abdominal pain (7.6%), and headache (5.7%). Risk factors for AEs included age, overweight status, concomitant medication use, chronic illness, and fasting before MDA., Conclusions: Triple therapy with IDA is safe and well-tolerated, with some mild-to-moderate and transient adverse events among LF-infected individuals. The high incidence of AEs highlights the need for safety monitoring during MDA. The significant reductions in LF antigenemia prevalence and high CFA clearance rates underscore IDA's effectiveness in reducing LF transmission, positioning it as a key strategy for eliminating LF as a public health problem by 2030., Competing Interests: Declarations. Ethics approval and consent to participate: This study received ethical approval from the Kenyatta National Hospital-University of Nairobi Ethics and Research Committee (Ref No: KNH-ERC/A/413). Written informed consent and/or assent were obtained from adults, parents, or legal guardians of children before study enrolment. Consent for publication: Not applicable. Competing interests: The authors declare that they have no competing interests., (© 2025. The Author(s).)

Continuous professional development among stakeholders involved in drug safety monitoring and surveillance is imperative in strengthening pharmacovigilance (PV) systems. The "Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa" (PROFORMA) project aims to enhance the national PV infrastructure, post-marketing surveillance systems and clinical trial regulatory capabilities in Ethiopia, Tanzania, Kenya and Rwanda. To achieve this, training, including short-term training (STT) activities, at various levels is required. This article aims to describe the experiences of the authors during the development and implementation of STT in an attempt to improve the PV training landscape of these countries. To identify gaps, a baseline assessment of PV teaching and practices at the national medicines regulatory authorities (NMRAs) and medical universities was conducted. Five successive training sessions, tailored to each country's specific needs and regulatory environments, were conducted; three focusing on fundamental concepts in PV and two dedicated to training-of-trainers courses. The training targeted staff from PV units of the NMRAs and medical universities. Enabling participation from all four countries in the same training fostered cross-country learning and collaboration. The contribution of STT to university education and the operational methodologies within NMRAs are explored, showcasing the impact on knowledge transfer and skill development in each country. In conclusion, by investing strategically in STT activities and fostering partnerships with academic institutions and NMRAs, we demonstrated a sustainable approach to PV capacity strengthening in resource-limited settings. The success of this model underscores its potential for adoption and replication across the African continent, offering a valuable framework for strengthening drug safety regulation and ultimately protecting public health., Competing Interests: Declarations Funding This short-term training was part of the “Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa” (PROFORMA) project supported by the European and Developing Countries Clinical Trials Partnership (EDCTP) 2 programme supported by the European Union (grant number CSA2016S-1618). Conflict of Interest Eugène van Puijenbroek is an Editorial Board member of Drug Safety. Eugène van Puijenbroek was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. All other authors declare no relevant conflicts of interest relevant to this article. Ethics Approval Not applicable. Consent to Participate Not applicable. Consent for Publication Not applicable. Code Availability The code of the e-learning modules developed is not available. Availability of Data and Material Not Applicable. Author Contributions The design of the manuscript was determined by EvP. The baseline assessment was conducted by AB. Views from academic institutions and national medicines regulatory authorities were provided by AB, CK, LN, TDG, AF, OM, EM, MO, AG and EL. All authors contributed to manuscript drafting and revision. All authors approved the final version to be published and agreed to be accountable for all aspects of the work., (© 2024. The Author(s).)

Introduction: This study assessed the prevalence and risk factors of nephrotoxicity in paediatric patients receiving aminoglycoside therapy at the Kenyatta National Hospital (KNH) in Kenya., Methods: Between July and September 2018, a prospective cohort study involving children receiving aminoglycoside treatment was carried out at KNH. Before beginning and after finishing the aminoglycoside therapy, the levels of serum creatinine were assessed. Descriptive statistics were used to describe the patients' clinical and sociodemographic features. Associations between nephrotoxicity and maternal and paediatric variables were assessed using multivariable logistic regression., Results: The final analysis comprised 195 children and the prevalence of nephrotoxicity was 10.3%. Neonates made up 28.7% (58/195) of the total and their risk of developing nephrotoxicity was 3.54 (95% CI 1.6-8.21) times higher than that of other children ( P  =   0.003). Neonates with low birth weight were 4.73 (95% CI: 1.8-12.5) times more likely to develop nephrotoxicity than those whose birth weight was >2500 g ( P  = 0.002). Neonatal patients with sepsis had a 4.91 (95% CI: 2.07-11.62) times greater association with acute kidney injury than neonates receiving treatment for other illnesses ( P  = 0.001). Sixty-five percent (13/20) of children who developed nephrotoxicity were switched to cephalosporins., Conclusions: Aminoglycosides were more nephrotoxic to asphyxiated, low-birth-weight neonates with sepsis. Routine monitoring of kidney function should be done within 72 h of starting aminoglycoside treatment in all neonates., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy.)

Introduction: Dual diethylcarbamazine and albendazole (DA) therapy is the standard mass drug administration (MDA) regimen for lymphatic filariasis in Kenya. Following the recent World Health Organization recommendation, Kenya piloted triple therapy with ivermectin, diethylcarbamazine, and albendazole (IDA) in MDA., Objective: We conducted a community-based, observational, cohort event monitoring study to compare the types, frequency, severity, and predictors of adverse events following dual versus triple therapy in 20,421 eligible residents., Methods: Residents in Kilifi (n = 10,010) and Mombasa counties (n = 10,411) received DA and IDA through MDA campaigns, respectively. Adverse events were actively monitored through house-to-house visits on days 1, 2, and 7 after MDA. Any clinical events reported before and after MDA were cross-checked and verified to differentiate pre-existing events from MDA-associated adverse events., Results: Overall, 5807 and 3102 adverse events were reported by 2839 and 1621 individuals in the IDA and DA groups, respectively. The incidence of experiencing one or more adverse events was significantly higher (p < 0.0001) in the IDA group (27.3%; 95% confidence interval [CI] 26.4-28.2) than in the DA group (16.2%; 95% CI 15.5-16.9). Dizziness (15.9% vs 5.9%) and drowsiness (10.1% vs 2.6%) were the most common adverse events and significantly higher in the IDA group compared with the DA group (p < 0.0001). Most adverse events were mild or moderate with a few severe cases (IDA = 0.05%; 95% CI 0.35-0.78, DA = 0.03%; 95% CI 0.14-0.60). Female sex, obesity, taking three or more diethylcarbamazine or ivermectin tablets, and having pre-existing clinical symptoms were significant predictors of adverse events following IDA treatment., Conclusions: Ivermectin, diethylcarbamazine, and albendazole as a combination is as safe and well tolerated as DA to use in MDA campaigns with no serious life-threatening adverse events. Systemic mild-to-moderate adverse events with a few severe cases and transient adverse events are more common with IDA treatment than with DA treatment. Hence, integrating pharmacovigilance into a MDA program is recommended for the timely detection and management of adverse events., (© 2023. The Author(s).)

Introduction: Antimicrobial resistance (AMR) is a global concern. Currently, the greatest mortality due to AMR is in Africa. A key driver continues to be high levels of dispensing of antibiotics without a prescription., Areas Covered: A need to document current rates of dispensing, their rationale and potential ways forward including antimicrobial stewardship programmes (ASPs). A narrative review was undertaken. The highest rates of antibiotic purchasing were in Eritrea (up to 89.2% of antibiotics dispensed), Ethiopia (up to 87.9%), Nigeria (up to 86.5%), Tanzania (up to 92.3%) and Zambia (up to 100% of pharmacies dispensing antibiotics without a prescription). However, considerable variation was seen with no dispensing in a minority of countries and situations. Key drivers of self-purchasing included high co-payment levels for physician consultations and antibiotic costs, travel costs, convenience of pharmacies, patient requests, limited knowledge of antibiotics and AMR and weak enforcement. ASPs have been introduced in some African countries along with quality targets to reduce inappropriate dispensing, centering on educating pharmacists and patients., Expert Opinion: ASP activities need accelerating among community pharmacies alongside quality targets, with greater monitoring of pharmacists' activities to reduce inappropriate dispensing. Such activities, alongside educating patients and healthcare professionals, should enhance appropriate dispensing of antibiotics and reduce AMR.

The introduction of effective vaccines in December 2020 marked a significant step forward in the global response to COVID-19. Given concerns with access, acceptability, and hesitancy across Africa, there is a need to describe the current status of vaccine uptake in the continent. An exploratory study was undertaken to investigate these aspects, current challenges, and lessons learnt across Africa to provide future direction. Senior personnel across 14 African countries completed a self-administered questionnaire, with a descriptive analysis of the data. Vaccine roll-out commenced in March 2021 in most countries. COVID-19 vaccination coverage varied from low in Cameroon and Tanzania and up to 39.85% full coverage in Botswana at the end of 2021; that is, all doses advocated by initial protocols versus the total population, with rates increasing to 58.4% in Botswana by the end of June 2022. The greatest increase in people being fully vaccinated was observed in Uganda (20.4% increase), Botswana (18.5% increase), and Zambia (17.9% increase). Most vaccines were obtained through WHO-COVAX agreements. Initially, vaccination was prioritised for healthcare workers (HCWs), the elderly, adults with co-morbidities, and other at-risk groups, with countries now commencing vaccination among children and administering booster doses. Challenges included irregular supply and considerable hesitancy arising from misinformation fuelled by social media activities. Overall, there was fair to reasonable access to vaccination across countries, enhanced by government initiatives. Vaccine hesitancy must be addressed with context-specific interventions, including proactive programmes among HCWs, medical journalists, and the public.

Introduction: Antimicrobial resistance (AMR) is a concern as this increases morbidity, mortality, and costs, with sub-Saharan Africa having the highest rates globally. Concerns with rising AMR have resulted in international, Pan-African, and country activities including the development of national action plans (NAPs). However, there is variable implementation across Africa with key challenges persisting., Areas Covered: Consequently, there is an urgent need to document current NAP activities and challenges across sub-Saharan Africa to provide future guidance. This builds on a narrative review of the literature., Expert Opinion: All surveyed sub-Saharan African countries have developed their NAPs; however, there is variable implementation. Countries including Botswana and Namibia are yet to officially launch their NAPs with Eswatini only recently launching its NAP. Cameroon is further ahead with its NAP than these countries; though there are concerns with implementation. South Africa appears to have made the greatest strides with implementing its NAP including regular monitoring of activities and instigation of antimicrobial stewardship programs. Key challenges remain across Africa. These include available personnel, expertise, capacity, and resources to undertake agreed NAP activities including active surveillance, lack of focal points to drive NAPs, and competing demands and priorities including among donors. These challenges are being addressed, with further co-ordinated efforts needed to reduce AMR.

Antimicrobial stewardship encourages appropriate antibiotic use, the specific activities of which will vary by institutional context. We investigated regional variation in antibiotic use by surveying three regional public hospitals in Kenya. Hospital-level data for antimicrobial stewardship activities, infection prevention and control, and laboratory diagnostic capacities were collected from hospital administrators, heads of infection prevention and control units, and laboratory directors, respectively. Patient-level antibiotic use data were abstracted from medical records using a modified World Health Organization point-prevalence survey form. Altogether, 1,071 consenting patients were surveyed at Kenyatta National Hospital (KNH, n = 579), Coast Provincial General Hospital (CPGH, n = 229) and Moi Teaching and Referral Hospital (MTRH, n = 263). The majority (67%, 722/1071) were ≥18 years and 53% (563/1071) were female. Forty-six percent (46%, 489/1071) were receiving at least one antibiotic. Antibiotic use was higher among children <5 years (70%, 150/224) than among other age groups (40%, 339/847; P < 0.001). Critical care (82%, 14/17 patients) and pediatric wards (59%, 155/265) had the highest proportion of antibiotic users. Amoxicillin/clavulanate was the most frequently used antibiotic at KNH (17%, 64/383 antibiotic doses), and ceftriaxone was most used at CPGH (29%, 55/189) and MTRH (31%, 57/184). Forty-three percent (326/756) of all antibiotic prescriptions had at least one missed dose recorded. Forty-six percent (204/489) of patients on antibiotics had a specific infectious disease diagnosis, of which 18% (37/204) had soft-tissue infections, 17% (35/204) had clinical sepsis, 15% (31/204) had pneumonia, 13% (27/204) had central nervous system infections and 10% (20/204) had obstetric or gynecological infections. Of these, 27% (56/204) had bacterial culture tests ordered, with culture results available for 68% (38/56) of tests. Missed antibiotic doses, low use of specimen cultures to guide therapy, high rates of antibiotic use, particularly in the pediatric and surgical population, and preference for broad-spectrum antibiotics suggest antibiotic use in these tertiary care hospitals is not optimal. Antimicrobial stewardship programs, policies, and guidelines should be tailored to address these areas., Competing Interests: The authors have declared that no competing interests exist.

The effects of genetic variation of cytochrome P450 2B6 (CYP2B6) and constitutive androstane receptor (CAR) on efavirenz (EFV) plasma concentration was evaluated among 312 HIV patients in Nairobi Kenya. The EFV plasma concentration at steady-state were determined using ultra-high-performance liquid chromatography with a tandem quadruple mass spectrometer (LC-MS/MS). Thirteen CYP2B6 (329G>T, 341T>C, 444 G>T/C, 15582C>T, 516G>T, 548T>G, 637T>C, 785A>G, 18492C>T, 835G>C, 1459C>T and 21563C>T) and one CAR (540C>T) single nucleotide polymorphisms (SNPs) were genotyped using real-time polymerase chain reaction. HIV drug resistance mutations were detected using an in-house genotypic assay. The EFV concentration of patients ranged from 4 ng/mL to 332697 ng/mL (median 2739.5 ng/mL, IQR 1878-4891.5 ng/mL). Overall, 22% patients had EFV concentrations beyond therapeutic range of 1000-4000 ng/mL (4.5%% < 1000 ng/mL and 31.7% > 4000 ng/mL). Five SNPs (15582C>T, 516G>T, 785A>G, 983T>C and 21563C>T) were associated with higher EFV plasma concentration while 18492C>T with lower EFV plasma concentration (p<0.05). Strong linkage disequilibrium (LD) was observed for 15582C>T, 516G>T, 785A>G, 18492C>T, 983T>C, 21563C>T, 1459C>T and CAR 540C>T. Sixteen haplotypes were observed and CTGCTTCC, CTGCTTCT, TTGCTTCT and CGACCCCT were associated with high EFV plasma concentration. In multivariate analysis, factors significantly associated with EFV plasma concentration included; the presence of skin rash (β = 1379, 95% confidence interval (CI) = 3216.9-3416.3; p < 0.039), T allele of CYP2B6 516G>T (β = 1868.9, 95% CI 3216.9-3416.3; p < 0.018), the C allele of CYP2B6 983T>C (β = 2638.3, 95% CI = 1348-3929; p < 0.0001), T allele of CYP2B6 21563C>T (β = 1737, 95% CI = 972.2-2681.9; p < 0.0001) and the presence of 5 to 7 numbers of SNPs per patient (β = 570, 95% CI = 362-778; p < 0.0001) and HIV viral load ≤1000 cells/mL (β = -4199.3, 95% CI = -7914.9 --483.6; p = 0.027). About 36.2% of the patients had EFV plasma concentrations beyond therapeutic window, posing high risk of treatment failure or toxicity. The SNPs of CYP2B6 516G>T, CYP2B6 983T>C, 21563C>T, presence of higher numbers of SNPs per patient and haplotypes CTGCTTCC, CTGCTTCT, TTGCTTCT and CGACCCCT could efficiently serves as genetic markers for EFV plasma concentration and could guide personalization of EFV based ART treatment in Kenya., Competing Interests: The authors have declared that no competing interests exist.

HIV-related stigma, lack of disclosure and social support are still hindrances to HIV testing, care, and prevention. We assessed the association of these social-psychological statuses with nevirapine (NVP) and efavirenz (EFV) plasma concentrations among HIV patients in Kenya. Blood samples were obtained from 254 and 312 consenting HIV patients on NVP- and EFV-based first-line antiretroviral therapy (ART), respectively, and a detailed structured questionnaire was administered. The ARV plasma concentration was measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). There were 68.1% and 65.4% of the patients on NVP and EFV, respectively, who did not feel guilty for being HIV positive. The disclosure rates were approximately 96.1% and 94.6% of patients on NVP and EFV, respectively. Approximately 85% and 78.2% of patients on NVP and EFV, respectively, received social support as much as needed. There were 54.3% and 14.2% compared to 31.7% and 4.5% patients on NVP and EFV, respectively, with supratherapeutic and suboptimal plasma concentrations. Multivariate quantile regression analysis showed that feeling guilty for being HIV positive was associated with increased 954 ng/mL NVP plasma concentrations (95% CI 192.7 to 2156.6; p = 0.014) but not associated with EFV plasma concentrations (adjusted β = 347.7, 95% CI = - 153.4 to 848.7; p = 0.173). Feeling worthless for being HIV positive was associated with increased NVP plasma concentrations (adjusted β = 852, 95% CI = 64.3 to 1639.7; p = 0.034) and not with EFV plasma concentrations (adjusted β = - 143.3, 95% CI = - 759.2 to 472.5; p = 0.647). Being certain of telling the primary sexual partner about HIV-positive status was associated with increased EFV plasma concentrations (adjusted β 363, 95% CI, 97.9 to 628.1; p = 0.007) but not with NVP plasma concentrations (adjusted β = 341.5, 95% CI = - 1357 to 2040; p = 0.692). Disclosing HIV status to neighbors was associated with increased NVP plasma concentrations (adjusted β = 1731, 95% CI = 376 to 3086; p = 0.012) but not with EFV plasma concentrations (adjusted β = - 251, 95% CI = - 1714.1 to 1212.1; p = 0.736). Obtaining transportation to the hospital whenever needed was associated with a reduction in NVP plasma concentrations (adjusted β = - 1143.3, 95% CI = - 1914.3 to - 372.4; p = 0.004) but not with EFV plasma concentrations (adjusted β = - 6.6, 95% CI = - 377.8 to 364.7; p = 0.972). HIV stigma, lack disclosure and inadequate social support are still experienced by HIV-infected patients in Kenya. A significant proportion of patients receiving the NVP-based regimen had supra- and subtherapeutic plasma concentrations compared to EFV. Social-psychological factors negatively impact adherence and are associated with increased NVP plasma concentration compared to EFV., (© 2021. The Author(s).)

Aims: As survival among people living with HIV (PLHIV) improves with universal HIV treatment, new strategies are needed to support management of co-morbidities like type 2 diabetes (T2D). We assessed prediabetes and T2D prevalence and risk factors using haemoglobin A1c (HbA1c) among PLHIV on antiretroviral therapy (ART) in Central Kenya., Methods: This cross-sectional study, conducted at a rural and urban site, enrolled PLHIV aged ≥35 years on ART for at least 5 years. HbA1c was assayed using Cobas b 101 ® , a point-of-care device. HbA1c levels ≥6.5% were considered diagnostic of T2D. For pre-diabetic HbA1c levels (5.7%-6.4%), participants were requested to return the following day for a fasting blood glucose (FBG) to rule out T2D. Risk factors were assessed using multivariable log-binomial regression., Results: Of the 600 completing study procedures, the prevalence of diabetes was 5% (30/600). Ten participants were known to have diabetes; thus, prevalence of newly diagnosed T2D was 3.4% (20/590). Prevalence of prediabetes (HbA1c 5.7%-6.4%) was 14.2% (84/590). Significant predictors of elevated HbA1c were increase in age (Prevalence ratio [PR]: 1.10, CI: 1.02, 1.18, p = .012), hypertension (PR: 1.43, CI: 1.07-2.3, p = .015), central adiposity (PR: 2.11, CI: 1.57-2.84, p < .001) and use of Efavirenz (PR: 2.09, CI: 1.48, 2.96, p < .001)., Conclusion: There is a high prevalence of prediabetes, a significant predictor of T2D, among PLHIV in Central Kenya. Point-of-care HbA1c may help identify PLHIV with prediabetes in a single screening visit and provide an opportunity for early intervention., (© 2021 The Authors. Endocrinology, Diabetes & Metabolism published by John Wiley & Sons Ltd.)

Preventive chemotherapy with diethylcarbamazine citrate (DEC) and albendazole (ALB) is the core intervention strategy to eliminate lymphatic filariasis (LF). We conducted a large-scale prospective active safety surveillance study to identify the incidence, type, severity, and risk factors for adverse events (AEs) following mass drug administration (MDA) of single-dose DEC and ALB in 10,010 participants from Kilifi County, Kenya. AEs were actively monitored and graded at 24 h, 48 h, and on day 7 Post-MDA. Out of 10,010 enrolled study participants, 1621 participants reported a total of 3102 AEs during a seven-day follow-up. The cumulative incidence of AEs was 16.2% (95% CI, 15.5-16.9%). The proportion of participants who experienced one, two, or ≥three types of AEs was 9.2%, 4.6%, 2.4%, respectively. AEs were mild (87.3%), moderate (12.4%), and severe (0.3%) and resolved within 72 h. The five most common AEs were dizziness (5.9%), headache (5.6%), loss of appetite (3.3%), fever (2.9%), and drowsiness (2.6%). Older age, taking concurrent medications, ≥three tablets of DEC, and type of meal taken before MDA were significant predictors of AEs. One in six participants experienced systemic mild-to-moderate severity grading and transient AEs. DEC and ALB co-administration for the elimination of LF is generally safe and well-tolerated.

Monitoring the safety of medicines used in public health programs (PHPs), including the neglected tropical diseases (NTD) program, is a WHO recommendation, and requires a well-established and robust pharmacovigilance system. The objective of this study was to assess the pharmacovigilance systems within the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania. The East African Community Harmonized Pharmacovigilance Indicators tool for PHPs was used to interview the staff of the national NTD programs. Data on four components, (i) systems, structures, and stakeholder coordination; (ii) data management and signal generation; (iii) risk assessment and evaluation; and (iv) risk management and communication, were collected and analyzed. The NTD programs in the four countries had a strategic master plan, with pharmacovigilance components and mechanisms to disseminate pharmacovigilance information. However, zero individual case safety reports were received in the last 12 months (2017/2018). There was either limited or no collaboration between the NTD programs and their respective national pharmacovigilance centers. None of the NTD programs had a specific budget for pharmacovigilance. The NTD program in all four countries had some safety monitoring elements. However, key elements, such as the reporting of adverse events, collaboration with national pharmacovigilance centers, and budget for pharmacovigilance activity, were limited/missing.

Background: The COVID-19 pandemic has already claimed considerable lives. There are major concerns in Africa due to existing high prevalence rates for both infectious and non-infectious diseases and limited resources in terms of personnel, beds and equipment. Alongside this, concerns that lockdown and other measures will have on prevention and management of other infectious diseases and non-communicable diseases (NCDs). NCDs are an increasing issue with rising morbidity and mortality rates. The World Health Organization (WHO) warns that a lack of nets and treatment could result in up to 18 million additional cases of malaria and up to 30,000 additional deaths in sub-Saharan Africa., Objective: Document current prevalence and mortality rates from COVID-19 alongside economic and other measures to reduce its spread and impact across Africa. In addition, suggested ways forward among all key stakeholder groups., Our Approach: Contextualise the findings from a wide range of publications including internet-based publications coupled with input from senior-level personnel., Ongoing Activities: Prevalence and mortality rates are currently lower in Africa than among several Western countries and the USA. This could be due to a number of factors including early instigation of lockdown and border closures, the younger age of the population, lack of robust reporting systems and as yet unidentified genetic and other factors. Innovation is accelerating to address concerns with available equipment. There are ongoing steps to address the level of misinformation and its consequences including fines. There are also ongoing initiatives across Africa to start addressing the unintended consequences of COVID-19 activities including lockdown measures and their impact on NCDs including the likely rise in mental health disorders, exacerbated by increasing stigma associated with COVID-19. Strategies include extending prescription lengths, telemedicine and encouraging vaccination. However, these need to be accelerated to prevent increased morbidity and mortality., Conclusion: There are multiple activities across Africa to reduce the spread of COVID-19 and address misinformation, which can have catastrophic consequences, assisted by the WHO and others, which appear to be working in a number of countries. Research is ongoing to clarify the unintended consequences given ongoing concerns to guide future activities. Countries are learning from each other., (Copyright © 2020 Ogunleye, Basu, Mueller, Sneddon, Seaton, Yinka-Ogunleye, Wamboga, Miljković, Mwita, Rwegerera, Massele, Patrick, Niba, Nsaikila, Rashed, Hussein, Hegazy, Amu, Boahen-Boaten, Matsebula, Gwebu, Chirigo, Mkhabela, Dlamini, Sithole, Malaza, Dlamini, Afriyie, Asare, Amponsah, Sefah, Oluka, Guantai, Opanga, Sarele, Mafisa, Chikowe, Khuluza, Kibuule, Kalemeera, Mubita, Fadare, Sibomana, Ramokgopa, Whyte, Maimela, Hugo, Meyer, Schellack, Rampamba, Visser, Alfadl, Malik, Malande, Kalungia, Mwila, Zaranyika, Chaibva, Olaru, Masuka, Wale, Hwenda, Kamoga, Hill, Barbui, Bochenek, Kurdi, Campbell, Martin, Phuong, Thanh and Godman.)

Introduction: The increased access to medicinal products in Africa is not well-matched with the pharmacovigilance capacity to monitor drug safety. The objective of this study was to assess the functionality and identify the strengths and limitations of the national pharmacovigilance systems in Ethiopia, Kenya, Rwanda, and Tanzania, and compare these systems., Methods: Legal and statutory documents governing the pharmacovigilance systems of each participating country were examined by assessors prior to on-site review. The staff of the pharmacovigilance unit of the National Medicines Regulatory Authorities (NMRAs) were interviewed using the East African Community Harmonized Pharmacovigilance Indicators tool, supplemented with indicators from the World Health Organization (WHO) Global Benchmarking Tool. Responses were recorded, and data were analyzed., Results: The pharmacovigilance systems were supported by law and regulations in line with international standards. Standard operating procedures for receiving, processing, and communicating suspected adverse event reports were in place, but reporting of suspected medicine-related harm from stakeholders was inadequate in all countries. The number of Individual Case Safety Reports (ICSRs) received by NMRAs in Kenya, Ethiopia, and Tanzania (mainland) were 35.0, 6.7, and 4.1 per million inhabitants, respectively, in the last calendar year. At the time of assessment, Rwanda did not have an operational system. Overall, ≤ 1% of the total number of health facilities per country submitted ICSRs. Only Kenya and Tanzania had a designated budget for pharmacovigilance activities and an electronic ICSR reporting system. The national pharmacovigilance systems in all four countries did not have access to data on drug utilization., Conclusions: The national pharmacovigilance systems in the four East African countries have policy and legal frameworks defined by law and regulation to conduct pharmacovigilance activities. However, the four national pharmacovigilance systems are at different levels of capacity and performance with respect to conducting pharmacovigilance activities. Targeted interventions are needed to strengthen the pharmacovigilance systems to enable evidence-based decision making for patient safety.

Background: There has been an appreciable increase in the number of people in Africa with metabolic syndrome and Type 2 diabetes (T2DM) in recent years as a result of a number of factors. Factors include lifestyle changes, urbanisation, and the growing consumption of processed foods coupled with increasing levels of obesity. Currently there are 19 million adults in Africa with diabetes, mainly T2DM (95%), estimated to grow to 47 million people by 2045 unless controlled. This has a considerable impact on morbidity, mortality and costs in the region. There are a number of issues to address to reduce the impact of T2DM including improving detection rates and current access to services alongside addressing issues of adherence to prescribed medicines. There are also high rates of co-morbidities with infectious diseases such as HIV and tuberculosis in patients in Africa with T2DM that require attention., Objective: Document ongoing activities across Africa to improve the care of patients with T2DM especially around issues of identification, access, and adherence to changing lifestyles and prescribed medicines. In addition, discussing potential ways forward to improve the care of patients with T2DM based on ongoing activities and experiences including addressing key issues associated with co-morbidities with infectious diseases., Our Approach: Contextualise the findings from a wide range of publications including internet based publications of national approaches coupled with input from senior level government, academic and other professionals from across Africa to provide future guidance., Ongoing Activities: A number of African countries are actively instigating programmes to improve the care of patients with T2DM starting with improved diagnosis. This recognises the growing burden of non-communicable diseases across Africa, which has been neglected in the past. Planned activities include programmes to improve detection rates and address key issues with diet and lifestyle changes, alongside improving monitoring of care and activities to enhance adherence to prescribed medicines. In addition, addressing potential complexities involving diabetes patients with infectious disease co-morbidities. It is too early to fully assess the impact of such activities., Conclusion: There are a number of ongoing activities across Africa to improve the management of patients with diabetes including co-morbidities. However, more needs to be done considering the high and growing burden of T2DM in Africa. Ongoing research will help further benefit resource allocation and subsequent care., (Copyright © 2020 Godman, Basu, Pillay, Mwita, Rwegerera, Anand Paramadhas, Tiroyakgosi, Okwen, Niba, Nonvignon, Sefah, Oluka, Guantai, Kibuule, Kalemeera, Mubita, Fadare, Ogunleye, Distiller, Rampamba, Wing, Mueller, Alfadl, Amu, Matsebula, Kalungia, Zaranyika, Masuka, Wale, Hill, Kurdi, Timoney, Campbell and Meyer.)

Background: Currently about 19 million people in Africa are known to be living with diabetes, mainly Type 2 diabetes (T2DM) (95%), estimated to grow to 47 million people by 2045. However, there are concerns with early diagnosis of patients with Type 1 diabetes (T1DM) as often patients present late with complications. There are also challenges with access and affordability of insulin, monitoring equipment and test strips with typically high patient co-payments, which can be catastrophic for families. These challenges negatively impact on the quality of care of patients with T1DM increasing morbidity and mortality. There are also issues of patient education and psychosocial support adversely affecting patients' quality of life. These challenges need to be debated and potential future activities discussed to improve the future care of patients with T1DM across Africa., Methodology: Documentation of the current situation across Africa for patients with T1DM including the epidemiology, economics, and available treatments within public healthcare systems as well as ongoing activities to improve their future care. Subsequently, provide guidance to all key stakeholder groups going forward utilizing input from senior-level government, academic and other professionals from across Africa., Results: Whilst prevalence rates for T1DM are considerably lower than T2DM, there are concerns with late diagnosis as well as the routine provision of insulin and monitoring equipment across Africa. High patient co-payments exacerbate the situation. However, there are ongoing developments to address the multiple challenges including the instigation of universal health care and partnerships with non-governmental organizations, patient organizations, and pharmaceutical companies. Their impact though remains to be seen. In the meantime, a range of activities has been documented for all key stakeholder groups to improve future care., Conclusion: There are concerns with the management of patients with T1DM across Africa. A number of activities has been suggested to address this and will be monitored.

Objectives: To evaluate the practice of aminoglycoside use/monitoring in Kenya and explore healthcare worker (HCW) perceptions of aminoglycoside monitoring to identify gaps and opportunities for future improvements, given the low therapeutic index of aminoglycosides., Methods: This was a two-phase study whereby we reviewed patients' medical records at Kenyatta National Hospital (October-December 2016) in Phase 1 and interviewed HCWs face to face in Phase 2. Outcome measures included describing and evaluating the practice of aminoglycoside use and monitoring and compliance to guidelines. Data were analysed using descriptive and inferential analysis., Results: Overall, out of the 2318 patients admitted, 192 patients (8.3%) were prescribed an aminoglycoside, of which 102 (53.1%) had aminoglycoside doses that did not conform to national guidelines. Aminoglycoside-related adverse effects were suspected in 65 (33.9%) patients. Monitoring of aminoglycoside therapy was performed in only 17 (8.9%) patients, with no therapeutic drug monitoring (TDM), attributed mainly to knowledge and skill gaps and lack of resources. Out of the 28 recruited HCWs, 18 (64.3%) needed training in how to perform and interpret TDM results., Conclusions: The practice of using and monitoring aminoglycosides was suboptimal, raising concerns around potential avoidable harm to patients. The identified gaps could form the basis for developing strategies to improve the future use of aminoglycosides, not only in Kenya but also in other countries with similar settings and resources., (© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy.)

Objective: Antibiotics are essential with inappropriate use leading to antimicrobial resistance (AMR). Currently, little is known about antibiotic use among hospitals in Kenya, which is essential to tackle as part of the recent national action plan addressing rising AMR rates. Consequently, the objective was to overcome this gap in a leading referral hospital in Kenya. The findings will subsequently be used to develop quality improvement programs for this and other hospitals in Kenya., Methods: This was a point prevalence survey. Data on antibiotic use were abstracted from patient medical records by a pharmacy team., Findings: The prevalence of antibiotic prescribing was 54.7%, highest in the intensive care unit and isolation wards. Most antibiotics were for treatment (75.4%) rather than prophylaxis (29.0%). The majority of patients on surgical prophylaxis were on prolonged duration (>1 day), with only 9.6% on a single dose as per current guidelines. Penicillins (46.9%) followed by cephalosporins (44.7%) were the most prescribed antibiotic classes. The indication for antibiotic use was documented in only 37.3% of encounters. Generic prescribing was 62.5% and empiric prescribing was seen in 82.6% of encounters. Guideline compliance was 45.8%., Conclusion: Several areas for improvement were identified including addressing prolonged duration for prophylaxis, extensive prescribing of broad-spectrum antibiotics, high rates of empiric prescribing, and lack of documenting the indication for antimicrobials. Initiatives are ongoing to address this with pharmacists playing a key role., Competing Interests: There are no conflicts of interest., (Copyright: © 2019 Journal of Research in Pharmacy Practice.)

Background: Medicines can constitute up to 70% of total health care budgets in developing countries as well as considerable expenditure in hospitals. Inventory management techniques can assist with managing resources efficiently. In Kenyatta National Hospital (KNH), a leading hospital in Kenya, over 30% of expenditure is currently allocated to medicines, and this needs to be optimally managed. Objective: To investigate drug consumption patterns, their costs and morbidity patterns at KNH in recent years. Methodology: Cross-sectional retrospective record review. Inventory control techniques, ABC (Always, Better, and Control), VEN (Vital, Essential, and Non-essential) and ABC-VEN matrix analyses were used to study drug expenditure patterns. Morbidity data was extracted from the Medical Records. Results: Out of an average of 811 medicine types procured annually (ATC 5), 80% were formulary drugs and 20% were non-formulary. Class A medicines constituted 13.2-14.2% of different medicines procured each year but accounted for an average of 80% of total annual drug expenditure. Class B medicines constituted 15.9-17% of all the drugs procured yearly but accounted for 15% of the annual expenditure, whilst Class C medicines constituted 70% of total medicines procured but only 5% of the total expenditure. Vital and Essential medicines consumed the highest percentage of drug expenditure. ABC-VEN categorization showed that an average of 31% of medicine types consumed an average of 85% of total drug expenditure. Therapeutic category and Morbidity patterns analysis showed a mismatch between drug expenditure and morbidity patterns in over 85% of the categories. Conclusion: Class A medicines are few but consume the largest proportion of hospital drug expenditure. Vital and essential items account for the highest drug expenditure, and need to be carefully managed. ABC-VEN categorization identified medicines where major savings could potentially be made helped by Therapeutic category and Morbidity pattern analysis. There was a high percentage of non-formulary items, which needs to be addressed. Inventory control techniques should be applied routinely to optimize medicine use within available budgets especially in low and middle income countries.

Introduction: There is continued unmet medical need for new medicines across countries especially for cancer, immunological diseases, and orphan diseases. However, there are growing challenges with funding new medicines at ever increasing prices along with funding increased medicine volumes with the growth in both infectious diseases and non-communicable diseases across countries. This has resulted in the development of new models to better manage the entry of new medicines, new financial models being postulated to finance new medicines as well as strategies to improve prescribing efficiency. However, more needs to be done. Consequently, the primary aim of this paper is to consider potential ways to optimize the use of new medicines balancing rising costs with increasing budgetary pressures to stimulate debate especially from a payer perspective. Methods: A narrative review of pharmaceutical policies and implications, as well as possible developments, based on key publications and initiatives known to the co-authors principally from a health authority perspective. Results: A number of initiatives and approaches have been identified including new models to better manage the entry of new medicines based on three pillars (pre-, peri-, and post-launch activities). Within this, we see the growing role of horizon scanning activities starting up to 36 months before launch, managed entry agreements and post launch follow-up. It is also likely there will be greater scrutiny over the effectiveness and value of new cancer medicines given ever increasing prices. This could include establishing minimum effectiveness targets for premium pricing along with re-evaluating prices as more medicines for cancer lose their patent. There will also be a greater involvement of patients especially with orphan diseases. New initiatives could include a greater role of multicriteria decision analysis, as well as looking at the potential for de-linking research and development from commercial activities to enhance affordability. Conclusion: There are a number of ongoing activities across countries to try and fund new valued medicines whilst attaining or maintaining universal healthcare. Such activities will grow with increasing resource pressures and continued unmet need.

Aim: Zidovudine and tenofovir form the backbone of antiretroviral therapy in Kenya. However, their side-effects may affect the quality of life (QoL) of patients. The aim was to compare the health-related quality of life (HRQoL) of adult patients on tenofovir versus zidovudine based regimens in a referral hospital in Kenya to provide future guidance. Methods: A comparative cross sectional study among 501 adult out-patients on either tenofovir or zidovudine was undertaken in Kenyatta National Hospital between 2015 and 2016. The Medical Outcome Study HIV Health Survey (MOS-HIV) was administered along with other key aspects of treatment. Linear regression analysis was performed to identify determinants of HRQoL. Results: Patients on zidovudine had a higher Physical Health Summary Score (PHSS) and Mental Health Summary Score (MHSS) compared to those on tenofovir. The presence of any symptom of the disease and a stated inability to cope were negatively associated with PHSS, whilst having a regular source of income improved PHSS. Being on tenofovir, symptom of illness [β = -1.24; 95% CI (-2.253, -0.226)], absence of pain [β=0.413; 95% CI (0.152, 0.674)] and patient stated inability to cope with HIV [β = -1.029; 95% CI (-1.441, -0.617)] affected the MHSS. Patients on tenofovir and second line regimens had more signs and symptoms of illness. Conclusion: Participants on zidovudine based regimens showed a better performance across all aspects of HRQoL. These are considerations for the future.

Background and Aims: A substantial amount of antibiotic use in hospitals may be inappropriate, potentially leading to the development and spread of antibiotic resistance, adverse effects, mortality and increased hospital costs. The objective was to assess current patterns of antibiotic use in a leading referral hospital in Western Kenya. This would lead to the identification of opportunities for quality improvement in this hospital and others across Kenya., Methodology: A point prevalence survey was carried out with data abstracted principally from patient medical records supplemented by interviews from physicians when needed. The pattern of antibiotic use was analyzed by descriptive methods. Differences in antibiotic use and indications between the selected wards were compared using the Chi-square test or Fisher's exact tests., Results: Among the patients surveyed, 67.7% were on antibiotics. The most common classes of antibiotics prescribed were third generation cephalosporins (55%), imidazole derivatives like metronidazole (41.8%) and broad spectrum penicillins (41.8%). The most common indication for antibiotic use was medical prophylaxis (29%), with local guidelines advocating antibiotic prophylaxis in mothers after delivery of their child as well as in neonates with birth asphyxia and low weight at birth. Dosing of antibiotics was seen as generally optimal when assessed against current recommendations., Conclusion: Whilst the dosing of antibiotics seemed adequate, there was high use of antibiotics in this hospital. This needs to be urgently reviewed with currently appreciable empiric antibiotic use. Programmes are being instigated to address these concerns. This includes developing antibiotic guidelines and formularies especially for empiric use as well as implementing antimicrobial stewardship activities.

Objectives: Irrational use of antibiotics is a major driver of antimicrobial resistance (AMR), exacerbated by dispensing of antibiotics without a prescription especially for typically viral infections. Such dispensing is common despite legislation. Pharmacists play a key role in advising on medicines, especially in countries where most patients seek pharmacist help as they cannot afford both physician fees and medicines. Consequently, our objective was to ascertain pharmacists' skills and knowledge regarding antibiotics when patients present to them with typically viral infections., Methods: This was a qualitative cross-sectional survey among 370 community pharmacists in Albania, with carefully selected and validated topics. The main outcome measure was knowledge of antibiotics and current legislation., Results: Variable knowledge regarding antibiotics among community pharmacists. 55% knew colds are caused by viruses and 93% that antibiotics are ineffective against influenza. However, 18% believed if colds last >4 days an antibiotic can bring a patient back to work, and only 13% stated antibiotics are ineffective against viruses. Encouragingly, 93% knew penicillins can cause anaphylactic shock, 74% that antibiotics kill bacteria causing infections, and only 7% that antibiotic misuse cannot cause AMR. However, 13% stated the main disadvantage of antibiotics is that they are ineffective against viruses and 93% admitted they had no treatment protocols to consult in their daily work to direct patient care., Conclusion: Encouraging signs regarding pharmacists' knowledge of antibiotics in Albania; however, concerns. Instigating educational programmes among patients and pharmacists and greater enforcement of legislation should reduce AMR rates in Albania and across countries., (Copyright © 2018 International Society for Chemotherapy of Infection and Cancer. Published by Elsevier Ltd. All rights reserved.)

Objective: The objective of this study was to evaluate the extent of self-medication of antibiotics and dispensing practices in Kenya., Methods: A cross-sectional study was carried out at three selected pharmacies in Nairobi (Kenya), between January and March 2017, targeting principally antibiotic prescriptions for systemic use issued and dispensed as well as antibiotics sold over-the-counter without a prescription. The quality of antibiotics prescribed and dispensed was assessed against key WHO and other criteria. Benchmarking was used to assess the quality of antibiotics prescribed as there are no predetermined levels, just guidance and the rationale. Key indicators included: utilization of penicillins, percentage utilization of third-and fourth-generation of cephalosporins versus first and second generation, utilization of macrolides including lincosamides and utilization of quinolones as a percent of total systemic antibiotic use., Findings: There was a low level of dispensing of antibiotics without a prescription with over 90% (94.1%) of antibiotics dispensed with a valid prescription. The most common antibiotics dispensed were the penicillins at just over 50% of all antibiotics, the cephalosporins at over 12% (12.6%) and the fluoroquinolones at just under 12% (11.7%). There were concerns with high use of third and fourth generation cephalosporins versus first- and second-generation as well as co-amoxiclav versus other penicillins., Conclusion: Low levels of self-medication of antibiotics and high adherence to quality standards for dispensing are encouraging and provide direction to other countries. Educational initiatives are needed though to address high levels of co-amoxiclav prescribing., Competing Interests: There are no conflicts of interest.

Aim: Hypertension is a leading global health problem requiring lifelong treatment. However, adherence to antihypertensive medicines is a problem, greater among developing countries. Consequently, there is a need to determine current adherence rates and their associations among developing countries to plan future initiatives., Materials & Methods: Cross-sectional study among adult outpatients with essential hypertension in Tanzania. Predesigned questionnaires were used to gather information on adherence rates and patient-related beliefs. The main outcome measure was adherence., Results: A total of 180 participants were included, with females making up 65%. High-adherence rates were seen in 54% of the patients. Patients' belief about their medication and its necessity was higher in the high adherent group and concerns about their medicines and their necessity were higher in the low adherent group. Conclusion & recommendations: Adherence rates were low compared with a suggested level ≥80%. Educational initiatives are needed to address knowledge and concerns with hypertension to improve future outcomes.

The second Medicines Utilization Research in Africa (MURIA) group workshop and symposium again brought researchers together from across Africa to improve their knowledge of drug utilization (DU) methodologies and exchange ideas to further progress DU research in Africa. This built on extensive activities from the first conference including workshops and multiple publications. Anti-infectives were again the principal theme for the 2016 symposium following the workshops. This included presentations regarding strategies to improve antibiotic utilization among African countries, such as point-prevalence studies, as well as potential ways to reduce self-purchasing of antibiotics. There were also presentations on antiretrovirals including renal function and the impact of policy changes. Concerns with adherence in chronic treatments as well as drug-drug interactions and their implications were also discussed. The deliberations resulted in a number of agreed activities including joint publications before the next MURIA conference in Namibia in 2017.

The relative bioavailabilities of three carbamazepine tablet formulations available in the Kenyan market (Temporal(R), Taver(R) and Carbamazepine Lincoln) compared with the innovator formulation (Tegretol(R)) were evaluated in seven healthy African volunteers (5 males, two females; aged 22-36 years), according to a randomised fourway crossover study design, following oral administration of single 200 mg doses with a three week washout period. In vitro dissolution profiles of the tablets were also evaluated. Relative bioavailabilities ((F)rel) of Temporal(R), Taver(R) and Carbamazepine Linocoln were 101.2%, 82.2% and 71.6% respectively, compared with Tegretol(R). Percent drug content dissolved in vitro after I hour were 91.3%, 75.9% and 39.3% for Temporal(R), Taver(R) and Carbamazepine Lincoln, respectively. It was concluded that Temporal(R) was bioequivalent to Tegretol(R) while Taver(R) and Carbamazepin Lincoln were bioinequivalent to Tegretol(R). Administration of Taver(R) or Carbamazepine Lincoln might lead to poor control of epileptic seizures.