Introduction The association between omeprazole and hypertension is poorly documented. The summar... more Introduction The association between omeprazole and hypertension is poorly documented. The summary of product characteristics of omeprazole approved by major regulators did not mention hypertension as an adverse drug event. Triggered by a locally reported case, this study was conducted to assess the possible causal relationship between omeprazole and hypertension. Methods Globally reported cases of hypertension following use of omeprazole submitted to the World Health Organization global database, VigiBase, were retrieved on 5 March 2024 and analyzed descriptively. Besides this, a literature search was made to identify preclinical, clinical, and epidemiological information on the association between omeprazole and hypertension or increased blood pressure using different data sources. Relevant information, gathered from different data sources, was finally systematically organized into an Austin Bradford-Hill causality assessment framework to assess the causal relationship between omeprazole and hypertension. Results VigiBase indicated a total of 1043 cases of hypertension related to omeprazole from 36 different countries. In the global database, a statistical signal was triggered (IC 025 : 0.12) on association of omeprazole and hypertension. From the 1043 cases, 65.0% and 10.6% were reported as 'serious' and 'fatal', respectively. Hypertension resolved following withdrawal of omeprazole in 85 cases and recurred after re-introduction of the suspect drug in 14 cases. In 225 cases, omeprazole was the only suspected drug, while in 122 cases, omeprazole was the sole drug administered. When only these 122 cases were considered, 29 cases had positive dechallenge, four cases were with positive rechallenge and the median time-to-onset was 2 days. Literature search identified a possible biological mechanism and some experimental evidence that indicates omeprazole could possibly cause hypertension. Conclusion Currently available totality of evidence suggests there is a possible causal relationship between omeprazole and hypertension. Hence, it is recommended to monitor and report any incidence of hypertension related to omeprazole, and further epidemiological studies are recommended to corroborate the suggested causal association.
ObjectiveAntimicrobial resistance is a global public health challenge. Dispensing of antibiotics ... more ObjectiveAntimicrobial resistance is a global public health challenge. Dispensing of antibiotics without prescription (DAWP), a major contributor to antibiotic resistance, is extensive in Eritrea. This study was, therefore, aimed at deeply understanding, qualitatively, the pharmacy professionals’ perspective on the factors that trigger DAWP and how this practice could be mitigated.DesignA qualitative exploratory study design was employed.SettingDrug retail outlets of Asmara, capital of Eritrea, and pharmaceutical services of Eritrea.ParticipantsThirty pharmacy professionals who were owners and employees of the drug retail outlets stationed in Asmara and six key informants from the pharmaceutical services of all administrative regions of Eritrea, selected purposively, were the study participants.Data collection and analysisThe data were collected using focus group discussions and key informant interviews between March and September 2020. The collected data were transcribed verbatim, ...
Clinical, Cosmetic and Investigational Dermatology
The use of skin lightening agents (SLAs) is common among African females with black skin color. A... more The use of skin lightening agents (SLAs) is common among African females with black skin color. Although they usually contain harmful ingredients and can cause complications, their use remains to be a common practice. This study was conducted to assess the awareness, perception, and utilization of SLAs among females residing in Asmara, Eritrea. Methods: A cross-sectional analytical study using a quantitative approach was conducted in representative samples of all beauty salons available in Asmara from May to July, 2021. The study participants were selected using two-stage stratified cluster sampling and data were collected through a face-to-face interview using a structured questionnaire. Descriptive analysis and logistic regression, at bivariate and multivariate level, were performed. Results: The study enrolled 721 females and 684 completed the study. The majority of the respondents had the perception that SLAs can make someone light colored (84.4%), look beautiful (67.8%), trendy and fashionable (55.0%), and white skin is more attractive than dark skin (58.8%). About two-thirds (64.2%) reported they had previously used SLAs, mainly influenced by friends (60.5%). Approximately 46% were current users, while 53.6% stopped it mainly due to adverse effects, fear of adverse effects and ineffectiveness. A total of 150 products including natural ingredients were mentioned being used to lighten the skin, and Aneeza, Natural face, and Betamethasone containing brands were among the top used products. The occurrence of at least one adverse effect due to the use of SLAs was 43.7%, while 66.5% were satisfied with the use of SLAs. Additionally, employment status and perception of SLAs were found to be determinants of being a current user. Conclusion: Utilization of SLAs, including products containing harmful or medicinal ingredients, was prevalent among the females of Asmara city. Thus, coordinated regulatory interventions are recommended to tackle unsafe practices and raise public awareness to promote the safe use of cosmetics.
Background Antipsychotics are well-known to cause potentially serious and life-threatening advers... more Background Antipsychotics are well-known to cause potentially serious and life-threatening adverse drug reactions (ADRs) that have been reported to be also one of the major reasons for non-adherence. In Eritrea, shortage of psychiatrists and physicians, inadequacy of laboratory setups and unavailability of second-generation antipsychotics in the national list of medicines would seem to amplify the problem. This study’s objective is to determine the impact of adverse effects of first-generation antipsychotics on treatment adherence in outpatients with schizophrenia at Saint Mary Neuro-Psychiatric National Referral Hospital. Methods A cross-sectional study design was employed. All eligible adult patients with diagnosed schizophrenia (n = 242) who visited the hospital during the study period were enrolled. Data on ADRs, adherence and other variables were collected from patients using a self-administered questionnaire, interview and through medical cards review. The collected variables ...
Abstract Tamsulosin hydrochloride, a selective alpha‐adrenergic blocking agent has been previousl... more Abstract Tamsulosin hydrochloride, a selective alpha‐adrenergic blocking agent has been previously associated with priapism. Priapism is a medically serious condition that, if not intervened, can cause permanent erectile dysfunction. This study was conducted to investigate whether the association of tamsulosin and priapism is causal. All currently available evidence such as experimental, biological, toxicological, published studies, and safety data mined from the WHO global pharmacovigilance database was systematically organized into the Austin Bradford Hill causality assessment framework. In the international pharmacovigilance database, a strong association between tamsulosin and priapism (IC025 = 4.1; PRR025 = 19.9; ROR025 = 20) was observed. There were 122 cases of priapism associated with tamsulosin submitted to the database from 23 countries. In 87.7% of the cases, tamsulosin was reported as a ‘sole suspect,’ and in 50.8%, it was the only drug administered. In several patients, priapism resolved following discontinuation of tamsulosin and recurred after its reintroduction. Both in the published and unpublished data, for majority of the cases, the time to onset of priapism was within few days following the first intake of tamsulosin. Cases of priapism, particularly those published, were consistent in their clinical features with patients experiencing prolonged painful erection that required aspiration of cavernosal blood, irrigation of the corpora cavernosa, and treatment with vasopressors. Other alpha‐adrenergic blocking agents that are structurally analogous with tamsulosin have also been associated with priapism. In several cases, tamsulosin was used off‐label, for the treatment of ureteral calculi expulsion. Eight patients experienced priapism that ended up with serious complications such as ejaculation disorders and erectile dysfunction. The currently available totality of evidence suggests that the association of tamsulosin and priapism is causal. Healthcare professionals are therefore recommended to cautiously prescribe tamsulosin and ensure that consumers are aware of the potential risk of priapism.
Background: ADRs to antipsychotics are amongst the major challenges in the treatment of patients ... more Background: ADRs to antipsychotics are amongst the major challenges in the treatment of patients with psychotic disorders. The extent of patient-reported ADRs assessed in many studies using standardized scales is found to be inconsistent. However, there is a paucity of such research in Eritrea. The aim of the study is therefore to determine the magnitude, nature, and the possible risk factors associated with ADRs of the first generation antipsychotics in outpatients with schizophrenia at Saint Mary Neuro-Psychiatric National Referral Hospital in Asmara, Eritrea, using the LUNSERS self-rating scale. Methods: A cross-sectional, descriptive and analytical study design utilizing a quantitative approach was employed. Data were collected from patients' self-administered questionnaires, interviews, and medical records. The collected variables were analyzed using SPSS 22.0 with descriptive statistics, correlation, t-tests, ANOVA, and multiple regression. Statistical significance was tested at P-value<0.05. Results: In this study, 93.8% of the research participants experienced at least one ADR. LUNSERS total mean score of the relevant items was 28.01 (SD=18.46) with 24.7% of the study participants scoring medium-to-high. The prevalence of the categories of ADRs was psychic (91.3%), autonomic (78.1%), extra-pyramidal (76.9%), miscellaneous (66.5%), hormonal (58.3%), anti-cholinergic (44.2%), and allergic reactions (44.2%). At multivariate level, factors significantly and positively associated with total ADR score were smoking (P=0.028) and being at secondary educational level (P=0.015). Conclusion: There was high prevalence of ADRs with moderate-to-high overall ADR scores in a significant number of patients. The most frequently reported ADRs were psychic, autonomic, extra-pyramidal, hormonal, and miscellaneous. Smoking and secondary level of education were found to be the main determinants of ADRs.
ObjectiveTo measure knowledge, attitude and practice of antibiotics and antibiotic resistance (AB... more ObjectiveTo measure knowledge, attitude and practice of antibiotics and antibiotic resistance (ABR) and their determinants in the Eritrean urban population.DesignA population-based, nation-wide, cross-sectional study.SettingUrban settings of Eritrea.ParticipantsMembers of the general public aged ≥18 years and living in 13 urban places of Eritrea. Three-stage stratified cluster sampling was used to select the study participants.Data collection and analysisDate were collected from July 2019 to September 2019 in a face-to-face interview using a structured questionnaire. The collected data were double entered and analysed using Census and Survey Processing system (V.7.0) and SPSS (V.23), respectively. Descriptive statistics, χ2 test, t-tests, analysis of variance, factorial analysis and multivariable logistic regression were performed. All analyses were weighted and p<0.05 was considered significant.Primary and secondary outcome measuresMain outcome variables were knowledge, attitude...
ObjectiveTo measure knowledge, attitude and practice of antibiotics and antibiotic resistance (AB... more ObjectiveTo measure knowledge, attitude and practice of antibiotics and antibiotic resistance (ABR) and their determinants in the Eritrean urban population.DesignA population-based, nation-wide, cross-sectional study.SettingUrban settings of Eritrea.ParticipantsMembers of the general public aged ≥18 years and living in 13 urban places of Eritrea. Three-stage stratified cluster sampling was used to select the study participants.Data collection and analysisDate were collected from July 2019 to September 2019 in a face-to-face interview using a structured questionnaire. The collected data were double entered and analysed using Census and Survey Processing system (V.7.0) and SPSS (V.23), respectively. Descriptive statistics, χ2 test, t-tests, analysis of variance, factorial analysis and multivariable logistic regression were performed. All analyses were weighted and p<0.05 was considered significant.Primary and secondary outcome measuresMain outcome variables were knowledge, attitude...
Introduction The association between omeprazole and hypertension is poorly documented. The summar... more Introduction The association between omeprazole and hypertension is poorly documented. The summary of product characteristics of omeprazole approved by major regulators did not mention hypertension as an adverse drug event. Triggered by a locally reported case, this study was conducted to assess the possible causal relationship between omeprazole and hypertension. Methods Globally reported cases of hypertension following use of omeprazole submitted to the World Health Organization global database, VigiBase, were retrieved on 5 March 2024 and analyzed descriptively. Besides this, a literature search was made to identify preclinical, clinical, and epidemiological information on the association between omeprazole and hypertension or increased blood pressure using different data sources. Relevant information, gathered from different data sources, was finally systematically organized into an Austin Bradford-Hill causality assessment framework to assess the causal relationship between omeprazole and hypertension. Results VigiBase indicated a total of 1043 cases of hypertension related to omeprazole from 36 different countries. In the global database, a statistical signal was triggered (IC 025 : 0.12) on association of omeprazole and hypertension. From the 1043 cases, 65.0% and 10.6% were reported as 'serious' and 'fatal', respectively. Hypertension resolved following withdrawal of omeprazole in 85 cases and recurred after re-introduction of the suspect drug in 14 cases. In 225 cases, omeprazole was the only suspected drug, while in 122 cases, omeprazole was the sole drug administered. When only these 122 cases were considered, 29 cases had positive dechallenge, four cases were with positive rechallenge and the median time-to-onset was 2 days. Literature search identified a possible biological mechanism and some experimental evidence that indicates omeprazole could possibly cause hypertension. Conclusion Currently available totality of evidence suggests there is a possible causal relationship between omeprazole and hypertension. Hence, it is recommended to monitor and report any incidence of hypertension related to omeprazole, and further epidemiological studies are recommended to corroborate the suggested causal association.
ObjectiveAntimicrobial resistance is a global public health challenge. Dispensing of antibiotics ... more ObjectiveAntimicrobial resistance is a global public health challenge. Dispensing of antibiotics without prescription (DAWP), a major contributor to antibiotic resistance, is extensive in Eritrea. This study was, therefore, aimed at deeply understanding, qualitatively, the pharmacy professionals’ perspective on the factors that trigger DAWP and how this practice could be mitigated.DesignA qualitative exploratory study design was employed.SettingDrug retail outlets of Asmara, capital of Eritrea, and pharmaceutical services of Eritrea.ParticipantsThirty pharmacy professionals who were owners and employees of the drug retail outlets stationed in Asmara and six key informants from the pharmaceutical services of all administrative regions of Eritrea, selected purposively, were the study participants.Data collection and analysisThe data were collected using focus group discussions and key informant interviews between March and September 2020. The collected data were transcribed verbatim, ...
Clinical, Cosmetic and Investigational Dermatology
The use of skin lightening agents (SLAs) is common among African females with black skin color. A... more The use of skin lightening agents (SLAs) is common among African females with black skin color. Although they usually contain harmful ingredients and can cause complications, their use remains to be a common practice. This study was conducted to assess the awareness, perception, and utilization of SLAs among females residing in Asmara, Eritrea. Methods: A cross-sectional analytical study using a quantitative approach was conducted in representative samples of all beauty salons available in Asmara from May to July, 2021. The study participants were selected using two-stage stratified cluster sampling and data were collected through a face-to-face interview using a structured questionnaire. Descriptive analysis and logistic regression, at bivariate and multivariate level, were performed. Results: The study enrolled 721 females and 684 completed the study. The majority of the respondents had the perception that SLAs can make someone light colored (84.4%), look beautiful (67.8%), trendy and fashionable (55.0%), and white skin is more attractive than dark skin (58.8%). About two-thirds (64.2%) reported they had previously used SLAs, mainly influenced by friends (60.5%). Approximately 46% were current users, while 53.6% stopped it mainly due to adverse effects, fear of adverse effects and ineffectiveness. A total of 150 products including natural ingredients were mentioned being used to lighten the skin, and Aneeza, Natural face, and Betamethasone containing brands were among the top used products. The occurrence of at least one adverse effect due to the use of SLAs was 43.7%, while 66.5% were satisfied with the use of SLAs. Additionally, employment status and perception of SLAs were found to be determinants of being a current user. Conclusion: Utilization of SLAs, including products containing harmful or medicinal ingredients, was prevalent among the females of Asmara city. Thus, coordinated regulatory interventions are recommended to tackle unsafe practices and raise public awareness to promote the safe use of cosmetics.
Background Antipsychotics are well-known to cause potentially serious and life-threatening advers... more Background Antipsychotics are well-known to cause potentially serious and life-threatening adverse drug reactions (ADRs) that have been reported to be also one of the major reasons for non-adherence. In Eritrea, shortage of psychiatrists and physicians, inadequacy of laboratory setups and unavailability of second-generation antipsychotics in the national list of medicines would seem to amplify the problem. This study’s objective is to determine the impact of adverse effects of first-generation antipsychotics on treatment adherence in outpatients with schizophrenia at Saint Mary Neuro-Psychiatric National Referral Hospital. Methods A cross-sectional study design was employed. All eligible adult patients with diagnosed schizophrenia (n = 242) who visited the hospital during the study period were enrolled. Data on ADRs, adherence and other variables were collected from patients using a self-administered questionnaire, interview and through medical cards review. The collected variables ...
Abstract Tamsulosin hydrochloride, a selective alpha‐adrenergic blocking agent has been previousl... more Abstract Tamsulosin hydrochloride, a selective alpha‐adrenergic blocking agent has been previously associated with priapism. Priapism is a medically serious condition that, if not intervened, can cause permanent erectile dysfunction. This study was conducted to investigate whether the association of tamsulosin and priapism is causal. All currently available evidence such as experimental, biological, toxicological, published studies, and safety data mined from the WHO global pharmacovigilance database was systematically organized into the Austin Bradford Hill causality assessment framework. In the international pharmacovigilance database, a strong association between tamsulosin and priapism (IC025 = 4.1; PRR025 = 19.9; ROR025 = 20) was observed. There were 122 cases of priapism associated with tamsulosin submitted to the database from 23 countries. In 87.7% of the cases, tamsulosin was reported as a ‘sole suspect,’ and in 50.8%, it was the only drug administered. In several patients, priapism resolved following discontinuation of tamsulosin and recurred after its reintroduction. Both in the published and unpublished data, for majority of the cases, the time to onset of priapism was within few days following the first intake of tamsulosin. Cases of priapism, particularly those published, were consistent in their clinical features with patients experiencing prolonged painful erection that required aspiration of cavernosal blood, irrigation of the corpora cavernosa, and treatment with vasopressors. Other alpha‐adrenergic blocking agents that are structurally analogous with tamsulosin have also been associated with priapism. In several cases, tamsulosin was used off‐label, for the treatment of ureteral calculi expulsion. Eight patients experienced priapism that ended up with serious complications such as ejaculation disorders and erectile dysfunction. The currently available totality of evidence suggests that the association of tamsulosin and priapism is causal. Healthcare professionals are therefore recommended to cautiously prescribe tamsulosin and ensure that consumers are aware of the potential risk of priapism.
Background: ADRs to antipsychotics are amongst the major challenges in the treatment of patients ... more Background: ADRs to antipsychotics are amongst the major challenges in the treatment of patients with psychotic disorders. The extent of patient-reported ADRs assessed in many studies using standardized scales is found to be inconsistent. However, there is a paucity of such research in Eritrea. The aim of the study is therefore to determine the magnitude, nature, and the possible risk factors associated with ADRs of the first generation antipsychotics in outpatients with schizophrenia at Saint Mary Neuro-Psychiatric National Referral Hospital in Asmara, Eritrea, using the LUNSERS self-rating scale. Methods: A cross-sectional, descriptive and analytical study design utilizing a quantitative approach was employed. Data were collected from patients' self-administered questionnaires, interviews, and medical records. The collected variables were analyzed using SPSS 22.0 with descriptive statistics, correlation, t-tests, ANOVA, and multiple regression. Statistical significance was tested at P-value<0.05. Results: In this study, 93.8% of the research participants experienced at least one ADR. LUNSERS total mean score of the relevant items was 28.01 (SD=18.46) with 24.7% of the study participants scoring medium-to-high. The prevalence of the categories of ADRs was psychic (91.3%), autonomic (78.1%), extra-pyramidal (76.9%), miscellaneous (66.5%), hormonal (58.3%), anti-cholinergic (44.2%), and allergic reactions (44.2%). At multivariate level, factors significantly and positively associated with total ADR score were smoking (P=0.028) and being at secondary educational level (P=0.015). Conclusion: There was high prevalence of ADRs with moderate-to-high overall ADR scores in a significant number of patients. The most frequently reported ADRs were psychic, autonomic, extra-pyramidal, hormonal, and miscellaneous. Smoking and secondary level of education were found to be the main determinants of ADRs.
ObjectiveTo measure knowledge, attitude and practice of antibiotics and antibiotic resistance (AB... more ObjectiveTo measure knowledge, attitude and practice of antibiotics and antibiotic resistance (ABR) and their determinants in the Eritrean urban population.DesignA population-based, nation-wide, cross-sectional study.SettingUrban settings of Eritrea.ParticipantsMembers of the general public aged ≥18 years and living in 13 urban places of Eritrea. Three-stage stratified cluster sampling was used to select the study participants.Data collection and analysisDate were collected from July 2019 to September 2019 in a face-to-face interview using a structured questionnaire. The collected data were double entered and analysed using Census and Survey Processing system (V.7.0) and SPSS (V.23), respectively. Descriptive statistics, χ2 test, t-tests, analysis of variance, factorial analysis and multivariable logistic regression were performed. All analyses were weighted and p<0.05 was considered significant.Primary and secondary outcome measuresMain outcome variables were knowledge, attitude...
ObjectiveTo measure knowledge, attitude and practice of antibiotics and antibiotic resistance (AB... more ObjectiveTo measure knowledge, attitude and practice of antibiotics and antibiotic resistance (ABR) and their determinants in the Eritrean urban population.DesignA population-based, nation-wide, cross-sectional study.SettingUrban settings of Eritrea.ParticipantsMembers of the general public aged ≥18 years and living in 13 urban places of Eritrea. Three-stage stratified cluster sampling was used to select the study participants.Data collection and analysisDate were collected from July 2019 to September 2019 in a face-to-face interview using a structured questionnaire. The collected data were double entered and analysed using Census and Survey Processing system (V.7.0) and SPSS (V.23), respectively. Descriptive statistics, χ2 test, t-tests, analysis of variance, factorial analysis and multivariable logistic regression were performed. All analyses were weighted and p<0.05 was considered significant.Primary and secondary outcome measuresMain outcome variables were knowledge, attitude...
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