Potentially Inappropriate Use of Medication and Its Determinants Among Ambulatory Older Adults in Six Community Chain Pharmacies in Asmara, Eritrea: A Cross-Sectional Study Using the 2023 American Geriatric Society Beers Criteria®.

Background: Potentially inappropriate medication (PIM) use is one of the main drug-related problems encountered in older adults. It is associated with adverse drug events, morbidity, mortality, increased economic costs, and negative effects on the quality of life that requires strict monitoring of prescriptions in older adults. Thus, the study aimed to assess potentially inappropriate medication use and its determinants among older adults. Methods: A cross-sectional study was conducted among all outpatient prescriptions dispensed to older adults (aged 65 years and above) in six community chain pharmacies in Asmara, Eritrea. Data were collected retrospectively, between June 16 and July 16, 2023. PIMs were detected using the 2023 American Geriatric Society (AGS) Beers Criteria®. Descriptive statistics and logistic regression analysis were performed using IBM SPSS® (Version-26.0). Results: A total of 2680 outpatient prescriptions dispensed to older adults were included in this study. The prevalence of PIM among prescriptions was 18.1% (95% CI: 16.7, 19.6). Moreover, a total of 470 medications were found to be avoided in older adults. The most commonly prescribed PIMs were sulfonylureas (27.2%) and substituted alkylamines (16.2%). The prevalence of prescriptions containing medications to be used with caution in older adults was 13.2% (95% CI: 12.0, 14.5). Age (Adjusted Odds Ratio (AOR))=0.98, 95% CI: 0.97, 0.99), polypharmacy (AOR=2.77, 95% CI: 1.49, 5.15), and general practitioner prescriber (AOR=1.38, 95% CI: 1.11, 1.70) were significantly associated with PIMs. Conclusion: A considerable number of ambulatory older adults were exposed to PIMs which require a close attention by policymakers, program managers, and healthcare professionals.

Omeprazole and Risk of Hypertension: Analysis of Existing Literature and the WHO Global Pharmacovigilance Database.

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 (IC025: 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.

Tamsulosin and risk of priapism: A causality assessment using Austin Bradford Hill Criteria.

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.