Pharmacoepidemiology, Volume 5, Issue 1 (March 2026) – 9 articles

Background: Furosemide is one of the most frequently prescribed loop diuretics for cardiovascular conditions, particularly in the management of volume overload and acute elevations in blood pressure. However, detailed real-world data describing its utilization characteristics and documented safety outcomes in primary healthcare settings remain limited, especially in underrepresented health systems. Objective: This study aimed to describe real-world patterns of furosemide utilization, including indications and concomitant treatment patterns, and to document associated adverse drug events and short-term clinical outcomes in routine primary healthcare practice. Methods: A retrospective pharmacoepidemiological observational study was conducted between January and December 2025 in a primary healthcare center. Medical records of 1300 adult patients who received furosemide for cardiovascular indications were reviewed. Indications included arterial hypertension, hypertensive crises, and conditions related to volume overload. Utilization characteristics were operationalized as indication distribution, monotherapy versus combination therapy, and recurrence patterns within the study period. Data collected included demographic characteristics, primary and comorbid diagnoses, blood pressure values recorded before and after administration, furosemide dose and route of administration, concomitant antihypertensive therapy, documented adverse drug events as recorded in routine clinical documentation, recurrent presentations related to hypertensive crises, and the need for hospital referral. Descriptive statistics and paired comparative analyses were performed, with statistical significance set at p < 0.05. Results: The mean patient age was 62.4 ± 11.8 years, with a male predominance (54.1%). Arterial hypertension was the most frequent recorded indication (78.6%), while 32.4% of patients had multiple cardiovascular diagnoses. A statistically significant reduction in systolic blood pressure (from 176.3 ± 18.5 mmHg to 148.7 ± 16.2 mmHg, p < 0.001) and diastolic blood pressure (from 101.2 ± 11.4 mmHg to 89.6 ± 9.8 mmHg, p < 0.001) was observed between measurements recorded before and after administration during the same clinical episode. Recurrent presentations related to hypertensive crises were documented in 27.9% of patients during the study period. Adverse drug events were documented in 9.6% of cases, most commonly dehydration and suspected electrolyte disturbances as noted in routine clinical records. Hospital referral was required in 6.8% of patients. Conclusions: In this real-world primary healthcare cohort, furosemide was commonly used across a heterogeneous mix of cardiovascular indications, predominantly in combination with other antihypertensive agents. Observed temporal reductions in blood pressure and documented adverse events reflect routine clinical practice rather than controlled treatment effects. These findings provide descriptive pharmacoepidemiological evidence from a primary care setting and underscore the importance of careful monitoring, documentation, and rational prescribing in patients receiving loop diuretics. Full article

Background: Preterm prelabour rupture of membranes (PPROM) is the spontaneous rupture of fetal membranes prior to 37 weeks of pregnancy. Latency antibiotics, including macrolides with or without group B streptococcus (GBS)-covering antibiotics, are recommended as part of expectant management. Currently, there is no consensus on whether GBS-covering antibiotics should be prescribed. The primary objective of this retrospective cohort study was to characterize practice variation in GBS-covering antibiotic prescribing in PPROM. The secondary objective was to explore the association between maternal characteristics and GBS-covering antibiotic prescribing. Methods: Pregnant women with PPROM prescribed azithromycin (institutional standard antibiotic regimen) in 2024 and not in active labour were included. Maternal characteristics, stratified by GBS status, were compared. The association between antibiotic prescribing for GBS coverage and maternal factors was assessed using odds ratios. Two-sided p-values < 0.05 were considered statistically significant. Results: Out of the 181 admissions assessed for eligibility, 146 patients were included. Their GBS status at PPROM diagnosis was negative (19/146; 13%), positive (8/146; 5%), or unknown (119/146; 82%). The frequency of GBS-covering antibiotics prescribing was 5/8 (63%) in the positive group, 4/19 (21%) in the negative group, and 65/119 (55%) in those with an unknown GBS status. Aminopenicillin-based and penicillin regimens accounted for (69/74; 93%) of antibiotic regimens. Half (38/74; 51%) of the GBS-covering antibiotics were prescribed for 3–7 days, with a 33/74 (45%) completion rate as prescribed at PPROM diagnosis. The main reason for antibiotic discontinuation was negative GBS recto-vaginal swabs or urine cultures collected in those with an unknown GBS status at PPROM diagnosis, highlighting the role of microbiology laboratory testing in adjusting antibiotic therapy and facilitating antimicrobial stewardship. Aside from GBS status, no maternal characteristics were associated with GBS-covering antibiotic prescribing. Conclusions: At PPROM diagnosis, GBS coverage was prescribed in 21%, 63%, and 55% of patients with a negative, positive, and unknown GBS status, respectively. Only GBS status was associated with GBS-covering antibiotic prescribing. Further research is required to determine the impact of GBS coverage on perinatal outcomes. Full article

Background: Acalabrutinib is a selective Bruton tyrosine kinase inhibitor widely used for chronic lymphocytic leukemia and mantle cell lymphoma. Real-world safety evidence from Latin America remains limited, which restricts local benchmarking and pharmacovigilance planning. In this study we aimed to assess exposure-adjusted adverse events in routine care in Mexico. Methods: We analyzed postmarketing surveillance datasets and spontaneous reports from March 2020 to August 2024, classifying events with MedDRA and summarizing seriousness, severity, and incidence per 100 patient-years. Results: A total of 266 patients were registered; 193 had evaluable exposure and safety data, contributing 242.73 patient-years. The overall adverse event incidence was 24.71 per 100 patient-years. Twenty-eight individual case safety reports documented 60 events. Forty-four events were serious. Among 33 events with reported severity, 14 were severe, 14 moderate, and five mild. Frequently affected system organ classes were blood and lymphatic, vascular, and infections. Seven deaths were reported; most were associated with COVID-19 complications or disease progression. Conclusions: The adverse event profile observed aligns with published trial experience and supports the tolerability of acalabrutinib in Mexican practice. These country-level, exposure-adjusted estimates provide actionable context for clinicians, institutional pharmacists and pharmacovigilance teams and point to the value of strengthening report completeness to improve signal detection in routine oncology care. Full article

Background: Pharmacovigilance is a critical component of patient safety, particularly among older adults with chronic diseases who are frequently exposed to polypharmacy. In Kosovo, adverse drug reactions (ADRs) reported by patients remain insufficiently recognized within the healthcare system. Polypharmacy, limited access to pharmaceutical counseling, and self-medication practices may contribute to increased medication-related harm. Capturing ADRs directly from patients provides valuable insight into medication safety challenges and communication gaps in clinical care. Objective: To assess the frequency, characteristics, and reporting behavior of adverse drug reactions among adults aged 60–75 years with chronic diseases in Kosovo, and to identify factors associated with awareness and reporting practices. Methods: A multicenter cross-sectional study was conducted between January and September 2025 in four major cities in Kosovo (Prishtina, Prizren, Peja, and Gjilan). A total of 1024 patients receiving continuous therapy for at least one chronic condition were surveyed using a structured questionnaire covering demographic characteristics, drug exposure, ADR experience, and reporting behavior. Statistical analyses included descriptive statistics, chi-square testing, and multivariable logistic regression to identify predictors of ADR reporting. Results: Overall, 47.3% of participants reported experiencing at least one ADR in the preceding 12 months. Among those, 39.5% reported the event to a healthcare professional, whereas 60.5% did not seek professional advice. The most frequently implicated drug classes were antihypertensives (32.8%), analgesics and non-steroidal anti-inflammatory drugs (27.4%), and antirheumatic agents (14.6%), with mainly gastrointestinal (24.1%) and cardiovascular (18.9%) manifestations. Approximately 19.8% of participants reported discontinuing medication due to adverse effects. Female patients were more likely to report ADRs compared to males (p < 0.01). Lack of prior counseling about potential side effects was independently associated with lower reporting (OR = 2.17; 95% CI: 1.41–3.33). Patients using more than six medications had a higher prevalence of ADRs (61.2%). Conclusion: Adverse drug reactions were frequently reported by older patients, while formal reporting to healthcare professionals remained limited. Strengthening patient education, improving patient–provider communication, and integrating clinical pharmacists into primary care may enhance pharmacovigilance practices and medication safety. Full article

Background/Objectives: To evaluate the incidence, characteristics, and clinical outcomes of intraocular inflammation (IOI) associated with intravitreal faricimab (IVF) in patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Methods: Following PRISMA guidelines, a comprehensive search of PubMed, Web of Science, Scopus, Embase, and CENTRAL databases was performed from their inception to February 2025. Using the random-effects model, weighted proportions, standardized mean differences, and weighted log odds ratios (OR) were pooled and calculated. A two-tailed p-value of <0.05 was considered statistically significant. The χ² (z) test and the Higgins I² test were used to assess studies heterogeneity. Results: We conducted a systematic review and meta-analysis of 24 studies (4761 patients; 5652 eyes). The most common diagnoses were nAMD (n = 4782, 94.6%) and DME (n = 845, 37.1%). The pooled proportion for IOI incidence in eyes receiving IVF was 3.0% (95% CI: 1.0–6.0). The odds of developing IOI did not differ significantly between the DME and nAMD groups (OR: 1.13, p = 0.78). Unspecified IOI was the most common sign (n = 210, 2.9% [95% CI: 1.2–7.3]), followed by anterior uveitis (n = 80, 1.9% [95% CI: 0.1–34.8]), vitritis (n = 63, 2.9% [95% CI: 0.2–32.1]), retinal hemorrhage (n = 27, 0.7% [95% CI: 0.0–15.3]), and endophthalmitis (n = 8, 0.5% [95% CI: 0.3–1.1]). Conclusions: While IVF demonstrates therapeutic efficacy, our findings highlight a clinically relevant risk of IOI. We, therefore, recommend vigilant clinical monitoring in patients receiving this therapy. Full article

Background: According to the literature, adverse drug reactions (ADRs) account for 5–10% of hospital admissions and affect 25–30% of hospitalized patients, but no data are available for Gabon. Objectives: To estimate the incidence of ADRs among hospitalized patients at the Libreville University Hospital Center (CHUL) and to classify them according to their frequency, severity, mechanism and preventability, while proposing appropriate risk minimization strategies. Patients and Methods: A 14-month, single-center, prospective study included all patients experiencing ADRs, excluding those without ADRs or with intentional overdoses. ADRs were analyzed using the World Health Organization (WHO) causality assessment, the ATC classification, and Rawlins and Thompson criteria. Data were actively collected from patients and hospital records. Results: Among 4999 patients, 105 experienced 177 adverse events (incidence: 3.5%, 95% CI: 1.7–2.5%). Among the identified ADRs, 42% were serious. Nausea and vomiting were the most frequent ADRs, mainly caused by analgesics (nefopam, tramadol) and antibiotics (amoxicillin–clavulanic acid). The gastrointestinal and nervous systems were the most affected. According to the Rawlins and Thompson classification, 90% of ADRs were type A, 8% type B, and 2% type E (withdrawal syndrome). Overall, 90% of ADRs were preventable. Conclusions: This study highlights the importance of pharmacovigilance at CHUL, Gabon, and emphasizes the role of healthcare professionals in ADR reporting and risk minimization. Full article

Probiotics and microbiome-based therapeutics are increasingly used to prevent antibiotic-associated diarrhea (AAD) and support gut microbiota health across children, adults, and elderly populations. Evidence synthesized in this narrative review from randomized controlled trials and meta-analyses (>20,000 participants) suggests that early probiotic administration, particularly Lactobacillus rhamnosus GG, Bifidobacterium species, multistrain formulations, and Saccharomyces boulardii, is associated with a 30–40% relative reduction in AAD incidence across heterogeneous studies, with absolute risk reductions of approximately 5–12% depending on baseline risk, strain, dose, and timing. Probiotics are generally well tolerated, with mild gastrointestinal adverse effects reported in 3–5% of users and rare serious events mainly in immunocompromised individuals. However, heterogeneity in formulations, populations, and limited long-term real-world data underscores the need for further pharmacoepidemiological studies, microbiome surveillance, and evaluation of antimicrobial resistance implications. Full article

Background/Objectives: Sodium-glucose cotransporter-2 (SGLT2) inhibitors are widely used in type 2 diabetes mellitus for glycemic control and cardiovascular–renal protection, but adverse effects such as acute kidney injury (AKI), urinary tract infection (UTI), euglycemic diabetic ketoacidosis (Eu-DKA), and acute pancreatitis remain concerns. We aimed to determine the prevalence of adverse drug reactions (ADRs) associated with SGLT2 inhibitor use. Methods: This retrospective study assessed the prevalence of these adverse events and identified factors associated with UTI among SGLT2 inhibitor users at Suddhavej Hospital (1 January 2019–15 August 2023). Data were extracted from the hospital electronic medical record system (BMS-HOSxP). Results: We analyzed 293 patients (59.73% male; mean age 63.08 ± 0.667 years; 62.08% aged >60). Dapagliflozin had the highest prevalence of AKI (11.42%) and UTI (13.40%). No acute pancreatitis cases were reported. Logistic regression identified female sex (odds ratios [OR] 2.31, 95% confidence intervals [CI] 1.08–4.96; p = 0.032), AKI diagnosis (OR 3.31, 95% CI 1.10–9.89; p = 0.032), age ≥ 60 years (OR 2.78, 95% CI 1.09–7.09; p = 0.033), and SGLT2 inhibitor use <6 months (OR 5.78, 95% CI 2.74–14.18; p = 0.017) as significant risk factors for UTI. Conclusions: Dapagliflozin was associated with the highest prevalence of AKI and UTIs. Female sex, AKI diagnosis, age ≥ 60 years, and SGLT2 inhibitor use <6 months were significant risk factors for UTI among SGLT2 inhibitor users. Full article

Objective: The objective of this study was to determine whether Non-Hispanic Black (NHB) or Non-Hispanic White (NHW) Alzheimer dementia patients with neuropsychiatric symptoms (ADNPS) differ regarding treatment with second-generation antipsychotics (SGAs), central acetylcholinesterase inhibitors (CAIs), and selective serotonin reuptake inhibitors (SSRIs). Methods: Pharmacologic and demographic factors associated with male and female ADNPS were examined using retrospective data collected from a registry from 2016 and 2020 in a regional AD care center. The logistic regression model was developed to generate odds ratios (OR) to determine factors that were associated with male or female ADNPS. Results: A total of 7031 AD patients were identified. Overall, 6237 patients were NHWs, and 794 were NHBs. Among the NHW AD patients, 1909 presented with behavioral disturbances or neuropsychiatric symptoms (NPS), and 168 NHB AD patients presented with NPS. In the adjusted analysis, NHW ADNPS patients were more likely to be treated with galantamine (OR = 1.538, 95% CI, 1.001–2.364, p = 0.049), memantine (OR = 1.222, 95% CI, 1.086–1.375, p < 0.001), olanzapine (OR = 2.323, 95% CI, 1.794–3.009, p < 0.001), risperidone (OR = 4.181, 95% CI, 3.539–4.939, p < 0.001), and escitalopram (OR = 1.401, 95% CI, 1.225–1.602, p < 0.001). In contrast, NHB ADNPS patients were more likely to be treated with memantine (OR = 2.601, 95% CI, 1.746–3.875, p < 0.001) and risperidone (OR = 5.526, 95% CI, 3.411–8.951, p < 0.001). Conclusions: Our findings show the use of memantine and risperidone to treat both NHB and NHW ADNPS patients. NHW ADNPS patients were more likely to be treated with galantamine, memantine, olanzapine, risperidone, and escitalopram. In contrast, NHB patients with ADNPS were more likely to be treated with memantine and risperidone. Full article