Patterns of adverse drug reactions in Jordan: a retrospective analysis of the National Pharmacovigilance Data Registry (2015-2021).

BACKGROUND: Post-marketing surveillance of drugs is a cornerstone of pharmacovigilance. This study was conducted to characterize patterns of adverse drug reactions (ADRs) reported in Jordan. RESEARCH DESIGN AND METHODS: ADR reports submitted to the pharmacovigilance database of the Jordan Food and Drug Administration during 2015-2021 were retrospectively analyzed. The most commonly reported drugs, drug classes, ADRs, and ADRs consequences were explored. Logistic regression identified possible predictors of reporting serious ADRs. RESULTS: A total of 2744 ADR reports were included, among which 28.4% were classified as serious. An annual increase in ADR reporting was observed. The most commonly implicated drug classes were antineoplastic and immunomodulating agents (24.0%), anti-infectives for systemic use (14.2%), and alimentary tract and metabolism (12.1%). Covid-19 vaccination was the most reported drug (22.8%). Fatigue (6.3%), injection site pain (6.1%), and headache (6.0%) were the top three common ADRs. Among ADRs with outcome information, 4.7% were fatal. Patient's age and intravenous medication use largely predicted reporting serious ADRs. CONCLUSIONS: This study provides contemporary insights into the post-marketing surveillance of drugs in Jordan. The findings are foundational for future studies exploring drug-ADRs causality relationships. Efforts that promote pharmacovigilance concepts should be sustained and enhanced at the national level.

Incidence, predictors, clinical outcomes, and economic burden of recurrent acute kidney injury: a retrospective cohort study.

OBJECTIVE: This study aimed to assess the incidence, predictors, mortality, and economic outcomes of recurrent Acute kidney injury (AKI) in Jordan. METHODS: This was a retrospective cohort study that included adult patients who were admitted with AKI to university hospitals in the country from 2010-2019. Recurrent episodes of AKI, laboratory data, baseline medication list, and death dates were retrieved from patient's medical records. The incidence rate of recurrent AKI was estimated. Predictors of recurrent AKI and mortality during the five years post-discharge was evaluated. Total admission charges were described and evaluated in total and by service provided. RESULTS: Among 1162 AKI patients, 57 patients (4.9%) died during the index admission (first admission during the study period), and among the survivors, 220 patients were re-hospitalized with a recurrent AKI during five years of follow-up. Patients with higher discharge serum creatinine level (SCr) at index admission had higher odds of AKI recurrence (OR = 1.001). Patients who were on respiratory, antineoplastic, or anticoagulant medications were also more susceptible to recurrence; ORs were 1.69, 2.77, and 4.16, respectively. Patients who were elderly, with recurrent AKI episodes, or with a more extended hospital stay at index admission were more likely to die during the five years post discharge. The median charge of recurrent admissions was higher than the median charge of the index admissions; 1519.17 JOD ($2142.7) versus 1362.85 JOD ($1922.2), respectively. CONCLUSIONS: Recurrent AKI is associated with increased mortality and health expenditures. Higher discharge SCr levels at index admission, and chronic comorbidities are associated with a higher likelihood of AKI recurrence.

Clinical Outcomes and Direct Medical Expenditures Associated With Intensive Care Unit Admission for Inpatients With COVID-19 in Jordan: A Retrospective Cohort Study.

OBJECTIVES: This study aimed to describe clinical outcomes and medical expenditures associated with COVID-19 admissions. In addition, this study aimed to investigate the impact of patients' characteristics and baseline comorbidities on intensive care unit (ICU) admission, mortality, and medical expenditures for hospitalized patients with COVID-19. METHODS: This retrospective cohort study included all hospitalized patients with confirmed COVID-19 in Prince Hamza Hospital and King Abdullah University Hospital, during the period from March 2020 to June 2021. Medical records and pharmacy data were followed and reviewed throughout their admissions. The ICU admission, inpatient mortality, hospital length of stay, and inpatient charges were described. Predictors of ICU admission and inpatient charges were evaluated. RESULTS: A total of 7694 COVID-19 hospital admissions were included. Approximately 1189 patients (15.5%) were admitted to ICU and 21.4% died in the hospital. The fatality rate among those admitted to ICU was 82.6% compared with 10.2% for non-ICU admitted patients. The average admission charge and charge per admission day were 1598.2 and 200.2 Jordanian dinar, respectively, and both charges were higher in ICU admitted patients than non-ICU admitted patients. Being older in age, smoker or ex-smoker, and having chronic diseases were all significantly associated with a higher likelihood of ICU admission and mortality among admitted patients. CONCLUSIONS: ICU admission in patients with COVID-19 is associated with poor clinical outcomes and substantial medical expenditures and is more likely among older adults, smokers, and those with chronic diseases.

The Impact of Multidrug-Resistant Acinetobacter baumannii Infection in Critically Ill Patients with or without COVID-19 Infection.

This is a single-center, retrospective, cohort study aimed to evaluate the clinical outcomes of multi-drug resistance in Acinetobacter baumannii infections (MDR-AB) in intensive care unit (ICU) patients with or without a COVID-19 infection and risk factors for blood stream infection. A total of 170 patients with MDR-AB were enrolled in the study. Of these, 118 (70%) patients were admitted to the ICU due to a COVID-19 infection. Comparing the COVID-19 and non-COVID-19 groups, the use of mechanical ventilation (98.31% vs. 76.92%, p = 0.000), the presence of septic shock (96.61% vs. 82.69%, p = 0.002), and the use of steroid (99.15% vs. 71.15%, p = 0.000) and tocilizumab therapies (33.05% vs. 0%, p = 0.000) were more prevalent and statistically more significant in patients with COVID-19 infections. The average length of the ICU stay (21.2 vs. 28.33, p = 0.0042) was significantly lower in patients with COVID-19 infections. Survival rate was 21.19% for the COVID-19 group and 28.85% for non-COVID-19 group with a p-value = 0.0361. COVID-19 status was associated with significantly higher hazards of death (HR 1.79, CI 95% 1.02-3.15, p = 0.043). Higher SOFAB (15.07 vs. 12.07, p = 0.0032) and the placement of an intravascular device (97.06% vs. 89.71%, p = 0.046) were significantly associated with the development of a bloodstream infection. Our study has shown that critically ill patients with an MDR-AB infection, who were admitted due to a COVID-19 infection, had a higher hazard for death compared to non-COVID-19 infected patients.

Predictors of Covid-19 case fatality rate: An ecological study.

BACKGROUND: The outbreak of novel coronavirus (Covid-19) has a significant burden on global health and could be associated with significant mortality. Limited information exists about determinants of its fatality worldwide. Thus, this ecological study examined the association of various predictors with Covid-19 fatality. METHODS: International data bases of Covid-19 statistics and health metrics available primarily at WHO were reviewed to collect information for 113 countries. The dependent variable was Covid-19 case fatality rate. Independent variables were demographic, social, clinical, economic, heath care and child health factors. RESULTS: Case fatality rate of Covid-19 varies across countries with an average of 4.2 ± 3.8%, and about half of countries had fatality rate >3.2% (median). Significant relationships were observed between Covid-19 fatality rate and socio-economic, clinical, and health variables at the unadjusted regression analysis. At the multivariate adjusted model, percentage of population with age>60 years was positively associated with Covid-19 fatality (B = 0.032, p = 0.005), while Polio-3 immunization at 1-year old was inversely related (B = -0.057, p = 0.017). CONCLUSIONS: This ecological investigation highlights the higher risk of death among elderly with Covid-19 pandemic and suggests that Polio-3 immunization coverage among 1-year-olds may be associated with better survival. Future research is warranted to validate these findings.