Drug, Healthcare and Patient Safety最新文献

Objective: We aimed to assess the occurrence and characteristics of antibiotic-associated adverse drug reactions (ADRs) in Malawi.

Methods: We retrospectively reviewed 304 patient records from medical wards in three hospitals in Southern Malawi. A global trigger tool was applied for the detection of suspected ADRs, and we used the Naranjo scale, the World Health Organization classification and the Schumock and Thornton scale for causality, seriousness and preventability assessment respectively. ADRs were also further characterized according to anatomical systems. Statistical analysis was done in STATA 14.1. The Chi-square test was used to determine the association between categorical variables and logistic regression analysis was used to measure the strength of the association between various independent variables and the occurrence of ADRs.

Results: Suspected ADRs were detected in 24% (73/304) of patients, of which 1.4% were definite, 15.1% were probable and 83.6% were possible ADRs. Most of the sADRs were gastrointestinal events (42.5%), followed by: musculoskeletal (26.3%); cardiovascular (16.3%); central nervous system (13.8%; and urinary events (1.3%). About 27% of the sADRs were serious events such as convulsions. The geriatric age group (≥65 years) was more likely to experience sADRs as compared to the younger age group, with an adjusted odds ratio (aOR) of 4.53, 95% CI (2.21-9.28), P<0.001. Patients taking more than one antibiotic medicine had a higher risk of developing sADRs as compared to patients who were administered one type of antibiotic medicine, aOR 2.14, 95% CI (1.18-3.90), p < 0.012. A long hospital stay of >3days was associated with a higher risk of sADRs with aOR of 5.11, 95% CI (2.47-10.55), p < 0.001 than those who stayed ≤ 3 days in the hospital.

Conclusion: We found a higher prevalence of serious sADRs associated with antibiotic medicines than reported elsewhere. This may, among others, contribute to high patient mortality, poor treatment adherence, antibiotic resistance and increased cost of care.

Background: Medication-related hospital admission (MRHA) is hospitalization due to drug-related problems. MRHAs have been reported to be on the rise in recent decades.

Objective: This study was aimed at determining the prevalence, patterns, and predictors of MRHA among patients visiting the emergency ward of the University of Gondar comprehensive specialized hospital, Ethiopia.

Methods: A cross-sectional study was conducted from June 1, 2022, to August 30, 2022 G.C. in the emergency ward at the University of Gondar Comprehensive Specialized Hospital. The AT-HARM 10 tool was used to collect data from participants who fulfilled the inclusion criteria. Data was entered into EpiData Manager 4.6.0.0 and was exported to Statistical Package for Social Sciences (SPSS) version 24 for analysis. Descriptive statistics were presented using frequency and percentage. Binary logistic regression was applied to identify factors associated with MRHAs with a 95% confidence level, and significance was declared at a p-value <0.05.

Results: The prevalence of MRHAs was 30.5% (95% CI = 27.7-36.4%). More than half (64.52%) of MRHAs were definitely preventable. The majority of MRHAs (48.39%) were severe. Non-compliance (41.12%), followed by untreated indication (26.61%) and adverse drug reaction (12.09%) were the most frequent causes of MRHAs. Renal impairment (AOR = 2.703, 95% CI: 1.29 to 5.663), chronic disease (AOR = 10.95, 95% CI: 4.691 to 25.559), history of traditional medication use (AOR = 2.089, 95% CI: 1.162 to 3.755), and history of hospitalization (AOR = 4.001, 95% CI: 1.98 to 8.089) were significantly associated with MRHAs.

Conclusion: MRHAs were substantially prevalent. Most of the MRHAs were definitely preventable. Renal impairment, chronic disease, history of traditional medication use, and history of hospitalization were predictors of MRHAs. At the university hospital, health care providers should strive to prevent and manage MRHAs appropriately.

Background: The manifestation and spread of neuroinvasive circulating vaccine-derived polioviruses (cVDPVs) across several countries, which led to the emergency use of the novel oral polio vaccine type 2 (nOPV2), raised concerns about adverse events following immunization (AEFI) surveillance. We assessed the attributes of AEFI with nOPV2 and examined stakeholder experiences and challenges in AEFI surveillance in Sierra Leone.

Methods: Using a mixed method approach, we retrospectively reviewed passive data collected during a 2021 immunization campaign, and conducted semi-structured, interviews with vaccinators, district AEFI focal persons, and key stakeholders at the national Expanded Program on Immunization and the National Medicines Regulatory Authority. AEFI were categorized using the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PTs) and System Organ Class (SOC). Outcomes were stratified as recovered or not, with preventability and causality assessed using the Schumock and Thornton and World Health Organization (WHO) algorithms, respectively.

Results: A total of 528 suspected AEFI were documented, predominantly affecting children aged 28 days to 23 months (63.3%). Most reported AEFI were administration site conditions and general disorders, with pyrexia being the predominant PT. Of 80 serious cases, 78 recovered, with 74 having an inconsistent causal relationship with the vaccine. Most serious cases (78) were deemed non-preventable, with only two being probably preventable. AEFI reporting was not routinely carried out across the group of people interviewed. AEFI reporting was not consistently performed, with discrepancies in defining reportable events and confusion over responsibility. Challenges with the open data kit (ODK) platform were noted, along with perceived inadequacies in training.

Conclusion: While the nOPV2 is relatively new, the majority of AEFI were not serious, and most serious cases were not causally linked to the vaccine. Participants exhibited variations in experience and awareness of AEFI reporting.

Pulmonary arterial hypertension (PAH) is a complex and incurable disease for which pulmonary vasodilators remain the core therapy. Of the three primary pathways that vasodilators target, the prostacyclin pathway was the earliest to be used and currently has the largest number of modalities for drug delivery. Inhaled treprostinil has been introduced as a treatment option in PAH and, more recently, pulmonary hypertension (PH) due to interstitial lung disease (PH-ILD), and the earlier nebulized form has been joined by a dry powder form allowing for more convenient use. In this review, we discuss inhaled treprostinil, focusing on the dry powder inhalation (DPI) formulation, and explore its dosing, applications, and evidence to support patient tolerance and acceptance. Recent trials underpinning the evidence for use of inhaled treprostinil and the most recent developments concerning the drug are discussed. Finally, the review looks briefly into premarket formulations of inhaled treprostinil and relevant early studies suggesting efficacy in PAH treatment.

Obstructive fibrinous tracheal pseudomembrane (OFTP) is a relatively rare complication of endotracheal intubation. Despite being well documented, the exact pathogenesis of OFTP remains unclear. Some studies suggest that it may arise from the early stage of ischemic tracheal wall injury caused by the cuff pressure during intubation. Diagnosis and treatment of OFTP can be facilitated through therapeutic bronchoscopy. In this case report, we describe a patient who presented with dyspnea following repeated intratracheal interventions and was diagnosed with OFTP. The patient was successfully treated with bronchoscopic cryotherapy and was subsequently discharged from the hospital.

Background: WHO estimates that 15.8% of substandard or falsified medical products are used to treat non-communicable diseases which account for 80% of the global burden including diabetes. The increased level of use of metformin hydrochloride tablets in clinical practice creates the need to monitor and ascertain the quality of the various brands available in the drug market for quality control assessment and generic substitution. This study aims to assess the pharmaceutical quality of seven brands of metformin tablets circulating in pharmacy outlets in Gondar City, North West Ethiopia.

Methods: Official Pharmacopoeia tests such as uniformity of weight, disintegration, assay, and dissolution tests were used to assess the physicochemical quality control parameters of metformin hydrochloride tablet brands. The unofficial tests conducted included crushing strength/hardness and friability.

Results: In all seven tests, the tested brands passed the BP official tests for uniformity of weight, friability, disintegration, and dissolution. Each product had a friability of less than 1% with a maximum of 0.385%. In contrast, none of the brands passed the non-official hardness test. Each product disintegrated in seven to twelve minutes, meeting the USP standards. Drug release rates in 45 min ranged from 78.9 to 92.6%, and drug content results were within the USP guidelines (96.55-102.76%).

Conclusion: The current study demonstrated that all seven brands of metformin hydrochloride 500 mg tablets adhered to the quality control parameters specified in the pharmacopeia, except for the hardness test across all brands.

Introduction: Drug therapy is a crucial component of health care and plays a vital role in preserving life. However, the irrational utilization of medications is a worldwide issue, particularly in developing nations.

Objective: To assess the prescription patterns of medications based on the World Health Organization's prescribing indicator among patients who were admitted with COVID-19 to Eka Kotebe General Hospital in Addis Ababa, Ethiopia, in June 2021.

Methods: A retrospective cross-sectional analysis was conducted to evaluate the prescription patterns of medications in patients admitted with COVID-19 at Eka Kotebe General Hospital from June 2021 to September 15, 2021. The data were extracted using card review formats and prescription assessment questionnaires, and a systematic random sampling procedure was employed to collect the data. Finally, the data were coded and analyzed using SPSS version 26 to meet the study's objectives. Descriptive statistics were employed to determine the frequency and prevalence, and the results were presented using tables and figures.

Results and discussion: The average number of medications prescribed per encounter was 2.64, which is above the WHO standard. The percentage of encounters in which antibiotics and injections were prescribed was 80.20% and 99.2%, which exceeds the upper limit of WHO standard range (20-26.8%) and (13.4-24.1%), respectively. All medications were prescribed using generic names and were included in Eka Kotebe General Hospital's essential drug list, which is in line with WHO standards.

Conclusion: The degree of polypharmacy and the prescription practices for antibiotics and injections at Eka Kotebe General Hospital deviated from the World Health Organization's standards. As a result, there is a need to enhance medical education programs to rationalize the prescription of antibiotics and injection use.

Gonorrhea, a sexually transmitted infection caused by Neisseria gonorrhoeae, is a grave public health concern. Gonorrhea is the second most reported sexually transmitted infection worldwide. The treatment of uncomplicated gonococcal infections has evolved dramatically in response to the emergence of antimicrobial resistance. Multiple resistance mechanisms (for example, beta-lactamase production, antimicrobial efflux, and target site modification) exist, some of which may cause multidrug-resistance. Ceftriaxone was first recommended as an option for uncomplicated gonococcal infections in 1985, and it is now a mainstay of therapy in all clinical practice guidelines. Ceftriaxone has consistently shown high microbiologic cure rates in clinical trials, and it has demonstrated an excellent safety profile. Although its use may be limited in patients with hypersensitivity to penicillins, the risk of using ceftriaxone in such patients is overestimated. The emergence of reduced ceftriaxone susceptibility in N. gonorrhoeae, coupled with a lack of diverse treatment alternatives and the limited pipeline of new antimicrobials, is a significant threat to the treatment of gonorrhea.

Background: Multiple drug therapies are commonly used to achieve a desired therapeutic goal, especially in hospitalized patients. However, drug-drug interactions might occur and threaten the patients' safety.

Objective: This study aims to assess the prevalence and severity of potential drug-drug interactions (PDDIs) in the internal medicine ward at Soba Teaching Hospital.

Methods: A retrospective cross-sectional hospital-based study was carried out in the internal medicine ward at Soba Teaching Hospital from June 2021 to December 2021. The data was collected from patients' medical records. PDDIs were identified using Lexicomp^® drug interaction software.

Results: A total of 377 patients were included in this study, and overall prevalence of PDDIs was 62.9%. We have identified 989 potential DDIs and 345 pairs of interacting drugs, the mean of the PDDIs per patient was 4.17 ± 4.079. Among 345 PDDIs most were of moderate interactions 70.1% (n=242) followed by Minor interactions 19.1% (n=66). The most common type of interaction was of category C representing 63.5% (n=219). A significant association was observed between the occurrence of PDDIs with patients' age, presence of chronic diseases, length of hospital stay, and number of medications received by the patients.

Conclusion: Drug-drug interactions were highly prevalent in the internal medicine ward. Therefore, certain attempts are required to increase the awareness of the physicians about these interactions and minimize their occurrence.