Drug, Healthcare and Patient Safety最新文献

Background: Fluoroquinolones (FQs) are among the most popular antimicrobials that are highly effective against various infections. Although FQs are the most frequently used and generally tolerated, there are issues with their safety. This study assessed the rate, severity, seriousness, outcomes, and types of FQs adverse drug reactions (ADRs) in reports submitted to a regional spontaneous ADR database.

Methods: This was a retrospective cross-sectional observational study involving all patients with reported ADRs related to FQs or other antibiotics (ABs) that were submitted to the Regional Pharmacovigilance Center (PVC) database between January 2019 and December 2022. Data were extracted in the form of Saudi ADR from the PVC database, which is consistent with the MedWatch ADR form of the U.S Food and Drug Authority (FDA).

Results: In total, 605 ADRs related to antibiotic use were reported. ADRs caused by FQs use were the most frequently reported (177; 29.3%), followed by penicillin (100; 23.4%) and cephalosporin (90; 21%). There was no significant difference in ADRs caused by FQs between men (104; 58%) and women (OR 1.17, 95% CI 0.82-1.67, p=0.386). FQ-related ADRs were more frequent among those over 40 years-old (OR 1.56, 95% CI 1.09-2.22, p=0.015). Most of the detected FQ-related ADRs were of moderate severity (157; 88.7%), required interventions (83; 46.9%), and recovered after receiving medical interventions (154; 87%). Patients who received FQs were fourfold more likely to experience neurological adverse events (OR 4.15, 95% CI 2.48-6.93, p <0.001).

Conclusion: The FQs drug class exhibited a higher incidence of ADRs than other ABs. Regularly assessing the safety of ABs is crucial to improve public and healthcare providers' awareness of the correct utilization of ABs and to limit the use of FQs to infections that cannot be effectively managed with alternative ABs.

Objective: This review summarized the real-world effectiveness outcomes of Janus kinase inhibitors (JAKi) for rheumatoid arthritis (RA) based on observational studies.

Methods: A systematic review followed PRISMA guidelines, with searches conducted in PubMed, Embase, and CINAHL from each database's inception to June 2, 2023. Studies were included if they evaluated real-world effectiveness outcomes of JAKi for US RA patients. Search terms included "RA", "JAKi", and "real-world". All citations were imported into COVIDENCE platform. Two reviewers independently performed title/abstract screening and full-text eligibility. For each article, study characteristics and effectiveness measures focusing on treatment pattern, clinical response, and patient-reported outcomes (PROs) of JAKi were extracted. Newcastle-Ottawa Scale (NOS) was utilized to assess the quality of the included articles.

Results: In total, 35 studies representing 252-30,556 patients were included. A majority used the administrative claims datasets (n=23, 65.71%), followed by 9 studies using electronic medical record (EMR) data and 3 studies using patient registry databases. Across claims-based studies, adherence, persistence, and effectiveness of JAKi were common outcomes. Adherence rates varied, with a proportion of days covered (PDC) ranging from 0.53 to 0.83 across 11 studies. Persistence of JAKi in RA patients was reported in 14 studies, where the median persistence time in treatment was reported to be between 121-516 days. Six studies applied effectiveness algorithms, with 14.8-26% of patients meeting effective treatment criteria. In addition, the most common measure of clinical response throughout the studies was Clinical Disease Activity Index (CDAI), with 10 articles reporting mean CDAI changes between -4.7 and 5.1. Across 12 studies that measured the PROs, the most prevalent PRO was pain, with the mean change in pain ranging from -9.3 to 8.9 across these studies.

Conclusion: Real-world studies on JAKi for RA reflect a range of effectiveness measures, illustrating the expanding role of JAKi in clinical practice.

Purpose: Rational self-medication (SM) practice among healthcare students is essential to promote the safe, effective, and economical use of medicines for self-diagnosed conditions. The study aimed to assess pharmacy students' knowledge, attitude, and practice about responsible self-medication.

Methodology: A cross-sectional online survey was conducted among Ugandan pharmacy students for one month from March 1 to March 31, 2024. The study included students enrolled in diploma, bachelor, and master of pharmacy programs in Uganda. Informed consent was obtained online by asking a question regarding willingness to participate. A non-probable snowball sampling technique was used to recruit students. A pre-validated questionnaire was used to obtain socio-demographics, self-medication practices, knowledge, attitudes, and practices about responsible self-medication. We used binary and multivariable logistic regression analysis to identify the factors associated with KAP regarding responsible self-medication.

Results: The prevalence of self-medication practice among pharmacy students was 96.73%. The self-medication is most common in headache (78.97%), cold, and cough (79.91%) illnesses. Painkillers (90.19%) and antibiotics (53.97%) are the most common medicines used for self-medication. Most pharmacy students have good knowledge (87.38%) and a positive attitude (96.03%) toward responsible self-medication. However, only 27.34% of students practice rational self-medication. Participants' university and parents' professions were significantly associated with good knowledge of responsible self-medication. Whereas factors such as gender, residence, and type of illness were significantly associated with rational self-medication practice.

Conclusion: The prevalence of self-medication was high among pharmacy students in Uganda. Painkillers and antibiotics are the most preferred drugs for self-medication. About 87.38% of pharmacy students have good knowledge, and 96.03% have a positive attitude toward responsible self-medication. Rational self-medication practice was low among students. We recommended training sessions to enhance safe self-medication practices among pharmacy students.

Niclofolan is a commonly used veterinary drug worldwide. We reported a case of acute niclofolan intoxication in a pregnant woman. We recorded in detail her toxic symptoms, including nausea, vomiting, asthenia, blurred vision, and aberrant blood values. Notably stillbirth was recorded for the first time as indicating its human reproductive toxicity. We also found that an oral therapeutic dosage as described in the literature was likely to lead to stillbirth. Furthermore, we described the treatments received by the patient, including critical care, drug therapy, and plasma exchange, the outcomes of which were excellent. By studying this case, we aimed to enhance recognition and treatment of niclofolan intoxication and to raise concern regarding veterinary drug abuse and exposure risk.

Background: The opioid crisis continues to be a public health concern worldwide due to the high rates of misuse and associated mortality. Opioid dispensing competencies are critical for pharmacy graduates to promote the rational use of opioids.

Purpose: To evaluate the opioids dispensing competencies among the final year Pharm-D students in Punjab, Pakistan.

Design: A multicenter cross-sectional study.

Methods: A validated survey was used to evaluate 11 competencies related to opioid use from the final year Pharm-D students from diversely located accredited institutes. On a summative scale, correct response to each survey item was worth a score/point. Descriptive statistics was used for categorical variables while independent t-test computed group differences.

Results: A total of n = 661 final year Pharm-D students from 28 institutes (8 public and 20 private) completed the survey with an overall response rate of 78.5%. Comparatively, the students who had either completed a community or hospital internship, or studying in the educational institutions located in the provincial capital demonstrated a significant higher competency score. There was no significant difference in the overall mean competency scores based on gender or system of assessment used in the Pharm-D degree programs. Among eleven opioid competencies, students received the lowest scores for "opioid overdose management", "opioid monitoring" and "therapeutic uses of opioids".

Conclusion: Pharm-D students in Pakistan require additional training and skills on many of the opioids related competencies to ensure patient's safety in healthcare settings. There is a need to revise the curriculum and teaching methodologies to improve the competencies of Pharm-D students in opioid dispensing.

Background: Medication use during pregnancy is prevalent with notable increases in the use of over-the-counter medications. In this era of information proliferation, it is important to understand where women of reproductive age obtain information on medication safety.

Objective: The main objective of this study was to determine the predictive factors associated with the utilization of pharmacists as a medication information safety resource among reproductive age women.

Methods: A cross-sectional evaluation of baseline characteristics, collected during an online knowledge intervention study, was conducted among women aged 18-44 who were living in the United States in 2018 to 2019. Descriptive statistics for all study variables were estimated. Logistic regression analyses were done to assess the predictors of the utilization of pharmacists as a medication safety resource.

Results: A total of 210 women of reproductive age were included in the study. The average age was 32.4 ± 6.5 years and the majority were White (69.5%), married (61.4%), and had at least a high school education level (86%). Fifty four percent of participants reported using pharmacists as a medication safety information resource. Findings from the multivariable analyses showed that women who reported difficulty understanding written medical information (p = 0.018) and those who were Black or African American (p = 0.008) had less odds of utilizing pharmacists as a medication information source.

Conclusion: Despite pharmacists being one of the most accessible health care professionals on medication information, only 54.3% of women surveyed utilized them as medication information sources. It was also found that women who had difficulty understanding written information and those who were Black or African American were less likely to utilize pharmacists as a medication safety information resource. Findings show opportunities for pharmacists to increase perceived value as medication safety experts among women of childbearing age. Additional studies need to be conducted given the study's limited generalizability.

Background: Sacubitril/valsartan (S/V) is used in managing heart failure with reduced ejection fraction (HFrEF), reducing morbidity and mortality while improving symptoms and prognosis. This study aims to evaluate the effectiveness of S/V in patients with reduced left ventricular ejection fraction (LVEF) and its safety.

Methods:  This retrospective cohort study included adult patients aged ≥18 years diagnosed with HFrEF, receiving S/V, and followed up at a tertiary hospital in Riyadh. Primary outcomes included improvements in LVEF on echocardiography and the number of hospitalizations due to acute decompensated heart failure (ADHF). Secondary outcomes assessed the safety profile of S/V. Multinomial logistic regression analysis was performed with statistical significance set at P < 0.05. .

Results: The study included 107 patients: 80 with LVEF < 30% and 27 with LVEF 30-40%. Six-month follow-up, LVEF improvement was categorized into three groups: no improvement, LVEF increased by 1 to <10 points, and LVEF increased by ≥10 points. The LVEF was similar across groups (P = 0.59). Although hospitalizations due to ADHF were not significantly different between groups, they numerically decreased after initiating S/V (P = 0.1). S/V was generally well tolerated.

Conclusion: This study suggests no significant benefit from S/V regarding LVEF improvement. It is recommended that heart failure clinics assess and titrate S/V to the maximum tolerated dose.

Aim: Influenza control demands multifaceted strategies, including antiviral drugs. Baloxavir, a recent addition to influenza treatment, acts as an inhibitor of the Polymerase acid (PA) component of the viral polymerase. However, mutations associated with resistance have been identified.

Purpose: This study analyzed PA gene sequences of influenza A and B viruses (IAV and IBV, respectively) reported in the Americas, retrieved from databases published until May 2023, to identify primary markers of resistance to baloxavir.

Patients and methods: PA gene sequences were obtained from the GISAID and NCBI databases, focusing on countries in the Americas with 500 or more sequences for IAV, and 50 or more sequences for IBV.

Results: Of the 58,816 PA sequences analyzed for IAV, only 55 (0.1%) harbored resistance markers, representing approximately 1 in 1000 occurrence. The most frequent markers were I38V (21 cases) and I38M (7 cases) at position 38 of PA, followed by E199G (9 cases) at position 199. For IBV, 14,684 sequences were analyzed, of which only eight presented a resistance marker (0.05%). Five sequences had the M34I marker, while the remaining three had the I38V marker. While frequency of resistance markers in PA is comparable to other regions, these results highlight the need for enhanced sequencing efforts, particularly in Latin America. Such efforts would serve to intensify influenza surveillance and inform public health interventions.

Conclusion: While baloxavir demonstrates efficacy against influenza, resistance markers have been identified, including pre-existing ones. Our study adds eight (IAV: six and IBV: two) new spontaneously occurring substitutions to the existing literature, highlighting the need for continued surveillance. Among these, I38M stands out due to its significant tenfold reduction in drug susceptibility. Therefore, vigilant monitoring of these resistance markers in IAV and IBV remains crucial for maintaining baloxavir's effectiveness and informing future public health interventions.