Drug, Healthcare and Patient Safety最新文献

A critical step in understanding and preventing potentially disastrous complications in the perioperative period is the accurate recording of their occurrence and subsequent analysis. However, the recording of intravenous infiltration and extravasation is likely inaccurate due to several factors: rare serious complications associated with infiltration/extravasation, limitation in ICD-10 codes to describe the injury, reliance on coders to record these events in searchable databases, and limited quality measures in anesthesiology to record these events. Although current literature cites results of studies that found rates of 16% and higher for intravenous infiltration, a limited internal review at University Hospital in Newark, NJ found significantly lower rates with only 14 instances recorded in an 18-month period across the institution. This leads the author to conclude that interventions are required to better track these events including such steps as staff education and more efficient/accessible reporting systems. The accurate recording and analyzing of data related to adverse events, and in particular regarding infiltration and extravasation, require revision and reinterpretation to gain an accurate picture of their rates.

Purpose: Eculizumab, a drug that blocks activation of the terminal complement pathway, is useful in the treatment of several rare diseases. However, eculizumab-related meningococcal disease is a serious problem. Because of the difficulty diagnosing meningococcal disease, deaths from meningococcal disease may have been overlooked. The purpose of this study was to clarify the trend of meningococcal infection in patients on eculizumab and to evaluate the effectiveness of risk communication.

Methods: Pharmacovigilance analysis was conducted using the Japanese Adverse Drug Event Report database between the first quarter of 2010 and the second quarter of 2019. Of the reports of deaths, those with adverse event terms of fever, shock, altered state of consciousness, loss of consciousness, sepsis, organ failure, and disseminated intravascular coagulation were analyzed as deaths with suspected meningococcal infection.

Results: Of the 3559.2 person-years of eculizumab-exposed patients, 17 patients died with symptoms of meningococcal disease (including two confirmed cases). The mortality rate of meningococcal disease in patients exposed to eculizumab in Japan was estimated to be 0.56 (confirmed cases) to 4.8 (suspected cases) per 1000 person-years. Based on data from the National Epidemiological Surveillance of Infectious Disease, the mortality rate of meningococcal disease in the general population in Japan is 0.0042 per 100,000 person-years. Thus, the mortality rate from meningococcal disease in eculizumab-exposed patients is estimated to be 13,000 to 114,000 times the mortality rate from meningococcal disease in the general population of Japan. Academic societies warned of deaths from meningococcal disease in the first quarter of 2018, calling for appropriate action. Thereafter, only one death with symptoms of meningococcal disease has been reported.

Conclusion: The analysis of the database showed that death from meningococcal disease in eculizumab-exposed individuals may occur more often than expected. This study also showed that appropriate risk communication reduced the fatality rate of meningococcal disease.

Background: One of the prevalent treatment modalities for cancer is chemotherapy. Adverse drug reactions, however, are becoming the world's major public health problem. More than half (54.5 percent) of cancer patients need hospitalization for further management, in addition to the increased health-care costs of treatment. The aim of this study was to evaluate adverse drug reactions associated with chemotherapy and related factors in hospitalized paediatric cancer patients in Ethiopia's north-west hospitals.

Methods: From July 1, 2017, to August 13, 2019, a cross-sectional study was carried out among 311 paediatric cancer patients at Gondar Comprehensive University, Specialized Hospital and Felegehiwot referral hospital. The data were entered into Epi Info version 7 and exported for further analysis to Statistical Product and Service Solutions (SPSS). To identify associated variables, both the bi-variate and multi-variate logistic regression analyses were computed. Variables with a P-value of less than 0.05 were considered statistically significant in the multivariate logistic regression analysis.

Results: The overall adverse drug reaction in this study was 41.5 percent ((95% CI: 35.8-47.2%)). Patients who received concomitant medications were at higher risk of experiencing adverse drug reactions (AOR: 2.60 (95% CI: 1.54-4.40)), according to the multivariate logistic regression analysis. Similarly, there was a risk of developing adverse drug reactions in patients taking four or more chemotherapy agents (AOR: 2.67 (95% CI: 1.52-4.68)). In addition, regimens based on etoposide (AOR: 1.99 (95% CI: 0.93-4.27)), mercaptopurine (AOR: 3.91 (95% CI: 1.06-14.46)) and doxorubicin (AOR: 2.32 (95% CI: 1.30-4.15)) were at higher risk for adverse drug reactions in patients.

Conclusion: Adverse drug reactions developed in a significant proportion of the study patients (2 out of 5 patients). Therefore, for pediatric cancer patients on concomitant medications and for patients on etoposide, mercaptopurine and doxorubicin drug regimens, efficient prevention and management of adverse drug reactions should be sought.

Background: Health professionals are at high risk of exposure for needlestick or sharp injury due to repeated exposure in clinical areas. This exposure leads to the acquiring of different infectious diseases like human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and other infectious diseases. Nurses and midwives having repeated exposure due to long working time, not wearing personal protective equipment, less work experience, and who are unable to apply infection prevention utilization guidelines are at high risk of needlestick and sharp injuries.

Methods: An institutional-based, cross-sectional study design was conducted in North Wollo Zone public hospitals. A simple random sampling technique was applied to select study subjects. The method of data collection was self-administered questionnaires that are structured and pretested from February to March 2019. The data were analyzed using both descriptive and analytical statistics. Binary logistic regressions were used to test the association between variables. Then, P-value <0.05 was considered as statistically significant in this study.

Results: Of the 147 respondents who participated in the study, 50.3% were female and 49.7% were male. The prevalence of needlestick and the sharp injuries was 75.5%. Recap practice of needle (AOR: 3.880; 95%CI: 1.666-9.036), working room (maternal care room) (AOR: 2.968; 95%CI: 1.012-8.703), and contagious room like emergency room (AOR: 3.587; 95%CI: 1.383-9.301) are significantly associated with needlestick and sharp injuries.

Conclusion: This study showed that three-quarters of the study subjects were exposed to needlestick injury at least once in the past year. Needle recapping practice and working room were associated with needlestick and sharp injuries. Then, health personnel should avoid the practice of recapping a needle and tale care themself to avoid needle and sharp injuries in the workplace.

Introduction: Healthcare-associated infection (HCAI) is a type of infection that is acquired while receiving healthcare services in a hospital or other healthcare settings. The objective of this study was to determine the incidence of HCAI and associated factors at Adama Hospital Medical College (AHMC), Adama city, Ethiopia.

Method: A hospital-based longitudinal study was conducted among 300 participants at AHMC from February to May 2017. The study participants' clinical characteristics were collected using a structured interview and clinical evaluations. Data were analyzed by descriptive statistics using SPSS software version 20. Various clinical samples collected from participants were processed and bacteria were isolated by using standard microbiological methods recommended by the World Health Organization.

Result: The total incidence rate of HCAI was 9.7 [95% CI: 7.1-12.9] cases per 1000 persons-days. Specific incidence rates were as follows: 8 cases per 1000 person-days [95% CI: 08.74, 20.66] for surgical site infections; 60.2 cases per 1000 device-days [95% CI: 33.47, 100.3] for catheter-associated urinary tract infections; 1.4 cases per 1000 device-days [95% CI: 0.06752, 6.656] for catheter-associated bloodstream infections; 14.1 cases per 1000 device-days [95% CI: 0.7047, 69.46] for ventilator-associated pneumonia; 73.5 cases per 1000 person-days [95% CI: 26.94, 163] for non-surgical skin break infections and 0.6 cases per 1000 person-days [95% CI: 0.02906, 2.864] for antibiotic-associated diarrhea. Most of the infections were caused by Gram-negative bacteria. Renal disease and type 2 diabetes mellitus were significantly associated with HCAI (P<0.05).

Conclusion: HCAI was predominant in this study. The major contributing factors for HCAI at AHMC were renal disease and type 2diabetes mellitus.

Background: Despite the fact that the majority of the acute diarrheal diseases are viral in origin and self-limited, routine and injudicious antibiotic treatment is a common practice globally and more prevalent in Africa. Indeed, the irrational use of antibiotics has a detrimental effect on the issue of antibiotics resistance and associated healthcare costs. Accordingly, a health center-based cross-sectional study is mandatory and was conducted due to the common malpractice of antibiotics use.

Objective: The aim of this study was to evaluate the antibiotic use pattern in the treatment of acute diarrheal disease in Chefa-robit health center, Kemissie, Northeastern Ethiopia.

Methods and materials: A retrospective cross-sectional study was conducted to evaluate the antibiotic utilization pattern for the treatment of acute diarrheal disease. Data was collected from 230 patients' record cards treated for acute diarrheal disease from January 2018 to December 2018 using structured questionnaires. The finding is presented using frequency distribution and percentages in tables as well as figures.

Results: Among the 230 patients, 49.60% were males and the rest were females. From the total, 172 of them were with watery type of diarrhea and 132 of them were prescribed antibiotics inappropriately out of which 77 were under 5 years. In addition, 27 patients were diagnosed with mucoid diarrhea and only eight of them were treated with antibiotics whereas 31 patients were with bloody type of diarrhea and 10 of them were not treated with antibiotics. Of the 230 cases, 161 (70%) patients received different types of antibiotics, and co-trimoxazole, amoxicillin and ciprofloxacin were the most prescribed antibiotics.

Conclusion: The study revealed that there is a high level of inappropriate antibiotics use which may fuel the increased antimicrobial resistance and associated costs nationally as well as globally.

Background: Ceftriaxone is one of the most commonly used antibiotics due to its availability, wide spectrum of activity and low toxicity. However, irrational use of ceftriaxone is one of the current issues in most countries, especially developing ones.

Objective: The aim of this study was to evaluate ceftriaxone utilization in different wards of Ras-Desta Memorial General Hospital (RDMGH) in Ethiopia.

Methods: An institution-based retrospective cross-sectional study was conducted on randomly selected 1,079 patients who were admitted to RDMGH from May 2017 to April 2018. A structured data abstraction format was used to collect data from patients' medical chart. Micromedex® drug interaction checker was used to identify significant drug-drug interactions, and national and international guidelines were used to evaluate the appropriateness of ceftriaxone use. The data were analyzed by using SPSS version 20.0.

Results: Among the 1,079 patients enrolled, ceftriaxone was utilized by 601 (55.7%) patients, and these patients were considered for evaluation of appropriateness and subsequent analysis. Among 601 patients, ceftriaxone was used for therapeutic purpose in 362 (60.2%) patients; of which, 359 (99.2%) were for empiric therapy and the rest 239 (39.8%) were for prophylaxis. In the majority of the patients, the dose of ceftriaxone was 2g/day 472 (78.6%) and for a duration of 2-7 days 409 (68.1%). Inappropriate use of ceftriaxone was observed among 237 (39.4%) patients with regard to indication, dose/frequency and duration. About half (49.3%) of the deviation from the guidelines was observed from surgical and gynecologic/obstetrics wards. Among the co-prescribed medications with ceftriaxone, ringer lactate, warfarin and heparin were found to have a significant drug-drug interaction.

Conclusion: This study revealed that inappropriate use of ceftriaxone was high in RDMGH. This may increase the emergence of resistant pathogens which may lead to treatment failure and increase cost of therapy. Therefore, adherence to current evidence-based guidelines is recommended.

Despite growing clinical confidence in generics and their potential to reduce long-term healthcare costs, the transplant community have had real concerns about the use of generic immunosuppressants. One such immunosuppressant is tacrolimus, a cornerstone of lifelong treatment for patients who have undergone a solid organ transplant. Tacrolimus has a narrow therapeutic index (NTI), giving rise to questions about the potential for clinically relevant altered drug exposure. Its use in transplant patients also gives rise to questions about the most discriminative subject population for bioequivalence studies. The recognised need for stringent criteria to support approval of generic drugs with an NTI led the European Medicines Association and Health Canada to provide detailed information on requirements for bioequivalence studies and introduce tighter bioequivalence limits for these drugs, including tacrolimus. The aim of this article is to illustrate how regulatory guidance is implemented during the clinical development of generic immunosuppressants, using a generic, once-daily prolonged-release formulation of tacrolimus as an example.

Background: Penicillins have never been associated with any form of hearing disorders. The Eritrean Pharmacovigilance Centre recently received two cases of hearing disorder (including one case of deafness) following the intake of amoxicillin capsules. This study was conducted to assess the causal link between amoxicillin and deafness.

Methods: Data mining was carried out in the WHO global database of individual case safety reports, VigiBase, and the Austin Bradford-Hill criteria were used to assess causality.

Results: A total of 94 cases of 'hearing disorders' related to amoxicillin were retrieved from VigiBase. Of these, 49 (52.1%) were reported as "deafness," and amoxicillin was marked as the sole suspected drug in 18 and the only drug administered in 13 cases. In the rest of the deafness cases (n=31), amoxicillin was concurrently administered with other drugs and reported as co-suspected. The median time to onset was three days and the outcome was marked as recovered (14), recovering (2), not recovered (16) and unknown (17). In five cases, deafness resolved following the withdrawal of amoxicillin.

Conclusion: There appears a causal association between amoxicillin and hearing loss that requires further substantiation with better epidemiologic studies.

Background: Antibiotic resistance has become one of the major global health threats. The lack of knowledge on antibiotics contributes to the indiscriminate use of these medications and subsequent antibiotic resistance.

Objective: To evaluate the knowledge and attitude of university students regarding antibiotics.

Methods: A cross-sectional study was conducted on university students at a private university in Malaysia in 2018, using a self-administered validated questionnaire.

Results: Of the 424 respondents included in this study, 25.7% had taken antibiotics in the previous month while 22.6% had good knowledge about antibiotics. The faculty to which the respondents were attached was the only determinant associated with the respondents' knowledge level on antibiotics. The odds of respondents from other faculties having poor knowledge level on antibiotics were significantly higher than those from the Faculty of Health and Medical Sciences (P<0.001). The study found that 77.8% of the respondents knew the roles of antibiotics in treating bacterial infections, but only 27.4% knew that antibiotics were not for viral infections. However, 46.5% of the respondents recognized that penicillin is an antibiotic, but only 35.4% and 9.2% knew that aspirin and diphenhydramine, respectively, are not antibiotics. More than 70% of the respondents were aware that antibiotics have side effects and that overuse of antibiotics could lead to resistance. However, 35.6% expected antibiotics to be prescribed for common colds and 33% would not complete their course of antibiotics.

Conclusion: The study shows that university students do not have adequate knowledge and about one-third have misconceptions about antibiotics. This calls for health education interventions at university level as this target population will be the future leaders of the country.