Drug, Healthcare and Patient Safety最新文献

{"title":"A Pharmacist-Driven Intervention Designed to Improve Medication Accuracy in the Outpatient Kidney Transplant Setting.","authors":"Elizabeth A Cohen,&nbsp;Danielle McKimmy,&nbsp;Anna Cerilli,&nbsp;Sanjay Kulkarni","doi":"10.2147/DHPS.S264022","DOIUrl":"https://doi.org/10.2147/DHPS.S264022","url":null,"abstract":"<p><strong>Background: </strong>Medication errors are one of the leading causes of complications and readmissions in healthcare and stem directly from inadequate medication lists. In transplantation, medication discrepancies can lead to fluctuating levels of immunosuppression, resulting in rejection, infection, or drug toxicity.</p><p><strong>Methods: </strong>We implemented a pharmacist-driven intervention designed to improve the accuracy of outpatient kidney transplant patients' medication lists in the electronic medical record (EMR). Baseline medication error rates (Phase 1) were collected, and the intervention was a dedicated pharmacist (Phase 2) who performed medication reconciliation with patients. The primary outcome was the percent of patients with inadequate medication reconciliation determined by any one error in medication reconciliation (Phase 1 vs Phase 2). Secondary outcomes included the number of medication errors, of all medications and high-risk medications, identified per patient sample using statistical process control phase analysis.</p><p><strong>Results: </strong>Pharmacist-driven medication reconciliation significantly reduced medication list discrepancies from 95% to 28% (<i>P</i><0.05). There were a total of 398 errors in the control group and 49 errors in the intervention group. In addition, there were 73 high-risk medication discrepancies in the control group and three in the intervention group. The total number of medication errors decreased post-intervention with a marked reduction in the variation of control limits (LCL, UCL: phase 1, -34.3, 113.9; phase 2, -7.1, 15.3) and average number of medication errors per sample (phase 1, 39.8; phase 2, 14.1). For high-risk medications, phase analysis demonstrated a marked reduction in control limit variation between phases (LCL, UCL: phase 1, -10.4, 25.0; phase 2, -0.5, 0.7) and average number of medication errors per sample (phase 1, 7.3; phase 2, 0.1).</p><p><strong>Discussion: </strong>A dedicated pharmacist improved medication list accuracy over conventional practice that utilizes transplant nurses and physicians. Further studies into the cost-effectiveness of this strategy should further justify this approach.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"12 ","pages":"229-235"},"PeriodicalIF":1.6,"publicationDate":"2020-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/DHPS.S264022","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38331435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Eperisone Hydrochloride and Non-Steroid Anti-Inflammatory Drugs (NSAIDs) for Acute Non-Specific Back Pain with Muscle Spasm: A Prospective, Open-Label Study.","authors":"Rizaldy Taslim Pinzon,&nbsp;Vincent Ongko Wijaya,&nbsp;Dessy Paramitha,&nbsp;Raymondus Rangga Bagaskara","doi":"10.2147/DHPS.S278467","DOIUrl":"https://doi.org/10.2147/DHPS.S278467","url":null,"abstract":"<p><strong>Background: </strong>Low back pain (LBP) occurs as a common condition and may harm the patient's quality-of-life. Non-steroid anti-inflammatory drugs (NSAIDs) and eperisone form a drug regiment that has been reported as effective in improving low back pain, yet the evidence for its efficacy and safety is lacking.</p><p><strong>Objective: </strong>The aim of this study was to evaluate the effect of eperisone hydrochloride and ibuprofen compared with ibuprofen alone in reducing symptoms of patients with acute non-specific back pain with a muscle spasm.</p><p><strong>Methods: </strong>This was an open-label, prospective study involving 100 subjects with symptoms of back pain and muscle spasm. Eligible participants were randomly allocated to an experimental group (54 patients) and a control group (46 patients). The experimental group received eperisone 50 mg three times daily + ibuprofen 400 mg twice daily, and the control group received ibuprofen 400 mg twice daily over a 4-week duration. The primary outcomes were measured with the visual analog scale (VAS), and finger-to-floor (FTF) distance at baseline, week 2, and week 4.</p><p><strong>Results: </strong>After 4 weeks of follow-up, results from 59 subjects were collected. In both groups, VAS and FTF were decreased compared to baseline. Clinically significant pain reduction (>50% than baseline) was observed to be higher in the experimental group compared with the control group in the fourth week (72.4% vs 46.7%, <i>P</i><0.05). At the end of the study, pain reduction in the experimental group was more significant compared to the control group (28.13±24.72 vs 34.42±28.47) and participants mobility (FTF distance <10 cm) improved in both groups, especially in the experimental group (75.9% vs 70%). There was no difference in adverse events between groups (<i>P</i>>0.05).</p><p><strong>Conclusion: </strong>The combination of eperisone hydrochloride and ibuprofen effectively reduces pain and improves functional outcomes over ibuprofen alone with a similar safety profile in these patients with acute non-specific back pain with muscle spasm.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"12 ","pages":"221-228"},"PeriodicalIF":1.6,"publicationDate":"2020-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/DHPS.S278467","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38643012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Under-Reporting of a Critical Perioperative Adverse Event: Intravenous Infiltration and Extravasation.","authors":"George Tewfik","doi":"10.2147/DHPS.S271832","DOIUrl":"https://doi.org/10.2147/DHPS.S271832","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"12 ","pages":"217-219"},"PeriodicalIF":1.6,"publicationDate":"2020-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/da/0e/dhps-12-217.PMC7671479.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38630271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk Analysis of Eculizumab-Related Meningococcal Disease in Japan Using the Japanese Adverse Drug Event Report Database.","authors":"Yumi Matsumura","doi":"10.2147/DHPS.S257009","DOIUrl":"https://doi.org/10.2147/DHPS.S257009","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"12 ","pages":"207-215"},"PeriodicalIF":1.6,"publicationDate":"2020-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/DHPS.S257009","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38623088","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Chemotherapy-Related Adverse Drug Reaction and Associated Factors Among Hospitalized Paediatric Cancer Patients at Hospitals in North-West Ethiopia.","authors":"Gashaw Workalemahu, Ousman Abubeker Abdela, Melaku Kindie Yenit","doi":"10.2147/DHPS.S254644","DOIUrl":"10.2147/DHPS.S254644","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"12 ","pages":"195-205"},"PeriodicalIF":1.6,"publicationDate":"2020-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/DHPS.S254644","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38591950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Prevalence of Needlesticks and Sharp Injuries, and the Associated Factors Among Midwives and Nurses in North Wollo Zone Public Hospitals, North East Ethiopia: An Institution-based Cross-sectional Study.","authors":"Addisu Getie,&nbsp;Adam Wondmieneh,&nbsp;Getachew Tesfaw","doi":"10.2147/DHPS.S273669","DOIUrl":"https://doi.org/10.2147/DHPS.S273669","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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, <i>P</i>-value <0.05 was considered as statistically significant in this study.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"12 ","pages":"187-193"},"PeriodicalIF":1.6,"publicationDate":"2020-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/DHPS.S273669","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38539076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Burden of Healthcare-Associated Infections and Associated Risk Factors at Adama Hospital Medical College, Adama, Oromia, Ethiopia.","authors":"Adinew Zewdu Chernet, Kassu Dasta, Feleke Belachew, Baharu Zewdu, Mengistu Melese, Musa Mohammed Ali","doi":"10.2147/DHPS.S251827","DOIUrl":"10.2147/DHPS.S251827","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Result: </strong>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).</p><p><strong>Conclusion: </strong>HCAI was predominant in this study. The major contributing factors for HCAI at AHMC were renal disease and type 2diabetes mellitus.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"12 ","pages":"177-185"},"PeriodicalIF":1.6,"publicationDate":"2020-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e6/da/dhps-12-177.PMC7569037.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38539075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Antibiotic Utilization Pattern During Acute Diarrheal Disease at Chefa-Robit Health Center, Kemissie, North East Amhara, Ethiopia.","authors":"Desye Misganaw, Kassaw Abtew","doi":"10.2147/DHPS.S256330","DOIUrl":"10.2147/DHPS.S256330","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods and materials: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"12 ","pages":"169-175"},"PeriodicalIF":1.6,"publicationDate":"2020-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/92/e7/dhps-12-169.PMC7534044.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38494245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug Use Evaluation of Ceftriaxone in Ras-Desta Memorial General Hospital, Ethiopia.","authors":"Oumer Sada Muhammed,&nbsp;Beshir Bedru Nasir","doi":"10.2147/DHPS.S260364","DOIUrl":"https://doi.org/10.2147/DHPS.S260364","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>The aim of this study was to evaluate ceftriaxone utilization in different wards of Ras-Desta Memorial General Hospital (RDMGH) in Ethiopia.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"12 ","pages":"161-168"},"PeriodicalIF":1.6,"publicationDate":"2020-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/DHPS.S260364","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38424156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Meeting Regulatory Requirements for Drugs with a Narrow Therapeutic Index: Bioequivalence Studies of Generic Once-Daily Tacrolimus.","authors":"Kaja Gantar, Katja Škerget, Ilya Mochkin, Aleksander Bajc","doi":"10.2147/DHPS.S256455","DOIUrl":"10.2147/DHPS.S256455","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"12 ","pages":"151-160"},"PeriodicalIF":1.6,"publicationDate":"2020-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c1/d2/dhps-12-151.PMC7489937.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38424155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}