Drug, Healthcare And Patient Safety[JOURNAL]
Sun
200 papers
Dyslipidemia and Associated Factors in Tenofovir Disoproxil Fumarate-Based Regimen Among Human Immunodeficiency Virus-Infected Ethiopian Patients: A Hospital-Based Observational Prospective Cohort Study.
Yazie TS
Drug Healthc Patient Saf · 2020 · PMID 33304107 · Full text
BACKGROUND: Studies showed conflicting results regarding the effect of broadly used tenofovir disoproxil fumarate (TDF)-based regimen on lipid profiles, and in Ethiopia, there is no data regarding the magnitude of dyslip...
BACKGROUND: Studies showed conflicting results regarding the effect of broadly used tenofovir disoproxil fumarate (TDF)-based regimen on lipid profiles, and in Ethiopia, there is no data regarding the magnitude of dyslipidemia and its associated factors. OBJECTIVE: The aim of this study was to determine the magnitude of dyslipidemia and its associated factors among adult human immunodeficiency virus (HIV)-infected patients in TDF-based regimen in Tikur Anbessa Specialized Hospital (TASH) in Ethiopia. METHODS: A hospital-based observational prospective cohort study was conducted on conveniently selected 63 patients in TASH from January to September, 2019. The data was analyzed by using SPSS version 21.0, and multivariate logistic regression was used to determine associated factors with dyslipidemia. RESULTS: The overall dyslipidemia was 73% and 77.8% at baseline and six months, respectively. The prevalence of total cholesterol (TC) ≥200 mg/d, triglyceride (TG) ≥150 mg/dL, low density lipoprotein cholesterol (LDL-c) ≥130 mg/dL, and high density lipoprotein cholesterol (HDL-c) <40 mg/dL was 38.1% vs 42.9%, 23.8% vs 31.7%, 17.5% vs 22.2%, and 41.3% vs 41.3% at baseline and six month follow-up, respectively. Age ≥50 years old (AOR = 0.6, 95% CI: 0.004-0.71, p = 0.026) and body mass index (BMI) ≥25 kg/m (AOR = 6.44, 95% CI: 1.34-30.9, p = 0.02) were significantly associated with TC ≥200 mg/dL. Having cancer (AOR = 0.04, 95% CI: 0.01-0.6, p = 0.019) and education level below diploma (AOR = 9.47, 95% CI: 1.15-77.96, p = 0.037) were significantly associated with overall dyslipidemia. CONCLUSION: In this study, the proportion of patients with dyslipidemia was higher at six month follow-up but there was no significant difference when compared to baseline. The mean LDL-c was significantly higher at six months compared to its baseline mean. The associated factors with dyslipidemia were age, BMI, having cancer and low level of education. Lipid profile monitoring is recommended in patients with a younger age and higher BMI.
Assessment of Drug Use Pattern Using WHO Core Prescribing Indicators at Outpatient Settings of Governmental Hospitals in Dessie Town.
Mengistu G, Misganaw D, Tsehay T … +2 more , Alemu BK, Bogale K
Drug Healthc Patient Saf · 2020 · PMID 33273863 · Full text
BACKGROUND: Enhancing the standards of medical treatment at all levels of the healthcare delivery system can improve the quality of life in developing countries. One method to promote rational drug use is an assessment o...
BACKGROUND: Enhancing the standards of medical treatment at all levels of the healthcare delivery system can improve the quality of life in developing countries. One method to promote rational drug use is an assessment of drug use pattern based on drug use indicators. OBJECTIVE: To evaluate prescription patterns at the outpatient pharmacy of Dessie Referral Hospital and Boru Meda Hospital at Dessie town. METHODS: An institution-based retrospective cross-sectional study was conducted to assess the prescribing patterns in governmental hospitals of Dessie town from April 1 to May 30, 2019. Six hundred eligible prescriptions were selected from each hospital through a systematic random sampling technique. RESULTS: The result of this study showed that both hospitals used standard prescriptions (100%). Age (99.0%) and name (94.7%) of patients were the most commonly recorded patient information while weight, address of patients and diagnosis were recorded only in 1.1%, 39.2% and 61.3% of the studied prescription papers, respectively. A total 2409 drugs were prescribed in the 1200 prescription papers and the percentage of encounters with injection(s) and antibacterial(s) was 9.0% and 42.6%, respectively. At each hospital, all drugs were prescribed from the Ethiopian essential drug list. CONCLUSION: The present study revealed the use of standard presecription papers at both hospitals. None of the patient-related information was completely written in all prescrptions. For drug-related information, only the name of the drug was written in all prescription papers. There is also a significant deviation from the acceptable WHO standard for prescribing antibiotics.
A Pharmacist-Driven Intervention Designed to Improve Medication Accuracy in the Outpatient Kidney Transplant Setting.
Cohen EA, McKimmy D, Cerilli A … +1 more , Kulkarni S
Drug Healthc Patient Saf · 2020 · PMID 33269008 · Full text
BACKGROUND: 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 flu...
BACKGROUND: 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. METHODS: 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. RESULTS: Pharmacist-driven medication reconciliation significantly reduced medication list discrepancies from 95% to 28% (<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). DISCUSSION: 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.
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.
Pinzon RT, Wijaya VO, Paramitha D … +1 more , Bagaskara RR
Drug Healthc Patient Saf · 2020 · PMID 33235514 · Full text
BACKGROUND: 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...
BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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%, <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 (>0.05). CONCLUSION: 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.
Under-Reporting of a Critical Perioperative Adverse Event: Intravenous Infiltration and Extravasation.
Tewfik G
Drug Healthc Patient Saf · 2020 · PMID 33223853 · Full text
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 intravenou...
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.
Risk Analysis of Eculizumab-Related Meningococcal Disease in Japan Using the Japanese Adverse Drug Event Report Database.
Matsumura Y
Drug Healthc Patient Saf · 2020 · PMID 33204170 · Full text
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...
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.
Chemotherapy-Related Adverse Drug Reaction and Associated Factors Among Hospitalized Paediatric Cancer Patients at Hospitals in North-West Ethiopia.
Workalemahu G, Abdela OA, Yenit MK
Drug Healthc Patient Saf · 2020 · PMID 33177883 · Full text
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 ne...
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.
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.
Getie A, Wondmieneh A, Tesfaw G
Drug Healthc Patient Saf · 2020 · PMID 33116914 · Full text
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 i...
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, -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.
Burden of Healthcare-Associated Infections and Associated Risk Factors at Adama Hospital Medical College, Adama, Oromia, Ethiopia.
Chernet AZ, Dasta K, Belachew F … +3 more , Zewdu B, Melese M, Ali MM
Drug Healthc Patient Saf · 2020 · PMID 33116913 · Full text
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 th...
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.
Evaluation of Antibiotic Utilization Pattern During Acute Diarrheal Disease at Chefa-Robit Health Center, Kemissie, North East Amhara, Ethiopia.
Misganaw D, Abtew K
Drug Healthc Patient Saf · 2020 · PMID 33061654 · Full text
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...
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.
Drug Use Evaluation of Ceftriaxone in Ras-Desta Memorial General Hospital, Ethiopia.
Muhammed OS, Nasir BB
Drug Healthc Patient Saf · 2020 · PMID 32982467 · Full text
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 countr...
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.
Meeting Regulatory Requirements for Drugs with a Narrow Therapeutic Index: Bioequivalence Studies of Generic Once-Daily Tacrolimus.
Gantar K, Škerget K, Mochkin I … +1 more , Bajc A
Drug Healthc Patient Saf · 2020 · PMID 32982466 · Full text
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 immunosuppre...
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.
Amoxicillin and Risk of Hearing Loss: Analysis of Reported Cases Submitted to the WHO Global Database.
Russom M, Afendi A, Ghebrenegus AS
Drug Healthc Patient Saf · 2020 · PMID 32904545 · Full text
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...
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.
Knowledge and Attitude of University Students on Antibiotics: A Cross-sectional Study in Malaysia.
Tiong TW, Chua SS
Drug Healthc Patient Saf · 2020 · PMID 32884359 · Full text
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. O...
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 (<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.
Metabolic Syndrome and Diabetes Risk Among Young Adult Students in the Health Sciences from Kathmandu, Nepal.
Sapkota M, Timilsina A, Shakya M … +5 more , Thapa TB, Shrestha S, Pokhrel S, Devkota N, Pardhe BD
Drug Healthc Patient Saf · 2020 · PMID 32884358 · Full text
BACKGROUND: The widespread dissemination of unhealthy dietary habits, childhood-teenage obesity, and sedentary lifestyle in young adults has paved the way for public health burden metabolic syndrome and early onset of ty...
BACKGROUND: The widespread dissemination of unhealthy dietary habits, childhood-teenage obesity, and sedentary lifestyle in young adults has paved the way for public health burden metabolic syndrome and early onset of type 2 diabetes mellitus. The aim of this study was to assess the prevalence and risk factors for metabolic syndrome and diabetes among young adult students. METHODS: This cross-sectional study was conducted among students of age group (18 to 25 years) studying at Manmohan Memorial Institute of Health Sciences and Central Institute of Science and Technology. The diabetes risk score of each individual was calculated by the Finnish Diabetes Risk Score (FINDRISC tool). Independent risk factors for diabetes and metabolic syndrome were measured by multivariable logistic regression analysis. The p-value of <0.05 was considered statistically significant in this study. RESULTS: A total of 825 students were recruited and 739 (89.6%) students completed the study with all the fulfilled criteria. The metabolic syndrome (Harmonized Joint Scientific Statement (HJSS) criteria) was present in 7.1%, and the most prevalent defining component was low HDL-C (78%); 74.8% of students were under low risk, 22.18% were at slightly elevated risk, 2.02% were at moderate risk, and 1.01% were at high risk of diabetes. The cardiometabolic risk factors like BMI, TC, and LDL-C were higher at a significant level (p<0.001) with an increased diabetes risk score. Independent lifestyle risk factor for metabolic syndrome was current smoking (AOR, 4.49, 95% CI 1.38-14.62) whereas, an independent lifestyle risk factor for diabetes was low adherence to physical exercise (AOR, 4.81, 95% CI, 2.90-7.99). CONCLUSION: Metabolic syndrome is present, although in low numbers in young adults putting them at risk to develop diabetes in the near future. Early assessment of metabolic syndrome and diabetes risk in young may provide insights for preventive and control plans for risk population.
Areas of Potential Improvement for Hospitals' Patient-Safety Culture in Western Ethiopia.
Garuma M, Woldie M, Kebene FG
Drug Healthc Patient Saf · 2020 · PMID 32848480 · Full text
BACKGROUND: Patient-safety culture is an important component of health-care quality and currentlyan issue of high concern globally. In Ethiopia, little is known about patient-safety culture in hospitals. We assessed the...
BACKGROUND: Patient-safety culture is an important component of health-care quality and currentlyan issue of high concern globally. In Ethiopia, little is known about patient-safety culture in hospitals. We assessed the patient-safety culture and associated factors among health-care workers in public hospitals of East Wollega Zone, western Ethiopia. METHODS: This institution-based cross-sectional study was conducted among 421 health-care workers selected using simple random sampling from March 4 to March 29, 2019. A standardized measuring 12 patient safety-culture components was used for data collection. Data were cleaned and entered into EpiData version 3.1 and analysis done using SPSS version 25 (IBM). Bivariate and multivariate linear regression analyses were performed. Significance was set at 95% CI and <0.05, and unstandardized β-coefficients were used to measure extent of association. RESULTS: This study revealed that the level of patient-safety culture was 49.2% and patient safety culture-component scores ranged from 29.2% for nonpunitive responses to error to 77.9% for teamwork within a hospital unit. Age ≥45 years (=13.642, CI: 5.324-21.959; =0.001), 1-5 years' experience at the current hospital (=5.559, 95% CI 2.075-9.042; =0.002), and working in general hospitals (=11.988, 95% CI 7.233-16.743; <0.001) and primary hospitals (=6.408, 95% CI 2.192-10.624; =0.003) were factors associated with better scores on patient-safety culture. CONCLUSION: Overall scores for patient-safety culture were low. Improving the current state of patient safety in public hospitals would require tailored interventions to address low-scoring components, such as nonpunitive responses to error.
Pharmaceutical Quality of Selected Metronidazole and Ciprofloxacin Infusions Marketed in South Eastern Nigeria.
Oli AN, Ibeabuchi MU, Enweani IB … +1 more , Emencheta SC
Drug Healthc Patient Saf · 2020 · PMID 32765114 · Full text
BACKGROUND: Pharmaceutical products need to be of good quality and it is even more critical when it comes to life saving medicaments like infusions. OBJECTIVE: This research surveyed the quality fitness of some ciproflox...
BACKGROUND: Pharmaceutical products need to be of good quality and it is even more critical when it comes to life saving medicaments like infusions. OBJECTIVE: This research surveyed the quality fitness of some ciprofloxacin and metronidazole infusion samples marketed in South-eastern of Nigeria. METHODS: Using Official Compendial methods, microbiological quality, active pharmaceutical ingredients quantitation, pH and particle count tests were evaluated on eighty infusion bottles (from eight pharmaceutical companies) of each of the two drugs. RESULTS: Out of the sixteen brands tested, 2 metronidazole brands and 1 ciprofloxacin brand (representing 18.75% of the total 16 brands/makes) were contaminated while the remaining 13 brands (81.25%) were found sterile. The active pharmaceutical ingredients quantitative assay showed that all the brands of ciprofloxacin infusion were between the 95% and 105% limit of label claim while one metronidazole brand has <95-110% limit label claim. Six brands each of the two drugs evaluated fall below the acceptable pH range [ciprofloxacin (3.5-4.6) and metronidazole (4.8-5.2)], while the other two brands of both drugs passed the test. In the antibacterial study, and were susceptible to the ciprofloxacin (5 µg). However, recorded inhibition zone diameters within resistant and intermediate range. spp was susceptible (at minimum inhibitory concentrations of 100 µg/mL) to all the brands of metronidazole, while none of the brands were effective on spp. All the brands passed the test for particulate contamination. The particles size range was <10µm. CONCLUSION: About eighty-one percent (81.25%) of the infusions have acceptable good microbiological quality. However, 18.75% that failed the tests is a concern knowing that these are lifesaving products.
Development and Psychometric Validation of a Questionnaire to Evaluate Knowledge and Attitude Towards Medication Error Reporting Among Pharmacists.
Mamat R, Awang SA, Ab Rahman AF
Drug Healthc Patient Saf · 2020 · PMID 32523381 · Full text
PURPOSE: Assessment of medication errors (ME) is crucial to improving the quality of health care. A questionnaire that can be used to explore pharmacists' perspectives regarding ME would be very useful as part of an ongo...
PURPOSE: Assessment of medication errors (ME) is crucial to improving the quality of health care. A questionnaire that can be used to explore pharmacists' perspectives regarding ME would be very useful as part of an ongoing process of quality improvement in patient care. The aim of this study was to develop and validate a questionnaire to measure perceived causes of ME and attitude towards ME reporting among pharmacists. METHODS: The questionnaire was developed from the literature together with outcomes from focus group discussions. It was divided into two domains which are knowledge on ME and attitude towards ME reporting. Content validity index (I-CVI), exploratory factor analysis (EFA), Cronbach alpha and intraclass correlation coefficient (ICC) to assess test-retest reliability were obtained during the validation process. RESULTS: Overall Cronbach alpha for internal consistency was good (0.742), where subscale of the questionnaire demonstrated adequate internal consistency, with Cronbach alpha value 0.83 for knowledge and 0.70 for reporting behaviour attitude. The I-CVI showed good scores (knowledge=0.88) and (attitude=0.81), while ICC was moderately accepted with a value of 0.77. Two factors were extracted from the 16 items in EFA. CONCLUSION: The questionnaire to assess knowledge on ME and attitude towards ME reporting among pharmacists is valid and reliable. It demonstrates good psychometric properties.
Updated Evaluation of the Safety, Efficacy and Tolerability of Pirfenidone in the Treatment of Idiopathic Pulmonary Fibrosis.
Gulati S, Luckhardt TR
Drug Healthc Patient Saf · 2020 · PMID 32440226 · Full text
Idiopathic Pulmonary Fibrosis (IPF) is a chronic fibrotic disease characterized by a progressive decline in lung function with a median survival of 3-5 years after diagnosis. The course of disease is highly variable and...
Idiopathic Pulmonary Fibrosis (IPF) is a chronic fibrotic disease characterized by a progressive decline in lung function with a median survival of 3-5 years after diagnosis. The course of disease is highly variable and unpredictable, often punctuated by episodes of acute respiratory failure, known as acute exacerbations. The incidence of IPF is on the rise due to the aging population, as age is the most important risk factor for this disease. Pirfenidone and nintedanib are the two anti-fibrotic drugs approved for IPF which have shown reduction in lung function decline. This review will discuss the efficacy, safety and tolerability profile of pirfenidone from clinical trials and the real-world clinical experience. Pirfenidone reduces the decline in lung function and improves progression-free survival in patients with IPF. It is generally well tolerated with the most common side effects being gastrointestinal and phototoxicity.
Drug Therapy Problems and the Role of Clinical Pharmacist in Surgery Ward: Prospective Observational and Interventional Study.
Tefera GM, Zeleke AZ, Jima YM … +1 more , Kebede TM
Drug Healthc Patient Saf · 2020 · PMID 32440225 · Full text
BACKGROUND: Drug therapy problems (DTPs) are of major concern in health care because of the associated increased cost of treatment, morbidity, and mortality. Thus, clinical practice should constitute the mainstream pract...
BACKGROUND: Drug therapy problems (DTPs) are of major concern in health care because of the associated increased cost of treatment, morbidity, and mortality. Thus, clinical practice should constitute the mainstream practice of clinical pharmacy in every ward. However, nothing is known about DTPs and the role of clinical pharmacist in the surgical ward of Ethiopia (the neglected ward). OBJECTIVE: To assess the prevalence of DTP among patients hospitalized at the surgical ward and the role of clinical pharmacists in their identification and resolution. METHODS: Hospital-based prospective observational and interventional study design was used with daily patients' chart review using a semi-structured questionnaire among hospitalized adult patients at the surgical ward. After identification of DTP, verbal communication was used as a means of intervention with the treating physician. Acceptance of clinical pharmacist's intervention was considered only if a change was made to the patients' medication order. To identify determinants of DTPs, multiple stepwise forward logistic regression analysis was done by SPSS version 20.0. Statistical significance was considered at p-value < 0.05. Written informed consent was sought and the data were secured. RESULTS: The response rate was 97.1% (300) for the final analysis. The mean (±SD = standard deviation) age of the participants was 42.62 ±18.29 with male (67%) predominance. DTP was identified in 76% of study participants. A total of 449 DTPs were identified, which equates with an average of 1.97 per patient. Dose too low 124/449 (27.6%) and dose too high 81/449 (18.0%) were found to be the most common types of DTPs. The intervention rate was 86.0% (196/228 per patients) and 86.2% (387/449 DTPs), with the acceptance rate of 85.2% (167/196 per patients) and 78% (302/387 per DTP) which mean (67.3%) 302/449 of the problems were fully resolved by the clinical pharmacist. Poly-pharmacy [AOR, 7.23; 95% CI, 2.29-22.13: P-value < 0.001] and hospital stay > 20 days [AOR, 5.42; 95% CI, 2.74-10.70; p < 0.001] were the only independent predictors for DTPs. CONCLUSION AND RECOMMENDATION: This study identified a high prevalence of DTP which was independently predicted by the presence of poly-pharmacy and >20 days of hospital stay. The rate of intervention provided and acceptance from the physician was high, which is one indicator that the role of clinical pharmacists in the identification and resolution of DTP was paramount in the surgery ward and should be implemented as a must not as optional.
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