Drug, Healthcare and Patient Safety最新文献

Purpose: To characterize medical device reports about elastomeric pumps delivering local anesthesia made to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.

Patients and methods: We conducted a retrospective review of medical device reports submitted to MAUDE from January 2010 to July 2018. A systematic, computerized algorithm was used to identify records pertaining to elastomeric pumps using local anesthesia. Included records indicated the use of local anesthesia or were determined to involve the use of local anesthetics (if they did not contain specific information on drug use). Reports were analyzed within the MAUDE event type categories of malfunction, injury, death, other, and missing. Possible cases of liver injury or surgical site infection were also identified. Manual review of narratives provided in MAUDE was performed by 2 reviewers to identify possible or probable cases of local anesthetic system toxicity (LAST).

Results: From a pool of 384,285 reports about elastomeric pumps from the MAUDE database, 4093 met inclusion criteria for involving elastomeric pumps to deliver local anesthetics, with the peak number of reports occurring in 2014. Of these identified reports, 3624 (88.5%) were categorized as malfunctions, 292 (7.1%) as injuries, and 8 (0.2%) as involving death. We identified 13 cases (0.3%) of possible liver injury and 51 cases (1.2%) of possible surgical site infection; 139 reports (3.4%) were determined to be probably (n=53) or possibly (n=86) associated with LAST.

Conclusion: Malfunction of elastomeric pumps delivering local anesthetics leaves patients vulnerable to injury or death. Our study indicates that reports of malfunction, injury, and death have been reported to the MAUDE database. These reports likely reflect an underrepresentation of cases in the real-world population, emphasizing the need for more comprehensive medical device reporting.

Background: Heart-failure patients are at high risk of experiencing drug-therapy problems, owing to polypharmacy, comorbidities, and usually advanced age. Drug-therapy problems can lead to poor clinical outcomes, increased health-care costs and decreased quality of life, and thus strategies for identifying, resolving, and preventing them are urgently needed. Therefore, this study aimed at investigating the incidence and predictors of drug-therapy problems among hospitalized heart-failure patients.

Methods: This hospital-based prospective observational study was conducted from February 1 to May 31, 2014 at Jimma University Specialized Hospital. Patients of either sex aged 18 years and above with chronic heart failure and complete medical records were enrolled. Patients with high-output heart failure, <1 day of hospital stay, unwilling to give written informed consent, and unconscious without caregivers were excluded. Data were collected from medication charts, laboratory reports, patients/caregivers, morning multidisciplinary meetings, and ward rounds. Multivariate binary logistic regression analysis was done to identify independent predictors of drug-therapy problems.

Results: A total of 104 heart-failure patients (mean age 51.20±15.66 years, females 51.9%) were consecutively enrolled, and 95 (91.3%) had experienced at least one drug-therapy problem (total 268, mean 2.82±1.39 encounters per patient). Of these problems, 45.5% were the need for additional drugs, followed by noncompliance (22.0%), inappropriate dosing (9.3%), unnecessary drugs (9.0%), ineffective drugs (8.2%), and adverse drug reactions (6.0%). None of the independent variables was found to be an independent predictor of having at least one drug-therapy problem. However, the number of clinical/pharmacological risk factors (AOR 7.93), female sex (AOR 3.24), and length of hospital stay (AOR 12.98) were predictors of noncompliance.

Conclusion: Patients suffered from a large number of drug-therapy problems. Drugs with survival benefit were underused. Noncompliance and the need for additional drug therapy were the most frequently identified drug-therapy problems. Numbers of clinical/pharmacological risk factors, length of hospital stay, and female sex were identified as predictors for noncompliance.

Background: The aim of this research was to evaluate quality control parameters of available brands of paracetamol tablets in Gondar city since standard quality parameters are essential for a better quality of the product. The different brands of paracetamol tablets were obtained from local pharmacies in Gondar town and the University of Gondar (UOG) hospital pharmacies.

Methods: Five brands of paracetamol, from each, 102 tablets were collected from private pharmacies, government health centers, and UOG pharmacies. The popular brands in the city, Panadol, Para-denk, Paramol, Paracetamol (EPHARM), and Cadimol, conventional tablets of 500 mg strength were chosen and the tablets were assessed for different quality parameters: weight variation, hardness, friability, disintegration, dissolution, and drug content (assay) using compendial methods. The tablets were evaluated to check if they comply with the specifications of USP (United States Pharmacopeia).

Results: From the results, it was observed that all the brands of paracetamol have passed the tests and met the specifications of USP. Results of weight variation, hardness, friability, and disintegration time ranged from 0.46 to 1.11%, 117.0 to 174.70 N, 0.07 to 0.63%, and 01 to 08 minutes for all the tablets, respectively. The dissolution profiles of all the brands are within the acceptable label claim. The assay results showed that the drug content of the paracetamol brands ranged from 95.04% to 106.81%. The dissolution rate was significantly different (p < 0.05) as compared to code 1 with all brands tested at 30 minutes. The disintegration time of different brands was also significantly different from the comparator (code 1) except code 2.

Conclusion: Based on the finding from this study, there were no significant deviations from pharmacopeia standards and specifications. The brands studied were safe enough and could be used to achieve the desired therapeutic effect.

[This retracts the article DOI: 10.2147/DHPS.S67328.].

[This retracts the article DOI: 10.2147/DHPS.S24798.].

Background: Surgical site infections are global healthcare problems. Although surgical site infections are preventable, they still cause significant morbidity, high death rates, and financial stress on national budgets and individual patients. Inappropriate uses of surgical antimicrobial prophylaxis are increasing and worsening patients' quality of life. This study determined the incidence and risk factors of surgical site infections.

Methods: Institution-based retrospective cross-sectional study was conducted using a structured data abstraction format on patients who were attending at the surgical ward of Borumeda hospital from April 1, 2017, to March 31, 2019. The data were collected during July 15-30, 2019. A systematic random sampling technique was employed to select 227 surgical cases. Multivariate logistic regression was computed using the statistical package for social sciences version 23.

Results: The incidence of surgical site infections was 46.7%. Prophylaxis was administered to 188 (82.8%) surgical cases. Prophylaxis was recommended for 151 (66.5%). Out of these, only 143 (94.7%) received prophylaxis. One hundred seventy-four (78.4%) of the procedures had appropriate indication. The compliance of surgical antimicrobial prophylaxis use was 13.7%. The predictors of surgical site infections were receiving prophylaxis more than 24 h after surgery (AOR=3.53, 95% CI: 1.22-10.17), clean-contaminated wounds (AOR=4.54, 95% CI: 1.33-15.53), surgical procedure of thyroidectomy (AOR=5.2, 95% CI: 0.9-21.4), appendectomy (AOR = 29, 95% CI: 6.2-141.7), cholecystectomy (AOR = 21, 95% CI: 3.5 -126.7), hernia (AOR= 8.8, 95% CI: 1.2-62.2), skin and deep tissue (AOR = 125, 95% CI: 7.8-196.7), and orthopedic (AOR=57, 95% CI: 1.6-209.5).

Conclusion: There was high inconsistency between surgical antimicrobial prophylaxis practice and international surgical site infections prevention guideline. Wrong selection of antimicrobial agents was the most noncompliant to the guidelines. The incidence of surgical antimicrobial prophylaxis was high and requires due attention. The duration of postoperative prophylaxis should be kept to less than 24 h.

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/m² (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.

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.

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% (P<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.

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%, P<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 (P>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.