Drug, Healthcare And Patient Safety[JOURNAL]
Sun
200 papers
Potential drug-drug interactions in inpatients treated at the Internal Medicine ward of Tikur Anbessa Specialized Hospital.
Tesfaye ZT, Nedi T
Drug Healthc Patient Saf · 2017 · PMID 28860861 · Full text
PURPOSE: Although the concomitant use of multiple drugs often increases therapeutic effectiveness, certain combinations result in unwanted drug-drug interactions (DDIs). Most interactions go unnoticed by physicians due t...
PURPOSE: Although the concomitant use of multiple drugs often increases therapeutic effectiveness, certain combinations result in unwanted drug-drug interactions (DDIs). Most interactions go unnoticed by physicians due to the absence of new clinical signs and symptoms, and because they often produce a worsening of already existing symptoms. Quantification of the occurrence of the potential DDIs is essential to prevent the harmful effects associated with interactions. This study was launched to assess the prevalence of potential DDIs in the Internal Medicine ward of Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia. PATIENTS AND METHODS: Cross-sectional data were gathered from the medical charts of 252 randomly selected patients who were admitted to the Internal Medicine ward during August 23 to October 23, 2013, and exposed to at least two concomitant drugs. Potential DDIs were identified using Medscape Drug Interaction Checker. The data were analyzed using SPSS software. Logistic regression analysis was used to determine the presence of association between variables and -value <0.05 was considered statistically significant. RESULTS: At least one potential DDI was found in 78.2% of the patients. The mean number of potential interactions per patient was 3.7±3.4. Out of the 719 potential interactions identified, 49.8% were pharmacokinetic type, 44.6% were pharmacodynamic and the remaining 5.6% were unknown mechanisms. Major potential DDIs accounted for 13.1% of the whole interactions; 53.5% were moderate interactions; and the remaining 33.4% were minor interactions. Ceftriaxone, cimetidine and heparin were the three most involved drugs in major potential interactions. Prescription of five or more concomitant drugs was associated with high risk of encountering potential DDIs. CONCLUSION: The findings of this study showed that the prevalence of potential DDIs among inpatients was high. Pharmacists should closely review drugs prescribed for patients and avoid dispensing combinations of drugs that may have serious DDIs.
Prediction of drug-related problems in diabetic outpatients in a number of hospitals, using a modeling approach.
Al-Taani GM, Al-Azzam SI, Alzoubi KH … +4 more , Darwish Elhajji FW, Scott MG, Alfahel H, Aldeyab MA
Drug Healthc Patient Saf · 2017 · PMID 28814901 · Full text
OBJECTIVE: Drug-related problems (DRPs) are considered a serious, expensive, and important undesirable complication of health care. However, as current health care resources are limited, pharmacist DRP services cannot be...
OBJECTIVE: Drug-related problems (DRPs) are considered a serious, expensive, and important undesirable complication of health care. However, as current health care resources are limited, pharmacist DRP services cannot be provided to all patients. Using a modeling approach, we aimed to identify risk factors for DRPs so that patients for DRP-reduction services can be better identified. METHODS: Patients with diabetes from outpatient clinics from five key university-affiliated and public hospitals in Jordan were assessed for DRPs (drug without an indication, untreated indication, and drug efficacy problems). Potential risk factors for DRPs were assessed. A logistic regression model was used to identify risk factors using a randomly selected, independent, nonoverlapping development (75%) subsample from full dataset. The remaining validation subsample (25%) was reserved to assess the discriminative ability of the model. RESULTS: A total of 1,494 patients were recruited. Of them, 81.2% had at least one DRP. Using the development subsample (n=1,085), independent risk factors for DRPs identified were male gender, number of medications, prescribed gastrointestinal medication, and nonadherence to self-care and non-pharmacological recommendations. Validation results (n=403) showed an area under the receiver operating characteristic curve of 0.679 (95% confidence interval=0.629-0.720); the model sensitivity and specificity values were 65.4% and 63.0%, respectively. CONCLUSION: Within the outpatient setting, the results of this study predicted DRPs with acceptable accuracy and validity. Such an approach will help in identifying patients needing pharmacist DRP services, which is an important first step in appropriate intervention to address DRPs.
Adaptation of the European Commission-recommended user testing method to patient medication information leaflets in Japan.
Yamamoto M, Doi H, Yamamoto K … +5 more , Watanabe K, Sato T, Suka M, Nakayama T, Sugimori H
Drug Healthc Patient Saf · 2017 · PMID 28652818 · Full text
BACKGROUND: The safe use of drugs relies on providing accurate drug information to patients. In Japan, patient leaflets called Drug Guide for Patients are officially available; however, their utility has never been verif...
BACKGROUND: The safe use of drugs relies on providing accurate drug information to patients. In Japan, patient leaflets called Drug Guide for Patients are officially available; however, their utility has never been verified. This is the first attempt to improve Drug Guide for Patients via user testing in Japan. PURPOSE: To test and improve communication of drug information to minimize risk for patients via user testing of the current and revised versions of Drug Guide for Patients, and to demonstrate that this method is effective for improving Drug Guide for Patients in Japan. METHOD: We prepared current and revised versions of the Drug Guide for Patients and performed user testing via semi-structured interviews with consumers to compare these versions for two guides for Mercazole and Strattera. We evenly divided 54 participants into two groups with similar distributions of sex, age, and literacy level to test the differing versions of the Mercazole guide. Another group of 30 participants were divided evenly to test the versions of the Strattera guide. After completing user testing, the participants evaluated both guides in terms of amount of information, readability, usefulness of information, and layout and appearance. Participants were also asked for their opinions on the leaflets. RESULTS: Response rates were 100% for both Mercazole and Strattera. The revised versions of both Guides were superior or equal to the current versions in terms of accessibility and understandability. The revised version of the Mercazole guide showed better ratings for readability, usefulness of information, and layout (<0.01) than did the current version, while that for Strattera showed superior readability and layout (<0.01). CONCLUSION: User testing was effective for evaluating the utility of Drug Guide for Patients. Additionally, the revised version had superior accessibility and understandability.
Update on the renal toxicity of iodinated contrast drugs used in clinical medicine.
Andreucci M, Faga T, Serra R … +2 more , De Sarro G, Michael A
Drug Healthc Patient Saf · 2017 · PMID 28579836 · Full text
An important side effect of diagnostic contrast drugs is contrast-induced acute kidney injury (CI-AKI; a sudden decrease in renal function) occurring 48-72 hours after injection of a contrast drug that cannot be attribut...
An important side effect of diagnostic contrast drugs is contrast-induced acute kidney injury (CI-AKI; a sudden decrease in renal function) occurring 48-72 hours after injection of a contrast drug that cannot be attributed to other causes. Its existence has recently been challenged, because of some retrospective studies in which the incidence of AKI was not different between subjects who received a contrast drug and those who did not, even using propensity score matching to prevent selection bias. For some authors, only patients with estimated glomerular filtration rate <30 mL/min/1.73 m are at significant risk of CI-AKI. Most agree that when renal function is normal, there is no CI-AKI risk. Many experimental studies, however, are in favor of the existence of CI-AKI. Contrast drugs have been shown to cause the following changes: renal vasoconstriction, resulting in a rise in intrarenal resistance (decrease in renal blood flow and glomerular filtration rate and medullary hypoxia); epithelial vacuolization and dilatation and necrosis of proximal tubules; potentiation of angiotensin II effects, reducing nitric oxide (NO) and causing direct constriction of descending vasa recta, leading to formation of reactive oxygen species in isolated descending vasa recta of rats microperfused with a solution of iodixanol; increasing active sodium reabsorption in the thick ascending limbs of Henle's loop (increasing O demand and consequently medullary hypoxia); direct cytotoxic effects on endothelial and tubular epithelial cells (decrease in release of NO in vasa recta); and reducing cell survival, due to decreased activation of Akt and ERK1/2, kinases involved in cell survival/proliferation. Prevention is mainly based on extracellular volume expansion, statins, and -acetylcysteine; conflicting results have been obtained with nebivolol, furosemide, calcium-channel blockers, theophylline, and hemodialysis.
Patient safety attitudes of pharmacy students in an Ethiopian university: a cross-sectional study.
Tegegn HG, Abebe TB, Ayalew MB … +1 more , Bhagavathula AS
Drug Healthc Patient Saf · 2017 · PMID 28507450 · Full text
INTRODUCTION: Patient safety is a major health care concern and is being included in an undergraduate curriculum as it plays a major role in lessening harm. Therefore, we aim to assess the attitude of pharmacy students t...
INTRODUCTION: Patient safety is a major health care concern and is being included in an undergraduate curriculum as it plays a major role in lessening harm. Therefore, we aim to assess the attitude of pharmacy students toward patient safety. METHODS: A cross-sectional study using a self-administered questionnaire containing 21 items was conducted at the University of Gondar among fourth and fifth year students. Data analysis was performed to calculate mean, standard deviation, percentages, and logistic regressions using SPSS software version 22 (IBM Corporation, Armonk, NY, USA). Statistical significance was set at <0.05. RESULTS: A total of 83 pharmacy students (fourth year groups=50, fifth year groups=33) participated in the study with response rate of 92%. Majority of the students 70/83 (84.33%) had the overall positive attitude of patient safety. Most of the respondents (80.7%) agree or strongly agree that after an error occurs, an effective strategy is to work hard to be more careful. Most of them (79.6%) believe that pharmacists should routinely spend part of their professional time working to improve patient care. About half (48.2%) of pharmacy students disagree or strongly disagree that pharmacists should discuss and report errors to an affected patient and their family even if the patient is not harmed. No significant association between the attitude of pharmacy students toward patient safety and their age, sex and year of study was found. CONCLUSION: Pharmacy students have the overall good attitude to patient safety. However, they claimed the culture and attitude within the pharmacy workplace lacked for patient safety. Moreover, standardized patient safety course should be considered in the curriculum for junior pharmacy students to improve their attitude toward patient safety.
Update on the usage and safety of epinephrine auto-injectors, 2017.
Posner LS, Camargo CA
Drug Healthc Patient Saf · 2017 · PMID 28356773 · Full text
Anaphylaxis is a serious, potentially fatal allergic reaction. Guidelines recommend prompt intramuscular injections of epinephrine as the first-line therapy for anaphylaxis. Delayed epinephrine treatment may cause undesi...
Anaphylaxis is a serious, potentially fatal allergic reaction. Guidelines recommend prompt intramuscular injections of epinephrine as the first-line therapy for anaphylaxis. Delayed epinephrine treatment may cause undesirable clinical outcomes, including death. In the community, epinephrine auto-injectors (EAIs) are commonly used to treat anaphylaxis. This literature review examines several recent concerns regarding the safety of EAIs that may prevent the timely administration of epinephrine. Reports of cardiovascular complications are linked with epinephrine administration, although recent studies suggest that these events are much more commonly associated with intravenous epinephrine rather than with EAIs. Recent studies have also highlighted accidental injections of EAIs in patients' or caregivers' fingers and lacerations associated with the use of EAI in children. However, the data suggest that both accidental injections and lacerations are rare and require limited medical intervention. In addition, patients may receive conflicting information on the safety and efficacy of using expired EAIs. Overall, it is believed that the benefits of using EAIs far outweigh the potential risks of not administering an EAI. Although legitimate safety concerns are associated with EAIs, adverse events are rare. Continued training of medical providers, caregivers, and patients may be beneficial to address these concerns and reduce EAI-associated injuries while ensuring that patients receive necessary medical care.
Quantifying the relationship between patient characteristics and involvement in developing and implementing a treatment plan.
Roy NT, Ulrich EE
Drug Healthc Patient Saf · 2017 · PMID 28144164 · Full text
OBJECTIVE: Improving the patient-physician relationship through patient involvement in the care may lead to improved patient safety and better health outcomes. There exists a gap in knowledge in identifying factors that...
OBJECTIVE: Improving the patient-physician relationship through patient involvement in the care may lead to improved patient safety and better health outcomes. There exists a gap in knowledge in identifying factors that affect self-reported patient involvement in individualized treatment plans. The objectives of this study were to 1) describe patients' perceptions of their involvement in the creation and implementation of their treatment plans and 2) determine if patient involvement varied by medical condition or demographic characteristics. METHODS: This study was a cross-sectional analysis of data from the "Quality of Care" module of the 2008 Health and Retirement Study (HRS). The individuals of HRS surveys were older than 50 years. One-way analyses of variance were conducted to determine differences between patient characteristics and involvement in creating a treatment plan. A linear regression was conducted to determine predictors of the summed involvement score. RESULTS: Average summed scores for each domain (shared decision-making, counseling, and follow-up) and overall involvement scores were ~50%. Linear regression showed that being non-White, older age, and diagnosed with a psychiatric condition or diabetes were predictors of increased self-reported involvement in the development and communication of a patient's treatment plan. CONCLUSION: Age, race, and having diabetes or a psychiatric condition were the major predictors affecting patient involvement in care, although overall involvement in care was low for all groups. PRACTICE IMPLICATIONS: Patient involvement in care was lower than expected and should be further studied to determine the effects of involvement on health outcomes.
Development and validation of evaluation tools of nursing students' clinical pharmacology unit.
Navabi N, Ghaffari F, Shamsalinia A … +1 more , Faghani S
Drug Healthc Patient Saf · 2016 · PMID 28008285 · Full text
INTRODUCTION: The need for valid, reliable, and objective tools has always been emphasized in studies related to the clinical assessment of nursing students. The aims of this study were to develop and assess the validity...
INTRODUCTION: The need for valid, reliable, and objective tools has always been emphasized in studies related to the clinical assessment of nursing students. The aims of this study were to develop and assess the validity and reliability of the tools used to evaluate the clinical pharmacology unit. METHODS: This study was a methodological one, conducted in 2016. An item pool was developed based on the literature review and personal interviews with faculty members. The tool's validity was determined through assessment of face validity, content validity, and construct validity, using exploratory factor analysis on the data provided by 264 second- and third-semester nursing students of the Islamic Azad University of Babol University of Medical Sciences. Reliability was determined through internal and external consistency, using a Cronbach's coefficient of the correlation between classes. RESULTS: Based on the exploratory factor analysis, all items with a special value of >1 were grouped into six factors: 1) professional behavior; 2) effective communication; 3) recognition of medical terminology; 4) nursing actions before administering medicine; 5) nursing actions while administering medicine; and 6) nursing actions after administering medicine. These factors explained 77% of the total variance of the concept of assessment of the clinical pharmacology unit. In this study, reliability was demonstrated by a Cronbach's alpha coefficient of 0.96; the correlation coefficient between floors for the total tool was 0.91, ranging from 0.64 to 0.89 in its dimensions. CONCLUSION: The evaluation tool of the clinical pharmacology unit has an acceptable construct validity and satisfactory reliability and validity. Therefore, it can be used to evaluate the clinical pharmacology unit in the nursing education system in Iran.
Implementation of co-trimoxazole preventive therapy policy for malaria in HIV-infected pregnant women in the public health facilities in Tanzania.
Kamuhabwa AA, Gordian R, Mutagonda RF
Drug Healthc Patient Saf · 2016 · PMID 28008284 · Full text
BACKGROUND: In 2011, Tanzania adopted a policy for provision of daily co-trimoxazole prophylaxis to HIV-infected pregnant women for prevention of malaria and other opportunistic infections. As per the policy, HIV-infecte...
BACKGROUND: In 2011, Tanzania adopted a policy for provision of daily co-trimoxazole prophylaxis to HIV-infected pregnant women for prevention of malaria and other opportunistic infections. As per the policy, HIV-infected pregnant women should not be given sulfadoxine-pyrimethamine (SP) for intermittent preventive therapy. The challenges associated with this policy change and the extent to which the new policy for prevention of malaria in pregnant women coinfected with HIV was implemented need to be assessed. AIM: To assess the implementation of malaria-preventive therapy policy among HIV-infected pregnant women in the public health facilities in Dar es Salaam, Tanzania. METHODOLOGY: The study was conducted in Kinondoni Municipality, Dar es Salaam, Tanzania, from January 2015 to July 2015. Three hundred and fifty-three HIV-infected pregnant women who were attending antenatal clinics (ANCs) and using co-trimoxazole for prevention of malaria were interviewed. Twenty-six health care workers working at the ANCs were also interviewed regarding provision of co-trimoxazole prophylaxis to pregnant women. A knowledge scale was used to grade the level of knowledge of health care providers. Focus group discussions were also conducted with 18 health care workers to assess the level of implementation of the policy and the challenges encountered. RESULTS: Twenty-three (6.5%) pregnant women with known HIV serostatus were using co-trimoxazole for prevention of opportunistic infections even before they became pregnant. Out of the 353 HIV-infected pregnant women, eight (2.5%) were coadministered with both SP and co-trimoxazole. Sixty (16.7%) pregnant women had poor adherence to co-trimoxazole prophylaxis. Out of the 26 interviewed health care providers, 20 had high level of knowledge regarding malaria-preventive therapy in HIV-infected pregnant women. Lack of adequate supply of co-trimoxazole in health facilities and inadequate training of health care providers were among the factors causing poor implementation of co-trimoxazole prophylaxis for prevention of malaria in HIV-infected pregnant women. CONCLUSION: There is a need to continue sensitization of pregnant women and communities about the importance of early attendance to the ANCs for testing of HIV and provision of co-trimoxazole prophylaxis. Availability of co-trimoxazole in the health facilities, regular training, and sensitization of health care providers are necessary for effective implementation of this policy.
Pattern of chemotherapy-related adverse effects among adult cancer patients treated at Gondar University Referral Hospital, Ethiopia: a cross-sectional study.
Belachew SA, Erku DA, Mekuria AB … +1 more , Gebresillassie BM
Drug Healthc Patient Saf · 2016 · PMID 27994485 · Full text
BACKGROUND: Adverse drug reactions (ADRs) are a global problem and constitute a major clinical problem in terms of human suffering. The high toxicity and narrow therapeutic index of chemotherapeutic agents makes oncology...
BACKGROUND: Adverse drug reactions (ADRs) are a global problem and constitute a major clinical problem in terms of human suffering. The high toxicity and narrow therapeutic index of chemotherapeutic agents makes oncology pharmacovigilance essential. The objective of the present study was to assess the pattern of ADRs occurring in cancer patients treated with chemotherapy in a tertiary care teaching hospital in Ethiopia. METHODS: A cross-sectional study over a 2-year period from September 2013 to August 2015 was conducted on cancer patients undergoing chemotherapy at Gondar University Referral Hospital Oncology Center. Data were collected directly from patients and their medical case files. The reported ADRs were assessed for causality using the World Health Organization's causality assessment scale and Naranjo's algorithm. The severities of the reported reactions were also assessed using National Cancer Institute Common Terminology CTCAE version 4.0. The Pear-son's chi-square test was employed to examine the association between two categorical variables. RESULTS: A total of 815 ADRs were identified per 203 patients included in the study. The most commonly occurring ADRs were nausea and vomiting (18.9%), infections (16.7%), neutropenia (14.7%), fever and/or chills (11.3%), and anemia (9.3%). Platinum compounds (31.4%) were the most common group of drugs causing ADRs. Of the reported ADRs, 65.8% were grades 3-4 (severe level), 29.9% were grades 1-2 (mild level), and 4.3% were grade 5 (toxic level). Significant association was found between age, number of chemotherapeutic agents, as well as dose of chemotherapy with the occurrence of grades 3-5 toxicity. CONCLUSION: The high incidence of chemotherapy-related ADRs among cancer patients is of concern. Setting up an effective ADR monitoring and reporting system (onco-pharmacovigilance) and creating awareness among health care professionals regarding the importance of ADR reporting may help prevent the problem.
Positive clinical outcomes derived from using K12 to prevent streptococcal pharyngotonsillitis in children: a pilot investigation.
Di Pierro F, Colombo M, Zanvit A … +1 more , Rottoli AS
Drug Healthc Patient Saf · 2016 · PMID 27920580 · Full text
BACKGROUND: K12 (BLIS K12) is a probiotic strain producing the bacteriocins salivaricin A2 and salivaricin B, both of which strongly antagonize the growth of , the most important bacterial cause of pharyngeal infections...
BACKGROUND: K12 (BLIS K12) is a probiotic strain producing the bacteriocins salivaricin A2 and salivaricin B, both of which strongly antagonize the growth of , the most important bacterial cause of pharyngeal infections in humans. It successfully colonizes and exhibits persistence in the oral cavity and is endowed with an excellent safety profile. Previous observations of a small group of children indicated that the use of BLIS K12 could also reduce the occurrence of viral pharyngitis. The present study focused on a further evaluation of the role of BLIS K12 in the control of pediatric streptococcal disease and moreover whether its use could also help provide protection against various nonstreptococcal infections. METHODS: In total, 48 children with a recent history of recurrent pharyngeal streptococcal disease were enrolled in the treated group. The control group comprised 76 children known to have had a very low recent occurrence of oral streptococcal disease. The treated children were given BLIS K12 daily for 90 days. The number of episodes of streptococcal pharyngotonsillitis, tracheitis, viral pharyngitis, rhinitis, flu, laryngitis, acute otitis media, enteritis, and stomatitis was recorded during probiotic treatment and for a follow-up period of 9 months, and this was compared with the episodes of the control group over the corresponding period. RESULTS: Compared with the pretreatment time period, 2013, a 90% reduction of streptococcal pharyngeal disease was observed in 2014; compared with untreated children, a statistically significant reduction of all of the other disease conditions assessed, other than stomatitis, was detected in the probiotic-treated children. CONCLUSION: In agreement with previous findings, in the present study, it was found that the daily use of BLIS K12 has been associated with a concurrent and persisting reduction in the occurrence of pharyngeal, recurrent, streptococcal disease. Moreover, the benefits to children may also extend to a reduction of nonstreptococcal diseases, including tracheitis, viral pharyngitis, rhinitis, flu, laryngitis, acute otitis media, and enteritis.
Point prevalence of hospital-acquired infections in two teaching hospitals of Amhara region in Ethiopia.
Yallew WW, Kumie A, Yehuala FM
Drug Healthc Patient Saf · 2016 · PMID 27601932 · Full text
PURPOSE: Hospital-acquired infection (HAI) is a major safety issue affecting the quality of care of hundreds of millions of patients every year, in both developed and developing countries, including Ethiopia. In Ethiopia...
PURPOSE: Hospital-acquired infection (HAI) is a major safety issue affecting the quality of care of hundreds of millions of patients every year, in both developed and developing countries, including Ethiopia. In Ethiopia, there is no comprehensive research that presents the whole picture of HAIs in hospitals. The objective of this study was to examine the nature and extent of HAIs in Ethiopia. METHODS: A repeated cross-sectional study was conducted in two teaching hospitals. All eligible inpatients admitted for at least 48 hours on the day of the survey were included. The survey was conducted in dry and wet seasons of Ethiopia, that is, in March to April and July 2015. Physicians and nurses collected the data according to the Centers for Disease Control and Prevention definition of HAIs. Coded and cleaned data were transferred to SPSS 21 and STATA 13 for analysis. Univariate and multivariable logistic regression analyses were used to examine the prevalence of HAIs and relationship between explanatory and outcome variables. RESULTS: A total of 908 patients were included in this survey, the median age of the patients was 27 years (interquartile range: 16-40 years). A total of 650 (71.6%) patients received antimicrobials during the survey. There were 135 patients with HAI, with a mean prevalence of 14.9% (95% confidence interval 12.7-17.1). Culture results showed that Klebsiella spp. (22.44%) and Staphylococcus aureus (20.4%) were the most commonly isolated HAI-causing pathogens in these hospitals. The association of patient age and hospital type with the occurrence of HAI was statistically significant. CONCLUSION: It was observed that the prevalence of HAI was high in the teaching hospitals. Surgical site infections and pneumonia were the most common types of HAIs. Hospital management should give more attention to promoting infection prevention practice for better control of HAIs in teaching hospitals.
Extent of dispensing prescription-only medications without a prescription in community drug retail outlets in Addis Ababa, Ethiopia: a simulated-patient study.
Erku DA, Mekuria AB, Surur AS … +1 more , Gebresillassie BM
Drug Healthc Patient Saf · 2016 · PMID 27471409 · Full text
PURPOSE: This study was aimed at assessing the extent of dispensing prescription-only medications without a prescription in community drug retail outlets (CDROs) of Addis Ababa, Ethiopia. METHODS: A descriptive cross-sec...
PURPOSE: This study was aimed at assessing the extent of dispensing prescription-only medications without a prescription in community drug retail outlets (CDROs) of Addis Ababa, Ethiopia. METHODS: A descriptive cross-sectional observational study design was used to sample 31 pharmacies, 25 drug stores, and two rural drug vendors from August 11, 2015, to October 21, 2015, through a simple random sampling method. A simulated-patient method of visit was implemented to collect data. Requests of six tracer prescription-only medicines (amoxicillin + clavulanic acid capsule, amitriptyline, captopril, glibenclamide [also known as glyburide], omeprazole capsule, and sildenafil citrate) and upper respiratory tract infection were selected as the simulated clinical scenario. RESULTS: Amoxicillin-clavulanic acid capsule was dispensed when requested in 87.93% of the dispensaries. All of the CDROs dispensed omeprazole upon request. Sildenafil citrate (Viagra) was in stock in 96.55% of the CDROs, all of which issued the requested number of tablets without asking why or for whom the drug was needed. Amitriptyline, captopril, and glibenclamide (glyburide) were dispensed in 84.48%, 89.65%, and 87.93% of CDROs upon the provision of an empty container. Antibiotics were obtained from 75.86% of CDROs for presentation of upper respiratory tract infection symptoms. Among the dispensed antibiotics, the most common was amoxicillin (93.18%), followed by amoxicillin-clavulanic acid capsule (72.72%), and azithromycin (50%). Only 4.5% of the dispensaries asked about drug allergies, and 15.9% of the CDROs informed the simulated patient about the possible side effects of the drugs. CONCLUSION: This study revealed a very high rate of dispensing of prescription-only medicines without a prescription. Antimicrobials and drugs for chronic diseases were obtained with ease from almost all of the randomly sampled CDROs. Putting good dispensing practice into effect and adhering to the existing national laws and regulations regarding the same are necessary. It is also necessary to adopt a strong and explicit line of action, especially toward the irrational use of antibiotics.
Topiramate-induced maculopathy in IgG4-related disease.
DaCosta J, Younis S
Drug Healthc Patient Saf · 2016 · PMID 27354829 · Full text
This report describes a case of reversible topiramate-induced maculopathy in a 32-year-old female patient with IgG4-related disease. The patient presented with decreased vision associated with anterior uveitis and cystoi...
This report describes a case of reversible topiramate-induced maculopathy in a 32-year-old female patient with IgG4-related disease. The patient presented with decreased vision associated with anterior uveitis and cystoid macula edema, which was unresponsive to oral and topical steroids. Following topiramate cessation, both cystoid macula edema and vision improved. The ocular side effects of topiramate and putative pharmacological mechanisms for topiramate-induced maculopathy in the context of IgG4-related disease are discussed. This report highlights that neurologists and ophthalmologists should be aware that patients presenting with topiramate-associated maculopathy should be advised to discontinue topiramate promptly to prevent irreversible loss of vision.
The virgin land of quality management: a first measure of patient safety climate at the National Hospital of the Faroe Islands.
Kristensen S, Túgvustein N, Zachariassen H … +3 more , Sabroe S, Bartels P, Mainz J
Drug Healthc Patient Saf · 2016 · PMID 27217800 · Full text
PURPOSE: The Faroe Islands are formally part of the Kingdom of Denmark, but the islands enjoy extensive autonomy as home ruled. In Denmark, extensive quality management initiatives have been implemented throughout hospit...
PURPOSE: The Faroe Islands are formally part of the Kingdom of Denmark, but the islands enjoy extensive autonomy as home ruled. In Denmark, extensive quality management initiatives have been implemented throughout hospitals, this was not the case in the Faroese Islands in 2013. The purpose of this study is to investigate the patient safety culture in the National Hospital of the Faroe Islands prior to implementation of quality management initiatives. METHODS: The Danish version of the Safety Attitudes Questionnaire (SAQ-DK) was distributed electronically to 557 staff members from five medical centers of the hospital, and one administrative unit. SAQ-DK has six cultural dimensions. The proportion of respondents with positive attitudes and mean scale scores were described, and comparison between medical specialties, and between clinical leaders and frontline staff was made using analysis of variance and chi-square test, respectively. RESULTS: The response rate was 65.8% (N=367). Job satisfaction was rated most favorable, and the perceived culture of the top management least favorable. Safety climate was the dimension with the greatest variability across the 28 units. The diagnostic center had the most favorable culture of all centers. More leaders than frontline staff had positive attitudes toward teamwork and safety climate, and working conditions, respectively. Also, the leaders perceived these dimensions more positive than the frontline staff, P<0.05. Among three management levels, the unit management was perceived most favorable and the top management least favorable. CONCLUSION: The management group is recommended to raise awareness of their role in supporting a safe and caring environment for patients and staff, moreover the leaders should ensure that every day work achieves its objectives; keeping the patients safe. Furthermore, following the development in patient safety culture over time is recommended.
Seasonality in acute liver injury? Findings in two health care claims databases.
Weinstein RB, Schuemie MJ, Ryan PB … +1 more , Stang PE
Drug Healthc Patient Saf · 2016 · PMID 27099532 · Full text
BACKGROUND: Presumed seasonal use of acetaminophen-containing products for relief of cold/influenza ("flu") symptoms suggests that there might also be a corresponding seasonal pattern for acute liver injury (ALI), a know...
BACKGROUND: Presumed seasonal use of acetaminophen-containing products for relief of cold/influenza ("flu") symptoms suggests that there might also be a corresponding seasonal pattern for acute liver injury (ALI), a known clinical consequence of acetaminophen overdose. OBJECTIVE: The objective of this study was to determine whether there were any temporal patterns in hospitalizations for ALI that would correspond to assumed acetaminophen use in cold/flu season. METHODS: In the period 2002-2010, monthly hospitalization rates for ALI using a variety of case definitions were calculated. Data sources included Truven MarketScan(®) Commercial Claims and Encounters (CCAE) and Medicare Supplemental and Coordination of Benefits (MDCR) databases. We performed a statistical test for seasonality of diagnoses using the periodic generalized linear model. To validate that the test can distinguish seasonal from nonseasonal patterns, we included two positive controls (ie, diagnoses of the common cold [acute nasopharyngitis] and influenza), believed to change with seasons, and two negative controls (female breast cancer and diabetes), believed to be insensitive to season. RESULTS: A seasonal pattern was observed in monthly rates for common cold and influenza diagnoses, but this pattern was not observed for monthly rates of ALI, with or without comorbidities (cirrhosis or hepatitis), breast cancer, or diabetes. The statistical test for seasonality was significant for positive controls (P<0.001 for each diagnosis in both databases) and nonsignificant for ALI and negative controls. CONCLUSION: No seasonal pattern was observed in the diagnosis of ALI. The positive and negative controls showed the expected patterns, strengthening the validity of the statistical and visual tests used for detecting seasonality.
Safety of apixaban for venous thromboembolism prophylaxis: the evidence to date.
Trkulja V
Drug Healthc Patient Saf · 2016 · PMID 26937206 · Full text
Apixaban, a direct orally active anticoagulant (selective, direct factor Xa inhibitor) is approved for (primary) prevention of venous thromboembolism (VTE) in patients undergoing elective total-hip or total-knee arthropl...
Apixaban, a direct orally active anticoagulant (selective, direct factor Xa inhibitor) is approved for (primary) prevention of venous thromboembolism (VTE) in patients undergoing elective total-hip or total-knee arthroplasty, for acute treatment/prevention of recurrent events in patients with VTE, and extended prophylaxis in patients with a history of VTE. Another approved use is prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The present overview focuses on the safety of apixaban specifically in the VTE setting. Apixaban displays favorable pharmacokinetic properties: simple twice-daily dosing, low inter- and intrasubject variability, dose and time linearity, and multiple elimination pathways not critically dependent on either renal or metabolic mechanisms. An extensive nonclinical program and the overall clinical development program (all approved and tested indications) provided no signal that would indicate any particular specific safety concern related to apixaban apart from the increased risk of bleeding. With regard to the approved VTE indications, safety (and efficacy) was assessed in five large pivotal Phase III trials. In comparison to currently recommended standard treatments, apixaban shows superior efficacy, while at the same time no excess risk of bleeding in patients undergoing total-hip or total-knee arthroplasty. In treatment of VTE, apixaban shows noninferior efficacy and a reduced risk of bleeding, whereas in extended prophylaxis it reduced the risk of VTE/VTE-related deaths, with no increased risk of relevant bleedings in comparison to placebo. Documented clinical experience with apixaban in daily practice is currently sparse. However, its use is progressively increasing, and there has been no signal so far that would materially change the perception of its safety profile as defined in the premarketing trials.
Clinical utility, safety, and efficacy of pregabalin in the treatment of fibromyalgia.
Bhusal S, Diomampo S, Magrey MN
Drug Healthc Patient Saf · 2016 · PMID 26937205 · Full text
Fibromyalgia is a chronic debilitating medical syndrome with limited therapeutic options. Pregabalin, an anticonvulsant and α-2-Δ subunit receptor ligand, is one of the anchor drugs approved by the US Food and Drug Admin...
Fibromyalgia is a chronic debilitating medical syndrome with limited therapeutic options. Pregabalin, an anticonvulsant and α-2-Δ subunit receptor ligand, is one of the anchor drugs approved by the US Food and Drug Administration for the treatment of fibromyalgia. The drug has shown clinically meaningful benefits across multiple symptom domains of fibromyalgia. Efficacy of pregabalin in fibromyalgia pain has been evaluated in at least five high-quality randomized trials, two long-term extension studies, a meta-analysis, a Cochrane database systematic review, and several post hoc analyses. These studies also hint towards a meaningful benefit on sleep, functioning, quality of life, and work productivity. Side effects of pregabalin, although common, are mild to moderate in intensity. They are noted early during therapy, improve or disappear with dose reduction, and are not usually life- or organ threatening. In most patients, tolerance develops to the most common side effects, dizziness, and somnolence, with time. With close clinical monitoring at initiation or dose titration, pregabalin can be effectively used in primary care setting. Pregabalin is cost saving with long-term use and its cost-effectiveness profile is comparable, if not better, to that of other drugs used in fibromyalgia. In the present era of limited therapeutic options, pregabalin undoubtedly retains its role as one of cardinal drugs used in the treatment of fibromyalgia. This review intends to discuss the clinical utility of pregabalin in the management of fibromyalgia with a focus on efficacy, safety, and cost-effectiveness.
A fatal adverse effect of cefazolin administration: severe brain edema in a patient with multiple meningiomas.
Tribuddharat S, Sathitkarnmanee T, Kitkhuandee A … +3 more , Theerapongpakdee S, Ngamsaengsirisup K, Chanthawong S
Drug Healthc Patient Saf · 2016 · PMID 26929668 · Full text
Cefazolin is commonly administered before surgery as a prophylactic antibiotic. Hypersensitivity to cefazolin is not uncommon, and the symptoms mostly include urticaria, skin reaction, diarrhea, vomiting, and transient n...
Cefazolin is commonly administered before surgery as a prophylactic antibiotic. Hypersensitivity to cefazolin is not uncommon, and the symptoms mostly include urticaria, skin reaction, diarrhea, vomiting, and transient neutropenia, which are rarely life threatening. We present a rare case of fatal cefazolin hypersensitivity in a female who was diagnosed with multiple meningiomas and scheduled for craniotomy and tumor removal. Immediately after cefazolin IV administration, the patient developed acute hypertensive crisis, which resolved within 10 minutes after the treatment. This was followed by unexplained metabolic acidosis. The patient then developed severe brain edema 100 minutes later. The patient had facial edema when her face was exposed for the next 30 minutes. A computed tomography scan revealed global brain edema with herniation. She was admitted to the intensive care unit for symptomatic treatment and died 10 days after surgery from multiorgan failure. The serum IgE level was very high (734 IU/mL). Single-dose administration of cefazolin for surgical prophylaxis may lead to rare, fatal adverse reaction. The warning signs are sudden, unexplained metabolic acidosis, hypertensive crisis, tachycardia, and facial angioedema predominating with or without cutaneous symptoms like urticaria.
Benefit-risk assessment of golimumab in the treatment of refractory ulcerative colitis.
Pugliese D, Felice C, Landi R … +3 more , Papa A, Guidi L, Armuzzi A
Drug Healthc Patient Saf · 2016 · PMID 26893582 · Full text
Significant advances in the management of patients with ulcerative colitis (UC) have been made since the introduction of anti-tumor necrosis factor (TNF)-alpha agents, especially for those who fail or do not tolerate con...
Significant advances in the management of patients with ulcerative colitis (UC) have been made since the introduction of anti-tumor necrosis factor (TNF)-alpha agents, especially for those who fail or do not tolerate conventional therapies. Two drugs, infliximab first, then adalimumab afterward, showed effectiveness in inducing and maintaining long-term remission both in pivotal trials as well as in clinical practice. However, approximately 25% of patients with UC, who fail or do not tolerate all available therapies, require a colectomy for refractory disease. The therapeutic scenario of UC has been recently upgraded by the introduction of golimumab, the latest anti TNF-alpha agent to be approved. Golimumab is a totally humanized monoclonal antibody, administered by a subcutaneous injection every 4 weeks. Treatment with golimumab has shown to be effective to induce sustained clinical benefit in tough-to-treat patients with UC, including steroid and/or immunosuppressive refractory and steroid-dependent patients. In this review, we summarize all available efficacy and safety data of golimumab in UC, analyzing the potential therapeutic position for the treatment of refractory patients with UC.
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