Drug, Healthcare And Patient Safety[JOURNAL]
Sun
200 papers
Over-the-Counter Medicine Utilization by Beneficiaries Under Medical Schemes in South Africa.
Padayachee N, Rothberg A, Butkow N … +1 more , Truter I
Drug Healthc Patient Saf · 2020 · PMID 32425615 · Full text
BACKGROUND: South African medical insurance schemes (known as medical schemes) cover about 17% of the population. Within these schemes, access to medicines for a defined set of chronic diseases is mandated by legislation...
BACKGROUND: South African medical insurance schemes (known as medical schemes) cover about 17% of the population. Within these schemes, access to medicines for a defined set of chronic diseases is mandated by legislation. However, much of the responsibility for treatment of minor conditions with non-prescription over-the-counter (OTC) medicines has been transferred to the individuals within the medical schemes. The overall expenditure on pharmacist-assisted therapy (PAT)/OTC medicines in South Africa is considerable and medical schemes endeavor to limit amounts paid out by devising strategies that will limit their financial exposure. AIM: To investigate how benefit design and other factors within two medical schemes influenced access to and payment for OTC medicines and to explore whether access to OTC medicines by individuals impacted on utilization of other health-care services. METHODS: Medical scheme data were obtained from a leading administrator for two health plans: one with comprehensive benefits covering 4593 beneficiaries (designated HI) and the other with lower benefits covering 54,374 beneficiaries (LO). Extracted data included beneficiary demographics, OTC medicines prescribed by doctors and/or dispensed by pharmacists, and monetary amounts claimed by individuals and paid by the medical schemes. Doctor consultations, costs and payments were also extracted, as were beneficiaries' records of their chronic disease(s) and any episode(s) requiring hospitalization. RESULTS: Some 60-70% of beneficiaries submitted claims for OTC medicines accessed directly or recommended by a pharmacist, and 80-90% claimed OTC medicines that were prescribed by a doctor during a consultation. Amounts claimed and percentages of original products prescribed were substantially higher when accessed directly by beneficiaries or recommended by pharmacists than when doctors prescribed the medicines. In multivariate analysis, there was no clear advantage of offering access to OTC medicines in order to reduce visits to general practitioners, although in the LO plan it appeared that beneficiaries with chronic diseases made less use of the OTC benefit and more use of medical specialists. CONCLUSION: Within these two plans, there were higher costs and greater use of original products when beneficiaries or pharmacies accessed OTC medicines than when these medicines were prescribed by doctors. A key question is whether access to these medicines and the costs thereof would be managed better if paid for directly by individuals and not as insured benefits through the medical scheme.
Management of L-Dopa Overdose in the Competitive Inhibition State [Expression of Concern].
Drug Healthc Patient Saf · 2020 · PMID 32425614 · Full text
Abstract loading — click title to view on PubMed.
Monoamine Depletion by Reuptake Inhibitors [Expression of Concern].
Drug Healthc Patient Saf · 2020 · PMID 32425613 · Full text
Abstract loading — click title to view on PubMed.
Anemia and Related Factors Among Highly Active Antiretroviral Therapy Experienced Children in Hawassa Comprehensive Specialized Hospital, Southern Ethiopia: Emphasis on Patient Management.
Fenta DA, Nuru MM, Yemane T … +2 more , Asres Y, Wube TB
Drug Healthc Patient Saf · 2020 · PMID 32214854 · Full text
BACKGROUND: Human Immunodeficiency Virus (HIV) and its therapy cause a variety of hematological abnormalities that have been known to be one of the most common causes of morbidity and mortality in HIV-positive children....
BACKGROUND: Human Immunodeficiency Virus (HIV) and its therapy cause a variety of hematological abnormalities that have been known to be one of the most common causes of morbidity and mortality in HIV-positive children. One of the commonly observed hematologic manifestations in HIV-positive children is anemia and it has a multifactorial source. We intended to assess the prevalence, as well as its related factors of anemia among Highly Active Antiretroviral Therapy (HAART), experienced children. METHODS: A hospital-based cross-sectional study was employed at Hawassa comprehensive specialized hospital from February 15-June 15, 2018. Overall, 273 HAART-practiced children were included in the study. Socio-demographic variables and clinical data were collected using a standard and pretested questionnaire. Medical records were reviewed for each study participant using a standard checklist. Blood specimens were collected and examined for complete blood count, CD4 cell count and blood film for hemoparasites and morphological classification of anemia, whereas stool specimens were collected and examined for intestinal parasites. Data were entered into Epidata and transferred to SPSS (Statistical Package for Social Science) version 20 software. Descriptive analysis was done for prevalence and binary and multivariate logistic regression was used to determine factors associated with anemia. Statistical significance was stated at P-value<0.05. RESULTS: The overall prevalence of anemia in this study was 11.4%. Morphologically the predominant anemia was Normocytic Normochromic anemia which accounted for 64.5%. In the current study, children within the age group of <7years (AOR: 3, CI: 1.2-7.5, P=0.02), those who were rural residents (AOR: 2.6, CI: 1.0-6.6, P=0.042) and those with viral load >150 copies/mL (AOR: 3.4, CI: 1.36-8.3, P=0.009) were found to be significantly associated with anemia. CONCLUSION: The prevalence of anemia in this study was 11.4%. It was significantly associated with different factors such as age, residence and viral load. Therefore, regular follow-up management should be emphasized for HAART-experienced children. Hence, there is a need for a longitudinal study to be conducted further to explore the causes of anemia due to HIV and the pattern of hemoglobin changes with HAART- experienced children will be very important.
A Retrospective Study of Acute Poisoning Cases and Their Management at Emergency Department of Dessie Referral Hospital, Northeast Ethiopia.
Getie A, Belayneh YM
Drug Healthc Patient Saf · 2020 · PMID 32184673 · Full text
BACKGROUND: Poisoning causes significant patient morbidity and mortality worldwide. It is a common reason for emergency department visits and hospitalizations. Acute poisoning needs immediate effective management to prev...
BACKGROUND: Poisoning causes significant patient morbidity and mortality worldwide. It is a common reason for emergency department visits and hospitalizations. Acute poisoning needs immediate effective management to prevent patient mortality or sequela. This study was carried out to determine the pattern of acute poisoning cases and their management at the emergency department of Dessie referral hospital, northeast Ethiopia. METHODS: A retrospective cross-sectional study of all registered poisoning cases managed at the emergency department of Dessie referral hospital was conducted from March 10 to May 2, 2018. RESULTS: There were a total of 147 registered poisoning cases listed in the registry during the study period, of which 120 cases (81.6%) had complete data and were included in the study. Among the total of 120 studied poisoning cases, 66 (55%) were females, and 53 (44.2%) were in the age group of 21-30 years. The causative poison was documented for 118 cases. Organophosphates were the most common poisoning agents involved in 54 (45%) of the cases followed by sodium hypochlorite, 27 (22.5%), and food poisoning, 19 (15.8%). Among the total patients, 77 (64.2%) were self-poisoned intentionally, 31 (25.8%) were poisoned in an unintentional manner and the rest, 12 (10%), had an unknown manner of poisoning. Mental disorder, 25 (20.8%); family disharmony, 23 (19.2%); and marital disharmony, 19 (15.8%) were the three most common causes of intentional poisoning. In all cases of acute poisoning, both pharmacological and non-pharmacological treatment approaches were used. Cimetidine was the most commonly used pharmacologic treatment, 118 (98.3%), followed by antiemetic, 107 (89.2%); proton pump inhibitor, 87 (72.5%), and atropine, 67 (55.8%). ANOVA did not show a statistically significant difference (>0.05) in the frequency of poisoning cases across seasons. CONCLUSION: Among 120 acute poisoning cases, 77 (64.2%) were intentional poisoning cases. Organophosphate poisoning accounts for 45% of the total poisoning cases. The three major reasons for intentional poisoning were mental disorders (20.8%), family disharmony (19.2%) and marital disharmony (15.8%). Cimetidine (98.3%) was the most commonly used pharmacologic treatment of the poisoning cases.
Drug Use and Type of Adverse Drug Events-Identified by a Trigger Tool in Different Units in a Swedish Pediatric Hospital.
Nydert P, Unbeck M, Pukk Härenstam K … +2 more , Norman M, Lindemalm S
Drug Healthc Patient Saf · 2020 · PMID 32099481 · Full text
PURPOSE: The objectives of our study were to determine drug use, type and incidence of all adverse event associated with drug or drug-related processes (Adverse Drug Events, ADE) among pediatric inpatients in relation to...
PURPOSE: The objectives of our study were to determine drug use, type and incidence of all adverse event associated with drug or drug-related processes (Adverse Drug Events, ADE) among pediatric inpatients in relation to hospital unit and length of stay. PATIENTS AND METHODS: 600 pediatric (0-18 years) admissions at a Swedish university hospital during one year were included and stratified in blocks to 150 neonatal, surgical/orthopedic, medicine and emergency-medicine unit admissions, respectively. Adverse events were identified from medical records using a pediatric trigger tool. All triggers identifying an adverse event related to drugs and drug-related devices were included. Data on drug use were extracted from the hospital drug-data warehouse. RESULTS: In total, 17794 daily drug orders were administrated to 486 (81.0% exposed) admissions. Parental nutrition, potassium salts and morphine constituted half of all high-risk drugs prescribed. Two-thirds of intravenous irritating drug doses consisted of vancomycin, esomeprazole and meropenem. In 129 (21.5%) admissions, at least one ADE was identified, out of which 21 ADE were classified as more severe (National Coordinating Council Medication Error Reporting Prevention-Index, NCCMERP≥F). The ADE incidence was 47.4 (95% confidence interval: 39.4-57.3) per 1000 admission days and varied by unit category. In neonatal units, 56.9 (49.5-65.4) ADEs/1000 admission days were detected, in surgery/orthopedic 54.2 (40.3-72.8), in medicine 44.1 (33.1-58.7), and in emergency-medicine 14.3 (7.7-26.7) ADEs/1000 admission days were found. The most common types of ADEs were identified by triggers that were not directly aiming at drugs including insufficiently treated pain (incidence peaking already in the first days), skin, tissue or vascular harm (peaking at the end of the first week) and hospital-acquired infections (peaking in later admission days). CONCLUSION: Adverse drug events are common in pediatric patients. The incidence of ADEs and type of ADE varies by hospital unit and length of hospital stay.
Use of Atypical Antipsychotics in Long-Term Care Residents with Parkinson's Disease and Comorbid Depression.
Chekani F, Holmes HM, Johnson ML … +3 more , Chen H, Sherer JT, Aparasu RR
Drug Healthc Patient Saf · 2020 · PMID 32099480 · Full text
PURPOSE: According to the 2015 American Geriatrics Society (AGS) Beers criteria, most antipsychotics are inappropriate in Parkinson's disease (PD) patients due to the risk of worsening Parkinsonian symptoms. This study e...
PURPOSE: According to the 2015 American Geriatrics Society (AGS) Beers criteria, most antipsychotics are inappropriate in Parkinson's disease (PD) patients due to the risk of worsening Parkinsonian symptoms. This study examined the incidence and predictors of inappropriate antipsychotic use among long-term care residents with PD and comorbid depression. PATIENTS AND METHODS: This retrospective cohort study utilized 2007-2009 Minimum Data Set (MDS) linked to Chronic Condition Warehouse (CCW) Medicare data files involving patients with PD and comorbid depression. Using a 12-month baseline and a 24-month follow-up, the study examined incidence of inappropriate atypical antipsychotics, namely asenapine, brexpiprazole, iloperidone, lurasidone, olanzapine, paliperidone, risperidone, or ziprasidone as specified in the 2015 AGS Beers criteria. Appropriate atypical antipsychotic included aripiprazole, clozapine, or quetiapine. Multivariable logistic regression was used to examine various sociodemographic and clinical factors associated with inappropriate antipsychotic use in PD based on the Andersen Behavioral Model. RESULTS: The incidence of atypical antipsychotic use was 17.50% (13,352/76,294) among PD patients over a 2-year follow-up. The percentage of inappropriate use among atypical antipsychotic users was 36.32%. The likelihood of inappropriate antipsychotic use was higher for patients who had dementia (OR=1.22, 95% CI: 1.12-1.33) or Chronic Obstructive Pulmonary Disease ((OR=1.13, 95% CI: 1.03-1.24). However, patients who were taking levodopa (OR=0.62, 95% CI: 0.57-0.67), dopamine agonists (OR=0.90, 95% CI: 0.82-0.98), Catechol-O-methyltransferase (COMT) inhibitors (OR=0.77, 95% CI: 0.68-0.86), Monoamine Oxidase (MAO) inhibitors type B (OR=0.72, 95% CI: 0.60-0.86), or amantadine (OR=0.84, 95% CI: 0.71-0.98) were less likely to receive inappropriate antipsychotics. CONCLUSION: More than one-third of PD patients used inappropriate antipsychotics among those who were treated with atypical antipsychotic medications. Various socio-demographics and clinical factors were associated with inappropriate antipsychotic use in older patients with PD. Concerted efforts are needed to reduce inappropriate atypical antipsychotic use among PD patients.
Rational Drug-Use Evaluation Based on World Health Organization Core Drug-Use Indicators in a Tertiary Referral Hospital, Northeast Ethiopia: A Cross-Sectional Study.
Mamo DB, Alemu BK
Drug Healthc Patient Saf · 2020 · PMID 32021478 · Full text
BACKGROUND: Irrational use of drugs is often observed in health-care systems throughout the world, particularly in developing countries. The World Health Organization estimates that more than half of all medicines are pr...
BACKGROUND: Irrational use of drugs is often observed in health-care systems throughout the world, particularly in developing countries. The World Health Organization estimates that more than half of all medicines are prescribed, dispensed, or sold inappropriately and that half of all patients fail to take them correctly. Therefore, the study was aimed at investigating the practice of rational drug use in a referral and teaching hospital in Northeast Ethiopia. METHODS: A hospital-based cross-sectional design was employed to conduct the study from February 2019 to May 2019. Systematic random sampling was used to select prescriptions dispensed in outpatient pharmacies. Convenient sampling was employed to select patient attendants and their prescriptions in outpatient departments during the study period. Data were collected using a structured and technical observational checklist for prescribing, patient care, and health-facility indicators. Face-to-face interviews were also employed to assess patient knowledge of correct dosage among patient-care indicators. Data were analyzed using SPSS version 20. Descriptive statistics are given using frequency, proportions, and summary measures. RESULTS: An average of 2.5 drugs per encounter were prescribed, with 34.64% and 13.80% of prescriptions being antibiotics and injections, respectively. Generics were used in 90.53% of prescription, and nearly 83% of drugs were prescribed from an essential-drug list. Average consultation and dispensing times were 1.57 minutes and 47 seconds, respectively. A total of 362 drugs were prescribed, with 82.6% actually dispensed and only 22.7% adequately labeled. The hospital had its own drug formulary and essential drug list, but no standard treatment guidelines. Moreover, except propyl thiouracil, all key essential drugs included in the study were available. CONCLUSION: The majority of World Health Organization-stated core drug-use indicators were not met by the referral hospital in this study, which is especially problematic regarding patient-care indicators.
Patient Safety Culture and Associated Factors Among Health Care Providers in Bale Zone Hospitals, Southeast Ethiopia: An Institutional Based Cross-Sectional Study.
Kumbi M, Hussen A, Lette A … +2 more , Nuriye S, Morka G
Drug Healthc Patient Saf · 2020 · PMID 32021477 · Full text
INTRODUCTION: Patient safety is a serious global public health issue and a critical component of health care quality. Unsafe patient care is associated with significant morbidity and mortality throughout the world. In Et...
INTRODUCTION: Patient safety is a serious global public health issue and a critical component of health care quality. Unsafe patient care is associated with significant morbidity and mortality throughout the world. In Ethiopia health system delivery, there is little practical evidence of patient safety culture and associated factors. Therefore, this study aims to assess patient safety culture and associated factors among health care providers in Bale Zone hospitals. METHODS: A facility-based cross-sectional study was undertaken using the "Hospital Survey on Patient Safety Culture (HSOPSC)" questionnaire. A total of 518 health care providers were interviewed. Analysis of variance (ANOVA) was employed to examine statistical differences between hospitals and patient safety culture dimensions. We also computed internal consistency coefficients and exploratory factor analysis. Bivariate and multivariate linear regression analyses were performed using SPSS version 20. The level of significance was established using 95% confidence intervals and a p-value of <0.05. RESULTS: The overall level of patient safety culture was 44% (95% CI: 43.3-44.6) with a response rate of 93.2%. Factor analysis indicated that hours worked per week, participation in a patient safety program, reporting of adverse events, communication openness, teamwork within hospital, organizational learning and exchange of feedback about error were among factors that were significantly associated with the patient safety culture. CONCLUSION: According to the Agency for Health Research and Quality, the overall classification of patient safety score and most of the scores related to dimensions were low. Hours worked per week, participation in a patient safety program, reporting of adverse events and most safety dimensions were found to be factors associated with patient safety culture. Well-designed patient safety interventions need to be integrated with organizational policies to address all dimensions of patient safety culture.
Inappropriateness of Intravenous Antibiotic Prescriptions at Hospital Discharge at a Tertiary Care hospital in Thailand.
Mahatumarat T, Pinmanee N, Injai W … +1 more , Chaiwarith R
Drug Healthc Patient Saf · 2019 · PMID 31908542 · Full text
BACKGROUND: Intravenous antibiotics, either as outpatient parenteral antimicrobial therapy (OPAT) or transition of care to community-based management, is a common practice in tertiary care hospitals to minimize hospital...
BACKGROUND: Intravenous antibiotics, either as outpatient parenteral antimicrobial therapy (OPAT) or transition of care to community-based management, is a common practice in tertiary care hospitals to minimize hospital stays. However, infectious disease consultation was not mandated for those prescriptions. Therefore, we conducted this study to evaluate the appropriateness of intravenous antibiotic prescriptions at hospital discharge. METHODS: This retrospective cross-sectional study was conducted among patients receiving care at the internal medicine units of the Maharaj Nakorn Chiang Mai Hospital from November 1, 2015, to April 30, 2016. Intravenous antibiotics at hospital discharge were reviewed by an infectious diseases (ID) specialist. RESULTS: One hundred and twenty-nine prescriptions for 117 patients were reviewed. The most common diagnoses requiring intravenous antibiotics at hospital discharge were upper urinary tract infection (34.2%) and hepatobiliary tract infections (15.4%). The most common intravenous antibiotic was ceftriaxone (36.4%), followed by ertapenem (20.1%). Overall, the inappropriateness of prescriptions was 85.3%. The most common reason for inappropriateness was a failure to switch to oral antibiotics (52.7%), followed by incorrect duration (16.3%). CONCLUSION: Antimicrobial stewardship should be considered for intravenous antibiotics at hospital discharge to reduce the inappropriateness of those prescriptions.
Assessment of the Appropriateness of Ceftazidime Use in a Tertiary Teaching Hospital, Northern Ethiopia.
Gebremichael TG, Gebreyesus HH, Gebremariam A
Drug Healthc Patient Saf · 2019 · PMID 31908541 · Full text
BACKGROUND: Ceftazidime is nowadays one of the most commonly used antibiotics due to its high antibacterial potency, wide spectrum of activity, and low potential for toxicity. However, the global trend shows huge misuse...
BACKGROUND: Ceftazidime is nowadays one of the most commonly used antibiotics due to its high antibacterial potency, wide spectrum of activity, and low potential for toxicity. However, the global trend shows huge misuse of ceftazidime. OBJECTIVE: This study was conducted to assess the appropriateness of ceftazidime use and to identify areas of intervention to prevent inappropriate use in different wards of Ayder Compressive Specialized Hospital, a tertiary teaching Hospital, Mekelle-Ethiopia. METHODS: A facility-based prospective cross-sectional study design was steered on 327 patients who received ceftazidime during their hospitalization in the selected wards from February 1 to April 30, 2019. RESULTS: In the assessment of the appropriateness of ceftazidime use, 2,084 (70.8%) were appropriate. Appropriateness of indication was 295 (90.2%), the effectiveness of ceftazidime use was 221 (67.6%), correct dose of ceftazidime use was 264 (80.4%), and the correct frequency of ceftazidime use was 230 (70.3%). Its use was empiric in 275 participants (84.1%) and specific in 52 (15.9%) participants. The most common indication for ceftazidime use was uncomplicated pneumonia, at 112 (34.3%). One hundred and seventy-one (52.3%) participants had intervention to prevent inappropriate use of ceftazidime. Changing the drug combination (96, 29.4%), increasing the dose (13, 4%), decreasing the dose (21, 6.4%), holding the (21, 6.4%), and discontinuation of ceftazidime (20, 6.1%) were among the interventions. CONCLUSION: This study revealed that more than one-fourth of the ceftazidime use was inappropriate. This may lead to the emergence of resistant pathogens which in turn lead to treatment failure and increased the cost of therapy. Therefore, adherence to current evidence-based guidelines and initiating antimicrobial stewardship are recommended.
ACE-Inhibitor Related Angioedema Is Not Sufficiently Reported to the Danish Adverse Drug Reactions Database.
Cornwall JEL, Bygum A, Rasmussen ER
Drug Healthc Patient Saf · 2019 · PMID 31908540 · Full text
PURPOSE: The primary objective of this study was to calculate the report rate of angiotensin-converting enzyme inhibitor-related angioedema (ACEi-AE). Secondary objectives were to determine factors suspected to affect th...
PURPOSE: The primary objective of this study was to calculate the report rate of angiotensin-converting enzyme inhibitor-related angioedema (ACEi-AE). Secondary objectives were to determine factors suspected to affect the likelihood of ACEi-AE being reported and to investigate potential differences in angioedema risks between different ACEis. PATIENTS AND METHODS: Patient data from two cohorts comprising 176 patients with ACEi-AE were compared with report data from the Danish Adverse Drug Reactions Database, administered by the Danish Medicines Agency (DKMA). The study period was 1994-2015. Data were linked using unique personal identification numbers and birth dates. Cohort data and report data were compared with ACEi sales numbers from MedStat, an official database containing annual pharmaceutical drug sale data in Denmark. RESULTS: ACEi-AE was reported in two out of 176 cases resulting in a report rate of 1.1%, meaning that 98.9% of the cases were not reported. Since 1994, a total of 417 ACEi-AE reports were made to the DKMA. Fifty-eight percent of these were made by general practitioners or physicians with unknown workplaces and 35% by hospital staff. Enalapril and ramipril were the most sold ACEi's in the study period (40.3% and 42.6%, respectively). Enalapril was associated with 54.7% of ACEi-AE reports while ramipril was associated with 14.2%. ACEi substance received was known for 141 cohort patients, of which 53.9% were prescribed enalapril and 17.0% received ramipril. CONCLUSION: ACEi-AE was found to be severely underreported in Denmark, greatly limiting the available incidence data for this potentially life-threatening adverse reaction.
Epidemiology of Preventable Drug-Related Problems (DRPs) Among Hospitalized Children at KAMC-Jeddah: a Single-Institution Observation Study.
AlAzmi A, Ahmed O, Alhamdan H … +5 more , AlGarni H, Elzain RM, AlThubaiti RS, Aseeri M, Al Shaikh A
Drug Healthc Patient Saf · 2019 · PMID 31819660 · Full text
AIM: Drug-related problems (DRPs) "are the unwanted effects of drugs that potentially lead to a harmful outcome" thereby requiring considerable attention. Hospitalized pediatric patients, in particular, represent a popul...
AIM: Drug-related problems (DRPs) "are the unwanted effects of drugs that potentially lead to a harmful outcome" thereby requiring considerable attention. Hospitalized pediatric patients, in particular, represent a population at risk of DRPs. The epidemiology of preventable DRPs among children in Saudi Arabia remains scarce, which thus poses distinct challenges to all healthcare professionals. We aim to characterize preventable DRPs among hospitalized children at KAMC-Jeddah. METHODS: A prospective observational study of children (≤15 years) admitted to pediatric units (excluding cancer units) at KAMC-Jeddah over a 3-month period (May 29 to August 30, 2016) is carried out to determine the incidence of preventable DRPs and investigate the possible associated factors (gender, age, admission location, type of admission, and number of medications). RESULTS: A total of 319 DRPs were identified among 235 patients, of which 280 DRPs (87.8%, 280/319) were deemed preventable. The majority of preventable DRPs were related to dose selection (78%, 219/280). None of the preventable DRPs were life threatening or fatal, and the majority were assessed as moderate in severity (94.3%, 264/280). There was no significant difference between DRP incidences with age mean 3.5 (P=0.389), gender mean (P=0.436), and weight mean 13.47 (P=0.323). Younger children (age ≤2years) admitted to PICU were more likely to have DRP (OR 4.44, 95% CI, 1.87 to 10.52, P=0.00001). Scheduled admissions were 2.89 times more likely to be exposed to DRP compared to transferred admissions (OR 2.8, 95% CI, 1.83 to 4.70, P=0.005). Additionally, DRP incidences increased proportionally to the number of medications. CONCLUSION: Our data suggest that establishing appropriate prevention strategies towards improvement and safety in medicine use among this vulnerable patient population is a high priority.
Opioids and frequency counts in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database: a quantitative view of the epidemic.
Veronin MA, Schumaker RP, Dixit RR … +1 more , Elath H
Drug Healthc Patient Saf · 2019 · PMID 31695510 · Full text
BACKGROUND: The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), contains information on adverse drug events and medication error reports submitted to the FDA through the MedWatch program. A sign...
BACKGROUND: The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), contains information on adverse drug events and medication error reports submitted to the FDA through the MedWatch program. A significant number of adverse events reported in the FAERS database have been for opioid use. The objective of this study was to determine the frequency counts and associated deaths of opioid drug names in the FAERS database. METHODS: Drug data were obtained from the DRUG and OUTCOME files in the database. Drugs identified included: morphine, fentanyl, oxycodone, hydrocodone, tramadol, hydromorphone, methadone, codeine, oxymorphone, meperidine, propoxyphene, diphenoxylate, and heroin. Frequency counts and concomitant deaths of opioid drug names were determined via the MySQL database management system. RESULTS: Fifteen different opioid drugs identified in the FAERS database were associated with ADEs, including death, and 3 drugs (oxycodone, hydrocodone, fentanyl) accounted for more than half of the reports. The highest frequency count value was 158,181 for oxycodone, which represents approximately 20.2% of the frequency counts for the opioids. The lowest frequency count value was 2,161 for dextromethorphan, which represents approximately 0.3% of the total. The opioid with the highest proportion of deaths to drug count was heroin (71.8%), followed by dextromethorphan (55.6%), methadone (37.2%), morphine (26.8%), and propoxyphene (23.7%). CONCLUSION: The FAERS database represents an important source for detection and reporting of adverse drug events (ADEs), in particular the opioids and related drugs. It remains a challenge to estimate the true incidence of ADEs for this class of drugs in the general population.
Safety And Tolerability Of Extended-Release Guaifenesin In Patients With Cough, Thickened Mucus And Chest Congestion Associated With Upper Respiratory Tract Infection.
Tripathi S, Nikhare A, Sharma G … +2 more , Shea T, Albrecht H
Drug Healthc Patient Saf · 2019 · PMID 31632154 · Full text
PURPOSE: An extended-release (ER) formulation of the expectorant guaifenesin has recently been launched in India for the treatment of productive cough accompanied by mucus (phlegm). Although the safety profile of ER guai...
PURPOSE: An extended-release (ER) formulation of the expectorant guaifenesin has recently been launched in India for the treatment of productive cough accompanied by mucus (phlegm). Although the safety profile of ER guaifenesin marketed in the USA is well documented, there were limited safety data available in the Indian population. The aim of this study was to further elucidate the safety profile of ER guaifenesin in patients with acute upper respiratory tract infection (URTI). PATIENTS AND METHODS: A prospective, post-marketing surveillance study enrolled 552 adults with cough, thickened mucus and chest congestion due to URTI, who took ER guaifenesin 1200 mg (Mucinex, Reckitt Benckiser; two 600 mg tablets) every 12 hrs for 7 days. Adverse events (AEs) were recorded and questionnaires administered to patients and investigators. RESULTS: A total of 29 treatment-emergent AEs were recorded in 28/552 patients, including gastrointestinal (n = 11), nervous system (n = 8), psychiatric (n = 3), respiratory, thoracic and mediastinal (n = 2), skin and subcutaneous tissue (n = 2), and general disorders (n = 3). All AEs were mild in severity and no serious AEs or deaths occurred. The majority of both patients and investigators were either satisfied or very satisfied with improvements in treatment outcomes. CONCLUSION: This study found that ER guaifenesin was well tolerated and had a favorable safety profile in otherwise healthy patients suffering from symptoms of cough, thickened mucus and chest congestion associated with URTI. Registered trial NCT03725085 (ClinicalTrials.gov) and CTRI/2014/07/004730 (ctri.nic.in).
Safety and tolerability of macitentan in the management of pulmonary arterial hypertension: an update.
Wong AK, Channick RN
Drug Healthc Patient Saf · 2019 · PMID 31564989 · Full text
Macitentan is a medication in the endothelin receptor antagonist class, approved for treatment of pulmonary arterial hypertension in 2013 based on the results of the pivotal SERAPHIN Trial (Study with an Endothelin Recep...
Macitentan is a medication in the endothelin receptor antagonist class, approved for treatment of pulmonary arterial hypertension in 2013 based on the results of the pivotal SERAPHIN Trial (Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome). Macitentan was shown in initial trials to reduce the likelihood of a morbidity/mortality event. Real-world use of this medication additionally reveals a reduced risk of hospitalizations related to pulmonary arterial hypertension, improved health-related quality of life scores, potential clinical utility in other conditions (such as chronic thromboembolic pulmonary hypertension and pulmonary hypertension related to congenital heart disease), and has a similar safety profile as demonstrated in initial trials.
Selexipag in the management of pulmonary arterial hypertension: an update.
Coghlan JG, Picken C, Clapp LH
Drug Healthc Patient Saf · 2019 · PMID 31496830 · Full text
Selexipag is a compound that was designed to overcome the issues associated with oral administration of prostanoid compounds, beraprost and treprostinil in the treatment of pulmonary hypertension (PAH). As a selective IP...
Selexipag is a compound that was designed to overcome the issues associated with oral administration of prostanoid compounds, beraprost and treprostinil in the treatment of pulmonary hypertension (PAH). As a selective IP agonist, it was designed to avoid the off-target prostanoid effects especially in the gastrointestinal system. To place this compound in context, this paper briefly reviews the efficacy, tolerability, and safety of subcutaneous, inhaled, and oral prostanoid preparations and comparesthemto selexipag. Selexipag is the first agent targeting a prostanoid receptor where a reduction in the primary efficacy morbidity/mortality composite end-point has been demonstrated. While safety outcomes favor selexipag over placebo, tolerability issues remain. Efficacy in terms of improvement in effort tolerance, hemodynamic and mortality benefit is less than seen with IV therapy. This is the first prostanoid demonstrated in a clinical trial to have added benefit in those on background double combination therapy and the first non IV prostanoid to demonstrate outcome benefit in the connective tissue disease (CTD) population in a randomized controlled trial.
Critical evaluation of the validity of drug promotion materials in Ethiopia.
Hailu HG, Gobezie MY, Yesuf TA … +1 more , Workneh BD
Drug Healthc Patient Saf · 2019 · PMID 31440103 · Full text
PURPOSE: This study was conducted to evaluate the validity of drug promotion materials (DPMs) in Ethiopia. METHODS: A cross sectional document review was done. DPMs were evaluated for fulfilment of the World Health Organ...
PURPOSE: This study was conducted to evaluate the validity of drug promotion materials (DPMs) in Ethiopia. METHODS: A cross sectional document review was done. DPMs were evaluated for fulfilment of the World Health Organization's (WHO) criteria for ethical promotion of drugs. They were also evaluated for font size, type of formulation, claims made, pictures depicted, retrievability and source of references used. RESULTS: A total of 235 DPMs were collected from the community and hospital pharmacies. Documents promoting devices and equipment, orthopedic appliances, reminder cards and drug lists were excluded, leaving 173 promotional materials. Antimicrobials were the most promoted drugs (27.2%) followed by respiratory drugs (11.0%) and gastrointestinal drugs (9.8%). Brand name was written in all of the DPMs while approved generic names, indication and active ingredient per dosage form were written in 94.8%, 92.5% and 62.4% respectively. Side effects and contraindications were written in 27.2% and 18.5% of the DPMs. A total of 223 claims were made. Efficacy was the dominant claim (62.3%) followed by safety (8.5%). Pictorial demonstrations were used in 84.4% of the DPMs. Almost half of the pictures depicted, 47.3%, were the cover of the drug products. Only 48.6% of the DPMs has supported their claims with references. Review articles account for 23.3% of the references. Only 5.8% of the journal articles were published after the year 2013. CONCLUSION: We conclude that the design and content of studied drug promotional materials are most effective as sales materials rather than thorough informational vehicles. The WHO and Food, Medicine and Health Care Administration and Control Authority of Ethiopia recommendations are rarely met.
Utilization of over-the-counter analgesics in two private medical insurance schemes in South Africa.
Padayachee N, Rothberg AD, Truter I … +1 more , Butkow N
Drug Healthc Patient Saf · 2019 · PMID 31410069 · Full text
INTRODUCTION: In South Africa there is an easy access to over-the-counter (OTC) medicines and expenditure is high. Certain OTC products are available to the public in general stores, while others may only be available at...
INTRODUCTION: In South Africa there is an easy access to over-the-counter (OTC) medicines and expenditure is high. Certain OTC products are available to the public in general stores, while others may only be available at pharmacies. It is also common for OTC medicines to be prescribed by a doctor for treatment of minor illnesses. Individuals with medical insurance usually have cover for these products, but typically only to a limited extent. AIM: To investigate the utilization patterns in two medical insurance schemes of OTC analgesic products in the Anatomical Therapeutic Chemical (ATC) category N02BE51 which includes medicines containing paracetamol and varying combinations of codeine, caffeine and antihistamines. METHODOLOGY: Data were obtained for two benefit plans, one with generous, high benefits (HI), the other with lower benefits (LO). Data covered utilization of OTC medicines in the N02BE51 group, indicating whether the medicines were purchased at a pharmacy or dispensed by a doctor. Doctors were further categorised as contracted/network or non-network providers. Product costs and volumes were analysed according to access directly by the beneficiary, recommendation by a pharmacist, or prescription from a doctor. RESULTS: Compared to doctors, pharmacists issued more-expensive products. Average costs were higher in the HI plan compared to the LO plan. Pharmacists showed a preference for dispensing larger and more expensive pack sizes. Doctors showed better cost containment: the average cost of products in HI was twice that of LO. Doctors dispensing directly to patients issued smaller pack sizes and lower-priced products. Contracted network doctors did not appear to impact on costs. CONCLUSION: Among the privately-insured individuals studied, the avaiIability, cost and formulation of N02BE51 OTC products appeared to be poorly regulated, whether by the consumer, pharmacist, medical insurance scheme or legislation. Doctors demonstrate better cost containment by prescribing less costly, smaller pack-size alternatives compared to pharmacists.
Evaluation of vancomycin use in university-affiliated hospitals in Southern Khorasan Province (East Iran) based on HICPAC guidelines.
Mahi-Birjand M, Ziaee M, Bijari B … +4 more , Khalvati R, Abedini MR, Golboei Mousavi H, Ziaee A
Drug Healthc Patient Saf · 2019 · PMID 31040721 · Full text
BACKGROUND: Vancomycin resistance has raised concerns about its effectiveness prospect in the treatment of patients with Gram-positive infections. The Healthcare Infection Control Practices Advisory Committee (HICPAC) ha...
BACKGROUND: Vancomycin resistance has raised concerns about its effectiveness prospect in the treatment of patients with Gram-positive infections. The Healthcare Infection Control Practices Advisory Committee (HICPAC) has recently established guidelines to delineate improper use of vancomycin. In this light, we sought out to determine the appropriateness of vancomycin prescription using the HICPAC guidelines. SETTING: The study was carried out in two university-affiliated hospitals, Valiasr and Imam Reza, with 297 and 234 beds, respectively, from May 2012 to May 2013. METHODS: This retrospective study evaluated the vancomycin prescription and usage in the hospitals. Total vancomycin use was determined and expressed as vancomycin courses per 298 admitted patients. The patient information was collected on a data collection sheet as follows: demographic variables, etiology and localization of infection, microbiological data, duration of vancomycin treatment, reasons for vancomycin prescription, prescribed antibiotic dosing, and patient regimen. RESULTS: The average age of the patients and vancomycin treatment duration were 55.965 years and 10.5 days, respectively. Septicemia (15.7%) was the most common cause of vancomycin administration. Vancomycin use was documented to be appropriate and inappropriate in 236 (89.4%) and 28 (10.6%) patients, respectively. No statistically significant differences were found among the wards and hospitals ( values =0.66 and 0.54, respectively) in terms of appropriateness of vancomycin use based on the HICPAC criteria. In addition, 29.21% and 62% of all patients exhibited complete and partial recovery, respectively. We found that 90% of the cases showed compliance with the HICPAC recommendations. CONCLUSION: Comprehensive programs are required to improve the vancomycin use in the hospitals. Vancomycin use should be monitored due to its large-scale empiric use. The rate of improper use of vancomycin in the infection and intensive care unit services may be high, and pharmacists must take appropriate action to optimize the use of the drug.
About
- Frequency
- Sun
- Papers found
- 200
- RSS feed
- Subscribe