Drug, Healthcare And Patient Safety[JOURNAL]
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200 papers
Adherence to risk management guidelines for drugs which cause vitamin D deficiency - big data from the Swedish health system.
Nordqvist O, Lönnbom Svensson U, Brudin L … +2 more , Wanby P, Carlsson M
Drug Healthc Patient Saf · 2019 · PMID 30962725 · Full text
PURPOSE: Several medications are known to cause vitamin D deficiency. The aim of this study is to describe vitamin D testing and supplementation in patients using these "risk medications", thereby assessing adherence to...
PURPOSE: Several medications are known to cause vitamin D deficiency. The aim of this study is to describe vitamin D testing and supplementation in patients using these "risk medications", thereby assessing adherence to medical guidelines. PATIENTS AND METHODS: A database with electronic health records for the population in a Swedish County (≈240,000 inhabitants) was screened for patients prescribed the pre-defined "risk medications" during a 2-year period (2014-2015). In total, 12,194 patients were prescribed "risk medications" pertaining to one of the three included pharmaceutical groups. Vitamin D testing and concomitant vitamin D supplementation, including differences between the included pharmaceutical groups, was explored by matching personal identification numbers. RESULTS: Corticosteroids were prescribed to 10,003 of the patients, antiepileptic drugs to 1,101, and drugs mainly reducing vitamin D uptake to 864. Two hundred twenty-six patients were prescribed >1 "risk medication". Seven hundred eighty-seven patients (6.5%) had been tested during the 2-year period. There were no differences regarding testing frequency between groups. Concomitant supplements were prescribed to 3,911 patients (32.1%). It was more common to be prescribed supplements when treated with corticosteroids. Vitamin D supplementation was more common among tested patients in all three groups. Women were tested and supplemented to a higher extent. The mean vitamin D level was 69 nmol/L. Vitamin D deficiency was found in 24.1% of tested patients, while 41.3% had optimal levels. It was less common to be deficient and more common to have optimal levels among patients prescribed corticosteroids. CONCLUSION: Adherence to medical guidelines comprising testing and supplementation of patients prescribed drugs causing vitamin D deficiency needs improvement in Sweden.
Evaluation to improve the quality of medication preparation and administration in pediatric and adult intensive care units.
Hermanspann T, van der Linden E, Schoberer M … +4 more , Fitzner C, Orlikowsky T, Marx G, Eisert A
Drug Healthc Patient Saf · 2019 · PMID 30936751 · Full text
PURPOSE: To determine the type, frequency, and factors associated with medication preparation and administration errors in adult intensive care units (ICUs) and neonatal ICUs (NICUs)/pediatric ICUs (PICUs). PATIENTS AND...
PURPOSE: To determine the type, frequency, and factors associated with medication preparation and administration errors in adult intensive care units (ICUs) and neonatal ICUs (NICUs)/pediatric ICUs (PICUs). PATIENTS AND METHODS: We conducted a prospective direct observation study in an adult ICU and NICU/PICU in a tertiary university hospital. Between June 2012 and June 2013, a clinical pharmacist and medical student observed the nursing care staff on weekdays during the preparation and administration of intravenous drugs. We analyzed the frequency and type of preparation and administration errors and factors associated with errors. RESULTS: Six hundred and three preparations in the adult ICU and 281 in the NICU/PICU were observed. Three hundred and eighty-five errors occurred in the adult ICU and 38 in the NICU/PICU. There were 5,040 and 2,514 error opportunities, with overall error rates of 7.6% and 1.5%, respectively. The total opportunities for error meant each single step of preparation and administration that was relevant for the drug. Most errors applied to the category "uniform mixing" (adult ICU: n=227, 59%; NICU/PICU: n=14, 37%). The multivariate logistic regression results showed a significantly different influence of the "preparation type" for the adult ICU compared with the NICU/PICU with regard to the occurrence of an error. Preparations for adult patients of the LCD type (liquid concentrate with diluent into syringe or infusion bag) were more often associated with errors than the P (powder in a glass vial that must be reconstituted and diluted if necessary), =0.012, and LC (liquid concentrate into syringe), =0.002 type. CONCLUSION: "Uniform mixing" was the most erroneous preparation step in intravenous drug preparations in two ICUs. Improvement of nurse training and the preparation of prefilled syringes in the pharmacy might reduce errors and improve the quality and safety of drug therapy.
Pulmonary hypertension occurring with diazoxide use in a preterm infant with hypoglycemia.
Kylat RI
Drug Healthc Patient Saf · 2019 · PMID 30881142 · Full text
Pharmacologic modulation to open the K channels with diazoxide is useful in treating hyperinsulinemia. Diazoxide is being used more often in neonates with hyperinsulinemic hypoglycemia. This report highlights a case of s...
Pharmacologic modulation to open the K channels with diazoxide is useful in treating hyperinsulinemia. Diazoxide is being used more often in neonates with hyperinsulinemic hypoglycemia. This report highlights a case of severe pulmonary hypertension (PH) with re-opening of ductus arteriosus in an extremely premature infant after the use of diazoxide. The rapid onset of PH with respiratory failure was completely reversible. This case emphasizes the need for extreme caution with use of diazoxide in the premature infant population, especially those with chronic lung disease of prematurity. In addition, the use of diazoxide should be limited to the persistent form of congenital hyperinsulinism, after adequate work up has been completed to evaluate for other causes of hypoglycemia. It is postulated that development of PH could be related to K agonsim.
Pattern of medication use in geriatric patients at primary health care facilities in Karawang, Indonesia.
Abdulah R, Insani WN, Putri NE … +3 more , Purba HP, Destiani DP, Barliana MI
Drug Healthc Patient Saf · 2019 · PMID 30799958 · Full text
BACKGROUND: Rational drug use is a critical component in patient care, particularly among the elderly who often have multiple medical problems. The aim of this study was to assess the pattern of medication use among the...
BACKGROUND: Rational drug use is a critical component in patient care, particularly among the elderly who often have multiple medical problems. The aim of this study was to assess the pattern of medication use among the elderly visiting primary health care facilities. METHODS: A retrospective cross-sectional study was conducted at 25 primary health care facilities in Karawang District, Indonesia, and patients aged ≥60 years visiting the facilities from January to December 2014 were included. A systematic random sampling technique was used to select the study samples. Each prescription was assessed using the WHO prescribing indicators. RESULTS: A total of 10,118 prescriptions with 31,927 drugs were assessed. The average number of drugs prescribed was 3.15 (range: 1-7). Drugs prescribed by generic name comprised 98.09% (n=31,318) of the total number of drugs. Medical appointments wherein an antibiotic was prescribed constituted 23.45% (n=2373) of the total number of prescriptions. No injections were prescribed in this study setting. Drugs prescribed from the essential drug list comprised 83.07% (n=26,522). Paracetamol (13.44%), vitamin B complex (8.05%), and aluminum-magnesium hydroxide (7%) were the most frequently prescribed drugs, whereas amoxicillin (44.03%), chloramphenicol (13.10%), and ciprofloxacin (12.00%) were the most frequently prescribed antibiotics. CONCLUSION: Our findings highlight that polypharmacy and prescription of essential drugs remain subjects of concern in geriatric health care. Regular medication review and promoting the use of the essential drug list among health care professionals are encouraged in primary care settings.
Ceftriaxone-associated nephrolithiasis and gallstone in adults.
Azarkar G, Birjand MM, Ehsanbakhsh A … +3 more , Bijari B, Abedini MR, Ziaee M
Drug Healthc Patient Saf · 2018 · PMID 30588126 · Full text
BACKGROUND: Ceftriaxone (CTX) is widely used for the treatment of bacterial infections; however, side effects such as gallstone and nephrolithiasis have been reported in children. There is limited information about urina...
BACKGROUND: Ceftriaxone (CTX) is widely used for the treatment of bacterial infections; however, side effects such as gallstone and nephrolithiasis have been reported in children. There is limited information about urinary tract calculi as CTX side effects in adults. Therefore, the present study was aimed to evaluate the incidence of gallstone and nephrolithiasis following CTX administration. METHODS: The present study was conducted in the Vali-e-Asr Hospital. Eighty-four patients with various infectious diseases with different daily treatment (mean ± SD: 4.19±2.54) were included in this study, consisting of 49 females and 35 males. The mean of total doses used in patients was 10.2143 (SD: 5.8585). To detect possible gallstone, gallbladder sludge, and urolithiasis, patients were evaluated by serial ultrasound before and after CTX treatment. Patients with renal and hepatobiliary dysfunction were excluded from the study and did not receive any nephrotoxic drugs during this study. Demographic parameters including age, sex, body mass index, dosage of CTX, as well as the duration of treatment and hospitalization were determined. Statistical significances were determined using Fisher's exact test and independent -test. RESULTS: Results from our study showed that the incidence of gallstone and nephrolithiasis were 8.8% and 1.5% following CTX administration, respectively. Surprisingly, we found a significant correlation in terms of age between patients with and without gallstone (=0.03). CONCLUSION: Our findings suggest that the patients' age might play a role in the development of such a complication. This indicates the need for a close monitoring of CTX-treated patients to assess the possible formation of gallstone and nephrolithiasis.
Clinical factors predicting drug-induced liver injury due to flucloxacillin.
Lindh M, Hallberg P, Yue QY … +1 more , Wadelius M
Drug Healthc Patient Saf · 2018 · PMID 30538582 · Full text
OBJECTIVES: Drug-induced liver injury (DILI) is a serious adverse reaction due to flucloxacillin. The pathogenesis is not fully understood. Female sex, age over 60 years, and a longer treatment duration have been suggest...
OBJECTIVES: Drug-induced liver injury (DILI) is a serious adverse reaction due to flucloxacillin. The pathogenesis is not fully understood. Female sex, age over 60 years, and a longer treatment duration have been suggested to be predisposing factors. Carriers of HLA-B*57:01 have an 80-fold increased risk, but due to the rarity of the reaction, testing of all patients is not cost-effective. We aimed to validate and detect clinical risk factors for flucloxacillin DILI. METHODS: Clinical characteristics of flucloxacillin-treated patients with (n=50) and without DILI (n=2,330) were compared in a retrospective case control study. Cases were recruited from the Swedish database of spontaneously reported adverse drug reactions. Treated controls were selected from the Swedish Twin Registry. Statistical comparisons were made using chi-squared test and logistic regression. The significance threshold was set to <0.00357 to correct for multiple comparisons. Reliable variables were tested in a multiple regression model. RESULTS: DILI was associated with female sex, OR 2.79, 95% CI 1.50-5.17, =0.0011, and with a history of kidney stones, OR 5.51, 95% CI 2.21-13.72, =0.0003. Cases were younger than controls, OR per increase in years 0.91, 95% CI 0.88-0.94, <0.0001, probably due to selection bias. No difference in treatment duration was detected, OR 1.03, 95% CI 0.98-1.08, =0.1790. CONCLUSION: We established female sex as a risk factor for flucloxacillin-induced DILI, and a history of kidney stones was identified as a potential risk factor. Clinical risk factors for flucloxacillin-induced DILI could be used to indicate whom to test for HLA-B*57:01 before treatment.
A pilot study on secondhand tobacco exposure: parental knowledge about health impact and feasibility of cessation.
Walia H, Miller R, Tumin D … +2 more , Tobias JD, Sebastian R
Drug Healthc Patient Saf · 2018 · PMID 30410406 · Full text
INTRODUCTION: As the primary source of smoke exposure is in the home, the smoking behaviors of parents and other caregivers are key determinants of a child's exposure to secondhand smoke. The perioperative period offers...
INTRODUCTION: As the primary source of smoke exposure is in the home, the smoking behaviors of parents and other caregivers are key determinants of a child's exposure to secondhand smoke. The perioperative period offers an opportunity to discuss smoking cessation strategies. METHODS: This prospective study included 97 parents or caregivers of patients undergoing dental surgery. Caregivers were surveyed in the dental waiting room during the preoperative phase. The primary aim was to determine the feasibility of using the preoperative encounter to offer smoking cessation resources to parents of pediatric patients. The secondary aim was to compare willingness to receive smoking cessation resources according to the knowledge of the risks of secondhand smoking (ie, being aware of secondhand smoking and knowing that it posed a risk to their child). RESULTS: Awareness of risks due to secondhand smoking was 65% in the overall cohort and 58% among current smokers (=0.284 vs nonsmokers). Among smokers in our study, only a small percentage (12%) were interested in smoking cessation help. Knowledge of the risks of secondhand smoke may not be sufficient for smokers to express willingness to receive help. CONCLUSION: The outpatient clinic may be a teaching opportunity for smoking cessation for caregivers. However, we found that only a small percentage of caregivers were interested in receiving information about smoking cessation. This was despite the fact they were aware of the potential adverse effects of secondhand smoke on their children.
Predictors of non adherence to antiretroviral therapy at an urban HIV care and treatment center in Tanzania.
Sangeda RZ, Mosha F, Aboud S … +6 more , Kamuhabwa A, Chalamilla G, Vercauteren J, Van Wijngaerden E, Lyamuya EF, Vandamme AM
Drug Healthc Patient Saf · 2018 · PMID 30174460 · Full text
BACKGROUND: Measurement of adherence to antiretroviral therapy (ART) can serve as a proxy for virologic failure in resource-limited settings. The aim of this study was to determine the factors underlying nonadherence mea...
BACKGROUND: Measurement of adherence to antiretroviral therapy (ART) can serve as a proxy for virologic failure in resource-limited settings. The aim of this study was to determine the factors underlying nonadherence measured by three methods. PATIENTS AND METHODS: This is a prospective longitudinal cohort of 220 patients on ART at Amana Hospital in Dar es Salaam, Tanzania. We measured adherence using a structured questionnaire combining a visual analog scale (VAS) and Swiss HIV Cohort Study Adherence Questionnaire (SHCS-AQ), pharmacy refill, and appointment keeping during four periods over 1 year. Overall adherence was calculated as the mean adherence for all time points over the 1 year of follow-up. At each time point, adherence was defined as achieving a validated cutoff for adherence previously defined for each method. RESULTS: The proportion of overall adherence was 86.4% by VAS, 69% by SHCS-AQ, 79.8% by appointment keeping, and 51.8% by pharmacy refill. Forgetfulness was the major reported reason for patients to skip their medications. In multivariate analysis, significant predictors to good adherence were older age, less alcohol consumption, more advanced World Health Organization clinical staging, and having a lower body mass index with odds ratio (CI): 3.11 (1.55-6.93), 0.24 (0.09-0.62), 1.78 (1.14-2.84), and 0.93 (0.88-0.98), respectively. CONCLUSION: We found relatively good adherence to ART in this setting. Barriers to adherence include young age and perception of well-being.
Development and validation of a questionnaire to self-assess patient knowledge of direct oral anticoagulants (KODOA-test).
Metaxas C, Albert V, Stahl M … +2 more , Hersberger KE, Arnet I
Drug Healthc Patient Saf · 2018 · PMID 30050329 · Full text
OBJECTIVE: Few studies have examined associations between patient knowledge of direct oral anticoagulants (DOAC) and clinical outcomes, mostly because of the lack of validated questionnaires for assessing knowledge. The...
OBJECTIVE: Few studies have examined associations between patient knowledge of direct oral anticoagulants (DOAC) and clinical outcomes, mostly because of the lack of validated questionnaires for assessing knowledge. The aim of this study was to develop and validate a questionnaire to self-assess knowledge of DOAC. METHODS: Twelve anticoagulation experts participated in the questionnaire development process to ensure content validity. The Knowledge Of Direct Oral Anticoagulants (KODOA)-test was submitted to patients on DOAC and to pharmacists to assess construct validity. Responsiveness was evaluated after educational counseling. Test-retest reliability was assessed to ensure stability over time, and Cronbach's α was calculated for internal reliability. Index of difficulty and item discrimination (-value) were calculated to assess the performance of single items. RESULTS: The KODOA-test contains 15 items with multiple-choice answers. Each correct answer scores 1 point (max. score of 15). The KODOA-test was administered to 32 patients on DOAC and 28 pharmacists. Pharmacists scored significantly higher than patients at baseline (median score 13.3 vs 10.0; <0.001), supporting construct validity. Patient scores increased significantly after educational counseling (median score 11 [interquartile range 2] vs 14 [interquartile range 3]; <0.001). Test-retest and Cronbach's α were acceptable with a Pearson's correlation of 0.8 and an α of 0.67. The index of difficulty for most items was satisfactory (0.38-0.72) and the mean -value was 42.5%. CONCLUSION: The KODOA-test is a brief, valid, and reliable knowledge self-assessment questionnaire that may be used in clinical trials to investigate associations between knowledge increase and patient-related outcomes.
Erratum: Long-term safety profile of tolvaptan in autosomal dominant polycystic kidney disease patients: TEMPO Extension Japan Trial [Corrigendum].
Drug Healthc Patient Saf · 2018 · PMID 30038524 · Full text
[This corrects the article on p. 93 in vol. 9, PMID: 29123425.].
[This corrects the article on p. 93 in vol. 9, PMID: 29123425.].
Therapeutic potential of medicinal marijuana: an educational primer for health care professionals.
Mouhamed Y, Vishnyakov A, Qorri B … +6 more , Sambi M, Frank SS, Nowierski C, Lamba A, Bhatti U, Szewczuk MR
Drug Healthc Patient Saf · 2018 · PMID 29928146 · Full text
With the proposed Canadian July 2018 legalization of marijuana through the Cannabis Act, a thorough critical analysis of the current trials on the efficacy of medicinal marijuana (MM) as a treatment option is necessary....
With the proposed Canadian July 2018 legalization of marijuana through the Cannabis Act, a thorough critical analysis of the current trials on the efficacy of medicinal marijuana (MM) as a treatment option is necessary. This review is particularly important for primary care physicians whose patients may be interested in using MM as an alternative therapy. In response to increased interest in MM, Health Canada released a document in 2013 for general practitioners (GPs) as an educational tool on the efficacy of MM in treating some chronic and acute conditions. Although additional studies have filled in some of the gaps since the release of the Health Canada document, conflicting and inconclusive results continue to pose a challenge for physicians. This review aims to supplement the Health Canada document by providing physicians with a critical yet concise update on the recent advancements made regarding the efficacy of MM as a potential therapeutic option. An update to the literature of 2013 is important given the upcoming changes in legislation on the use of marijuana. Also, we briefly highlight the current recommendations provided by Canadian medical colleges on the parameters that need to be considered prior to authorizing MM use, routes of administration as well as a general overview of the endocannabinoid system as it pertains to cannabis. Lastly, we outline the appropriate medical conditions for which the authorization of MM may present as a practical alternative option in improving patient outcomes as well as individual considerations of which GPs should be mindful. The purpose of this paper is to offer physicians an educational tool that provides a necessary, evidence-based analysis of the therapeutic potential of MM and to ensure physicians are making decisions on the therapeutic use of MM in good faith.
Concomitant use of opioid medications with triptans or serotonergic antidepressants in US office-based physician visits.
Molina KC, Fairman KA, Sclar DA
Drug Healthc Patient Saf · 2018 · PMID 29760569 · Full text
BACKGROUND: Opioids are not recommended for routine treatment of migraine because their benefits are outweighed by risks of medication overuse headache and abuse/dependence. A March 2016 US Food and Drug Administration (...
BACKGROUND: Opioids are not recommended for routine treatment of migraine because their benefits are outweighed by risks of medication overuse headache and abuse/dependence. A March 2016 US Food and Drug Administration (FDA) safety communication warned of the risk of serotonin syndrome from using opioids concomitantly with 5-hydroxytryptamine receptor agonists (triptans) or serotonergic antidepressants: selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Epidemiological information about co-prescribing of these medications is limited. The objective of this study was to estimate the nationwide prevalence of co-prescribing of an opioid with a serotonergic antidepressant and/or triptan in US office-based physician visits made by 1) all patients and 2) patients diagnosed with migraine. METHODS: National Ambulatory Medical Care Survey (NAMCS) data were obtained for 2013 and 2014. Physician office visits that included the new or continued prescribing of ≥1 opioid medication with a triptan or an SSRI/SNRI were identified. Co-prescribed opioids were stratified by agent to determine the proportion of co-prescriptions with opioids posing a higher risk of serotonergic agonism (meperidine, tapentadol, and tramadol). RESULTS: Of an annualized mean 903.6 million office-based physician visits in 2013-2014, 17.7 million (2.0% of all US visits) resulted in the prescribing of ≥1 opioid medication with a triptan or an SSRI/SNRI. Opioid-SSRI/SNRI was co-prescribed in 16,044,721 visits, while opioid-triptan was co-prescribed in 1,622,827 visits. One-fifth of opioid co-prescribing was attributable to higher-risk opioids, predominantly tramadol (18.6% of opioid-SSRI/SNRI, 21.8% of opioid-triptan). Of 7,672,193 visits for patients diagnosed with migraine, 16.3% included opioid prescribing and 2.0% included co-prescribed opioid-triptan. CONCLUSION: During a period approximately 2 years prior to an FDA warning about the risk of serotonin syndrome from opioid-SSRI/SNRI or opioid-triptan co-prescribing, use of these combinations was common in the USA. Studies on prescribing patterns following the March 2016 warning, and on the risk of serotonin syndrome associated with these co-prescriptions, are needed.
Evaluating cardiac risk: exposure response analysis in early clinical drug development.
Grenier J, Paglialunga S, Morimoto BH … +1 more , Lester RM
Drug Healthc Patient Saf · 2018 · PMID 29713203 · Full text
The assessment of a drug's cardiac liability has undergone considerable metamorphosis by regulators since International Council for Harmonization of Technical Requirement for Pharmaceuticals for Human Use E14 guideline w...
The assessment of a drug's cardiac liability has undergone considerable metamorphosis by regulators since International Council for Harmonization of Technical Requirement for Pharmaceuticals for Human Use E14 guideline was introduced in 2005. Drug developers now have a choice in how proarrhythmia risk can be evaluated; the options include a dedicated thorough QT (TQT) study or exposure response (ER) modeling of intensive electrocardiogram (ECG) captured in early clinical development. The alternative approach of ER modeling was incorporated into a guidance document in 2015 as a primary analysis tool which could be utilized in early phase dose escalation studies as an option to perform a dedicated TQT trial. This review will describe the current state of ER modeling of intensive ECG data collected during early clinical drug development; the requirements with regard to the use of a positive control; and address the challenges and opportunities of this alternative approach to assessing QT liability.
Evaluation of vancomycin therapy in the adult ICUs of a teaching hospital in southern Iran.
Vazin A, Mahi Birjand M, Darake M
Drug Healthc Patient Saf · 2018 · PMID 29670404 · Full text
BACKGROUND: Vancomycin resistance in intensive care units (ICUs) accounts for significant morbidity and excess costs. The objective of the present study was to determine the appropriateness of vancomycin use in the vario...
BACKGROUND: Vancomycin resistance in intensive care units (ICUs) accounts for significant morbidity and excess costs. The objective of the present study was to determine the appropriateness of vancomycin use in the various ICUs of Nemazee Hospital, Shiraz, Iran. METHODS: This prospective study was performed on 95 critically ill patients (48 males and 47 females) who were treated with vancomycin for at least 3 subsequent doses in 6 ICUs during 12 months. Required demographic, clinical, and paraclinical data were collected by a pharmacist. Fifteen indexes were considered for evaluation of vancomycin use. RESULTS: Ventilator-associated hospital-acquired pneumonia (22.6%), sepsis (22.1%) and CNS infection (12.6%) were found to be the most important indications for vancomycin prescription. Vancomycin was prescribed empirically in 81% of patients. None of the patients received loading dose, and most of the patients received fixed dose. The rate of prolonged empiric antibiotic therapy was 68.5% in patients who received vancomycin. The mean score of vancomycin use in the ICUs of Nemazee Hospital was 7.1±0.6 out of 15, implying that the rate of vancomycin use was in accordance with the guideline proposed by the Department of Clinical Pharmacy of Nemazee Hospital based on Infectious Diseases Society of America by 47.3%. CONCLUSION: Based on our results, the weakness in using vancomycin was related to not administering loading dose, the practice of prescribing fixed-dose vancomycin and prolonged duration of empiric therapy. Efforts to improve the pattern of vancomycin prescription and utilization in these ICUs should be undertaken.
Calculating reading ease score of patient package inserts in Iran.
Zarea Gavgani V, Mirzadeh-Qasabeh S, Hanaee J … +1 more , Hamishehkar H
Drug Healthc Patient Saf · 2018 · PMID 29593437 · Full text
BACKGROUND: The patient package inserts (PPIs), which contain the necessary information about medications intended for patients, need to be expressed in a clear language comprehensible to everyone. OBJECTIVE: This study...
BACKGROUND: The patient package inserts (PPIs), which contain the necessary information about medications intended for patients, need to be expressed in a clear language comprehensible to everyone. OBJECTIVE: This study aimed to evaluate the readability and understandability of the drug package inserts for the inexpert people. METHODS: The readability of the 158 PPIs of the 33 drugs, registered and manufactured in Iran, was calculated. The main criterion for selecting PPIs to include in this study was of those top-selling drugs during the year 2015 according to the Social Security Organization in Iran. The PPIs were collected from the pharmacies of the three major cities, namely, Tabriz, Ardabil and Meshgin Shahr. Then, using the Flesch-Dayani readability (FDR) tool adjusted for the Persian language, the average number of the words and syllables was counted to calculate and grade the readability score of the selected PPIs. RESULTS: This study showed that the average FDR readability score for all the 33 drugs is 52.52, which are graded 10th-11th. Of the PPIs, 70.89% were difficult to read, and on average, the readability of the PPIs was five times difficult than the standard ones. Only 13.92% PPIs were suitable for the 5th-7th grade, and 15.19% of the package inserts ranked in the 8th-9th reading grade. CONCLUSION: A considerable number of the PPIs in Iran have low readability level and were not suitable for the inexpert readers. Since the treatment cost is very high, people tend to use medications arbitrarily or simply use old prescriptions. This study suggests the necessity of a major improvement in the readability level of the PPIs in order to ensure the usefulness of the PPIs to the majority of the consumers.
Prevalence of medication errors in primary health care at Bahrain Defence Force Hospital - prescription-based study.
Aljasmi F, Almalood F, Al Ansari A
Drug Healthc Patient Saf · 2018 · PMID 29445304 · Full text
BACKGROUND: One of the important activities that physicians - particularly general practitioners - perform is prescribing. It occurs in most health care facilities and especially in primary health care (PHC) settings. OB...
BACKGROUND: One of the important activities that physicians - particularly general practitioners - perform is prescribing. It occurs in most health care facilities and especially in primary health care (PHC) settings. OBJECTIVES: This study aims to determine what types of prescribing errors are made in PHC at Bahrain Defence Force (BDF) Hospital, and how common they are. METHODS: This was a retrospective study of data from PHC at BDF Hospital. The data consisted of 379 prescriptions randomly selected from the pharmacy between March and May 2013, and errors in the prescriptions were classified into five types: major omission, minor omission, commission, integration, and skill-related errors. RESULTS: Of the total prescriptions, 54.4% (N=206) were given to male patients and 45.6% (N=173) to female patients; 24.8% were given to patients under the age of 10 years. On average, there were 2.6 drugs per prescription. In the prescriptions, 8.7% of drugs were prescribed by their generic names, and 28% (N=106) of prescriptions included an antibiotic. Out of the 379 prescriptions, 228 had an error, and 44.3% (N=439) of the 992 prescribed drugs contained errors. The proportions of errors were as follows: 9.9% (N=38) were minor omission errors; 73.6% (N=323) were major omission errors; 9.3% (N=41) were commission errors; and 17.1% (N=75) were skill-related errors. CONCLUSION: This study provides awareness of the presence of prescription errors and frequency of the different types of errors that exist in this hospital. Understanding the different types of errors could help future studies explore the causes of specific errors and develop interventions to reduce them. Further research should be conducted to understand the causes of these errors and demonstrate whether the introduction of electronic prescriptions has an effect on patient outcomes.
Older adults and high-risk medication administration in the emergency department.
Kim M, Mitchell SH, Gatewood M … +7 more , Bennett KA, Sutton PR, Crawford CA, Bentov I, Damodarasamy M, Kaplan SJ, Reed MJ
Drug Healthc Patient Saf · 2017 · PMID 29184448 · Full text
BACKGROUND: Older adults are susceptible to adverse effects from opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and benzodiazepines (BZDs). We investigated factors associated with the administration of elevated...
BACKGROUND: Older adults are susceptible to adverse effects from opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and benzodiazepines (BZDs). We investigated factors associated with the administration of elevated doses of these medications of interest to older adults (≥65 years old) in the emergency department (ED). PATIENTS AND METHODS: ED records were queried for the administration of medications of interest to older adults at two academic medical center EDs over a 6-month period. Frequency of recommended versus elevated ("High doses" were defined as doses that ranged between 1.5 and 3 times higher than the recommended starting doses; "very high doses" were defined as higher than high doses) starting doses of medications, as determined by geriatric pharmacy/medicine guidelines and expert consensus, was compared by age groups (65-69, 70-74, 75-79, 80-84, and ≥85 years), gender, and hospital. RESULTS: There were 17896 visits representing 11374 unique patients >65 years of age (55.3% men, 44.7% women). A total of 3394 doses of medications of interest including 1678 high doses and 684 very high doses were administered to 1364 different patients. Administration of elevated doses of medications was more common than that of recommended doses. Focusing on opioids and BZDs, the 65-69-year age group was much more likely to receive very high doses (1481 and 412 doses, respectively) than the ≥85-year age groups (relative risk [RR] 5.52, 95% CI 2.56-11.90), mainly reflecting elevated opioid dosing (RR 8.28, 95% CI 3.69-18.57). Men were more likely than women to receive very high doses (RR 1.47, 95% CI 1.26-1.72), primarily due to BZDs (RR 2.12, 95% CI 2.07-2.16). CONCLUSION: Administration of elevated doses of opioids and BZDs in the older population occurs frequently in the ED, especially to the 65-69-year age group and men. Further attention to potentially unsafe dosing of high-risk medications to older adults in the ED is warranted.
Long-term safety profile of tolvaptan in autosomal dominant polycystic kidney disease patients: TEMPO Extension Japan Trial.
Muto S, Okada T, Yasuda M … +3 more , Tsubouchi H, Nakajima K, Horie S
Drug Healthc Patient Saf · 2017 · PMID 29123425 · Full text
AIM: The aim of this trial (ClinicalTrials.gov identifier: NCT01280721) was to investigate the long-term safety profile of tolvaptan in Japanese patients with autosomal dominant polycystic kidney disease (ADPKD). METHODS...
AIM: The aim of this trial (ClinicalTrials.gov identifier: NCT01280721) was to investigate the long-term safety profile of tolvaptan in Japanese patients with autosomal dominant polycystic kidney disease (ADPKD). METHODS: This open-label multicenter trial was conducted to examine adverse drug reactions (ADRs) related to tolvaptan up to an additional 3 years in 135 Japanese patients who participated in the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes (TEMPO) 3:4 trial at doses of 60-120 mg/d. Blood samples were collected at baseline; at weeks 1, 2, and 3; at month 3; and every 3 months thereafter. RESULTS: In total, 134/135 (>99%) patients experienced ADRs. The most frequent ADRs were thirst (77.0%), pollakiuria (57.0%), polyuria (37.8%), and hyperuricemia (14.8%). Any unexpected ADRs were not reported in this trial. Most ADRs occurred early during treatment. Fourteen patients (10.4%) experienced hepatic events, and 8 (5.9%) experienced >3-fold increases above the upper limits of normal in serum alanine aminotransferase or aspartate aminotransferase levels between 3 and 9 months following tolvaptan initiation, which recovered after drug interruption. Of the 8 patients, 7 (5.2%) were previously allocated to the placebo arm in the TEMPO 3:4 trial and 4 (3.0%) discontinued due to the hepatic events. One patient (0.7%) was previously allocated to tolvaptan and experienced similar events in the TEMPO 3:4 trial. None of the hepatic ADRs met Hy's Law laboratory criteria. CONCLUSION: ADRs observed in this extension trial were similar to those identified in the TEMPO 3:4 trial and hepatic events were not progressive.
A suspected case of autoinduction of voriconazole metabolism in a patient with cerebral aspergillosis.
Ferguson MJ, Randles ML, de Freitas DG
Drug Healthc Patient Saf · 2017 · PMID 28932128 · Full text
OBJECTIVE: This study aims to report a case of accelerated metabolism of voriconazole in a patient with cerebral aspergillosis. CASE SUMMARY: A 36-year-old woman developed cerebral aspergillosis after immunosuppressive t...
OBJECTIVE: This study aims to report a case of accelerated metabolism of voriconazole in a patient with cerebral aspergillosis. CASE SUMMARY: A 36-year-old woman developed cerebral aspergillosis after immunosuppressive treatment for suspected atypical hemolytic uremic syndrome/thrombotic thrombocytopenic purpura. She was treated with voriconazole using therapeutic drug monitoring to guide dosing. After an initial high level, her dose was reduced, but over the following weeks, she required several dose increases in order to achieve a voriconazole level within the target range. The patient's dose requirements eventually stabilized at 700 mg twice daily. Cimetidine and omeprazole were added in an effort to inhibit the metabolism of voriconazole. DISCUSSION: The metabolism of voriconazole is known to be highly variable among different patients depending on pharmacogenetic factors; however, an increasing rate of voriconazole metabolism in a single patient over time is not well recognized. Therapeutic drug monitoring of voriconazole in this case facilitated the use of large doses while controlling for toxicity. CONCLUSION: This case is further evidence of autoinduction in voriconazole metabolism. Therapeutic drug monitoring of voriconazole is useful in detecting variation in a patient's metabolism of voriconazole over time.
Early rehospitalizations of frail elderly patients - the role of medications: a clinical, prospective, observational trial.
Ekerstad N, Bylin K, Karlson BW
Drug Healthc Patient Saf · 2017 · PMID 28860862 · Full text
BACKGROUND AND OBJECTIVE: Early readmissions of frail elderly patients after an episode of hospital care are common and constitute a crucial patient safety outcome. Our purpose was to study the impact of medications on s...
BACKGROUND AND OBJECTIVE: Early readmissions of frail elderly patients after an episode of hospital care are common and constitute a crucial patient safety outcome. Our purpose was to study the impact of medications on such early rehospitalizations. PATIENTS AND METHODS: This is a clinical, prospective, observational study on rehospitalizations within 30 days after an acute hospital episode for frail patients over the age of 75 years. To identify adverse drug reactions (ADRs), underuse of evidence-based treatment and avoidability of rehospitalizations, the Naranjo score, the Hallas criteria and clinical judgment were used. RESULTS: Of 390 evaluable patients, 96 (24.6%) were rehospitalized. The most frequent symptoms and conditions were dyspnea (n = 25) and worsened general condition (n = 18). The most frequent diagnoses were heart failure (n = 17) and pneumonia/acute bronchitis (n = 13). By logistic regression analysis, independent risk predictors for rehospitalization were heart failure (odds ratio [OR] = 1.8; 95% CI = 1.1-3.1) and anemia (OR = 2.3; 95% CI = 1.3-4.0). The number of rehospitalizations due to probable ADRs was 13, of which two were assessed as avoidable. The number of rehospitalizations probably due to underuse of evidence-based drug treatment was 19, all of which were assessed as avoidable. The number of rehospitalizations not due to ADRs or underuse of evidence-based drug treatment was 64, of which none was assessed as avoidable. CONCLUSION: One out of four frail elderly patients discharged from hospital was rehospitalized within 1 month. Although ADRs constituted an important cause of rehospitalization, underuse of evidence-based drug treatment might be an even more frequent cause. Potentially avoidable rehospitalizations were more frequently associated with underuse of evidence-based drug treatment than with ADRs. Efforts to avoid ADRs in frail elderly patients must be balanced and combined with evidence-based drug therapy, which can benefit these patients.
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