Incidence of drug-related adverse events related to the use of high-alert drugs: A systematic review of randomized controlled trials.

Background: High-alert medication (HAM) is more predictable to cause significant harm to the patient, even when used as intended. The damage related to the HAM lead not only suffering to the patient, but also raise the additional costs associated with care. Objective: Evaluate the incidence of drug-related adverse events related to the use of high-alert medications. Methods: It was conducted an active search for information through COCHRANE databases, LILACS, SciELO, SCOPUS, PubMed/MEDLINE and WEB OF SCIENCE. The search strategy included the following terms: "Patient safety", "Medication errors" and "Hospital" and "High Alert Medications" or "Dangerous Drugs" in different combinations. Then two reviewers independently conducted a preliminary evaluation of relevant titles, abstracts and finally full-text. Studies quality was evaluated according to PRISMA declaration. Results: The systematic review evaluated seven articles, which showed that only 11 HAM identified in the literature could have serious events. The most frequently cited were warfarin (22.2%) which progressed from deep vein thrombosis to gangrene, suggesting lower initial doses, followed by cyclophosphamide (22.2%) and cyclosporine (22.2%) which presented invasive fungal infection and death. In addition to these, morphine was compared with its active metabolite (M6G), with M6G causing fewer serious clinical events related to nausea and vomiting, reducing the need for concomitant use of antiemetics. Conclusions: The most reported drug classes in the articles included that were related to incidence of drug-related adverse events in use of high-alert medications: morphine, M6G-glucuronide, haloperidol, promethazine, ivabradine, digoxin, warfarin, ximelagatran, cyclophosphamide, cyclosporine, and ATG. The formulate protocols for the use of these medications, with importance placed on evaluating, among the classes, the medication that causes the least harm.

Influence of drug-related problems on length of hospital stay of women with a history of preeclampsia: A multicenter study.

BACKGROUND: Approximately 5-7 % of pregnant women have hypertension during pregnancy, requiring antihypertensive drug treatment. There have been a lack of studies evaluating how drug-related problems (DRPs) affect morbidity or mortality in the postpartum period among women with a history of preeclampsia. OBJECTIVE: To determine the influence of drug-related problems on length of hospital stay of postpartum women with a history of preeclampsia. METHODS: This cross-sectional study included postpartum women diagnosed with preeclampsia, from June to November 2016, in two teaching maternity hospitals in Brazil. The outcomes assessed were, length of hospital stay of postpartum women. The DRPs were classified through the Pharmaceutical Care Network Europe Foundation (PCNE) v 8.01. RESULTS: 600 women were included, and 354 (59%) were exposed to at least one DRP. The most frequent DRPs were no administration of the prescribed medication, lack of prescription of a medication, although the indication was clear, and ineffectiveness (unknown reason). In patients exposed to DRP, the average length of hospital stay after labour was 5.4 (S.D. 3.6) days versus 4.4 (S.D. 3.3) days in patients non-exposed to DRP (p = 0.0001). The period (in days) to achieve blood pressure control after labour was 4.5 (S.D. 3.5) 3.5 (S.D. 3.2), respectively (p = 0.0001). There were no deaths during the study. CONCLUSION AND RELEVANCE: Drug-related problems significantly increased the length of hospital stay in postpartum women with a history of preeclampsia.

Harm Prevalence Due to Medication Errors Involving High-Alert Medications: A Systematic Review.

OBJECTIVE: The aim of the study was to determine the prevalence and main types of harm caused by high-alert medication after medication errors (MEs) in hospitals. METHOD: A literature systematic review was conducted on PubMed, Scopus, Web of Science, and Lilacs. Eligible studies published until June 2017 were included. RESULT: Of 6244 studies identified through searching four electronic databases, five studies meeting the selection criteria of this study were analyzed. There was wide variation in the overall prevalence of harm due to MEs involving HAM, from 3.8% to 100%, whereas the pooled prevalence was 16.3%. Overall, 0.01% of harm caused by MEs involving HAM resulted in death. The severity of errors ranged from 0.1% to 19.2% for moderate errors, 0.2% to 15.4% for serious errors, and 1.9% lethal to the patients. The highest prevalences of harm occurred after errors involving potassium chloride 15%, insulin, and epoprostenol. The lowest prevalence of harm was related to errors of anticoagulants administration. The methodological heterogeneity limited direct comparisons among the studies. CONCLUSIONS: Of the 15 drugs on the list of Institute for Safe Medication Practices HAMs in the United States and Brazil, nine did not present scientific evidence of the potential for harm. In general, few studies, characterized by methodological and conceptual heterogeneity, were performed to determine the harm prevalence resulting from errors involving these drugs.

Adverse drug reactions in high-risk pregnant women: A prospective study.

BACKGROUND: Because pregnant women are often excluded from clinical trials, there is still very limited information about the risk and safety of prescription drugs during pregnancy. OBJECTIVE: We aimed to determine the prevalence of Adverse Drug Reactions (ADRs) in high-risk pregnant women after hospital admission. A prospective study was carried out in a teaching maternity hospital in Brazil during six months. Causality of ADRs was assessed through the Naranjo Algorithm and Korean Algorithm for ADR Causality Assessment. Severity of ADRs was assessed using Hartwig's Severity Assessment Scale. RESULTS: The prevalence of ADRs among the 294 inpatients studied was 8.8%. The mean age was 27.14 (±7.5) y.o. Patient's age was related to the presence of ADRs, while the manifestation of these events was not associated with any adverse pregnancy outcome. 75.9% of the ADRs reported in the study were of mild severity and 24.1% were of moderate severity. No ADR was caused by drug-drug interaction; however, a significant increase in blood pressure was observed in all patients using concurrent methyldopa and ferrous sulfate. CONCLUSION: Overall, ADRs were not common events among high-risk pregnant women and no adverse pregnancy outcomes following these events were observed.

'What is not written does not exist': the importance of proper documentation of medication use history.

Medications are perceived as health risk factors, because they might cause damage if used improperly. In this context, an adequate assessment of medication use history should be encouraged, especially in transitions of care to avoid unintended medication discrepancies (UMDs). In a case-controlled study, we investigated potential risk factors for UMDs at hospital admission and found that 150 (42%) of the 358 patients evaluated had one or more UMDs. We were surprised to find that there was no record of a patient and/or relative interview on previous use of medication in 117 medical charts of adult patients (44.8%). Similarly, in the medical charts of 52 (53.6%) paediatric patients, there was no record of parents and/or relatives interviews about prior use of medications. One hundred thirty-seven medical charts of adult patients (52.4%) and seventy-two medical charts of paediatric patients (74.2%) had no record about medication allergies and intolerances. In other words, there was a lack of basic documentation regarding the patient's medication use history. As patients move between settings in care, there is insufficient tracking of verbal and written information related to medication changes, which results in a progressive and cumulative loss of information, as evidenced by problems associated with clinical transfers and medication orders. Proper documentation of medication information during transfer is a key step in the procedure; hence, it should be rightly performed. It remains unclear whether interviews, and other investigations about medication use history have been performed but have not been recorded as health-care data. Therefore, it is crucial to the improvement of medication use safety that documentation of all drug-related information-even if not directly related to the actual event-become routine practice in health-care organizations, since 'what is not written does not exist'.

Left ventricular mass and cardiothoracic index in patients with chronic renal disease on hemodialysis.

INTRODUCTION: Left ventricular hypertrophy (LVH) is an independent predictor of cardiovascular risk in patients with chronic renal disease (CRD) on hemodialysis (HD). OBJECTIVE: To show the usefulness of chest radiography in the diagnosis of LVH in CRD patients on HD. METHODS: Cross-sectional study including 100 patients (58 men and 42 women), mean age 46.2 ± 14.0 years, with CRD of all causes, for at least six months on HD. Were obtained echocardiogram and chest x-rays of patients, always up to one hour after the end of HD sessions. RESULTS: LVH was detected in 83 patients (83%), of whom 56 (67.4%) had the concentric pattern and 27 (32.6%) with eccentric pattern of LVH. Cardiomegaly - defined by cardiothoracic index (CTI) > 0.5 - was present in 61 patients (61%). The following were the sensitivity, specificity and accuracy, respectively, for the variable ICT: 66.2%, 70.5% and 68.0%. The Pearson correlation between ICT and index of left ventricular mass (LVMI) was 0.552 (p < 0.05) and positive likelihood ratio of 2.2. CONCLUSION: Chest radiography is a safe and useful as a diagnostic tool of LVH in CKD patients on HD.

The 8-item Morisky Medication Adherence Scale: validation of a Brazilian-Portuguese version in hypertensive adults.

BACKGROUND: The Morisky Medication Adherence Scale (MMAS-8) remains one of the most widely used mechanisms to assess patient adherence. Its translation and testing on languages in addition to English would be very useful in research and in practice. OBJECTIVE: To translate and examine the psychometric properties of the Portuguese version of the structured self-report eight-item Morisky Medication Adherence Scale among patients with hypertension. METHODS: The study was designed as a cross-sectional survey conducted in six Family Health Units of the Brazilian Unified Health System, in Maceió, between March 2011 and April 2012. After a standard "forward-backward" procedure to translate MMAS-8 into Portuguese, the questionnaire was applied to 937 patients with hypertension. Reliability was tested using a measure of internal consistency (Cronbach's alpha), and test-retest reliability. Validity was confirmed using known groups validity. Three levels of adherence were considered based on the following scores: 0 to <6 (low); 6 to <8 (medium); 8 (high). RESULTS: The mean age of respondents was 57.1 years (SD = 12.7 years), and 71.5% were female. The mean number of prescribed antihypertensives per patient was 1.62 (SD = 0.67). The mean score for the medication adherence scale was 5.78 (SD = 1.88). Moderate internal consistency was found (Cronbach's alpha = 0.682), and test-retest reliability was satisfactory (Spearman's r = 0.928; P < 0.001). A significant relationship between MMAS-8 levels of adherence and BP control (chi-square, 8.281; P = 0.016) was found. 46.0%, 33.6%, and 20.4% of patients had low, medium, and high adherence, respectively. The self-report measure sensitivity, specificity, positive and negative predictive values were 86.1%, 31.2%, 57.4% and 68.3% respectively. CONCLUSIONS: Psychometric evaluation of the Portuguese version of the MMAS-8 indicates that it is a reliable and valid measure to detect patients at risk of non-adherence. The MMAS-8 could still be used in routine care to support communication about the medication-taking behavior in hypertensive patients.