Drugs & Therapy Perspectives

First reports of adverse drug reactions

Management and evaluation of treatment adherence and effectiveness in chronic venous disorders: results of the international study VEIN Act Program Abstract Objective The aim of this study was to examine worldwide chronic venous disease (CVD) burden and evaluate effectiveness, adherence and satisfaction with conservative treatment. Materials and methods The VEIN Act Program (VAP) was an international, prospective, observational study that enrolled adult outpatients with lower-limb pain consulting for any CVD-related clinical presentation. Patients' CVD symptoms, Clinical Etiological Anatomic Pathophysiologic (CEAP) classification, and symptom intensity were recorded. After prescribing conservative treatments, patients returned for a follow-up visit. Result A total of 567 physicians enrolled 7987 patients, 7397 of whom were included in the analysis. Patients were mainly female (79.3%), mean age was 54.0 ± 15.1 years and mean body mass index was 26.8 ± 4.8 kg/m2. CEAP clinical classifications were C0s (3.6%), C1 (19.4%), C2 (21.8%), C3 (32.0%) and C4–C6 (23.2%). Symptoms were reported by 89.6% of patients and were present across all CEAP classes. Mean intensity (10 cm visual analog scale) was > 5 cm for all symptoms. Only 30.7% of patients had previously consulted for leg problems, and 24.3% had previously received treatment. Conservative treatment alone was prescribed to 78.3% of patients, and in association with operative treatment in 21.6% of patients, and consisted mostly of venoactive drugs (VADs) [99.6%, mostly micronized purified flavonoid fraction] and compression therapy (63.4%) in combination with lifestyle changes such as weight loss. Adherence to prescribed duration was 65.2% for VADs, but only 29.1% wore compression therapy as prescribed. Symptom relief was high with VADs and compression therapy (> 96%), and the majority of patients were satisfied (94.1%). Conclusion Conservative treatments were beneficial across the spectrum of CVD, highlighting the importance of identifying patients early in the disease course.

Ertugliflozin in type 2 diabetes: a profile of its use Abstract Oral ertugliflozin (Steglatro™), a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, is approved in numerous countries as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes (T2D), either as monotherapy or add-on therapy to other antihyperglycaemic agents; specific indications may vary between individual countries. In numerous well-designed VERTIS trials and extension studies in adults with inadequately controlled T2D, ertugliflozin monotherapy, initial combination therapy to sitagliptin and add-on therapy to metformin or to metformin plus sitagliptin consistently provided effective and durable glycaemic control, and reduced bodyweight and blood pressure. Ertugliflozin is generally well tolerated, with a good benefit/risk profile. The availability of ertugliflozin/metformin (Segluromet™) and ertugliflozin/sitagliptin (Steglujan™) fixed-dose combinations (FDCs) may potentially improve compliance/adherence in patients requiring intensification of antihyperglycaemic treatment with combination therapy to achieve adequate glycaemic control. Given the proven benefits of other SGLT2 inhibitors on cardiovascular (CV) and renal outcomes, results from the ongoing VERTIS CV outcome trial are awaited with interest.

When managing ulcerative colitis in older patients, understanding their overall health profile is key Abstract Ulcerative colitis (UC) in patients aged > 60 years is increasingly common. The treatment of UC aims to induce and maintain clinical remission, with 5-aminosalicylates the mainstay for mild UC. In moderate-to-severe or refractory UC, oral corticosteroids, thiopurines, anti-TNF agents, vedolizumab and tofacitinib are treatment options to induce and/or maintain remission. To facilitate compliance and minimize adverse drug events, treatment should be tailored to patients' general health status, comorbidities and existing medications.

The off-label use of medicines in pediatric outpatients in Bulgaria based on an analysis of their prescription data Abstract Background The off-label use of medicines is a common practice that occurs over a wide range of therapeutic areas in both adults and children, but occurs much more frequently in pediatric population. So far, the extent of off-label use among children in Bulgaria has not been studied. Objective The aim of this nested, retrospective, non-interventional, single-center study is to provide data on the frequency, type, and the most common situations in which off-label medicines are prescribed in daily pediatric practice in Bulgaria. Methods The data on prescriptions of 360 pediatric outpatients, treated during a 1-year period, were recorded and provided for analysis. The summaries of product characteristics (SmPC) were used as reference documents for the assessment of prescriptions. Descriptive statistics, with absolute frequencies, means, and standard deviation, were used to analyze the processed data. Results The results from this study show that most pediatric patients (78%) were exposed to off-label use. Half of the medicines prescribed off-label were used for a therapeutic indication other than the one listed in the SmPC. We found that certain medicines were used 100% off-label, and certain diseases were also 100% treated with off-label medications. Conclusion Although the study was limited to one center, it deserves attention as it reveals many different aspects of the off-label use of medications in pediatric patients in Bulgaria. Further studies involving a larger number of medical centers are needed to establish more accurate data on off-label prescribing in pediatric patients at a national level.

Intravenous medication errors in Selangor, Malaysia: prevalence, contributing factors and potential clinical outcomes Abstract Introduction Medication errors may have serious implications to both the patient and the healthcare system, and may also compromise patient safety and significantly impact healthcare costs. Therefore, assessing the prevalence and factors associated with intravenous medication errors will significantly improve the quality of care and hospital services. Objective The aim of this study was to determine the prevalence of intravenous medication errors and their potential clinical outcomes. Additionally, this study evaluates the relationship between medication errors and the factors associated with their occurrences. Methods This prospective study was conducted using a direct observation technique and medication record reviews in a secondary hospital in Malaysia. The preparation and administration of intravenous drugs were observed for a total of 213 doses using a checklist supplemented with a review of medication charts. Results Medication administration errors were detected in 85% (181/213) of the doses observed. Overall, 307 errors were identified. After excluding the 39 wrong-time errors, 66.7% (142/213) remained erroneous. More errors were detected during the drug administration stage (62.5%) than in the drug preparation stage (37.5%). Central nervous system drugs recorded the highest error rate at 94.1%. Overall, a total of 43 errors (14.3%) were found to be potentially severe. In a bivariate analysis, the occurrence of errors was significantly associated with nurses' experience and level of education. Conclusion Intravenous preparation and administration errors were highly prevalent in a resource-restricted secondary hospital in Malaysia. Targeted and prompt remedial actions such as training and enforcing existing standard operating procedures to reduce medication errors should be implemented.

Human α 1 -proteinase inhibitor (Respreeza ® ) in α 1 -antitrypsin deficiency emphysema: a profile of its use in the EU Abstract Augmentation therapy with human α1-proteinase inhibitor (Respreeza®) is an effective and generally well tolerated treatment option for patients with severe α1-antitrypsin deficiency. In the 2-year RAPID trial, intravenous Respreeza 60 mg/kg once weekly was associated with a trend towards reduced mean annual rate of lung density loss (as measured by computed tomography) at total lung capacity (TLC) and functional residual capacity (FRC) combined, and at FRC alone, with a significant reduction seen at TLC alone. The continued efficacy of Respreeza in slowing the progression of emphysema was demonstrated in a 2-year open-label extension of the RAPID trial. Although lung density loss was slowed when treatment was initiated later in the disease course, lung density loss prior to treatment was not recovered.

Identify potentially inappropriate medications in older adults with chronic kidney disease and deprescribe when possible Abstract Older adults with chronic kidney disease (CKD) often receive treatment with multiple medications and are vulnerable to adverse treatment-related outcomes. Although specific guidelines for deprescribing (defined as the process of eliminating or reducing the use of unnecessary and/or inappropriate medications) in older patients with CKD are lacking, a systemic process should be used to assess the individual patient, identify the use of potentially inappropriate medications (PIMs), and deprescribe such medications when possible. Dosage tapering is needed when some commonly used PIMs (e.g. proton pump inhibitors and oral antidiabetic drugs) are deprescribed, but not when others (e.g. statins) are discontinued. Patient involvement and a collaborative approach are important factors in the success of the deprescribing process.

The use of fluoroquinolones and macrolides for sinusitis: a retrospective cross-sectional study Abstract Background and objective β-Lactam antibiotics are the recommended first-line treatment for acute bacterial sinusitis. Fluoroquinolones are recommended in patients with hypersensitivity reactions to penicillins, and macrolide antibiotics are no longer recommended. The objectives of this study were to understand whether outpatient antibiotic prescribing practices adhere to treatment guidelines and to describe rates of fluoroquinolone and macrolide antibiotic prescribing for the treatment of sinusitis. Methods This was a retrospective cross-sectional study using US National Ambulatory Medical Care Survey (NAMCS) data. The prevalence of antibiotic prescribing for sinusitis was estimated, and the antibiotic prescribing pattern was measured. Additionally, significant factors associated with various antibiotic prescribing during the visits related to sinusitis were identified. Results Among physician visits related to sinusitis from 2013 to 2016 (n = 2739), 66.4% involved antibiotic prescribing. Visits with antibiotic prescribing showed greater proportions of patients aged < 18 years (21.7 vs 11.1%, p < 0.001), patients reporting fever (79.8 vs 50.7%, p < 0.001), and patients seeing family physicians or internal medicine specialists (68.4 vs 44.8%, p < 0.001) than those without antibiotic prescribing. Penicillins, macrolides, cephalosporins, and fluoroquinolones were prescribed in 42.2%, 30.6%, 15.2%, and 9.5% of the visits involving antibiotic prescribing for sinusitis, respectively. The odds of fluoroquinolone/macrolide prescribing were reduced by 73% if patients visited pediatricians and by 59% with otolaryngologists. Conclusions Macrolides were the most common inappropriate antibiotic class prescribed for sinusitis. This study identifies a need for more focused attention to improve prescribing for sinusitis and adherence to the treatment guidelines.

Outcome measures in pediatric polypharmacy research: a scoping review Abstract Introduction Various methods have been used to interpret the reports of pediatric polypharmacy across the literature. This is the first scoping review that explores outcome measures in pediatric polypharmacy research. Objectives The aim of our study was to describe outcome measures assessed in pediatric polypharmacy research. Methods A search of electronic databases was conducted in July 2017, including Ovid Medline, PubMed, Elsevier Embase, Wiley Cochrane Central Register of Controlled Trials (CENTRAL), EBSCO CINAHL, Ovid PsycINFO, Web of Science Core Collection, ProQuest Dissertations and Thesis A&I. Data were extracted about study characteristics and outcome measures, and also synthesized by harms or benefits mentioned. Results The search strategy initially identified 8169 titles and screened 4398 using the inclusion criteria after de-duplicating. After the primary screening, a total of 363 studies were extracted for the data analysis. Polypharmacy (prevalence) was identified as an outcome in 31.4% of the studies, prognosis-related outcomes in 25.6%, and adverse drug reactions in 16.5%. A total of 265 articles (73.0%) mentioned harms, including adverse drug reactions (26.4%), side effects (24.2%), and drug–drug interactions (20.9%). A total of 83 studies (22.9%) mentioned any benefit, 48.2% of which identified combination for efficacy, 24.1% combination for treatment of complex diseases, and 19.3% combination for treatment augmentation. Thirty-eight studies reported adverse drug reaction as an outcome, where polypharmacy was a predictor, with various designs. Conclusions Most studies of pediatric polypharmacy evaluate prevalence, prognosis, or adverse drug reaction-related outcomes, and underscore harms related to polypharmacy. Clinicians should carefully weigh benefits and harms when introducing medications to treatment regimens.

Alexandros Sfakianakis
Anapafseos 5 . Agios Nikolaos
Crete.Greece.72100
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6948891480

alsfakia@gmail.com