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This work aimed to evaluate and compare the benefits of the energy restricted Mediterranean diet (MD) and Standard hypolipemic diet (SHD) accompanied by exercise on metabolic syndrome parameters. A 12-month, randomized, single-blinded, diet-controlled study was conducted on 124 obese participants in the University Hospital Dubrava. Participants were assigned to the MD (n = 63) or the SHD (n = 61) and received the same amount of nutritional education and guidance on physical activity. The completion rate was 67.7 %. Both diets produced significant beneficial changes in body weight and waist circumference (P < 0.001 for MD and SHD). Compared with the SHD, HDL cholesterol increased (P = 0.031) and systolic blood pressure (SBP) decreased (P = 0.020) in the MD group. Fasting plasma glucose decreased significantly in both diet groups (P < 0.001 for MD; P = 0.026 for SHD). Although both diets accompanied by physical activity yielded similar weight reduction results, adherence to the MD was associated with more prominent reduction of the MetS components, namely HDL level elevation and SBP reduction.
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Dieta Mediterránea , Síndrome Metabólico , Peso Corporal , Ejercicio Físico , Humanos , ObesidadRESUMEN
BACKGROUND: Competency frameworks that prompt personal and professional development have become an important component of lifelong learning; they are driven by healthcare professionals' need for development and professional recognition. This study aimed to evaluate the self-assessed competencies of community pharmacist-preceptors by using Croatian Competency Framework (CCF) and to identify competencies to be improved. The secondary aim was to explore the association between community pharmacists' characteristics (i.e. age, education etc.) and self-assessed competency performance. METHODS: The study subjects were community pharmacist-preceptors who provide support to and mentor student trainees enrolled in pre-registration training for pharmacy students. At the beginning of their mentorship, the pharmacist-preceptors assessed their competencies on a four-point Likert scale by using the Croatian Competency Framework (CCF), a validated tool for assessment and self-assessment of community and hospital pharmacists. Data were collected via e-mail in the period from October 2015 to April 2016. RESULTS: Of the 260 community pharmacists approached, final analysis included 223 respondents. The response rate was 85.8%. Community pharmacist-preceptors assessed themselves as the most competent in competencies pertaining to the cluster "Organization and management competencies" (M = 3.64, SD = 0.34), while they considered themselves as the least competent in the competencies pertaining to the cluster "Pharmaceutical public health competencies" (M = 2.75, SD = 0.77). Younger pharmacists with a postgraduate qualification who worked for large pharmacy chains in the capital city area and who had been in their current posts for a shorter period perceived themselves to be more competent. CONCLUSION: This research represents the first analysis of the CCF in practice and identifies community pharmacist-preceptor competencies that require improvement. Consequently, areas for additional professional education were defined. Implementing modalities to measure and support development of preceptors' competences is essential for improvement of student training programmes.
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Educación Continua , Educación en Farmacia , Preceptoría , Competencia Profesional/normas , Mejoramiento de la Calidad/organización & administración , Autoevaluación (Psicología) , Adulto , Educación Continua/organización & administración , Educación Continua/normas , Educación en Farmacia/organización & administración , Educación en Farmacia/normas , Femenino , Investigación sobre Servicios de Salud , Humanos , Masculino , Persona de Mediana Edad , Farmacéuticos , Preceptoría/organización & administración , Preceptoría/normas , Aprendizaje Basado en Problemas , Estudiantes de FarmaciaRESUMEN
PURPOSE: The aim of this study was to measure the prevalence of potentially inappropriate medications (PIMs) by using the EU(7)-PIM list, STOPP (Screening Tool of Older Persons' potentially inappropriate Prescriptions) version 2 criteria and the new comprehensive protocol. METHODS: This prospective study involved a sample of 276 consecutive elderly patients discharged from the university teaching hospital. Age, gender, diagnoses, medication history and medicines at discharge were recorded. The main outcome measure was the prevalence of PIMs according to each set of criteria: EU(7)-PIM list, STOPP version 2 criteria and comprehensive protocol. RESULTS: The median patient age (range) was 74 (65-92) years. The median number of prescribed medications was 7 (1-17). STOPP identified 393 PIMs affecting 190 patients (69%), EU(7)-PIM list identified 330 PIMs in 184 patients (66.7%) whilst the comprehensive protocol identified 134 PIMs in 102 patients (37%). STOPP version 2 criteria identified significantly more PIMs per patient than the other two protocols (p < 0.001). Gender (p = 0.002), glomerular filtration rate (p = 0.039) and number of comorbidities (p = 0.001) were associated with the proportion of PIMs for the STOPP version 2 criteria only. CONCLUSION: A very high PIM prevalence at discharge was reported suggesting the urgent need for actions to reduce them. STOPP version 2 criteria identified significantly more PIMs than the EU(7)-PIM list and the comprehensive protocol and was found as a more sensitive tool for PIM detection.
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Hospitales Universitarios/estadística & datos numéricos , Prescripción Inadecuada/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Croacia , Femenino , Hospitalización , Humanos , Masculino , Lista de Medicamentos Potencialmente InapropiadosRESUMEN
AIM: To evaluate the clinical pharmacist-led medication reconciliation process in clinical practice by quantifying and analyzing unintentional medication discrepancies at hospital admission. METHODS: An observational prospective study was conducted at the Clinical Department of Internal Medicine, University Hospital Dubrava, during a 1-year period (October 2014 - September 2015) as a part of the implementation of Safe Clinical Practice, Medication Reconciliation of the European Network for Patient Safety and Quality of Care Joint Action (PASQ JA) project. Patients older than 18 years taking at least one regular prescription medication were eligible for inclusion. Discrepancies between pharmacists' Best Possible Medication History (BPMH) and physicians' admission orders were detected and communicated directly to the physicians to clarify whether the observed changes in therapy were intentional or unintentional. All discrepancies were discussed by an expert panel and classified according to their potential to cause harm. RESULTS: In 411 patients included in the study, 1200 medication discrepancies were identified, with 202 (16.8%) being unintentional. One or more unintentional medication discrepancy was found in 148 (35%) patients. The most frequent type of unintentional medication discrepancy was drug omission (63.9%) followed by an incorrect dose (24.2%). More than half (59.9%) of the identified unintentional medication discrepancies had the potential to cause moderate to severe discomfort or clinical deterioration in the patient. CONCLUSION: Around 60% of medication errors were assessed as having the potential to threaten the patient safety. Clinical pharmacist-led medication reconciliation was shown to be an important tool in detecting medication discrepancies and preventing adverse patient outcomes. This standardized medication reconciliation process may be widely applicable to other health care organizations and clinical settings.
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Hospitales Universitarios/organización & administración , Conciliación de Medicamentos/organización & administración , Servicio de Farmacia en Hospital/organización & administración , Adulto , Anciano , Anciano de 80 o más Años , Croacia , Femenino , Hospitalización , Humanos , Masculino , Errores de Medicación , Persona de Mediana Edad , Admisión del Paciente , Médicos , Medicamentos bajo Prescripción , Estudios Prospectivos , Calidad de la Atención de Salud , UniversidadesRESUMEN
BACKGROUND: Use of medicinal products in paediatric patients is identified as a risk factor for the occurrence of medication errors. OBJECTIVES: To describe and identify root causes of medication errors in children and adolescents spontaneously reported to Agency for Medicinal Products and Medical Devices of Croatia (Agency). METHOD: Agency's adverse drug reaction database was searched by using the Standardised MedDRA Query: medication errors (Broad) with data lock point set at 30th June 2022. Cases in which medication errors occurred in patients up to 18 years of age were analysed according to the patients' age group and gender, reporter's qualification, seriousness, reported preferred terms and active substances. For the first 30 most frequently reported active substances, an in-depth analysis was performed to identify the root cause of medication errors. RESULTS: Altogether, 6254 reports were spontaneously reported to the Agency, out of which 1947 (31 %) contained at least one preferred term belonging to Standardised MedDRA Query medication errors. More than half of patients experiencing medication errors belonged to the age group 2-11 years (66 %) and male gender (53 %). The most frequently reported ME PTs included accidental exposure to product by a child (64 %) and accidental overdose (17 %). Medication error root causes for the first 30 most frequently involved active substances included misinterpretation of prescribed dosage due to a very small volume resulting in salbutamol overdose; replacing millilitre and milligram units resulting in paracetamol solution overdose; interchange between medicinal products due to primary package similarities resulting in cholecalciferol overdose and interchange between oral solution and syrup resulting in valproate overdose. CONCLUSIONS: Healthcare professionals should counsel caregivers about the importance of keeping medicinal products out of children's reach and provide detailed instructions on how to appropriately use medicinal products.
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Sobredosis de Droga , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Adolescente , Niño , Humanos , Masculino , Preescolar , Análisis de Causa Raíz , Sistemas de Registro de Reacción Adversa a Medicamentos , Errores de Medicación , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiologíaRESUMEN
BACKGROUND: This study aims to create a comprehensive framework for the development and implementation of digital medication adherence technologies (DMATech), focusing on critical stages where engagement of medication users (MU) is considered meaningful, i.e. adds significant value, as agreed upon by participating stakeholders. METHODS: Through a literature review and expert consensus, a framework was outlined covering key DMATech development and implementation phases and steps. An in-person workshop with MU representatives and adherence experts, using the Nominal Group Technique, further refined these stages for MU engagement. RESULTS: The DMATech framework included three phases: 'Innovation,' 'Research and Development,' and 'Launch and Implementation,' each encompassing multiple steps. The workshop, attended by five MU representatives and nine adherence experts, identified critical stages for MU input including context analysis, ideation, proof of concept, prototype creation, DMATech's iteration, critical evaluation, healthcare implementation, real-world assessment, and improvement. Nevertheless, there was a divergence of consensus regarding the importance of MUs engagement in regulatory, financial, and marketing aspects. CONCLUSIONS: This study provides a holistic framework for DMATech development and implementation and underscores the necessity of MU engagement at various stages. Modes of MU engagement cannot be generalized; a case-by-case evaluation of engagement strategies is essential.
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Tecnología Digital , Cumplimiento de la Medicación , Humanos , Participación de los Interesados , Participación del PacienteRESUMEN
BRCA1/2 mutations and homologous recombination deficiency (HRD) predispose to increased sensitivity to poly(ADP-ribose)polymerase (PARP) inhibitor treatment. Our aim was to evaluate the PARP inhibitors effect on progression free survival (PFS) in a subpopulation with homologous recombination proficient status (HRD-BRCA-). A systematic literature search was performed for all studies reporting on the effect of PARP inhibitors regarding PFS in the HRD-BRCA- subpopulation, in patients with epithelial ovarian, tubal or primary peritoneal cancers (EOC). Five studies were included, enrolling a population of 3413 patients, with 1070 of them being HRD-BRCA-. PARP inhibitors were effective in the treatment of EOC, regardless of HRD and BRCA status or line of therapy. The estimated pooled effect hazard ratio (HR), assessing PFS for PARP inhibitors compared with control, was 0.76 (95% CI: 0.65-0.88, I2 = 46%) in the HRD-BRCA- subpopulation. Comparing both subpopulations with HRD positive status (HRD+ BRCA+, HRD+ BRCA-) versus the HRD-BRCA-subpopulation, we have found statistically significant differences in the effect on PFS (P < 0.05 for every interaction test) favouring HRD positive subpopulations (HRD+ BRCA+, HRD+ BRCA-). In the HRD-BRCA- subpopulation of patients, PARP inhibitors used as the second- or later-line of therapy showed more pronounced effect then when given as first line treatment (P = 0.04). Treatment of EOC with PARP inhibitors showed a significant effect regarding PFS in the HRD-BRCA- subpopulation, although a much higher benefit was evident for patients with HRD+ status (HRD+ BRCA+ and HRD+ BRCA-). In the HRD- subpopulation second line PARP inhibitor treatment showed greater benefit compared to first line PARP inhibitor treatment.
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Neoplasias Ováricas , Inhibidores de Poli(ADP-Ribosa) Polimerasas , Femenino , Humanos , Inhibidores de Poli(ADP-Ribosa) Polimerasas/farmacología , Inhibidores de Poli(ADP-Ribosa) Polimerasas/uso terapéutico , Proteína BRCA1/genética , Proteína BRCA2/genética , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/genética , Recombinación HomólogaRESUMEN
Fluoropyrimidines (FPs) are antineoplastic drugs widely used in the treatment of various solid tumors. Nearly 30% of patients treated with FP chemotherapy experience severe FP-related toxicity, and in some cases, toxicity can be fatal. Patients with reduced activity of DPD, the main enzyme responsible for the breakdown of FP, are at an increased risk of experiencing severe FP-related toxicity. While European regulatory agencies and clinical societies recommend pre-treatment DPD deficiency screening for patients starting treatment with FPs, this is not the case with American ones. Pharmacogenomic guidelines issued by several pharmacogenetic organizations worldwide recommend testing four DPD gene (DPYD) risk variants, but these can predict only a proportion of toxicity cases. New evidence on additional common DPYD polymorphisms, as well as identification and functional characterization of rare DPYD variants, could partially address the missing heritability of DPD deficiency and FP-related toxicity.
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Antimetabolitos Antineoplásicos , Deficiencia de Dihidropirimidina Deshidrogenasa , Dihidrouracilo Deshidrogenasa (NADP) , Fluorouracilo , Variantes Farmacogenómicas , Humanos , Antimetabolitos Antineoplásicos/efectos adversos , Antimetabolitos Antineoplásicos/toxicidad , Capecitabina/efectos adversos , Deficiencia de Dihidropirimidina Deshidrogenasa/genética , Dihidrouracilo Deshidrogenasa (NADP)/genética , Fluorouracilo/efectos adversos , Fluorouracilo/toxicidad , GenotipoRESUMEN
This perspective, pre- and post-intervention study with a one-year follow-up primarily aimed to ascertain prescribers' approval rate of pharmacists' interventions and clinical status of hypertension following comprehensive medication management (CMM) intervention in the ambulatory care clinic. Between January 2018 and January 2022 overall 100 patients with hypertension and other comorbidities were referred to the CMM services at the Health Centre Zagreb - Centar (HCZC). Out of 275 interventions directed to prescribers, 73.1 % of interventions were approved, 12.4 % were rejected and 14.5 % were not reviewed. The percentage of patients with a blood pressure goal increased from 45 % at the initial consultation to 82.5 % at the patients' latest encounter (p < 0.001). The average number of drug therapy problems (DTPs) per patient totaled 3.53 ± 1.80, where 98 % of patients had one or more DTPs, 48 % had 4 or more DTPs, whereas 26 % had 5 or more DTPs. Sub-therapeutic dosage (32.6 %) and the need for additional drug therapy (30.9 %) were the two most commonly identified DTPs. These results reinforce the need to integrate pharmacy-led services in the primary care setting with the aim of improving patients' health outcomes.
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Hipertensión , Servicios Farmacéuticos , Humanos , Farmacéuticos , Hipertensión/tratamiento farmacológico , Atención AmbulatoriaRESUMEN
This observational, cross-sectional study conducted at the University Hospital Centre Zagreb (UHC Zagreb) aimed to explore patients' beliefs about adjuvant endocrine therapy (AET) as well as their association with non-adherence and sociodemographic and clinical factors. Out of 420 early breast cancer (BC) patients included in the study, 79.5 % perceived AET necessary and important for their health, as measured by the Belief About Medicines Questionnaire (BMQ), with the mean necessity score (20.4 ± 3.68) significantly higher than the mean concerns score (13 ± 4.81) (p < 0.001). Based on the Medication Adherence Report Scale (MARS-5), 44.4 % (n = 182) of the participants were non-adherers, out of which 63.2 % (n = 115) were unintentional and 36.8 % (n = 67) intentional non-adherers. Significantly higher concern beliefs were found among patients that were younger (p < 0.001), employed (p < 0.001), intentionally non-adherent to AET (p = 0.006), had a lower body-mass index (p = 0.005) and a higher level of education (p < 0.001), were premenopausal at the time of diagnosis (p < 0.001), taking tamoxifen treatment (p = 0.05) and receiving ovarian suppression (p < 0.001). Younger patients should be recognized as being at risk of non-adherence as they hold greater concern beliefs about medicines.
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Neoplasias de la Mama , Supervivientes de Cáncer , Humanos , Femenino , Neoplasias de la Mama/tratamiento farmacológico , Estudios Transversales , Croacia , Cumplimiento de la Medicación , Encuestas y Cuestionarios , Conocimientos, Actitudes y Práctica en SaludRESUMEN
Since diabetes tends to progressively worsen over time, glycemic control often deteriorates in spite of taking regular therapy. Therefore, numerous research studies are by and large focused on finding more efficient therapy, both new medicines for treating type 2 diabetes mellitus, as well as supplements that could serve as an addition to conventional treatment modalities. A variety of herbal preparations have been shown to have modest short-term beneficial effects on glycemia, but of these, the best studied is American ginseng (AG). AG has been shown to be effective in improving glycemic control in type 2 diabetes through increasing post-prandial insulin levels and decreasing postprandial glycemic response. However, high variability in ginsenosides may result in just as high variability in antidiabetic efficacy of over-the-counter ginseng products. Therefore, the availability of standardized extracts of AG could assist greatly in advancing our knowledge on the role of this traditionally used herb and result in a wider application of ginseng product in diabetes management. The aim of this review is to outline the efficacy and safety of American ginseng for AG preparations on glycemic control in patients with type 2 diabetes as well as to increase awareness of the evidence supporting the use of these therapies in diabetes care.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Índice Glucémico/efectos de los fármacos , Hiperglucemia/tratamiento farmacológico , Panax , Preparaciones de Plantas/administración & dosificación , HumanosRESUMEN
The aim of this research was to assess the impact of comprehensive medication management (CMM) services on patients' health-related quality of life (HRQoL) and frequency of adverse drug reactions (ADRs) in older patients with cardiovascular diseases (CVDs). A prospective, pre- and post-intervention study with a one-year follow-up was conducted at the Health Care Centre ZagrebCentre (HCZC). The Euro-Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) was used to measure the HRQoL at baseline (initial visit at the HCZC) and 12 months following CMM services. The ADRs collected at the initial assessment of the CMM services and throughout follow-up consultations were analyzed according to the occurrence mechanism, seriousness, expectedness and distribution of the Preferred Term according to the System Organ Class. Following the CMM intervention, 65 patients reported significant improvement in dimensions "self-care" (p = 0.011) and "usual activities" (p = 0.003), whereas no significant change was found in the "mobility" (p = 0.203), "pain/discomfort" (p = 0.173) and "anxiety/depression" (p = 0.083) dimensions and the self-rated VAS scale (p = 0.781). A total of 596 suspected ADR reports were found, the majority at patients' initial assessment (67.3%), with a mean ± SD of 9.2 ± 16.9 per patient. The CMM services significantly reduced the rate of suspected ADRs, namely 2.7 ± 1.7 ADRs per patient at the initial assessment vs. 1.0 ± 1.5 ADRs per patient at the last consultation (p < 0.001). The obtained results indicate that CMM services may improve patients' HRQoL. Additionally, as CMM services diminished the proportion of ADRs following 1-year patient follow-up, they may serve as a viable solution for safety management.
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BACKGROUND AND OBJECTIVES: Constipation is one of the most common gastrointestinal conditions, particularly among older individuals. This study aimed to evaluate the efficacy and safety of selected multistrain probiotics on functional constipation and laboratory blood parameters in the elderly living in a nursing home. SUBJECTS AND METHODS: Sixty participants (42 females and 18 males) aged 77.9 ± 8.84 years with functional constipation, who met the eligibility criteria, completed the study. In a double-blind, placebo-controlled, parallel design, each participant was randomized to receive either the selected probiotic mixture (N = 28) or placebo (N = 32) for 12 weeks as an adjunct to their usual diet and medications. The liquid probiotic formulation containing Bifidobacterium animalis subsp. lactis BLC1, Lactobacillus acidophilus LA3 and Lactobacillus casei BGP93 was tested for the first time. RESULTS: Supplementation of selected probiotics resulted in a slight but nonsignificant increase in cumulative stool frequency compared with placebo. However, after the 71st day of the treatment, the cumulative number of stools was significantly higher in the probiotic group (P < 0.05) when the influence of laxative was excluded. The trend towards an increase in the difference between the two groups, which began 1 week after the probiotic intervention, pointed out to their prolonged effect. There were no significant dependent or independent effects of treatment and time on most of the 27 laboratory blood parameters tested. CONCLUSIONS: Multistrain probiotic supplementation was found to be efficacious, safe and well tolerated in the elderly with functional constipation.
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Bifidobacterium animalis , Probióticos , Anciano , Masculino , Femenino , Humanos , Probióticos/uso terapéutico , Estreñimiento/tratamiento farmacológico , Estreñimiento/microbiología , Lactobacillus acidophilus , Heces/microbiología , Método Doble CiegoRESUMEN
The paper aims to identify and measure the costs and savings associated with the delivery of Comprehensive Medication Management (CMM) services in Croatia in patients diagnosed with hypertension accompanied by at least one additional established cardiovascular disease (CVD) and/or type 2 diabetes mellitus (DMT2) who use five or more medicines daily. The budget impact analysis (BIA) employed in this study compares the total costs of CMM to the cost reductions expected from CMM. The cost reductions (or savings) are based on the reduced incidence of unwanted clinical events and healthcare service utilisation rates due to CMM. The BIA model is populated by data on medication therapy costs, labour, and training from the pilot CMM intervention introduced in Zagreb's main Health Centre, while relevant international published sources were used to estimate the utilisation, incidence, and unwanted clinical events rates. Total direct costs, including pharmacists' labour and training (EUR 2,667,098) and the increase in the cost of prescribed medication (EUR 5,182,864) amounted to EUR 7,849,962 for 3 years, rendering the cost per treated patient per year EUR 57. CMM is expected to reduce the utilisation rates of healthcare services and the incidence of unwanted clinical events, leading to a total 3-year reduction in healthcare costs of EUR 7,787,765. Given the total CMM costs of EUR 7,849,962, CMM's 3-year budget impact equals EUR 92,869, rendering per treated patient an incremental cost of CMM EUR 0.67. Hence, CMM appears to be an affordable intervention for addressing medication mismanagement and irrational drug use.
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The objective of this study was to evaluate the impact of comprehensive medication management (CMM) services on healthcare utilisation and cardiovascular risk factors among older patients with established cardiovascular diseases (CVDs). This quasi-experimental study that was performed at the Croatian primary care ambulatory clinic included patients aged 65 to 80 years. Patients were divided into intervention (65 patients) and control groups (68 patients) and were followed-up for one year. Pharmacists provided face-to-face consultations to patients from the intervention group. Groups were compared with regards to the clinical parameters (blood pressure, HbA1c, LDL, TC) and healthcare utilisation (hospital admission, emergency visits, unplanned GP visits). The CMM intervention significantly improved systolic blood pressure (p = 0.038), diastolic blood pressure (p = 0.001), total cholesterol (p = 0.014), low-density lipoprotein cholesterol (p = 0.005), and glycosylated haemoglobin (p = 0.045) in comparison with the control group. Patients included in CMM services had statistically and clinically lower systolic (−9.02 mmHg, p < 0.001) and diastolic blood pressure (−4.99 mmHg, p < 0.001) at the end of the study. The number of hospital admissions and unplanned GPs visits were 3.35 (95% CI 1.16−10.00) and 2.34 (95% CI 1.52−3.57) times higher in the control group compared to the intervention group, respectively. This study demonstrated that pharmacists providing CMM services can significantly contribute to better clinical outcomes and lower healthcare utilisation, thus potentially contributing to total healthcare savings.
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Administración del Tratamiento Farmacológico , Farmacéuticos , Anciano , LDL-Colesterol , Humanos , Cumplimiento de la Medicación , Aceptación de la Atención de SaludRESUMEN
AIM: To analyze potential and actual drug-drug interactions reported to the Spontaneous Reporting Database of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and determine their incidence. METHODS: In this retrospective observational study performed from March 2005 to December 2008, we detected potential and actual drug-drug interactions using interaction programs and analyzed them. RESULTS: HALMED received 1209 reports involving at least two drugs. There were 468 (38.7%) reports on potential drug-drug interactions, 94 of which (7.8% of total reports) were actual drug-drug interactions. Among actual drug-drug interaction reports, the proportion of serious adverse drug reactions (53 out of 94) and the number of drugs (n=4) was significantly higher (P<0.001) than among the remaining reports (580 out of 1982; n=2, respectively). Actual drug-drug interactions most frequently involved nervous system agents (34.0%), and interactions caused by antiplatelet, anticoagulant, and non-steroidal anti-inflammatory drugs were in most cases serious. In only 12 out of 94 reports, actual drug-drug interactions were recognized by the reporter. CONCLUSION: The study confirmed that the Spontaneous Reporting Database was a valuable resource for detecting actual drug-drug interactions. Also, it identified drugs leading to serious adverse drug reactions and deaths, thus indicating the areas which should be in the focus of health care education.
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Interacciones Farmacológicas , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Agencias Gubernamentales , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Croacia/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/complicaciones , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/mortalidad , Femenino , Humanos , Incidencia , Masculino , Polifarmacia , Estudios RetrospectivosRESUMEN
BACKGROUND: New European (EU) pharmacovigilance (PV) legislation, introduced in 2012, widened the scope of an Adverse Drug Reactions (ADR) definition so that it also includes noxious and unintended response to a medicinal product arising from the use outside the terms of the marketing authorisation (MA), whereby the use outside the MA also includes off-label use, overdose, misuse, abuse and medication errors (MEs). OBJECTIVES: To explore the ADRs arising from the use outside the terms of the MA reports in the Croatian pharmacovigilance database. METHODS: A retrospective, observational study of the HALMED PV database was undertaken before and after the implementation of the new legislation in Croatia. The outcome measure included ADRs arising from the use of the products outside the terms of the MA. An assessment was performed based on the information provided in a reference document, an SmPC, using predefined criteria. RESULTS: Among 679 ADRs included in the analysis, 162 (23,9%) ADR reports were related to the use outside of the MA, 370 (54,5%) were related to the use within the MA and 147 (21,6%) were adjudged as not-assessable. Our study demonstrated a significant increase in the number of ADRs arising from the use outside the terms of the MA after the implementation of the new legislation (Pâ¯=â¯0,039), primarily due to a notable increase in the number of overdose reports received by the poisoning centre, while the number of ADRs caused by MEs did not change significantly (pâ¯=â¯0,672). CONCLUSION: This study elucidated partial implementation of the new EU PV legislation and the need for instilling proper education for patients and HCPs, improving reporting systems and strengthening collaboration between relevant stakeholders.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Croacia , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Humanos , Mercadotecnía , Farmacovigilancia , Estudios RetrospectivosRESUMEN
OBJECTIVE: The aim of this study was to determine the frequency and type of drug therapy problems (DTPs) in older institutionalized adults. METHOD: We conducted a cross-sectional observational study from February to June 2016 at a 150-bed public nursing home in Croatia, where comprehensive medication management (CMM) services were provided. A rational decision-making process, referred to as the Pharmacotherapy Workup method, was used to classify DTPs. RESULTS: Data were prospectively collected from 73 residents, among which 71% were age 75 years or older. The median number of prescribed medications per patient was 7 (2-16) and polypharmacy (> 4) was recorded for 54 (74.0%) patients. A total 313 DTPs were identified, with an average of 4.3 ± 2 DTPs per patient. The most frequent DTP was needing additional drug therapy (n = 118; 37.7%), followed by adverse drug reaction (n = 55; 17.6%). Lactulose (14.4%), tramadol (6.7%), and potassium (6.4%) were the medications most frequently related to DTPs. CONCLUSION: The high prevalence of DTPs identified among older institutionalized adults strongly suggests the need to incorporate new pharmacist-led CMM services within existing institutional care facilities, to improve the care provided to nursing home residents.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Administración del Tratamiento Farmacológico/organización & administración , Casas de Salud/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Croacia/epidemiología , Estudios Transversales , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Femenino , Necesidades y Demandas de Servicios de Salud , Humanos , Masculino , Casas de Salud/organización & administración , Farmacéuticos/organización & administración , Polifarmacia , Prevalencia , Estudios Prospectivos , Mejoramiento de la CalidadRESUMEN
The global workforce needs to be competent, flexible, adaptable, sustainable, and patient-focused. A competency approach towards education, development, and professional practice strengthens services and increases better health outcomes. This paper will provide a global perspective on competency approaches from different health care professions. It will focus on two case reports, describing the use of competency methodologies at an undergraduate and postgraduate level, as well as supporting the internship and/or pre-registration training. Challenges and opportunities will be highlighted by addressing some of the key questions posed for this special edition.