Impact of a Digital Tool on Pharmacy Students' Ability to Perform Medication Reviews: A Randomized Controlled Trial.

Digital Medication Review Tools (DMRTs) are increasingly important in pharmacy practice. To ensure that young pharmacists are sufficiently competent to perform medication reviews after graduation, the introduction of DMRTs teaching in academic education is necessary. The aim of our study was to demonstrate the effect of DMRTs use on pharmacy students' performance when conducting a medication review (MR) in a randomized controlled pre-post design. Forty-one pharmacy students were asked to complete a MR within 60 min, followed by a 10-min consultation with (intervention group) and without a DMRT (control group). The MR performance was subdivided into four categories: communication skills, subjective and objective patient data, assessment, and plan. Performance was assessed using objective structured clinical examinations (OSCEs) and analytical checklists. With the use of DMRTs, the overall performance was improved by 17.0% compared to the control group (p < 0.01). Improvement through DMRTs was seen in the subcategories "Assessment" and "Plan". Furthermore, pharmacy students liked using DMRTs and felt more confident overall. Our study results demonstrate that DMRTs improve the performance of MRs, hence DMRTs should become an integral part of pharmacy curriculum. Consequently, digitally enabled pharmacists using DMRTs will be better prepared for their professional careers in pharmacy practice.

Evaluating real-world data in COVID-19 antigen and PCR testing.

OBJECTIVE: COVID-19 testing is an important pillar in fighting the SARS-CoV-2 pandemic. Even though billions of tests have been conducted, little is known on performance of testing sites. This is a retrospective observational study with real-world data from a pharmacist-led COVID-19 testing center in Germany during the Omicron subvariant BA.4 and BA.5 wave in June 2022. MATERIALS: The rapid antigen tests employed were purchased from Anbio Biotechnology (Xiamen, China). The RT-PCR was performed on Egens YS-qPCR-1 real-time system with Kewei multiple real-time PCR kits for detection of SARS-CoV-2 (Beijing Kewei Clinical Diagnostic Reagent Inc., Beijing, China). METHODS: The study followed the STARD 2015 guideline. In this retrospective cohort study, the performance of testing sites was compared. RESULTS: During the study period, 7,112 patients were tested by rapid antigen tests and 1,025 RT-PCR tests conducted. Included were 233 patients who were referred by other testing sites for confirmation of positive results. A positive predictive value of 99.6% was calculated for the antigen tests in the pharmacist-led testing center. Referred positive patients from non-medical sites were antigen and RT-PCR negative in 16 cases, which led to a positive predictive value of 88.8%. Difference between site performance was statistically significant (p < 0.05). CONCLUSION: Results indicate that nucleic acid amplification confirmation is crucial in the context of the current testing strategy in Germany. Higher standards in antigen-testing, however, can make nucleic acid amplification in active COVID-19 infections unnecessary and testing cost efficient. This study provides the first data in the world on COVID-19 testing performance, and how it can be optimized.

Functions of mHealth Diabetes Apps That Enable the Provision of Pharmaceutical Care: Criteria Development and Evaluation of Popular Apps.

Personal digital health apps for managing diabetes should include functions that enable the provision of pharmaceutical care services and allow within-app communication with pharmacists and other healthcare providers, thereby improving patient outcomes. The primary aim of this study was to assess the functions of diabetes apps that were relevant to providing pharmaceutical care services (i.e., medication management, adherence, non-pharmacological management, interoperability, and communication). Sixteen criteria related to pharmaceutical care were developed and then used to assess ten popular diabetes apps. The highest numbers of pharmaceutical care criteria were met by the apps Diabetes:M and mySugr (11 criteria); Contour™Diabetes, Dario Health, and OneTouch Reveal® (ten); and DiabetesConnect and ESYSTA (nine); followed by Glucose Buddy (eight), meala (seven), and lumind (three). The most prevalent functions were related to promoting adherence and non-pharmacological management, but most criteria relevant to medication management were lacking. Five apps allowed within-app communication between patients and healthcare professionals (HCPs); however, no app included communication with pharmacists. High-quality diabetes apps are powerful tools to support pharmaceutical care and remotely monitor diabetes patients. Improvements are needed as they often lack many medication management functions, including within-app communication with HCPs (especially pharmacists). To maximize diabetes app use and improve outcomes, app developers should consider including pharmacists alongside other healthcare providers when customizing app designs.

EMDIA Case Series-Effective Medication Therapy Management (MTM) for Diabetes Type 2 Patients-A Proof of Concept Study.

Background: A 2016 meta-analysis of pharmaceutical care for patients with diabetes mellitus showed that the following four components were most effective: (a) individual goal setting, (b) sending feedback to the physician, (c) reviewing the medication, and (d) reviewing blood glucose measurements. Methods: To formulate a hypothesis regarding the effect of these four pharmaceutical care components on glycemic control in patients with diabetes mellitus and the feasibility of these components in practice. Ten patients with type 2 diabetes were included in the case series and received medication therapy management over four months. Results: The four care components were feasible in everyday practice and could be implemented within one patient visit. The average visits were 49 and 28 min at the beginning and end of the study, respectively. The glycated hemoglobin values did not change over the study period, though the fasting blood glucose decreased from 142 to 120 mg/dl, and the number of unsolved drug-related problems decreased from 6.9 to 1.9 per patient by the study end. Conclusions: This case series supports the hypothesis that community pharmacists can implement structured pharmaceutical care in everyday pharmacy practice for patients with type 2 diabetes mellitus.

Orodispersible minitablets of enalapril for use in children with heart failure (LENA): Rationale and protocol for a multicentre pharmacokinetic bridging study and follow-up safety study.

INTRODUCTION: Treatment of paediatric heart failure is based on paradigms extensively tested in the adult population assuming similar underlying pathophysiological mechanisms. Angiotensin converting enzyme inhibitors (ACEI) like enalapril are one of the cornerstones of treatment and commonly used off-label in children. Dose recommendations have been extrapolated from adult experience, but the relationship between dose and pharmacokinetics (PK) in (young) children is insufficiently studied. Furthermore, appropriate paediatric formulations are lacking. Within the European collaborative project LENA, a novel formulation of enalapril orodispersible minitablets (ODMT), suitable for paediatric administration, will be tested in (young) children with heart failure due to either dilated cardiomyopathy or congenital heart disease in two pharmacokinetic bridging studies. Paediatric PK data of enalapril and its active metabolite enalaprilat will be obtained. In a follow-up study, the safety of enalapril ODMTs will be demonstrated in patients on long-term treatment of up to 10 months. Furthermore, additional information about pharmacodynamics (PD) and ODMT acceptability will be collected in all three studies. METHODS AND ANALYSIS: Phase II/III, open-label, multicentre study. Children with dilated cardiomyopathy (DCM) (n = 25; 1 month to less than 12 years) or congenital heart disease (CHD) (n = 60; 0 to less than 6 years) requiring or already on ACEI will be included. Exclusion criteria include severe heart failure precluding ACEI use, hypotension, renal impairment, hypersensitivity to ACEI. For those naïve to ACEI up-titration to an optimal dose will be performed, those already on ACEI will be switched to an expected equivalent dose of enalapril ODMT and optimised. In the first 8 weeks of treatment, a PK profile will be obtained at the first dose (ACEI naïve patients) or when an optimal dose is reached. Furthermore, population PK will be done with concentrations detected over the whole treatment period. PD and safety data will be obtained at least at 2-weeks intervals. Subsequently, an intended number of 85 patients will be followed-up up to 10 months to demonstrate long-term safety, based on the occurrence of (severe) adverse events and monitoring of vital signs and renal function. ETHICS AND DISSEMINATION: Clinical Trial Authorisation and a favourable ethics committee opinion were obtained in all five participating countries. Results of the studies will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBERS: EudraCT 2015-002335-17, EudraCT 2015-002396-18, EudraCT 2015-002397-21.

Development of clinical pharmacy services in Australia, Austria, Belgium, Bosnia-Herzegovina, Canada, Germany, Japan, Kosovo, Switzerland, the Netherlands, Thailand, USA and correlation with educational standards, level of research, and implemen.

OBJECTIVE: This study aimed to compare determinants of professional development between different countries to identify barriers and facilitators of development towards clinical pharmacy services and stimulate discussion of under-used potential and opportunities. MATERIALS: The study was conceived as a survey. The questionnaire was administered to a group of experts. METHODS: The survey was conducted as a cross-sectional study with descriptive and correlation analysis. A questionnaire was developed and adjusted to the study focus, covering aspects on general regulations for community pharmacies, professional education, implementation of clinical pharmacy services, and research in patient care. Results were compared for analyses. RESULTS: A total of twelve countries were included in this survey. Pharmacy studies took between 4 and 6 years plus residency in most countries. Curricula remained drug-oriented only in Austria, Bosnia-Herzegovina, and Germany; these three countries had the least pharmacotherapy content in their curricula. Canada, the USA, and Australia have established clinical pharmacy services in almost all fields of practice. Most other countries have implemented at least some clinical services, with the exception of Bosnia-Herzegovina, Germany, and Kosovo. The correlation coefficient between education, research, and implementation was 0.91. CONCLUSION: The results of the survey show that clinical pharmacy services are established to very different extents among the participating countries. The strong correlation suggests that achieving a successful transition in professional practice needs to address several aspects of education and research to reach progress. The collected data might help to identify potential areas of improvement to foster implementation of clinical pharmacy services.
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Effective Interventions for Diabetes Patients by Community Pharmacists: A Meta-analysis of Pharmaceutical Care Components.

OBJECTIVE: To evaluate randomized controlled trials (RCTs) that included interventions provided by community pharmacists for patients with type 1 and 2 diabetes, the analysis of each component of the intervention(s), and the description of the training that the pharmacists received. DATA SOURCES: The literature research was conducted in PubMed and in the Cochrane Central Register of Controlled Trials (January 2000 to April 2016) for RCTs with interventions provided by community pharmacists for patients with diabetes. Corresponding authors were contacted about missing data and intervention and training design. STUDY SELECTION AND DATA EXTRACTION: RCTs published in English or German were included if pharmaceutical care or medication therapy management was conducted by community pharmacists with diabetes patients. Basic information, intervention and training design data were extracted. DATA SYNTHESIS: The literature research resulted in 11 eligible studies for further analysis. The corresponding authors of 6 studies responded to our request and sent their raw data. The calculated meta-analytical effect of 640 analyzed patients was a hemoglobin A1C (A1C) difference of -0.66%, with a 95% CI of -0.86% to -0.45%. The analysis revealed that most intervention elements had a significant positive meta-analytical effect on the A1C values. CONCLUSIONS: Our meta-analysis suggests that community pharmacist-led interventions can improve glycemic control in patients with type 1 and 2 diabetes. The most effective intervention components were patient centered and interdisciplinary. Pharmaceutical care interventions should, therefore, include the following components: sending feedback to the physician, setting individual goals, reviewing medication, and assessing patients' health beliefs and medication knowledge.

Provision of pharmaceutical care by community pharmacists across Europe: Is it developing and spreading?

RATIONALE, AIMS, AND OBJECTIVES: Pharmaceutical care involves patient-centred pharmacist activity to improve medicines management by patients. The implementation of this service in a comprehensive manner, however, requires considerable organisation and effort, and indeed, it is often not fully implemented in care settings. The main objective was to assess how pharmaceutical care provision within community pharmacy has evolved over time in Europe. METHOD: A cross-sectional questionnaire-based survey of community pharmacies, using a modified version of the Behavioural Pharmaceutical Care Scale (BPCS) was conducted in late 2012/early 2013 within 16 European countries and compared with an earlier assessment conducted in 2006. RESULTS: The provision of comprehensive pharmaceutical care has slightly improved in all European countries that participated in both editions of this survey (n = 8) with progress being made particularly in Denmark and Switzerland. Moreover, there was a wider country uptake, indicating spread of the concept. However, due to a number of limitations, the results should be interpreted with caution. Using combined data from participating countries, the provision of pharmaceutical care was positively correlated with the participation of the community pharmacists in patient-centred activities, routine use of pharmacy software with access to clinical data, participation in multidisciplinary team meetings, and having specialized education. CONCLUSIONS: The present study demonstrated a slight evolution in self-reported provision of pharmaceutical care by community pharmacists across Europe, as measured by the BPCS. The slow progress suggests a range of barriers, which are preventing pharmacists moving beyond traditional roles. Support from professional bodies and more patient-centred community pharmacy contracts, including remuneration for pharmaceutical care services, are likely to be required if quicker progress is to be made in the future.

Impact of Insulin Delivery Method on Hypoglycemia Incidence in Pediatric Type 1 Diabetes Mellitus Patients.

INTRODUCTION: Insulin therapy of pediatric patients with type 1 diabetes mellitus (T1DM) is highly demanding due to their dynamic growth, development and different daily life activities. GOAL: To determine the optimal insulin delivery method for the prevention of hypoglycemia recorded by continuous monitoring of glucose in patients with insulin pump and PEN. MATERIAL AND METHODS: The study included patients up to 18 years of age with diagnosed T1DM and treated with insulin pump and by insulin therapy with PEN at the Pediatric Clinic of the Clinical Center in Sarajevo. The study involved 149 patients, and lasted for 3 years. Patients were divided into two groups: group of patients on insulin pump therapy and group on insulin PEN. RESULTS: There were 73 patients (49.6%) on insulin pump therapy and 79 patients (52.4%) on the insulin PEN therapy. There was no significant difference in the age between genders nor groups with different insulin application methods. There were no significant differences in the number of anamnestic hypoglycemia in patients with a different mode of insulin application (83.56% vs. 81.58%, p=0.114, F=2.533 < Fk=3.919). The number of hypoglycemia episodes in history is higher with the PEN therapy than in the insulin pump group. CONCLUSION: The number of anamnesis hypoglycemia as well as hypoglycemia from CGM records did not differ significantly in patients with IP and PEN therapy. The CGM record was significantly more valuable in the presentation of hypoglycemia compared to the history of hypoglycemia in all patients studied. Continuous monitoring of glycemia due to the ability to show glycemia variability and unrecognized hypoglycemia as well as predictive options for long-term metabolic control should be performed for all T1DM patients at least once a year.

Diabetes Stewardship ­ Pharmaceutical care of adolescents with type 1 diabetes mellitus provided by community pharmacists. / Pharmazeutische Betreuung von Jugendlichen mit Diabetes mellitus Typ 1 Zeit für "Diabetes Stewardship"?

Diabetes mellitus Type 1 is one of the most common diseases in childhood. Severe, secondary diseases like hypertension or blindness are results of micro- and macrovascular complications caused by insufficient glycaemic control. Especially adolescent patients with type 1 diabetes have a lower adherence rate. The DIADEMA trial proved that community pharmacist in collaboration with diabetologists and diabetes advisors can have a positive impact on the therapy of adolescents with type 1 diabetes. This article highlights and explains which components of the pharmacist intervention caused the preferable adjustments and improved the insulin therapy of the patients.

Pharmaceutical care of an adolescent with type 1 diabetes. / Wie betreuen wir als Apotheker einen Jugendlichen mit Diabetes mellitus Typ 1? Ein Beispiel aus der klinischen Praxis.

This article describes the pharmaceutical care of an adolescent with type 1 diabetes mellitus, who took part in the DIADEMA study. Diabetes was diagnosed for three years and his baseline HbA1c-value was 9.3 %. In the DIADEMA study adolescents received pharmaceutical care provided by community pharmacists in addition to usual care provided by diabetologists and diabetes educators. Patients in the intervention group received monthly scheduled visits with the community pharmacists and on-demand telephone calls. Fundamental contents of the pharmacistá¾½s interventions were in particular self-monitoring of blood glucose, prevention of acute and long-term diabetes complications and conscientious consumption of alcohol. Furthermore difficulties in individual insulin therapy and current life conditions were addressed.

Pharmaceutical care of adolescents with diabetes mellitus type 1: the DIADEMA study, a randomized controlled trial.

BACKGROUND: Physiological and psychological changes during puberty and a low adherence to complex treatment regimens often result in poor glycemic control in adolescents with type 1 diabetes mellitus (T1DM). The benefit of pharmaceutical care in adults with diabetes mellitus type 2 has been explored; however, evidence in adolescents with T1DM is scarce. OBJECTIVE: To evaluate the impact of pharmaceutical care in adolescents with T1DM provided by pharmacists, in collaboration with physicians and diabetes educators on important clinical outcomes (e.g., HbA1c and severe hypoglycemia) SETTING: At the outpatient Helios Paediatric Clinic and at the 12 regular community pharmacies of the study patients with 14 pharmacists in the Krefeld area, Germany, and at the University Pediatric Clinic with one clinical pharmacist on-site in Sarajevo, Bosnia-Herzegovina. METHODS: A randomized, controlled, prospective, multicenter study in 68 adolescents with T1DM. The intervention group received monthly structured pharmaceutical care visits delivered by pharmacists plus supplementary visits and phone calls on an as needed basis, for 6 months. The control group received usual diabetic care. Data were collected at baseline and after 3 and 6 months. MAIN OUTCOME MEASURES: The between-group difference in the change from baseline in glycosylated hemoglobin (HbA1c) and the number of severe hypoglycemic events in both groups. RESULTS: The improvement from baseline in HbA1c was significantly greater in the intervention group than in the control group after 6 months (change from baseline -0.54 vs. +0.32%, p = 0.0075), even after adjustment for country-specific variables (p = 0.0078). However, the effect was more pronounced after only 3 months (-1.09 vs. +0.23%, p = 0.00002). There was no significant between-group difference in the number of severe hypoglycemia events. (p = 0.1276). CONCLUSION: This study suggests that multidisciplinary PhC may add value in the management of T1DM in adolescents with inadequate glycemic control. However, the optimal methods on how to achieve sustained, long-term improvements in this challenging population require further study.