OAR@UM Collection:

Shared care guidelines for patient medicines management in breast and colon cancer

Sun, 01 Jan 2017 00:00:00 GMT

Title: Shared care guidelines for patient medicines management in breast and colon cancer Abstract: The introduction of oral chemotherapy has lead to cancer patients receiving these medications through community pharmacies rather than having to visit a hospital to have their oncology medication administered. This change represents a shift from therapy being given in hospital, to therapy being given in the patient’s own home. In this context, community pharmacists can provide a significant intervention by supporting patients to manage and prevent oral chemotherapy side effects, thus avoiding unwarranted trips to hospital, which saves money and time, resulting in an improvement in the patient’s quality of life. The aim of this research was to compile shared care guidelines for oral chemotherapy used in the management of breast, colon and prostate cancer. Five shared care guidelines were created for: capecitabine, everolimus, abiraterone, enzalutamide and ruxolitinib. The developed documents were validated by a panel of experts consisting of four oncologists, a principal and a senior pharmacist within the compounding section at Mater Dei Hospital, and a senior pharmacist at Sir Anthony Mamo Oncology Hospital. A patient focus group was developed during which five patients receiving oral chemotherapy from a community pharmacy were invited to participate in the focus group and given a questionnaire to capture the patient’s experience about the service received from the community pharmacist. The developed shared care guidelines were presented to community pharmacists during an educational program about managing chemotherapy side effects. Scored questionnaires were handed out to the pharmacists before and after the program to determine if there was an improvement in responses. The validation panel reported on the content and validity of the shared care guidelines developed. The educational program was carried out for 11 community pharmacists who are currently practicing in community pharmacies where dispensing of oncology oral therapy is undertaken. The mean response rate before the educational program was 5.45% whilst the mean response rate after the program was 80%. From the patient focus group issues related to information presented to the patient about what side effects to be expected, how these side effects should be handled and how these medications should be stored were identified. These points were used to develop the framework for the shared care guidelines and each guideline now consists of indications, administration, side effects and storage information. The shared care guidelines were developed within a collaborative framework and are intended to further substantiate effective communication between healthcare professionals at different settings, namely: the hospital multidisciplinary team and the community pharmacist dispensing the oral chemotherapy drugs. Description: PharmD

Detecting signals of electrocardiogram QT prolongation and QT shortening : regulatory implications

Sun, 01 Jan 2017 00:00:00 GMT

Title: Detecting signals of electrocardiogram QT prolongation and QT shortening : regulatory implications Abstract: Drug-induced changes to the conductivity of the human ether-a-go-go related gene (hERG) potassium channels, affect cardiac repolarisation and put patients at risk of fatal cardiac arrhythmias such as Torsade de Pointes. Healthcare professionals and patients benefit from knowing which medicinal products cause this adverse event, in order to minimise co-prescribing of such drugs or to carry out appropriate monitoring. The aim of this study was to detect and characterize the QT change liability of authorised medicinal products. The methodology was in two parts. Study 1 involved extracting signals from the Eudravigilance database, and in study 2 an in-depth assessment of unexpected signals through review of literature, preclinical, adverse drug reaction and clinical trial data was performed. Proportional reporting ratios were used to identify statistical associations between drugs and QT change and expectedness was checked through the product information (PI). A list for the frequency of expectedness was created. Drugs not expected to cause QT changes were evaluated within the Bradford Hill criteria for association. Four hundred and seventeen candidates with a potential signal of QT modulation were identified. Of these, 12 products did not have QT change as an expected adverse event and so were assessed. Results from the assessment showed that changes to the PI of mirabegron, asenapine and pantoprazole could be warranted and signals on QT prolongation for mirabegron and asenapine were reported to the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). In March 2017, the PRAC rapporteurs for these active substances (Spain and United Kingdom) agreed to take regulatory action and update the SPCs within the next periodic safety review procedures, starting in quarter four 2017. For pantoprazole, an emergent signal of hypokalaemia may warrant further separate investigation. For QT shortening, fingolimod and olanzapine were assessed, and the data for these two drugs did not lead to a recommendation for change to the PI due to lack of robust evidence. In conclusion, this study presents a number of outputs; (1) inferences on (a) mirabegron, (b) asenapine and (c) pantoprazole, (2) assessment recommendations for preclinical assessors and marketing authorisation holders looking at hERG studies, (3) reflections on the pharmacological basis of short QT, and (4) an innovative proposal for a QT drugs list with risk categorisation. Description: PharmD

Patient-centred monitoring in chronic disease management in the community pharmacy

Sun, 01 Jan 2017 00:00:00 GMT

Title: Patient-centred monitoring in chronic disease management in the community pharmacy Abstract: Chronic diseases present a number of challenges for healthcare systems worldwide. Community pharmacists are in a unique position to participate in the chronic care of their patients through patient monitoring and medication management. The aim of this research was to evaluate the impact of a pharmacist-led chronic disease management service by identifying drug-related problems (DRPs) and assessing the pharmacist intervention on patient health outcomes. A chronic disease management service was implemented in a community pharmacy. Fifty patients taking at least one chronic medication were recruited. Two medication review sessions were held; an initial session and a follow-up session after 4 months. During the sessions, point-of-care testing for blood pressure, blood glucose and HbA1c monitoring as well as lifestyle advice were provided. A pharmaceutical care plan with recommendations to solve DRPs was developed for each patient. Forty-eight patients completed the study, with a mean age of 69 years and taking an average of 5 medications daily. A total of 207 DRPs were identified with a mean of 4.25 DRPs per patient, which mainly involved undertreatment (18.8%), monitoring (18.4%) and compliance (17.9%) issues. Most DRPs were solved (78.6%) or partially solved (16.5%). Following the pharmacist intervention, there was a decrease in systolic blood pressure by 10mmHg (p<0.001), diastolic blood pressure by 4mmHg (p=0.001), fasting blood glucose by 1.7mmol/L (p<0.001) and HbA1c level by 0.5% (p<0.001). Medication compliance improved from a mean score of 17.7 to 21.7 out of a total score of 25 (p<0.001) and patient satisfaction increased from a mean score of 2.61 to 4.11 after intervention out of a total score of 5 (p<0.001). The patient-centred monitoring service had a significant positive impact, suggesting that expanding the role of community pharmacists in chronic disease management can improve patient health outcomes. Description: PharmD

Safer anticoagulation management in the community : a pharmacist-led approach

Sun, 01 Jan 2017 00:00:00 GMT

Title: Safer anticoagulation management in the community : a pharmacist-led approach Abstract: Therapeutic monitoring in patients on warfarin is essential to enhance treatment efficacy with less complications. Medicine use review (MUR) enables individualised patient assessment to check and balance drug-related problems (DRPs). The aim of this research was to develop and implement a pharmacist-led MUR for patients on warfarin, assess patient knowledge and adherence, and address identified risks with prescribed treatment. Patients on warfarin attended a structured MUR session, during which baseline information to assess patient knowledge and adherence to warfarin treatment was collected. Point-of-care INR testing was performed with the CoaguChek®XS device. Medication reconciliation was performed to identify DRPs and to recommend clinical interventions. Patients were followed-up after two months to evaluate the impact of pharmacist intervention and degree of implementation of the pharmacist researcher‟s recommendations by the physician, pharmacist or patient. A total of 100 patients (56 male, 44 female; mean age 70.5 ±10.30, range 33-89 years) were assessed. Forty patients had an INR value outside the target range. The mean score in the warfarin knowledge test improved significantly from 7 to 10 points out of 12 post-intervention (p<0.05). The number of patients who were non-adherent to warfarin decreased from 25 to 11 post-intervention (p<0.05). Post-intervention a significant improvement in INR control was observed where time spent within therapeutic range increased from 69% to 80% (p<0.05). A total of 632 medications were reconciled (mean 6 ±2.76, range 1-16 medications/patient). A total of 481 DRPs (mean 5 ±1.83, range 0-9 DRPs/patient) were identified, out of which 40% were related to warfarin. Need for monitoring (30%), lack of compliance (20%) and need for patient education (19%) were the top three DRPs identified. Eighty-four percent of the pharmacist researcher‟s recommendations were accepted, 20% of which resulted in changes to drug treatment. Ninety patients would be willing to use the proposed MUR service, if implemented. Improvement in patient knowledge, adherence, INR control and the high proportion of implemented recommendations suggest that pharmacist-led MUR improves therapeutic outcomes and patient safety. Description: PharmD