Han de Gier

Preventing hospital admissions by reviewing medication (PHARM) in primary care: design of the cluster randomised, controlled, multi-centre PHARM-study

BackgroundMedication can be effective but can also be harmful and even cause hospital admissions. Medication review or pharmacotherapy review has often been proposed as a solution to prevent these admissions and to improve the effectiveness and safety of pharmacotherapy. However, most published randomised controlled trials on pharmacotherapy reviews showed no or little effect on morbidity and mortality. Therefore we designed the PHARM (Preventing Hospital Admissions by Reviewing Medication)-study with the objective to study the effect of the total pharmaceutical care process on medication related hospital admissions and on adverse drug events, survival and quality of life.Methods/DesignThe PHARM-study is designed as a cluster randomised, controlled, multi-centre study in an integrated primary care setting. Patients with a high risk of a medication related hospital admission are included in the study with randomisation at GP (general practitioner) level. We aim to include 14200 patients, 7100 in each arm, from at least 142 pharmacy practices.The intervention consists of a patient-centred, structured, pharmaceutical care process. This process consists of several steps, is continuous and occurrs over multiple encounters of patients and clinicians. The steps of this pharmaceutical care process are a pharmaceutical anamnesis, a review of the patients pharmacotherapy, the formulation and execution of a pharmaceutical care plan combined with the monitoring and follow up evaluation of the care plan and pharmacotherapy. The patients own pharmacist and GP carry out the intervention. The control group receives usual care.The primary outcome of the study is the frequency of hospital admissions related to medication within the study period of 12 months of each patient. The secondary outcomes are survival, quality of life, adverse drug events and severe adverse drug events. The outcomes will be analysed by using mixed-effects Cox models.DiscussionThe PHARM-study is one of the largest controlled trials to study the effectiveness of the total pharmaceutical care process. The study should therefore provide evidence as to whether such a pharmaceutical care process should be implemented in the primary care setting.Trial RegistrationTrial number: NTR 2647

Pharmacist-Led Self-management Interventions to Improve Diabetes Outcomes: A Systematic Literature Review and Meta-Analysis

Background: Treatment of diabetes requires a strict treatment scheme which demands patient self-management. Pharmacists are in a good position to provide self-management support. This review examines whether pharmacist-led interventions to support self-management in diabetes patients improve clinical and patient-reported outcomes. Methods: This review was conducted according to the PRISMA guidelines. An extended literature search was conducted with the keywords “pharmacist,” “diabetes,” and “self-management” using the electronic databases Pubmed, Embase, CINAHL, PsycINFO, Web of Science, and the Cochrane Library from the beginning of the database through September 2017. In addition reference lists of systematic reviews and included studies were searched. Eligibility criteria included; self-management intervention tested with an RCT, performed in an ambulatory care setting, led by a pharmacist and reporting at least one clinical- or patient-reported outcome. Primary outcomes were HbA1c (—as this is a clinical parameter for long-term diabetes follow-up), self-management and components of intervention. Secondary outcomes were blood glucose, blood pressure, BMI, lipids, adherence to medication, quality of life, and diabetes knowledge. For the meta-analysis HbA1c values were pooled with a random-effects model in Revman 5.3. Risk of bias was assessed with the Cochrane Risk of Bias tool. Results: Twenty-four studies representing 3,610 patients were included. Pharmacist-led self-management interventions included education on diabetes complications, medication, lifestyle, and teaching of self-management skills. Some studies focused on patient needs through a tailored intervention. No key components for a successful self-management intervention could be identified. Pharmacist-led self-management interventions improve HbA1c levels with a mean of 0.71% (CI −0.91, −0.51; overall effect P < 0.0001) and had a positive effect on blood pressure (SBP −5.20 mm Hg [−7.58; −2.92], DBP −3.51 mmHg [−6.00; −1.01]), BMI (−0.49 kg/m2 [−0.79; −0.19]), lipids (total cholesterol −0.19 mmol/l [−0.33; −0.05], LDL-C mmol/l −0.16 [−0.26; −0.06], HDL-C 0.32 mmol/l [0.02; 0.61]), self-management skill development, and adherence to medication. Conclusion: Pharmacist-led self-management interventions significantly improve HbA1c values in diabetes patients. These results underline the added value of pharmacists in patient-related care. Pharmacists should offer self-management support to diabetes patients in order to improve diabetes outcomes.

Association Between Workarounds and Medication Administration Errors in Bar Code-Assisted Medication Administration: Protocol of a Multicenter Study

Background Information technology-based methods such as bar code-assisted medication administration (BCMA) systems have the potential to reduce medication administration errors (MAEs) in hospitalized patients. In practice, however, systems are often not used as intended, leading to workarounds. Workarounds may result in MAEs that may harm patients. Objective The primary aim is to study the association of workarounds with MAEs in the BCMA process. Second, we will determine the frequency and type of workarounds and MAEs and explore the potential risk factors (determinants) for workarounds. Methods This is a multicenter prospective study on internal medicine and surgical wards of 4 Dutch hospitals using BCMA systems to administer medication. We will include a total of 6000 individual drug administrations using direct observation to collect data. Results The project was funded in 2014 and enrollment was completed at the end of 2016. Data analysis is under way and the first results are expected to be submitted for publication at the end of 2017. Conclusions If an association between workarounds and MAEs is established, this information can be used to reduce the frequency of MAEs. Information on determinants of workarounds can aid in a focused approach to reduce workarounds and thus increase patient safety. Trial Registration Netherlands Trial Register NTR4355; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4355 (Archived by WebCite at http://www.webcitation.org/6pqTLxc6i).

299 Risk communication in medicines and driving using pictograms

Background: Appropriate communication towards patients using driving impairing medicines about risk on fitness to drive can be supported by the use of pictograms. To evaluate and compare the effectiveness of various pictograms and warnings (e.g. a French, a Dutch and a newly developed EU rating model) in communicating risk, several experiments were conducted. Methods: Structured interviews (experiment 1) and written questionnaires (experiment 2) were used respectively among drivers (n = 270) visiting one out of four community pharmacies in Groningen (n = 4) and patients who were drivers (n = 298) and starting a new treatment with a driving impairing medicine visiting community pharmacies (n = 38) in the Netherlands, to compare various pictograms and warnings. Results: Compared to general warnings and pictograms, the EU rating model allowed patients to better understand the potential risk estimate when using impairing medicines. Addition of a side-text to the rating model resulted in a significantly higher estimated level of driving risk and a significant increase in intention to change driving behaviour. Age was the strongest predictor influencing participants’ preference for pictograms to express a warning message and levels of impairment. Conclusions: Implementation of the rating model in clinical practice should be considered, but factors such as age and education of patients need attention in designing and implementing new pictograms.