Clinical pharmacists in Dutch general practice: an integrated care model to provide optimal pharmaceutical care.

Background Medication-related harm is a major problem in healthcare. New models of integrated care are required to guarantee safe and efficient use of medication. Aim To prevent medication-related harm by integrating a clinical pharmacist in the general practice team. This best practice paper provides an overview of 1. the development of this function and the integration process and 2. its impact, measured with quantitative and qualitative analyses. Setting Ten general practices in the Netherlands. Development and implementation of the (pragmatic) experiment We designed a 15-month workplace-based post-graduate learning program to train pharmacists to become clinical pharmacists integrated in general practice teams. In close collaboration with general practitioners, clinical pharmacists conduct clinical medication reviews (CMRs), hold patient consultations for medication-related problems, carry out quality improvement projects and educate the practice staff. As part of the Pharmacotherapy Optimisation through Integration of a Non-dispensing pharmacist in a primary care Team (POINT) intervention study, ten pharmacists worked full-time in general practices for 15 months and concurrently participated in the training program. Evaluation of this integrated care model included both quantitative and qualitative analyses of the training program, professional identity formation and effectiveness on medication safety. Evaluation The integrated care model improved medication safety: less medication-related hospitalisations occurred compared to usual care (rate ratio 0.68 (95% CI: 0.57-0.82)). Essential hereto were the workplace-based training program and full integration in the GP practices: this supported the development of a new professional identity as clinical pharmacist. This new caregiver proved to align well with the general practitioner. Conclusion A clinical pharmacist in general practice proves a feasible integrated care model to improve the quality of drug therapy.

Non-dispensing pharmacist integrated in the primary care team: effect on the quality of physician's prescribing, a non-randomised comparative study.

Background Especially in elderly with polypharmacy, medication can do harm. Clinical pharmacists integrated in primary care teams might improve quality of pharmaceutical care. Objective To assess the effect of non-dispensing clinical pharmacists integrated in primary care teams on general practitioners' prescribing quality. Setting This study was conducted in 25 primary care practices in the Netherlands. Methods Non-randomised, controlled, multi-centre, complex intervention study with pre-post comparison. First, we identified potential prescribing quality indicators from the literature and assessed their feasibility, validity, acceptability, reliability and sensitivity to change. Also, an expert panel assessed the indicators' health impact. Next, using the final set of indicators, we measured the quality of prescribing in practices where non-dispensing pharmacists were integrated in the team (intervention group) compared to usual care (two control groups). Data were extracted anonymously from the healthcare records. Comparisons were made using mixed models correcting for potential confounders. Main outcome measure Quality of prescribing, measured with prescribing quality indicators. Results Of 388 eligible indicators reported in the literature we selected 8. In addition, two more indicators relevant for Dutch general practice were formulated by an expert panel. Scores on all 10 indicators improved in the intervention group after introduction of the non-dispensing pharmacist. However, when compared to control groups, prescribing quality improved solely on the indicator measuring monitoring of the renal function in patients using antihypertensive medication: relative risk of a monitored renal function in the intervention group compared to usual care: 1.03 (95% CI 1.01-1.05, p-value 0.010) and compared to usual care plus: 1.04 (1.01-1.06, p-value 0.004). Conclusion This study did not demonstrate a consistent effect of the introduction of non-dispensing clinical pharmacists in the primary care team on the quality of physician's prescribing.This study is part of the POINT-study, which was registered at The Netherlands National Trial Register with trial registration number NTR-4389.

Pharmacists' responses to cues and concerns of polypharmacy patients during clinical medication reviews-A video observation study.

OBJECTIVE: The research questions of this study are 1) How do pharmacists respond to negative emotions of patients during a clinical medication review (CMR)? 2) How do patients express negative emotions during a CMR? 3) Who (pharmacist or patient) initiates a negative emotion to be discussed during a CMR? METHODS: We used video-recordings to observe 132 CMR interviews of 49 pharmacists. Videos were coded with the Verona coding definitions on emotional sequences(-provider responses) (VR-CoDES(-P)). RESULTS: In total 2538 negative emotions were identified, mainly expressed as cues (95.0 %). Often cues were expressed as verbal hints to hidden concerns (33.2 %) or were related to cognitive or physical causes (28.3 %).Three-quarters of the negative emotions were elicited by patients. 2670 pharmacists' responses were coded. The most common response was non-explicit providing space (77.6 %) and the least common response was explicit reducing space (5.8 %). CONCLUSION: Pharmacists are mainly non-explicitly providing space in their responses. While this hinders their ability to capture patients' problems it also may enable patients to initiate topics. PRACTICE IMPLICATIONS: Pharmacists are able to respond to patients' negative emotions. Training should focus on developing pharmacist's skills to be more explicit in their responses to get more in-depth knowledge of patients' problems.

Design of a 15-month interprofessional workplace learning program to expand the added value of clinical pharmacists in primary care.

BACKGROUND AND PURPOSE: Clinical pharmacists who work in the general practice settings bring an improvement to patient care and outcomes. Postgraduate training for an independent clinical role does not often occur in the primary health care setting. When it does, the design of the curriculum is infrequently based on interprofessional workplace learning principles and it does not always integrate practical experience with classroom-based learning activities. This could lead to situations where clinical pharmacists are insufficiently trained to apply clinical reasoning skills and direct patient care in the general practice setting. EDUCATIONAL ACTIVITY AND SETTING: A program was designed, including competencies and learning objectives, based on results from focus group interviews with stakeholders and the literature on interprofessional workplace learning. Ten participants were selected for a pilot run of the program and were asked several times for their opinion about the program. FINDINGS: A 15-month training program was offered to pharmacists who became clinical pharmacists with the responsibility to perform patient consultations in general practice. The program was based on interprofessional workplace learning principles and facilitated the participants' skill in connecting the evidence, the patients' perspective and their own professional perspective. The 10 participating pharmacists were satisfied with the program. DISCUSSION AND SUMMARY: The training program provided increased opportunities to clinical pharmacists to add value in general practice. The training program enabled pharmacists to advance their skills in direct patient care and to improve the alignment between different professionals in the primary care domain.

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.

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).

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.

Medication assessment tool to detect care issues from routine data: a pilot study in primary care.

BACKGROUND: Medication assessment tools (MATs) may be implemented in routine electronic data sources in order to identify patients with opportunities for optimisation of medication therapy management (MTM) and follow-up by a multi-disciplinary team. OBJECTIVE: (1) To demonstrate the use of a MAT for cardiovascular conditions (MAT CVC) as a means of profiling potential opportunities for MTM optimisation in primary care and (2) to assess the performance of MAT CVC in identifying actual opportunities for better care. SETTING: Members of a pharmacotherapy discussion group, i.e. two single-handed general practitioners (GPs), three GP partners, and community pharmacists (CPs) from each of two community pharmacies, in a rural part of the Netherlands. METHODS: MAT CVC comprises 21 medication assessment criteria, each of which is designed to detect a specific care issue and to check whether it is 'addressed' by provision of guideline recommended care or 'open' in the presence ('open explained') or absence ('open unexplained') of pre-specified explanations for guideline deviations. (1) Relevant data was extracted from linked GP and CP electronic records and MAT CVC assessment was conducted to profile the population of CVC patients registered with both, participating CPs and GPs, in terms of 'open unexplained' care issues. (2) A purposive sample of patients with 'open unexplained' care issues was reviewed by each patient's GP. MAIN OUTCOME MEASURES: Number and proportion of 'open unexplained' care issues per MAT CVC criterion and per patient. The number of patients with MAT CVC detected 'open unexplained' care issues to be reviewed (NNR) in order to identify one that requires changes in MTM. RESULTS: In 1,876 target group patients, MAT CVC identified 6,915 care issues, of which 2,770 (40.1 %) were 'open unexplained'. At population level, ten MAT CVC criteria had particularly high potential for quality improvement. At patient level, 1,277 (68.1 %) target group patients had at least one 'open unexplained' care issue. For patients with four or more 'open unexplained' care issues, the NNR was 2 (95 % CI 2-2). CONCLUSION: The study demonstrates potential ways of using MA TCVC as a key component of a collaborative MTM system. Strategies that promote documentation and sharing of explanations for deviating from guideline recommendations may enhance the utility of the approach.

Patients' motives for participating in active post-marketing surveillance.

PURPOSE: Web-based intensive monitoring is a method to actively collect information about adverse drug reactions (ADRs) using patients as a source of information. To date, little is known about patients' motivation to participate in this kind of active post-marketing surveillance (PMS). Increased insight in this matter can help us to better understand and interpret patient reported information, and it can be used for developing and improving patient-based pharmacovigilance tools. The aim of this study is to gain insight into patients' motives for participating in active PMS and investigate their experiences with such a system. METHOD: A mixed model approach combining qualitative and quantitative research methods was used. For both parts, patients participating in a web-based intensive monitoring study about the safety of anti-diabetic drugs (excluding insulins) were used. A questionnaire was developed based on the results from qualitative interviews. The data collected through the questionnaires was analysed with descriptive statistics. Relations between patient characteristics and motives were analysed using a t-test or a Chi-squared test. RESULTS: 1332 (54.6%) patients responded to the questionnaire. The main motive for participation was altruism. Often experiencing ADRs or negative experiences with drugs were not important motives. The patient's gender played a role in the different motives for participation. For men, potential future personal benefit from the results was more important than for women. The overall opinion about the system was positive. CONCLUSION: The knowledge that patients participate in this kind of research from an altruistic point of view may strengthen patient involvement in pharmacovigilance.

Risk analysis and user satisfaction after implementation of computerized physician order entry in Dutch hospitals.

BACKGROUND: Computerized physician order entry (CPOE) in hospitals is widely considered to be important for patient safety, but implementation is lagging behind and user satisfaction is often low. Risk analysis methods may improve the implementation process and thus user satisfaction. Objective The aim of our study was to determine the association of performing risk analysis with user satisfaction after implementation of CPOE. Setting All hospitals in the Netherlands. METHOD: A cross-sectional study using a questionnaire was performed. All Dutch hospital pharmacies were asked about the extent of implementation of CPOE in the hospitals they served, the performance of (retrospective or prospective) risk analysis and the satisfaction with CPOE of doctors, nurses and pharmacists. Only hospitals that had implemented inpatient CPOE on at least 70 % of the wards were included in the primary analysis. MAIN OUTCOME MEASURE: The primary outcome measure was the proportion of hospital pharmacists with a satisfaction level of 4 or 5 (i.e. 'satisfied'). The secondary outcome measure was the proportion of medical doctors and nurses with a satisfaction level of 4 or 5 (i.e. satisfied). The main determinant was the performance of a formal method of prospective or retrospective risk analysis. RESULTS: The questionnaire was sent to all 79 Dutch hospital pharmacies. Questionnaires were returned by 70 hospital pharmacies, serving 72 separate hospitals. In 40 hospitals the CPOE was implemented on at least 70 % of the wards. The association of risk analysis with the proportion of satisfied users was determined within this group of 40 hospitals. For hospital pharmacists we found that the performance of risk analysis showed a statistically non-significant trend towards an association with satisfaction [OR 3.3 (95 % CI 0.8-14.1)]. For medical doctors the performance of risk analysis was associated with satisfaction [OR 10.0 (95 % CI 1.8-56.0)]. Also a statistically non-significant trend towards an association with satisfaction was found for nurses [OR 4.5 (95 % CI 0.8-24.7)]. CONCLUSION: Although not statistically significant, the user satisfaction with CPOE seems to be associated with the performance of risk analysis during the implementation of CPOE. This suggests that the CPOE implementation process can be optimized by performing risk analysis before and/or after implementation.

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

BACKGROUND: Medication 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/DESIGN: The 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 occurs over multiple encounters of patients and clinicians. The steps of this pharmaceutical care process are a pharmaceutical anamnesis, a review of the patient's 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 patient's 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. DISCUSSION: The 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 NUMBER: NTR 2647.