How Clinical Integration of Pharmacists in General Practice has Impact on Medication Therapy Management: A Theory-oriented Evaluation.

BACKGROUND: Data on medication-related hospital admissions suggest that there is an opportunity for improved pharmaceutical care. Hence, concerns about medication-related hospital admissions is a driver to extend and integrate the role of community pharmacists in general practice. AIM: The aim of this paper is to give a systematic description of 1) what integrating a non-dispensing pharmacist (NDP) in general practice entails and 2) how this integrated care model is expected to contribute to patients' medication therapy management. METHODS: Based on ethnographic data collected by NDPs in general practices in the Netherlands, we conducted a theory evaluation. RESULTS: The impact of NDPs providing integrated care can be explained by 1) the specific expertise NDPs bring into general practice and the tailored solutions they offer for individual patients, including deviation from medical protocols when necessary, 2) the reconciliation of interprofessional tensions caused by overlapping tasks with practice nurses, which results in a distinct patient population, 3) the conduct of clinical medication reviews aligned to the work processes of the GP practice and 4) the integration of quality management work into clinical work. CONCLUSION: The success of integrated pharmaceutical care is dependent on how NDPs collaborate with GPs and practice nurses. NDPs need to mobilize clinical pharmaceutical expertise into general practice. Yet, integrating quality management into clinical work is key to integrate pharmaceutical care. Paradoxically, full integration requires from NDPs to develop a distinct role in general practice.

Non-dispensing pharmacists' actions and solutions of drug therapy problems among elderly polypharmacy patients in primary care.

OBJECTIVE: To evaluate the process of clinical medication review for elderly patients with polypharmacy performed by non-dispensing pharmacists embedded in general practice. The aim was to identify the number and type of drug therapy problems and to assess how and to what extent drug therapy problems were actually solved. METHOD: An observational cross-sectional study, conducted in nine general practices in the Netherlands between June 2014 and June 2015. On three pre-set dates, the non-dispensing pharmacists completed an online data form about the last 10 patients who completed all stages of clinical medication review. Outcomes were the type and number of drug therapy problems, the extent to which recommendations were implemented and the percentage of drug therapy problems that were eventually solved. Interventions were divided as either preventive (aimed at following prophylactic guidelines) or corrective (aimed at active patient problems). RESULTS: In total, 1292 drug therapy problems were identified among 270 patients, with a median of 5 (interquartile range 3) drug therapy problems per patient, mainly related to overtreatment (24%) and undertreatment (21%). The non-dispensing pharmacists most frequently recommended to stop medication (32%). Overall, 83% of the proposed recommendations were implemented; 57% were preventive, and 35% were corrective interventions (8% could not be assessed). Almost two-third (64%) of the corrective interventions actually solved the drug therapy problem. CONCLUSION: Non-dispensing pharmacists integrated in general practice identified a large number of drug therapy problems and successfully implemented a proportionally high number of recommendations that solved the majority of drug therapy problems.

Learning Through Boundary Crossing: Professional Identity Formation of Pharmacists Transitioning to General Practice in the Netherlands.

PURPOSE: To unravel boundary crossing as it relates to professional identity formation in pharmacists transitioning from a community pharmacy to working as nondispensing clinical pharmacists in general practice, with the aim of optimizing their education. METHOD: This was a multiple-case study, including two-stage interviews, peer feedback, and individual reflection, that collected data in 2014-2016 from eight clinical pharmacists working in general practice in the Netherlands. These pharmacists acted-without a workplace role model-as pharmaceutical care providers in general practices during a 15-month training program. In within-case and cross-case analysis, data were collected regarding pharmacists' role development in practice and perceptions of learning processes, and examined through the lens of professional identity formation and boundary crossing. RESULTS: Analysis of data collected during and after the training program demonstrated that the clinical pharmacists who applied the learning mechanisms of reflection and transformation developed a patient-care-oriented professional identity. Some clinical pharmacists, who learned mainly through the mechanism of identification, did not integrate the new patient-care-oriented role into their professional identity. They felt that their workplace provided limited opportunities for reflection and transformation. Learning with peers on formal training days was seen as highly valuable for professional identity formation; it counterbalanced the lack of a role model in the workplace. CONCLUSIONS: Professional identity formation in the transition from community pharmacist to clinical pharmacist in general practice benefited from reflective, on-the-job training. This permitted transformative, boundary-crossing learning with peers and supported professional identity formation oriented to providing practice-based pharmaceutical care.

Expectations, concerns, and needs of patients who start drugs for chronic conditions. A prospective observational study among community pharmacies in Serbia.

BACKGROUND: During the initiation of treatment of a chronic disease, patients may have varying interests, expectations, concerns, and reasons to stop treatment, influencing compliance with prescribed treatment. Thus, healthcare professionals are expected to integrate these needs into medicines management. OBJECTIVES: To determine what information is important to patients; assess predictors of patients' interests, expectations, concerns, reasons to stop therapy; evaluate drug-related problems following initiation of therapy and summarize how pharmacists resolve them during patient-pharmacist counselling. METHODS: In 2014, a four-month study was performed in Serbian community pharmacies, as part of the Pharmaceutical Care Quality Indicators Project led by the European Directorate for the Quality of Medicines & Healthcare. Seventy community pharmacists were asked to participate in the study. Pharmacists recruited adult patients who consented to participate in the study and who initiated treatment, lasting at least six months. Patients completed an open-ended questions form. After two-to-four weeks, a patient-pharmacist consultation was performed. RESULTS: Forty-four community pharmacists (response rate 62.9%) sent back the completed forms from 391 patients (response rate 67.1%). The total number of dispensed drugs was 403. In terms of drug safety, 29.4% of patients sought information, 32.5% expressed concerns, and 28.1% of patients cited it as a reason to discontinue treatment. During the first weeks of therapy, 18% of patients experienced practical problems, while 27.3% reported adverse drug reactions. CONCLUSION: Safety issues are a major focus of patients' prescribed new medicines for long-term treatment.

The degree of integration of non-dispensing pharmacists in primary care practice and the impact on health outcomes: A systematic review.

BACKGROUND: A non-dispensing pharmacist conducts clinical pharmacy services aimed at optimizing patients individual pharmacotherapy. Embedding a non-dispensing pharmacist in primary care practice enables collaboration, probably enhancing patient care. The degree of integration of non-dispensing pharmacists into multidisciplinary health care teams varies strongly between settings. The degree of integration may be a determinant for its success. OBJECTIVES: This study investigates how the degree of integration of a non-dispensing pharmacist impacts medication related health outcomes in primary care. METHODS: In this literature review we searched two electronic databases and the reference list of published literature reviews for studies about clinical pharmacy services performed by non-dispensing pharmacists physically co-located in primary care practice. We assessed the degree of integration via key dimensions of integration based on the conceptual framework of Walshe and Smith. We included English language studies of any design that had a control group or baseline comparison published from 1966 to June 2016. Descriptive statistics were used to correlate the degree of integration to health outcomes. The analysis was stratified for disease-specific and patient-centered clinical pharmacy services. RESULTS: Eighty-nine health outcomes in 60 comparative studies contributed to the analysis. The accumulated evidence from these studies shows no impact of the degree of integration of non-dispensing pharmacists on health outcomes. For disease specific clinical pharmacy services the percentage of improved health outcomes for none, partial and fully integrated NDPs is respectively 75%, 63% and 59%. For patient-centered clinical pharmacy services the percentage of improved health outcomes for none, partial and fully integrated NDPs is respectively 55%, 57% and 70%. CONCLUSIONS: Full integration adds value to patient-centered clinical pharmacy services, but not to disease-specific clinical pharmacy services. To obtain maximum benefits of clinical pharmacy services for patients with multiple medications and comorbidities, full integration of non-dispensing pharmacists should be promoted.

Association between workarounds and medication administration errors in bar-code-assisted medication administration in hospitals.

Objective: To study the association of workarounds with medication administration errors using barcode-assisted medication administration (BCMA), and to determine the frequency and types of workarounds and medication administration errors. Materials and Methods: A prospective observational study in Dutch hospitals using BCMA to administer medication. Direct observation was used to collect data. Primary outcome measure was the proportion of medication administrations with one or more medication administration errors. Secondary outcome was the frequency and types of workarounds and medication administration errors. Univariate and multivariate multilevel logistic regression analysis were used to assess the association between workarounds and medication administration errors. Descriptive statistics were used for the secondary outcomes. Results: We included 5793 medication administrations for 1230 inpatients. Workarounds were associated with medication administration errors (adjusted odds ratio 3.06 [95% CI: 2.49-3.78]). Most commonly, procedural workarounds were observed, such as not scanning at all (36%), not scanning patients because they did not wear a wristband (28%), incorrect medication scanning, multiple medication scanning, and ignoring alert signals (11%). Common types of medication administration errors were omissions (78%), administration of non-ordered drugs (8.0%), and wrong doses given (6.0%). Discussion: Workarounds are associated with medication administration errors in hospitals using BCMA. These data suggest that BCMA needs more post-implementation evaluation if it is to achieve the intended benefits for medication safety. Conclusion: In hospitals using barcode-assisted medication administration, workarounds occurred in 66% of medication administrations and were associated with large numbers of medication administration errors.

Elderly polypharmacy patients' needs and concerns regarding medication assessed using the structured patient-pharmacist consultation model.

OBJECTIVE: To evaluate elderly polypharmacy patients' needs and concerns regarding medication through the Structured Patient-Pharmacist Consultation (SPPC). METHODS: Older patients on chronic treatment with ≥5 medications were asked to fill in the SPPC form at home. A consultation with the community pharmacist, structured according to patient's answers, followed within 2-4 weeks. Logistic regression associated patients' individual treatment with care issues and consultation outcomes. RESULTS: Out of 440 patients, 39.5% experienced problems, and 46.1% had concerns about medication use. 122 patients reported reasons for discontinuing treatment. The main outcome of the consultation was a better understanding of medication use (75.5%). Side effects and/or non-adherence were identified in 50% of patients, and 26.6% were referred to the doctor. Atrial fibrillation, COPD, anticoagulants, benzodiazepines, and beta agonists/corticosteroids were associated with problems during medication use. Patients with diabetes improved their understanding of medication use significantly. CONCLUSION: Patients on benzodiazepines, anticoagulants, and beta agonists/corticosteroids, with atrial fibrillation and/or COPD, may have a higher potential for non-adherence. Counseling patients based on the SPPC model may be particularly useful for patients with diabetes. PRACTICE IMPLICATIONS: The SPPC model is a useful tool for counseling based on patient needs.

Evaluation of drug-related problems in older polypharmacy primary care patients.

AIMS AND OBJECTIVES: Targeting older patients with predictive factors for drug-related problems (DRPs) could make clinical medication reviews more cost-effective. The aim of this study was to identify the number, type, and potential predictive factors for DRPs in older polypharmacy patients. METHODS: Community pharmacists performed clinical medication reviews and documented DRPs, types of interventions, and their implementation in older patients. RESULTS: Three hundred eighty-eight medication reviews were analyzed, 964 DRPs (average 2.5 ± 1.9), and 1022 interventions (average 2.6 ± 2.0) were identified. The overall implementation rate of interventions was 70.1%, the highest was observed in interventions aiming to resolve the lack of therapy monitoring (86.8%). Patients with ≥12 medications had an increased risk of ≥5 DRPs (P < .001). Asthma was associated with lack of adherence (P = .002), lack of aspirin, statins, and proton pump inhibitors use with additional therapy needed (P = .002-.004). Predictive factors for drug interactions were antihypertensive medications and/or medications with narrow therapeutic index (P < .05). Lack of efficacy was associated with diabetes (P = .006). Nonsteroidal anti-inflammatory drugs were risk factors for inappropriate drug selection (P = .002). Lack of monitoring was associated with hypertension (P = .013), whereas benzodiazepines (P < .001) and aspirin (P = .021) were overused. CONCLUSION: Patients with asthma, hypertension, and diabetes and lack of statin, antithrombotic agent, and/or proton pump inhibitor use were associated with higher risks for DRPs.

Implications of a clinical medication review and a pharmaceutical care plan of polypharmacy patients with a cardiovascular disorder.

Background A clinical medication review, including patient involvement, is expected to improve pharmaceutical care. Objective To determine whether a clinical medication review followed by a pharmaceutical care plan decreases the number of potential drug-related problems (DRPs) and pharmaceutical care issues (PCIs) and leads to a positive effect on relevant clinical and laboratory parameters for elderly cardiovascular patients with multiple drug use. Setting Randomized controlled trial in eight primary care settings in the Netherlands. Method Elderly polypharmacy patients with a cardiovascular disorder were randomized into two groups. Intervention patients received a clinical medication review, followed by a pharmaceutical care plan developed in cooperation between these patients' pharmacists and general practitioners (GPs), and agreed to by the patients. Control patients received care as usual. Patient data were collected at the start of the study (t = 0) and after 1-year follow-up (t = 1). Main outcome measure Decrease in potential DRPs and pharmaceutical PCIs, improvement of clinical and laboratory parameters. Results 512 patients were included. An average of 2.2 potential DRPs and pharmaceutical PCIs were defined per patient in the intervention group. After 1-year follow-up, 47.2 % of potential DRPs and PCIs were resolved. In total, 156 care interventions were proposed (0.9/patient), 108 of which were implemented after 1 year (69.2 %). For control-group patients, a total of 47 proposed care interventions were documented for 255 patients (0.2/patient); after 1 year, 43 had been implemented (91.5 %). The study intervention (p < 0.001) and the number of medicines used (p = 0.030) had a significant effect on the number of interventions proposed. Small biochemical changes in cardiovascular risk factors did occur, but the differences were small and not considered clinically relevant. Conclusion The integrated use of a clinical medication review with a pharmaceutical care plan in a primary care setting supports the detection of and decrease in DRPs and pharmaceutical PCIs in almost half of the patients. Its benefit in terms of control of cardiovascular risk factors and safety parameters was relatively low. Risk stratification might be necessary to decide which patients might benefit most from this type of intervention.

Design of the POINT study: Pharmacotherapy Optimisation through Integration of a Non-dispensing pharmacist in a primary care Team (POINT).

BACKGROUND: In the Netherlands, 5.6 % of acute hospital admissions are medication-related. Almost half of these admissions are potentially preventable. Reviewing medication in patients at risk in primary care might prevent these hospital admissions. At present, implementation of medication reviews in primary care is suboptimal: pharmacists lack access to patient information, pharmacists are short of clinical knowledge and skills, and working processes of pharmacists (focus on dispensing) and general practitioners (focus on clinical practice) match poorly. Integration of the pharmacist in the primary health care team might improve pharmaceutical care outcomes. The aim of this study is to evaluate the effect of integration of a non-dispensing pharmacist in general practice on the safety of pharmacotherapy in the Netherlands. METHODS: The POINT study is a non-randomised controlled intervention study with pre-post comparison in an integrated primary care setting. We compare three different models of pharmaceutical care provision in primary care: 1) a non-dispensing pharmacist as an integral member of a primary care team, 2) a pharmacist in a community pharmacy with a predefined training in performing medication reviews and 3) a pharmacist in a community pharmacy (care as usual). In all models, GPs remain accountable for individual medication prescription. In the first model, ten non-dispensing clinical pharmacists are posted in ten primary care practices (including 5 - 10 000 patients each) for a period of 15 months. These non-dispensing pharmacists perform patient consultations, including medication reviews, and share responsibility for the pharmaceutical care provided in the practice. The two other groups consist of ten primary care practices with collaborating pharmacists. The main outcome measurement is the number of medication-related hospital admissions during follow-up. Secondary outcome measurements are potential medication errors, drug burden index and costs. Parallel to this study, a qualitative study is conducted to evaluate the feasibility of introducing a NDP in general practice. DISCUSSION: As the POINT study is a large-scale intervention study, it should provide evidence as to whether integration of a non-dispensing clinical pharmacist in primary care will result in safer pharmacotherapy. The qualitative study also generates knowledge on the optimal implementation of this model in primary care. Results are expected in 2016. TRIAL REGISTRATION NUMBER: NTR4389 , The Netherlands National Trial Register, 07-01-2014.

A study comparing the effectiveness of three warning labels on the package of driving-impairing medicines.

BACKGROUND: Several medicines are known to potentially impair patients' driving fitness. Appropriate communication towards patients about this risk can be supported by the use of package warning labels. OBJECTIVE: To compare the effectiveness of a standing practice yellow/black label-with written warning-with a newly developed rating model in communicating risk on driving-impairing medicines (DIMs). Furthermore, the added value of a side-text in the rating model was determined. SETTING: Community pharmacies in the Netherlands. METHOD: In a cross-sectional study, patients with a first dispensing of a DIM were asked by their community pharmacists (n = 38) to fill out a written questionnaire to compare each of the three warning labels. A 2 [yellow/black label vs. rating model (pair 1) and rating model with side-text vs. rating model without side-text (pair 2)] × 3 [category of driving-impairment: I = minor risk, II = moderate risk, III = severe risk] design was used. The category of driving-impairment varied per respondent, depending on the DIM the patient collected. MAIN OUTCOME MEASURE: (1) estimated level of driving risk valued by patients (2) intention to change driving behaviour after seeing the warning label. RESULTS: An estimated number of 992 patients were approached. As 298 questionnaires were analysed, the net response rate was 30%. With the yellow/black label, respondents considered DIMs of all three categories of driving-impairment to equally impair driving fitness, while with the rating model the estimated risk was higher when the category referred to a higher level of driving-impairment. 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. Only 8.0% of the patients using a category III DIM estimated the level of driving risk correctly when seeing the yellow/black label, while this was 26.7% for the rating model and 43.0% for the rating model with side-text. CONCLUSION: The yellow/black label, which is standing practice in the Netherlands, is less effective in terms of estimated risk and intention to change driving behaviour, compared to a newly developed rating model. This model is even more effective when a side-text is added. Implementation of the rating model in clinical practice should be considered.

Prevalence of medicinal drugs in suspected impaired drivers and a comparison with the use in the general Dutch population.

The aim of this study was to investigate the prevalence of psychotropic medicines in drivers suspected of driving under the influence of medicinal and illicit drugs in The Netherlands and to compare the prevalence of selected impairing medicines with the use of these medicines in the general Dutch population. In total, 3038 blood samples of suspected impaired drivers in The Netherlands have been analyzed for the presence of medicinal and illicit drugs between January 2009 and December 2012. In 94% (2842/3038) of the cases medicinal and/or illicit drugs were detected. Medicinal drugs were found in 33% of the blood samples, with the highest prevalence for anxiolytics. In 86% of the cases illicit drug-positive results were obtained, with the highest prevalence for cannabis. At least in 56% of the blood samples poly-drug use was determined, including medicinal and/or illicit drugs. The highest prevalence of poly-medicine use was found for combinations including anxiolytic and hypnotic drugs. In general, the prevalence of driving impairing medicines in suspected impaired drivers is higher than the use of these medicines in the general Dutch population, due to a positive selection bias in the first population. Differences between both populations may be explained by the used methodological approach (e.g., classification criteria of analytical findings, sample selection bias) and abuse of certain medicinal drugs (e.g., diazepam). Negative effects of medicinal drugs on driving performance determine largely the prevalence in the population of suspected impaired drivers. The degree of impairment depends on different factors, including pharmacokinetic properties of the drug and pharmacodynamic aspects. More research is needed to study the prevalence of all prescribed driving impairing medicines and to investigate if providing additional information to medicinal drug users on driving impairing medicines would lower the prevalence of medicinal drug positive drivers.

The evaluation of patient self-completion concordance forms used in community pharmacy: a comparison of two European countries.

OBJECTIVES: To evaluate the use of patient self-completion concordance forms in Dutch and Bulgarian pharmacies. Second, to show any differences in pharmacy practice and patient behaviour in two European countries: the Netherlands and Bulgaria. METHODS: A random sample of 500 pharmacies were approached per country. Patients at the start of a chronic treatment were invited to participate. At the first dispensing patients received a self-completion concordance form (SCCF). Patients were asked to fill in the SCCF at home and bring it to the appointment for their consultation at the second dispensing. After the consultations patients and pharmacists were asked to fill in a questionnaire. KEY FINDINGS: Twenty-four Dutch pharmacies (99 patients) and 41 Bulgarian pharmacies (241 patients) sent back study results. A higher proportion of Bulgarian patients answered questions on the SCCF compared to Dutch patients. Patients from both countries are satisfied with the SCCF, consultation and newly started medicine. CONCLUSIONS: Although differences between pharmacies from the Netherlands and Bulgaria exist, the SCCF can be used at the start of chronic treatment. More research in other European countries will be necessary to further develop the use of the SCCF in community pharmacies. Eventually this could be used to develop indicators to measure patient involvement in pharmaceutical care.

Medication reconciliation to solve discrepancies in discharge documents after discharge from the hospital.

BACKGROUND: When patients are admitted to, and discharged from hospital there is a high chance of discrepancies and errors occurring during the transfer of patients' medication information. This often causes drug related problems. Correct and fast communication of patients' medication information between community pharmacy and hospital is necessary. OBJECTIVE: To investigate the number, type, and origin of discrepancies within discharge documents and between discharge documents and information in the pharmacy computer system, concerning the medication of patients living independently when they are discharged from hospital. Second, to test which variables have an impact on the number of discrepancies found and to study the time spent on the medication reconciliation process. SETTING: One quality-certified community pharmacy in the Netherlands. METHODS: Pharmacists reviewed discharge documents of patients discharged over one year. This information was compared to information available in the pharmacy computer system. Discrepancies were discussed with medical specialists and/or general practitioners. Type and origin of discrepancies were classified. Differences in variables between hospitals were tested using Independent-Samples Mann-Whitney U Test and Pearson Chi Square test. Poisson regression analysis was performed to test the impact of variables on the number of discrepancies found. MAIN OUTCOME MEASURE: Number, type and origin of discrepancies for all independently living patients discharged from the hospital. RESULTS: During the study period, 100 discharges took place and were analyzed. No differences were found between the two main hospitals, a university hospital and a teaching hospital. In total, 223 discrepancies were documented. Sixty-nine discharges (69.0 %) required consultation with a patients' medical specialist. A majority of the discrepancies (73.1 %) have their origin in hospital information. The number of discrepancies found increased with the number of medicines prescribed at discharge. The community pharmacist spent, on average, 45 min on the medication review after discharge. This included 11 min for counseling the patient. CONCLUSION: Many discrepancies were found between different information sources at patient discharge from hospital. A majority of the discrepancies had their origin in hospital information. The number of medicines after discharge was related to the number of discrepancies found. The medication reconciliation process took an average of 45 minutes per patient.

How effective are pictograms in communicating risk about driving-impairing medicines?

OBJECTIVES: To evaluate and compare the effectiveness of 2 pictograms in communicating risk in terms of respondents' level of understanding, estimated level of driving risk, and intention to change driving behavior. The added value of a side-text was also investigated. METHODS: Two experiments were conducted among 270 drivers visiting a pharmacy. Experiment one used a 2 (rating model vs. triangle model pictogram, same side-text) × 3 (minor vs. moderate vs. severe driving risk) between-subjects design. Respondents (n = 30 per condition) were exposed to one of the 6 conditions. To verify the added value of the side-text, a 2 (rating model with side-text vs. rating model without side-text) × 3 (same categories as before) between-subjects design was used. RESULTS: Although the majority of the respondents understood that the pictograms were related to driving behavior, less than 10 percent and about 36 percent of the respondents looking at the triangle model and at the rating model, respectively, understood it fully. For all categories of risk, respondents who saw the rating model pictogram associated the pictogram significantly more often with risk of medication intake for driving than those who saw the triangle model pictograms. Those exposed to the triangle model overestimated the driving risk of the lowest category and underestimated the risk of the highest category; 78.8 percent of the respondents stated they were (very) likely to change their driving behavior if they were confronted with the pictogram. The added value of the side-text was not confirmed. CONCLUSIONS: Despite not being fully self-explanatory in conveying warnings and safety-related information, the pictograms evaluated in this research provided good insight into the different levels of driving risks, especially the rating model pictogram, because respondents' intentions to change their driving behaviors increased with higher categories of risk. The added value of the side-text in the rating model pictogram was not confirmed in this research. Pictograms can be seen as a valuable means to reinforce both written and spoken information given to patients by health care providers at the time of consultation.

Development of a web-based pharmaceutical care plan to facilitate collaboration between healthcare providers and patients.

BACKGROUND: In medication therapy management there is a need for a tool to document medication reviews and pharmaceutical care plans (PCPs) as well as facilitate collaboration and sharing of patient data between different healthcare providers. Currently, pharmacists and general practitioners (GPs) have their own computer systems and patient files. To facilitate collaboration between different healthcare providers and to exchange patient data we developed a paper-based tool. As a result the structured collection of all relevant information for a clinical medication review was more protocol driven. The tool also enabled to plan interventions and follow-up activities: the PCP. The PCP was piloted among three GPs and six community pharmacists. Interviews with all healthcare providers concluded the PCP was found a very useful tool to collect and share patient data. A disadvantage was the time spent to collect all information. We therefore developed our PCP into a web-based tool: the web-based PCP (W-PCP). OBJECTIVES: Development of a W-PCP to (1) provide healthcare providers with information from pharmacist- and GP computer systems and (2) facilitate collaboration between healthcare providers and patients. Development and Application: W-PCP facilitates uploading and sharing of patient data among health care professionals and collaboration between professionals and patients on performing treatment plans. The W-PCP is a stand-alone application developed by cocreation using a generic software platform that provides developmental speed and flexibility. METHOD: The W-PCP was used in three research lines, two in primary care and one in a hospital setting. Outcomes measures were defined as satisfaction about efficiency and effectiveness during data sharing and documentation in providing care and conducting medication reviews using the W-PCP. First experiences concerning the use of W-PCP in a primary care setting were collected by a questionnaire and interviews with pharmacists and GPs using the W-PCP. RESULTS: A questionnaire about first experiences with the W-PCP was sent to 38 healthcare providers. 17 healthcare providers returned the questionnaire (response 44.7%). The use of W-PCP resulted in positive experiences from participating healthcare providers. One of the needs expressed is to have the W-PCP application integrated in the current pharmacy and GP computer systems. All experiences, needs, and ideas for improvement of the current application were collected. On the basis of experiences and requirements collected, the application will be further developed. CONCLUSIONS: The W-PCP application can potentially support successful collaboration between different healthcare providers and patients, which is important for medication therapy management. With this application, a successful collaboration between different healthcare providers and patients could be achieved.

A comparison of pharmacoepidemiological study designs in medication use and traffic safety research.

In order to explore how the choice of different study designs could influence the risk estimates, a case-crossover and case-time-control study were carried out and their outcomes were compared with those of a traditional case-control study design that evaluated the association between the exposure to psychotropic medications and the risk of having a motor vehicle accident (MVA). A record-linkage database availing data for 3,786 cases and 18,089 controls during the period 2000-2007 was used. The study designs (i.e., case-crossover and case-time-control) were derived from published literature, and the following psychotropic medicines were examined: antipsychotics, anxiolytics, hypnotics and sedatives, and antidepressants, stratified in the two groups selective serotonin reuptake inhibitors (SSRIs) and other antidepressants. Moreover, in order to further investigate the effects of frequency of psychoactive medication exposure on the outcomes of the case-crossover analysis, the data were also stratified by the number of defined daily doses (DDDs) and days of medication use in the 12 months before the motor vehicle accident. Three-thousand seven-hundred fifty-two cases were included in this second part of the case-crossover analysis. The case-crossover design did not show any statistically significant association between psychotropic medication exposure and MVA risk [e.g., SSRIs-Adj. OR = 1.00 (95 % CI: 0.69-1.46); Anxiolytics-Adj. OR = 0.95 (95 % CI: 0.68-1.31)]. The case-time-control design only showed a borderline statistically significant increased traffic accident risk in SSRI users [Adj. OR = 1.16 (95 % CI: 1.01-1.34)]. With respect to the stratifications by the number of DDDs and days of medication use, the analyses showed no increased traffic accident risk associated with the exposure to the selected medication groups [e.g., SSRIs, <20 DDDs-Adj. OR = 0.65 (95 % CI: 0.11-3.87); SSRIs, 16-150 days-Adj. OR = 0.55 (95 % CI: 0.24-1.24)]. In contrast to the above-mentioned results, our recent case-control study found a statistically significant association between traffic accident risk and exposure to anxiolytics [Adj. OR = 1.54 (95 % CI: 1.11-2.15)], and SSRIs [Adj. OR = 2.03 (95 % CI: 1.31-3.14)]. Case-crossover and case-time-control analyses produced different results than those of our recent case-control study (i.e., case-crossover and case-time-control analyses did not show any statistically significant association whereas the case-control analysis showed an increased traffic accident risk in anxiolytic and SSRI users). These divergent results can probably be explained by the differences in the study designs. Given that the case-crossover design is only appropriate for short-term exposures and the case-time-control design is an elaboration of this latter, it can be concluded that, probably, these two approaches are not the most suitable ones to investigate the relation between MVA risk and psychotropic medications, which, on the contrary, are often use chronically.

Are selective serotonin reuptake inhibitors safe for drivers? What is the evidence?

BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs) are widely used medications to treat several psychiatric diseases and, above all, depression. They seem to be as effective as older antidepressants but have a different adverse effect profile. Despite their favorable safety profile, little is known about their influence on traffic safety. OBJECTIVE: To conduct a literature review to summarize the current evidence on the role of SSRIs in traffic safety, particularly concerning undesirable effects that could potentially impair fitness to drive, experimental and pharmacoepidemiologic studies on driving impairment, 2 existing categorization systems for driving-impairing medications, and the European legislative procedures for assessing fitness to drive before issuing a driver's license and driving under the influence of medicines. METHODS: The article search was performed in the following electronic databases: MEDLINE, PsycINFO, ScienceDirect, and SafetyLit. The English-language scientific literature was searched using key words such as SSRIs and psychomotor performance, car crash or traffic accident, and adverse effects. For inclusion in this review, papers had to be full-text articles, refer to possible driving-related adverse effects, and be experimental or pharmacoepidemiologic studies on SSRIs and traffic accident risks. No restrictions concerning publication year were applied. RESULTS: Ten articles were selected as background information on driving-related adverse effects, and 15 articles were selected regarding experimental and pharmacoepidemiologic work. Regarding SSRI adverse effects, the most reported undesirable effects referring to driving impairment were anxiety, agitation, sleep disturbances, headache, increased risk of suicidal behavior, and deliberate self-harm. Regarding the remaining issues addressed in this article, inconsistencies were found between the outcomes of the selected experimental and epidemiologic studies and between the 2 existing categorization systems under evaluation. Some pitfalls of the current legislative scenario were identified as well. CONCLUSIONS: Based on the current evidence, it was concluded that more experimental and epidemiologic research is needed to elucidate the relationship between SSRI use and traffic safety. Furthermore, a revision of the existing categorization systems and harmonized European legislation in the field of medication use and driving were highly recommended.

Predictors for patient knowledge and reported behaviour regarding driving under the influence of medicines: a multi-country survey.

BACKGROUND: Reports on the state of knowledge about medicines and driving showed an increased concern about the role that the use of medicines might play in car crashes. Much of patient knowledge regarding medicines comes from communications with healthcare professionals. This study, part of the DRUID (Driving Under the Influence of Drugs, alcohol and medicines) project, was carried out in four European countries and attempts to define predictors for knowledge of patients who use driving-impairing medicines. The influence of socio-demographic variables on patient knowledge was investigated as well as the influence of socio-demographic factors, knowledge and attitudes on patients' reported behaviour regarding driving under the influence of medicines. METHODS: Pharmacists handed out questionnaires to patients who met the inclusion criteria: 1) prevalent user of benzodiazepines, antidepressants or first generation antihistamines for systemic use; 2) age between 18 and 75 years old and 3) actual driver of a motorised vehicle. Factors affecting knowledge and reported behaviour towards driving-impairing medicines were analysed by means of multiple linear regression analysis and multiple logistic regression analysis, respectively. RESULTS: A total of 633 questionnaires (out of 3.607 that were distributed to patients) were analysed. Patient knowledge regarding driving under the influence of medicines is better in younger and higher educated patients. Information provided to or accessed by patients does not influence knowledge. Patients who experienced side effects and who have a negative attitude towards driving under the influence of impairing medicines are more prone to change their driving frequency behaviour than those who use their motorised vehicles on a daily basis or those who use anti-allergic medicines. CONCLUSIONS: Changes in driving behaviour can be predicted by negative attitudes towards driving under the influence of medicines but not by patients' knowledge regarding driving under the influence of medicines. Future research should not only focus on information campaigns for patients but also for healthcare providers as this might contribute to improve communications with patients regarding the risks of driving under the influence of medicines.

Medication review and reconciliation with cooperation between pharmacist and general practitioner and the benefit for the patient: a systematic review.

This article systematically reviews the literature on the impact of collaboration between pharmacists and general practitioners and describes its effect on patients' health. A systematic literature search provided 1041 articles. After first review of title and abstract, 152 articles remained. After review of the full text, 83 articles were included. All included articles are presented according to the following variables: (i) reference; (ii) design and setting of the study; (iii) inclusion criteria for patients; (iv) description of the intervention; (v) whether a patient interview was performed to involve patients' experiences with their medicine-taking behaviour; (vi) outcome; (vii) whether healthcare professionals received additional training; and (viii) whether healthcare professionals received financial reimbursement. Many different interventions are described where pharmacists and general practitioners work together to improve patients' health. Only nine studies reported hard outcomes, such as hospital (re)admissions; however, these studies had different results, not all of which were statistically significant. Randomized controlled trials should be able to describe hard outcomes, but large patient groups will be needed to perform such studies. Patient involvement is important for long-term success.