Inconclusiveness of psychometric testing of medication adherence questionnaires.

PURPOSE: To propose a paradigm change for the validation procedures of medication adherence questionnaires. METHODS: A total of 121 validation procedures of unique questionnaires for medication adherence were analyzed. RESULTS: "Construct validity" and "internal consistency" were most often assessed, and test results varied largely. A more in-depth analysis indicated that the assessment of medication non-adherence included distinct but related constructs, such as the extent to which doses are missed, and the attempt to identify different facets of medication-taking behavior. Consequently, each construct requires a different measurement approach with different psychometric tests for establishing its validity and reliability. CONCLUSION: Results show that assessing the validity and reliability of adherence questionnaires with standard procedures including statistical tests is inconclusive. Refinement of the constructs of non-adherence is needed in pharmacy and medical practice. We suggest a distinction between the (i) extent of missed doses over the past 2 weeks, (ii) modifiable reasons for non-adherence behavior, and (iii) unmodifiable factors of non-adherence. Validation procedures and corresponding statistical methods should be selected according to the specific single constructs.

Development and validation of the 15-STARS - A novel self-report pharmacy-based questionnaire to screen for medication non-adherence.

BACKGROUND: Published scales measuring medication adherence are myriad. There is a need for a tool that guides towards downstream adherence interventions. OBJECTIVE: To develop and validate a self-report questionnaire able to detect modifiable determinants of medication non-adherence. METHODS: Workshops, surveys and meetings were used to identify items. Validation was performed in French and German (Switzerland) between March and April 2022. Face validation, content validation, construct validation, internal consistency and test-retest reliability were assessed. The questionnaire was finalized in August 2022. RESULTS: The first draft in English included 13 items divided into four areas. Following translation, validation was performed with 144 patients (63 German-, 81 French-speaking) who were recruited in 35 community pharmacies. Acceptability was good (<5% missing data). Psychometric properties were acceptable with good content validity and moderate construct validity. Internal consistency was acceptable for the French version (Cronbach's alpha = 0.71 [item 1-5] - 0.61 [item 6-9]) and less acceptable for the German version (Cronbach's alpha = 0.43 [item 1-5] - 0.45 [item 6-9]). Test-retest was given for all items (r = 0.52 to 1.0) except item 10 in French (r = 0.25). The final instrument is a 15-item questionnaire called the 15-STARS (Screening Tool for AdheRence to medicineS) that assesses practical difficulties with medicine use, reasons for non-adherence, doses missed, and need for further help. CONCLUSIONS: Our findings support the validity and clinical utility of the 15-STARS questionnaire. Reliability was inconclusive due to incoherent internal consistency, but explainable by the single-item nature of the scale. This new tool will enable the detection of patients who experience difficulties that negatively influence medication adherence. Pharmacists will be able to propose specific and tailored adherence interventions to the patients. Next steps will focus on evaluating its usefulness for developing targeted interventions that optimize medication adherence in routine care and research settings.

Knowledge and attitudes of German and Swiss community pharmacists towards biologicals and biosimilars - a prospective survey before and after the COVID-19 pandemic.

BACKGROUND: Knowledge, attitudes and substitution laws of biosimilars are not consistent across countries. Biosimilar acceptance among patients and healthcare professionals may be suffering from gaps in knowledge and understanding about biosimilars and their regulatory approval process. Pharmacists' roles and responsibilities changed considerably during the COVID-19 pandemic. Thus, they might have gained new skills and self-confidence in counseling and substitution of biosimilars. AIMS: To examine and compare the knowledge, perceptions and information needs of German and Swiss pharmacists regarding original biologicals and biosimilars in 2020 and 2022. METHODS: We conducted an online survey among Swiss and German community pharmacies in February 2020 (before) and August 2022 (after the COVID-19 pandemic). Descriptive statistics were calculated and the Chi-Square test was used for comparisons among categorical variables. RESULTS: A total of 764 pharmacists took part in the survey (390 in 2020 and 374 in 2022) with comparable demographics. The frequency of dispensing biologicals remained similar between German and Swiss pharmacists in 2020 and 2022, but the Swiss dispensation of biosimilars increased significantly in 2022 compared to 2020. Concerning the understanding of the term biosimilars, knowledge remained moderate in both countries in both years. Participants were equally familiar with the term and most felt sufficiently informed. In both countries, substitution with a biosimilar showed the least confidence of all attitudes. A third of the participants indicated correct substitution rules in their country. In both years, around 85% of the participants were highly interested in additional training on this topic. DISCUSSION/CONCLUSION: The results indicate that similarities and differences between Germany and Switzerland regarding knowledge and attitudes towards biologicals and biosimilars remained unchanged before and after the COVID-19 pandemic. An influence of the pandemic is unlikely. There is still a clear lack of knowledge among community pharmacists on biosimilars, especially regarding the substitution rules. Due to a rising market with many benefits but also big challenges to overcome, the topic of biosimilars should receive more attention in the future. This requires additional training for pharmacists.

Patients' Use of a Standardized Medication List - A Mixed Methods Study.

Purpose: A medication list (ML) is a document listing the patient's entire medication, instructions for use, and indications. In Germany, a national standard was established in 2016 by law. However, data on patients' use of this standardized ML are scarce. We investigated (i) patients' practical use of the ML, (ii) patients' understanding of the ML, (iii) completeness and correctness of the current ML version, and (iv) reasons why patients did not adhere to their ML. Patients and Methods: Community pharmacists recruited patients possessing a standardized ML with ≥5 medications. Information sources to evaluate the ML were: (a) brown bag analysis, (b) practical demonstration, (c) patient interview, and (d) patient file. Data were analyzed using qualitative and quantitative methods. Results: Two hundred and eighty-eight patients (median age: 76 years, range: 27-95) were enrolled. (i) 38.5% of the patients used their ML regularly to prepare their medication and 73.3% to inform their physician. (ii) Overall, patients' understanding of the ML was good, with >80% of the patients being able to identify all relevant information. (iii) While n = 2779 medications were actually taken, n = 2539 were documented on the ML. No ML was fully correct and complete. Regarding particularly relevant items, ie, active ingredient, strength, dosage, medication missing or listed but not taken, 79.2% of ML were incorrect or incomplete. Handwritten modifications on the ML were frequent. (iv) Almost 60% of all patients did not follow their ML with "fear of adverse drug reactions" being the most frequently (n = 50) mentioned reason. Conclusion: Completeness and correctness of the current ML version was poor with handwritten modifications being frequent. Additionally, most of the patients did not adhere to their ML. This indicates that measures that lead to correct and up-to-date ML and improvements in patient counseling about their medication should be developed and implemented into routine practice.

Self-care and self-medication as central components of healthcare in Germany - on the way to evidence-based pharmacy.

In Germany, self-care is, above all interpreted as the prevention and treatment of minor injuries and illnesses by the patients themselves - that is, without a physician's prescription or medical advice. Maintaining one's health in the sense of a preventive approach through non-medicinal measures also plays an important role. Self-medication in this context is the treatment with approved over-the-counter-(OTC)-medications. In addition, other OTC-products such as dietary supplements as well as complementary and alternative medicines including homeopathic medications are frequently requested options by pharmacy customers. OTC-medications are central components of the German healthcare system, with expert advice from pharmacists in community pharmacies (CP) enabling safe and effective treatment. Additionally, screening for appropriate self-medication by pharmacists ensures that serious illnesses receive timely medical attention. In addition to prescribed medication, self-medication is an important part of the CP business in Germany. In contrast to prescription products, the price of OTC-products is not regulated. As a consequence, the price of OTC-products (including also pharmacy-only drugs) is influenced by competition among CPs and mail-order pharmacies, respectively. The sales of OTC-products for self-medication outside pharmacies, e.g. in drugstores and supermarkets, is restricted to a limited number of specific products. Evidence-based counseling in CPs, while generally advocated still remains a challenge. The evidence for the usage of OTC-products from clinical studies is not yet optimally integrated into everyday pharmacy practice. Information tools such as EVInews offering regular newsletters and a database have been developed to reduce the evidence-to-practice gap and to improve the overall counseling quality. Furthermore, the switching of drugs from prescription-only to pharmacy-only status also challenge CPs to provide adequate and updated guidance.

Task sharing in an interprofessional medication management program - a survey of general practitioners and community pharmacists.

BACKGROUND: Pharmacist-led medication review and medication management programs (MMP) are well-known strategies to improve medication safety and effectiveness. If performed interprofessionally, outcomes might even improve. However, little is known about task sharing in interprofessional MMP, in which general practitioners (GPs) and community pharmacists (CPs) collaboratively perform medication reviews and continuously follow-up on patients with designated medical and pharmaceutical tasks, respectively. In 2016, ARMIN (Arzneimittelinitiative Sachsen-Thüringen) an interprofessional MMP was launched in two German federal states, Saxony and Thuringia. The aim of this study was to understand how GPs and CPs share tasks in MMP when reviewing the patients' medication. METHODS: This was a cross-sectional postal survey among GPs and CPs who participated in the MMP. Participants were asked who completed which MMP tasks, e.g., checking drug-drug interactions, dosing, and side effects. In total, 15 MMP tasks were surveyed using a 5-point Likert scale ranging from "I complete this task alone" to "GP/CP completes this task alone". The study was conducted between 11/2020 and 04/2021. Data was analyzed using descriptive statistics. RESULTS: In total, 114/165 (69.1%) GPs and 166/243 (68.3%) CPs returned a questionnaire. The majority of GPs and CPs reported (i) checking clinical parameters and medication overuse and underuse to be completed by GPs, (ii) checking storage conditions of drugs and initial compilation of the patient's medication including brown bag review being mostly performed by CPs, and (iii) checking side-effects, non-adherence, and continuous updating of the medication list were carried out jointly. The responses differed most for problems with self-medication and adding and removing over-the-counter medicines from the medication list. In addition, the responses revealed that some MMP tasks were not sufficiently performed by either GPs or CPs. CONCLUSIONS: Both GPs' and CPs' expertise are needed to perform MMP as comprehensively as possible. Future studies should explore how GPs and CPs can complement each other in MMP most efficiently.

Patients' perception on generating medication plans in an interprofessional medication management program: a mixed-methods study.

A medication plan (MP) provides an overview of a patient's entire medication. In the interprofessional medication management program ARMIN (ARzneiMittelINitiative Sachsen-Thueringen), MPs are jointly generated by general practitioners (GPs) and community pharmacists (CPs). We aimed to assess patients' initial acceptance of the service, how they use the printed MP, and whether they perceived a benefit from it. This was evaluated with mixed-methods: a cross sectional written (quantitative) survey followed by semi-structured (qualitative) interviews. The data were analysed separately and compared. Qualitative data were analysed by thematic analysis. For the survey, 103 patients (mean 73 years) were involved. Benefits indicated were: improved communication between GPs and CPs, safer handling of the medication, and increased knowledge on dosages and indications. Ninety-six percent of the patients used their MP, 51% regularly. Regular use was significantly associated with older age, higher number of drugs, and need for assistance with the medication. Ten patients were interviewed. Results from interviews agreed with the results from the survey but revealed some additional aspects (e.g., patients reported an increased feeling of safety). Health-care professionals should consider providing MPs for their patients. This interprofessional cooperation also meets patient's need for safety in health issues.

Primary healthcare policy and vision for community pharmacy and pharmacists in Germany.

Germany is the highest populated country in Europe with a population of 82.3 million in 2019. As in many other developed countries, it has an aging population. Approximately 10% of the gross domestic product is spent on healthcare. The healthcare system is characterized by its accessibility. Patients are generally free to choose their primary care physicians, both family doctors and specialists, pharmacy, dentist, or emergency service. Up to a certain income, health insurance is mandatory with the statutory health insurance (SHI) system, covering 88% of the population. Major challenges are the lack of cooperation and integration between the different sectors and healthcare providers. This is expected to change with the introduction of a telematic infrastructure that is currently being implemented. It will not only connect all providers in primary and secondary care in a secure network but will also enable access to patients' electronic record/medical data and at the same time switch from paper to electronic prescriptions. Approximately 52,000 of the 67,000 pharmacists are working in approximately 19,000 community pharmacies. These pharmacies are owner-operated by a pharmacist. Pharmacists may own up to three subsidiaries nearby to their main pharmacy. Community pharmacy practice mainly consists of dispensing drugs, counselling patients on drug therapy and safety, and giving advice on lifestyle and healthy living. Many cognitive pharmaceutical services have been developed and evaluated in the past 20 years. Discussions within the profession and with stakeholders on the national level on the roles and responsibilities of pharmacists have resulted in nationally agreed guidelines, curricula, and services. However, cognitive services remunerated by the SHI funds on the national level remain to be negotiated and sustainably implemented. A law passed in November 2020 by parliament will regulate the remuneration of pharmaceutical services by the SHI funds with an annual budget of EUR 150 million. The type of services and their remuneration remain to be negotiated in 2021. The profession has to continue on all levels to advocate for a change in pharmacy practice by introducing pharmacy services into routine care.

Community pharmacists' preparedness for substituting biologics and dispensing biosimilars - Lessons learned from a multinational survey.

Interchangeability between biological medicines and biosimilars, and subsequent substitution by pharmacists represent an important opportunity for costs savings for health care systems. Because biological medicines are complex products, the expert role of the pharmacist to inform patients and support physicians is indispensable. However, regulations on substitution of biosimilars differ around the globe, such that a substitution that is allowed in one country may be forbidden in another. Overall, pharmacists' knowledge of biosimilar medicines is incomplete and hesitancy to engage in substitutions is perceptible. As counter-balancing remedy, continued education about biosimilars is needed among practicing community pharmacists.

[The PRIMA Project - Electronically-Supported Physician-Pharmacist Cooperation to Generate and Update Medication Plans in Germany]. / Das Projekt PRIMA ­ Elektronische Erstellung und Aktualisierung von Medikationsplänen als gemeinsame Aufgabe von Ärzten und Apothekern.

BACKGROUND: A complete overview on the patient's medication is one precondition for medication safety. For this, a complete and current medication plan (MP) is an appropriate instrument. We aimed to develop and implement software to evaluate and exchange medication plans in local software systems of general practitioners (GPs) and community pharmacies (CPs). Furthermore, it was the aim to evaluate feasibility and acceptance of the defined processes. METHODS: CPs and GPs were involved to pilot the software in several steps. Additionally, they generated and updated MP according to pre-defined processes and responsibilities. Feasibility and acceptance were evaluated in a survey and a workshop. RESULTS: For the first time in Germany, the technical requirements were established to generate and exchange MP electronically. Four software systems of CPs and one software system of GPs were involved. Solved Problems were technical errors, errors relevant for medication safety, differences in display of the medication data, and limited capacity of the barcode on the MP printout. Eleven GP and CP teams recruited 196 patients. 60 % were satisfied with the defined processes. 80 % of the GPs and 63 % of CPs agreed with the defined responsibilities. GPs considered the initial compilation on patient's medication in the CP as useful. The professional exchange between GPs and CPs improved: 70 % of GPs referred to increased knowledge on medication and 88 % of CPs received more information on patients' health conditions. The structured collaboration between GPs and CPs was considered to be important (25 %) or very important (75 %) for the quality of medication plans. DISCUSSION: An electronic MP was successfully implemented for the first time in local software systems. Processes and responsibilities were accepted by both professions. These are important prerequisites for sustainably implementing the MP in daily practice.

[Standardized national medication plan : The pilot projects MetropolMediplan 2016, model region Erfurt, and PRIMA]. / Der bundeseinheitliche Medikationsplan in der Praxis : Die Pilotprojekte MetropolMediplan 2016, Modellregion Erfurt und PRIMA.

Since 1 October 2016, all legally insured persons are entitled to a nationwide medication plan (BMP) under certain conditions (according to § 31a SGB V, E-Health Law). The catalogue of measures of the 3rd Action Plan 2013-2015 for the improvement of drug therapy safety (AMTS) provided for the testing of a medication plan in practice, including its acceptance and practicability in three model projects. These three projects - MetropolMediplan 2016, Erfurt, and PRIMA - are presented and recommendations are derived on the basis of the collected findings. Overall, the BMP was welcomed by the participating patients in all projects and led to an increase in satisfaction and an improvement in competence with regard to medication. Both doctors and pharmacists rated the interdisciplinary cooperation via the medium BMP very positively. The high effort and lack of technical infrastructure without electronic availability of the last current version of a BMP of the individual patient was perceived as negative. An original data comparison of the BMP data with the drugs actually taken in the MetropolMediplan 2016 project showed that only 36% of the patients were in agreement with the BMP and the drugs presently taken. The paper version of the BMP has therefore not yet been able to solve the problem of the timeliness and completeness of the medication. In addition to various proposals for the further development of BMP, all parties involved require the BMP to be available electronically across all sectors. The BMP should therefore be an important instrument for improving AMTS in the future.

Evaluating patients' comprehensibility of a standardized medication plan.

PURPOSE: A standardized medication plan for patients has been developed and recently enacted into German law depicting all medicines taken. It can only increase medication safety if patients use and understand it. We evaluated patients' comprehensibility of the medication plan and analyzed potential variables influencing patients' understanding. METHODS: The medication plan template v2.0 was first tested in N = 40 patients, and the "Evaluation Tool to test the handling of the Medication Plan" (ET-MP) was developed, rating patients' understanding from 0 to 100 %. The cut-off, distinguishing if patients understand the medication plan, was set at 90 %. The ET-MP was then applied to an amended medication plan questioning N = 40 general internal medicine (GIM) and N = 50 patients with chronic heart failure (CHF). RESULTS: The mean (± standard deviation (SD)) age of the study cohort was 69 ± 13 years, 47 % female. Patients took 8 ± 3 drugs chronically. The CHF patients had a lower level of education compared to the GIM group (p = 0.004). The overall ET-MP score was 82 ± 21 % (GIM 86 ± 19 %, CHF 78 ± 23 %; p = 0.16). Forty-three percent achieved a score >90 %. A moderate correlation was found between the ET-MP score and the level of education (r = 0.45) and age (r = -0.46), respectively (both p < 0.001). Cognitively impaired CHF patients (p = 0.03) and patients with advanced CHF (p = 0.006) achieved a lower ET-MP score. In the CHF cohort, signs of depression or a lower level of self-care behaviour were not associated with a lower ET-MP score. CONCLUSION: The ET-MP is suitable to explore patients' understanding of a medication plan. Less than 50 % of the patients reached a score above 90 %. Higher age and lower level of education but not the diagnosis of CHF seem to correlate with impaired understanding of the standardized medication plan. In addition to a medication plan, a significant number of patients are in need of further and continuous care to improve medication safety.

Patients' handling of a standardized medication plan: a pilot study and method development.

PURPOSE: The Action Plan for Medication Safety by the German Federal Ministry of Health introduced a standardized medication plan (MP), a printable document for the patient. The practical handling needs to be tested before the nationwide implementation in Germany. Therefore, the aims of our study were 1) to develop an instrument to evaluate the usage of the standardized MP, 2) to assess if patients can locate, and 3) understand important information. Moreover, we explored patients' opinion and suggestions regarding the standardized MP template. PATIENTS AND METHODS: We conducted a cross-sectional study to evaluate the practical handling of the standardized MP. We interviewed 40 adult patients in seven community pharmacies in Germany, who took at least five medicines regularly and gave their written informed consent. The interview consisted of questions regarding finding and understanding information provided on a mock-up MP, patients' opinion and the execution of the information on the MP by filling pill boxes. We eventually developed a new evaluation method to quantify the practical handling of the MP by rating the pill boxes filled by the patients. RESULTS: Overall, the participants rated the MP positively. Thirty-nine (98%) participants found important information on a mock-up standardized MP. Patients were questioned to identify if they understood information on medical intake as it relates to meals. In particular, they were questioned about medicine intake "1 hour before a meal", which 98% (n=39) interpreted correctly, and "during a meal", which 100% (n=40) interpreted correctly. The less precise advice of "before a meal" was interpreted correctly by 73% (n=29), and only 15% (n=6) correctly interpreted the term "after the meal". The evaluation of the filled pill boxes resulted in the "Evaluation Tool to test the handling of the Medication Plan" (ET-MP) - a weighted scoring system. CONCLUSION: The standardized MP is clearly arranged, and patients are able to find important information. The findings of this study resulted in minor but important revisions of the standardized MP template. The developed evaluation tool ET-MP may serve as an objective instrument to assess patients' ability to transfer written information on the MP into practical handling of medicines.

Drug-related problems in prescribed medicines in Germany at the time of dispensing.

BACKGROUND: Drug-related problems (DRPs) can have an important impact on the effectiveness and safety of pharmacotherapy. In Germany, the frequency of DRPs in prescribed medicines in ambulatory care is not yet known. Objective To quantify DRPs in prescribed medicines identified by community pharmacists (CPs) at the time the medicine is dispensed. SETTING: German CPs in four different regions. METHOD: We invited CPs to document one hundred consecutive patients presenting prescriptions using a standardized documentation form. For each patient, person- and medication-related as well as identified DRP-related data were documented. Data were transcribed electronically, coded if necessary, checked for validity, and analyzed. MAIN OUTCOME MEASURE: Nature and frequency of DRPs. RESULTS: In total, 143 CPs documented 14,231 patients with 24,422 prescribed drugs and identified DRPs in 2,556 patients (18.0%). Analyses resulted in 0.23 DRPs per patient and 0.13 DRPs per prescribed medicine. Four DRPs were responsible for almost 70% of all DRPs: Potential drug-drug interaction (22.9%), dose not known to patient (21.7%), patient insecure due to generic substitution (13.5%), and insufficient patient knowledge of correct drug use (10.9%). If a patient's drug file was kept in the pharmacy, specific types of DRPs were detected more frequently e.g., drug-drug interactions (p < 0.001). Interventions primarily comprised counselling, monitoring, and changing drug or instructions for use. The prescribing physician was contacted in 28% of DRPs resulting in a change of these prescriptions in 50% of the cases. Overall and according to the pharmacists, more than 90% of the DRPs detected were partially (10.4%) or completely (85.4%) solved. CONCLUSION: We quantified DRPs in prescribed medicines in daily ambulatory care practice in Germany. When filling a prescription, in nearly 20% of the patients relevant DRPs were revealed. According to the pharmacists, the majority could be partially or completely solved during the encounter at the pharmacy. Keeping a patient's drug file including patient specific data may facilitate the detection of DRPs and shall, therefore, be offered to patients more often.

Compliance with antithrombotic guidelines in surgery patients in German hospitals: a multicenter study involving pharmacy interns.

Despite the existence of antithrombotic guidelines, there is low compliance with these guidelines in clinical practice. Until now pharmacy interns (PIs) have not been involved in this process. The objectives were to involve PIs to evaluate compliance with antithrombotic guidelines for VTE prophylaxis in surgery patients, and in cases of noncompliance to carry out pharmaceutical interventions. The study was conducted in 7 hospitals in Germany involving 27 PIs within the project "Pharmacy interns on the ward" (P-STAT 2). Pharmacy interns determined the thromboembolic risk, documented antithrombotic medication, and checked the compliance with current antithrombotic guidelines. A total of 6491 patients were enrolled; 5695 patients received antithrombotic prophylaxis. Antithrombotic guideline was followed in 77.5% patients. Many patients are not receiving appropriate VTE prophylaxis or heparin bridging regimen despite the fact that evidence-based antithrombotic guidelines are available. Pharmacy interns may play an important role in antithrombotic management.

Nature and frequency of drug-related problems in self-medication (over-the-counter drugs) in daily community pharmacy practice in Germany.

PURPOSE: To quantify drug-related problems (DRPs) in self-medication (over-the-counter [OTC] drug use) identified by community pharmacists (CPs) in Germany at the time the drug is dispensed. METHODS: One hundred CPs were asked to document 100 consecutive customers presenting symptoms or requesting OTC drugs using a standardized documentation form. The number of 10,000 encounters seemed reasonable to evaluate the set objective. For each encounter, data such as age, sex, and first or repeated request and the availability of a patient file in the pharmacy including drug history were documented. Furthermore, identified DRPs, problem descriptions, and solutions were documented. Data were transcribed electronically, coded, checked for validity, and analyzed. RESULTS: In total, 109 CPs documented 12,567 encounters identifying DRPs in 17.6% of all cases. Four indications comprised more than 70% of all DRPs: pain, respiratory, gastrointestinal, and skin disorders. Four DRPs were responsible for almost 75% of all DRPs identified: self-medication inappropriate (29.7%), requested product inappropriate (20.5%), intended duration of drug use too high including abuse (17.1%), and wrong dosage (6.8%). If a drug history was available, significantly more cases with wrong dosage (p < 0.05) and drug-drug interactions (p < 0.001) were detected. All patients with identified DRPs were counseled accordingly. Furthermore, the most frequent interventions were referral to a physician (39.5%) and switching to a more appropriate drug (28.1%). CONCLUSIONS: In nearly one of five encounters, a direct pharmacist-patient interaction about self-medication revealed relevant DRPs. Having access to patient files including data on prescription and OTC drugs may increase patient safety.

Evaluation of the Pharmacy Safety Climate Questionnaire in European community pharmacies.

OBJECTIVE: To evaluate the internal reliability, factor structure and construct validity of the Pharmacy Safety Climate Questionnaire (PSCQ) when applied to a pan-European sample of community pharmacies. DESIGN: A cross-sectional survey design was used. SETTING: Community pharmacies in Denmark, Germany, the Netherlands, Portugal and Great Britain. PARTICIPANTS: A total of 4105 members of the community pharmacy workforce, all drawn from one of the five participating countries. MAIN OUTCOME MEASURES: Each participant completed a copy of the Pharmacy Safety Climate Questionnaire in his or her respective language and rated the perceived safety of the pharmacy in which he or she worked. RESULTS: Exploratory and confirmatory factor analyses of the data identified four factors that accounted for item responses, with 24 of the original 34 items loading onto them. They were labelled organizational learning, blame culture, working conditions and safety focus. These factors were found to have an acceptable level of reliability (with Cronbach's alpha values ranging from 0.70 to 0.92) and to predict the rating of pharmacy safety. CONCLUSIONS: This study provided information on the PSCQ's psychometric properties when used in community pharmacies in different European countries. A modified version of the original PSCQ (known as PSCQ-4) is presented, and further work is proposed to demonstrate its application to safety improvements in pharmacies.

Population pharmacokinetics of high-dose carboplatin in children and adults.

INTRODUCTION: Although for conventional dosing of carboplatin, several strategies are available to individualize the dose based on renal function measurements, such approaches are still rare for high-dose regimens with autologous stem cell support. The purpose of this study was to investigate the influence of patient- and regimen-specific factors on the pharmacokinetics of carboplatin and to compare the performance of different dose individualization strategies (Calvert, Newell, Chatelut, flat dosing, dosing according to body surface area). PATIENTS AND METHODS: A combined data set with 69 patients from five studies, including 13 pediatric patients, was subject to a population pharmacokinetic analysis using NONMEM. RESULTS: The covariate analysis revealed that carboplatin clearance after high-dose chemotherapy was highly related to creatinine clearance, body height, and infusion duration. After inclusion of these covariates, the population parameter variability of clearance decreased from 53% in the base model to 21% in the final model. We also developed an alternative model that related body weight, instead of height, to clearance by means of allometric scaling. An evaluation of the predictive performance of existing a priori dose individualization strategies revealed that flat dosing is appropriate for adult patients with normal renal function receiving a 1-hour infusion. For a long-term infusion schedule, a dose increase may be necessary. The existing dosing strategies performed poorly for the children in our data set. For this subpopulation, our allometric scaling model may be most appropriate. CONCLUSION: The two population pharmacokinetic models presented can be applied to estimate individual carboplatin clearance in high-dose chemotherapy based on body weight or height, infusion duration, and creatinine clearance. After prospective evaluation, our models may be suitable for dose adjustments.

Pharmaceutical care in community pharmacies: practice and research in Germany.

OBJECTIVE: To discuss the provision of pharmaceutical care in community pharmacies in Germany including community pharmacy, organization and delivery of health services, pharmacy education, community pharmacy services, research in community pharmacy, and future plans for community pharmacy services. FINDINGS: In Germany, cognitive pharmaceutical services have been developed for more than 12 years. Several studies and programs have shown that pharmaceutical care and other pharmaceutical services are feasible in community pharmacy practice and that patients benefit from these services. In 2003, a nationwide contract was established between representatives of the community pharmacy owners and the largest German health insurance fund. In this so-called family pharmacy contract, remuneration of pharmacists for provision of pharmaceutical care services was successfully negotiated for the first time. In 2004, a trilateral integrated care contract was signed that additionally included general practitioners, combining the family pharmacy with the family physician. Within a few months, the vast majority (>17 000) of community pharmacies have registered to participate in this program. CONCLUSIONS: German community pharmacies are moving from the image of mainly supplying drugs toward the provision of cognitive pharmaceutical services.

Effect of selenite combined with chemotherapeutic agents on the proliferation of human carcinoma cell lines.

Selenite is frequently used in combination with cancer chemotherapeutic agents to reduce side effects. However, the cytoprotective activity of selenite may also reduce the efficacy of chemotherapeutic drugs on tumor cells. This study was designed to examine the effects of selenite combined with cytotoxic agents used in clinical protocols [e.g., doxorubicine, docetaxel, 5-fluorouracil (5-FU), methotrexate (MTX), mafosphamide, mitomycin C, gemcitabine, etoposide, cisplatin, irinotecan, and oxaliplatin] on the proliferation of various carcinoma cell types. The data demonstrated that selenite had no marked effects on the antiproliferative activity of docetaxel, doxorubicine, 5-FU, MTX, and mafosphamide in MDA-MB-231 breast cancer cells. Likewise, no consistent changes were observed in A549 lung cancer cell proliferation when selenite was combined with cisplatin, etoposide, gemcitabine, or mitomycin C. On the other hand, selenite potentiated the cytotoxicity of 5-FU, oxaliplatin, and irinotecan in HCT116 colon cancer cells by approx 1.1-fold, 2.7-fold, and 2.6-fold, respectively. In SW620 colon cancer cells, selenite induced a 1.5-fold and 4.3-fold increase of the antiproliferative activity of 5-FU and oxaliplatin, respectively. Whereas irinotecan showed no effects on SW620 cell growth, a combination with selenite resulted in 23% inhibition. Our results indicate that selenite did not reduce the antiproliferative activity of chemotherapeutic agents in vitro. In addition, selenite was able to increase the inhibitory activity of docetaxel in A549 lung cancer cells, and of 5-FU, oxaliplatin, and irinotecan in HCT116 and SW620 colon cancer cells implying selenite is potentially useful as an adjuvant chemotherapeutic agent.