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.

PHARMacy-based interdisciplinary program for patients with Chronic Heart Failure (PHARM-CHF): rationale and design of a randomized controlled trial, and results of the pilot study.

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119.

In search of a standard when analyzing medication adherence in patients with heart failure using claims data: a systematic review.

To determine and address medication non-adherence is important and may improve patient outcomes. Our aim was to perform a systematic review on the operationalization of adherence measures in patients with heart failure using claims data. We searched the MEDLINE, EMBASE, and Cochrane databases. A quality check of the full-text articles was performed using the Quality in Prognosis Studies tool. We included 28 studies. Eleven studies used the medication possession ratio, 15 the proportion of days covered, and six studies used own methods to calculate medication adherence. Almost all studies used an observation period of 1 year. Twenty-one studies considered angiotensin converting enzyme inhibitors or angiotensin receptor antagonists, 17 beta-blockers, 11 diuretics, eight mineralocorticoid receptor antagonists, six digitalis-glycosides, and six statins. Eight studies looked at single substance classes; 18 studies analyzed more than one drug class. Different assumptions for the dosage were used. In seven studies, switching within therapeutic classes was allowed. Three studies allowed stockpiling, nine studies censored hospital stays, and four studies censored death. Seventeen studies dichotomized the results, applying the cutoff ≥ 0.8 to define a patient as adherent. Eight studies analyzed adherence as a continuous value. The reporting quality of the methodology applied varied widely between studies. A gold standard is currently not available for the quantification of medication adherence in patients with chronic heart failure via claims data. To assess the methodology, the following parameters should be described: method of measurements, observation period, substances, dosing, switches, stockpiling, truncations, statistical analysis, and cutoff for adherence.

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.

Age-related medication adherence in patients with chronic heart failure: A systematic literature review.

BACKGROUND: Chronic heart failure (CHF) is prevalent among the elderly and is characterized by high mortality and hospitalization rates. Non-adherence to medications is frequent and related to poor clinical outcomes. It is often assumed that older age is related to poorer medication adherence compared with younger age. We analyzed the existing evidence of age as a determinant of medication adherence in patients with CHF. METHODS: A systematic search of the bibliographic database MEDLINE and all Cochrane databases was performed. Studies were included if they examined medication adherence in adult patients with CHF, evaluated factors contributing to medication adherence, and analyzed the relationship between age and medication adherence. Articles classified as studies with poor quality were excluded. RESULTS: A total of 1565 titles were found, and ultimately, 17 studies, which provide data for a total of 162,727 patients, were analyzed. Seven studies showed a statistically significant relationship between age and medication adherence: six articles demonstrated that increased age is correlated with higher medication adherence, and one study showed that patients in the age range of 57 to 64 years are affected by non-adherence to angiotensin-converting enzyme inhibitors. Ten studies found no significant relationship. CONCLUSIONS: The results suggest that older age alone is not related to poorer medication adherence compared with younger patients with CHF. More attention should be paid to younger newly-diagnosed patients with CHF. Future studies are required to explore medication adherence in CHF in different, standardized, and specific age groups and should be sufficiently powered to assess clinical endpoints.

Pharmaceutical care: the PCNE definition 2013.

BACKGROUND: Twenty-three years after Hepler and Strand published their well-known definition of Pharmaceutical Care (PhC), confusion remains about what the term includes and how to differentiate it from other terms. The board of the Pharmaceutical Care Network Europe (PCNE) felt the need to redefine PhC and to answer the question: "What is Pharmaceutical Care in 2013". OBJECTIVE: The aims of this paper were to review existing definitions of PhC and to describe the process of developing a redefined definition. METHODS: A literature search was conducted in the MEDLINE database (1964-January 2013). Keywords included "Pharmaceutical Care", "Medication (Therapy) Management", "Medicine Management", and "Pharmacist Care" in the title or abstract together with the term "defin*". To ease comparison between definitions, we developed a standardised syntax to paraphrase the definitions. During a dedicated meeting, a moderated discussion about the definition of PhC was organised. RESULTS: The initial literature search produced 186 hits, with eight unique PhC definitions. Hand searching identified a further 11 unique definitions. These 19 definitions were paraphrased using the standardised syntax (provider, recipient, subject, outcome, activities). Fourteen members of PCNE and 10 additional experts attended the moderated discussion. Working groups of increasing size developed intermediate definitions, which had similarities and differences to those retrieved in the literature search. At the end of the session, participants reached a consensus on a "PCNE definition of Pharmaceutical Care" reading: "Pharmaceutical Care is the pharmacist's contribution to the care of individuals in order to optimize medicines use and improve health outcomes". CONCLUSIONS: It was possible to paraphrase definitions of PhC using a standardised syntax focusing on the provider, recipient, subject, outcomes, and activities included in PhC practice. During a one-day workshop, experts in PhC research agreed on a definition, intended to be applicable for the present time, representative for various work settings, and valid for countries inside and outside of Europe.