Pharmaceutical Care Network Europe definition of quality indicators for pharmaceutical care: a systematic literature review and international consensus development.

BACKGROUND: Over the past 40 years, the tasks of pharmacists have shifted from logistic services to pharmaceutical care (PhC). Despite the increasing importance of measuring quality of care, there is no general definition of Quality Indicators (QIs) to measure PhC. Recognising this, a working group in a European association of PhC researchers, the Pharmaceutical Care Network Europe (PCNE), was established in 2020. AIM: This research aimed to review existing definitions of QIs and develop a definition of QIs for PhC. METHOD: A two-step procedure was applied. Firstly, a systematic literature review was conducted to identify existing QI definitions that were summarised. Secondly, an expert panel, comprised of 17 international experts from 14 countries, participated in two surveys and a discussion using a modified Delphi technique to develop the definition of QIs for PhC. RESULTS: A total of 182 QI definitions were identified from 174 articles. Of these, 63 QI definitions (35%) cited one of five references as the source. Sixteen aspects that construct QI definitions were derived from the identified definitions. As a result of the Delphi study, the panel reached an agreement on a one-sentence definition of QIs for PhC: "quality indicators for pharmaceutical care are validated measurement tools to monitor structures, processes or outcomes in the context of care provided by pharmacists". CONCLUSION: Building upon existing definition of QIs, an international expert panel developed the PCNE definition of QIs for PhC. This definition is intended for universal use amongst researchers and healthcare providers in PhC.

[Quality indicators for medication reviews in community pharmacies]. / Qualitätsindikatoren zur Bewertung von Medikationsanalysen in öffentlichen Apotheken.

BACKGROUND: Medication reviews conducted in community pharmacies are a measure to reduce drug-related problems and to increase medication safety. Since 2014, a guideline for medication reviews has been available in Germany. However, the sole existence of a guideline does not guarantee a high quality of this novel service. Quality indicators can contribute to ensure appropriate quality standards. So far, no such indicators have been available in Germany. This project therefore aims at developing suitable indicators to assess the quality of medication reviews type 2a in community pharmacies. METHODS: Based on a literature review, potential quality indicators were generated. Using a two-step Delphi method applying the RUMBA criteria, a set of structure, process, and outcome indicators was developed. RESULTS: The literature review identified 23 potential indicators. Nine further indicators derived from the guideline for medication reviews and expert opinion were amended. After discussion in a focus group, the 32 indicators were reduced to a preliminary set of twelve indicators used for the Delphi survey. Following two Delphi rounds, a final indicator set consisting of three structure indicators, one process indicator and two outcome indicators, was generated. DISCUSSION: The set of quality indicators is potentially suitable for measuring the quality of medication reviews in German community pharmacies. In the next step, these indicators need to be evaluated with regard to their validity and applicability in daily routine.

Effect of training and structured medication review on medication appropriateness in nursing home residents and on cooperation between health care professionals: the InTherAKT study protocol.

BACKGROUND: Pharmacotherapy in residents of nursing homes is critical due to the special vulnerability of this population. Medical care and interprofessional communication in nursing homes are often uncoordinated. As a consequence, polypharmacy and inappropriate medication use are common and may lead to hospitalizations and health hazards. The aim of this study is to optimize communication between the involved professional groups by specific training and by establishing a structured medication review process, and to improve medication appropriateness and patient-relevant health outcomes for residents of nursing homes. METHODS/DESIGN: The trial is designed as single-arm study. It involves 300 nursing home residents aged ≥ 65 years and the members of the different professional groups practising in nursing home care (15-20 general practitioners, nurses, pharmacists). The intervention consists of interprofessional education on safe medication use in geriatric patients, and a systematic interprofessional therapy check (recording, reviewing and adapting the medication of the participating residents by means of a specific online platform). The intervention period is divided into two phases; total project period is 3 years. Primary outcome measure is the change in medication appropriateness according to the Medication Appropriateness Index. Secondary outcomes are cognitive performance, occurrence of delirium, agitation, tendency of falls, total number of drugs, number of potentially dangerous drug-drug interactions and appropriateness of recorded analgesic therapy regimens according to the Medication Appropriateness Index. Data are collected at t0 (before the start of the intervention), t1 (after the first intervention period) and t2 (after the second intervention period). Cooperation and communication between the professional groups are investigated twice by qualitative interviews. DISCUSSION: The project aims to establish a structured system for monitoring of drug therapy in nursing home residents. The newly developed online platform is designed to systematize and to improve the communication between the professional groups and, thus, to enhance quality and safety of drug therapy. Limitations of the study are the lack of a control group and the non-randomly recruited study sample. TRIAL REGISTRATION: DRKS Data Management, DRKS-ID: DRKS00007900.

[Information content of medication schedules prior to the implementation of the federal standard medication plan]. / Informationsgehalt von Medikationsplänen vor dem Hintergrund der Einführung des einheitlichen patientenbezogenen Medikationsplans.

BACKGROUND: Polypharmacy and complex medication regimens are challenging in patient care. Written information like a medication schedule is the main component in this context. To exchange these data the federal medication plan is an adequate medium. However there is insufficient knowledge of whether structures for implementation exist and which categories are already used in daily practice. It is also unknown how often an update for these schedules is necessary. METHODS: During a medication review including a brown-bag analysis the current medication from 500 patients was assessed and compared to the medication schedule available. In this way we established both the categories of the federal medication plan that are already in use and the age of the plan. Age and frequency of data within the different categories were compared to the number of deviations. In addition, these data were analyzed for different authorships. RESULTS: None of the 399 medication schedules fully complied with the draft. The brand name was listed in only 33.8 %, but with large deviations (41 %) from the currently used brand. Brand names and the name of the active component were used in a mixed manner. Dosage was missing in 34.6 % of the medications, and in 80.2 % the formulations were not provided. Indication was lacking in 95.2 % of the medications and intake recommendations in 96.7 %. Large differences were seen with different authors. The average age of the plans was 4.5 months [range 0-12 months]. The number of discrepancies increased by 50 % after two months, statistical significance was reached after 4.5 months (p=0.039). CONCLUSION: The complete categories of the federal medication plan are not commonly used in everday practice. Essential information such as the correct brand name, dosages and intake recommendations as well as medication relevant safety data concerning galenic form and indication is not fully provided. To achieve implementation and completeness of medication plans, interprofessional collaboration of all healthcare professions with the involvement of patients is reasonable. Updating is necessary after each change in medication but should also be routinely conducted every 3 months.

Interprofessional Medication Management in Patients With Multiple Morbidities.

BACKGROUND: Medication reviews and medication management are being used more and more around the world to improve medication safety. Both of these tools were originally conceived as pharmaceutical care activities and have recently been developed into interdisciplinary approaches. We studied the efficacy of interprofessional medication management for multimorbid patients that takes their medical conditions, but also their general living situation into account. METHODS: A comprehensive medication management was performed, which involved the collection of information on the drugs each patient took, the way they were stored, the patient's drug intake and handling, and any problems that arose with pharmacotherapy. The interventional approach was evaluated over a period of 15 months in a cluster-randomized controlled trial with a stepped wedge design. The primary endpoint was the quality of pharmacotherapy, as assessed with the Medication Appropriateness Index (MAI). A mixed model was used to analyze efficacy. RESULTS: 162 patients were enrolled in the study; 142 were included in the intention-to-treat analysis (53.3% women, mean age 76.8 ± 6.3 years). The mean total MAI score decreased significantly (p ≤ 0.001) from the control phase (29.21, 95% CI [26.09; 32.33]) to the intervention phase (22.27 [19.00; 25.54]), with an effect strength (Cohen's d) of -0.24 [-0.36; -0.13]. The number of drug-related problems declined as well. CONCLUSION: In this study, interprofessional collaboration increased medication safety. Working across disciplinary boundaries allowed for a decrease in drugrelated problems and brought up aspects outside the purview of the primary care physician.

Priority Setting and Influential Factors on Acceptance of Pharmaceutical Recommendations in Collaborative Medication Reviews in an Ambulatory Care Setting - Analysis of a Cluster Randomized Controlled Trial (WestGem-Study).

BACKGROUND: Medication reviews are recognized services to increase quality of therapy and reduce medication risks. The selection of eligible patients with potential to receive a major benefit is based on assumptions rather than on factual data. Acceptance of interprofessional collaboration is crucial to increase the quality of medication therapy. OBJECTIVE: The research question was to identify and prioritize eligible patients for a medication review and to provide evidence-based criteria for patient selection. Acceptance of the prescribing general practitioner to implement pharmaceutical recommendations was measured and factors influencing physicians' acceptance were explored to obtain an impression on the extent of collaboration in medication review in an ambulatory care setting. METHODS: Based on data of a cluster-randomized controlled study (WestGem-study), the correlation between patient parameters and the individual performance in a medication review was calculated in a multiple logistic regression model. Physician's acceptance of the suggested intervention was assessed using feedback forms. Influential factors were analyzed. RESULTS: The number of drugs in use (p = 0.001), discrepancies between prescribed and used medicines (p = 0.014), the baseline Medication Appropriateness Index score (p<0.001) and the duration of the intervention (p = 0.006) could be identified as influential factors for a major benefit from a medication review, whereas morbidity (p>0.05) and a low kidney function (p>0.05) do not predetermine the outcome. Longitudinal patient care with repeated reviews showed higher interprofessional acceptance and superior patient benefit. A total of 54.9% of the recommendations in a medication review on drug therapy were accepted for implementation. CONCLUSIONS: The number of drugs in use and medication reconciliation could be a first rational step in patient selection for a medication review. Most elderly, multimorbid patients with polymedication experience a similar chance of receiving a benefit from a medication review. Longitudinal patient care should be preferred over confined medication reviews. The acceptance of medication reviews by physicians supports further implementation into health care systems. TRIAL REGISTRATION: ISRCTN ISRCTN41595373.

Effect evaluation of an interprofessional medication therapy management approach for multimorbid patients in primary care: a cluster-randomized controlled trial in community care (WestGem study protocol).

BACKGROUND: Pharmaceutical practice worldwide is developing towards patient care. Medication Review (MR) and Medication Therapy Management (MTM) are evolving as the most prominent services in pharmaceutical care and have a strong potential to provide a large benefit for patients and society. MTMs can only be performed in an interprofessional, collaborative setting. Several international studies have explored the effects of a MTM on the quality of therapy and costs. For Germany the data is still deficient. This study aims to provide data on the effects of an interprofessional MTM regarding quality of therapy, quality of life, costs and cost-effectiveness. METHOD/DESIGN: The study is designed as a cluster-randomized controlled trial in primary care, involving 12 outpatient clinics (clusters) and 165 patients. Primary care units are allocated to interventions using a Stepped Wedge Design. All units are initially assigned to the control group. After a 6 month observation period, general practitioners (GP) are randomly allocated to one of three groups and the interprofessional medication therapy management approach is implemented sequentially per each group with a lag of 3 months between. The primary outcome is the change in the quality of therapy measured by the MAI (Medication Appropriateness Index). Secondary outcomes include changes in the number of drug related problems, medication complexity, changes in drug-adherence, changes in health-status and function, quality of life, direct costs and the incremental cost-effectiveness ratio. The acceptance of the interprofessional Medication Therapy Management approach is assessed by qualitative methods. DISCUSSION: The patient interview and brown bag review are activities, typically provided by the pharmacist. In this trial the patient is blinded to the pharmacist. The strength of having the patient blinded to the pharmacists is to exclude skepticism of the patient toward unknown pharmacies, which might be a major confounder in a regional and community setting. A weakness is that some patient related data might reach the pharmacists in a way, which might differ from self-acquired data. TRIAL REGISTRATION: Current controlled trials ISRCTN41595373 .

Discrepancies on Medication Plans detected in German Community Pharmacies.

RATIONALE, AIMS AND OBJECTIVES: A current medication plan was identified as important patient safety factor. Information is needed on how many patients possess such a plan and what problems can be identified with its use. This study tried to define factors that influence accuracy of medication plans and to detect discrepancies from planned and actually administered medication in polypharmacy patients. METHODS: Participants of the 'Apo-AMTS' course in Germany evaluated medication plans from their patients during performing medication reviews in community pharmacies. Discrepancies were defined as additional or missing drugs and deviations in dosage and drug names for Rx drugs and missing or additional self-medication. RESULTS: Eighty per cent of the patients possessed a medication plan mainly written by general practitioners. Only 6.5% of the plans showed no discrepancies. Most discrepancies were seen on medication plans written by medical specialists and general practitioners, mainly name aberrations (41%) followed by additional drugs taken (30%) and prescribed drugs no longer taken (18%). Dosage variance was seen in 11% of all discrepancies. Deviations from the plan were observed frequently with antihypertensives (31.4%), analgesics (11.3%) and antidepressants/hypnotics as well as lipid-lowering drugs (6.7%). Four hundred thirty-three OTC drugs were not listed, mainly analgesics, mineral supplements and laxatives. CONCLUSION: Many patients possess a medication plan but most of these plans showed discrepancies which limits the use as patient safety indicator. Community pharmacies offering medication reviews have an essential position to use the medication plan as a central link between patients and their prescribers, and therefore improve patient safety.