Clinical pharmacy services are reimbursed in Germany: challenges of real world implementation remain

Over the last two decades, community pharmacy has experienced major changes as the role of pharmacists is evolving from a product to a service and a patient focus. As part of this change, new and innovative clinical pharmacy services aimed at improving medicines use and patient outcomes have been designed, both nationally and internationally. Since June 2022, five services are reimbursed by all statutory health insurance funds and private insurance companies in Germany: medication review for patients with polymedication; blood pressure control in hypertension; assuring proper inhalation techniques for patients receiving a new device or a device change; medication review including a follow-up for patients taking oral anticancer drugs or immunosuppressants post-transplantation. Beyond reimbursement, the upscaling and sustainable provision of these professional services are now the main challenges. Implementation research will provide important information for the further development of pharmaceutical care programs

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We thank Dr. Kalmanovich and colleagues for their comments on our randomized controlled trial on improving medication adherence and quality of life of heart failure (HF) patients by a pharmacist‐led interdisciplinary approach.1 This study showed that pharmacy care safely improved adherence to HF medications and quality of life. These data extend recent consensus statements of both the Canadian Cardiovascular Society guidelines for the management of HF2 and the German clinical practice guideline on chronic HF3 that acknowledge the available evidence of pharmacist care and interdisciplinary care.4, 5 Topics and tasks include prevention of HF, particularly by improving adherence to antihypertensives, providing medication reviews, assuring appropriate self‐medication, and improving both medication safety and adherence.4 We congratulate Kalmanovich et al. to their research plan. Their study will hopefully provide additional randomized evidence for the effects of interdisciplinary care in patients with HF

Comparison of different strategies to measure medication adherence via claims data in patients with chronic heart failure

Medication adherence correlates with morbidity and mortality in patients with chronic heart failure (CHF), but is difficult to assess. We conducted a retrospective methodological cohort study in 3,808 CHF patients, calculating adherence as proportion of days covered (PDC) utilizing claims data from 2010 to 2015. We aimed to compare different parameters’ influence on the PDC of elderly CHF patients exemplifying a complex chronic disease. Investigated parameters were the assumed prescribed daily dose (PDD), stockpiling, and periods of hospital stay. Thereby, we investigated a new approach using the PDD assigned to different percentiles. The different dose assumptions had the biggest influence on the PDC, with variations from 41.9% to 83.7%. Stockpiling and hospital stays increased the values slightly. These results queries that a reliable PDC can be calculated with an assumed PDD. Hence, results based on an assumed PDD have to be interpreted carefully and should be presented with sensitivity analyses to show the PDC's possible range

Development and implementation of blood pressure screening and referral guidelines for German community pharmacists

Involvement of community pharmacists in the detection and control of hypertension improves patient care. However, current European or North‐American guidelines do not provide specific guidance how to implement collaboration between pharmacists and physicians, especially when and how to refer patients with undetected or uncontrolled hypertension to a physician. The German Society of Cardiology and the ABDA – Federal Union of German Associations of Pharmacists developed and tested referral recommendations for community pharmacists, embedded in two guideline worksheets. The project included a guideline‐directed blood pressure (BP) measurement and recommendations when patients should be referred to their physician. A “red flag” referral within 4 weeks was recommended when SBP was >140 mm Hg or DBP >90 mm Hg (for subjects 160 mm Hg or >90 mm Hg (≥80 years) in undetected individuals, or >130 mm Hg or >80 mm Hg (140 mm Hg or >80 mm Hg (≥65 years) in treated patients. BP was measured in 187 individuals (86 with known hypertension, mean [±SD] age 62 ± 15 years, 64% female, and 101 without known hypertension, 47 ± 16 years, 75% female) from 17 community pharmacies. In patients with hypertension, poorly controlled BP was detected in 55% (n = 47) and were referred. A total of 16/101 subjects without a history of hypertension were referred to their physician because of uncontrolled BP. Structured BP testing in pharmacies identified a significant number of subjects with undetected/undiagnosed hypertension and patients with poorly controlled BP. Community pharmacists could play a significant role in collaboration with physicians to improve the management of hypertension

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

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

PCNE definition of medication review: reaching agreement

Background Medication review is important in an era, in which polypharmacy is increasing. To date, no agreed international definition of medication review exists. Objective The aim was to reach agreement on an internationally applicable definition of medication review. Setting An international group of experts in medication review. Methods A working group of the Pharmaceutical Care Network Europe (PCNE) was established to agree on a definition including a classification of medication review. First, a survey with the aim of systematically gathering viewpoints on a definition of medication review was conducted. Second, a workshop was held to achieve an agreement. Finally, during the General Assembly of PCNE, the definition was approved. To ensure a better understanding of the scope and the considerations behind the definition, a position paper was created. Main outcome measure An internationally agreed definition of medication review. Results 58 PCNE members from 20 different countries completed the online survey. Then, 22 participants from 11 different countries (not only PCNE members) elaborated the final definition during a workshop. The final PCNE version agreed was: "Medication review is a structured evaluation of a patient's medicines with the aim of optimising medicines use and improving health outcomes. This entails detecting drug-related problems and recommending interventions". Overall, the consensus process included 225 people from 35 countries and resulted also in a classification of medication review taking into account the type and source of available information. Conclusion Involvement of an international community from research and practice and the use of a systematic process led to an agreement on the term medication review and on a classification valid for all settings and professions

Pharmacy-based interdisciplinary intervention for patients with chronic heart failure: results of the PHARM-CHF randomized controlled trial

Aims Medication non-adherence is frequent and is associated with high morbidity and mortality in patients with chronic heart failure (CHF). We investigated whether an interdisciplinary intervention improves adherence in elderly CHF patients. Methods and results The study population (mean age 74 years, 62% male, mean left ventricular ejection fraction 47%, 52% in New York Heart Association class III) consisted of 110 patients randomized into the pharmacy care and 127 into the usual care group. The median follow-up was 2.0 years (interquartile range 1.2-2.7). The pharmacy care group received a medication review followed by regular dose dispensing and counselling. Control patients received usual care. The primary endpoint was medication adherence as proportion of days covered (PDC) within 365 days for three classes of heart failure medications (beta-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and mineralocorticoid receptor antagonists). The main secondary outcome was the proportion of adherent patients (PDC >= 80%). The primary safety endpoint was days lost due to unplanned cardiovascular hospitalizations (blindly adjudicated) or death. Pharmacy care compared with usual care resulted in an absolute increase in mean adherence to three heart failure medications for 365 days [adjusted difference 5.7%, 95% confidence interval (CI) 1.6-9.8, P = 0.007]. The proportion of patients classified as adherent increased (odds ratio 2.9, 95% CI 1.4-5.9, P = 0.005). Pharmacy care improved quality of life after 2 years (adjusted difference in Minnesota Living with Heart Failure Questionnaire scores -7.8 points (-14.5 to -1.1; P = 0.02), compared to usual care. Pharmacy care did not affect the safety endpoints of hospitalizations or deaths. Conclusion Pharmacy care safely improved adherence to heart failure medications and quality of life

The evidence for pharmacist care in outpatients with heart failure: a systematic review and meta-analysis

Aims: Patients with heart failure (HF) have poor outcomes, including poor quality of life, and high morbidity and mortality. In addition, they have a high medication burden due to the multiple drug therapies now recommended by guidelines. Previous reviews, including studies in hospital settings, provided evidence that pharmacist care improves outcomes in patients with HF. Because most HF is managed outside of hospitals, we aimed to synthesize the evidence for pharmacist care in outpatients with HF. Methods and results: We conducted a systematic literature search in PubMed of randomized controlled trials (RCTs) and integrated the evidence on patient outcomes in a meta-analysis. We found 24 RCTs performed in 10 countries, including 8029 patients. The data revealed consistent improvements in medication adherence (independent of the measuring instrument) and knowledge, physical function, and disease and medication management. Sixteen RCTs were included in meta-analyses. Differences in all-cause mortality (odds ratio (OR) = 0.97 [95% CI, 0.84–1.12], Q-statistic, P = 0.49, I2 = 0%), all-cause hospitalizations (OR = 0.86 [0.73–1.03], Q-statistic, P = 0.01, I2 = 45.5%), and HF hospitalizations (OR = 0.89 [0.77–1.02], Q-statistic, P = 0.11, I2 = 0%) were not statistically significant. We also observed an improvement in the standardized mean difference for generic quality of life of 0.75 ([0.49–1.01], P < 0.01), with no indication of heterogeneity (Q-statistic, P = 0.64; I2 = 0%). Conclusions: Results indicate that pharmacist care improves medication adherence and knowledge, symptom control, and some measures of quality of life in outpatients with HF. Given the increasing complexity of guideline-directed medical therapy, pharmacists' unique focus on medication management, titration, adherence, and patient teaching should be considered part of the management strategy for these vulnerable patients