The contribution of retail pharmacists to optimising medication safety – a comparison of German, Australian and Swiss models

Pharmaceuticals are effective and efficient as a form of therapy in outpatient and inpatient care, provided they are used correctly. However, with increasing treatment options due to new drug developments and the simultaneous use of multiple drugs (polypharmacy), the complexity of drug therapy is increasing. Chronically ill and multimorbid patients, in particular, are often treated with several different drugs, increasing the risk of adverse drug reactions (ADRs) and drug-related harm [1]. The risk of ADRs in these patients, in addition to potential drug interactions, increases due to age-associated changes in pharmacokinetics and pharmacodynamics [2]. Ensuring drug therapy safety (DTS), especially in chronically ill patients, therefore represents a particular challenge in drug supply.

>> Adverse drug reactions (ADRs) not only cause individual suffering but also have significant economic consequences: In 2002, Schneeweiß et al. estimated the annual costs for the German healthcare system due to unplanned hospitalizations following ADRs at 400 million euros [4]. Based on a probability model for medical costs from the USA, Stark et al. estimated the adverse drug reactions that occurred within one year.
Drug-related adverse events (ADEs) amounted to approximately 2 million, resulting in costs of approximately 816 million euros
[5]. The Federal Association of German Pharmacists (ABDA) even speaks of a cost-containment potential of 1.8 billion euros through increased patient compliance and a reduction in drug risks [6]. The optimization of AMTS is therefore becoming increasingly important in the field of health services research [7].
Studies from inpatient and long-term care facilities suggest the positive influence of a multidisciplinary approach on improving AMTS [8, 9]. Furthermore, various publications emphasize the importance of intensive pharmaceutical care provided by community pharmacies for the AMTS of seniors [10, 11]. Strategies that address the above-mentioned factors on the AMTS of seniors are presented below. They require a validated, transparent communication and action process between physicians and pharmacists. The prerequisite for the successful implementation of these strategies is the definition of goals and the continuous review of the effectiveness of the measures with regard to goal achievement. If the strategies are consistently pursued, it appears possible to minimize errors in the medication process and thus also optimize AMTS.
To effectively and efficiently support AMTS, pharmacists can use Medication Management (MM). Medication management provides tools that enable pharmacists to collaborate with physicians, patients, and caregivers to manage the medication process safely, effectively, and efficiently.
This article presents current developments in medication management models in German retail pharmacy that involve pharmacists more comprehensively than before in the responsibility for AMTS. Examples from Switzerland and Australia are cited as a guideline.
Compared to Germany, community pharmacists institutionalize patient care more strongly through pharmaceutical services and regular interdisciplinary exchange. Even though the established care measures presented here have been implemented in countries with differently financed and organized healthcare systems compared to Germany, elements of these measures may be transferable to the German situation.
The ATHINA project
The ATHINA project is a model initiated by the North Rhine Chamber of Pharmacists to promote medication management in community pharmacies and began in February 2013. The "ATHINA - Medication Therapy Safety in Pharmacies" project aims to expand and promote pharmacist competence in medication management. The goal of the pharmacists involved is to be able to implement the medication management required by the ApoBetrO in community pharmacies in a practical and quality-assured manner.
Participating community pharmacists offer patients with polypharmacy and patients over 60 years of age a medication check using the so-called brown bag method. According to Larrat et al., the developers of this medication check, this involves checking all of a patient's medications and foodstuffs. The patient brings these to a pharmacist [13]. In the ATHINA project, the medications brought to the pharmacist are checked for duplicate prescriptions, interactions, and side effects, as well as possible dosage errors, application problems, and abnormalities in patient compliance [14]. The results of the medication check by the pharmacist as part of the ATHINA pilot study are documented. The pharmacist prepares a report and discusses it with the patient. Furthermore, the pharmacist conducts training sessions as needed, clarifies medication-related abnormalities with the treating physicians, and documents them. The patient receives a completed medication plan listing all medications, including their indications, dosage, and instructions for use [14]. A recent study from the USA demonstrates the positive effects on treatment adherence in chronic patients through a brown bag review. Furthermore, healthcare professionals in the study identified incorrect prescriptions by physicians and misuse by patients [15].
At the end of the ATHINA project, a comprehensive evaluation of the documentation forms will be conducted. Given the current study results from the US, the evaluation of the German project is eagerly awaited.
The Pharm-CHF study
The German Advisory Council on the Assessment of the Health Care System (SVR) emphasizes the importance of interdisciplinary and cross-disciplinary cooperation to ensure therapeutic safety and the intended use of medicines, to care for chronically ill patients, and to prevent adverse drug reactions [16]. The Pharm-CHF study (Pharmacy-based Interdisciplinary Program for Patients with Chronic Heart Failure) was launched in October 2012. It investigated the intensive care of patients with chronic heart failure by physicians and pharmacists using a continuous interdisciplinary program to improve medication adherence and reduce medication risks [17]. This multicenter, randomized study is the first study of this magnitude conducted jointly by physicians and pharmacists in Germany to examine a program for improving medication adherence with regard to clinical endpoints (mortality, unplanned cardiovascular-related hospitalization) [17].
While the patients in the control group are treated according to standard standards, the patients in the intervention group receive intensive care. This includes the creation of a medication plan, regular, structured physician contact, and the provision of individually prescribed medication in a weekly dosing aid by the pharmacist [18]. Furthermore, the pharmacist checks the patient's blood pressure weekly and inquires about possible symptoms, side effects, or intolerances that could be attributed to the medication or indicate a worsening of the condition. If necessary, the pharmacist contacts the physician and discusses any abnormalities with them [18]. A pilot study in Merzig/Schwemlingen has already been successfully completed [19].
In this model, community pharmacists influence adherence through patient-specific pharmaceutical services (e.g., weekly dosing assistance, application training) and positively influence medication safety through medication checks. Furthermore, regular communication between pharmacists and physicians and the creation of a medication plan contribute to ensuring compliance with the AMTS. The study is scheduled to end in April 2015.1
However, neither the ATHINA project nor the Pharm-CHF study are institutionalized services available to affected patients as part of their medically prescribed pharmacotherapy.
ABDA-KBV future concept
A first step towards a binding, institutionalized and interdisciplinary medication management system is planned with the ABDA-KBV future concept for pharmaceutical supply. The concept was implemented with its essential elements as Section 64a of the Statutory Health Insurance Supply Structure Act (GKV-VStG) in December 2011.
“Model project for pharmaceutical supply” was inserted into the Social Code Book V (SGB V).
The ABDA-KBV model consists of the elements of active ingredient prescription, medication catalog, and medication management. These should be introduced and implemented gradually in the order specified. The central element of the overall concept, medication management for patients with polypharmacy, will be discussed in more detail here. In this concept, medication management stands for cooperative, continuous care of chronically ill patients with polypharmacy by a physician and a pharmacist. Potential participants are contacted about the concept by their health insurance company, the treating physician, or the pharmacist. If the patient agrees to participate in the concept, they select a treating physician and a supervising pharmacist for one calendar year. The content of medication management includes the recording of the patient's entire medication, including self-medication, and the review of drug risks by one of the two selected trusted persons. The physician or pharmacist compiles a preliminary medication list and a risk report. In the subsequent discussion between the two healthcare professionals, necessary interventions are discussed and an up-to-date and complete medication plan is drawn up. During the further course of the care year, the patient is continuously monitored and compliance is encouraged. Drug risks associated with changes in medication are monitored using software-supported interaction checks.
minimized and the medication plan is continuously updated. Any change in medication or newly emerging problems in drug therapy lead to an exchange of information between the doctor and pharmacist [20].
The ABDA-KBV future concept for pharmaceutical supply offers medication management for patients with polypharmacy, a joint approach for physicians and pharmacists to optimize the AMTS. The cooperation between both professional groups is binding, institutionalized, and patient-oriented. Implementation is planned with the "ARMIN" project (Saxony/Thuringia Pharmaceutical Initiative) as a less complex model project under Section 63 of the Social Code Book V of the AOK Plus in Saxony and Thuringia [21]. The evaluation of model projects, mandatory under Section 65 of the Social Code Book V, should then provide important information for future cross-health insurance implementation under Section 64a of the Social Code Book V. The launch of "ARMIN" is scheduled for January 2014.
These examples demonstrate that medication management with the involvement of community pharmacists to optimize the drug delivery system is becoming increasingly important in German pharmaceutical care. Nevertheless, it is clear that there is currently no binding institutionalized model available to all patients, especially high-risk patients such as seniors with multiple morbidities. As shown below, countries such as Switzerland and Australia are further ahead in this regard. In both countries, medication management systems with the involvement of community pharmacists are contractually agreed upon with the health insurance providers and are offered and implemented in an institutionalized manner. Furthermore, interdisciplinary collaboration between physicians and pharmacists is required and promoted by the health insurance providers.
The following section presents medication management projects from Switzerland and Australia, as well as an example of interdisciplinary collaboration between physicians and community pharmacists. Despite the differences in healthcare systems, the experiences gained may be of significant importance for the development of AMTS projects in Germany.
The Polymedication Check (PMC) in Switzerland
Since September 2010, the PMC has been part of the Swiss compulsory health insurance benefits catalogue and can be provided by pharmacists for patients taking four or more prescribed medications over a period of ≥ three months [22]. The check includes the clarification of both patient-related and medication-related difficulties with the prescribed polypharmacy in long-term therapy. The goal of this pharmaceutical service is to increase the efficiency and safety of drug therapy with the involvement of both pharmacists and patients [23, 24].
A pilot study conducted shortly after the implementation of the PMC aimed to analyze initial experiences with the new pharmaceutical service [22]. It showed that the knowledge of medications and pharmacotherapy provided by pharmacists increased patient empowerment.3 The patients participating in the study were on average 72 years old (±10.4 years) and took an average of 9.4 different medications (±3.3). The pharmacist's consultation enabled and motivated them to use their medications as intended [22]. As a compliance aid, pharmacists frequently recommended a weekly dosing system following the PMC. This support and other simplifications in medication therapy initiated by the pharmacists were accepted and recognized by the patients [25]. Furthermore, patients expressed high satisfaction with the service offered and rated the PMC as helpful [22].
The polymedication check, administered by community pharmacists, targets high-risk patients such as seniors and those with multiple morbidities. Its inclusion in the benefits catalogue of compulsory health insurance allows for broad availability of the medication check for those affected. The success of the pharmaceutical intervention will be evaluated in a randomized controlled trial. The study is currently being prepared [27].
The agreement between Swiss pharmacists and the cost carriers of compulsory health insurance includes not only direct patient services but also interdisciplinary cooperation between physicians and pharmacists. Fixed groups of five to eight physicians meet several times a year in quality circles under the leadership of a specially trained community pharmacist. The goal of this exchange is the progressive optimization of medical prescriptions in terms of efficiency and drug safety [28]. Within the framework of the quality circles, the head pharmacist informs the physicians in his circle about their individual prescribing behavior and provides objective treatment recommendations. In addition, he provides them with the latest knowledge about medications. The pharmacist's recommendations are based on the scientific data prepared by the scientific commission of the quality circles of the Swiss Pharmacists Association, as well as comparative statistical figures on the respective prescribing behavior of individual physicians. The latter are provided by the Ofac billing center (Office de invoicing des assurances et caisses-maladie) [29]. In joint discussions, treatment consensuses are sought and agreed upon, taking regional specifics into account, and the physicians commit to their best possible implementation. The implementation of the medically evidence-based treatment and prescription recommendations is reviewed annually by the head pharmacist. For this purpose, the head pharmacist prepares an evaluation of each district physician's prescribing behavior and provides recommendations for further optimization. The evaluation refers to
both an internal and an external comparison.
The circle results are published by the participating insurers
validated. Previous results confirm that participants in the exchange groups have achieved significant cost savings through changes in prescribing behavior, as well as increased independence from the pharmaceutical industry. Furthermore, the collaboration between physicians and pharmacists serves to promote mutual
Increased trust and improved patient safety [29].
The evaluations of the circles and the polymedication check offer payers the opportunity to review and manage the effectiveness and efficiency4 of the measures. A review of the goal achievement and cost-effectiveness of pharmaceutical interventions is also recommended for current and future medication management projects in Germany.
In Australia, the provision of prescription drugs is part of the scope of services provided by the state-run health service. In addition to the provision of pharmaceuticals, the agreement between the government and the pharmacy profession also includes special programs to improve pharmaceutical care for the population, in which community pharmacists can participate under certain quality conditions. These programs recognize the contribution of evidence-based professional pharmaceutical services to improving health and are separately remunerated [30].
The agreement gives special priority to medication management programs. These programs aim to improve the quality of medication use and reduce adverse drug reactions (ADEs), particularly among seniors and patients with polypharmacy [31]. The agreement between the Commonwealth and pharmacists distinguishes four types of medication management:
• The medication check for patients with polypharmacy
• the medication check for recently diagnosed or poorly controlled diabetics
• Medication management for residents in retirement and nursing homes
• a doctor-prescribed home medication review (HMR) [32]

The HMR requires collaboration between the general practitioner, patient, and accredited pharmacist. If certain risk parameters are present and the patient consents, the pharmacist visits the patient at home and checks all medications found there for compatibility and whether they meet any indications. They also explain their medication and its intended use to the patient. Following the home visit, the pharmacist writes a report and sends it to the referring general practitioner. The doctor and patient then jointly prepare a
Medication plan that makes it easy for the patient to understand how to use their medications as intended [33].
Compared to the brown bag method, this medication check requires close collaboration between the treating physician and pharmacist. Furthermore, the pharmacist's home visit to the patient allows for the identification of dietary supplements, for example, that may be relevant to the assessment of the overall medication. However, with the brown bag method, there is no guarantee that the patient will consider these important and bring them to the pharmacy.
Another pharmaceutical service that pursues the goal of AMTS and is offered within the framework of the Australian Health Service concerns patient-specific medication provision in monthly blister packs (Dose Administration Aids, DAA). As early as 2004, Connor et al. demonstrated in the WHO Bulletin that the use of individually packaged medication doses increases patient adherence [34]. The evaluation study of DAAs conducted as part of the third and fourth agreements between the Australian Commonwealth and the pharmacy profession identified four main risk factors that are often associated with low adherence and can lead to an increased risk of medication-related problems. It is assumed that the affected patients can benefit enormously from improved adherence. They are therefore considered the main target group for DAA services [35].
Below, the presented concepts from Germany (D), Switzerland (CH), and Australia (AUS) are assigned to a medication management level based on the pharmaceutical instruments used. This classification is based on the tiered scheme of the Pharmaceutical Care Network Europe (PCNE) and the German Pharmaceutical Society (DPhG) [36].
The examples from Switzerland and Australia show that community pharmacists there implement extended medication management in an institutionalized manner. Clinical medication management is rather difficult to implement in everyday outpatient care due to a lack of structural prerequisites [36]. However, the close interdisciplinary exchange makes it easier for pharmacists to also consider clinical data. Compared to their German colleagues, pharmacists in Switzerland and Australia are thus more closely involved in ensuring AMTS beyond pure drug distribution. The provision of pharmaceutical services by pharmacists is remunerated in accordance with the respective agreements between the payers and service providers, as are the
Collaboration between different healthcare professions is promoted. The pharmaceutical care services covered by compulsory health insurance aim, on the one hand, to support patient compliance. On the other hand, pharmacists influence overall medication through medication checks. Through quality circles, as described for Switzerland, as well as other cross-disciplinary activities, pharmacists can also participate in the development of treatment guidelines and positively influence physicians' prescribing practices. This includes responsibility for the cost-effectiveness of drug therapy.
Lessons to learn
ATHINA, PHARM-CHF, and the ABDA-KBV future concept for pharmaceutical supply show that a rethinking of medication management with the involvement of community pharmacists has also taken place in Germany. However, pharmaceutical services are not yet part of standard care within the statutory health insurance (SHI). Switzerland and Australia, however, already offer such services in an institutionalized way in everyday care and thus actively involve community pharmacists in the responsibility for community medication management. Scientific studies demonstrate the benefits of pharmaceutical services, such as the polymedication check [35], quality circles [37], home medication check [38], and patient-specific medication provision [39] for community medication management of patients, especially seniors.
What steps are necessary to ensure that community pharmacists in Germany, comparable to those in Switzerland and Australia, are actively and bindingly involved in the strategies for optimizing the AMTS shown in Figure 2? This requires, in particular, a greater emphasis on clinical and geriatric pharmacy in pharmacy training, continuing education, and continuing professional development. If regular joint lessons for physicians and pharmacists are held during the course of study, the different perspectives of the healthcare professionals on the drug can be brought together. This promotes understanding of the other profession and facilitates continued collaboration in everyday professional life.
Scientific studies from both abroad and in Germany provide important information on the effectiveness and efficiency of pharmaceutical services, particularly medication management. From this, quality requirements for service providers can be derived in the next step. Pharmacists' efforts should be appropriately compensated, similar to those in Switzerland and Australia. This requires regular review of pharmaceutical interventions for their success and cost-effectiveness based on defined parameters. Medication management and pharmaceutical services extend far beyond the dispensing of medications, with the obligation to provide advice and information pursuant to Section 20 of the Pharmaceutical Practice Regulations (ApBetrO). A change in the remuneration structure in outpatient pharmaceutical care, from the current remuneration solely for dispensing medications to remuneration for pharmaceutical services such as medication management, is urgently recommended.
Community pharmacists can make an important contribution to the AMTS through pharmaceutical services and in cooperation with other healthcare professionals. This opportunity should be exploited more extensively in Germany than before. The examples of Switzerland and Australia demonstrate how this can be done.