Pharmaceutical care for patients with gynaecological malignancies in the outpatient setting : a pilot study

Pharmaceutical care in oncology aims at reducing treatment-related toxicity and improve patients’ quality of life. The objective of this pilot study was to develop a specific pharmaceutical care model for breast and ovarian cancer including patient counselling, optimisation of supportive medication and the implementation of a therapeutic algorithm for antiemetic prophylaxis. Additionally, it is the objective of this pilot study to assess the value and feasibility of therapeutic drug monitoring in outpatient settings for patients treated with antineoplastic agents, in particular carboplatin and its contribution to pharmaceutical care. Patients with breast or ovarian cancer treated with chemotherapy for the first time were included. The feasibility and outcome of this pharmaceutical care model was investigated using a prospective, multi-centred, sequential control group design. Quality of life (QoL) served as the primary endpoint. Patient satisfaction with the information on cancer treatment and the response to the antiemetic treatment were evaluated as secondary endpoints. The results regarding the health-related quality of life were difficult to interprete. Looking at the complete treatment period the global health status/QoL decreased in the control group in the median relatively to the baseline by 14% compared to only 6% in the intervention group by (p = 0.563, Mann-Whitney U-test). The quality of life could not be improved but stabilised in comparison to the control group. For certain symptom scales an improvement could be achieved (e.g. pain, constipation) which was not statistically significant. The global satisfaction with information on cancer treatment was significantly improved throughout the study (CG: median = 3.94, IG: median = 4.41, p = 0.014, Mann-Whitney U-test). Two of the 4 subscales also improved significantly. The patients’ perception of pharmacists much improved throughout the study. Only 15% of the patients in the control group described the pharmacist as one of their most important sources of information compared to 68.4% in the intervention group. This increase was statistically significant (p = 0.001, Mann-Whitney U-test). The strongest criterion to assess the success of the prevention of nausea and emesis is the complete response (CR) to the antiemetic treatment. Looking at the full treatment period for the intervention group an increase in the number of cycles with CR in emesis could be achieved (p = 0.155). The incidence of nausea could not be improved by the intervention. The monitoring of carboplatin confirmed results of previous earlier publications on this topic. In the median the achieved AUC differed from the target AUC by 21.7%. The doses necessary to achieve the target AUC would have needed to be in the mean 31.1% (SD 13.65%) higher than the actual dose given. This pilot study can be rated as an inital contribution to the development of pharmaceutical care models in oncology. Patients with breast and ovarian cancer seem to benefit from pharmaceutical care as demonstrated by improved clinical and subjective outcomes. The pharmaceutical care model was feasible and integrated in the daily routine. It was well accepted by patients and health care providers. The results of the TDM show a necessity to reconsider the individual dosing strategies for carboplatin in combination with paclitaxel. It proved to be feasible in the outpatient setting and was tolerated by the patients. In future pharmaceutical care research in oncology further effort should be made to develop improved outcome parameters which are capable of reflecting the impact of pharmaceutical care and allow conclusions on the quality of care. Additionally it should focus on additional aspects such as further patient needs, pharmacoeconomic aspects and standardisation for the integration into disease management programmes

Minimising treatment-associated risks in systemic cancer therapy

Aim of the review To review the consequences of drug-related problems (DRP) in systemic cancer therapy and identify specific contributions of the pharmacist to minimise treatment-associated risks. Method Searches in PubMed, Embase and the Cochrane Library were conducted. Bibliographies of retrieved articles were examined for additional references. Only papers in English between 1980 and 2007 were included. Results In systemic cancer therapy there is an enormous potential for DRP due to the high toxicity and the complexity of most therapeutic regimens. The most frequently reported DRP can be classified into adverse effects, drug–drug interactions, medication errors, and non-adherence. Pharmacists have enhanced efforts to assure quality and safety in systemic cancer therapy together with other health care providers. In consequence, oncology pharmacy has evolved as a novel specialist discipline. The endeavour to merge and co-ordinate individual activities and services of the pharmacist has led to pharmaceutical care concepts which aim at offering novel solutions to the various DRP. Conclusion Pharmaceutical care for cancer patients should be developed within research projects and integrated into disease management programs in order to ensure broad implementation

Acceptance of an oncologic addendum for the application of the German Standardized Medication Plan in oral anticancer drug therapy

Background: The Federal Standardized Medication Plan (BMP) offers the possibility of providing patients with specific information on drug therapy. Cancer patients who are treated with oral anticancer drugs have a great need for information as they take the drugs independently in their home environment. Providing specific instructions for oral anticancer drugs may enhance the patient role and improve medi-cation safety.Methods: In a four-step process (needs assessment, compilation of the text modules, pilot and main phase), an oncologic addendum for the BMP was developed and subjected to an acceptance test. Also, a needs assessment was conducted with oncologists, pharmacists and patients to identify important information to be included in the oncologic addendum. Subsequently, the acceptability of the BMP including the addendum ('Onko-BMP') was tested among health care providers and patients in two study phases (pilot and main phase). Updates made to the Onko-BMP were documented at each follow-up visit. At the end of the observation period, discrepancies between a brown bag review and the latest Onko-BMP were identified to evaluate its completeness. In addition, acceptance of the Onko-BMP was analyzed using qualitative methods. At the end of the pilot phase the patients were interviewed and completed a questionnaire at the end of the main phase. Focus interviews and a focus group were conducted with the health care providers.Results: A total of 347 health care providers and cancer patients participated in the needs assessment, including 167 oncologists, 130 pharmacists, and 50 patients. Suggestions for additional information to be included in the oncologic addendum mainly included instructions for how to take the medication, therapy-limiting side effects as well as potentially relevant interactions with over-the-counter drugs. Ten patients participated in the pilot phase and 60 patients in the main phase of the project. The use of the Onko-BMP was positively evaluated by all participants. The majority of the 178 updates in the main phase were made by the patients themselves. Most frequently, missing items were added (62). After com-parison with the brown bag at the end of the observation period, 175 discrepancies for a total of 270 pro-ducts, including food supplements (mean 6.3 +/- 3.9), and 245 drugs (mean 5.7 +/- 3.1) taken by the patients were detected, 49 of which were due to missing drugs on the Onko-BMP, mainly on-demand medication (30). 82 documented discrepancies were for prescription drugs. In the qualitative surveys, health care providers indicated that there is a high need for the Onko-BMP. In particular, its use could strengthen the patient's role in therapy. The frequently missing or poor technical requirements for working with the BMP were perceived as limiting its widespread use. Assignment of clear responsibilities and remuneration of all professionals involved were identified as important influential factors for an efficient use of the Onko-BMP. Patients considered the added value of the Onko-BMP primarily to be in their being able to inform their treating physicians and pharmacists about their medication.Conclusions: The developed Onko-BMP gained a high level of acceptance among patients and health care providers. It can improve education about oral anticancer drugs and thereby strengthen the patient role. However, in order to ensure widespread use of the tool, the necessary conditions should be created on the part of the health care providers. In particular, the IT infrastructure for its use in daily routine needs to be improved in order to exploit its full potential and ensure its successful large-scale implemention

Clinical pharmacy services in Germany: a national survey

Objectives Clinical pharmacy services in German hospitals appear to be underdeveloped compared with other European countries. However, recent developments have increased the interest in expanding these services. Detailed data about the current state of clinical pharmacy services in Germany are lacking. This survey establishes the current level of pharmacy services in Germany and the barriers to implementation. Methods An online survey conducted in 2017 was distributed to directors of all 389 German hospital pharmacies. The survey contained 26 questions addressing hospital and pharmacy characteristics, clinical pharmacy services provided, the number of clinical pharmacists and the frequency as well as the quality assurance of these services. Results There were 133 responses (34%). Of these, 84 (63%) pharmacies provided some form of clinical pharmacy services. Based on the 389 contacted pharmacies, a clinical pharmacy service is available in at least 22% of hospital pharmacies in Germany. On average there are 2.4 full-time equivalent (FTE) clinical pharmacists per hospital employed, although there is a wide variation in numbers (0.3-22 FTE) and service provision between hospitals. Clinical pharmacy services are generally provided on a daily or weekly basis, with a principal focus on general surgery, critical care and general medicine wards. Conclusions This is the first survey providing a detailed picture of clinical pharmacy services in Germany. There is wide variation in clinical service provision among hospitals, with some hospitals having developed a comprehensive range of clinical services. Compared with other countries, particularly the UK where the focus has shifted to provision of 7-day clinical services, the gap in clinical pharmacy services remains large. The focus should be turned to refining clinical pharmacy services in hospital admissions and discharge planning while also improving Health IT, the opportunities for specialisation and aligning education in accordance with the EAHP common training framework

Incidence of infections due to third generation cephalosporin-resistant Enterobacteriaceae - a prospective multicentre cohort study in six German university hospitals

BackgroundInfections caused by third generation cephalosporin-resistant Enterobacteriaceae (3GCREB) are an increasing healthcare problem. We aim to describe the 3GCREB infection incidence and compare it to prevalence upon admission. In addition, we aim to describe infections caused by 3GCREB, which are also carbapenem resistant (CRE).MethodsIn 2014-2015, we performed prospective 3GCREB surveillance in clinically relevant patient specimens (screening specimens excluded). Infections counted as hospital-acquired (HAI) when the 3GCREB was detected after the third day following admission, otherwise as community-acquired infection (CAI).ResultsOf 578,420 hospitalized patients under surveillance, 3367 had a 3GCREB infection (0.58%). We observed a similar 3GCREB CAI and HAI incidence (0.28 and 0.31 per 100 patients, respectively). The most frequent pathogen was 3GCR E. coli, in CAI and HAI (0.15 and 0.12 per 100 patients). We observed a CRE CAI incidence of 0.006 and a HAI incidence of 0.008 per 100 patients (0.014 per 1000 patient days).ConclusionsComparing the known 3GCREB admission prevalence of the participating hospitals (9.5%) with the percentage of patients with a 3GCREB infection (0.58%), we conclude the prevalence of 3GCREB in university hospitals to be about 16 times higher than suggested when only patients with 3GCREB infections are considered. Moreover, we find the HAI and CAI incidence caused by CRE in Germany to be relatively low