EAHP European Statements Survey 2018, focusing on Section 1: Introductory Statements and Governance, Section 3: Production and Compounding, and Section 4: Clinical Pharmacy Services.

OBJECTIVES: The 2018 EAHP European Statements Survey focused on sections 1, 3 and 4 of the European Statements of Hospital Pharmacy. Statistical data on the level of implementation and on the main barriers to implementation of the Statements were collected. A further aim was to identify barriers in general, such as lack of awareness. METHODS: An online questionnaire was sent to all hospital pharmacies in EAHP member countries. Data were analysed at Keele University School of Pharmacy, UK. As with previous reports, the survey was divided into three sections: section A, asking general questions about the hospital pharmacy; Section B, addressing questions about the current activity of pharmacists around each statement from Sections 1, 3 and 4; and Section C, focusing on their ability to implement the statements. RESULTS: 719 complete responses were obtained from a sample of 5164 hospital pharmacies, giving a response rate of 14% (719/5164). Section A results indicated that 45% (323/719) of responders worked in teaching hospitals, 79% (568/719) of hospital pharmacies had 10 or fewer pharmacists, and 48% (345/719) of hospital pharmacies served over 500 beds. Section B results found a high percentage of positive responses for activity in section 1 (introductory statements and governance) and section 3 (production and compounding). However, responses to questions in section 4 (clinical pharmacy services) were more variable, with 6 of the 15 questions being answered positively by less than half of respondents. The five questions that revealed the lowest implementation levels were then analysed in greater detail. These questions corresponded to Statements 4.4, 4.5, 4.8, 1.1, and 4.2, which need the greatest effort for implementation. The major identified barriers to implementation were 'lack of capacity' and that 'other health professionals in the hospital fulfil the tasks'. CONCLUSIONS: This survey provides useful information on the implementation status (and the barriers to, and drivers of implementation) of sections 1, 3 and 4 of the Statements. This will allow the EAHP to plan its implementation support programme for its members. To increase the quality of data, as well as the feedback to hospital pharmacies, the EAHP is planning to combine the survey with the self-assessment tool of the European Statements of Hospital Pharmacy.

Lessons learnt from the COVID-19 pandemic: results of EAHP survey on the future crisis preparedness of hospital pharmacies.

AIM: The present survey aimed to collect information on the lessons learnt from the COVID-19 pandemic by hospital pharmacists. It focused on the shortages of health goods and the experiences of hospitals during the first phase of the crisis. METHODS: A 17-question survey was conducted by EAHP, looking at the experiences of hospital pharmacists during the COVD-19 pandemic. The survey ran from 16 September to 23 December 2020. Statistical analysis included backward stepwise logistic regression (BSLR), Pearson's χ2 test, t-test and one-way ANOVA, as appropriate; p≤0.05 was considered statistically significant. RESULTS: 1466 hospital pharmacists answered the survey fully. 58%, 63% and 69% of them experienced shortages in medicines, disinfectants and personal protective equipment (PPE), respectively. BSLR showed that being a COVID-19 dedicated hospital increased the risk of medicine shortages (OR 1.63, 95% CI 1.15 to 2.31) but the shortages of disinfectants and PPE were lower (OR 0.62, 95% CI 0.44 to 0.88; OR 0.60, 95% CI 0.42 to 0.85). Being a specialised hospital reduced the odds of medicine shortages (OR 0.59, 95% CI 0.40 to 0.88), while countries with a greater percentage of the population infected had increased odds for all three types of shortages (OR 1.16, 95% CI 1.01 to 1.23; OR 1.34, 95% CI 1.19 to 1.50; OR 1.21, 95% CI 1.09 to 1.35). The odds were also higher in answers submitted in September compared with December. The classes of medicines with highest reported shortages were anaesthetics, antibiotics and muscle relaxants. The main entities that provided support were the national competent authorities and manufacturers. CONCLUSION: Medicine shortages affected the work of hospital pharmacists during the early stages of the pandemic. The features of the crisis and the feedback described in this survey can provide interesting insights for a more resilient healthcare framework in the future.

Antimicrobial resistance (AMR).

The position paper of the European Association of Hospital Pharmacists (EAHP) highlights the importance of the prudent use of antimicrobial drugs through antibiotic stewardship to ensure efficient therapy for patients with life-threatening infections. EAHP calls on national governments and health system managers to utilise the specialised background and knowledge of the hospital pharmacist in multi-professional antibiotic stewardship teams. In addition, the paper recommends the universal application of infection prevention and control measures among healthcare professionals. Due to the lack of funding, EAHP urges increased investment to support the development of innovative proposals and the encouragement of practice-based research projects to investigate new fields of infectious disease control such as immunotherapy and to optimise the cost-effectiveness of systems for surveillance on antibiotic use and resistance. In relation to the 'One Health approach' of the European Commission, EAHP strongly supports regulatory oversight and proper implementation of measures in the veterinary and agriculture sectors at European, national and local level.

Hospital antibiotic management in Germany--results of the ABS maturity survey of the ABS International group.

BACKGROUND: There is much discussion about which measure or bundle of measures is most efficient in hospital antibiotic management programs, and it is often unknown which parts of such programs are readily available. The ABS International group conducted a survey to estimate the prevalence and characteristics of country-specific hospital antibiotic management programs and program components. This paper summarizes the results for Germany. METHODS: The survey was conducted in April and May 2007. A questionnaire with various items related to hospital antibiotic management including control of consumption and availability of diagnostic microbiology was sent to hospital pharmacists through the ADKA (Bundesverband Deutscher Krankenhausapotheker). The questionnaires were analyzed by calculating mean scores for the various items and topics. MAIN FINDINGS: Of 400 questionnaires sent, 48 were returned and evaluable. Most respondents represented general hospitals in the southern part of Germany. Items that scored high were related to frequency of evaluation of antibiotic resistance data (4.48), availability of (simple) management tools for antibiotic prescribing (4.05), and control of antibiotic consumption (4.02). Items related to the availability of trained and dedicated antibiotic management officers scored very low. CONCLUSIONS: Shortage of trained and dedicated personnel may limit the organization of effective antibiotic management in many German hospitals.

EAHP European Statements Survey 2017, focusing on sections 2 (Selection, Procurement and Distribution), 5 (Patient Safety and Quality Assurance) and 6 (Education and Research).

OBJECTIVES: The 2017 EAHP European Statements Survey focussed on sections 2, 5 and 6 of the European Statements of Hospital Pharmacy. Statistical data on the level of implementation and on the main barriers to implementation of the Statements were collected. A further aim was to identify barriers in general, such as lack of awareness. METHODS: An online questionnaire was sent to all hospital pharmacies in European Association of Hospital Pharmacists (EAHP) member countries. Data were analysed at Keele University School of Pharmacy, UK by and the EAHP Survey Group. RESULTS: There were 783 complete responses (response rate 17.4%). Some 42% of responders worked in teaching hospitals, 76% of hospital pharmacies had 10 or less pharmacists, and 46% of hospital pharmacies served over 500 beds.Five questions revealing the lowest implementation levels were further analysed in greater detail. Only 30% of respondents reported that their hospital pharmacists routinely publish hospital pharmacy practice research, and only 50% are involved in the development of local or national guidelines. 45% of respondents reported that computerised decision support was used to reduce the risk of medication errors in their hospitals, 69% stated that they had contingency plans for medicines shortages and 60% answered that they had had reason to contact their medicines authority because of drug shortages. 63% reported that the transcription step had been eliminated from the medicines administration process. CONCLUSIONS: The survey has provided the EAHP with an overview of the implementation level as well as the barriers to and drivers of implementation of sections 2, 5 and 6. This is important for informing the plans of EAHP and its members so that implementation can be fully supported.

[HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals]. / HERA-QUEST: HTA-Evaluation generischer Arzneimittel zur Verbesserung von Qualität, Oekonomie, Patientensicherheit und Transparenz bei Produktumstellungen in Kliniken.

In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands on quality and transparency, triggered by, amongst others, current legislation (Hospital Structures Act, anti-corruption legislation).

[Renal impairment in patients with thromboembolic event: prevalence and clinical implications. A systematic review of the literature]. / Niereninsuffizienz bei Patienten mit einem thromboembolischen Ereignis: Prävalenz und klinische Implikationen. Eine systematische Übersicht der Literatur.

BACKGROUND AND STUDY OBJECTIVES: The assessment of the renal function of patients with a deep vein thrombosis/pulmonary embolism (VTE patients) is of utmost importance for the selection/dosage of an agent in the initial anticoagulation management of these patients because the majority of available anticoagulants are cleared renally. Specifically, there is a high risk of drug accumulation and subsequent bleedings in patients with severe renal insufficiency. Consequently, specific recommendations have been made for the initial anticoagulation management of these patients in both product labels and AWMF treatment recommendations: some drugs should not be used in these patients, for other drugs a careful use, intensified screening (anti-Xa), or, in the case of enoxaparin, a dose-adjustment are recommended.This literature review aimed to answer the following questions: · What is the prevalence of renal insufficiency in VTE patients?. · Which data are available with regard to the real-world initial anticoagulation management and corresponding clinical outcomes (recurrent VTE events, bleedings, mortality) of these patients? METHODOLOGY: We did a systematic review of existing publications in german or english published in 2004-2014. Only quantitative analyses have been included in the review. RESULTS: We identified 1,135 publications, 37 of them were included in our review. The prevalence of renal insufficiency in VTE patients, defined as CrCl < 60 ml / min, was reported to be 12.3 %-71.9 % related to all VTE patients. The prevalence of severe renal insufficiency, defined as CrCl < 30 ml / min, was reported to be 3,3 %-13,6 %. The substantial ranges in reported prevalences are mainly due to differences in the characteristics of patients addressed in the different publications.A CrCl < 30 ml / min is an independent predictor for both mortality and lethal recurrent pulmonary embolism, possibly also for severe bleedings in VTE patients. In addition to that, a severe renal insufficiency may also be a predictor for the probability that a first VTE event occurs.Several anticoagulants approved for the initial anticoagulation management of VTE patients face the risk of drug accumulation in renally insufficent patients. So, for example, a standard enoxaparin dosage was shown to be associated with elevated bleeding risk compared to adjusted enoxaparin dosage in renally insufficient patients. However, similar data do not exist for other low molecular weight heparins (LMWHs) or unfractioned heparins (UFHs). Only for two LMWHs, Certoparin and Tinzaparin, safety data with regard to renally insufficient patients have been published so far.None of the included studies showed advantages of UFH therapy in comparison to LMWH therapy in initial anticoagulation management of VTE patients. In contrast to that, available evidence shows disadvantageous efficacy/safety of UFH in comparison to LMWH treatment. However, this evidence is not based on head-to-head comparisons but is derived from registry and observational study data only. CONCLUSION: A detailed knowledge of product labels is of utmost importance in the inital anticoagulation treatment of VTE patients because several agents may not be used in the addressed patients with severe renal insufficiency at all while others may be used based on specific dosage/surveillance schemes only. We also recommend to critically appraise the current AWMF treatment guideline because it still recommends initial anticoagulation management with UFHs in VTE patients with severe renal insufficiency. Available data do not support that recommendation.

[Risk Management of Teratogenic Drugs ~The Current States of Practice in Europe, US and Japan~].

Thalidomide was approved for the treatment of multiple myeloma in Japan under a risk management program, named TERMS, in 2008. Since then, we have been conducting a survey of the stakeholders to assess the effectiveness of TERMS. These surveys showed patients had enough knowledge of the risks of thalidomide. In the USA, legislation in 2007 granted its U.S. Food and Drug Administration (FDA) the authority to require Risk Evaluation and Mitigation Strategies (REMS) when necessary to ensure that a drug's benefits outweigh its risks. As of 2015, more than 70 drugs, including thalidomide, have REMS programs. In Germany, in the early 1960s, over 5000 children were born with deformities. Therefore, the safety regulations in Germany go far beyond the European Medicines Agency (EMA) safety regulations at the time of thalidomide re-approval; thalidomide can be prescribed by a special prescribing form, including both proof of the patients' awareness of information about the risks, and participation in a pregnancy prevention program. While Japan has taken similar safety measures, a portion of thalidomide is still privately imported there. By March 2013, 594 patients have been registered to Japan's Safety Management System for Unapproved Drugs (SMUD), which was introduced by the Ministry of Health, Labour and Welfare (MHLW) in 2009. The number of females of child bearing potential (FCBPs) was 33 and the fraction (33/594=5.6%) was higher than that (48/7370=0.7%) in the case of TERMS. Risk management of thalidomide is described in this review.

Prevalence of renal insufficiency in hospitalised patients with venous thromboembolic events: a retrospective analysis based on 6,725 VTE patients.

Renal impairment (RI) is an important factor in the selection of anticoagulant therapy in venous thromboembolic event (VTE) patients. In particular, the risk of bleeding events is higher for VTE patients with a glomerular filtration rate (GFR) below 30 mL/min. The aim of this study was to collect data on the prevalence of RI in hospitalised VTE patients in Germany. Furthermore, we investigated how renal function changed during inpatient treatment. We conducted a retrospective chart review in six German hospitals. All patients with a VTE diagnosis who were treated as inpatients from 2007-2011 were included. Patients were categorised according to their renal function. RI was estimated from serum creatinine values. Persistent RI was defined as an estimated glomerular filtration rate (eGFR) of <30 mL/min over at least 72 hours. Renal function could be determined for 5,710 VTE patients. Of these 21.4% had an eGFR>90 mL/min, 38.1% had an eGFR of 60-89 mL/min, 17.3% had an eGFR of 45-59 mL/min, 12.5% had an eGFR of 30-44 mL/min, 7.2% had an eGFR of 15-29 mL/min and 3.6% of the VTE patients had end-stage renal disease. Persistent severe RI was observed in 74.8% of patients with an eGFR <30 mL/min. Overall, 40.6% of the VTE patients investigated had an eGFR <60 mL/min; 10.8% had an eGFR <30 mL/min. Almost three quarters of RI-VTE patients suffered from persistent severe RI. These results suggest that more than one in ten VTE patients is exposed to a high risk of accumulating anticoagulants; most of these RI patients also face an increased risk of mortality.

[Medication errors and medication reconciliation from a hospital pharmacist's perspective]. / Bericht aus der Praxis: Medikationsfehlererfassung und Medication Reconciliation aus Sicht der Krankenhausapotheker.

To reduce medication errors and other drug-related problems, their systematic discovery, documentation and evaluation is essential. The web-based documentation database ADKA-DokuPIK enables both the documentation and the publication of annotated individual cases and, moreover, systematic errors or accumulations of risk drugs may be determined. Medication reconciliation is another important component to increase safety in drug therapy. Hospital pharmacists may support and significantly improve this process. In Germany some initial information from various projects is available. Medication reconciliation performed by hospital pharmacists may significantly increase the completeness and accuracy of medication regimens. Patient counselling together with the necessary drug supply at discharge improves patients' knowledge, closes supply gaps and improves the satisfaction of all parties.