Investigation of the hospital pharmacy profession in Europe.

OBJECTIVE: From 1995, the European Association of Hospital Pharmacists (EAHP) has regularly investigated the progress of the hospital pharmacy profession in Europe, and identified key barriers and drivers of this. The most recent 'Investigation of the Hospital Pharmacy Profession in Europe' was conducted from November 2022 to March 2023. METHODS: The online questionnaire was sent to all hospital pharmacies in EAHP member countries. The investigation was drafted using the same questions as the 2015 baseline survey. Where possible and relevant, responses were compared with the data from previous surveys that monitored the implementation of the EAHP statements. Keele University, Centre for Medicines Optimisation, School of Pharmacy and Bioengineering, UK analysed the data. RESULTS: The overall number of responses was 653, with a better response rate of 19% compared with 14% in 2018 statements survey. The findings indicated that participating hospital pharmacies have similar characteristics to previous surveys. Section 1 (Introductory statements and governance), section 2 (Selection, procurement and distribution), section 3 (Production and compounding), section 5 (Patient safety and quality assurance) questions were generally answered positively, with results ranging from 52% to 90%. However, results for section 4 (Clinical pharmacy services) returned lower levels of positivity, with responses from 8 of the 15 questions being less than 60%. When asked what is preventing hospital pharmacists from achieving implementation of these activities, most answers were limited capacity, not considered to be a priority by managers, or other healthcare professionals do this. The last section focused on self-assessment and action planning, with fewer than 50% of positive responses; COVID-19 preparedness and vaccines with mixed positive and negative responses. Furthermore, implementation of the falsified medicines directive impacted the medication handling processes in 50% or more of the answers. Regarding sustainability, the majority (59%) of respondents felt a greater focus should be on sustainability from an organisational or management perspective. CONCLUSION: Results offer valuable insights into the hospital pharmacy profession throughout Europe. While there have been improvements in certain areas, challenges remain, particularly in implementing clinical pharmacy services. The findings provide a foundation for further dialogue, advocacy, and strategic planning to advance the role of hospital pharmacists and enhance patient care in Europe's healthcare systems.

Results of EAHP's 2023 shortages survey.

AIMS AND OBJECTIVE: The aim of the European Association of Hospital Pharmacists (EAHP)'s 2023 shortages survey was to collect data on causes and mitigation strategies of shortages of medicines and medical devices and their impact on patient care. The survey targeted hospital pharmacists (HPs), physicians (PHYs), nurses (NRS) and other healthcare professionals (OHCPs). A separate set of questions addressed patients (PTNs). METHODS: A 49-question survey was carried out by a team at EAHP, collecting information from European HPs, PTNs, NRS, PHYs and OTHCs on shortages of medicines and medical devices in their respective countries. The survey ran from 27 February to 19 May 2023. The results were analysed by EAHP. RESULTS: There were 1497 HP responses to the 2023 survey. While 95% (n=1429) of HPs and 86% (n=127) of OHCPs consider medicine shortages an ongoing problem, 84% (n=48) of PHYs and 68% (n=15) of NRS also agreed. Shortages of active pharmaceutical ingredients (77%, n=1148), manufacturing (67%, n=1007) and supply chain problems (50%, n=752) are major causes of shortages according to HPs as well as NRS and OHCPs; PHYs (49%, n=18) consider pricing to be the driver. More than 60% (n=765) of HPs, 55% (n=11) of NRS, 57% (n=30) of PHYs and 46% (n=56) of OHCPs experienced shortages of medical devices in 2022. Antimicrobials were most affected, according to all respondent groups, followed by analgesics, anaesthetics, cardiovascular and paediatric medicines. HPs (59%, n=269), NRS (57%, n=4), OHCPs (56%, n=37) and PHYs (54%, n=14) consider delays in care as the main consequence of medication shortages. CONCLUSIONS: Shortages of medicines and medical devices affect healthcare services and patient care. Increased transparency and access to information regarding ongoing and emerging shortages as well as better preparedness of healthcare professionals is crucial to their effective management.

Perspectives of primary care physicians on academic detailing for antimicrobial stewardship: feasibility and impact assessment.

OBJECTIVE: To understand primary care physicians' perspectives on academic detailing from an antimicrobial stewardship team to combat antibiotic overuse for upper respiratory infections and bronchitis in the COVID-19 era, which will help prevent avoidable outpatient visits. METHODS: In this prospective study, 14 female Croatian physicians completed standardized qualitative interviews using a semi-structured guide. The data were analyzed using inductive methodology based on reflexive thematic analysis. We used a theoretically informed approach based on a conceptual framework of healthcare intervention implementability focused on three domains: acceptability, fidelity, and feasibility. RESULTS: We identified six key themes highlighting barriers to changing prescribing practices, with patient pressure and specialist recommendations having an impact on the effectiveness of academic detailing. Despite challenges, primary care physicians described appreciation of direct interaction with evidence-based practices and reported usefulness, effectiveness, and further need for academic detailing. CONCLUSION: This study highlights the complex dynamics involved in implementing healthcare interventions and provides valuable insights for enhancing strategies directed at improving antibiotic prescribing practices. Specifically, our findings emphasize factors influencing behavior changes in physicians' antibiotic prescribing. The authors advocate for a collaborative approach involving community and hospital-based professionals to provide tailored guidance and address questions, ultimately improving prescribing practices.

Patients perspectives on drug shortages in six European hospital settings - a cross sectional study.

BACKGROUND: It is known that drug shortages represent a major challenge for all stakeholders involved in the process, but there is little evidence regarding insights into patients' awareness and perspectives. This study aimed to investigate the patients-perceived drug shortages experience and their view on outcomes in different European hospital settings. Furthermore, we wanted to explore information preferences on drug shortages. METHODS: A retrospective, cross sectional, a mixed method study was conducted in six European hospital settings. One hospital (H) from each of this country agreed to participate: Bosnia and Herzegovina (H-BiH), Croatia (H-CR), Germany (H-GE), Greece (H-GR), Serbia (H-SE) and Poland (H-PO). Recruitment and data collection was conducted over 27 months from November 2017 until January 2020. Overall, we surveyed 607 patients which completed paper-based questionnaire. Questions related to: general information (demographic data), basic knowledge on drug shortages, drug shortages experienced during hospitalization and information preferences on drug shortage. Differences between hospital settings were analyzed using Chi-squared test or Fisher's exact test. For more complex contingency tables, Monte Carlo simulations (N = 2000) were applied for Fisher's test. Post-hoc hospital-wise analyses were performed using Fisher's exact tests. False discovery rate was controlled using the Bonferroni method. Analyses were performed using R: a language and environment for statistical computing (v 3.6.3). RESULTS: 6 % of patients reported experiences with drug shortages while hospitalized which led to a deterioration of their health. The majority of affected patients were hospitalized at hematology and/or oncology wards in H-BiH, H-PO and H-GE. H-BiH had the highest number of affected patients (18.1 %, N = 19/105, p < 0.001) while the fewest patients were in H-SE (1 %, N = 1/100, p = 0.001). In addition, 82.5 %, (N = 501/607) of respondents wanted to be informed of alternative treatment options if there was a drug shortage without a generic substitute available. Majority of these patients (66.4 %, N = 386/501) prefer to be informed by a healthcare professional. CONCLUSIONS: Although drug shortages led to serious medical consequences, our findings show that most of the patients did not perceive shortages as a problem. One possible interpretation is that good hospital management practices by healthcare professionals helped to mitigate the perceived impact of shortages. Our study highlights the importance of a good communication especially between patients and healthcare professionals in whom our patients have the greatest trust.

Risks in Antibiotic Substitution Following Medicine Shortage: A Health-Care Failure Mode and Effect Analysis of Six European Hospitals.

Introduction: Medicine shortages result in great risk for the continuity of patient care especially for antimicrobial treatment, potentially enhancing resistance rates and having a higher economic impact. This study aims to identify, describe, assess, and assign risk priority levels to potential failures following substitution of antimicrobial treatment due to shortages among European hospitals. Furthermore, the study investigated the impact of corrective actions on risk reduction so as to provide guidance and improve future patient care. Methods: Health-care failure mode and effect analysis (HFMEA) was applied to hospitals in Austria (H-AT), Belgium (H-BE), Croatia (H-CR), Greece (H-GR), Spain (H-SP), and Serbia (H-SR). Multidisciplinary teams identified processes, failure modes, causes, and corrective actions related to antibiotic substitution following medicine shortages. Characteristics of study hospitals as well as severity, probability, and hazard scores (HSs) of failure modes/causes were analyzed using Microsoft Office Excel 2010 and IBM SPSS Statistics® via descriptive and inferential statistics. Results: Through HFMEA, 74 failure modes were identified, with 53 of these scoring 8 or above on the basis of assigned severity and probability for a failure. Severity of failure modes differed before and after corrective actions in H-CR, H-GR, and H-SR (p < 0.005). Their probability differed in all study hospitals (p < 0.005) when compared before and after corrective actions aimed to be implemented. The highest number of failure-mode causes was detected in H-CR (46) and the lowest in H-SP (16). Corrective actions can address failure modes and lower HSs; therein, all teams proposed the following: structuring communication among stakeholders, introducing electronic prescribing, strengthening pharmacists' involvement, and increasing effectiveness of the ward stock assessment. These proposed actions led to HS reductions up to 83%. Conclusion: There is a lack of structure in addressing risks associated with antibiotic substitution following shortages. Furthermore, lack of communication, data scarcity on availability of antibiotics, non-supportive information technology (IT) systems, and lack of internal substitution protocols hinder quick assessment of alternatives addressing patient needs. Nevertheless, the study shows that health-care professionals manage to secure optimal antimicrobial treatment for patients using available IT and human resources.

Severe hyperglycaemia following pazopanib treatment: The role of drug-drug-gene interactions in a patient with metastatic renal cell carcinoma-A case report.

WHAT IS KNOWN AND OBJECTIVE: Pazopanib is a tyrosine kinase inhibitor with hyperglycaemia as a known adverse event, but case reports of severe hyperglycaemia are exceptional. We report a case of severe hyperglycaemia following pazopanib administration in a patient with metastatic renal cell carcinoma. CASE SUMMARY: Severe hyperglycaemia developed in a patient one month following initiation of pazopanib therapy. As drug-drug-gene interactions may lead to hyperglycaemia, pharmacogenetic assessment was requested. The obtained findings indicated intermediate function of both OATP1B1 and P-glycoprotein transporters, which may cause prolonged pazopanib bioavailability and increased toxicity. Pazopanib was discontinued and, following patient recovery, was reintroduced at a lower dose. WHAT IS NEW AND CONCLUSION: The pharmacogenetic profiling of the patient on polypharmacy enabled better management of pazopanib therapy.

Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications.

INTRODUCTION: While medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice. METHODOLOGY: A semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns. RESULTS: The participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy. CONCLUSION: The study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe.

Antimicrobial stewardship effectiveness on rationalizing the use of last line of antibiotics in a short period with limited human resources: a single centre cohort study.

OBJECTIVE: Antibiotics reserve (ARs) are given as a last line of treatment when other antibiotics are no longer effective. Rising threat of antimicrobial resistance makes growing use of ARs a real problem to patient safety. A single centre interventional cohort study was conducted in order to measure impact on clinical outcomes of A-team programme with limited human resources in a short period. A-team programme started on 01. September 2017. RESULTS: In 3 months preintervention and 3 months intervention period, from 3038 and 3156 hospitalized adult patients, 249 (59% of them were male, median age = 69 years) and 96 (51% of them were male, median age = 70 years) received parenteral ARs. Total duration of hospitalization of patients on AR was reduced from 28 to 17 days of hospitalization on 100 patient-days (OR = 1.92; 95% CI 1.83-2.01; p < 0.001) with no statistical significant difference in rehospitalisation due to infection of patients that were treated with ARs within 2 months after discharge. Despite short period of time and limited human resources, A-team restrictive interventions rationalised parenteral AR use and led to positive impact on clinical outcomes. These results could help our and other A-teams in similar situation in continuing with the programme to bring more evidence.