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.

Biosimilar medicines.

Biological medicines have become indispensable in the treatment of patients with serious diseases such as cancer and inflammatory diseases. Biosimilars are medicines which are developed to be similar to existing biological medicines (the 'reference product'). For the European market, they are approved by the European Medicines Agency. Owing to the rising importance of biosimilar medicines, the European Association of Hospital Pharmacists (EAHP) decided to set out its position on key issues concerning biosimilar medicines in a position paper. The topics included the role of hospital pharmacists in the uptake of biosimilar medicines in healthcare with regard to selection, procurement, logistics, information, education and collecting real-life experience (eg, in monitoring and pharmacovigilance). In addition, the paper touches on the views of the association for the naming of biosimilar medicines, extrapolation of indications, interchangeability, switching and substitution of biosimilar medicines and the provision of information about biosimilar medicines.

EAHP European Statements survey 2015.

OBJECTIVES: The 2015 EAHP European Statements survey was related to sections 2, 5 and 6 of the European Statements of Hospital Pharmacy (Statements). In addition to collection of statistical data about the level of implementation of the Statements, it was also intended to identify important barriers to their implementation. METHODS: The online questionnaire was sent to all hospital pharmacies in EAHP member countries. Data were analysed by researchers from Keele University School of Pharmacy, UK and the EAHP Survey Group. RESULTS: There were a total of 949 responses (response rate 18%). In the first part of the survey, data was collected on hospital pharmacy setting. While almost half of hospital pharmacies served over 500 beds, 80% of hospital pharmacies had 10 or less pharmacists. In section B, we gathered evidence about the degree of implementation of sections 2, 5 and 6 of the Statements and the main barriers to and drivers of implementation. Five questions with the lowest implementation level were then further analysed. Only five countries had 50% or more of hospital pharmacies reporting that the hospital pharmacists routinely publish hospital pharmacy practice research. 67% of participants stated that they had contingency plans for medicines shortages. The majority of countries (n=20) have less than half of respondents using computerised decision support to reduce the risk of medication errors. When asked if an audit had been undertaken in the past 3 years to identify priorities in medicines use processes, the mean percentage of positive responses for a country was 58%. CONCLUSIONS: EAHP has gained an informative overview of the implementation level as well as the barriers to and drivers of implementation in sections 2, 5 and 6. This is essential to inform the plans for EAHP to best support their implementation.

EAHP European Statements baseline survey 2015: first steps on the implementation journey.

An implementation plan was developed in conjunction with the publication of the European Statements of Hospital Pharmacy. Subsequently a baseline survey on the status of the Statements was conducted with specific questions on awareness, capability and capacity seen as crucial to informing future implementation plans. The baseline survey showed that, 18 months after agreement at the European Summit of Hospital Pharmacy, hospital pharmacists across Europe have a growing awareness of the Statements. There is a significant variation across Europe with awareness levels ranging from 100% to less than 30%. Capacity within European Healthcare systems to achieve implementation is challenging with less than 10% of respondents in most countries indicating sufficient capacity to implement the services described in the Statements. Staff skills and experience to implement the changes was identified by respondents at less than 20% in many countries. The implementation plan will need to be constantly updated and modified to sustain progress.

EAHP European Statements baseline survey 2015: results.

OBJECTIVES: The European Statements baseline survey was designed to give an insight to how well the European Statements of Hospital Pharmacy (the Statements) are being implemented and to help inform the European Association of Hospital Pharmacists (EAHP) implementation strategy for the Statements. METHODS: The online questionnaire was sent to all hospital pharmacies in EAHP member countries. More than 1000 pharmacists completed the survey, which was analysed by Keele University and presented to EAHP. RESULTS: The survey provided general data for each country about the staffing levels and skill mix within each hospital, how well each hospital was implementing each Statement and finally about what were the barriers to implementation for European hospital pharmacists. The survey identified that, generally, the sections covering more traditional roles of hospital pharmacists (procurement, compounding) were being well implemented-96% of respondents indicated that their hospitals had clear processes in place around the procurement of medicines; 91% indicated "When medicines require manufacture or compounding, we either produce them in our hospital pharmacy or we outsource to an approved provider". Compared with that, clinical pharmacy services, multidisciplinary approaches and active engagement in education and practice research activities are challenging areas in most EAHP member countries. In only 29% of hospitals, the pharmacists enter all medicines used onto the patient's medical record on admission. 49% of responders agreed that the pharmacists in their hospital routinely publish hospital pharmacy practice research. Insufficient capacity and capability in terms of staffing and resources seemed to be main reasons given for low implementation of some of the Statements. CONCLUSIONS: After analysis of data from more than 1000 questionnaires, EAHP gained a necessary overview of Statements implementation level and barriers to implementation, needed for informed and efficient progress of EAHP implementation projects.