The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
A toolbox for patients safety challenge
European Statement
Patient Safety and Quality Assurance
Author(s)
CHIARA CARCIERI, SILVIA SCALPELLO, MARISA FIORDELISI, MARIA CARMEN AZZOLINA, ANNALISA GASCO
Why was it done?
Errors in drug therapy affect the entire drug management process. The literature show that 56% of patients are at risk of having medications discrepancies and errors at transitions of care. Ineffective communication between healthcare professionals and patients/care-giver or interprofessional, can generate patient intake errors, sub-adherence and therapeutic failures. This harms are avoidable and the aim of this work was to minimise errors and optimise medicines use by different strategy, as recomands by the World Health Organization (WHO) in The Global Patient Safety Action Plan 2021–2030.
What was done?
At the Mauriziano Hospital a multilevel system has been developed to prevent, early identify, resolve and monitor the problems that, in different steps of patients path, can generate risks related to therapy at transitions of care.
How was it done?
Different tools has been developed and implemented in the patients clinical path in order to assurance risk management for patients in transition of care:
1. Hospital pharmacist consulting has been activated to support physician in for in patients medical reconciliation;
2. Therapeutic reconnaissance and reconciliation electronic card (SRR-T) has been developed and integrated in the dicharge letter;
3. Classification of the hospital pharmacists interventions in the transition of care to avoid medical errors was created as risk management tool.
4. Telepharmacy service to monitor patients follow-up at distance was activated.
5. Educational paths have been implemented to improve patient medication literacy throught professional counselling by pharmacists in discharges.
What has been achieved?
Medication safety tools implemented have improved communication between healthcare professionals (intra and inter-hospital) and between healthcare professionals and patients. The patient-centred approach allows to focus on key points in the medication process to correct intake therapy and minimized correlated risks. Physician was supported by pharmacists and facilitated in the correct management of prescriptins. In 4 months the pharmacists carried out 470 corrective interventions of which 31 with possible clinical impact for the patient. Appropriate process put in place allow to minimize expenditure of supplementary health resources by National Healthcare Service.
What next?
In the future it will be useful to develop specific pathways for polytherapy patients and invest in automation of processes such as drug logistics.
HANDLING OF HAZARDOUS DRUGS IN HEALTHCARE SETTINGS – HAZARD EVALUATION AND PROTECTIVE MEASURES RELATED TO EXPOSURE LEVELS
European Statement
Patient Safety and Quality Assurance
Author(s)
Falko Schüllner, Martina Jeske, Martin Munz, Sabine Bischinger, Anna Reich
Why was it done?
The right handling of hazardous drugs in healthcare settings is essential to ensure occupational safety and health as the use and number of these potent drugs increase. In the last decades, protection at the workplace has become more important and several organizations analyze substances for this very reason. Although the antineoplastic drugs remain the principal focus, other drugs may also be considered hazardous because they are potent or cause irreversible effects.
What was done?
In this study drugs used in the University Hospital considered hazardous and to describe potential exposure values were evaluated in connection with exposure limits. A health risk assessment was conducted regarding protective measures related to exposure levels.
How was it done?
The National Institute for Occupational Safety and Health (NIOSH) assumes five categorizations with hazardous potential. According to their ATC-Code, substances from this categorization were listed. Findings of the European Chemicals Agency (C&L inventory), European Directorate for the Quality of Medicines & HealthCare, manufacturer’s guidance, European public assessment report, and safety data sheets were compared with categorization from the International Agency for Research on Cancer, NIOSH, Food and Drug Administration pregnancy categories, and publications from the German Berufsgenossenschaft für Gesundheit und Wohlfahrtspflege. The topic of exposure was divided into a determination of exposure limits in safety data sheets or in the “Grenzwerteverordnung” and into published information regarding exposure in healthcare settings. Monoclonal antibodies were examined separately. For risk assessment purposes, Stoffenmanager and other relevant tools were used.
What has been achieved?
717 substances were analyzed. 461 of them showed at least one probable hazardous or hazardous characteristic. It was possible to establish 177 threshold values, 124 for hazardous substances. The range of threshold values for the criterion “hazardous” was 0,015 μg/m3 – 10 mg/m3. Further research yielded a few public health publications referring to exposure values.It is hardly possible to quickly obtain information on the hazard potential of drugs, but C&L inventory has shown good results . Beside, there is a lack of data on exposure limit values, which is due to the difficulty in providing safety data sheets from manufacturers. As a result, exposure tools are not readily available for use by healthcare workers.
What next?
In an ongoing process every new drug will be evaluated towards the hazardous properties respectively associated exposure limits and communicated to the health care workers in the institution.
IMPLEMENTATION DESIGN OF A SECURITY STRATEGY IN THE HANDLING OF HAZARDOUS DRUGS IN A SOCIAL HEALTH CENTRE
European Statement
Patient Safety and Quality Assurance
Author(s)
CRISTINA MORA HERRERA, VICTORIA VAZQUEZ VELA
Why was it done?
Occupational exposure to HD can cause health damage to exposed healthcare professionals, so protective measures must be taken
What was done?
The hazardousness of drugs can cause damage due to exposure in healthcare workers from Social Health Centers (CSS). As an objective, the design of a security strategy in the handling of hazardous drugs (HD) was proposed with the elaboration of a safety working procedure (SWP) and preventive measures. In addition, the HDs were identified, with proposals for alternatives and recommendations for handling and administration were released.
How was it done?
Observational cross-sectional study to identify employment MPs in a public CSS. The demographic characteristics of the patients and their Pharmacotherapeutic prescription were recorded. A total of 107 residents were included, with a mean age of 78.9 years and 59.8% (64) men. The average stay in the center was 7.4 years (1-27). Regarding functional capacity, 53.3% were considered assisted, 89% of them with grade III -II assessment, that is, large dependents and severe dependents. Of the valid group (46.7%), 70% belonged to socially excluded. The most prevalent pathologies in the center are vascular, neurodegenerative, osteomuscular and respiratory. The mean number of medications per patient was 4.8. Only 6 patients did not receive Pharmacological treatment.
The design of the security strategy was structured in 3 phases; 1st)Elaboration of an SWP with assignment of functions/responsibilities, preventive measures to be adopted in the handling of HDs, description of the circuit and quality indicators of the strategic procedure; 2nd)Carrying out a descriptive observational cross-sectional study to identify the HDs used. The list of active principles (AP) included “NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2014” was compared with those included in the GFT of the center; 3rd)Releasing of recommendations through information sessions/ workshops for healthcare professionals.
What has been achieved?
An effective and safe employment system/circuit is established in the SWP, with relative preventive measures to control associated risks that may occur in handling and/or administration. 22 HDs were identified. A safer alternative was proposed for 9. Recommendations for the handling of HDs, associated risks and proper use of PPE were disseminated through 2 training sessions.
What next?
The identification of hazardous drugs and communication of improvement actions made it possible to implement a standard work procedure guaranteed safety in handling, and to provide an adequate means to avoid exposure due to healthcare workers.
ISMP MEDICATION SAFETY SELF ASSESSMENT® FOR HIGH-ALERT MEDICATIONS – ASSESSMENT OF THE SAFETY OF SYSTEMS AND PRACTICES ASSOCIATED WITH SIX CATEGORIES OF HIGH-ALERT MEDICATIONS
European Statement
Patient Safety and Quality Assurance
Author(s)
A. Sonnleitner-Heglmeier, M. Jeske, C. Petter, S. Grimm, S. Kerndler, U. Horvath
Why was it done?
The aim of this initiative was to assess, from December 14, 2018 to February 7, 2019, the practices associated with six high-risk drug classes – opioids, insulin, anticoagulants, methotrexate for non-oncological indications, muscle relaxants, chemotherapeutics – and high-risk drugs in general at the Unversity Hospital Innsbruck using the ISMP Medication Safety Self Assessment® for high-risk drugs. A further reason was to build up a strong and active cooperation amongst interdisciplinary teams with the focus on clinical pharmacy to raise awareness towards the competencies of clinical pharmacists.
What was done?
We translated, adjusted and introduced the Medication Safety Self Assessment® for High-Alert Medications from the Institute for Safe Medication Practice (ISMP) – U.S.A. to our university hospital. With a clinical pharmaceutical approach in multidisciplinary teams, we revealed challenges on different wards in the hospital and discussed and planed appropriate solutions.
How was it done?
The first step was to find an appropriate assessment accreditation programm which was found by the ISMP Medication Safety Self Assessment® for High-Alert Medications. This tool offers the opportunity to assess the safety of systems and practices associated with up to 11 categories of high-alert medications. As the assessment was written in english it had to be translated by us into german for a better basis for discussions. Further, as the ISMP assessment is implemented in the U.S.A., words and processes had to be adjusted to the work in an austrian university hospital. To optimize the outcome of the ISMP, the drug therapy pharmacy department, health care practitioners, and care management, jointly implemented a quality assurance project.
What has been achieved?
Different hazardous workflows and medication handling processes beginning from pharmacy despensing until receiving patients got identified and discussed. The urgent need of a patient data management system was emphasized to safely ensure a closed loop medication management. This would allow a clear and trackable communication in and between different wards and reduction in errors made by clincal staff.
What next?
The foundation was built for compulsory personal trainings done by clinical pharmacists on different wards. The awareness towards the importance of clinical pharmacy was strongly increased leading to more inclusion e.g. developing guidelines.
DEFINING DOSAGE REGIMENS OF ERLOTINIB AND GEFITINIB IN NON-SMALL CELL LUNG CANCER PATIENTS USING MODELLING AND SIMULATION (submitted in 2019)
European Statement
Clinical Pharmacy Services
Author(s)
SOFIA KONSTANTINIDOU, VANGELIS KARALIS
Why was it done?
Tyrosine kinase inhibitors (TKIs), like erlotinib and gefitinib, are widely used in anticancer therapy. However, after long term administration of TKIs, resistance is observed in the majority of patients. Thus, it is necessary to be able to define individualised dosage regimens for TKIs in cancer patients. Nowadays, modelling and simulation approaches represent the most powerful tool in the hands of clinical pharmacists towards precision medicine.
What was done?
Population pharmacokinetic (PK) – pharmacodynamic (PD) modelling was utilised to simulate erlotinib and gefitinib dosage regimens for non-small cell lung cancer. In silico clinical trials with virtual patients, of several resistance levels, were simulated in order to optimise pharmacotherapy and get better therapeutic outcomes.
How was it done?
The utilised PK/PD model and average parameter values were obtained from the study of Eigenmann and colleagues. This model was fully validated using statistical criteria and goodness of fit plots. In order to simulate many possible conditions that may occur in clinical practice, several different values of erlotinib and gefitinib clearance, absorption rate, pharmacodynamic characteristics (like tumor volume), and resistance were assessed. In addition, several dosage schemes were simulated. The entire modelling work was performed in Monolix® 2019R1.
What has been achieved?
Concentration vs. time and effect vs. time plots for the virtual patients were simulated for a variety of conditions and tumour resistance levels. For both TKIs, decrease of body clearance led to higher plasma concentrations, as well as more intense and longer duration of the effect (i.e. tumour volume shrinkage). Enhanced drug effect on resistant cells resulted in a decrease in tumour volume. In addition, a variety of concentration-time profiles were simulated, making it possible to choose the best regimen for each patient.
What next?
In this study, the use of modelling techniques led to the simulation of many conditions of patients and adjustment of dosage regimens according to their needs. Wider application of in silico methods using virtual patients will allow the design of the most appropriate individualised dosage schemes tailored to the patients’ requirements.
Development of a guide intravenous administration
European Statement
Clinical Pharmacy Services
Author(s)
Gregorio Romero Candel, Esther Domingo Chiva, Jose Marco del Rio, Marca Diaz Rangel, Wals Valladolid, Sergio Plata Paniagua, Nuria Maryinez Monteagudo
Why was it done?
Critically ill patients often require the administration of several intravenous drugs. Besides, we have many times limited intravenous accesses in which the administration of drugs and other intravenous compounds such as parenteral nutrition must be shared.
Because of that, it is very important to have drug administration guides standarizing every-day clinical practice.
This guide was developed in order to reduce the health care workers burden and promote patient’s safety.
What was done?
We developed an updated guide on direct intravenous administration of drugs for health care workers of both critical care and emergency departments.
How was it done?
A database with every intravenous drug that is included in the Pharmacotherapeutic Guide in our hospital was prepared, alphabetically organized by Active Pharmaceutical Ingredient (API). The following data were collected: API, tradename, available dosage forms and recommendations for direct intravenous administration.
For each API, a bibliographic research of information was conducted, among other hospital administration guides, manufacturer´s product information, drug databases (BOT plusR, Micromedex) and requests of information to the technical departments of the manufacturer.
In case of a discrepancy in the information, the guide with higher evidente or more recent was selected.
The antineoplastic drugs were not included in this guide because they are not used or prepared in critical care or emergency departments.
What has been achieved?
This guide promotes safe administration of drugs in critically ill patients, being a useful, accesible and easy-to-use tool for nurses.
Its elaboration allows us to standarize the direct intravenous drug administration, to inform every health care worker and make them aware about its importance. Besides, the Pharmacy Department actively participated in the process of safe drug administration in our hospital
What next?
We are still working on the same departments to improve safety in drug therapy in critically ill patients. Currently, improvement measures that are being developed are: new pharmacotherapeutic protocols specifically for this unit; drugs and drug-diluent compatibility guidelines and new training sessions.