The EAHP EU Monitor is a regular round up of news relevant to hospital pharmacy in Europe.
24th EAHP Congress - registration and abstract submission open
The registration for EAHP’s annual Congress – the largest educational event for hospital pharmacists in Europe – is open. Join us from 27th to 29th March 2019 in Barcelona, Spain. After letting hospital pharmacists show us what they can do in the previous edition, the 24thCongress of the EAHP will turn its focus towards individualised pharmacotherapy.
Under the theme ‘Personalised Hospital Pharmacy – Meeting the needs of every patient’ hospital pharmacists will be enabled to explore all aspects of tailored medication and the approach to treatment for different patient groups and individuals. 3 key notes together with more than 20 seminars and workshops will analyse personalised hospital pharmacy from all angles linked to the European Statements of Hospital Pharmacy. Based on the success of last year’s congress, the Synergy programme has been extended and will continue with many relevant topics.
In addition to Congress registration also the abstract submission has opened. Hospital pharmacists are cordially invited to submit their abstracts by 15thOctober 2018. Original contributions from all fields of hospital pharmacy are welcomed for poster presentation. The poster award nominees will be determined in November 2018 and provided with the opportunity to give an oral presentation during the 24thEAHP Congress.
Learn more about the abstract submission process HERE
European Commission - Working Document on combatting HIV/AIDS, viral hepatitis and tuberculosis
Prior to the 22nd International AIDS Conference in Amsterdam and the World Hepatitis Day, the European Commission released a staff working document on combatting HIV/AIDS, viral hepatitis B and C and tuberculosis in the European Union and neighbouring countries. It contains an overview of EU policy initiatives and activities which aim at helping Member States with meeting the global sustainable development goal of ending the AIDS and tuberculosis epidemics by 2030 and to fight hepatitis and other communicable diseases.
The staff working document presents current epidemiological data on HIV/AIDS, viral hepatitis and tuberculosis in Europe as well as a state of play on the actions taken towards the implementation of the sustainable development goal 3.3. In relation to the main policy initiatives pursued by the EU it should be noted that the support of Member States stretches across several policy areas including but not limited to public health, research, drugs policy, development cooperation, accession and neighbourhood policy as well European structural funds. The overall observations underline the EU’s influence on the ground and the good initiatives that lead to several successes in tackling HIV/AIDS, viral hepatitis and tuberculosis.
EU-OSHA: Call for entries to the Good Practice Awards 2018-19
The European Agency for Safety and Health at Work (EU-OSHA) has opened the call for applications for the Healthy Workplaces Good Practice Awards 2018-19. The 14thedition of the Good Practice Awards is part of EU-OSHA’s campaign ‘Healthy Workplaces Manage Dangerous Substances’.
The call is open to real-life examples of innovative and effective occupational safety and health management in the handling and use of dangerous substances. Entries should clearly describe the type of good management practices that have been implemented in the workplace and outline their achievements. Good practice entries can be submitted by all organisations that are active in the EU as well as in candidate countries and potential candidate countries.
The jury of the Good Practice Awards is looking for recent initiatives that can be replicated in other workplaces across the EU and which show demonstrable improvements in safety and health in relation to dangerous substances. In addition, the measures should priorities the collective over the individual and actively involve the workers themselves.
In case your organisation has undertaken such an initiative submit it to your national focal point to participate in the Good Practice Awards 2018-19.
Find out more about the award HERE
EMA publishes database on all medicines authorised in the EEA
The European Medicines Agency (EMA) recently published a database containing information on all medicines authorised in the European Economic Area (EEA). Its scope covers products which have a valid marketing authorisation. The database provides information for the following data fields: product name (product short name: brand name or the concatenation of the generic name and the company name), active substance, route of administration, country of authorisation and name of the marketing authorisation holder. In addition, it details the country of location of the pharmacovigilance system master file and the marketing authorisation holder's contact email address and telephone number for pharmacovigilance enquiries. The information contained in the database will be updated periodically by EMA.
More information HERE.
Global survey - Education about biological medicines, including biosimilars
PhD researcher Liese Barbier (KU Leuven, Leuven, Belgium) and Prof Arnold G. Vulto (Erasmus University Medical Centre, Rotterdam, the Netherlands) in collaboration with the Hospital Pharmacy Section of the International Pharmaceutical Federation (FIP) are currently gathering data on the education about biological medicines and biosimilars.
Their survey is part of the academic research program of the MABEL Fund (“Market Analysis of Biologics and Biosimilars following loss of exclusivity”). The MABEL Fund is a collaboration between the University of Leuven and the Erasmus University Medical Centre and investigates the off-patent biological medicines market. It will take approximately 15 minutes to complete the survey. Your answers will be anonymized and treated confidentially. The deadline to complete the survey is 26 August 2018. If you have any questions, please feel free to contact us via the following e-mail addresses: liese.barbier[at]kuleuven[dot]be or a.vulto[at]gmail[dot]com
EJHP: Physical stability of an all-in-one parenteral nutrition admixture for preterm infants upon mixing with micronutrients and drugs
The online first edition of the European Journal of Hospital Pharmacy (EJHP) has published an original article focusing on the physical stability of an all-in-one parenteral nutrition admixture for preterm infants. In the study seven drugs were mixed in three mixing ratios with one standard total parenteral nutrition admixture to investigate their Y-site compatibility. Overall, this study did not provide sufficient evidence to recommend Y-site infusion of the tested drugs and the preterm admixture; however, it might offer some additional support to other compatibility data.
[EAHP Statement Corner]
European Statements of Hospital Pharmacy
Adopted in 2014, the European Statements of Hospital Pharmacy express commonly agreed objectives which every European health system should aim for in the delivery of hospital pharmacy services. EAHP is working now on implementing the Statements within our 35 member countries.
EAHP has developed several initiatives to help its members move towards implementation: from setting up a network of national implementation ambassadors to designing a self-assessment tool and a European training programme. Do you want to learn more about the European Statements of Hospital Pharmacy? Do you want to help your hospital move towards implementation? Then don’t forget to visit our website www.statements.eahp and don’t hesitate to send an email to the EAHP Implementation at Statements[at]eahp[dot]eu should you have any questions about the Statements or the implementation project.
EMA- Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements
This addendum to the Guideline has been developed to provide specific guidance on paediatric clinical development programmes that are required to support the authorisation of antibacterial agents for treatment of infectious diseases in paediatric patients. This Addendum provides guidance on clinical data requirements to support the approval of an antibacterial agent to treat infectious diseases in paediatric patients, both when extrapolation of efficacy from adults (source population) to paediatric patients (target population) is possible, and when this is not the case.
Deadline – 30th August 2018
More information HERE
Commission - Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products
The consultation seeks the views of interested parties on the specific issue of the impact of duplicate marketing authorisations of biological medicinal products on the availability of biosimilars to healthcare professionals and patients.
Deadline – 13th September 2018
More information HERE
Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections
This concept paper proposes the development of a single guideline on the clinical evaluation of medicinal products indicated for treatment of bacterial infections. The development of this single guideline is intended to merge, revise and add to the guidance that is currently included in two separate documents.
Deadline – 13th September 2018
More information HERE
EMA- Draft guideline on clinical evaluation of vaccines
This guideline addresses the clinical evaluation of vaccines intended for the prevention of infectious diseases. It includes considerations for trials intended to document the safety, immunogenicity and efficacy of new candidate vaccines and to support changes in the prescribing information of licensed vaccines. It also considers the need for and use of vaccine effectiveness studies.
Deadline – 30th October 2018
More information HERE