Merry Christmas and a Happy New Year

Merry Christmas and good health to all!

2012, which soon comes to an end, fills us with memories of a period of hardship due to the financial crisis and its consequences, but also of a year full of new projects and new partnerships offering an optimistic view for the future.

We are looking forward to a new productive year, wishing you all Merry Christmas, Happy Holidays and a happy, peaceful and creative 2013!

European Hospital and Community Pharmacists issue joint statement on future pharmacist roles

The two organisations representing community and hospital pharmacists in Europe have come together to make a declaration on the development of the pharmacy profession.

The joint statement by the Pharmaceutical Group of the European Union (PGEU) and the European Association of Hospital Pharmacists (EAHP) represents a call to action to national governments to, firstly, enable pharmacists to increase their role in optimising patient use of medicines, and, secondly, to improve the systems supporting multi-professional care across Europe.
EAHP and PGEU believe that pharmacists, as experts in medicines, should be at the heart of national strategies to ensure best outcomes for patients. This includes pharmacists educating patients about the optimal use of their medicines, and helping to ensure that potential polypharmacy problems, which can arise when a patient takes multiple medications, are satisfactorily resolved and reconciled.
The development of these roles for pharmacists is especially relevant in view of Europe’s ageing population, combined with the pressures on public spending that are likely for the foreseeable future. In this sense, it has never been more important to ensure national spending on medicines achieves intended outcomes in a cost-effective manner.

Pharmacists, in both community and hospital settings, are uniquely placed to facilitate this, so long as health policy makers recognise the opportunity and make the necessary commitments to its achievement.

Finally, the joint statement also highlights the need for multi-professional approaches to healthcare delivery to ensure integrated and seamless patient care. This includes improving systems for communication between health sectors when a patient transfers between hospital and community (and vice-versa), especially in relation to situations where changes are made to a patient’s medication.
PGEU and EAHP call for commitment from Governments to achieving multi-professional care, and for the integration of the multi-professional team concept within health professional education curriculums.

Speaking on the publication of the statement, Dr. Roberto Frontini, EAHP President said:

“The joint statement by EAHP and PGEU represents our shared goals in maximising the benefits the health service derives from pharmacists’ expertise in medicines. More than ever before decision makers in the health sector must ask and answer important questions about improving value and the outcomes achieved for patients. The pharmacist’s positive role in ensuring optimal use of medicines by patients is therefore a central consideration to successfully meeting the challenges of today and tomorrow.”

Ms Isabelle Adenot, PGEU President said:

“While patients receive primary care as well as hospital-based care, European pharmacists practice in both settings and share the challenge of improving the rational use of medicines. Having a common roadmap can help them to progress. This is the purpose of our joint statement.”

Statement here.

Source

http://www.eahp.eu/news/EU-monitor

Putting patients in the driving seat: A digital future for healthcare

The European Commission has unveiled an Action Plan to address barriers to the full use of digital solutions in Europe's healthcare systems. The goal is to improve healthcare for the benefit of patients, give patients more control of their care and bring down costs. While patients and health professionals are enthusiastically using telehealth solutions and millions of Europeans have downloaded smartphone apps to keep track of their health and wellbeing, digital healthcare has yet to reap its great potential to improve healthcare and generate efficiency savings.

The Action Plan (full list of actions in MEMO/12/959) attempts to increase the pace of change and improvement in healthcare by:

• clarifying areas of legal uncertainty;
• improving interoperability between systems;
• increasing awareness and skills among patients and healthcare professionals; 
• putting patients at the centre with initiatives related to personal health management and supporting research into personalised medicine; 
• ensuring free legal advice for start-up eHealth businesses. 

The Commission also commits to issue a mHealth (Mobile Health) Green Paper by 2014 addressing quality and transparency issues.

An accompanying Staff Working Paper gives a legal overview of how current EU legislation applies to cross border telemedicine (services such as teleradiology, teleconsultation or telemonitoring). Currently, telemedicine falls within the scope of several legal instruments. The paper clarifies the issues a healthcare practitioner faces in delivering cross-border telemedicine, for example:

• Do they need to be licensed/registered in the Member State of the patient?
• How should health data be processed? Will a given service be reimbursable? 
• What is the liability regime applicable in case of legal action? 

Neelie Kroes, Commission Vice President for the Digital Agenda, said "Europe's healthcare systems aren't yet broken, but the cracks are beginning to show. It's time to give this 20th Century model a health check. The new European eHealth Action Plan sets out how we can bring digital benefits to healthcare, and lift the barriers to smarter, safer, patient-centred health services."

Tonio Borg, Commissioner for Health and Consumer Policy, said: "eHealth solutions can deliver high quality, patient-centric, healthcare to our citizens. eHealth brings healthcare closer to people and improves health systems' efficiency. Today's Action Plan will help turn the eHealth potential into better care for our citizens. The eHealth Network under the Cross-Border Healthcare Directive channels our joint commitment to find interoperable solutions at EU level."

Members of the new eHealth Network, established by the Cross-border Healthcare Directive will help implement the Action Plan and provide a direct link to the national healthcare authorities and government departments.

Background

The new eHealth Action Plan responds to the 2009 request of Member States. To prepare the new plan, the Commission ran a public consultation in 2011.

The Digital Agenda for Europe includes three specific actions on eHealth aimed at widespread deployment of telemedicine, patients' access to their health data and interoperability.

Despite the economic crisis, the global telemedicine market grew from $9.8 billion in 2010 to $11.6 billion in 2011, while the global mHealth market is set to grow to €17.5 billion a year by 2017.

Some EU governments are spending up to 15% of their budgets on healthcare.

These facts indicate fast-changing situation that the eHealth Action plan must be flexible enough to address.

The European Commission has been active in eHealth for over a decade. Past Commission actions include:

• 2004 first eHealth action plan.
• 2008 Commission Communication on telemedicine.
• 2008 Large scale pilot Renewing Health, which is measuring the efficiency and cost effectiveness of telemedicine services across 9 regions of Europe.
• 2008 Recommendation on interoperable Electronic Health Records.
• 2011 adoption of the first EU law with provisions on the inter-operability of eHealth, the Directive on Patients' rights in cross border healthcare.
• 2011 epSOS Large Scale pilot has brought together 23 countries to pilot cross-border patient summaries and ePrescription services across Europe.
• 2011 European Innovation Partnership on Active and Healthy Ageing (EIPAHA) which builds on 261 commitments from over 3000 EIP AHA stakeholders to improve the quality of life of four million European senior citizens between now and 2015. The commitments include the roll out of integrated care and chronic disease management using innovative telemonitoring solutions.
• 2012 Launch of the eHealth Network bringing together all EU Member States to work on guidelines for the interoperability of eHealth.

For more information

EHealth action plan 2012-2020: Frequently Asked Questions (MEMO/12/959)

Ehealth website http://ec.europa.eu/digital-agenda/en/european-ehealth-policy

Commissioner Neelie Kroes:

http://ec.europa.eu/commission_2010-2014/kroes/

http://blogs.ec.europa.eu/neelie-kroes/

http://twitter.com/neeliekroeseu

Commissioner Tonio Borg:

http://ec.europa.eu/commission_2010-2014/borg/index_en.htm

http://ec.europa.eu/health/ehealth/policy/index_en.htm

eHealth Action Plan and Staff Working document, Staff Working Paper on Telemedicine:

http://ec.europa.eu/digital-agenda/news-redirect/9139

Source

http://europa.eu/rapid/press-release_IP-12-1333_en.htm

Call for expressions of interest in membership in the Expert Panel to provide advice on effective ways of investing in health

The European Commission has published a Call for expressions of interest in membership in the multisectoral and independent Expert Panel to provide advice on effective ways of investing in health(708 KB) . The Expert Panel has been established by Commission Decision 2012/C 198/06 of 5 July 2012.
The work of the panel is based on the principles of excellence, independence, multi-sectorial approach and transparency.
Members of the panel are appointed by the Commission on the basis of their expertise in one or more of the fields of expertise and collectively cover the widest possible range of disciplines. The fields of expertise are set out in detail in Annex I to Decision 2012/C 198/06 and include:

• health planning and budget prioritisation
• health services research
• hospital and health care management
• health care provision, and
• health education and promotion

Members are appointed to the panel for a term of three years and may serve up to three consecutive terms.
If interested, please fill out the online application form which is available in Adobe Acrobat pdf format only. Please attach also a CV and list of publications. The application form is available at the internet link below.
The closing date for the submission of applications is 23 November 2012.
Only online applications submitted via this Internet site will be considered.
More information on the Call Expert Panel is available here.

Contact information
For any further information on this call, please contact
SANCO-CALL-PANEL@ec.europa.eu

Source

http://ec.europa.eu/health/healthcare/consultations/call_expertpanel_healthinnovation_en.htm

REgioNs of Europe WorkINg toGether for HEALTH

RENEWING HEALTH, REgioNs of Europe WorkINg toGether for HEALTH, is an european project, partialy funded under the ICT Policy Support Programme, by the European Community.

RENEWING HEALTH aims at implementing large-scale real-life test beds for the validation and subsequent evaluation of innovative telemedicine services using a patient-centred approach and a common rigorous assessment methodology. 

It involves a Consortium of 9 of the most advanced European regions in the implementation of health-related ICT services. In those regions the service solutions are already operational at local level for the tele-monitoring and the treatment of chronic patients suffering from diabetes, chronic obstructive pulmonary or cardiovascular diseases. 

The services are designed to give patients a central role in the management of their own diseases, fine-tuning the choice and dosage of medications, promoting compliance to treatment, and helping healthcare professionals to detect early signs of worsening in the monitored pathologies. These services will be scaled up, integrated with mainstream Health Information Systems, grouped into a limited number of clusters bringing together services with similar features, trialled and assessed with a rigorous and common assessment methodology, and using a common set of primary indicators. 

Although integration of the service solutions at regional level is the highest priority for the Project partners, the use of international standards and the progressive convergence towards common interoperable architectures will be equally sought to prepare and facilitate their scaling up at national and European levels. Each cluster of pilots will operate as a multi-centre clinical trial measuring the efficiency and the cost effectiveness of the implemented solutions. 

The Project is supported by the Health Authorities of the partners and they are fully committed to deploy the telemedicine services in their territory, cooperating in a network that let them an overview not only among partners, but even on other European initiatives with similar objectives. 
Total financing: 14.000.000 € 
European co-financing: 7.000.000 €

The Consortium is composed of 9 Regional Authorities or regional healthcare providers. They represent most advanced realities at European level in the implementation and integration of ICT-based healthcare services for citizens and healthcare professionals. They will be supported by eHealth Competence Centres which, in most cases, are part of the regional organisation or are closely related to it.

Patients suffering from chronic disease and specialists of these diseases will be represented at local level through their local associations which will be invited to have a close look at the trials. Patients are also represented in the Consortium by their European Associations in an advisory role (User Advisory Board), ensuring that the point of view of the main stakeholders is properly taken into consideration throughout the entire duration of RENEWING HEALTH. Even industry is represented through associations by means of involving, on a voluntary basis, the main international eHealth players, in an Industrial Advisory Board.

The partners of the Consortium:

Italy

Veneto Region

Denmark

Region Syddanmark

Sweden

County Council of Norrbotten

eHealth Innovation Centre, EIC - Lulea Tekniska Universitet

Norway

Northern Norway Regional Health Authority

Norwegian Centre for Integrated Care and Telemedicine

Spain

Departament de Salut - Generalitat de Catalunya

Catalan Agency for Health Technology Assessment and Research

Fundació TicSalut

Finland

South Karelia Social and Health Care District

Greece

Intermunicipal Development Company Digital Cities of Central Greece S.A.

e-Trikala AE

Municipality of Trikala

Regional Health Authority of Sterea & Thessaly

Austria

Land Kärnten

Krankenanstalten Betriebsgesellschaft

Germany

Pflegewerk Managementgesellschaft

Advisory Board

European Patient's Forum

European Health Telematics Association

Continua Health Aliance Source

http://www.renewinghealth.eu

European Medicines Agency gives recommendations to deal with sterility assurance concerns for DepoCyte

The European Medicines Agency has today agreed a number of precautionary measures to deal with manufacturing deficiencies which could affect the sterility of DepoCyte (cytarabine), an anti-cancer medicine used to treat lymphomatous meningitis. These measures are intended to protect patients from potentially harmful effects, while they also allow continued access to treatment for patients who have no suitable alternatives.

At present, there is no evidence of any microbial contamination of product on the market or risk to patients. However, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended, as a precautionary measure, that DepoCyte be recalled from all European Union countries where suitable alternative treatments are available. For patients already initiated on DepoCyte and for whom alternative treatments are not appropriate, it may be possible for doctors to request a supply of DepoCyte to continue the treatment. In EU countries without suitable therapeutic alternatives, DepoCyte will remain on the market, but with specific recommendations to monitor patients’ safety, in particular for signs and symptoms of infection.

A question-and-answer document with detailed recommendations for healthcare professionals is available on the Agency’s website. Healthcare professionals will be receiving a letter explaining the measures that will apply in their country.

DepoCyte is a prolonged release liposomal suspension for injection containing cytarabine for the intrathecal treatment of lymphomatous meningitis. This means it is administered by injecting it directly into the cerebrospinal fluid.

A recent inspection carried out jointly by France and the United Kingdom at the manufacturing site for DepoCyte in San Diego in the United States, Pacira Pharmaceuticals Inc, identified a number of manufacturing deficiencies. The findings relate to a lack of adequate sterility assurance in the manufacturing process. Following assessment of the available data, the CHMP concluded that these findings pose a theoretical risk of sterility failure, even though currently there are no data to indicate that there has been a negative impact on the finished product. Production and batch release of DepoCyte are currently on hold. New batches of DepoCyte will only be manufactured once all deficiencies have been resolved and a re-inspection has indicated the manufacturing site to be compliant with good manufacturing practice (GMP) requirements.

Notes

The inspection was conducted by the UK and French medicines regulatory agencies in July 2012. DepoCyte has been authorised in the European Union since 11 July 2001 and is marketed in Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, as well as Iceland and Norway. Lymphomatous meningitis is a condition in which cells from a lymphoma (a tumour in the lymphatic system) have spread to the spinal fluid and the meninges (the membranes that surround the brain and spinal cord). Therapeutic alternatives include medicines containing non-liposomal cytarabine, methotrexate or thiotepa. It should be noted that not all alternative products are approved for intrathecal use. For further information on indications and posology of alternative treatments, the product information should be consulted.

Source

EMA

EAHP European Congress of Hospital Pharmacy 2013, start submitting abstracts

The European Association of Hospital Pharmacists (EAHP) has issued a call for abstracts for the European Congress in Paris in 2013. 

The Congress of EAHP will take place at the Palais de Congrès, in Paris from 13 to 15 March 2013. 


Congress Focus: "Improving patient outcomes - a shared responsibility"

More information about the conference is available HERE . 

The deadline for abstract submission is 15 October 2012. 

Complete information on the submission process and criteria are available HERE . 

The second announcement is HERE.


Source

EAHP

EAHP General Assembly sees integration of Iceland

The EAHP (European Association of Hospital Pharmacists) held its annual general assembly in Budapest, Hungary from 15 to 16 June 2012. 58 representatives from 29 member countries of the EAHP gathered to discuss relevant issues related to the further development of hospital pharmacy in Europe.


EAHP Board Members and delegates from represented member countries shared points of view and perspectives about the current challenges for healthcare systems in Europe and gave valuable input to a wide variety of EAHP projects, ambitions and core activities.

Highlights of the general assembly (GA) included the integration of a new country - Iceland. Eva Agustsdottir and Thorunn Godnumndsdottir, representatives of Hospital Pharmacy Section of the Pharmaceutical Society of Iceland, gave the GA a brief overview of the history and current status of the profession in their country. The GA was delighted to unanimously accept their application for membership. Iceland is now the 32nd member country of EAHP.

Elections were held at the GA for key positions within the EAHP board. The Assembly said a fond and grateful farewell to long-serving Board Members Elfriede Dolinar (Austria) and Prof. Dr. Vagn Handios (Denmark). Education, Science and Research, respectively. Re-elected President Dr Roberto Frontini thanked them warmly for their significant contributions to the work of the Association. Mrs. Tajda Miharija Gala (Slovenia) was elected as the new Vice-President and Prof Dr Cees Neef (The Netherlands) as the new Director of Education, Science and Research. The Assembly also elected to the Board for the first time Dr Petr Horak from the Czech Republic, and Joan Pappard from the Republic of Ireland. The new Board Members will share the title of Director of Professional Development.

The Annual GA also took the opportunity to redefine the EAHP's mission and goals. To be efficient, one must adapt to the times and on the occasion of its 40th anniversary, the EAHP Board reviewed and considered the ongoing mission of the Association. The Board proposed to the Assembly some redefinitions which were ratified by the GA with some amendments. The new mission clarifies EAHP's representative function, as well as emphasizing the Association's overall patient-centred focus. The new goals make explicit the EAHP's objective of hospital pharmacy specialisation.

The EAHP Mission 

EAHP represents and develops the hospital pharmacy profession within Europe in order to ensure the continuous improvement of care and outcomes for patients in the hospital setting. This is achieved through science, research, education, practice, as well as sharing best-practice and responsibility with other healthcare professionals.

EAHP Goals 

1. To develop hospital pharmacy in order to promote the best and safest use of medicines and medical devices for the benefit of patients in Europe

2. To create a platform for the education and training of hospital pharmacists to a level of specialisation and maintain continusing professional development (CPD)
3. To uphold the interests and advance the position of European hospital pharmacists within the healthcare systems, the EU and national authorities

The future of EAHP educational activities 

The GA approved a number of reforms to the provision of EAHP educational activities. The BEAM summits, which were held between 2009 and 2012, will be discontinued in their present format. The Academy Seminar series will be maintained, but with a wider target audience. The Assembly requested the Board conduct more research into the potential, feasibility and desirability of creating the pan-European Hospital Pharmacy Masters courses. Their findings will be reported to the 2013 General Assembly, which will take place in Athens, Greece.

Final results of the 2010 EAHP Survey of hospital pharmacy practice in Europe

Mrs Tajda Miharija Gala presented to the Assembly the final results of the EAHP 2010 Survey. This will be officially released and presented to the public through the EAHP website. The survey will reveal how hospital pharmacy is practiced in different European countries and show the trend of development in the services provided across Europe.

Policy Matters 

On political matters, delegates reviewed and discussed statements proposed by the Board in a number of areas including medicines bar coding, clinical trials and medicines shortages. Delegates made useful recommendations for amendments and additions. Final statements will be published on the EAHP website over the Summer period.

Source

http://www.hospitalpharmacyeurope.com

Latest orphan designations and/or marketing authorisations

Medicinal products intended for rare diseases can receive an “orphan drug” label based on a defined number of criteria as summarised below:

• The product is intended for an indication with a prevalence not exceeding 5 in 10 000 persons in the EU.
• The disease is life-threatening, seriously debilitating or a serious and chronic condition.
• No satisfactory method of diagnosis, prevention or treatment of the condition is already authorised in the EU. If any method exists, then the medicinal product has to demonstrate that it provides a significant benefit compared to the product for which orphan designation is being requested.

Committee for Orphan Medicinal Products

A positive opinion on orphan designation is given by the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) based in London with the final decision made by the European Commission.

The COMP was created as part of the EU Regulation on Orphan Medicinal Products to review EU applications for the label "orphan drug”.

Orphan designation at any stage of development

Orphan designation is possible at any stage of drug development as long as proper scientific justification of the medical plausibility of the product in the indication requested is demonstrated.

The research may be pre-clinical (not yet tested on human subjects) or may have reached the human clinical trial phase.

Orphan designation does not indicate an endorsement for the use of the drug for the designated condition. Efficacy, safety and quality criteria first need to be satisfied for the granting of a marketing authorisation.

In addition to the position of Vice-Chair, EURORDIS has held two of the three seats assigned to patient organisation representatives on the COMP since its creation in 2000.

Detailed information on European orphan drug designation applications is available on theEMA website

A full list of designated and authorised orphan drugs in Europe available at: ec.europa.eu

6 June 2012

Treatment of meningioma

N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide

Treatment of schwannoma

N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide

Treatment of Wiskott-Aldrich syndrome

Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene

Treatment of cytomegalovirus disease in patients with impaired cell mediated immunity

Letermovir

Treatment of pancreatic cancer

Polyinosine-polycytidylic acid coupled with the polycationic polyethyleneimine

Treatment of ovarian cancer

1-(4-{4-amino-7-[1-(2-hydroxyethyl)-1H-pyrazol-4-yl] thieno [3,2-c]pyridin-3-yl}phenyl)-3-(3-fluorophenyl) urea

Treatment of glioma

Adenovirus-associated vector containing human Fas-c gene

Treatment of adrenoleukodystrophy

Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA

25 May 2012

Treatment of soft tissue sarcoma

Yttrium (90Y)-DTPA-radiolabelled chimeric monoclonal antibody against frizzled homologue 10

Source

EURORDIS

Online access to suspected side-effect reports

The European Medicines Agency has today begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: www.adrreports.eu. 

The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. The launch of the new website is part of the Agency’s continuing efforts to ensure EU regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy.

The information published today relates to approximately 650 medicines and active substances authorised through the centralised procedure, which is managed by the Agency. Information on the website is presented in the form of a single report per medicine or active substance. Each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by Member States and marketing-authorisation holders. These aggregated data can be viewed by age group, sex, type of suspected side effect and by outcome. Within a year the Agency aims to additionally publish suspected side effect reports for common drug substances used in nationally authorised medicines.

A side effect (also known as an adverse drug reaction) includes side effects arising from use of a medicine within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisation, including overdose, misuse, abuse and medication errors, and those associated with occupational exposure.

All information on the website relates to suspected side effects. Suspected side effects may not be related to or caused by the medicine, and as a result, the published information cannot be used to determine the likelihood of experiencing a side effect or as an indication that a medicine is harmful. All users of the website are asked to read and accept a disclaimer explaining how to understand the information before they view a web report.

Medicines are an important part of modern healthcare, providing effective treatments for many diseases and conditions. For a medicine to be authorised for use in the EU the benefits of the medicine must always outweigh the risks.

Today’s launch also highlights the importance of side effect reporting and pharmacovigilance in safeguarding public health within the EU. Side-effect reporting is a key element in ensuring the detection of new or changing safety issues, and the Agency continues to further strengthen its work with partners and stakeholders across Europe to ensure a robust system for safety signal detection.

In June, the Agency will launch the website in the remaining 22 official EU languages.

Notes

• The European database of suspected adverse drug reaction reports:http://www.adrreports.eu
• Patients, consumers and healthcare professionals report suspected side effects to either the national medicines regulatory authority or thepharmaceutical company that holds the marketing authorisation for the medicine. These reports are then transmitted electronically toEudraVigilance. The Agency, on behalf of European Member States, is responsible for the development, maintenance and coordination of EudraVigilance.
• Pharmaceutical companies that hold the marketing authorisation for a medicine in the European Economic Area (EEA) are also legally required to submit to EudraVigilance all reports of suspected unexpected adverse reactions that are serious and that occurred in a third country (non-EEA) where they hold a marketing authorisation. The web reports present information on suspected side effects that have occurred in both the EEA and outside the EEA.  
• A web report does not include reports from studies (e.g. clinical trials and non-interventional studies) or other types of reports, i.e. they only include spontaneous reports.
• Web reports can only be viewed with Adobe Reader 10.x and Adobe FlashPlayer 10.2.
• Frequently asked questions and a short guide on how to interpret web reports can be found online.
• The Management Board of the European Medicines Agency approved the EudraVigilance access policy in December 2010. The access policy describes how stakeholders, such as national medicines regulatory authorities in EEA countries, healthcare professionals, patients and consumers, as well as marketing authorisation holders and research organisations, can access information on suspected side effects submitted electronically to EudraVigilance.
• More information on the 2010 pharmacovigilance legislation can be found on the Agency’s website.

Source

http://www.adrreports.eu/
EMA

EAHP Academy Seminar "What do we need to know about building or reconstructing a hospital pharmacy?"

 
Target group of the seminar
The target group comprises hospital pharmacy managers, mainly head of pharmacies or deputies from the new EU- Countries and new members of EAHP.

Teaching goals
To ensure patient safety hospital pharmacists have to ensure:

• the correct medical supply including purchasing, stock- keeping and delivery of drugs
• the compliance with pharmaceutical and drug-related legal regulations as well as with all other laws and regulations related to pharmacies
• the compliance with the general rules of hygiene and of the science of pharmacy
• the quality assured production and compounding of medicines
• pharmaceutical counselling like drug information and clinical pharmacy services.

EU- legislation on production of medicines in hospital pharmacies like GMP guidelines and influences the technical and interior equipment of the production areas. Recent developments of logistic of drugs were characterised by the improvement of the supply chain using automation and track and trace.
A huge number of hospital pharmacies are more then 15 years old and do not fulfil the state of technology and science. Hospitals therefore are forced to reconstruct or rebuild the hospital pharmacy.
The seminar should give support in planning or replanning the hospital pharmacy.

Learning objectives

Seminar I: Planning of a state of the art hospital pharmacy production

The seminar gives theoretical information about regulatory requirements for hospital pharmacy production. This includes process description, quality risk management, quality management, feasibility study and user requirements to design qualification. In the following workshops the participants will work on the above mentioned topics on practical examples.
At the end of the seminar the participants will:

• have the skills to identify the relevant requirements for the hospital pharmacy they are working for.

Seminar II:Planning the logistic of a hospital pharmacy

This seminar gives theoretical information about logistics of hospital pharmacies and examples of the recent developments in the supply chain of drugs.
At the end of the seminar the participants will:

• get an overview about actual developments in the supply of medicines
• know about advantages and disadvantages of automation systems for picking packages
• know about advantages and disadvantages of unit dose systems
• know about track and trace during transport and delivery including the use of RFID
• know about the latest developments in barcoding
• be able to take in consideration the different developments either material or administrative and adapt to the hospital and hospital pharmacy needs.

 Speakers' biographies

View the bios of presenting speakers for the Academy seminar 2012.

2012 Academy seminar programme

View the detailed programme schedule.

The city of Thessaloniki

Some useful information on the most interesting places to visit in Thessaloniki.

10/01/2012 

 

Registration and hotel reservation

Welcome participants to the 2012 EAHP Academy Seminar!

Venue and public transportation

View the Academy Seminar's venue and how to reach the hotel by public transportation

Source 

EAHP

EU: PONTE platform prototype to be released soon

A prototype of the 'Efficient Patient Recruitment for Innovative Clinical Trials of Existing Drugs to other Indications' platform (PONTE platform) will be released this month (April 2012). The wider research community will thus have the opportunity to test run and review the tools that the platform will offer.


PONTE is a European project intended to establish a platform to help new uses for existing drugs. It will offer vital assistance throughout each stage of the process - from the moment an idea is generated through to the selection of suitable volunteers for the trial.

Once work on refining and perfecting the system is complete, PONTE will act as a one-stop search, query and decision support tool. By linking to existing medical knowledge databases, it will give near-instant access to information about any disease, drug or drug properties. This will aid researchers as they develop their hypotheses for new applications for existing medicines. If, for example, there is the possibility that a particular drug for high blood pressure may be useful in treating arthritis, PONTE will help to uncover it. The platform will then utilise data stored by individual hospitals to establish whether sufficient patients meet the criteria for a trial to be able to proceed. PONTE can select pre-consenting volunteers immediately - ensuring the right people for the right trial at the right time. To complete the jigsaw, the system will provide a step-by-step guide for setting up clinical protocol, in turn ensuring all aspects have been completed well in advance of the start of the trial.

PONTE will simplify the whole clinical trials process so that it will be easier to come up with the right concept and select the right patients. As well as saving money, this will give the public quicker access to drugs which may be able to help them. The platform is expected to be launched in a year's time.

Further information: 

• Source - PONTE Project
• PONTE Project website  

Source

ePractice

European Commission establishes new eHealth Stakeholder Group

European Commission establishes new eHealth Stakeholder Group

Following the recent call for expression of interest (closed in January 2012), the European Commission has selected the members to participate in its new eHealth Stakeholder Group. Members of the group, appointed for a period of three years, are expert representatives of European umbrella organisations active in the eHealth sector.

The group is expected to contribute to the development of legislation and policy related to eHealth. Policy areas of specific interest include relevant actions of theDigital Agenda for Europe on eHealth and the forthcoming eHealth Action Plan.

Complete list of the 29 selected member organisations, representatives and substitutes (pdf)

Source

http://ec.europa.eu/information_society/activities/health/policy/stakeholders_group/index_en.htm

New 24-hour drug robot at Worthing Hospital, UK

WORTHING Hospital has employed a new worker who never sleeps.

The newest addition to the pharmacy department at Worthing Hospital is a drug-dispensing robot, which works 24 hours a day to give staff instant access to 1,700 different medicines around the clock.

While the department has had a pharmacy robot for the last four years, the development means the majority of drugs can now be dispensed to ward staff at all times, compared to just 200 of the most common drugs. The new machine will also increase the reliability and accuracy of dispensing the drugs.

Saffron Mawby, head of medicines management at Western Sussex Hospitals NHS Trust, said:

“This latest development, giving patients those benefits around the clock, is a significant improvement to the service we can provide. Having key medicines available when they are needed is an important part of our patients’ clinical care and this new technology will help our in-patients get the medicines they need, faster than ever before, no matter what the time.”

The £20,000 system was bought by the Friends of Worthing Hospital, and will mean the trust will save on the expense of on-call pharmacy staff having to travel to hospital out of hours.

Lucy Shade, senior pharmacist at Worthing Hospital, said:

“The machine brings real benefits in terms of speed, safety, and releasing pharmacy staff to spend more time on the wards during the day, seeing patients. This new improvement to our out-of-hours service will significantly improve the service to our in-patients at night and at weekends.”

Source

http://www.shorehamherald.co.uk/

EAHP meet European Commission to discuss hospital pharmacy specialisation

On Wednesday 22 February Dr Roberto Frontini, President of the EAHP, accompanied by Policy Officer Richard Price, met with senior officials at the European Commission to discuss the future possibilities for recognition of hospital pharmacy specialisation. 

EAHP presented a paper to the Internal Market and Services Directorate General (DG MARKT), which is leading a review of the Professional Qualifications Directive, exploring the feasibility of a new mechanism called a Common Training Requirement, being applied to specialisms in the sectoral professions. 

This would enable a minimum of 9 member states to collaborate in the construction of a framework for recognizing common qualifications. EAHP consider this has the potential to greatly increase the mobility of hospital pharmacists with specialized qualifications in the future. 

However, the Commission do not currently intend that the proposed Common Training Requirement will apply to the 7 “automatically recognized professions” (medical doctors, veterinarians, dentists, architects, nurses, midwives and pharmacists).

A useful exchange of views took place at the meeting and a greater understanding of each other’s positions was achieved. There is still much deliberations to be held on the proposed reform of the Professional Qualifications Directive, with Member State Governments beginning their examination of the Commission’s December 2011 proposals in the coming weeks, and the European Parliament commencing its formal discussions on 28 February. 

EAHP will continue to make the case for new mechanisms to be created to enable hospital pharmacy specialization to be recognized across borders and will present its proposals to MEPs and others for consideration over the coming months.

Source

EAHP

112 day: 74 % of Europeans don't know what emergency number to call when travelling in the EU

Whether for skiing holidays, family days out, business travel or visits to this summer's sporting events, including the London Olympics or Euro 2012 UEFA football in Poland and Ukraine, millions of Europeans and visitors need access to emergency services in and outside their home country. Yet only 34% of regular travellers and 26% of all Europeans know that 112 is the single emergency number they can call, both in and outside their home country when in trouble. 
 

Many major rail, air and other transport companies have joined Vice Presidents Neelie Kroes and Siim Kallas in a campaign to raise 112 awareness rates. The emergency number will be publicised without cost to taxpayers on e-tickets, in on-board magazines, on their company websites and through their staff. The list of participating companies can be consulted on www.112.eu. 

Vice Presidents Kroes and Kallas have decided to work together to ensure every European can access a 112 smartphone app, in their own language. In recent years many 112 mobile apps have been developed, but much more can be done in this field. 

Vice President Neelie Kroes said "You can save a life by knowing and dialing 112. But 112 only helps if people know about it. So we are working with travel companies to catch attention while people are en route to their destination."

Vice President Siim Kallas said "I welcome the commitment of the transport sector in Europe to make every traveller aware of the 112 emergency number. 112 is an essential safety tool in transport. The list of participating companies will be open all year long and judging from the interest shown, many more companies are likely to follow." 

 

Background

112 is the European emergency number, reachable from fixed and mobile phones, free of charge, everywhere in the EU. 112 links the caller to the relevant emergency service (local police, fire brigade or medical services) and is available 24-hours a day. 112 is now operational in all EU member states alongside existing national emergency numbers (like 999 or 110). Denmark, Finland, Malta, The Netherlands, Portugal, Romania and Sweden, and have decided to make 112 their sole or main national emergency number. 112 is also being used in countries outside the EU, such as in Croatia, Montenegro and Turkey. Ukraine has also committed to introduce this number in the cities which will host Euro 2012 football matches (Donetsk, Kharkiv, Kiev and Lviv) by the beginning of the sports event.

The Eurobarometer survey published today shows that Europeans' awareness of the availability of 112 in their country and in other EU Member States is stagnating. To address this issue, Vice-Presidents Kallas and Kroes wrote to the main transport companies on 27 January 2012 calling on them to inform their passengers about the 112 emergency number. This initiative builds on a similar campaign successfully launched by former MEP Diana Wallis last year. It is also supported by the 112 European Foundation.

Mobile phone applications – apps – are computer software developed for mobile phones that help users complete a task. They can be pre-installed on phones by manufacturers and are available for purchase and download through "app stores".

A report on how each Member State is implementing 112 (also issued today) gives a snapshot of the different languages to which 112 call centres can respond

• English can be used in 25 countries (besides UK, Ireland and Malta): Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden, as well as Croatia, Iceland and Norway.
• 14 countries (besides Belgium, France and Luxembourg) can deal with calls in French: Bulgaria, Czech Republic, Finland, Germany, Greece, Ireland, Italy, Lithuania, The Netherlands, Norway, Poland, Romania, Slovakia and Spain.
• German can be used in 112 calls in 12 countries: Bulgaria, Czech Republic, Finland, Hungary, Italy, Lithuania, The Netherlands, Norway, Poland, Slovakia, Spain and Romania (in addition to Austria, Belgium, Germany and Luxembourg)
• Italian speakers can also make 112 calls in their native language in the Czech Republic, Croatia, Romania, Slovenia and Spain.
• Russian speakers can get help over 112 in the Czech Republic, Estonia, Finland, Latvia, Lithuania, Poland, Romania and Slovakia.
• In the UK, emergency call centres can rely on interpretation services covering 170 languages, while in France a similar service can deal with 40 languages;

Useful links

112 website (available in English, French, German, Italian, Polish and Spanish): www.112.eu

Transport companies and organisations participating in the 112 promotion campaign

How 112 works in my country:

Kids' corner (available in all 23 official EU languages):

Full report and summary of Eurobarometer "The European Emergency Number 112" and

COCOM report and annex on the implementation of 112:

Digital Agenda website

Neelie Kroes' website

Follow Neelie Kroes on Twitter