Saturday, December 24, 2011

Merry Christmas!


Tuesday, December 20, 2011

European Medicines Agency (EMA) formalises interaction with healthcare professionals

The European Medicines Agency has set out its plans to establish regular interaction with a network of European organisations representing doctors, nurses and pharmacists. In the framework for interaction between the European Medicines Agency and healthcare professionals, published today, the Agency describes its plans to:

  • access the best possible independent expertise in matters related to medicines;
  • contribute to more efficient and targeted communication to healthcare professionals;
  • enhance the understanding of the European Union (EU) medicines regulatory network by healthcare professional organisations.

Organisations will need to fulfil a range of criteria in order to be able to be involved in the Agency's activities. These include being representative of healthcare professionals across the EU or European Economic Area (EEA), a specific interest in medicines, and transparency over sources of funding.

The Agency has been interacting with healthcare professionals since it was founded in 1995, but the new framework for interaction aims to make this relationship more structured and complete. As part of its implementation, the Agency will transform its Healthcare Professionals' Working Group (HCPWG), which has been meeting since 2006, into a working party with links to all scientific committees dealing with human medicines.

The framework of interaction and criteria to be fulfilled by healthcare professionals' organisations were endorsed by the Agency's Management Board on 15 December 2011.


Saturday, December 10, 2011

The European Association of Hospital Pharmacists (EAHP) announces new publisher for the European Journal of Hospital Pharmacy

The European Association of Hospital Pharmacists (EAHP) announces a new partnership with the BMJ Group to publish the peer review journal European Journal of Hospital Pharmacy: Science and Practice (EJHP), launching in January 2012.

The existing journals EJHP Science and EJHP Practice will be combined to make the new journal.

Learn more about this exciting development from the EAHP President and Editor in Chief.

Benefits provided by the new journal include:

· Knowledge – the journal will concentrate on scientific content which will help you in your daily practice and professional content which will develop your career
· In-depth – coverage of all aspects of hospital pharmacy including clinical, therapeutic, economic and social disciplines giving you the full picture
· Ease – all the information that you require will be in one easy to read journal saving you time

EJHP will become more and more an educational tool answering the emerging questions of the pharmacy profession and will also continue to give updated information on professional and political developments.

Find out what the EAHP President’s views are on this new exciting development.

To submit a new paper, become a reviewer or for further information, please visit



Monday, October 17, 2011

Connectathon 2012 to be held in Bern, Switzerland

More than 300 IT professionals from 70 companies are expected to attend the Twelfth Annual IHE Conntectathon, to be held next year at the Bern Expo in Bern, Switzerland from May 21 to May 25.

The decision to bring the Connectathon in Switzerland is a fantastic opportunity for stakeholders to move eHealth activities forward in our country and to continue to make interoperability progress in Europe,” said Christian Hay, user Co-Chair of IHE Suisse.

[See also: Connectathon expands to weeklong program]

The event is an intensive “connectivity marathon” for testing the interoperability of health information systems. Companies implementing IHE Technical Framework Profile specifications in their products will have a chance to test their applications with systems from other vendors.

Connectathon will also offer a full program of workshops and meetings, bringing together stakeholders from European health IT projects. In addition, a major eHealth day conference will be held on May 24.

Results from Connectathon are published on the IHE-Europe website. Vendors are able to refer to the IHE Integration Statements to show compliance of their products with IHE Integration Profiles.

[See also: IHE pharmacy trials a 'step forward' for medication integration ]


Friday, September 30, 2011

The European Journal of Hospital Pharmacy: Science and Practice

The European Association of Hospital Pharmacists (EAHP) announces a new partnership with the BMJ Group to publish the peer review journal European Journal of Hospital Pharmacy: Science and Practice (EJHP), launching in January 2012.

The existing journals EJHP Science and EJHP Practice will be combined to make the new journal.

Learn more about this exciting development from the EAHP President and Editor in Chief.

Benefits provided by the new journal include:

· Knowledge – the journal will concentrate on scientific content which will help you in your daily practice and professional content which will develop your career

· In-depth – coverage of all aspects of hospital pharmacy including clinical, therapeutic, economic and social disciplines giving you the full picture

· Ease – all the information that you require will be in one easy to read journal saving you time

EJHP will become more and more an educational tool answering the emerging questions of the pharmacy profession and will also continue to give updated information on professional and political developments.

Find out what the EAHP President’s views are on this new exciting development.

To submit a new paper, become a reviewer or for further information, please visit

Please note: authors who have submitted papers after 1st September 2011 to EJHP Science or EJHP Practice will need to re-submit to EJHP: Science and Practice using the new Instructions for Authors.


Friday, September 09, 2011

Strategy to Better Protect Public Health by Strengthening and Rationalising EU Pharmacovigilance

Public consultation on a concept paper on implementing measures for the performance of pharmacovigilance activities
In order to harmonise the performance of the new pharmacovigilance activities introduced by the amended pharmacovigilance legislation (cf. Regulation (EU) No 1235/2010 and Directive 2010/84/EU) the Commission shall adopt several implementing measures. Those measures supplement essential details of the new pharmacovigilance system with the more technical details that have to be observed by marketing authorisation holders, national competent authorities and the European Medicines Agency in the daily practice of applying the new provisions.

With the public consultation the European Commission intends to describe the scope and content of the implementing measure which it is currently considering and seeks views and feedback from stakeholders on those issues. A more detailed description can be found in the concept paper pdf - 109 KB [109 KB] .

The period of consultation ends on 7 November 2011. All citizens and organisations (public and private) are welcome to contribute to this consultation. For more information on how to contribute, please read the concept paper.

Received contributions will be published on the internet. For more information on the processing of personal data in the context of this consultation, read the specific Privacy Statement pdf - 16 KB [16 KB] .


Public Health


Saturday, July 02, 2011

Who Owns Patient Data?

If nature has made any one thing less susceptible than all others of exclusive property, it is the action of the thinking power called an idea, which an individual may exclusively possess as long as he keeps it to himself; but the moment it is divulged, it forces itself into the possession of every one, and the receiver cannot dispossess himself of it. Its peculiar character, too, is that no one possesses the less, because every other possesses the whole of it. He who receives an idea from me, receives instruction himself without lessening mine; as he who lights his taper at mine, receives light without darkening me. -- Thomas Jefferson

Topic 3 on the June 20 #HITsm Tweetchat got into discussions of who owns patient data. The moral high ground today seems to be towards "patient ownership."  Reality is just a bit different, and I think the discussion of ownership is not all that useful.  It should be about rights and responsibilities with respect to patient data, rather than a discussion of ownership.  My statement on this is remarkably similar to a post made by Dave Hitz on his blog.

With all due respect to patient advocates who claim ownership of the data, I don't see this enshrined in law, nor do I think "ownership" should be.  The challenge to think about are the needs of providers, who collect and organize this data to run their practices. The existence and organization of that data is essential to their practice.  Could you imagine the merger, acquisition or other disposition of a healthcare provider practice where the data they used to operate didn't go with the business?  Would that benefit patients? Almost certainly not.

What I do see in regulation is the right to obtain the data that a provider has on me (or you).  If you think about it, data is something easily shared.  After all, it's pretty easy to make copies of information, as Jefferson alludes to in the above quote.

As of now, the HIPAA Privacy regulation gives patients the right to access their information under 45 CFR §164.524 and the right to amend it under 45 CFR §164.526. Providers have the responsibility to make it available and to amend it as appropriate subject to review by the provider (with respect to accuracy,  appropriateness and source).  There are a lot of caveats here which clearly need to be change.  Provisions of this regulation are the cause of Regina Holliday's 73¢ Mural.

HITECH and Meaningful Use change that, but they assert it as a provider responsibility, rather than a patient right.  Providers that want to obtain Meaningful Use incentives have to provide patients with an electronic copy of their record within three business days of the request (instead of the 30 allotted by HIPAA) for at least 50% of patients making the request.  This is a pretty low bar.

I'm certainly in agreement with the majority that believe patients should have better rights to their data than currently available in law or regulation, but when we talk about ownership, it only confuses the issue.

Keith W. Boone is a Standards Geek for GE Healthcare. He is a member of the HL7 Board, and co-chairs the Patient Care Coordination Planning Committee for Integrating the Healthcare Enterprise. Keith writes regularly on his blog about Healthcare Standards.


June 22, 2011 | Keith W. Boone

Sunday, June 26, 2011

Guidelines for Good Pharmaceutical Practice from FIP and WHO

The International Pharmaceutical Federation first adopted the guidelines for Good Pharmaceutical Practice in 1993. These guidelines were developed as a reference to be used by national pharmaceutical organisations, governments, and international pharmaceutical to set up nationally accepted standards of Good Pharmacy Practice.
The revised version of this document was endorsed by WHO in 1997 and subsequently approved by the FIP Council in 1997. The GPP Guidelines are based on the pharmaceutical care given by pharmacists. The guidelines recommend for national standards to be set:
  • The promotion of health;
  • The supply of medicines, medical devices, patient self-care;
  • Improving prescribing and medicine use by pharmacists’ activities.
These guidelines have been subsequently adapted and adopted in a wide number of developed countries. In certain cases, the national professional body has strived to adapt the guidelines and developed, in collaboration with the government, specific regulation/legislation on this matter.
Conscious of the need to help developing countries achieve GPP, the FIP Community Pharmacy Section Executive Committee established a working group to produce guidelines in this area in 1992. The paper, entitled “GPP in Developing Countries – Guidelines for Implementation”, was endorsed by the FIP CPS Executive Committee in September 1998.
Having realized the importance of continuing to increase awareness of GPP and stimulating its implementation, the FIP Bureau decided to request the BPP to focus on the theme and to develop a specific activity.
Two countries had been identified as pilot sites for GPP technical assistance to the implementation of these guidelines.

GPP update 2009-2010

The year 2009 was a transition year from the current procedure to the new procedure with regards to preparing FIP Statements of Policy, including the update of the Statement on Good Pharmacy Practice. The FIP Bureau has developed a new process in order to involve FIP's Member Organisations more intensely at an earlier stage of the drafting process by introducing an extra step of producing a reference paper.
As such, on 8 September 2009 at the FIP Congress in Istanbul the Council adopted a new Reference Paper on Good Pharmacy Practice. This paper is being used as the basis for renewal of the Good Pharmacy Practice Statement, a draft of which will be proposed to the Council at the FIP Congress Lisbon 2010.
The Working Group on the Reference Paper on Good Pharmacy Practice consisted of the following members:

Prof. Henri R. Manasse, Jr. Co-chair
Dr Dick F.J. Tromp, Co-chair
Dr Lowell Anderson
Mr Colin R. Hitchings
Ms Eeva Teräsalmi
Mr Raj Vaidya
Ms Jacqueline Surugue
Dr Frans van de Vaart
Ms Marthe Everard
Mr Ton Hoek - ex officio
Prof. Phil J. Schneider - ex officio

Previous Documents: 

Good Pharmacy Practice in Developing Countries: Recommendations for step-wise implementation

Developing Pharmacy Practice

In addition to the FIP involvement in Good Pharmacy Practice through these Guidelines, FIP together with WHO has published a joint handbook entitled "Developing pharmacy practice - A focus on patient care".

This handbook sets out a the new paradigm for pharmacy practice. Its aim is to
guide pharmacy educators in pharmacy practice, to educate pharmacy students and to guide pharmacists in practice to update their skills. The handbook, which brings together practical tools and knowledge, has been written in response to a need to define, develop and generate global understanding of pharmaceutical care at all levels.

Click here to download the English version: "Developing pharmacy practice - A focus on patient care"
Click here to download the French version: "Élargir la pratique pharmaceutique - Recentrer les soins sur les patients"
Click here to download the Spanish version: "Desarrollo de la práctica de farmacia - Centrada en la atención del paciente"
Click here to download the Russian version: "Развитие фармацевтической практики: фокус на пациента"
Click here to download the Chinese version: "开展药学实践 以患者为中心"


Tuesday, May 17, 2011

eHealth survey shows most hospitals online but telemedicine services not fully deployed

More than 90% of European hospitals are connected to broadband, 80% have electronic patient record systems, but only 4% of hospitals grant patients online access to their electronic records, according to the results of a survey conducted for the European Commission. 

European hospitals are more advanced than US hospitals in terms of external medical exchange, but they lag behind in using eHealth to view laboratory reports or radiology images. The survey provides useful data for the work of the EU eHealth Task Force on assessing the role of information and communications technologies (ICT) in health and social care, which is due to suggest ways for ICT to speed up innovation in healthcare to the benefit of patients, carers and the healthcare sector. 

The EU eHealth Task Force met for the first time in Budapest on 10th May (see IP/11/551) on the margins of eHealth week (10-12 May). The deployment of eHealth technologies in Europe, with a view to improving the quality of health care, reducing medical costs and fostering independent living for those needing care, is a key objective of the Digital Agenda for Europe, which for example sets a 2015 deadline for giving patients online access to their medical data (see IP/10/581, MEMO/10/199 and MEMO/10/200).

eHealth applications have a growing role in Europe's hospitals, according to the survey but there are still wide variations in take-up, with Nordic countries taking the lead. Large, public and university hospitals are generally more advanced in eHealth terms than smaller, private ones. The survey data was collected from 906 general public, private or university hospitals. The survey was carried out in 2010 in all 27 EU Member States, plus Croatia, Iceland, and Norway.

Encouraging eHealth deployment in hospitals

The survey shows that in general public, private and university hospitals in Europe are taking advantage of eHealth technologies to a greater or lesser extent:
  • 92% are connected to broadband and 41% of them have broadband speed of at least 50Mbps
  • 81% have one or more electronic patient records systems in place
  • 71% use online eBooking systems for patients' appointments with medical staff
  • 65% have a common patient record system and 61% have an IT-based archiving and communication system
  • 43% exchange radiology reports electronically
  • 39% use videoconferencing (mainly for consultations between internal medical staff and external specialists).
More services required for patients

The survey shows that services for patients, such as ePrescription, telemonitoring or access to patient records are not widely available in all EU hospitals:
  • 54% have WiFi
  • 30% use ePrescription for medicines
  • only 8% offer patients the opportunity to book their own hospital appointment online
  • 8% telemonitor patients at home
  • 5% have some form of electronic exchange of clinical care information with healthcare providers in other EU countries
  • only 4% grant patients online access to their electronic patient record.
A first set of benchmarking on the use of ICT by general practitioners was published in 2008 (IP/08/641).

For more information:
The survey's final report and related annexes are available at:
Digital Agenda website:
Neelie Kroes' website:
Website of European Commissioner for Health John Dalli:
Follow Neelie Kroes on Twitter:



Sunday, April 17, 2011

Highlights from the 2011 Connectathon in Pisa

Connectathon is a five-day ‘connectivity marathon’ for testing the interoperability of health information systems.

The IHE-Europe Connectathon creates a unique opportunity to test health IT applications with systems and products from other vendors in a real-time environment.

For five days in a vast hall that is hard-wired for high speed internet, more than 300 IT engineers come together in a casual but intensely concentrated setting to interconnect more than 100 systems and collaboratively solve problems. According to participants, the cost of identifying and fixing a system bug during a Connectathon is 10 times less expensive and difficult than de-bugging a system once it is installed at a hospital of clinic.

A clear benefit of this week of intensive work are the results for each Connectathon published on the IHE-Europe website. Proof of compliance to IHE Technical Frameworkprovides health IT users an assurance that an application they plan to use is compatible with other IHE-tested systems. More and more hospitals now include a requirement for IHE compliance in their Requests for Proposals to be sure a new application will interoperate with other healthcare systems.

Here are some highlights from the 2011 Connectathon in Pisa, Italy. You can find a Gallery from the Connectathons here.


Informatique Médicale,TIC & Pharmacie

Monday, March 21, 2011

Interested in Hospital Benchmarking across Europe?

eHealth Week is a collocation of the European Commission's High Level Ministerial Conference and the World of Health IT Conference and Exhibition.

In 2010 it was hailed as Europe's largest pan-European conference: an all encompassing event focusing on leadership and the continuum of care – healthcare from the home to the hospital. The event will also address other related subjects such as Pharma, Regional eHealth Solutions and Active and Healthy Aging Partnerships.


eHealth Week is a platform for all stakeholders in the Health IT community and compliments your national conference, by:

* Offering answers by high-level speakers
* Presenting a modern and wide-ranging exhibition, including an interoperability showcase to demonstrate how data can travel across different suppliers and borders.
* Allowing you to network with government- and industry leaders from across the European continent; an opportunity rarely seen at other European conferences.


Tuesday, May 10, 2011: Ministerial Conference (open to all) + side events
Wednesday, May 11, 2011: eHealth Week + side events + exhibition open
Thursday, May 12, 2011: eHealth Week + side events + exhibition open


Tuesday, March 01, 2011

Call for articles for the first issue of the International Pharmacy Journal 2011

Dear Colleagues,

The call for articles for the first issue of the International Pharmacy Journal 2011 is now open.

In this issue FIP will be focusing on “Sustainability”  - that is, methods and innovations that are allowing the pharmacy profession to be sustainable in a setting and expected future of replacing technologies, professional overlap, growing patient knowledge and empowerment and a changing healthcare scene.

We are asking the articles of the upcoming IPJ to focus on Sustainability in relation to the above mentioned issues in addition to an awareness of global and environmental sustainability and to showcase visionary ideals and proposed practical solutions for current and future challenges. 
Please direct any and all questions to Myriah Lesko, Editor International Pharmacy Journal at

We thank you in advance for your interest and contributions!

The FIP Publications Team

Wednesday, February 23, 2011

European Parliament to streamline prescription drug supply

The European Parliament has approved measures which should help streamline orders and supply of prescription drugs to pharmacies.

The plans, which will see changes to medicine packaging, will go some way towards cracking down on counterfeit drugs.

As part of the move, drug packets could be given electronic serialisation numbers, which would allow pharmacies to check the drug's authenticity.

The plans, rubber-stamped by MEPs this week, will also widen European regulation over online medicine sales. Plans are in place to give European internet pharmacies a common, recognisable logo.

The National Pharmacy Association (NPA) has called for the changes to be brought into force "in an efficient and non-bureaucratic way."

Raj Patel, NPA board member and head of the UK delegation to the Pharmaceutical Group of the European Union (PGEU), added: "This is one of the most significant European directives for community pharmacy that we have ever seen and its impact will be felt by pharmacists working across the EU."


Tuesday, February 01, 2011

Patients' Rights in Cross-Border Healthcare

An elderly German man with diabetes brings extra prescriptions with him on a trip to Italy but will the pharmacist accept the prescription? A Polish woman would like to receive hip surgery in the country where her grandchildren live and work but how can she organise this from Poland? A Portuguese man seeks cataract surgery from a specialist in Spain but will he be reimbursed? These are just a couple of cases where a patient may need clarity on rights and rules for cross-border healthcare.

A newly adopted EU law clarifies patients' rights to access safe and good quality treatment across EU borders, and be reimbursed for it. Patients travelling to another EU country for medical care will enjoy equal treatment with the citizens of the country in which they are treated. This new law will benefit EU patients in several other ways. It will make it easier for national health authorities to work closer together and exchange information on quality and safety standards of healthcare. It will help patients who need specialised treatment, for example those who are seeking diagnosis or treatment for a rare disease. It supports the development of "European Reference Networks" bringing together, on a voluntary basis, specialised centres of expertise already recognised in Europe. Health experts across Europe will be able to share best practices on healthcare and provide standards of excellence.
What scale are we talking about?
Patients prefer to receive healthcare in their own country. That is why the demand for cross-border healthcare represents only around 1% of public spending on healthcare, which is currently around €10 billion. This estimate includes cross-border healthcare which patients had not planned in advance (such as emergency care). This means less than 1% of the expenditure and movement of patients is for planned cross-border healthcare, like hip and knee operations or cataract surgery.
What about the existing legislation in this area (Regulations on social security)?
Citizens needing care (including emergency care) when temporarily abroad will continue to benefit from the existing Regulations scheme and be provided with the care they need.
For planned care, a patient can already apply for prior authorisation. This cannot be refused if he/she cannot be treated within a time limit which is medically justifiable.
Why do we need this new legislation then?
This Directive will not affect the benefits already offered to citizens through existing Regulations on social security. Although the existing rules – which focus on social security agreements, not on patients' rights - have been in place since 1971, clarification was still needed on the rights of EU citizens to receive healthcare in another Member State.
In the case of hospital care, one of the main achievements of this new Directive is that patients will be able to choose their healthcare provider.
For non-hospital care, patients will be able to seek healthcare abroad without prior authorisation or formalities, and claim reimbursement upon their return home. This Directive covers not only public, but also private providers.
For both hospital and non-hospital care, patients will have access to information on the quality and safety of the care they will receive.
This Directive also seeks to address other practical questions: where can I find information on quality standards applied by the hospital? How much will I be reimbursed? The European Court of Justice has confirmed1 that the right to seek cross-border healthcare already exists in the Treaty. However, this newly adopted Directive sets this out clearly in EU law and provides a uniform and coherent framework for all citizens in Europe.
Do I need authorisation from my national authority before going abroad for treatment?
National authorities can introduce a system of "prior authorisation" in 3 cases:
1) For healthcare which involves overnight hospital stay of at least one night;
2) for highly specialised and cost-intensive healthcare;
3) in serious and specific cases relating to the quality or safety the care provided abroad. In these 3 cases, patients may need to ask for permission in advance from their national health authority in charge of reimbursement.
Can this authorisation be refused?
National health authorities can refuse authorisation if the treatment in question, or the healthcare provider in question, could present a risk for the patient. Also, if appropriate healthcare can be provided at home in good time, authorisation can be refused but Member States will need to explain why such a decision is necessary.
What if I am refused authorisation?
Patients have the right to request a review of any administrative decision on cross-border healthcare for their individual case.
How much will I be reimbursed after receiving a treatment abroad?
Patients will be reimbursed the same amount as they would receive in their own country for the same type of healthcare. Member States where care is free of charge will need to inform patients about their reimbursement tariffs.
1 Kohll and Decker (1998); Ferlini (2000); Geraets-Smits and Peerbooms (2001); Vanbraekel (2001); Inizan (2003); Müller Fauré and Van Riet (2003); Leichtle (2004); Watts (2006); Stamatelaki (2007); Elchinov (2010).


Tuesday, January 04, 2011

Rare Disease Day 2011: Focus health inequalities

28th February 2011 marks the 4th International Rare Disease Day coordinated by EURORDIS and rare disease national alliances in 25 countries.

Rare Disease Day is intended to increase awareness of rare diseases amongst the general public, European, national and local health authorities and policy makers, health professionals, researchers, academics, the pharmaceutical and biotech industries, as well as the media.

Hundreds of patient groups and their partners, coordinated by national alliances at the country level, will organise a multitude of events to draw attention to rare diseases and the millions of people who are affected by them. Awareness-raising activities are planned across Europe, all the way to Russia, Georgia and Armenia, as well as in the US, Canada and as far as Australia, New Zealand, China and Japan!

This year, EURORDIS member national alliances in 25 countries will combine their efforts to put the spotlight on 'rare diseases and health inequalities' and converge around the slogan “Rare but Equal”.

More specifically, in 2011, Rare Disease Day will seek to draw attention to the:

* Gaps in health that exist for rare disease patients between and within countries in the EU;
* Gaps in health that exist for rare disease patients compared with other segments of society.

The campaign will serve to advocate for:

* Equal access for rare disease patients to health care and social services;
* Equal access to basic social rights: health, education, employment, housing;
* Equal access to orphan drugs and treatments.

Patients, caregivers, social workers and doctors who have a story they would like to share are encouraged to contact the Rare Disease Day organisers at

EURORDIS’ Council of National Alliances will meet in a week’s time to coordinate and plan the last details of this important event. If you would like to organise an awareness-raising activity you can still do so by contacting your national alliance or country organiser. To obtain their contact details go to

If you are not a patient organisation or cannot see your country in the country page of the website, and would like to organise an activity or simply help relay the message to others, you can sign up as Friend of Rare Disease Day and add your name to a growing list of sympathisers on the website.

You can also join the more than 10,000 fans who have already signed up to Rare Disease Day Facebook, and send your video or photo (with commentary in your own language) to the RDD Flickr site and YouTube channel especially created for this day.

As you can see there are plenty of ways to get involved! Let’s combine our efforts to give hope to rare disease patients all over the world!

If you would like to find out more about this year’s campaign, go to