daily dose thursday edition

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Speaking out for the patient What is the role of the hospital pharmacist? The hospital pharmacist’s agenda - patient safety first CONGRESS AGENDA: Full programme of activities Page 2 Thursday 26 March 2015 The EAHP Daily dose SYNERGY SATELLITE: Report from Wednesday Page 3 The musical duo FIVA welcomed the visitors to the 20th Congress of the European Association of Hospital Pharmacists. As well as leading the duo, Fiona Rolffs, violin, is a vascular surgeon whose PhD thesis was on “Pain and Music”. Multidisciplinary collaboration in action! KEYNOTE 2 PREVIEW: Interview with David Cousins Page 5 March 2015 Hamburg 20th Congress © Mariona Ribó Tevadaptor ® receives FDA 510(k) clearance under ONB product code Tevadaptor ® receives FDA 510(k) clearance under ONB product code What does ONB clearance mean? It means that the FDA has found that Tevadaptor ® meets the standard for closed system transfer devices. What is unique about Tevadaptor ® compared to other ONB devices? Tevadaptor ® has the TOXI-GUARD ® system, which prevents both airborne contaminants from entering the drug vial and the escape of hazardous drug vapors or liquid. TOXI-GUARD ® enables rapid equalization of pressure within the drug vial as diluent is added or drug is withdrawn. Have you visited the Tevadaptor booth at EAHP? We are waiting for you at booth #57 Patient education can be regarded as optional, an “add-on” to the more technical tasks of a hospital pharmacist. How much effort should be put into telling patients to take the green ones three times a day after food? Peggy Maguire presented an all-round view of the hospital pharmacist’s interaction with the patient. Putting the patient at the centre of her lecture, because she is passionate about the rights of each citizen to the appropriate health care. So from the point of view of the European Commission, the hospital pharmacist should be seen as an invaluable part of the care team being in a position to advise on drug selection, compliance and adverse drug reactions. To the European Public Health Alliance, of which EAHP is a member, hospital pharmacists are “in a unique position to advise on the appropriate use of antibiotics”. So hospital pharmacists are being asked by all sides to integrate themselves fully into the hospital team. As we know, this process proceeds by evolution not revolution: collect the evidence, collaborate with other stakeholders, build the role of the hospital pharmacist to the point at which they are the vital reference point for all matters to do with drugs. A position supported by the most important stakeholder – the patient. Mrs Maguire outlined the most important transitions of care at which a pharmacist is helpful: admission, admission or exit from intensive care, switching between wards and discharge home. Ideally, patients or their carers should speak briefly to a pharmacist, as well as their family doctor or pharmacy being sent a letter. While some patients or carers might have looked up the condition on the internet, they might have not been able to identify good sources of information. If each patient is not going home equipped in this way, their need to understand their medicines has not yet recognised. The fact is that education as a patient leaves hospital can prevent GP visits and even hospitalisation. With education and support the patient should have the confidence to manage their health. Expert patients – trained by medicines experts. Hospital pharmacists were sent on their way with a huge vote of confidence and appreciation. Thank you for your support, Peggy Maguire. © Mariona Ribó

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Speaking out for the patientWhat is the role of the hospital pharmacist?

The hospital pharmacist’s agenda - patient safety first

CONGRESSAGENDA:

Full programme of activities

Page 2

Thursday 26 March 2015The EAHP

Daily dose

SYNERGYSATELLITE:

Report fromWednesday

Page 3

The musical duo FIVA welcomed the visitors to the 20th Congress of the European Association

of Hospital Pharmacists. As well as leading the duo, Fiona Rolffs, violin, is a vascular surgeon

whose PhD thesis was on “Pain and Music”. Multidisciplinary collaboration in action!

KEYNOTE 2PREVIEW:

Interview with David Cousins

Page 5

March 2015 Hamburg

20th Congress

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ario

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ibó

Tevadaptor® receives FDA 510(k) clearance under ONB product code

Tevadaptor® receives FDA 510(k) clearance under ONB product code

What does ONB clearance mean?

It means that the FDA has found that Tevadaptor® meets the standard for closed system transfer devices.

What is unique about Tevadaptor® compared to other ONB devices?

Tevadaptor® has the TOXI-GUARD® system, which prevents both airborne contaminants from entering the drug vial and the escape of hazardous drug vapors or liquid.TOXI-GUARD® enables rapid equalization of pressure within the drug vial as diluent is added or drug is withdrawn.

Have you visited the Tevadaptor booth at EAHP?

We are waiting for you at booth #57

tevadaptor fda 0315.indd 6 11/03/2015 11:01:22

Patient education can be regarded as optional, an “add-on” to the more technical tasks of a hospital pharmacist. How much effort should be put into telling patients to take the green ones three times a day after food?

Peggy Maguire presented an all-round view of the hospital pharmacist’s interaction with the patient. Putting the patient at the centre of her lecture, because she is passionate about the rights of each citizen to the appropriate health care. So from the point of view of the European Commission, the hospital pharmacist should be seen as an invaluable part of the care team being in a position to advise on drug selection, compliance and adverse drug reactions. To the European Public Health Alliance, of which EAHP is a member, hospital pharmacists are “in a unique position to advise on the appropriate use of antibiotics”.

So hospital pharmacists are being asked by all sides to integrate themselves fully into the

hospital team. As we know, this process proceeds by evolution not revolution: collect the evidence, collaborate with other stakeholders, build the role of the hospital pharmacist to the point at which they are the vital reference point for all matters to do with drugs. A position supported by the most important stakeholder – the patient.

Mrs Maguire outlined the most important transitions of care at which a pharmacist is helpful: admission, admission or exit from intensive care, switching between wards and discharge home. Ideally, patients or their carers should speak briefly to a pharmacist, as well as their family doctor or pharmacy being sent a letter. While some patients or carers might have looked up the condition on the internet, they might have not been able to identify good sources of information.If each patient is not going home equipped in this way, their need to understand their medicines has not yet recognised. The fact is that education as a patient leaves hospital can prevent GP visits and even hospitalisation. With education and

support the patient should have the confidence to manage their health.

Expert patients – trained by medicines experts. Hospital pharmacists were sent on their way with a huge vote of confidence and appreciation.

Thank you for your support, Peggy Maguire.

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ario

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2 | 20th Congress of the EAHP

THURSDAY 26 MARCH

DATE/TIME MEETINGS/EVENTS ROOM CATEGORY CEUs

7.30 - 09.00SYNERGY SATELLITE breakfast event - Barcoding the single dose of drugs to improve patient safety - ACPE UAN: 0475-0000-15-004-L05-PT. De Rijdt; U. Kreysa; C. Dierickx

Hall 4 0.15

08.30 EXHIBITION OPENS Hall H

09.00 - 10.30 SEMINARS

Seminar M1 - Inspired by STOPP/START: a new prescription screening tool for adult patients - ACPE UAN: 0475-0000-15-011-L05-PB. Guignard; P.-O. Lang; A. Desnoyer Hall G1 Management

and organisation 0.15

Seminar C1 - Improving patient safety through multidisciplinary teamwork - ACPE UAN: 0475-0000-15-007-L05-PJ. Martin; R. Isaac Hall G2 Concept 0.15

Seminar CL1 - Medication safety in transitions of care - ACPE UAN: 0475-0000-15-016-L05-PM. Stebbins; T. Grimes Hall E Clinical 0.15

Seminar M2 - Risk analysis of the drug development process - focus on the patient - ACPE UAN: 0475-0000-15-012-L05-PL. Van Bortel; G. N. Castiglione Hall F Management

and organisation 0.15

Seminar CL3 - Patient safety through individualised therapy - ACPE UAN: 0475-0000-15-018-L05-PJ. Palka; A. Wesołowska Hall B Clinical 0.15

Workshop 1 - Ethical and legal dilemmas: focus on the patient - ACPE UAN: 0475-0000-15-021-L05-PC. Rehmann-Sutter; H.-P. Lipp Hall C1 0.15

Workshop 2 - How to manage methodologies underlying patient and professional safety? - ACPE UAN: 0475-0000-15-022-L05-PV. Leroux - CANCELLED Hall 7 0.15

Workshop 4 - A systematic approach to pharmaceutical care with a focus on data gathering - ACPE UAN: 0475-0000-15-024-L05-PA.Tonna; A. Weidmann Hall 8 0.15

Poster nominee oral presentations Hall D

10.30 - 11.00 Bayer - Meet The Expert: “Challenges in managing patients treated with NOACs and multiple comedications”Kurt Hersberger

Hall H,(Stand 76)

10.30 - 11.00 COFFEE BREAK AND ATTENDED POSTERS Hall H

11.00 - 12.00 Keynote 2 - Developing a safety culture: how to progress effectively? - ACPE UAN: 0475-0000-15-002-L04-PD. Cousins Hall 2 0.045

12.00 - 13.30 SEMINARS

Seminar C2 - Budgetary constraints and patient care - ACPE UAN: 0475-0000-15-008-L05-PA. Melo Gouveia; C. Sakellarides Hall G1 Concept 0.15

Seminar CL2 - Medical device vigilance - ACPE UAN: 0475-0000-15-017-L05-PA. Cavazzana; J.-F. Roche Hall G2 Clinical 0.15

Seminar M3 - The use of simulation in pharmacy education - ACPE UAN: 0475-0000-15-013-L04-PA. L. Seybert; S. Chapman Hall E Management

and organisation 0.15

Seminar C3 - Methodologies underlying patient safety - ACPE UAN: 0475-0000-15-009-L05-PB. D. Franklin; J. Duquesne Hall F Concept 0.15

Seminar M4 - Design for safety in drug development - ACPE UAN: 0475-0000-15-014-L04-PL. Büsing; G. Bejeuhr Hall B Management

and organisation 0.15

Workshop 3: Patient engagement and communication skills - ACPE UAN: 0475-0000-15-023-L05-PM. Kinnear; A. Sinclair; A. Cockburn Hall C1 0.15

Workshop 7: Medication reconciliation on admission - ACPE UAN: 0475-0000-15-027-L05-PJ. Smith; N. Mogford Hall 8 0.15

Good Practice Initiative oral presentations Hall 2

INDUSTRY SPONSORED SATELLITES

Cubist Hall 6

Teva Oncology Hall D

Abbvie Hall 4

13.30 - 15.00 LUNCH Hall H

13.30 - 15.00 Highlights of German Hospital Pharmacy - ACPE UAN: 0475-0000-15-030-L04-PM. Fellhauer; M. Baehr; C. Langebrake; C. Vetter-Kerkhoff; I. Krämer ; H. M. Seidling Hall E 0.15

Workshop 8: Evidence based clinical pharmacy - ACPE UPN: 0475-0000-15-028-L04-PP. Wiffen Hall 7 0.15

14.00 - 14.30Bayer - Meet The Expert“Strategies for prevention and management of bleeding”Peter Verhamme

Hall H, (Stand 76)

15.00 - 16.30 SEMINARS

Seminar C4 - Error causation and taxonomy - ACPE UAN: 0475-0000-15-010-L05-PK. Taxis; B. D. Franklin Hall G1 0.15

Seminar M5 - Patient safety and drug supply technologies - ACPE UAN: 0475-0000-15-015-L05-PR. Beard; R. Van der Meer Hall G2 0.15

Seminar M6 - Patient safety and compounding technologies - ACPE UAN: 0475-0000-15-031-L05-PK. Frenssen; A. Vermes Hall E 0.15

Seminar CL4 - Adherence and patient involvement - ACPE UAN: 0475-0000-15-019-L05-PP. van den Bemt; H. Van Onzenoort; M. O. Ibarra Barrueta Hall F 0.15

Seminar CL5 - Medication safety in vulnerable patient groups - ACPE UAN: 0475-0000-15-020-L05-PB.Wickop; S. Tomlin Hall B 0.15

Workshop 5 - The art of writing an abstract - ACPE UAN: 0475-0000-15-025-L04-PT. Hoppe-Tichy; L. J. Kjeldsen Hall C1 0.15

Workshop 6 - Developing a Lean Management culture - ACPE UAN: 0475-0000-15-026-L04-PN. Curatolo; H. Kjer Hall 7 0.15

INDUSTRY SPONSORED SATELLITES AND WORKSHOP

Pfizer workshop: “Make your voice heard”Leadership, advocacy and communication skills: helping today’s hospital pharmacist shape tomorrow’s professional landscapeCam Battley

Hall 8

Avantec Healthcare Hall 6

Fresenius Kabi Hall 4

Bayer HealthCare: “Confidence in Practice with Rivaroxaban in daily use” Hall D

16.30 - 17.00 COFFEE BREAK Hall H

17.00 - 18.30SYNERGY SATELLITE - Targeted drugs - scattered goalsACPE UAN: 0475-0000-15-006-L04-P | sponsored by an educational grant from Novartis OncologyT. Schoening; D. Jäger; O. Witt

Hall 2 0.15

20th Congress of the EAHP | 3

Report of Wednesday’s SYNERGY SATELLITEEvidence and pharmacovigilance of monoclonal antibody reference and biosimilar products

The Congress is a great opportunity for convening leaders of hospital pharmacy. An EAHP Members’ Meeting on Tuesday 24 March updated representatives from national hospital pharmacy associations with the latest news on EAHP activities and European matters that affect hospital pharmacy.

EAHP’s 2015 Baseline Survey

Petr Horák and Jonathan Underhill presented the first results of EAHP’s 2015 baseline survey of hospital pharmacy practice across Europe. The survey is a tool for EAHP members to benchmark the current state of hospital pharmacy in their country against neighbours and the European whole, and serves as primary reference for understanding the extent to which the European Statements of Hospital Pharmacy are being delivered.

The questionnaire was translated into 15 languages and investigated each EAHP country’s current position in relation to each of the 44 Statements. It also looked at matters such as capacity (number of hospital pharmacists) and capability (level of training and experience of the hospital pharmacists). Finally, it probed general issues about implementation of the statements, such as readiness and any barriers to implementation.

The biggest barriers to implementation observed in the preliminary analysis of answers were difficulties with the statements highlighted in the Panel. Other replies and comments suggested that some hospitals surveyed did not undertake or publish practice research.

The authors hope to publish their findings in June 2015.

Implementation of the Falsified Medicines Directive

A new Regulation is being finalised by the European Commission which will mandate hospital pharmacists in every EU country to conduct a ‘final check’ of every package of medicine in the hospital by scanning a ‘unique identifier’ (a 2D barcode). This will verify that the medicine is from the legitimate supply chain. John Chave, President of the European Medicines Verification Organisation (EMVO), kindly addressed the meeting, explaining some of the serious impacts that the Regulation could have for both community pharmacy and hospital pharmacy practice. Over 99% of drugs used in hospitals will be covered.

The Directive requires a verification of the medicine package at ‘the point of dispensing’. However it is problematic to define at exactly what point a medicine is dispensed in a hospital. It seems sensible to verify the unique identity of medicines by a barcode check when they are received in the hospital, preferably at bulk level. However there is a serious threat the opportunity to ‘check out’ medicines at a bulk level will not exist in the new Regulation, with potential major impacts for hospital pharmacy practice, staffing and resourcing.

Once published the Regulation will not be open to national interpretation, but will be binding on all EU member countries, and take effect in 2018.

EAHP members determined a need for national representations to be made to EU Governments highlighting serious concerns.

Report of EAHP members’ MEETING

EAHP CONGRESS APP 2015

View the programme schedule, floor plans and much more in the palm of your hand!

Available in app stores for iPhone and Android devices as “EAHP”.

Free Wi-Fi service will be available through the congress centre, with exception of session rooms and the exhibition hall.

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Brought to you by Bayer, EAHP Platinum Partner

Hospital pharmacists conduct a critical role in the care of patients in hospitals. To help those outside the profession to better understand some of these roles, EAHP has produced a short animated video telling the story of hospital pharmacy.

www.eahp.eu > media room > multimedia gallery

Check out the video “What hospital pharmacists do”

Statement

S44 The pharmacists in our hospital enter all medicines used onto the patient’s medical record on admission.

S45 The pharmacists in our hospital contribute to the transfer of information about medicines when patients move between and within healthcare settings.

S64 The pharmacists in our hospital routinely publish hospital pharmacy practice research.

S53 Our hospital uses an external quality assessment accreditation programme to assure our medicines use processes

S11 The pharmacists in our hospital work routinely as part of multidisciplinary team.

The 5 Statements that appear to have the biggest barriers to implementation

A trio of respected academics came with one strong message: biosimilar monoclonal antibodies must be evaluated individually for their usefulness for particular patient groups.

This synergy symposium was very well attended, width over 1400 participants. Members of the audience were asked to vote on 9 questions before the lectures, then after each 20-minute presentation they voted again on the 3 questions relevant to that presentation. To everyone’s satisfaction 600 or so participants registered their votes within a short time, and the change in the results after the presentations confirmed that opinion had been swayed: people had learned something.

We were reminded that monoclonal antibodies are very complex compared with the “small molecules” we traditionally regarded as drugs. All are approved by the EMA but their specification extends to their biotechnology-enabled production, formulation, indications and cost. There are many other factors that affect the choice of a

particular Mab: pharmaceutical quality, safety (especially immunogenicity) and efficacy (especially in extrapolated indications). The totality of functionality depends on the totality of the components of the product: the glycosylation pattern may affect such things as cell binding ability, ability to induce apoptosis and pharmacokinetic profile. In fact not even originator molecules are exactly the same from batch to batch, hence the saying “the process is the product”.

Once the complex molecules have been created, the downstream purification sequences are almost as important. They affect for example the degree of aggregation of the molecules, which in turn affects immunogenicity and the interaction between physical and chemical characteristics.

Professor Irene Kraemer concluded by suggesting what factors might influence the decision of the hospital’s Drug & Therapeutics committee to choose a particular product. The price is a major consideration, but not the only one. Each manufacturer (originator or biosimilar) should be

rated for availability of supply, medical support 24/7, traceability, and manufacturer’s experience with making the product, naming and documentation. Each of these factors should be given a weighting for its contribution to the product’s total core. Such considerations might each be given a score of 3% of the total. All of the categories and weightings are arbitrary but at least represent an attempt to be rational in the choice of agent.

Finally the main considerations will be clinical efficacy, price, safety, pharmacovigilance system, and the particular indication for which the formulary will allow its use in particular indications. The more important factors might be ranked at 25% of the total weighting assigned.

The facilitator commented that nothing is easy in hospital pharmacy; nevertheless the HPs should have a good idea how to go about including a new Mab in the formulary after seeing these talks.

4 | 20th Congress of the EAHP

Posters are received from all around the world for every Congress. From colleagues just like you. Be inspired by them. Pick up ideas and approaches; take them back to your own hospital. The abstracts book records all the ideas and reminds you when the award nominees will present their posters.

Could this be you?

Could you have a poster up next year? What good ideas have you introduced in your workplace? Don’t worry if your English is not very good. Once your abstract has been selected by the peer reviewers it will be edited

to present your ideas in clear English. What is needed is an account of your work: what was the issue or problem you faced, what did you do to clarify or resolve it and what was the outcome? A short introduction provides the background.

There is guidance on the website

The EAHP website gives a lot of guidance on poster submissions (www.eahp.eu > congresses > abstracts). Some results are best presented in table form for example. Submitting the poster in the right category helps send it to the right reviewers, and

guides the reader if they are looking for a certain topic.The main point of a poster is to present a new idea or information that has not yet been published, or a new way of tackling an old problem. It does not have to be a large, successful new scheme – though that would be great! A pilot project for a new way of working or a report of the multidisciplinary work you have undertaken to investigate a problem are both fine.

The EAHP can provide the guidance but your ideas are needed to drive hospital pharmacy forwards.

The Professional Qualifications Directive is the primary legal tool for all professionals in Europe to exercise their right to work in other countries and have qualifications recognised as equivalent. The European Commission views improving professional mobility as key to assisting economic growth in Europe as well as achieving free movement of labour.

A common training framework for hospital pharmacy specialisation in Europe would open up new possibilities of mobility for hospital pharmacists, act as a benchmark for hospital pharmacy specialisation for those countries not yet possessing such professional development systems, and see pharmacy develop professional pathways similar to those of doctors and dentists.

The new Professional Qualifications Directive makes it possible for EU Member States to decide on a common set of knowledge, skills and competences that are needed to pursue a given profession. Professionals who have gained their qualifications under such a common training framework will be able to have their qualification recognised automatically in all participating countries.

A common training framework must include at least 1/3 EU Member States (currently calculated as 10) to meet requirements, and whilst it can be proposed by professional associations, will need the approval of the relevant Member State Governments and the competent authorities for pharmacy qualification recognition in those countries. It will benefit patient care in every European country by raising standards of professional practice.

To set the ball rolling, EAHP’s common training framework project is being led by a combination of EAHP representatives and representatives from 7 EU countries with forms of legally mandatory hospital pharmacy specialisation (Belgium, Czech Republic, Italy, France, Netherlands, Spain, Portugal).

The EAHP representatives form a “steering committee” set up by the Board of Directors. In January 2015 it agreed an action plan by which it will lead the project of agreeing a common training framework for hospital pharmacy specialisation in Europe. Early tasks include conducting comprehensive mapping of the comparative competencies taught by specialisation programmes across Europe.

Congress POSTER WALKYour colleagues are improving patient care

EAHP PolicyCommon Training Framework

The Congress is delighted to welcome Paul W. Abramowitz, Chief Executive Officer of the American Society of Health-System Pharmacists (ASHP). Prior to joining ASHP in September 2011, Dr. Abramowitz worked in hospitals and health-systems for over 30 years, most recently as Associate Hospital Director for Professional Services and Chief Pharmacy Officer at the University of Iowa Hospitals and Clinics.

ASHP and EAHP

Congratulations to the EAHP on another successful year and congress. ASHP is pleased to be able to collaborate with EAHP on many professional fronts, sharing information and supporting each other in our common goals around pharmacist practice. In so many ways, your challenges are our challenges: dealing with medicine shortages, addressing the problems with antimicrobial resistance, advancing pharmacy practice in caring for patients, pharmacist specialisation, promoting safe use of medicines,

and the effective use of technology in the medication use process.

EAHP efforts to advance pharmacy practice through the development of the European Statements on Hospital Pharmacy, and the promotion of Good Practices Initiatives, are already having an impact in many parts of Europe. ASHP is undergoing similar practice changes through the ASHP Pharmacy Practice Model Initiative. Our two organizations have much to share and learn from each other in these strongly aligned initiatives.

ASHP values the strong, collegial relationship we have with EAHP. In the past few years, we have had the good fortune and friendship of EAHP Presidents Roberto Frontini and Jacqueline Surugue at many of the ASHP meetings, further building on our relationship and collaboration. We look forward to working with EAHP in the future, seeking ways to network and share information that allows pharmacists in our respective continents to advance what we do caring for patients.

Paul AbramowitzCEO of the ASHP

INTERVIEW©

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EAHP President Roberto Frontini honored with the ASHP Donald E. Francke Medal

Established in 1971, the ASHP Donald E. Francke Medal honors pharmacists who have made significant international contributions to health-system pharmacy. The medal is conferred at the discretion of the ASHP Board of Directors. It may be given annually to one person and may be presented to the recipient at the Society’s Summer Meeting, Midyear Clinical Meeting, or other appropriate function. The award consists of an inscribed medal, and the recipient is eligible for an honorarium equivalent to payment of his or her travel expenses to attend the event at which the award is bestowed. The recipient provides a lecture at that time.

20th Congress of the EAHP | 5

Hospital pharmacists are well aware that patients can unintentionally be harmed while in hospital. In 2002 the World Health Organisation recognised the importance of implementing effective systems to address patient safety and the need for a reporting and learning culture. Today I will ask: how are we doing on this important topic in European hospital pharmacy?

As part of the preparatory work towards creating the European Statements of Hospital Pharmacy I was asked to survey European hospital pharmacists on the use of service performance measurements. The questionnaire asked whether service performance measures were being collected for four types of services: medicines distribution, medicines manufacturing, clinical services and financial services. Responders were invited to indicate whether specified hospital pharmacy services were provided, if any measurement data had been collected in the 12 months before the survey and whether the data had been shared outside the pharmacy department.

Survey responses from 149 of hospital departments indicated that adverse drug reaction reporting was within

their scope of service; however only 81 (54.4%) departments collected any data, and of these only 58 (38.9%) shared this data outside the department. There were similar results for medication error incident reporting.

Under the new EU Directive 2010/84/EU that came into force in July 2012 national pharmacovigilance centres are required to expand their activities to include reporting and learning systems for medication errors.

In European Statement of Hospital Pharmacy 5.3, under patient safety and quality assurance there is a broad statement: In collaboration with other health care professionals, hospital pharmacists should ensure the development of appropriate quality assurance strategies for medication practices including the use of observation methodology, Medication Error Reporting Systems (MERS), and Clinical Incident Reporting System (CIRS) to detect errors and identify priorities for improvement.

Results from the survey indicated that the uptake of performance measurement in European hospital pharmacies is in the order costs>workload>quality>(clinical) safety. Apart from medical costs

data, there are relatively low rates of data sharing outside the pharmacy department. It is important to develop quality and safety measures at the same time as measures for cost and workload. If they are not, quality and safety may be threatened by cost cutting and increased workload.

So this is why we have to measure the services we provide, and the challenge that hospital pharmacy faces. How are we doing? I will be asking specific questions of individual hospital pharmacists and pharmacy departments and will outline how NHS England has responded. Medication Safety Officers, many of whom are pharmacists, have been appointed amongst other innovations.

Is there a role for safety officers and networks in other European countries to improve the reporting and learning culture? In whatever form your hospital or country decides to implement the Directive, I can offer some specific objectives you should try to meet.

KEYNOTE preview - David CousinsDeveloping a safety culture: how to progress effectively?

Room:

Hall 2

Thursday,

26 March

11:00 - 12:00David CousinsFormer Head of Safe Medication Practice and Medical Devices, NHS England

In this lecture, Dr David Cousins will take the new EAHP European Statements of Hospital Pharmacy and an accompanying survey on the use of metrics in hospitals, review them in the light of the revised EU directive on pharmacovigilance, which now includes medication errors, and ask how best we can apply systems for reporting and learning from errors in hospital pharmacy. This lecture is a “must” if you are trying to develop a culture of safety in your hospital or your country.

After nearly 20 years as a Chief Pharmacist in an NHS hospital Dr Cousins was appointed Head of Safe Medication Practice and Medical Devices, of the UK’s National Patient Safety Agency. Between 2012 to 2014 he was Head of Safe Medication Practice and Medical Devices, NHS England and is now medication and medical devices safety officer of a private healthcare company.

Dr Cousins has been researching and publishing on medication error prevention since 1990. He is the author of national guidance on safe medication practice for primary, secondary and tertiary healthcare providers and pharmaceutical and the medical devices industry in the UK.

Equashield enters Sweden, continuing surge of global expansionEquashield, a leading provider of Closed System Transfer Devices (CSTDs) for safe and simple handling of hazardous drugs, recently announced an exclusive Swedish partnership with CODAN TRIPLUS AB, a market leader in IV sets and accessories for infusion and transfusion therapy. The arrival of EQUASHIELD® II into Sweden caps off a year of rapid expansion for Equashield, which has penetrated eight global markets - throughout North America, Europe, Asia and Oceania - within the last 12 months.

The entrance of EQUASHIELD® II into the Swedish market is striking, as the first closed system device was developed in the Scandinavian country. Equashield’s technological innovations subsequently set a new standard for CSTDs, the key factor in CODAN selecting Equashield for this exclusive distribution partnership.

Equashield has continued to establish new strategic partnerships with global distributors following its FDA clearance under the ONB product code. “We are honored to offer our CSTD to Swedish healthcare facilities through our alliance with CODAN,” said Adi Baruch, Vice President of Sales and Business Development for Equashield. “We are appreciative of this strong partnership and proud to introduce a vital CSTD alternative to the market in Sweden.”

“The Swedish market for CSTDs has solidly developed over the past decade along with a significant focus on safe handling of hazardous substances,” said Lennart Bådersjö, General Manager of CODAN TRIPLUS. “Having thoroughly evaluated the EQUASHIELD® II closed system, we are confident this innovation is the strongest available solution on the market. We place great value in our partnership with Equashield, which allows CODAN to supply a cutting edge, easy-to-use system that provides an unparalleled level of protection to pharmacists and other healthcare professionals who work with hazardous medications.”

About Equashield

Equashield is a leading provider of Closed System Transfer Devices (CSTDs), clinically proven to protect healthcare professionals from hazardous drug exposure. Incorporating a pioneering design, the company’s flagship device, EQUASHIELD® II, covers more routes of exposure than alternative systems by preventing the contamination of syringe plungers and preventing exposure to drug vapor. No CSTD is faster to deploy or easier to use than EQUASHIELD® II. Both generations of EQUASHIELD have been cleared by the FDA ONB product code and substantiated in FDA-cleared labeling as preventing microbial ingress for up to seven days.

For more information visit the company’s website at www.equashield.com or contact Adi Baruch, Vice President of Sales and Business Development: [email protected]

About CODAN TRIPLUS AB

Part of the Danish/German-based global CODAN network, CODAN TRIPLUS AB was founded in 1977. The distributor is a well-known and respected supplier of a wide range of medical products in Sweden with a primary focus on infusion, gravity and pumps. Other CODAN TRIPLUS AB products include applications for OR, ICU, anesthesia, oncology and angiographic labs.

For more information visit the company’s website at www.codan.de

6 | 20th Congress of the EAHP

Publication of all clinical trial results is the aim of the AllTrials campaign. Since it started in January 2013, progress has been phenomenal. WHO, the European Commission and the US, UK and Canadian Governments have been persuaded to take action. Over 500 organisations have agreed to help, including EAHP and many of its member organisations. 80 patient groups signed up in one day! The culture of secrecy of clinical trial results is gradually changing.

In April 2014 the European Parliament, European Commission and national Governments finalised agreement on the changes that needed to be made to EU regulations. All drug trials in Europe will now need to be registered before they begin and a summary of the results published within a year of the trial’s end.

In June 2014, Vanessa’s Law was brought into being as Canada made the bold step of ensuring clinical trial information is made publicly available. And in the same

month, the European Medicines Agency (EMA) also decided to change its data sharing policy. One by one, individual pharmaceutical companies are making the positive decision to pro-actively share their data.

Universities are signing up to AllTrials at the request of their students and former students. In the US 22 congress representatives called on the National Institutes of Health to publicly disclose information on the sex and ethnicity of participants in all registered clinical trials.

However in July, it emerged, depressingly, that out of a sample of 400 completed trials registered on ClinicalTrials.gov, 30% hadn’t reported their results.

If you have not yet added your name or organisation’s voice to the collective call for improvement, visit the AllTrials campaign website today to do so www.alltrials.net.

We’ve listened to our members and are improving the way in which we conduct survey surveillance of practice development in Europe in a number of important ways:

• Shorter surveys – we understand how busy professionals can be, and have therefore rationalised the number of questions we will ask to only the most important and valuable;

• Quicker reporting times – the 2015 survey will commence a new annual cycle of survey activity designed to ensure faster turnaround times between the receipt of responses, and the publication of the analysis;

• Connected to the European Statements of Hospital Pharmacy – the statements now set out the shared agreement between Europe’s hospital pharmacists, patients and other healthcare professionals about what hospital pharmacy should be in all European countries.

The EAHP practice survey will now aim to help our members monitor progress towards their achievement.

The new annual cycle of practice survey will commence in autumn 2015.

To commence the new annual cycle of survey

activity, an initial baseline survey of hospital pharmacy practice was conducted in early 2015. We will use these results to produce a reliable barometer of year-by-year progress in practice development.

Stay updated for all the latest news about EAHP’s 2015 practice survey by signing up to

receive the EAHP EU Monitor.

EAHP Policy

EAHP members have adopted a new policy statement on antimicrobial resistance. The 34 national hospital pharmacy associations that make up EAHP see a crucial role for hospital pharmacists in antimicrobial stewardship, which should be promoted throughout Europe.

The escalating threat of antimicrobial resistance is a global public health concern and now seriously jeopardises the effectiveness of standard treatments, rendering some ineffective for their approved indications.

Unlike drugs used in the treatment of chronic non-communicable diseases, which do not become ineffective with use, antibiotics become ineffective within a few years of clinical use. This implies that developing antibiotics is not as profitable so very few new antibiotics are being developed by the pharmaceutical industry. The drought in novel antimicrobial agents makes the need for antibiotic stewardship even more urgent and important.

Pharmacy ‘stewardship’ key to tackling antimicrobial resistance

Pharmacists specialised in the area of infectious diseases/antimicrobials are well placed to provide expert high-level advice within health systems about combating antimicrobial resistance. There is also a role for all pharmacists working in all sectors to provide appropriate advice about antibiotics: to patients; prescribers; and those with responsibility for the functioning of health systems more generally.

Hospital pharmacists form a key resource for combating antimicrobial resistance, with their specialised background and knowledge in the area of appropriate antibiotic use. Roles should be expanded in this regard, and hospital pharmacists embedded in the heart of national and local strategic responses to the antimicrobial resistance crisis.

Hospital pharmacists should be empowered to make direct interventions within multidisciplinary care teams to achieve better use of antibiotics. This includes reviewing treatment duration, advising on stopping inappropriate antibiotic treatments, and educating other healthcare professionals on the restricted use of certain antibiotics.

Antibiotic stewardship has developed over the last decades, as has the number of specialist antimicrobial pharmacists and when systems have been implemented they are effective at improving clinical outcomes and preventing antimicrobial resistance. As well as intervening

directly hospital pharmacists can provide improved education about antibiotic use to other healthcare professionals and system managers (e.g. coordinating guidelines and avoiding long term prophylaxis), implement polices/procedures leading to a reduction in consumption and good prescribing practice.

Success stories: a reduction in the use of resistogenic antibiotics (fluoroquinolones and second and third generation cephalosporins) has had a positive effect on Clostridium difficile infection, MRSA as well as Extended-Spectrum-Beta-Lactamase incidence in many European countries. In Scotland multidisciplinary teams consisting of antimicrobial pharmacists; infectious disease physicians and microbiologists have been introduced as part of a holistic approach to the problem.

The European Association of Hospital Pharmacists urges the better use of existing antibiotics.

Roberto Frontini was interviewed at the launch of the new policy in January 2015.

“Hospital pharmacy is a profession that prides itself on its expertise. When it comes to improving the use of antibiotics within hospitals we believe there is a pressing need for system change. Pharmacists should come to the fore in hospitals as front line fighters against antimicrobial resistance.More countries should engage in such health system change. Share best practice, establish antimicrobial stewardship systems within hospitals, and improve the use of IT resources. While we see excellent progress in some European countries, when we look across Europe the picture appears all too patchy and uneven.”

“Pharmacists should be brought to the fore in hospitals as front line fighters against antimicrobial resistance”– Roberto Frontini

EAHP is also urging:

• the European Commission to review what further roles it can play, alongside Governments and other stakeholders, in improving the research environment for new antimicrobials, and,

• improvements in pan-European monitoring and regulation of antibiotic use in other sectors such as agriculture, the veterinary sector and aquaculture.

The AllTrials campaign

SURVEY 2015

Antimicrobial resistance: hospital pharmacists should be helped to do more

EAHP’s Practice Survey is changing

EAHP Member Associations passed policy in 2012 calling for improved regulation of clinical trials at the European level.

The profession jointly called for:

• a single European electronic portal for submitting trials for assessment;

• greater distinction being made in the assessment process between high risk and low risk trials;

• a process to be created to enable multi-sponsor trials; and

• more open access to clinical trial data, including making it a condition of licence applicants to publish trial data provided to the European Medicines Agency.

EAHP is pleased to tell Congress attendees that progress has now been made on all these points via the revised EU clinical trials regulation, finalised in 2014 and now in stages of implementation.

Improving the regulation of clinical trials

EAHP warmly thanks our industry partners for their continued commitment to supporting the goals of

hospital pharmacists.

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20th Congress of the EAHP | 7

KEYNOTE preview - Howard W. BergendahlSafety in high reliability industries - What healthcare professionals can learn

Mr Bergendahl’s education includes a Bachelor of Science degree in Biology/Chemistry, a Master of Science degree in Health Physics and a Juris Doctorate degree. He is also a licensed attorney, received a Senior Reactor Operator license from the United States Nuclear Regulatory Commission and he is a Certified Professional in Patient Safety. Howard’s career began in the nuclear power industry where he started as a Radiation Health and Safety Engineer and went on to spend 20 years operating and managing nuclear facilities. In 2003 he co-founded the Bergendahl Institute and for the last 10 years Howard has led the Institute in its mission to improve patient safety by assisting healthcare organizations to incorporate the nuclear industry lessons learned in areas of human error management and safety culture.

Is this your first visit to the EAHP Congress Mr Bergendahl, or have you been in close contact with the EAHP for several years?

This is my first EAHP Congress and I am very excited to participate because I know the Hospital Pharmacists have a difficult job and face many unique challenges.

What do the nuclear power industry and hospital pharmacy have in common?

Both industries rely heavily on individuals to perform precise activities with high risks for adverse outcomes. The working conditions are similar in that there are time pressures and potential safety impact to other people.

What are their common aspirations?

In both industries we practice the “art” of error management. We will never eliminate human error but we can prevent the inevitable errors from harming patients.

What can hospital pharmacy learn from the nuclear power industry?

A lot. The nuclear industry has been working steadily to find new ways to reduce human errors since the 1980s and has become one of the leaders in cultivating a culture of safety since the 1990s. We now know culture drives behaviours and overrides everything else.

What might your “take-home” message about safety be?

People are people. I’m always told nuclear power is different from healthcare because in healthcare we work with people versus machines so it is much more complex and variable. That is true. However, the emphasis and learning opportunities are not about the patient, they are about the caregivers and providers. It’s about how you behave, how you react to unexpected conditions, how you make decision and the organization culture that drives those behaviours and decisions.

These are the principles that should guide our attitude to safety:

•Weallmakemistakesandbecomecomplacentovertime;

•Noonecomestoworkplanningtomakeanerrorortohurt someone;• Weshouldstop“whenthingsdon’tseemright”versuswhen “something is wrong” (follow your instincts);•Organizationswillalwaysemphasizeproduction,leadersmust emphasize safety;•Culturecanmakepeopledothingsagainsttheirbetterjudgement.

The phrase “safety culture” is widely used but rarely understood. Even if you do fully understand the concept, turning that knowledge into actions that positively influence your organization can be a challenge. Today, your organization’s culture is creating the conditions and behaviours that will either produce excellent results or serious adverse events. If you are not actively trying to create a strong safety culture in your organization, it probably doesn’t exist. The reason for this is that all organizations exist to provide a product or a service. Therefore there is a natural emphasis on production that is reinforced at every performance evaluation. Every employee is aware of government or local policy, targets. Conversely, a safety culture is not naturally built in.

Thank you Mr Bergendahl, we look forward to learning from the nuclear industry how to create a strong safety culture and hope you enjoy your time in Hamburg.

In July 2014 the EAHP undertook a short tour of China, speaking in Shanghai and Beijing among other places. It was represented by EAHP President Prof. Roberto Frontini, Prof. Anthony Sinclair, Birmingham Children’s Hospital NHS Foundation Trust and Aston University and Prof. Phil Wiffen, Editor EJHP. Eminent speakers from China also participated.

This venture is part of a new era of partnership between Europe and China, in which both sides are eager to learn from the other. The Chinese side chose the topics information management while multidisciplinary team building and the advance of

pharmacology in European hospitals were topics EAHP spoke about. In addition Prof. Wiffen explained how to submit a paper to the European Journal of Hospital Pharmacy with a view to encouraging high quality submissions from China. Last year there was a special China symposium at the Congress; it is hoped that from now on the Chinese will start to submit posters to the Congress. This will help share knowledge between the two sides, to our mutual benefit.

The Congress has global aspirations; indeed as Prof. Cees Neef put it “Colleagues in Saudi Arabia, Russia, Japan and China have some of the

same problems as us. If they think the Congress is of sufficient stature that they can submit a poster or attend it, that’s fine, they are welcome.”

Matters particularly interesting to Europe include how does clinical pharmacy operate, or how do you ensure patient safety, in a hospital with 5-6,000 beds? How do the Chinese integrate traditional and modern medicine? How do you manage healthcare in such a large and rapidly-changing country? An exchange of ideas is always a gain for our profession.

From Brussels to Beijing

Friday, 27 March11:30 - 13:00Room: Hall 2

Howard W. Bergendahl MS, JD, CPPSPresident of the Bergendahl Institute

Practical Pharmaceuticstextbook

China TOURThe Practical Pharmaceutics textbook contains essential knowledge on the preparation, control, logistics, dispensing, and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation.

This book is an essential reference for any pharmacy engaged in preparation activities and for any student attempting to study the practicalities and legality behind this essential function of pharmacies.

This project is financed by the EAHP and the Dutch pharmaceutical organisations KNMP and NVZA.

1

Bouwm

an-Boer · Fenton-May · Le Brun Eds.

Yvonne Bouwman-Boer · V‘Iain Fenton-May · Paul Le Brun Editors

Practical PharmaceuticsAn international guideline for the preparation, care and use of medicinal products

Practical Pharmaceutics

Yvonne Bouwman-BoerV‘Iain Fenton-MayPaul Le Brun Editors

Book location

Practical Pharmaceutics

This book contains essential knowledge on the preparation, control, logistics, dispensing, and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation.From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers. It offers product knowledge for all pharmacists working directly with patients, and it will enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if nec-essary, and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacists to remind and focus them on the application of the medicines manufactured.The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and industries. Undergraduate as well as graduate pharmacy students will fi nd knowledge and backgrounds in a fully coherent way and fully supported with examples.

ISBN 978-0-000-00000-2

An international guideline for the preparation,care and use of medicinal products

Engage in the Twitter debate at #EAHP15

Twitter is an excellent tool for engaging in discussion with many colleagues, both at the

Congress, and beyond.

By using the Twitter hastag #EAHP15 you can keep in touch

with what people are saying about the keynote speeches, seminars, workshops and satellites and share your thoughts with the global hospital pharmacy “twitterati”!

You can follow EAHP on Twitter directly at @EAHPtweet.

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