The tri-monthly newsletter of the European Society News ESCP News ESCP News ESCP News ESCP News November 2014 November 2014 November 2014 November 2014 Number 165 Number 165 Number 165 Number 165 ISSN 135 ISSN 135 ISSN 135 ISSN 135 3 3 3 3 - - - - 0321 0321 0321 0321 A Few Words 1 Contents Contents Contents Contents : A Few words 1 ESCP life 2 Articles & Reports 3 ESCP Conferences 7 Announcements 8 E u r o p e a n S o c i e t y o f C l i n i c a l P h a r m a c y The overall aim of the Society is to develop and promote the rational and appropriate use of medicines by the individual and by The overall aim of the Society is to develop and promote the rational and appropriate use of medicines by the individual and by The overall aim of the Society is to develop and promote the rational and appropriate use of medicines by the individual and by The overall aim of the Society is to develop and promote the rational and appropriate use of medicines by the individual and by society. society. society. society. Dear Friends, Dear ESCP family, Dear Friends, Dear ESCP family, Dear Friends, Dear ESCP family, Dear Friends, Dear ESCP family, It is with much pleasure and with gratitude to our founding fathers and our predeces- sors, I can welcome you on our 35 years celebration party. The European Society of Clinical Pharmacy was founded in 1979 by nine clinical prac- titioners, researchers and educators from various countries across Europe: Eppo van der Kleijn, Netherlands, the first ESCP President; Joaquim Bonal, Spain; Gilles Aulagner, France; Paul Amacker, Switzer- land; Chris Barette, United Kingdom; Guiseppe Ostino, Italy; Dietrich Schaaf, West Germany; Hannu Turakka, Finland; Roy Jonkers, Netherlands. From 1979 to 2014, 17 Presidents have chaired ESCP. Today we opened our 43rd symposium. If I look back to the past five years only (Cf. p2), for the workshops we went from Upp- sala to Utrecht to Leuven to Edinburgh and ended up in Palermo. For the symposia we started in Lyon, passed by in Dublin, Barcelona and Prague and to finish and celebrate our anniversary in Copenhagen. Changing in the International Office Changing in the International Office Changing in the International Office Changing in the International Office Direction Direction Direction Direction But the anniversary of our society is the first but not the only reason why we are gathered here this evening. There is a second reason. We are also at a turning point in our society and more specifically at our international office. This evening we also want to celebrate and to thank Erik. Erik, you joined the GC 11 years ago. You must have had another idea of being a GC member when you started. You have been sailing with your colleagues at the time through the toughest seas and brought our society safely to the port. You indulged yourself with the society and became 5 years ago director of the IO. Words need to be invented to describe your dedication for the society. As we all know, behind every strong man stands a strong woman. Therefore, also a big thank you to the kind assistance of Heidi – having her support must have been instrumental in keeping you going all those years. We are all most grateful for all your work – I’m deliberately not going into detail because it is impossi- ble for us to imagine what it all comprised of. I know someone who will learn very soon all meanings of being the director of the IO of ESCP – good luck to you Edwin! Thank you so much for every- thing – it has been a pleasure working with you. I remember when I joined the GC in Geneva in 2009 you told me that there was a lot I had to learn … so I do hope I met your high expectations. Enjoy the evening, enjoy ESCP family! Siska Desplenter Siska Desplenter Siska Desplenter Siska Desplenter ESCP President president @escpweb.org ESCP is 35 years old ! ESCP is 35 years old ! ESCP is 35 years old ! ESCP is 35 years old ! 1979-1981 Eppo van der Kleijn (†) - Netherlands 1981-1983 Joaquim Bonal (†) - Spain 1983-1985 Gilles Aulagner - France 1985-1987 Aranda da Silva - Portugal 1988-1990 Adrian Shafford (†) - United Kingdom 1990-1992 Jean Pierre Delporte - Belgium 1992-1994 Gerhard Carstens - Germany 1994-1996 Ruud Dessing - Netherlands 1996-1998 Georges Zelger - Switzerland 1998-2000 Giovanna Scroccaro - Italy 2000-2002 Yechiel Hekster - Netherlands 2002-2004 Jacqueline Grassin - France 2004-2006 Jiri Vlcek - Czech Republic 2006-2008 Gert Laekeman - Belgium 2008-2010 Frank Jorgensen - Norway 2010-2012 Cecilia Bernsten - Sweden 2012-2014 Siska Desplenter - Belgium Photo Berry van Schaik Gert Laekeman Edwin van Aalten and Erik Gerbrands Photo Berry van Schaik Heidi and Erik Gerbrands Photo Berry van Schaik A part of ESCP family Photo Berry van Schaik
Transcript
The tri-monthly newsletter of the European Society News
ESCP News
ESCP News
ESCP News
ESCP News �� �� November 2014
November 2014
November 2014
November 2014 �� �� Number 165
Number 165
Number 165
Number 165 �� �� ISSN 135
ISSN 135
ISSN 135
ISSN 13533 33-- -- 0321
0321
0321
0321
A Few Words
1
ContentsContentsContentsContents : A Few words 1 ESCP life 2 Articles & Reports 3 ESCP Conferences 7 Announcements 8
E u r o p e a n S o c i e t y o f C l i n i c a l P h a r m a c y The overall aim of the Society is to develop and promote the rational and appropriate use of medicines by the individual and by The overall aim of the Society is to develop and promote the rational and appropriate use of medicines by the individual and by The overall aim of the Society is to develop and promote the rational and appropriate use of medicines by the individual and by The overall aim of the Society is to develop and promote the rational and appropriate use of medicines by the individual and by society.society.society.society.
Dear Friends, Dear ESCP family, Dear Friends, Dear ESCP family, Dear Friends, Dear ESCP family, Dear Friends, Dear ESCP family, It is with much pleasure and with gratitude to our founding fathers and our predeces-sors, I can welcome you on our 35 years celebration party.
The European Society of Clinical Pharmacy was founded in 1979 by nine clinical prac-titioners, researchers and educators from various countries across Europe: Eppo van der Kleijn, Netherlands, the first ESCP President; Joaquim Bonal, Spain; Gilles Aulagner, France; Paul Amacker, Switzer-land; Chris Barette, United Kingdom; Guiseppe Ostino, Italy; Dietrich Schaaf, West Germany; Hannu Turakka, Finland; Roy Jonkers, Netherlands. From 1979 to 2014, 17 Presidents have chaired ESCP.
Today we opened our 43rd symposium. If I look back to the past five years only (Cf. p2), for the workshops we went from Upp-sala to Utrecht to Leuven to Edinburgh and ended up in Palermo. For the symposia we started in Lyon, passed by in Dublin, Barcelona and Prague and to finish and celebrate our anniversary in Copenhagen.
Changing in the International Office Changing in the International Office Changing in the International Office Changing in the International Office DirectionDirectionDirectionDirection But the anniversary of our society is the first but not the only reason why we are gathered here this evening. There is a second reason. We are also at a turning point in our society and more specifically at our international office. This evening we also want to celebrate and to thank Erik.
Erik, you joined the GC 11 years ago. You must have had another idea of being a GC
member when you started. You have been sailing with your colleagues at the time through the toughest seas and brought our society safely to the port.
You indulged yourself with the society and became 5 years ago director of the IO. Words need to be invented to describe your dedication for the society. As we all know, behind every strong man stands a strong woman.
Therefore, also a big thank you to the kind assistance of Heidi – having her support must have been instrumental in keeping you going all those years. We are all most grateful for all your work – I’m deliberately not going into detail because it is impossi-ble for us to imagine what it all comprised of. I know someone who will learn very soon all meanings of being the director of the IO of ESCP – good luck to you Edwin!
Thank you so much for every-thing – it has been a pleasure working with you. I remember when I joined the GC in Geneva in 2009 you told me that there was a lot I had to learn … so I do hope I met your high expectations. Enjoy the evening, enjoy ESCP family!
Siska DesplenterSiska DesplenterSiska DesplenterSiska Desplenter ESCP President
president @escpweb.org
ESCP is 35 years old !ESCP is 35 years old !ESCP is 35 years old !ESCP is 35 years old !
1979-1981 Eppo van der Kleijn (†) - Netherlands 1981-1983 Joaquim Bonal (†) - Spain
1983-1985 Gilles Aulagner - France
1985-1987 Aranda da Silva ---- Portugal
1988-1990 Adrian Shafford (†) - United Kingdom
1990-1992 Jean Pierre Delporte ---- Belgium
1992-1994 Gerhard Carstens ---- Germany
1994-1996 Ruud Dessing ---- Netherlands
1996-1998 Georges Zelger ---- Switzerland
1998-2000 Giovanna Scroccaro ---- Italy
2000-2002 Yechiel Hekster ---- Netherlands
2002-2004 Jacqueline Grassin ---- France
2004-2006 Jiri Vlcek ---- Czech Republic
2006-2008 Gert Laekeman ---- Belgium
2008-2010 Frank Jorgensen ---- Norway
2010-2012 Cecilia Bernsten ---- Sweden
2012-2014 Siska Desplenter - Belgium
Photo Berry van Schaik
Gert Laekeman
Edwin van Aalten and Erik Gerbrands
Photo Berry van Schaik
Heidi and Erik Gerbrands
Photo Berry van Schaik
A part of ESCP family
Photo Berry van Schaik
ESCP News
ESCP News
ESCP News
ESCP News �� �� November 2014
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November 2014 �� �� Number 165
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ESCP Life
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ESCP International Workshop, Uppsala, Sweden 10–11 May 2010
ESCP International Workshop, Utrecht, Netherlands, 5–6 May 2011
ESCP International Workshop, Leuven, Belgium, 30 May–1 June 2012
ESCP International Workshop, Edinburgh, Scotland, 30–31 May 2013
ESCP International Workshop, Palermo, Sicily, Italy, 22–23 May 2014
ESCP-SFPC International Workshop, Nice, France, 22-23 June 2015
39th ESCP Symposium, Lyon, France, 21-23 October 2010
40th ESCP Symposium, Dublin, Ireland, 19-21 October 2011
41st ESCP Symposium, Barcelona, Spain, 29-31 October 2012
42nd ESCP Symposium, Prague, Czech Republic, 16-18 October 2013
43rd ESCP Symposium, Copenhagen, Denmark, 22-24 October 2014
44th ESCP Symposium, Lisboa, Portugal, 28-30 October 2015
ESCP Symposiums and International Workshops ESCP Symposiums and International Workshops ESCP Symposiums and International Workshops ESCP Symposiums and International Workshops from 2010 to 2014from 2010 to 2014from 2010 to 2014from 2010 to 2014
and in 2015and in 2015and in 2015and in 2015
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Number 165 �� �� ISSN 135
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Zamzam AhmedZamzam AhmedZamzam AhmedZamzam Ahmed.... I was born in the 13th of July 1978 in Doha, Qatar. I am currently living in London, UK, with my husband and our son Adam.
Education/work activitiesEducation/work activitiesEducation/work activitiesEducation/work activities I obtained my pharmacy bachelor degree from the University of Science and Technol-ogy, Jordan (2001). After undergoing train-ing in community pharmacy in Jordan I joined Hamad Medical Corporation in Doha, Qatar in 2002 as a staff pharmacist. There I worked in various pharmacy sec-tions at Hamad General Hospital (HGH) including: inpatient, outpatient, IV admix-ture, and quality assurance. I was then appointed drug information pharmacist, a role which enabled me to provide medicines-related information and advice to fellow healthcare professional as well as members of the public such as patients and carers. Furthermore, I edited the corporate bimonthly bulletin and sup-
ported the management of the corporate drug formulary. In 2004, I was selected to join a clinical pharmacy training program (a pioneer program in Qatar aimed to advance phar-macists role within the corporation and improve patient outcomes) in the corpora-tion which allowed me to join the clinical pharmacy team there - a huge step in my career. This was the beginning of my pas-sion for infectious diseases and I have been working in this field ever since. I took a special interest in tropical dis-eases, mycology and infections in solid transplant patients and have worked alongside a consultant in a transplant outpatient clinic and oncology wards. I have been also involved in developing corporate-wide antimicrobial polices and updating the antimicrobial formulary on regular basis. I have been part of various infectious diseases committees including the antimicrobial review committee and infection control committee and I was a liaison member with the WHO for the Lep-rosy and TB elimination program in Qatar. I am also a member of the European Soci-ety of Clinical Microbiology and Infectious Diseases and the American Society of Infectious Disease Pharmacists. In 2009 I moved to the UK to further en-hance my clinical skills and I obtained an
MSc in Clinical Pharmacy from the Depart-ment of Practice and Policy at the School of Pharmacy, University of London (UCL School of Pharmacy now). Before enrolling for my doctorate degree in 2011, I have worked for the School of Pharmacy as a research support assistant and I was involved in various grant applica-tions and research projects in both primary and secondary care in London. I have also supported teaching in the undergraduate degree (MPharm) and the above MSc at the School. My doctorate thesis was about electronic prescribing systems use in UK hospitals; exploring uptake, benefits, chal-lenges and economic outcomes of elec-tronic prescribing systems use.
ESCP activitiesESCP activitiesESCP activitiesESCP activities As a proud and active member of ESCP I have participated in several conferences and organised workshops in collaboration with colleagues in ESCP symposia. I was recently appointed as the infectious dis-ease special interest group leader in the society and am very excited about this opportunity. Now I am looking forward to contributing actively to the ESCP and to collaborating with colleagues in the field of infectious diseases.
ESCP SIG PaediatricsESCP SIG PaediatricsESCP SIG PaediatricsESCP SIG Paediatrics
The SIG Paediatrics presents a clinical case. If you cannot find the answer… see page 6.The SIG Paediatrics presents a clinical case. If you cannot find the answer… see page 6.The SIG Paediatrics presents a clinical case. If you cannot find the answer… see page 6.The SIG Paediatrics presents a clinical case. If you cannot find the answer… see page 6.
This case presents a five month old child suffering from congenital diaphragmatic hernia which was diagnosed during the mother’s pregnancy.
Congenital diaphragmatic hernia is a condition in which a hole in the dia-phragm allows abdominal organs to move into the chest and restricts lung development. This prevents the lungs from growing and developing normally. The conse-quences of this complication are pulmo-nary hypoplasia, persistent pulmonary hypertension and heart failure. The hole is closed surgically.
The patient was admitted to the pae-diatric recovery unit for cardiorespiratory distress syndrome.
Question 1Question 1Question 1Question 1. What is the definition of persistent pulmonary hypertension and how is it measured ?
Question 2. Question 2. Question 2. Question 2. What are the three classes of medications used for the treatment of persistent pulmonary hypertension ?
The physician calls the pharmacy for advices on to how prescribe trepros-tinil one administration of these medica-tions. A prescription for a child who weights 5 kg is: * Treprostinil: 20 ng/kg/min SC
Question 3. Question 3. Question 3. Question 3. How can treprostinil be ad-ministered and with which device?
The physician would like to prescribe these two medications: hydrochlorothi-azide: 2 mg/kg/day (5 mg/12h) and
spironolactone: 5 mg/kg/day (25 mg/24h). He only finds tablets available.
Question 4. Question 4. Question 4. Question 4. What can you propose?
You suggest preparation of an oral sus-pension in the pharmacy.
Question 5.Question 5.Question 5.Question 5. How do you go about it ?
Once the preparation is made, a tracabil-ity is established with an expiration date and a batch number. We give a syringe measure with the bottle.
* Sildenafil: 2 mg/kg/day (2,5 mg/6h)
The hospital has 20 mg tablets and oral suspension 2 mg/mL.
Question 6. Question 6. Question 6. Question 6. How will you administer sildenafil to this child ?
* General Committee: * General Committee: * General Committee: * General Committee: Siska Desplenter steps down as Presi-dent and Markus Lampert will take office as President; Siska Desplenter will stay for one more year as Past President. Olivier Bourdon will take office as Vice-President.
Tobias Dreischulte will take office as secretary (instead of Anne Gerd Granås). * International Office: * International Office: * International Office: * International Office: Erik Gerbrands steps down as Director of the IO; Edwin van Aalten will take office as Director, by January 1st, 2015.
Echos from the General Committee: Echos from the General Committee: Echos from the General Committee: Echos from the General Committee: changes in the leadership of ESCPchanges in the leadership of ESCPchanges in the leadership of ESCPchanges in the leadership of ESCP
Changing in the presidency, from Siska Desplenter to Markus Lampert
Photo Berry van Schaik
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International Journal of Clinical Pharmacy: International Journal of Clinical Pharmacy: International Journal of Clinical Pharmacy: International Journal of Clinical Pharmacy: 2013 Impact Factor 2013 Impact Factor 2013 Impact Factor 2013 Impact Factor
As you may have already heard, the 2013 Impact Factor is 1.250 (Thomson Reuters Journal Citation Reports® 2013) and for the last 3 years International Journal of Clinical Pharmacy has seen the following Impact Factor trend:
Of course, the impact factor is just one measure of the health of a journal; should you be interested in more information on alternative metrics that have developed over the past years, Springer has made an overview here (http://www.springer.com).
The impact factor The impact factor The impact factor The impact factor The impact factor is considered the num-ber 1 ranking value for scientific journals and has become a substantial part of any journal development discussion.
Introduced in the late 1950s by Eugene Garfield and published since the 1960s by the Institute for Scientific Information® (now Thomson Reuters), the yearly impact factor developments are now reported in the Thomson Reuters Journal Citation Reports®.
Impact factors are a benchmark of a jour-nal's reputation and reflect how frequently peer-reviewed journals are cited by other researchers in a particular year. The im-pact factor helps to evaluate a journal’s relative importance, especially when com-pared with others in the same field.
Calculation of the impact factorCalculation of the impact factorCalculation of the impact factorCalculation of the impact factor
The impact factor is basically the average number of citations counted in the Impact Factor year Y for articles published in the previous two years.
Citable articles are somewhat loosely defi-ned. In general, they include original re-search articles and review articles. They may also include editorials, if the editorial contains a lengthy reference list.
Alternative journal metricsAlternative journal metricsAlternative journal metricsAlternative journal metrics
A number of journal ranking metrics have emerged over the last years in an effort to broaden the evaluation of scholarly jour-nals. This list is a brief introduction to some of the more popular metrics.
5-year journal Impact Factor: In 2009 Thomson Reuters for the first time relea-sed the new 5-year journal Impact Factor in addition to the standard 2-year journal Impact Factor. The 5-year journal Impact Factor is the average number of times articles from the journal published in the past five years have been cited in the JCR (Journal Cita-tion Report) year. It is calculated by dividing the number of citations in the JCR year by the total number of articles published in the five previous years. Controversy around the Impact Factor tradition has not been able to deter the Impact Factor from rising to the most im-portant quality assessment tool in scientific journal publishing. It has to be noted that the value of the Impact Factor cannot be compared among different scientific disci-plines. For instance Microbiology journals have, on average, much higher Impact Factors than Mathematics or Engineering journals. The citation patterns in these disciplines are entirely different, therefore the numeri-cal values of their Impact Factors also differ significantly and comparisons would not yield appropriate results.
Eigenfactor: Similar to the 5-Year Journal Impact Factor, but weeds out journal self-
citations. The citation frequency as well as the prestige of the journals is taken into account. The type of publication and the citation patterns of different disciplines are not considered. Covers over 12,000 jour-nals worldwide, including Open Access journals and over 150,000 conference proceedings. The Eigenfactor only uses data from journals indexed by Thomson Reuters.
Google Scholar Metrics: Google Scholar Metrics summarize recent citations to many publications. You can browse the top 100 publications in several languages, ordered by their five-year h-index and h-median metrics.Scholar Metrics currently cover articles published between 2007 and 2011 (both years included).
SJR - SCImago Journal & Country Rank: It includes the journals and country specific indicators developed from the information contained in the Scopus® database from 1996. This metric doesn't consider all citations of equal weight; the prestige of the citing journal is taken into account. In general, self-citations are not included in the calculation.
SNIP - Source-Normalized Impact per Pa-per: SNIP measures a source’s contextual citation impact by weighing citations based on the total number of citations in a sub-ject field. It helps to make a direct compari-son of sources in different subject fields. SNIP especially considers the frequency at which authors cite other papers in their reference lists, the speed at which citation impact matures and the extent to which the database used in the assessment covers the field’s literature.
A total of 1,570 Springer journals are listed in the 2013 Thomson Reuters Journal Citation Reports® (JCR). 26 Springer journals were added to the JCR 2013 and have an Impact Factor for the first time. 56% of all Springer journals increased their Impact Factor from 2012 to 2013. 87% of Springer journals were cited more frequently.
In 2013, 12 open access journals have received their first Impact Factor. Now 179 of their 500 open access journals are listed by ISI and have an Impact Factor.
ContactContactContactContact
You can contact the author helpdesk for further questions on copyrights, plagiarism and piracy. http://www.springer.com/gp/authors-editors/journal-author/contact
Photo: IJCP Advisory Boardmeeting in Copenhagen, 23 Oct 2014
Photo Berry van Schaik
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43rd ESCP Symposium on Clinical Pharmacy, 43rd ESCP Symposium on Clinical Pharmacy, 43rd ESCP Symposium on Clinical Pharmacy, 43rd ESCP Symposium on Clinical Pharmacy, Copenhagen, Denmark, 22Copenhagen, Denmark, 22Copenhagen, Denmark, 22Copenhagen, Denmark, 22----24 Oct 201424 Oct 201424 Oct 201424 Oct 2014
Patient SafetyPatient SafetyPatient SafetyPatient Safety————Bridging the GapsBridging the GapsBridging the GapsBridging the Gaps
Reviewing abstracts for the Copenhagen symposium 2014Reviewing abstracts for the Copenhagen symposium 2014Reviewing abstracts for the Copenhagen symposium 2014Reviewing abstracts for the Copenhagen symposium 2014
In total 418 abstracts have been submit-ted. After the review process by 33 reviewers, 356 were accepted (62 rejec-ted = 17%). Of these 356, 24 authors were invited for an oral communication, 36 for a poster discussion forum and 296 for a
poster presentation.
As mentioned in Table 1, 37 countries have participated.
Table 2 shows the distribution of the accepted abstracts in each topic. The abstracts of all presented communi-
cations and posters will be published in IJCP. They will also be available on the Springer website www.springer link.com and the ESCP website www.escpweb.org.
Many reviewers (approx. 30) have contrib-uted to the review of the abstracts for the Copenhagen conference. There were 418 abstract submitted, and each abstract was reviewed by at least 2 reviewer. If the revie-wers scores showed a big discrepancy, then a third reviewer was assigned.
At the end, 60 abstracts were rejected due to low quality, or because the abstract was not about clinical pharmacy. Twenty-four abstract topic were assigned to the oral communica-tion sessions, and thirty-six to a poster pres-
entation forum. There will be around 330 posters on display in Copenhagen.
Comments on the abstract could be ranged under three types: language problems, for-mat problems and problems with the scope of the abstract. As for the latter, some ab-stracts were typical hospital pharmacy, but no clinical pharmacy (not involving patients in any way). As for the language, the language sometimes was so bad that the reader could not understand the sentences, and thus not understand what the abstract was about. The
problems with the structure were often found when a project, without a clear result, was submitted. But some abstract submitters also had trouble with the interpretation of the term ‘Main outcome measure’.
If you are unsure if you can prepare a proper abstract, come to the ESCP workshop ‘Successful abstract writing’, which is held at least once during every ESCP Symposium.
Foppe van MilFoppe van MilFoppe van MilFoppe van Mil [email protected]
Table 2: Number of accepted abstracts/topic
PrePrePrePre----Symposium Workshop I:Symposium Workshop I:Symposium Workshop I:Symposium Workshop I: ”Upscaling a development project to a research project”
Workshop leaders: Lene Juel Kjeldsen, PhD, Senior Researcher in Clinical Phar-macy Aim: – Demonstrate the differences between a development project and a research pro-ject; – Identify the research methodology, in-cluding design and evaluation, needed for a research project.
PrePrePrePre----Symposium Workshop II:Symposium Workshop II:Symposium Workshop II:Symposium Workshop II: "Safe and effective use of medicines for vulnerable patients"
Workshop leaders: Charlotte Rossing, PhD, Director of Research and Development, Danish college of Pharmacy Practice; Lotte Stig Nørgaard, Lektor, PhD, Det Sundheds-videnskabelige Fakultet, University of Co-penhagen Learning objective: – Participants will be introduced to how ethnicity can influence safe and effective use of medicines; – Participants will work with counselling tools on safe and effective use of medicine.
PrePrePrePre----Symposium Workshop III:Symposium Workshop III:Symposium Workshop III:Symposium Workshop III: "Network development - from vision to reality"
Workshop leader: Louise Winnecke Jen-sen, Cand.pharm. Danish college of Phar-macy Practice. Aim: This interactive workshop will focus on what the Division of Clinical Pharmacy at the Danish Pharmaceutical Society and the individual members can do to facilitate active networking among clinical pharma-cists in Denmark in order to promote the development of clinical pharmacy.
Based on reporting by the PRAC, the Euro-pean Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed restrictions on combining different classes of medicines that act on the renin-angiotensin system (RAS), a hor-mone system that controls blood pressure and the volume of fluids in the body. The medicines concerned are angiotensin-converting enzyme inhibitors (ACE-I), angio-tensin receptor blockers (ARB) and direct renin inhibitors. Combination of two of those medicines is not recommended. In particular, patients with diabetes-related kidney problems (diabetic nephropathy) should not be given an ARB with an ACE-inhibitor. Where combination of these medicines (dual blockade) is considered absolutely necessary, it must be carried out under specialist supervision with close monitoring
of kidney function, fluid and salt balance and blood pressure. This would include the licensed use of the ARBs candesartan or valsartan as add-on therapy to ACE-inhibitors in patients with heart failure who require such a combination. The combina-tion of aliskiren with an ARB or ACE-inhibitor is strictly contraindicated in those with kid-ney impairment or diabetes.
This recommendation is supported by con-siderable evidence from large clinical trials such as ONTARGET (1), ALTITUDE (2) and VA NEPHRON-D (3) and from meta-analyses such as that of Makani (4) (involving over 68,000 patients) demon-strating that dual RAS blockade through the combined use of ACE-inhibitors, ARBs or aliskiren is associated with an increased risk of adverse events, including hypoten-sion, hyperkalaemia and renal failure com-pared with monotherapy, in particular in patients with diabetic nephropathy. This is
of particular concern, as these patients and patients with renal impairment are already prone to developing hyperkalaemia.
ReferencesReferencesReferencesReferences 1. 1. 1. 1. Yusuf S, Teo KK, Pogue J, et al. (ONTARGET Investigators). Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med. 2008; 358(15): 1547-59. 2. 2. 2. 2. Parving HH, Brenner BM, McMurray JJ, et al. (ALTITUDE Investigators). Cardiorenal end points in a trial of aliskiren for type 2 diabetes. N Engl J Med. 2012; 367(23): 2204-13. 3. 3. 3. 3. Fried LF, Emanuele N, Zhang JH, et al. (VA NEPHRON-D Investigators). Combined angio-tensin inhibition for the treatment of diabetic nephropathy. N Engl J Med. 2013; 369(20): 1892-1903. 4. 4. 4. 4. Makani H, Bangalore S, Desouza KA, et al. Efficacy and safety of dual blockade of the renin-angiotensin system: meta-analysis of random-ised trials. BMJ. 2013; 346: f360. doi: 10.1136/bmj.f360.
Gert LaekemanGert LaekemanGert LaekemanGert Laekeman [email protected]
Decisions by CHMPDecisions by CHMPDecisions by CHMPDecisions by CHMP
ESCP SIG PaediatricsESCP SIG PaediatricsESCP SIG PaediatricsESCP SIG Paediatrics Answer of the clinical case (page 3).Answer of the clinical case (page 3).Answer of the clinical case (page 3).Answer of the clinical case (page 3).
Response 1. Response 1. Response 1. Response 1. Persistant pulmonary hypertension of the newborn is defined as the mean pulmonary artery blood pressure greater than 25 mm Hg measured by right heart catheterisation. The pressure can be much higher than 25 mmHg in some people. Therefore, persis-tent pulmonary hypertension can be label-led as mild, moderate, or severe based on the pressure results.
There are different tests for diagnosing persistent pulmonary hypertension (electrocardiogram, echocardiogram) but the gold standard is right heart catheterisa-tion. This test entails inserting a catheter through the groin into the femoral vein and advancing it to the right side of the heart. The catheter is connected to a device that can monitor and measure blood pressure in the right side of the heart and pulmonary arteries.
Response 2.Response 2.Response 2.Response 2. Prostanoids : epoprostenol, iloprost and treprostinild Prostacyclins are produced predominantly by endothelial cells and induce potent vaso-dilatation of all vascular beds. These com-pounds are the most potent endogenous inhibitors of platelet aggregation and also appear to have both cytoprotective and antiproliferative activities.
Endothelin receptor antagonists : ambricen-tan, bocentan, macitentan Activation of the endothelin system has been demonstrated in both plasma and lung tissue of patients with pulmonary arte-rial hypertension.
Phosphodiesterase type-5 inhibitors: silde-nafil, tadalafil Inhibition of the cGMP-degrading enzyme phosphodiesterase type-5 results in vasodi-latation through the NO/cGMP pathway at sites expressing this enzyme.
* Treprostinil: 20 ng/kg/min SC
Response 3.Response 3.Response 3.Response 3. Treprostinil is administered by continuous subcutaneous infusion device like an insu-lin pump. This allows continuous adminis-tration for the medication over 24 hours.
Response 4.Response 4.Response 4.Response 4. - Crush pills - Oral suspension available on the market - Oral suspension prepared by the pharmacy You suggest preparation of an oral suspen-sion in the pharmacy.
Response 5.Response 5.Response 5.Response 5. There are publications of paediatric litera-ture about the preparation of hydrochloro-thiazide oral suspension 5 mg/mL and spironolactone oral suspension 5 mg/mL. We use the excipient Ora-SweetMD Ora-PlusMD to prepare the suspension.
Ora-PlusMD is an aqueous-based vehicle consisting of a synergistic blend of suspen-ding agents that has a high degree of colloi-dal activity. The suspending agents form a structured, gel-like matrix which suspend particles and allow little settling. An anti-foam agent is incorporated into Ora-PlusMD to allow for vigorous shaking with minimal foam to solubilise the active ingre-dient.
Ora-SweetMD is a syrup vehicle which contains sucrose and others flavouring and sweetening agents which help increase palatability.
Ora-SweetMD and Ora-PlusMD are syrup vehicles used to simplify the process invol-ved in the extemporaneous compounding of oral suspensions They are buffered to a slightly acidic pH to help diminish degrada-tion of medicinal agents through oxidation. Medicated powders are incorporated into Ora-PlusMD and Ora-SweetMD to form
elegant, uniform, sweetened products and physically stable suspensions in minimum time and maximum dependability.
Once the preparation is made, a tracability is established with an expiration date and a batch number. We give a syringe measure with the bottle.
* Sildenafil: 2 mg/kg/day (2,5 mg / 6h)
The hospital has 20 mg tablets and oral suspension 2 mg/mL. How will you administrate sildenafil to this child ?
There is an oral suspension of sildenafil marketed (RevatioMD) in France and is available at the hospital. This form of silde-nafil contains sodium benzoate as a preser-vative. The sodium benzoate is contraindi-cated in children less than two months of age.
This form of Revatio® has only received a marketing authorisation for children over one year old because of a lack of clinical studies in children. Indeed, children under 2 months old have an immature detoxifica-tion pathway of benzoic acid, what makes this preservative toxic for these patients. Thus, oral sildenafil suspension cannot be used in this child.
We will crush sildenafil 20 mg tablets and incorporate the powder in Ora-PlusMD and Ora-SweetMD like the preparation of hydro-chlorothiazide and spironolactone.
(1) Congenital diaphragmatic hernia: Respiratory and vascular outcomes. Revue des Maladies Respiratoires (2012) 29, 337—346 (2) Laboratoire Fagron (3) Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J 2009; 34: 1219–1263.
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Acquisition of Pharmaceutical Skills: Acquisition of Pharmaceutical Skills: Acquisition of Pharmaceutical Skills: Acquisition of Pharmaceutical Skills: Simulation, Serious Games, Simulation, Serious Games, Simulation, Serious Games, Simulation, Serious Games, Innovative ApproachesInnovative ApproachesInnovative ApproachesInnovative Approaches
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Organising CommitteeOrganising CommitteeOrganising CommitteeOrganising Committee Edwin van Aalten (NL) Olivier Bourdon (FR) Valérie Chedru (FR) Rémy Collomp (chair) (FR) Julien Duquesne (FR) Jean Paul Fournier (FR) Erik Gerbrands (NL)
Organising CommitteeOrganising CommitteeOrganising CommitteeOrganising Committee Isabel V. Figueiredo (PT) - Chair Armando Alcovia (PT) Siska Desplenter (BE) Filipa Duarte-Ramos (PT) Erik Gerbrands (NL) Aurora Simon (PT) Edwin van Aalten (NL)
Scientific CommitteeScientific CommitteeScientific CommitteeScientific Committee Margarida Caramona (PT) - Chair Fernando Fernandez-Llimos (PT) Yolande Hanssens (QT) Gert Laekeman (BE) Anne Leendertse (NL) John McAnaw (SC) Ana C. Rama (PT) Foppe van Mil (NL)
The scientific programme includes keynote lectures, invited lectures, oral free communi-cations, scientific and industrysupported mini-symposia, workshops, and poster pre-sentations. The official Symposium language is English. No simultaneous translation will be available. Main Topics:Main Topics:Main Topics:Main Topics: • Official MI sources - Drug labelling and SmPCs - WHO Model Formulary - The role of Medicines Agencies • Drug information centres - Role of the pharmacists as MI provider - Future of DICs • Drug industry as MI provider - Medical Affairs departments - Potential risks and conflict of interests • New technologies in MI
- Clinical Decision Support Systems - Handhelds and tablets - Point of care information • Commercial MI sources - Clinical databases - Medicines compendia • From evidence base medicine to patient needs - Translating MI into practice - Applications to Pharmaco-economics • Teaching of MI at Schools of Pharmacy - Competencies - Articles critical appraisal All afternoon parallel sessions afternoon parallel sessions afternoon parallel sessions afternoon parallel sessions are scheduled including workshops, oral free communica-tions, poster discussion fora, and invited lectures. Workshops will be announced in the Preliminary Programme and via the ESCP symposium website.
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ESCP-SFPC Workshop « Acquisition of Pharmaceuti- cal Skills: Simulation, Serious Games, Innovative Approaches »
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United KingdomUnited KingdomUnited KingdomUnited Kingdom Abutaleb Mohammed..... Manchester Mai Alqubaisi ......................... Dundee Pasta Mehboob ................... Leicester
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