Merry Christmas!

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"BUON ANNO"
"JOYEUX NOEL"
"VESELE VANOCE"
"MELE KALIKIMAKA"
"NODLAG SONA DHUIT"
"BLWYDDYN NEWYDD DDA"
"GOD JUL"
"FELIZ NATAL"
"BOAS FESTAS"
"FELIZ NAVIDAD"
"MERRY CHRISTMAS"
"KALA CHRISTOUGENA"
"VROLIJK KERSTFEEST"
"FROHLICHE WEIHNACHTEN"
"BUON NATALE-GODT NYTAR"
"HUAN YING SHENG TAN CHIEH"
"WESOLYCH SWIAT-SRETAN BOZIC"
"MOADIM LESIMHA-LINKSMU KALEDU"
"HAUSKAA JOULUA-AID SAID MOUBARK"
"'N PRETTIG KERSTMIS"
"ONNZLLISTA UUTTA VUOTTA"
"Z ROZHDESTYOM KHRYSTOVYM"
"NADOLIG LLAWEN-GOTT NYTTSAR"
"FELIC NADAL-GOJAN KRISTNASKON"
"S NOVYM GODOM-FELIZ ANO NUEVO"
"GLEDILEG JOL-NOELINIZ KUTLU OLSUM"
"EEN GELUKKIG NIEUWJAAR-SRETAN BOSIC"
"KRIHSTLINDJA GEZUAR-KALA CHRISTOUGENA"
"SELAMAT HARI NATAL - LAHNINGU NAJU METU"
"SARBATORI FERICITE-BUON ANNO"
"ZORIONEKO GABON-HRISTOS SE RODI"
"BOLDOG KARACSONNY-VESELE VIANOCE "
"MERRY CHRISTMAS - - HAPPY NEW YEAR"
"ROOMSAID JOULU PUHI -KUNG HO SHENG TEN"
"FELICES PASUAS-EIN GLUCKICHES NEWJAHR"
"PRIECIGUS ZIEMAN SVETKUS SARBATORI VESLLE"
"BONNE ANNEBLWYDDYN NEWYDD DDADRFELIZ NATAL"
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The European Working Time Directive (EWTD) and the hospital pharmacists

In the latest edition of the EAHP EU Monitor, which informs us on EU matters that may impact our profession, there is the following report concerning the EWTD.

"On 7 November 2006, the Employment, Social Policy, Health and Consumer Affairs Council meeting under the Finnish Presidency initiative failed to reach an agreement on modifying the European Working Time Directive (EWTD). The Finns had proposed a compromise that did not meet the demands of the “anti opt-out” Member State representatives, who were requesting a set end date for the opt-out option. The Finnish proposal had been to “phase out” this option.

As the text remains unchanged, the EWTD provisions are still as follows:

* No more than 48 hours work per week (averaged over a 17-week reference period)
* 11 hours continuous rest in 24 hours
* 24 hours continuous rest in 7 days (or 48 hrs in 14 days)
* 20 minute break in work periods of over 6 hours
* 4 weeks annual leave
* Provisions for night workers
* Citizens of European Member States may ignore the above upon signing a derogation (“opt-out”)

This leaves hospital pharmacists with the problem of on-call time performed in the hospital, to be counted as part of their maximum 48 hours working time a week, whether the person does actually carry out some activities whilst on-call or does not (the European Court of Justice's rulings: SIMAP and Jaeger cases, held that on-call duty performed by health professionals and other workers, when they are required to be physically present at their places of work, must be regarded as working time)."

Source

You can find the whole article here: http://www.eahp.eu/asp/monitor_news_detail.asp?ID=15&m=11

Opening of Infostab website

The president of Infostab Dr. Jean Vigneron informed us that the Infostab website is now opened (november 24th 2006) !

the address is : http://www.infostab.com
or : http://www.infostab.org
or : http://www.infostab.fr

Currently, Dr. Jean Vigneron open the website with 13 languages (french, english,dutch, danish, german, portuguese, romanian, swedish, estonian, greek, spanish, slovak and czech) but 5 other languages are almost finished and could be opened soon (slovenian, latvian, lithuanian, italian, and russian). The other languages (hungarian, croatian, norwegian, polish, finnish and turkish) will be further translated.

The financial envelope of the public health programme for the period 2003-2008

The financial envelope of the public health programme for the period 2003-2008 is € 353.77 million.

According to the annual work plan the budget available for 2006 is € 55,817,661 million. This amount is divided into the "operational budget" of € 53,863,521 million, which will be used by awarding grants for projects and by issuing calls for tenders, and resources for technical and administrative assistance and support expenditure of € 1,954,140 million.

The intention is to allocate the operational budget in 2006 in a balanced way between the three objectives of the programme: health information, rapid reaction to health threats and addressing health determinants unless particular public health emergencies arise, justifying a reallocation of resources.

The Commission will implement the priorities defined in the Work Plan 2006 by awarding grants to selected projects that have been submitted under the Call for proposals 2006. The period for submitting applications ends on 19 May 2006.

Source
http://ec.europa.eu/health/ph_programme/budget/budget_en.htm

The European Union Pharmaceutical forum far from consensus

The EU high-level pharmaceutical forum still has a long way to go before tabling a consensus on the structural changes needed to improve competitiveness of the European pharmaceutical industry.


RELATED: * 'Member states want to block any change on pharmaceuticals'

The High Level Pharmaceutical Forum was established in June 2005 to examine the competitiveness of the EU's pharmaceutical industry and related public-health issues. It examines drugs pricing policies in member states to determine a balance between controlling expenditure, improving access to medicines and rewarding innovation.

The forum continues the work of the G10 Medicines Group on three issues: information to patients, relative effectiveness and pricing/reimbursement.

The High Level Pharmaceutical Forum published a progress report in its first meeting on 29 September 2006. The report describes the progress done on the three areas and gives directions for future work in the form of conclusions. None of the working groups has as yet achieved real results and much remains to be discussed before the forum is expected to deliver concrete results in June 2007.

The Information to patients working group has made the most progress since it was established in January 2006. Its work has concentrated on developing a 'model information package' on diseases using diabetes as an example, and on improving patient access to quality health information in all EU languages.

The working group on Pricing/Reimbursement (control of expenditure) is encouraged, in order to make further progress, to clarify views on the value of innovation in order to establish a sound basis for further discussion between stakeholders.

The working group on Relative effectiveness (assessing the effectiveness of medicines in comparison with other treatment options) aims to improve the degree of consensus between member states on the nature of the data required to carry out cost-effectiveness and relative effectiveness assessments and on the procedure to provide these data.

To read the whole article: http://www.euractiv.com/en/health/pharmaceutical-forum-far-consensus/article-158590?Source=RSS

Source
http://www.euractiv.com/en/health/pharmaceutical-forum-far-consensus/article-158590?Source=RSS

EAHP - EPSA Student Science Award

Beginning in 2007, EAHP will offer the Science Award to EPSA students to recognise and honour the best science research manuscript authored by undergraduate student(s).

This award recognises the student(s) for significant intellectual contributions that promise to promote the state of the art in hospital pharmacy and pharmaceutical research methods or theories.

Submission deadline: 15 November 2006

For more info, please visit EAHP http://www.eahp.eu/asp/news_detail.asp?ID=86&m=1

High-Tech Pharmacies are Safer for Patients

Using bar coding in the hospital pharmacy may help prevent dangerous prescription errors, according to a new study.

Reporting in the Sept. 19 issue of the Annals of Internal Medicine, researchers at Brigham and Women's Hospital in Boston compared the rates of medication dispensing errors before and after bar coding technology was implemented at the hospital pharmacy.

With the new technology, every dose of medication was affixed with a bar code, and these codes were scanned in as an additional step to ensure that the right medications were being dispensed. Without the bar coding, the pharmacists relied on visual inspections alone to make sure they were dispensing the right medication.

After implementing the bar coding technology, the rate of dispensing errors fell by 85 percent, and the rate of dispensing errors with the potential to harm patients fell by 63 percent.

The bar coding technology was most effective when it required the pharmacy staff to scan all doses of medications.

"Overall, the use of bar code scanning technology appears to have a significant impact on the rate of dispensing errors that were serious enough to potentially harm patients," lead author Eric Poon, an associate physician in the hospital's department of general medicine, said in a prepared statement.

Source

http://www.healthcentral.com/newsdetail/408/535002.html

The elderly are at risk of drug errors

The elderly are at risk of accidentally harming themselves by taking potentially lethal mixtures of medicines, an expert says.

Pharmacist Kim Munro, of Aberdeen's Robert Gordon University, found just 16% of patients were receiving help with taking their drugs. He surveyed 695 people aged 78 to 86 living in sheltered housing. The poll revealed half were taking more than five different medicines a day, with one in five taking at least 12. Some 14% of the sample were using highly toxic medicines such as warfarin. Meanwhile, anti-inflammatory and blood pressure drugs taken by more than half the people had a high risk of side effects.

The survey, presented at the British Pharmaceutical Conference in Manchester, also suggested the risk of making mistakes was increased by frequent changes in elderly people's medication routines.

Source - full article

BBC News
http://news.bbc.co.uk/1/hi/health/5321450.stm

Patients want better access to healthcare info

There is a need for a shift to a more patient-centred approach to healthcare and, especially, more efficient communication on disease and treatment options for patients, concludes a recent study on patient-organisation members' perception on the state of healthcare. A patient-centred approach aims to integrate the needs and expectations of patients into national healthcare systems, in particular by improving patients' access to treatment and information, ensuring their participation in healthcare decision-making and involvement in policy-making.

The Perceptions of healthcare survey, done for IAPO, the global alliance representing patients of all nationalities across all disease areas, includes input from ten EU member states. The study includes an analysis of the quality of healthcare and identifies the major challenges for improvements of government health-care policies. Patient organisations agree on three needs:

• timely access to the best treatment and information;
• right to participate in decision at the individual patient level, and;
• patient involvement in policy-making.

One of the Pharmaceutical Forum's main issues is information for patients. A multi-stakeholder group is currently working on developing a future EU health information strategy. Specific working groups have discussed, since early 2006, non-statutory information, statutory information and accessibility.

The Commission 2004 communication on patient mobility highlights the need to ensure access to the right information regarding the quality and availability of health services in different member states.

Source

http://www.euractiv.com/en/health/patients-want-better-access-healthcare-info/article-157327?Source=RSS

Doctors highlight risks of buying drugs from online pharmacies

A woman who bought drugs on the internet and took them for four years went blind as a result, doctors say.

The case highlights the dangers of the multimillion-pound international market in prescription medicines available from online pharmacies across the globe.The easy availability of drugs has allowed many people to bypass their doctors and self-prescribe medicines which they hope will boost their energy, improve their sex life or help them lose weight.

The 64-year-old woman from Sunderland diagnosed herself with chronic fatigue syndrome and, on the advice of a neighbour, bought oral steroids from an online pharmacy in Thailand. She later complained of loss of vision and doctors at Sunderland Eye Infirmary found cataracts in both eyes and signs of glaucoma (high pressure), both side effects of steroid use.

Dr Philip Severn and Dr Scott Fraser, consultant ophthalmologists, writing in The Lancet, warn colleagues to watch for patients who may have bought drugs online. "Some of the drug therapies can be counterfeit and contain a concoction of compounds that bear little resemblance to the drug named on the bottle," they say.

"Even if the patient receives the actual drug, there are many problems with this unchecked availability, including interactions with coexisting treatment, side effects and the lack of careful medical monitoring."

Popular lifestyle drugs including Viagra for impotence, Reductil for weight loss and Prozac for depression are among the biggest internet sellers. Many internet pharmacies offer online prescriptions allowing patients to consult a doctor by e-mail instead. The British Medical Association is opposed to the practice but it is not against the law.

The General Medical Council has successfully prosecuted doctors for inappropriate prescribing and failing to make adequate diagnoses over the internet.

Websites based abroad, which may use a ".co.uk" address, are not subject to British jurisdiction, and many sell medicines without a prescription as well as controlled drugs, such as stimulants and opiate-based painkillers.

The Medicines and Healthcare Products Regulatory Agency has warned of the growing problem of counterfeit drugs. Every year, the agency seizes £3m of stolen or faked Viagra, the best-selling internet drug.

Dr Fraser said he had heard of the dangers of buying drugs over the internet but it was the first time he had seen the effects. "Most patients aren't going to say if they have bought drugs over the Net," he said. "Buying drugs in this way is a gamble. Even if it is the right drug and it is not a counterfeit, because she wasn't monitored, she suffered the side effects.

"I am not saying doctors must be in control of all prescriptions, but with steroids, although they are life-saving drugs, patients must be monitored because of the side effects, which included diabetes, bone loss and eye problems."

The woman had catar-acts removed from both eyes and will require treatment for glaucoma for the rest of her life, Dr Fraser added.

The Royal Pharmaceutical Society said it was developing a register of approved online pharmacies.

Available onthe internet

* Viagra, made by Pfizer, for impotence. About £50 for four tablets. Most widely sold prescription drug on the internet.

* Xenical, made by Roche, for weight loss. About £65 for 85 capsules. Marketed as a potential panacea for the obesity epidemic.

* Prozac, made by Eli Lilley, for depression. About £20 for 30 tablets. The best known anti-depressant, with low toxicity compared to older drugs.

* Valium, made by Roche, for anxiety. About £50 for 30 tablets. Known as mother's little helper, it is effective but addictive.

* Ritalin, made by Novartis, for attention deficit disorder. About £20 for 60 tablets. Abused by students and others to increase concentration.

* Lipitor, made by Pfizer, for high cholesterol. About £40 for 30 tablets. The world's best-selling drug - counterfeit versions exist.



Source

You can find the complete article:
The Independent online http://news.independent.co.uk/

http://news.independent.co.uk/uk/health_medical/article1218435.ece
By Jeremy Laurance, Health Editor
Published: 11 August 2006

French lead in drugs consumption

According to a recent study of the structure and evolution of the five main EU pharmaceutical markets, the French spend the most on drugs per inhabitant, 284 euros annually, followed by the Germans (244 euros) and the British, Italians and Spanish (around 200 euros each). The French also consume the most medicines in quantities.

The drugs sales increased in all countries and, in total, these five countries counted for 70 billion euros in pharmaceutical sales in 2004. According to the study, conducted by the French Ministry of Health, the increase in turnover was mainly due to increased average price of medicines, around 10% in France and Germany between 2003-2004. The drugs for treating cardiovascular disease get the biggest market share in all five countries, around 25%, followed by medicines for treating the nervous and the digestive systems.

According to the study, the medicines are the cheapest in the UK, due to high generic drugs penetration and to parallel imports, whereas the medicines are, on average, the most expensive in Italy. Germany leads in consumption of generic drugs, which cast up for 22,7% of the pharmaceutical sales.

In some EU countries there has been a shift in national policies to promote the prescribtion of generic drugs as part of overall healthcare reforms to cut costs. In France, for example, doctors who sign up to an agreement with social insurance are required to prescribe cheaper medicines, a proportion of which must be generics.

Link

http://www.euractiv.com/en/health/french-lead-drugs-consumption/article-156799?Source=RSS

New and updated PRODIGY guidance

PRODIGY Knowledge is an up-to-date source of clinical knowledge that can help healthcare professionals and patients in managing the common conditions generally seen in primary and first-contact care. PRODIGY Knowledge is practical and reliable, supporting safe and effective clinical practice.

11 updated PRODIGY full guidance topics have been issued onto the PRODIGY Knowledge website www.prodigy.nhs.uk. To view a list and a summary of the changes to the updated guidance please see the summary of guidance changes.

Updated PRODIGY guidance
Acne vulgaris
Benzodiazepines/Z drugs - withdrawing treatment
Endometriosis
Hypertension in pregnancy
Insomnia
Opioid dependence
Pelvic inflammatory disease
Urethritis male
Urinary tract infection - children
Urinary tract infection (lower) - men
Urinary tract infection (lower) - women

Updated PRODIGY Patient Information Leaflets (PILs)
Updated patient information leaflets (PILs) for the PRODIGY guidance topics which were issued in May 2006 have been issued onto the PRODIGY website. To view a list of the updated PILs please click here http://www.prodigy.nhs.uk/.

Source

http://www.prodigy.nhs.uk/

Second Eastern European Conference on Rare Diseases and Orphan Drugs

The conference will be carried out on 8-9 September 2006 in the beautiful town of Plovdiv (Bulgaria) under the auspices of the Bulgarian Ministry of Health. It is organized by the Information Centre for Rare Diseases and Orphan Drugs - a project of the Bulgarian Association for Promotion of Education and Science.

This event is a logical continuation of the very successful First Eastern European Conference on Rare Diseases and Orphan Drugs, which took place on 27 May 2005 in Plovdiv, Bulgaria. The aim of this first and very important conference was to raise governmental and public awareness in Eastern Europe on rare diseases and orphan drugs.

For more information: http://www.conf2006.raredis.org/mission.php

Online shopping for Hospital Pharmacists from EAHP

All Hospital Pharmacists, members of the EAHP (European Association of Hospital Pharmacists) can now purchase publications produced by the
ASHP (American Association of Health System Pharmacists) at reduced prices. This is due to an agreement between EAHP και της ASHP.

The EAHP, in co-operation with Frismedia and Bibit, done everything to make sure that payment by credit card can be done safely through this website and delivery to your address is guaranteed.


Sources

EAHP http://www.eahp.eu
EAHP Bookstore http://www.eahp.eu/asp/bookstore.asp?m=8
ASHP http://www.ashp.org/
Frismedia http://www.frismedia.nl/main.html
Bibit http://www.bibit.com/

Hospital Pharmacies in the European Union

European Association of Hospital Pharmacists (EAHP) in colaboration with European Hospital and Healthcare Federation (Hope), published in 2002 a booklet under the title " Hospital Pharmacies in the European Union".

We give here the address from where you can download it because many of our colleagues are searching around the web to find it. We hope it will be a great source of information.

Sources

Booklet
http://www.hope.be/07publi/07newpublics/HosPharma.pdf

Hope
http://www.hope.be/

EAHP
http://www.eahp.eu

European Union gives boost to orphan drugs development

EU incentives for R&D on orphan drugs have proven successful, 22 new drugs have reached the market in five years. Patient organisations argue they cannot afford them.

More than 450 applications for orphan designation have been submitted between April 2000 and April 2005 and, of those, more than 260 have been designated and 22 have gone on to receive a marketing authorisation," concludes a Commission report on the impact of the first five years of the EU's orphan medicine regulation.

According to the Commission, the response to the orphan legislation, which provides for the pharma companies a 10-year market exclusivity for the orphan medicinal products, reduction of EMEA fees and support for R&D, has "far exceeded initial expectations".

Biotech industry has welcomed the report acknowledging the progress made, but states that "timely and equitable access for patients to the approved medicines remains an issue". It also claims that "additional economic incentives in most member states are still needed as some member states are delaying reimbursement of orphan drugs, thus limiting patient access to these drugs".

Eurodis, the umbrella patient organisation for rare disease patients in Europe, states that, often, when the products are available, patients cannot afford them, which is "not only inequitable because patient access to orphan drugs depends on the country where they live, but it is also totally unethical".

Links

EU official documents

Commission Staff working document: on the experience acquired as a result of the application of Regulation (EC) No 141/2000 on orphan medicinal products and account of the public health benefits obtained (Document on the basis of Article 10 of Regulation (EC) No 141/2000) (27 June 2006)
Commission Staff working document: Outcome of the consultation (3 June 2006)
Commission press release: Fighting rare diseases: 22 new orphan drugs in five years (26 June 2006) [FR] [DE]
Commission: Rare diseases
European Medicines Agency (EMEA)
CORDIS News: Orphan medicine legislation spurs on research, innovation and growth, claims report (27 June 2006)

Industry Federations
EuropaBio - European Biopharmaceutical enterprises joint press release: Orphan Medicines Regulation for rare diseases on the road to success (27 June 2006)

NGOs
European Organisation for Rare Diseases (Eurodis): Improving patient access to orphan drugs in Europe (April 2006)

ASHP Guidelines on Handling Hazardous Drugs

Developed by the ASHP Council on Professional Affairs and approved by the ASHP Board of Directors on January 12, 2006

In 1990, the American Society of Health-System Pharmacists (ASHP) published its revised Technical Assistance Bulletin (TAB) on handling cytotoxic and hazardous drugs. The information and recommendations contained in that document were current to June 1988. Continuing reports of workplace contamination and concerns for health care worker safety prompted the Occupational Safety and Health Administration (OSHA) to issue new guidelines on controlling occupational exposure to hazardous drugs in 1995. In 2004, the National Institute for Occupational Safety and Health (NIOSH) issued the “NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings.”

The following ASHP Guidelines on Handling Hazardous Drugs include information from these recommendations and are current to 2004.

The purpose of these guidelines is to
(1) update the reader on new and continuing concerns for health care workers handling hazardous drugs and
(2) provide information on recommendations, including those regarding equipment, that have been developed since the publication of the previous TAB.

Because studies have shown that contamination occurs in many settings, these guidelines should be implemented wherever hazardous drugs are received, stored, prepared, administered, or disposed. Comprehensive reviews of the literature covering anecdotal and case reports of surface contamination, worker contamination, and risk assessment are available from OSHA, NIOSH, and individual authors. The primary goal of this document is to provide recommendations for the safe handling of hazardous drugs.

These guidelines represent the recommendations of many groups and individuals who have worked tirelessly over decades to reduce the potential harmful effects of hazardous drugs on health care workers.

The research available to date, as well as the opinions of thought leaders in this area, is reflected in the guidelines. Where possible, recommendations are evidence based. In the absence of published data, professional judgment, experience, and common sense have been used.

You can download the complete Guidelines from the address:
http://www.ashp.org/bestpractices/new/Haz_AJHP.pdf

The ASHP Guidelines on Handling Hazardous Drugs together with the Quality Standards for Oncology Pharmacy Services (QUAPOS3, ESOP - European Society of Oncology Pharmacy - http://www.esop.li/index.html (http://ehpb.blogspot.com/2006/02/quapos-3-quality-standard-for-oncology.html) are the necessary documents for every Hospital Pharmacists.

Sources

ASHP

http://www.ashp.org/bestpractices/new/Haz_AJHP.pdf

Europeans find medical errors an important problem

The first survey ever on citizens' perceptions and experiences of medical errors in the EU shows that nearly 80% of Europeans find medical errors an important problem in their country.

A recent Eurobarometer survey on the perception of medical errors by Europeans reveals that almost four in five EU citizens (78%) classify medical errors as an important problem in their country. In Italy (97%), Poland (91%) and Lithuania (90%), the great majority of the respondents evaluated the problem as 'important'. Finland and Denmark clearly stand out from the other countries as their citizens (51% and 48% respectively) do not consider medical errors to be an imminent issue in their country.

According to the survey, most EU citizens trust medical professionals not to make a mistake while treating their patients. Dentists are the most trusted category with 74% of Europeans having confidence in them. However, many respondents doubted the quality of health care provided by other medical professional groups. This, according to the survey results, implied that "trust in the functioning of health care systems could be improved."

Q8 How worried should hospital patients be about serious medical errors?




48% of the EU citizens state that hospital patients should be worried about the possibility of a serious medical error whereas a very slight majority of 49% says the opposite.

Those living in Greece (75%), Latvia (74%) and Italy (69%) feel the most concerned, 28% of Greeks, 26% of Latvians and 17% of Italians rating as very worried. The highest share of those being very worried is found in Cyprus, the score reaching 31%.
The citizens of Sweden (20%), Austria (24%) and the Czech Republic (30%) remain less concerned.

Even if direct comparison with the question of citizens’ personal level of concern of suffering a serious medical error (Q7) is not reliable here, it can be pointed out that when the respondents are asked how worried a hospital patient should be to suffer a serious medical error, they seem to be more concerned about the possibility of a medical error than when they asked in the personal dimension.

All in all, it can be roughly generalised that citizens of Southern Europe and new Member States around the Baltic Sea appear to be somewhat more concerned of the safety of hospital patients while citizens of Western Europe, in particular of the Nordic Member States, seem to have more confidence in their healthcare system.

The findings of socio-demographic analysis are consistent with the already observed patterns though the tendencies are somewhat weak. Women, those in the two oldest age groups and less educated respondents express slightly more concern than their counterparts while managers and students remain less worried about the issue.

What comes to the cross-tabulation of questions, the same remarks can be made as
with the previous question but the differences are even stronger. A clear majority of those rating the problem as important also expresses concern over the safety of hospital patients and, as expected, this is also the case for those who have personal experiences of medical errors.

The Commission is set to integrate the results of this first analysis into the work of the patient safety working group.

Source

Eurobarometer: Special Eurobarometer on Medical Errors (January 2006) [FR] [DE]

Greek-Turkish meeting of Hospital Pharmacists

The first ever meeting among Greeks and Turkish Hospital Pharmacists was completed. The Seminar of Hospital Pharmacists organised by PEFNI Society (PanHellenic Society of Hospital Pharmacists), on first time in Greece and Turkey.

The speakers were reported on issues with regard to the antibiotics, the cytotoxics and pharmacoeconomics issues.

The audience constituted from Greeks and Turkish Hospital Pharmacists.

European Medicines Agency adopts first positive opinion for a medicinal product derived from transgenic biotechnology

London, 2 June 2006
Doc. Ref. EMEA/203163/2006

PRESS RELEASE

European Medicines Agency adopts first positive opinion for a medicinal product
derived from transgenic biotechnology

The European Medicines Agency has adopted the first positive opinion for a medicinal product derived from transgenic biotechnology. ATryn, from Genzyme Europe, contains antithrombin alfa, a recombinant-DNA human anti-clotting blood protein. Antithrombin alfa is extracted from the milk of goats which have the human antithrombin gene inserted, that enables them to produce the human protein in their milk.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted the positive opinion at its meeting of 29 May to 1 June 2006, recommending that ATryn should be authorised for use in patients with congenital antithrombin (AT) deficiency (inherited reduction of antithrombin) undergoing surgery, for the prophylaxis of deep-vein thrombosis (formation of clots in the vessels of the legs) and thromboembolism (formation of clots in other vessels of the body).

In February 2006, ATryn received a negative opinion. At the request of the company, the Committee started a procedure to re-examine its opinion, as part of which further expert advice was obtained.

At the end of this procedure the CHMP concluded that the benefits of ATryn outweigh its risks, and subsequently adopted a final positive opinion recommending that ATryn be granted a marketing authorisation.

Notes

1. A question and answer document with background information is available here.
2. A summary of opinion for ATryn is available here.
3. Congenital antithrombin deficiency is a rare condition that affects about 1 in 3.000 to 5.000 people.
4. The CHMP recommended the granting of a marketing authorisation under exceptional
circumstances for ATryn. Such authorisations are permissible, in accordance with Article 14(8) of Regulation (EC) 726/2004, for medicinal products for which the applicant can demonstrate that comprehensive data cannot be provided, for example because of the rarity of the condition, so long as it can be demonstrated that the benefits outweigh the risks. For more information see the relevant guideline here.
5. This press release, together with other information on the work of the European Medicines Agency, can be found on the EMEA website at: www.emea.eu.int

Links

European Medicines Agency http://www.emea.eu.int/
http://www.emea.eu.int/pdfs/general/direct/pr/20316306en.pdf

GTC Biotherapeutics http://www.gtc-bio.com/news.html

Genzyme Corp http://www.genzyme.com/

New EU portal on health launched

The Commission has launched a new Health-EU Portal to answer to the needs of an estimated third of the EU population searching for information on different health issues.

According to the Commission, every third European adult is surfing the internet trying to find information on health. To help these people to find their way around, the Commission has launched, in the context of the eHealth 2006 conference, a new portal on health. The Health-EU Portal aims to be a gateway and 'one-stop-shop' to simple and reliable information on 6 thematic health areas, divided in 47 health topics, touching upon issues from health insurance and infectious diseases to bioterrorism.

The site aims to provide citizens, patients, healthcare professionals and scientists with information on both health topics and related policies as well as on the latest developments in research.

The Health-EU Portal supplies links to all member states' health-related policies and other health issues, to a large number of specialist websites and to sites of NGOs and international organisations.

This 600 000 euro project is an initiative of the EU Public Health Programme 2003-2008 and corresponds also to the aspirations on the e-Europe Action Plan as the portal aims to provide citizens with simple, clear and scientifically sound information on-line.

Links

EU official documents
Commission: Health-EU Portal

Commission press release: Reliable health information at the click of a mouse – European Commission launches new Health Portal (10 May 2006) [FR] [DE]

EAHP - New extension for the website

EAHP -European Association of Hospital Pharmacists- has acquired a dot.EU extension for its website.

From now on you can reach the website via: http://www.eahp.eu).

The old address (http://www.eahponline.org) is still working.

6th ESCP educational course focusing on the patient with rheumatoid arthritis

ESCP informed us about the 6th ESCP EDUCATIONAL COURSE IN PATIENT CENTRED TEACHING focusing on the:

PATIENT WITH RHEUMATOID ARTHRITIS
19-21 July 2006,
Malta

The course is designed for pharmacists teaching and/or learning in a patient
care setting.

The course is intended to demonstrate the practice and teaching of patient-based
skills. The care of patients with rheumatoid arthritis will be used to illustrate
a structured approach to identifying and resolving drug therapy problems in the
hospital or community pharmacy. The pharmacists’ approach to the patient will
also be developed as a teaching method. Pharmaceutical care plans and quality
of life questionnaires will be shown as clinical, teaching and research tools
in the patient interview.

For detailed information on the 6th ESCP Educational Course in Patient Centred
Teaching programme or to register, please visit the ESCP website at www.escpweb.org
(select Meetings & Courses / Educational Courses)

***Read more about the programme - download the course’s brochure at: here
***Register before 15 June 2006 - download the registration form at: here

Please note that due to the interactive format of the Course, the number of participants is limited.

For more information, please contact:

European Society of Clinical Pharmacy (ESCP)
International Office
Avenue de Tervueren, 300
B-1150 Brussels, Belgium
Tel: +32-2-743 1542
Fax: +32-2-743 1550
E-mail: info@escpweb.org
www.escpweb.org

A machine fills prescriptions in hospital lobby

Is this machine the future for our profession? http://www.mankatofreepress.com/local/local_story_118010409.html?keyword=topstory

When a patient gets a prescription, the ER doctor asks if they want to use the dispenser. If so, the physician sends the prescription information to the machine. The patient, who gets a voucher, goes into the lobby and types a code into the machine.

The machine automatically looks up the person’s insurance information and labels and dispenses the drugs.

The cost is no more than a retail pharmacist and there is no added fee for using the machine.
There is a telephone on the machine that allows people to talk to a pharmacist from the company that operates the system.

The machine holds 80 different medications. Most are antibiotics and pain medicine, the most common prescriptions given in the ER. There are also some over-the-counter drugs in the machine, such as Tylenol. The machine not only dispenses pills, but also soluble medicine, such as the pink amoxicillin, an antibiotic commonly used for childhood ear infections. Those medicines come in pre-packaged amounts, with a powder in one packet and sterile water in another that can be mixed. So far, the machine has dispensed an average of nearly 20 prescriptions per day.

The machines had originally garnered some criticism from the pharmacy industry, which said a pharmacist is more likely to review a patient’s past prescription use, check for interactions or problems the patient may face and give other advice. But the criticism has mostly faded as the machines proliferate. Even some pharmacies in other states use a similar machine.

The InstyMeds was invented and developed in Minnesota by Ken Rosenblum, who started the Mendota Healthcare company. The Minnesota State Board of Pharmacy gave its approval of the machines in 2001. The machines are showing up in more hospitals, particularly in rural areas.


Recently, another company, Asteres, began producing self-dispensing prescription kiosks that are beginning to show up in pharmacies and grocery stores on the West and East coasts.




Source:
http://www.mankatofreepress.com/local/local_story_118010409.html?keyword=topstory

First biosimilar drug gets EU market authorisation

The EU has recently finalised its policy and legal framework for so-called biosimilars, opening the EU market for generic versions of biotechnology-derived drugs. The first such drug is about to enter the EU market.

All medicines enjoy a 20-year patent. After the expiry of the patent, other companies are allowed to develop and manufacture these medicines. Patent and data protection for the first bio-pharmaceuticals have just expired or are about to expire in Europe. This opens the market for new generic 'copies' of these products, referred to as biosimilars.

Until recently no legal framework existed for generic medicines derived from biotechnology. This issue was tackled in the review of EU pharmaceutical legislation ('Pharma Review 2001'), in which specific provisions establish the legal base for biogenerics, now called similar biological medicinal products. The general regulatory guideline for evaluating and approving similar biological medicinal products was to be transposed by member states before 30 October 2005.

The EU framework for biogenerics is, therefore, now in place. Once the patents and data exclusivity on the original bio-pharmaceutical product expire, selected biosimilar medicines can be launched on the European market after appropriate testing to confirm their safety, quality and efficacy. This will end big drugmakers' monopoly in bio-pharmaceuticals and could lower prices for biotech medicines due to market competition.
Issues:

The European Medicines Agency (EMEA) adopted its first ever positive opinion for a similar biological medicinal product in January 2006. The product, Omnitrope, contains growth hormone and is intended for the treatment of growth disturbance in children and adults. It is manufactured by the Swiss drugmaker Novartis AG's generics unit Sandoz GmbH and, according to EMEA's studies, demonstrated comparable quality, safety and efficiency as the reference medicinal product Genotropin, which is manufactured by Pfizer.

Omnitrope was given market authorisation, by the Commission, on 20 April 2006.

The EU is the first in the world to have defined a policy and legal framework for biosimilars. Absence of such regulation and biosimilars approval process in other countries, in particular in the United States, can lead to a competitive advantage to the EU biosimilars industry.

According to Commissionner Günter Verheugen, biosimilar medicines offer new opportunities "for the control of national healthcare expenditure".

“As more biotechnology-based products come off patent, biosimilars will play an increasingly important role by providing lowercost, safe and effective versions of patent-expired biological medicines,” said the CEO of Sandoz, Dr. Andreas Rummelt. With marketing authorisation granted in Europe, Sandoz now hopes that the US Food and Drug Administration (FDA) will act to approve Omnitrope in the US.

European Generic Medicines Agency (EGA) has welcomed the new legal framework and thinks that the EU is now set to become "the global centre for R&D and production of this new generation of affordable, biotech pharmaceuticals, giving the EU a huge competitive advantage over other countries like the United States and Japan".

"From the point of vew of innovation and stimulating R&D on the sector, having a legal framework for biosimilars is not necessarily a good thing, as it allows maket to 'copy' existing drugs," said the chairman of EuropaBio's biosimilar medicinal products working group, Tom Bols.

The current EU-framework does not address labelling of biosimilars. EuropaBio points to this as an outstanding issue and highlights the need for a unique name and label for a biosimilar: "Clear and distinct labelling is essential to avoid confusion between the innovator product and a biosimilar and to facilitate pharmacovigilance obligations."

Source:
http://www.euractiv.com/Article?tcmuri=tcm:29-154524-16&type=News&Ref=RSS

APIMEDICA2006 - Ist International Forum on Apitherapy

The "APIMEDICA2006 - Ist International Forum on Apitherapy" under the patronage of APIMONDIA is being organised in Athens, the capital of ancient and modern Greece.

Several new developments have contributed to our knowledge and understanding of the basic principles of using products of the beehive in modern medicine.

Increased problems with disease causing agents that has become resistant to modern antibiotics have made doctors all over the world asking for high quality, efficient alternative methods and means to cure diseases. APITHERAPY gives answers to this problem.

The high cost of many pharmaceutical products mean that they are not available for the majority of people in the world today. APITHERAPY might in many cases give an answer to the problem.

The co-operation within APIMONDIA of strong bodies working with the therapeutic and dietetic values of APITHERAPY has meant a strong development and new knowledge since our last Symposium in 1998.

APIMONDIA is with its Standing Commission on APITHERAPY actively involved in the developments. Extensive studies and research have been carried out in hospitals. Strong efforts are put into involving international organisations in the implementation of the methods in the hospitals around the world.

Doctors, scientists, administrators and development workers meet in Athens for the "APIMEDICA2006 - Ist International Forum on Apitherapy" 12 - 15 October 2006 to discuss and learn under the following broad headlines:

APITHERAPY and:
Health: Nutrition, prevention of stress,
Well being: Illnesses, Infectious diseases, Autoimmune diseases, Cancer.
Research issues.

Asger Søgaard Jørgensen
APIMONDIA PRESIDENT


The Greek Scientific Apitherapy Center, pursuing its efforts for the study, documentation and demonstration of the therapeutic qualities of bee products, organizes its 3rd annual conference.

This time, the scope of the event is considerably broadened; it has become international through the cooperation of Apimondia, the world organization for apiculture. Therefore, in October we host in our country "APIMEDICA 2006 - 1st International Forum on Apitherapy" which will be the worldwide event on the subject.

During the conference you will have the opportunity to learn the latest developments in the relevant field of research on a global scale as well as get informed by a number of specialists from various medical domains on the practical applications of apitherapy in health prevention, hygiene and treatment of various diseases.

We believe that the presence of the people involved in the health sector in this conference and the knowledge to be drawn from it will be most valuable for all and that through the dissemination of apitherapy we will contribute to the amelioration of health services and life quality.

D.A. Selianakis
President M.B. Greek Scientific Apitherapy Center

Source: http://www.apimedica2006.gr/page.asp?pid=1

European Commission warns about fake drugs on the internet

The European Commission (http://europe.eu.int/index_en.htm) has issued a warning that fakes of the medicine rimonabant are currently being sold via several websites. Rimonabant has been developed to treat obesity and related risk factors and smoking cessation[1].

The medicine is still under evaluation by the European Medicines Agency (EMEA). The product will only receive marketing authorisation by the European Commission once its quality, safety and efficacy have been satisfactorily established by the EMEA scientific committee, and this approval is still pending. Once approved, the company intends to market rimonabant under the name AcompliaTM.

Patients who buy unlicensed and counterfeit or illicit copies of rimonabant may be putting their health at risk. This latest example underlines European Commission concern that criminals are taking advantage of the anonymity of the internet to sell fake, adulterated and unlicensed medicines to an unsuspecting public, putting lives at risk as well as undermining the pharmaceutical industry.

Commission Vice-President Günter Verheugen responsible for enterprise and industry products said: “I am alarmed at the ever increasing number of counterfeit medicines sold via the internet. This represents a real danger to the health of patients. The Commission is working with European and international partners to do everything possible to ensure legal methods for marketing of medicines are respected and enforced.”

Counterfeiters try to bypass the foreseen regulatory pathways of licensing and supervision by competent authorities. According to a recent survey by the Member States, 170 medicines were identified to be counterfeit in the illegal distribution channels over the past 5 years. Such illegal trade often occurred through the internet. Among the cases identified, lifestyle, growth hormones for bodybuilding use and sleeping drugs played a particular role. Unauthorised copies and fakes of licensed medicines for the treatment of erectile dysfunction (e.g. ViagraR[2], CialisR[3]) and viral infections (e.g. TamifluR[4]) have also been on the sales lists of criminal counterfeiters. Counterfeits may include fakes which do not contain any of the medicine or the wrong medicine. At the same time, they may damage the image of a product and companies investing in the research and application of these products, while criminals try to make money without taking any responsibilities and risks.

To be marketed in the EU, all medicines must undergo a rigorous evaluation for authorisation to demonstrate that they are effective, adequately safe and of high quality. This is ensured by a robust regulatory system for the authorisation of new medicines. The EU also has a strong legal framework for the licensing, manufacturing and distribution of medicines. At the end of the distribution chain, only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including the legitimate sale over the Internet.

Member States enforcement services closely cooperate to combat fake medicines. To further protect patients and industry from criminal counterfeit activities, the Commission is currently analysing the situation and working together with Member States, the European Medicines Agency and international partners on what further actions may be necessary to safeguard public health.

[1] Developed by Sanofi Aventis
[2] market authorisation holder: Pfizer
[3] market authorisation holder: Lilly ICOS
[4] market authorisation holder: Hoffmann La Roche

Source:
http://europe.eu.int/rapid/pressReleasesAction

11th Congress of the EAHP, 22nd - 24th March 2006, Palexpo Congress Centre, Geneva, Switzerland

Hundreds of Hospital Pharmacists and other scientists from the health care sector were attended the 11th Congress of the EAHP from 22nd – 24th March 2006 in Geneva.

The main theme of the congress was “Quality and Medication Safety hand in hand”. In cooperation with the Swiss Society of Public Health and Hospital Pharmacists (GSASA) the Organising Committee succeeded to organize a successful congress.

Among the seminars and presentations were the following topics:

• Access to innovative oncology drugs in Europe
• The need for drug information exchange across European countries: creating a European information service network
• Quality of pharmaceutical services: a tool to help improve the safety of the medication process?
• Risk management in hospital pharmacy
• Stability of injectable drugs
• Barcode and Radio Frequency Identification (RFID) scanning: from theory to reality
• Evidence based drug formularies
• TPN for neonates: evolution over 30 years
• Drug distribution on trial – is nit dose the correct way forward?

The next 12th Annual Congress of the European Association of Hospital Pharmacists will take place in France, in the beautiful city of Bordeaux, from 21 to 23 March 2007.

Here are some photos from the 11th congress.

Six taken ill after drug TGN1412 clinical trial

Six men remain in intensive care after being taken ill during a clinical drugs trial in north-west London.

The healthy volunteers were testing an anti-inflammatory drug at a research unit based at Northwick Park Hospital when they suffered a reaction.
Relatives are with the patients, who suffered multiple organ failure. Two men are said to be critically ill.
An investigation has begun at the unit, run by Parexel, which said it followed recommended guidelines in its trial.

The men were being paid to take part in the early stages of a trial for the drug to treat conditions such as rheumatoid arthritis and leukaemia until they were taken ill on Monday within hours of taking it.
Eight volunteers were involved, but two were given a placebo at the unit which is on Northwick Park Hospital's grounds but is run independently.

TeGenero, which manufactures the drug, apologised to the sick men's families and said the medicine had shown no signs of problems in earlier tests.
The company's chief scientific officer, Thomas Hanke, said he and his colleagues were "devastated" by what had happened.
He said TGN1412 had been tested extensively in laboratories and on rabbits and monkeys, with no adverse effects and no drug-related deaths.

It was the first time the drug, designed to treat conditions such as rheumatoid arthritis, leukaemia and multiple sclerosis, had been tested on humans.

Scotland Yard said officers were talking to the MHRA and doctors.

Source and Links from BBC

Six taken ill after drug trials

Drugs trial men 'are improving'

Drug trial four 'are conscious'

Animal tests 'false reassurance'

Human drug trials 'fundamental'

Making a career out of drug tests

Q&A: Drug trials

North West London Hospitals NHS Trust

Parexel

MHRA

Tegenero

Stabilis 3 is ready!

Stabilis is a database of drugs for injection.

The following information is given for each drug:

- trade names in different countries
- stability in simple solution
- stability in admixtures
- factors which affect its stability
- incompatibilities
- routes of administration
- relevant references.

It has been compiled in an international language based οn pictograms (definitions in 24 languages are provided for all the pictograms in a special dictionary).

The database consists of:

- a series of Monographs
- summary information οn drugs for injection
- equivalent trade names and compounds
- classification by route of administration
- classification by pharmacological category
- stability in various container materials (EVA, elastomer, etc.)
- stability after freezing
- factors which can affect drug stability (container material, temperature, light, etc.)
- a dictionary translating the pictograms and abbreviations
- references

Chief editor of the project is our colleague Dr Jean Vigneron, Hospital Pharmacist, Nancy Teaching Hospital, France (vigneron.j@wanadoo.fr) .

Hospital Pharmacists who are interest can obtain it by sending their address to infostab@wanadoo.fr