If you have trouble viewing the newsletter, please click here.

Dear ESOP-members!

Approaching the end of 2017, the ESOP projects continue cooperation with the participation of various countries. We present to you EPIC project report, SIOPe & ESOP, the European Society of Oncology Pharmacy-European Commission Collaboration 2017 and the COST Action Program: European Medicines Shortages Research Network in November 2017 Newsletter.

We wish you enjoyable readings ...

Yours, Eda Gedikoglu

Chair of Publication

EPIC - Empowering Pharmacists to improve health care for oral chemotherapy patients:
Establishment of a European best-practice model

Background
The number of orally available anticancer agents has been growing continuously. Patients appreciate the easier handling, increased independence from medical facilities and being reminded less of their disease. Achilles' heel in oral anticancer therapy is the patients' adherence, thus both the will and the capability to take the medication exactly as prescribed by the oncologist. Parenteral and oral therapy require very different amounts of will and capability: The tablets and capsules must be swallowed regularly and precisely in the right dose in spite of nausea and emesis or severe skin reactions mentioned as side effects in the package leaflets or experienced as real adverse drug reactions. Also, most therapy regimens are complex, with specific time intervals between administration and meals and alternating days of therapy and days of pause. Therefore, counselling and comprehensive explanations concerning benefit, risks and the singular traits of oral anticancer therapy are pivotal for the empowerment of patients in oral anticancer therapy.
Patients will only be adherent, if they are fully convinced of the benefit of their oral anticancer therapy. Besides prolonged survival, this may also be an improved quality of life. Some patients have incorrect notions about their anticancer tablets, for example that they are less effective and / or less toxic than an infusion or just the "last try" before palliative treatment. There are other patients who feel left alone with their tablets, worried about the scarce visits at the oncologist or feel like guinea pigs trying the new agents. Such misconceptions ought to be identified by questions like "How do you feel with your therapy?" and corrected as quickly as possible because they are a threat to adherence. With fewer visits at the oncologists, patient self-administration and storage at the patient's home, community and hospital pharmacists have an increasingly important role in counselling the patient about his or her anticancer therapy.

Objective
EPIC-project directly targets pharmacists involved in the dispensing of oral chemotherapy with emphasis on education and adherence. Cancer patients receiving oral chemotherapy are targeted indirectly. The project aims to improve current practice in different countries with the aim of improving adherence to oral chemotherapy.

read more »

Reported by: Andreja Eberl

COST Action Program: European Medicines Shortages Research Network

Cost Action Program is a European funded project over 4 years to target the problem of drug shortages across the European Union. Representatives from various European countries met in Malta from 12-13th September. The European Society of Oncology Pharmacy was also present to target the issue of drug shortages for antineoplastic drugs.

In a presentation by the German delegate Dr. Andre Said the issue of drug shortages for antineoplastic and immunomodulating drugs represents 12% of the drug shortages in Germany. This study adds on to the study on drug shortages in Europe as presented by the European Society of Medical Oncology-European Society of Oncology Pharmacy collaboration.

The COST Action Program consists of 5 work packages. Working package 1 involves identifying a definition for drug shortages and the completion of databases on drug shortages for each country. The World Health Organisation provides two definitions on drug shortages: 1) from patient perspective; and 2) from clinical perspective. Working package 2 targets industry and regulation authorities. Working package 3 targets the supply chain. A training school is being developed on pharmaceutical supply chains. Medicine shortages are a loss of profit for industry and wholesalers and a burden on patients. Medicine shortages can lead to falsified substitutes smuggling and quality manufacturing issues. Working package 4 targets clinical issues and way forward on guideline development. Closer working is required between national procurement and the clinical team. Working package 5 targets the impact of drug shortages: 1) clinical outcomes, and 2) non-clinical e.g. socioeconomic, pharmacoeconomic and cost minimisation. A systematic review is being done.

The aim should always be to prevent drug shortages, support staff how to manage drug shortages and to ensure patient safety. When drug shortages occur a second-line drug might have to be selected which means this would not be the best treatment for the patient. Manufacturing is crucial to prevent shortages. Not meeting with increasing demands is a cause for shortages. Forecasting is required by drug companies in collaboration with the clinical team to identify beforehand increased drug demands. If drug shortages occur, life saving treatment can be delayed or denied. As regards to provision and procurement of drugs, it is important to maintain a multisource market. Tendering to single source supply due to extreme pricing policies is not recommended. Health Authorities can be the cause for regional shortages. Lower regulatory fees for medically essential medicines is one of the recommendations being put forward.

Reportedby Fiona Fenech, Malta

European Society of Oncology Pharmacy- European Commission Collaboration 2017

A meeting took place in Brussels on the 7th September between the European Society of Oncology Pharmacy and the European Health Commissioner Dr. Andriukaitis. Points discussed included safe handling of chemotherapy, drug shortages and educational training program on chemotherapy.

EU Commissioner agreed upon presentation of at least 7 countries he will put forward a recommendation to start using the yellow hand for safe chemotherapy handling for all staff across the supply chain from manufacture up till hospital or pharmacy. Full support was given on the actions and collaborations being undertaken on drug shortages. Furthermore Dr. Andriukaitis gave his full support on two of the ESOP projects: i) MASHA project on reducing chemotherapy contamination in hospitals, and ii) EPIC project on training and education of healthcare professionals dispensing oral chemotherapy and how to best support the patient.

Reported by: Fiona Fenech, Malta

SIOPe & ESOP

Dear Colleagues,

Oncology care is complex and need a comprehensive approach to get the best quality of healthcare outcomes. A complete team of healthcare professionals need to work together including but not limited to oncologist ;oncology pharmacist and oncology nurse . The improved survival rate for pediatric oncology is due to aggressive use of chemotherapy and subsequent comprehensive supportive care and symptom management. Medication accessibility and availability are essential in achieving such goals . The role of pharmacist in the medication management process start with selecting the medication and ensuring continuous supply.In cooperation with SIOPE and the ESOP pediatric oncology working group will start a long term cooperation with a project corresponding to Working Package 9 which is a part of the Joint Action on Rare Cancers (JARC). We are going to work together towards the objectives of this important project and its principal tasks:

9.1. Formulating recommendations to solve bottlenecks and barriers in accessibility of standard treatments across Europe (essential medicines and radiotherapy) and

9.2. Formulating recommendations to increase and facilitate timely access to innovative therapies for children and adolescents with newly diagnosed highrisk and relapsed malignancies and

9.3. Formulating solutions to deliver optimal care and research for young people with extremely rare cancers.

A meeting was held last week in the headquarter of SIOPE in Brussel to discuss the cooperation agenda and to set the launch if tge above mentioned projects based on the achievements of prior EU projects in whic ESOP cooperated with ESMO on this topic including guidelines for follow-up care and transition to adult Oncology.

The Attendees were :

SIOPE:

- Gilles Vassal, SIOPE Board Member (FR)
- Karsten Nysom, SIOPE Clinical Research Council Co-Chair (DK)

CCI Europe:
- Lejla Kameric, (BiH)
- Frederic Arnold (FR)

ESOP:
- Sherif Kamal, ESOP Paediatric Working Group Chair (EG)
- Svetlana Griskjane, ESOP Paediatric Working Group Co-Chair (LV)

ESMO:
- Nathan Cherny, Lead Coordinator, ESMO Anti-Cancer Medicines Availability Study (IL) (by telephone)
- Nicola Latino, ESMO Head Office, International Affairs, TBC (CH)

SIOPE Office:
- Samira Essiaf, CEO (BE)
- Olga Kozhaeva, Policy and Public Affairs Coordinator (BE)
- Elena Botanina, Administrative Assistant (BE)

IN THE AFTERNOON WE THEN STARTED IN Building the project and its implementation
WE FINISGED Defining the list of medicines and regional coverage
WE AGRRED ON Defining content and target respondents
we discussed the methods in data collection
we agreed tgat thus cire team will be tesponsible for the Management of the project

In conclusion we will start first step in nominating national contactpoints who will be our data reporters and who will complete our survey.

In the next month we need to map the pediatric oncology national contact for Europe. Therefor our working group is going to install a network within ESOP with those members who are willing and able to spread the questionaire in their country in order to get a clear overview about the current situation which can presented in the research program and finally alto to the EU authorities.

Please name yourself to the national delegates if you would like to take part in this important support for children with cancer.

The full report will folliw from SIOPE and will be available for the contact officiers and delegates .

Yours,
Sherif Kamal, ESOP Paediatric Working Group Chair (Egypt)

ESMO 2017 Congress, Madrid, Spain

ESOP has presented the Activities of the society during the ESMO congress in the society area of the exhibition. ESOP thanks all who helped with the care of the stand.

If you don't want to recieve any further ESOP Newsletters, please click to unsubscribe.