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Dear ESOP-members!

Oncology pharmacy is constantly developing, striving to renew itself by determining needs in the health sector. In this sense, national workshops and meetings are held in many countries. Some of these activities are organizations that are able to announce themselves from wider audiences as a result of international cooperation. ESOP supports anyone who strives to achieve the best standards in oncology pharmacy. In our newsletters, we aim to promote all activities in countries on behalf of oncology pharmacy and to inform our colleagues about these activities. By contributing to this international cooperation in oncology pharmacy, we aim to create a resource that can be utilized by everyone who contributes to this business and contributes to its development. This issue includes, the European Forum for Good Clinical Practice (EFGCP) Annual Conference 2017, "Implementation of Clinical Pharmacy Practice in the Care of Cancer Patient" section of the Clinical Pharmacy Working Group of Oncology Pharmacy-Macedonian Pharmaceutical Association, ), 22nd Congress of the European Associations of Hospital Pharmacists (EAHP), EBMT 2017, 10th BOPP Days. You will also find a short story of oncology pharmacy in Rwanda.

We hope you enjoy reading.

Yours, Eda Gedikoglu

Chair of Publication

The European Forum for Good Clinical Practice (EFGCP) - Annual Conference 2017

21 - 22 February 2017, Brussels, Belgium

The EFGCP is a non-profit organisation established for individuals with a professional involvement in the conduct of biomedical research. Its purpose is to promote good clinical practice and encourage the practice of common, high-quality standards in all stages of biomedical research throughout Europe.

The main topic of the Conference was the role of Ethical Standards in Clinical Trial Regulations. The participants included: Academic organisations, Pharma industry, Patient organisations, National Regulatory Authorities/Agencies, Ethics Committees, CROs, consulting firms, biotech companies and various other European institutions. During the two-day conference, different stakeholders talked about the preparations made for the inclusion of ethical standards in clinical trials.

There was a chance to exchange experiences and plans and get feedback on the various proposals.This enabled a broad audience to benefit from the discussions and conclusions coming out of this conference. In the plenary session and break-out groups, multi-stakeholder inputs and discussions highlighted the key issues requiring solutions.

Procedural arrangements to address the ethical challenges posed by the present Clinical Trials Regulation were discussed. This provided an opportunity to listen to the experts debate the key issues and provide examples on how these challenges can be met.

In summary, this conference was very interesting and enriched my knowledge of clinical trial regulations. It also helped to improve the level of collaboration between EFGCP and ESOP.

Reported by: Ewelina Korczowska

Implementation of Clinical Pharmacy Practice in The Care of Cancer Patient" Section of Clinical Pharmacy Working Group of Oncology Pharmacy- Macedonian Pharmaceutical Association

The educational meeting was held on 24th February 2017 in Skopje (FYRepublic of Macedonia) with the attendence of hospital and clinical pharmacists, oncologists and hematologists, scientists from the Faculty of Pharmacy in Skopje. The general objectives of the meeting were to raise the awareness of a clinical pharmacist in the pharmacological treatment of cancer patients as a member of the oncology team, to potentiate the role of the clinical pharmacists in preparation and administration of citotoxic drugs. At the end of presentations, the part icipants were able to discuss about topics.

A clinical pharmacist must prepare a counseling plan which aims at:

  • improvement of the quality of life of counseled patient
  • drug safety by safe application of the drugs
  • promotion of compliance and adherence
  • avoidance of side effects
  • supporting medical therapy and nursing activities
  • identification of drug related problems
  • motivating the patient to comply with his/her therapy plan by informing about drug effects and avoidance or reduction of side effects.
  • to initiate various types of educational events in the field of oncology pharmacy within the process of continuing education and professional development of the pharmacists and other health practitioners.

Scientific program was included following topics:

  • 'Assessing the need for oncology clinical pharmacist in health team in Macedonia' (Aleksandra Kapedanovska Nestorovska MSci, PhD, Faculty of Pharmacy, Ss "Cyril and Methodious)
  • 'Importance of clinical pharmacist on oncology ward regarding evaluation of side effects (BPharm, Pharm. Spec M Skelin, Croatia)
  • Originator and generic drugs- is there difference? ( Mr.pharm B.Indova)
  • Oral antineoplastic drugs and the role of the pharmacist ( Mr.pharm E.Javor, Croatia)
  • The clinical pharmacist as part of palliative treatment tea (Spec.Dr.M.Ristevski, University clinic of radiotherapy and oncology)
  • Nutrition advice in oncology patient ( L.Petrusevska Tozi, MSci, PhD, Faculty of Pharmacy, Ss "Cyril and Methodious )
  • Pharmaceutical care of patient using cannabis ( Z.Naumovska MSci, PhD, Faculty of Pharmacy, Ss "Cyril and Methodious)
  • Biba Dodeva, President of community, non-govermental organization for patient, Borka
  • Analysis of pharmacotherapy through the case of patient with colon cancer, Xelox protocol (Spec.Dr..B.Grozdanovska, University clinic of Radiotherapy and oncology and BPharm, Pharm. Spec O.Spasovska, University clinic of abdominal surgery)

Reported by: Olivera Spasovska

INTERNATIONAL CHILDHOOD CANCER AWARENESS DAY (ICCD 2017)

ICCD 2017 was held on 7th March 2017 in Brussels, Belgium. The contest of the conference was about ''Development Of Paediatric Cancer Medicines 'Milestones And The Road Ahead Towards More Life-Saving Innovation". A clear message was given at the conference that collaboration between all stakeholders is the only way to ensure an effective development of new drugs for paediatric cancers.

The European Society for Pediatric Oncology (SIOPE) International Childhood Cancer Awareness Day 2017 was the occasion to reflect upon the latest accomplishments and the persisting obstacles in the field of paediatric cancer drug development, and it also coincided with the ongoing preparation of the 10-year report regarding the EU Paediatric Medicines Regulation (EC No 1901/2006) by the European Commission.

To introduce safe and effective innovative treatments into standard care has been selected as one of the main objectives of the

widely endorsed SIOPE Strategic Plan for the next decade, and paediatric oncology partners have already reached a few milestones such as the European Parliament Resolution on the Regulation.

5 new objectives to speed up innovation were outlined by the partners in the multi-stakeholder Accelerate Platform including proposals on how to amend the Regulation:

  1. Paediatric drug development should be based on the drug's mechanism of action (MoA), and not on its specific indication (for adult/paediatric patients)
  2. Drug prioritisation based on strong biological, preclinical/clinical data as well as on the MoA to guide the choice of compounds to be evaluated in children;
  3. The existing delays in starting a paediatric investigation plan (PIP) should be reduced;
  4. The "18 years' dogma" in relation to clinical trials enrolment should be challenged, as it has been proven that trials including both adolescents and adults are feasible;
  5. New incentives and rewards should be proposed to making research in this field more "attractive".

During the event,different types of expertise - patients and parents' organisations, academic research, pharmaceutical companies and EU regulatory networks - engaged in an interactive discussion with EU stakeholders on how to synergise their efforts and ensure that these initiatives will not be isolated.

For instance, a representative from the Paediatric Rheumatology International Trials Organisation (PRINTO) explained how they successfully collaborate with pharmaceutical companies early in the drug approval process (starting in phase I, before the PIP) and, thus, proposed that the consultation between academia and regulatory agencies should start earlier in the process.

At the end of the event, all participants agreed that change needs happen, and they will not give up until the needs of childhood cancer patients will be met.

Reported by: Marta Trojniak

22ND CONGRESS OF THE EUROPEAN ASSOCIATION OF HOSPITAL PHARMACISTS (EAHP)

22nd Congress of the EAHP was held 22nd -24th March, at Cannes, in France. Many ESOP members attended, and oncology was a hot topic, with numerous posters on cytostatic compounding, cytostatic robotisation and clinical oncology pharmacy. Both ESOP president Klaus Meier and ESOP vice president Alain Astier were speakers at the conference. One of the ESOP board representatives also attended to a special networking meeting that was organised by the EAHP, where five societies/associations were invited to discuss possible collaborations and share information on priority projects.

ESOP has endorsed the fourty-four statements of hospital pharmacy that were drawn up by the EAHP, as can be seen on the EAHP website. Further collaborations will be looked upon in the next year.

Reported by: Mirjam Crul

EBMT 2017, Marseille, France

43rd Annual Meeting of the European Society for Blood and Marrow Transplantation was held on 26-29 March in Marseille ,France.

2nd Pharmacists Day was conducted on 28th March with the presentations included hot topics such as new options of treatment of graft versus host disease, conditioning regimens in patients with renal impairment, melphalan therapeutic drug monitoring in children, stem cell mobilization, vaccinations, mesenchymal stromal cells, Car T cells, fecal microbiota trans plantation. Also,this year there were excellent poster presentations.

Clinical Pharmacists had the chance of talking and discussing about their role in the multidisciplinary team. Questions and answers were placed about the hot topics with the hematologists enriched all the sessions. This initiative will continue next year as the 3rd Pharmacist Day in Lisbon.

Reported by: Mª Estela Moreno Martinez

10TH BOPP-DAYS

The 10th edition of the yearly 2-day BOPP conference was held on 10-11th March 2017 in Blankenberge, Belgium. The conference was conducted by the participation of more than 100 attendees including pharmacists and persons from industry and proofed again to be a successful formula to update the Belgian hospital pharmacists with the most recent developments in oncology.

Prof. Dr. A. Sacré (CHR Verviers) discussed new treatment strategies in castrate resistant prostate cancer: studies show that sequential use of the novel androgen-directed inhibitors seems not a good option for most patients, the biomarker AR-V7 is a negative predictor for anti-androgens but not for taxanes, the results of clinical trials with new antiandrogens, which a.o. interact with the testosterone synthesis, and the next-generation androgen receptor antagonists (less side effects) are promising, the timing of docetaxel: early for newly diagnosed and benefit with metastasis (CHAARTED, STAMPEDE trial), DNA repair defects and PARP inhibitors (olaparib), the

variable success of immunotherapy, although results of combination therapy are still pending and the promising use of radio isotopes.

Prof. Dr. J.F. Baurain (UCL Saint-Luc) gave a comprehensive overview of cancer immunotherapy and the immune-related adverse events, which are unpredictable, could be lethal and are not dose-related. Treatment strategies should be based on biomarkers or tumor type, combinations with eg IDO-, BRAF- MEK-inhibitors, T-VEC,.. It is only the beginning of a rapidly evolving science. Pharmacist J. Vandenbroucke (UZ Gent) explained with a well documented presentation the importance of stability data (microbial, chemical, physical, structural) to guarantee a safe and high-quality end product.

Four colleagues shared their experiences with the implementation of a clean room and/or an isolator, the resulting impact on the working process and the change in daily routine. Prof. Dr. J. Vansteenkiste (UZ Leuven) presented new and emerging systemic therapies in Non Small Cell Lung Cancer (NSCLC) from doublet chemotherapy over targeted therapy, immunotherapy and combinations with ramucirumab, nintedanib or anibody drug conjugates. He explained the European Society for Medical Oncology magnitude of clinical benefit scale and emphasized the early reimbursement approval (based on phase I instead of phase III results) of new tyrosine kinase inhibitors. In the interactive workshop prepared by the SIG Clinical Pharmacy topics like chemotherapy dosing in obese patients, therapeutic drug monitoring of antibiotics and drug interactions with enzalutamide were addressed.

The short communications session offered six colleagues the opportunity to present their work on dose banding of intravenous cytotoxics, risk analysis of chemotherapy preparation, the contribution of the clinical pharmacist in the management of oral anticancer treatments both in the hospital and at home, microbiological quality analysis in the cleanroom and continuing education and validation of the pharmacy staff.

Between the scientific sessions there was enough time for the 105 participants to visit the 28 exhibition stands.

Reported by: Birgit Tans

Overview on the Oncology Pharmacy in Rwanda

Introduction

In July 2012, Butaro District Hospital opened the cancer treatment centre in rural north of Rwanda, the Butaro Cancer Center of Excellence (BCCOE). This hospital has facilities for in- and out-patient care and resources for a more accurate diagnosis of cancer and treatment. In its first 2 years, 2326 patients were registered to have received cancer related services. To date, the treatment modalities at BCCOE include surgery and chemotherapy. If a patient requires radiation therapy, he/she is transferred to Tanzania or Uganda.

A team of physician and nurses at BCCOE is in charge of administering the chemotherapy which was selected in collaboration with the Dana Farber Cancer Institute advisory and supportive team.

Pharmacists have been trained about preparation of chemotherapy whereby they are given details of how to prepare them. The commonly found chemotherapy includes paclitaxel, tamoxifene and Gleevec though in recent days, the folinic acid, Bleomycin, cyclophasphamide, doxorubicin, methotrexate, vincristine, mercaptopurine and hydroxyurea.

It can be noted that on the authorized list of essential medicine of 2017 in Rwanda, a less than 5 chemotherapy drugs are listed. This demonstrate a gap which is still affecting cancer treatment in Rwanda whereby for example Oxaliplatin which is mostly found in the regimens used to treat colorectal cancer is not found on the list. Additionally, according to the 2012 GLOBOCAN data, it is estimated that the pharmacy staff needed in Rwanda based on cancer incidences within the two most populous provinces is 16 oncology pharmacists and 24 oncology pharmacy technicians despite the absence of a formal program that train oncology pharmacists.

Pharmacists' role in cancer care in Rwanda

To date, pharmacists in Rwanda play a major role in chemotherapy preparation at Butaro Cancer Center of Excellence (BCCOE) and King Faisal of Kigali. We make sure that appropriate doses are prepared to prevent under dosing or overdosing the patients including preparing the appropriate drug for the appropriate patient. We also follows good manufacturing practices so as to prevent other complications that might results from ineffective utilization of needles and syringes, or inappropriate handling of normal saline or D5W during chemotherapy preparation. Pharmacists serve also to remind physicians and nurses about potential side effects of the chemotherapy including potential pharmacokinetics and pharmacodinamics interactions that might arise during co-medication.

Secondly, pharmacists and pharmacy students are involved in various awareness raising campaigns and trainings that aims to educate and provide information to the general public about cancer screening programs, treatment and care. The campaigns also serve for advocating for access to treatment and care among the disadvantaged communities.

At my university (Muhimbili University of Health and Allied Sciences), as the future consultants in hospital and clinical pharmacy, we also take part into oncology pharmacy services at Ocean Road Cancer Institute, Dar es Salaam, Tanzania. I become involved in all levels of oncology pharmacy such as chemotherapy, nuclear medicine and major ward rounds.

On administrative level, I supervise and provide on job training for pharmacists who works in the chemotherapy procurement, preparation and dispensing. I organize and present at continuous medical education sessions on behalf of the department of pharmacy. I collaborate with pharmacists and pharmacy technicians to develop tools and resources that enable safe preparation and handling of chemotherapy including safe administration whereby treating physicians and nurses are advised constantly on effects of chemotherapy and their outcomes. I participate in the major ward round; evaluate patients' individual cases that might involve serious pharmacokinetics and pharmacodinamics interactions or chemotherapy administration which have contraindications.

Cancer care is new in Rwanda and other central and Eastern African countries and few patients are capable to access treatment. In addition to that, oncology pharmacy education haven't being taken into much consideration by the school of pharmacy and the government and it is of great emphasis to advocate for oncology pharmacy education for better access to oncology pharmacy services for cancer patients in Rwanda. I hope that the knowledge, skills and experience that I get at ORCI will be very useful toward cancer care and education of other pharmacists in Rwanda and in the region.

Reported by: Pacifique Ndayishimiye

11th Masterclass in Oncology Pharmacy

We thank the following companies for their unrestricted educational grant for the 11th Masterclass in Oncology Pharmacy, 22nd - 26th May 2017

More information »

* EUR 1500,00

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