The 6th Masterclass in Oncology Pharmacy, organised by ESOP and the Austrian Society of Oncology Pharmacy, was held in the city gallery in Mödling near Vienna, Austria, on 26–30 November 2012. The event was divided into two 2½-day courses: basic and intermediate. Both courses comprised theoretical and practical aspects of oncology pharmacy, covering issues that are important in daily practice for every pharmacist working in the oncology domain.
The Masterclass focused on the need for quality standards, the medication management process and the place of oncology pharmacists in the treatment of cancer patients. The quality standards in oncology pharmacy could, or rather should, be based on Quality Standard for the Oncology Pharmacy Service (QuapoS), which compiles quality on both the technical preparation services and clinical oncology pharmacy. These quality standards cannot exist without good manufacturing practice (GMP), which should be implemented in the daily oncology pharmacy practice. The main topics of GMP together with a workshop dedicated to writing standard operating procedures were presented in the basic course. Implementation of QuapoS and GMP can result in certification/accreditation of the pharmacy service.
The different experiences of pharmacists regarding drug therapy optimization, from prescription to documentation, can bring new quality to patient care. However, pharmacists need a strong grounding in education and training to enable full cooperation with physicians, nurses and other healthcare professionals. Hence, the basic part of the Masterclass also included important information relating to the classification and mechanism of action of antineoplastic drugs. This knowledge is indispensable for physicians and nurses as well as patients. Alongside older cytotoxic drugs, non-cytotoxic drugs comprise an interesting group of anticancer molecules, including novel targeted agents. After reviewing the available data on these drugs, it becomes clear that there is no targeted therapy without target optimisation, including patient genotyping. That is why this oncology domain remains so difficult and is still in the development phase. Unfortunately, genotyping is not widely available, especially in poor countries. Greater availability could provide better understanding of therapeutic problems and help establish better resolution for these problems.
The practical part of the basic Masterclass was largely dedicated to the preparation of antineoplastic drugs and included the requirements for facilities, including room design, furniture, and equipment, especially personal protective equipment, such as gloves, clothing, respiratory masks, safety goggles and spill kits. Further, the handling of cytotoxic drug preparations, including microbiological risks and how to monitor them, and the issue of pest control, were presented in this course, generating much practical discussion.
The main workshop focused on specialist devices involved in antineoplastic drug preparation. Devices for reconstitution and administration of cytotoxic drugs are classified as: protective devices for the handler of the vial or ampoule; protective devices for the operator of cytotoxic preparation; and protective devices for the administrator of cytotoxic drugs to the patients. These devices prevent contamination of the vial or ampoule, prevent drug leakage, minimize the risk of puncture, prevent accidental disconnection, protect against vapour- and aerosolrelease, and minimize the risk of antineoplastic drug contamination. A variety of devices ensures safety and high quality in the preparation and administration of anticancer drugs. Special note was paid to the problem of extravasation, which can occur during administration of anticancer drugs, including ways to resolve the problem.
Daily practice in oncology pharmacy brings many difficulties connected with physical-chemical stability of antineoplastic and biological drugs. Unfortunately, data presented by manufacturers concerning these aspects of their products are so insufficient that responsibility for the stability of drug preparations lies mainly with pharmacists. Thus, stability databases like ‘Infostab’, which was presented during the course, provide much of the information to support pharmacists and other oncology healthcare professionals. Infostab gathers information from monographs and references and assesses their content in terms of accuracy and usefulness in oncology practice.
The intermediate part of the Masterclass focused on clinical oncology pharmacy and its implementation in daily practice. Before pharmacists become members of a clinical team in the whole treatment process of cancer patients, they should be prepared to resolve some medical problems involved in this process. Thus, knowledge of the integration of pharmacokinetics/pharmacodynamics modelling will enable them to advise healthcare professionals and patients. Understanding PK/PD modelling of anticancer drugs can distinguish normal physiology from pathophysiology, explain the site of action of the drug and mechanism of its action, and can separate physiologic changes from the effect of the drug. It also can be very helpful in the dose calculation for individual patients.
It must be noted that the availability of different formulations of antineoplastic agents can lead to the occurrence of many difficulties both for the preparation of drugs and their administration to patients. For parenteral formulations, the critical aspects which should be taken into account are maintaining their sterility and stability, as well as selecting the best solvent for their reconstitution, and avoiding any incompatibility which can occur at every stage of preparation and administration. For oral formulations of anticancer drugs, which have increasing availability on the market, note should be taken of drug absorption and possible interactions with other drugs. It must not to be forgotten that patients may suffer not only from cancer but also from concomitant diseases. Thus, the oral treatment is difficult to plan, manage and modify. Patients often take many tablets or other oral formulations in one day. Some of them must be administered with food, and some without (fast conditions). The question arises how to plan the whole day with oral therapy; on the one hand to avoid interaction and adverse drug reactions, and on the other to increase the effectiveness of the treatment, as well as to maintain the patient’s quality of life and compliance. There is no ideal condition, but education in clinical oncology pharmacy and improving knowledge and skills – such as the interpretation of basic laboratory data in oncology as taught in this course – can help pharmacists advise healthcare professionals and patients about what they can do to make their anticancer therapy effective and safe. All the data concerning a patient’s condition are needed by the pharmacist in order to determine the correct dosing schedule, the correct solvent for drug reconstitution, and the treatment scheme.
Unfortunately, patients who are treated with anticancer drugs take very high doses, leading to adverse drug reactions. Luckily there are many ways to support cancer therapy, like administration of antiemetic and anti-diarrhoea drugs, bladder protection with mesna prophylaxis and proper hydration during treatment with platinum derivates, as well as mucositis treatment and protection against skin disorders. Pharmacists can also bring new ideas to this clinical part of oncology pharmacy and provide the tools which can help avoid medication errors.
Development of oncology pharmacy also concerns the clinical trials conducted with new formulations of anticancer drugs or treatment modification of older molecules, as well as pharmacoeconomic trials with outcomes that can lead to improved quality of life for patients. Such trials need input from pharmacists, who should be responsible for the management of all investigational medical products and their storage and dispensing in accordance with the standards for approved products. Every clinical trial needs to be conducted according with good clinical practice and GMP, and this can be ensured by pharmacists. One should remember that any results from clinical studies as well as pharmacoeconomic trials must be credible because they will be extrapolated to practical use.
All the above topics and workshops presented in the Masterclass lectures, both basic and intermediate, demonstrate the diversity of oncology pharmacy in daily practice. There are many activities connected with oncology pharmacy and one should remember that oncology pharmacists are not only trained to prepare anticancer drugs. Lecturers who presented the topics at this event noted that a pharmacist’s knowledge and skills are well suited to participating in the interdisciplinary team involved in cancer patients’ care.
The 6th Masterclass in Oncology Pharmacy was an educative event which gathered pharmacists from different European countries as well as Egypt, Ethiopia and Venezuela. This indicates that the pharmacists want to improve their daily practice and get involved in the anticancer therapy of suffering patients.
Dorota Eppel, MSc
Polish Mother’s Memorial Hospital Research Institute
PL-93338 Lodz, Poland
Teresa Pociecha, MSc
Szpital Uniwersytecki w Krakowie
PL-31501 Krakow, Poland