Masha

MASHA

Research about Environmental Contamination by Cytotoxics
And Management of Safe Handling Procedures

INTRODUCTION:

Since the early 1980s, international attention has increasingly been drawn to the potential risks associated with occupational exposure to antineoplastic, carcinogenic and other hazardous drugs used in the treatment of cancer. The topic has been widely debated over the years and this has led to the introduction of guidelines aimed at reducing occupational risk and the promotion of numerous interventions to reduce the risk amongst all professionals involved in oncology care.

The growing use of these drugs, new formulations, the diverse methods of administration to patients, the wider scope of indications (immunology, rheumatology, nephrology, veterinary oncology medicine) have a significant impact on hospitals, the scientific community, and the workers themselves.

Set against this background, ESOP (European Society of Oncology Pharmacy) established in 2022 a SIG (Special Interest Group) of safe working and occupational exposure, called MASHA SIG. MASHA is an acronym for Research about Environmental Contamination by Cytotoxics and MAnagement of Safe HAndling Procedures). The MASHA SIG comprises a group of experts who had the task of drafting a document/set of recommendations which would be freely available on the web for ESOP members and non-members. These recommendations would list in a concise, clear, and scientifically accurate way, some basic concepts around safe handling which could be widely disseminated to reduce the associated risk to healthcare personnel of exposure to antineoplastic agents. These are based on the ESOP Quality Standard for the Oncology Pharmacy Service (QuapoS) which provide accurate and detailed recommendations for the proper handling of oncology drugs.

The recommendations which the SIG has worked on since 2022 focus on the need for greater knowledge of the risk factors and the potential effects they may have on health. They describe the most appropriate use of personal protective equipment as well as the importance of strict adherence to the correct procedures.

ESOP’s MASHA SIG hopes the recommendations illustrate, in a concise way, the increased level of knowledge on occupational exposure. This will support everyone who handles oncology drugs and will diminish the risk of potential harm through occupational exposure to them.

Background:
Evaluation of environmental contamination with cytotoxic drugs in the hospital is one of the fundamental requirements to ensure the safety of all healthcare professionals. Safe handling procedures should be closely monitored in all areas where antineoplastic drugs are delivered, stored, prepared, administered and disposed of. Over the last few years environmental contamination with cytotoxic drugs in hospitals units has been reported in several publications. However, detailed information on surface contamination with antineoplastic drugs in European hospitals in areas where these drugs are handled, is still limited. Therefore, the European Society of Oncology Pharmacy (ESOP) undertook the first independent, multi-centre, pan European study, involving over a dozen hospitals, to measure the current state of cytotoxic contamination in the workplace. This project is called MASHA – Research about Environmental Contamination by Cytotoxics and Management of Safe Handling Procedures. The study is designed to investigate any possible weak points during drug preparation, transportation and application, and during the disposal of medical devices after treatment.

MASHA is first multicentre and non-commercial study conducted in the different European hospitals, including pharmacies and wards.

Objectives:
The MASHA project is consists of three parts, with each part having different goals.
The main goal of this project is to obtain an overview of the current situation in European hospitals with regards to cytotoxic contamination at various sites, including drug preparation (pharmacy) and administration areas (ward). The secondary objective is to evaluate the environmental contamination with cytotoxic drugs circulating within a facility known as the hospital medication system (process flow of drug), and to evaluate the impact of changes in local working practices. The preliminarily results will help to develop additional steps and programs to improve working conditions and quality control.

Materials and Methods:
A pilot study was conducted before the final form of the ESOP project was implemented. The study was carried out at nineteen hospitals in Europe but, for statistical evaluation, the results were collected from only fifteen of them.
An assessment of surface contamination was performed using wipe sampling. To collect the wipe samples a PharmaMonitor® kit was used, including all the materials needed for this purpose.
Wipe samples were taken from 10 comparable surfaces (5 in preparation areas and 5 in administration areas), in each of the participating hospitals. Each investigated surface was wiped according to the established sampling instructions using three tissues applied with special solvent adapted for these procedures.
Samples were collected from the following surfaces:

In the pharmacy

  • Sample 1 – Work surface of Biological Safety Cabinet/Isolator
  • Sample 2 – Floor under Biological Safety Cabinet/Isolator
  • Sample 3 – Top of dose checking counter in the clear area
  • Sample 4 – Top of checking counter in the storage area
  • Sample 5 – Refrigerator door including handle

In the ward

  • Sample 6 – Top of checking counter at nurse station
  • Sample 7 – Lid of cytotoxic waste container
  • Sample 8 – Armrest of patient chair
  • Sample 9 – Floor area around the infusion stand
  • Sample 10 – Phone, the one most often used in the ward

Each sample was analysed for the presence of 12 cytotoxic drugs: 5-fluorouracil, cyclophosphamide, ifosfamide, gemcitabin, etoposide, methotrexate, paclitaxel, docetaxel, topotecan, irinotecan, doxorubicin and epirubicin, using LC MS/MS.
The chemical analysis was done at the Institute of Energy and Environmental Technology e.V. (IUTA), in Duisburg, Germany.

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