MASHA PROJECT

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

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.

Results and Discussion:

The pilot study demonstrated the presence of surface contamination in the preparation and administration areas of all investigated hospitals, with the level of contamination different in each hospital.
Measurable amounts of at least one agent were detected on sampled surfaces in each hospital. The analysis showed that contamination occurred frequently but concentrations of substances were quite low (Figure 1).
Of the 1,595 results analysed in part I, 324 were positive (20%). In 11 of 15 hospitals (73%), substances were detected which were not prepared or administrated in the sampling day. After the implementation of the ESOP cleaning recommendations, only 14% of samples were positive.



Figure 1 Overview of the results after PART I, PART II and PART III

Contamination was detected mostly on work surfaces of BSCs/Isolators, floors (in pharmacies and wards) and the armrests of patient’s chairs (Figure 2 and Figure 3). The highest number of positive results was recorded with gemcitabine, 5-fluorouracil, cyclophosphamide and paclitaxel. The highest value was noticed for gemcitabin (170.5 ng/cm2) and 5-fluorouracil (36.9 ng/cm2) in PART I and PART II, respectively. 69% of wards (9/13) improved or stayed at the same level with regards to the number of positive samples.
There was no correlation between contamination and the amount of prepared drugs. In fact, there was less total contamination in hospitals where a higher number of preparations were prepared.



Figure 2 The percentage of positive results for all substances and all hospitals in pharmacies (PART I, PART II and PART III)



Figure 3 The percentage of positive results for all substances and all hospitals in the wards (PART I, PART II and PART III)

Conclusion:

Results and Discussion::

The ESOP pilot study provided a brief overview of the local procedures for safe handling of cytotoxic drugs in European hospitals. The results in PART I suggest that current cleaning procedures in some hospitals may not be effective in removing all drug residue from surfaces. In PART II and PART III of the study, improvements could be seen, with reduced positive samples, the amount of surface concentration detected and the reduction of the 90th percentile from 0.032 ng/cm2 to 0.021 ng/cm2.
In addition to the progress made in decreasing contamination through the use of supportive devices, it was necessary to implement a structure for the process of production and cleaning so as to reach stable clean results in the pharmacy and on the ward.


Sponsored by:

  • Berner International GmbH
  • B. Braun Melsungen AG
  • CODAN pvb Medical GmbH
  • TEVA GmbH