Contamination de surface avec les anticancéreux, résultats après la mise en place de mesures correctives
The United Kingdom has concentrated resources on implementing Good Manufacturing Process in hospital production. The standards that we work to are those described in the ’Quality Assurance of Aseptic Preparation Services’ edited by Alison M Beaney and available through the UK Pharmaceutical Press.
We are organised at a regional level throughout the UK covering an area of approximately 3 - 5 million population. At this level there is a quality control pharmacist who is responsible for auditing all the facilities in the region. My own region is in Wales which is physically 300 x 170 kilometres from one town edge to another.
Our focus has been on microbial and particulate contamination and we have avoided the chemical contamination problems that we are now producing.
In 2004 the major hospitals in Wales were assessed and found to have a varying level of chemical contamination.
One year later they have been reassessed and other hospitals have been included in the survey. All analysis has been carried out by Environmental Controls in the Netherlands.
Between the two surveys the level of contamination found was highlighted to all hospitals in Wales, during audit visits and via lectures at our two annual symposium. These are held for all staff working in aseptic units in Wales.
The results from the 2nd round of sampling indicated an overall reduction in contamination levels with the most dramatic being in hospitals, which had the highest levels in the 1st round. That hospital carried out a full risk assessment and implemented specific measures to contain the problems. It should be noted that there are still contamination levels in the cabinet but none outside.
The other hospitals have all implemented an awareness campaign, which had led to contamination levels below that which should have been expected from the results of the previous testing, with the exception of one major hospital in which the workload has dramatically increased.
The conclusion from the exercise is that contamination is unavoidable with current techniques but it can be contained. Pharmacy has a duty to protect its own workers and the clinical staff from exposure to cytotoxic contamination.