What the EC guidance tells us about handling hazardous medicinal products

The European Commission guidance document has been designed to lead users through issues relevant to their areas of practice when it comes to handling hazardous drugs, says Dr Paul Sessink, a member of the core team of authors and Managing Director, Exposure Control Sweden AB.

The first point to make about the document is that “it guides you through the issue of potential exposure to hazardous drugs. It’s not a law …. but parts of the guidance are already law within Europe” explains Dr Sessink.   A good example of this is the obligation for an employer to provide information and training to employees who have to handle hazardous drugs in the course of their work.

Many of the recommendations are based on ‘good practice’ in the member states. Readers could use these to check their own practice standards, he suggests.

The guidance extends beyond pharmacy; when hazardous drugs are administered “there is a lot of exposure – we know it from testing, from all kind of studies done, that actually the nurses are the biggest group that are exposed to hazardous drugs”, says Dr Sessink. “There are good examples [of] how you can improve working conditions and safety for nurses within the guidance document”, he adds.

Employers are obliged to carry out a both risk assessments and exposure assessments when hazardous drugs are used.

The guidance document also covers other areas including veterinary use of hazardous drugs and cleaning and waste management.

Key steps

The key steps in managing hazardous drugs are

• Identification of hazardous medicinal products
• Risk assessment of hazardous medicinal products
• Monitoring of exposure
• Repeat the above steps whenever necessary to stay up-to-date

It is the responsibility of the employer to take these steps, usually with help from suitably-qualified specialists, says Dr Sessink

Training for handling of hazardous medicinal products

Healthcare workers who need to handle hazardous medicinal products require additional training, beyond their basic training as, for example, pharmacists or pharmacy technicians. Furthermore, it is important that such training is regularly updated or refreshed to ensure that personnel are up-to-date with new products and devices and have not developed bad habits. “It should be a continuous process to make people …..  continuously aware about the potential risk of being exposed”, says Dr Sessink. Once again, it is the employer’s responsibility to ensure that this happens and such training should be funded by the employer and should take place during working hours and not the employee’s free time, he emphasises.  This is a legal requirement “so it’s nothing new, but it’s practically mostly not done”, he adds.

About Birgit Tans and Paul Sessink

Birgit Tans is a hospital pharmacist at the University Hospitals of Leuven in Belgium. For the past 30 years she has specialised in compounding of cytotoxic drugs and is an expert on safe handling of hazardous drugs.

Paul Sessink first studied chemistry and later completed a PhD on hazardous drug exposure. In 1995 he founded the company, Exposure Control to provide services related to monitoring of hazardous drugs in the working environment. The company has provided services to about 350 hospitals in the world.

 

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