The roundtable attracted more than 40 attendees from across the EU

On Thursday 7th March, the European Biosafety Network (EBN) organised a roundtable of more than 40 participants in the European Parliament on the prevention of exposure to hazardous drugs in the healthcare sector in Europe. The event was hosted by Sion Simon MEP, whose position on the Employment Committee has led to a prolonged engagement with issues surrounding hazardous drugs. He opened the event with a short introduction, in which he emphasised the strength of cross-sectoral cooperation and how it had aided progress in exposure prevention.

The discussion throughout praised the work of the EU institutions on the third batch of the Carcinogens and Mutagens Directive (CMD) which Yoline Kuipers of the European Commission stated should be finalised officially by April 2019, although further changes are not expected. It was recognised that it would accelerate the movement to adequately protect workers and patients, but that it did not alone guarantee progress. In the wide-ranging discussion that was held, current examples of hazardous drugs guidelines were analysed and calls were made for stringent legislation combined with clear and up to date guidance on hazardous drugs.

Amongst the case studies presented was the recent Italian consensus document on the management of risk to healthcare staff, in relation to the handling of antineoplastic drugs and prevention and safety measures. Professor Francesca de Plato (Italian Society of Hospital Pharmacy) outlined the society’s work in cooperation with the nursing sector and the advances they had made through this, but assured those present that there was still far more to be done.

Ian Lindsley, Secretary of the EBN, emphasised that the US had already done much of the necessary work on legislation, definitions and guidance, particularly their health and safety agency NIOSH, but that it would have to be “Europeanised”. Further, he emphasised that a list of hazardous drugs would need to be formalised as part of the CMD during the research and consultation work by the Commission in 2019 for a clear and uniform approach to exposure prevention.

Discussion was then focused on Spain, at first on a national level. Representatives of bodies including the Spanish General Nursing Council, the UGT and the National Institute of Health and Safety at Work emphasised that ongoing work has been making widespread improvements on a localised and regional government basis. Their ambition was now to bring different regulations and best practice guidelines into one place on a national level with a new national law on hazardous drugs.

Strong regional efforts have been made in Castilla-La Mancha, whose guidelines have now come to be regarded as the “gold standard” in exposure prevention. These recent publications were presented by Dña Regina Leal Eizaguirre and D. Iñigo Cortázar Neira of the Health Service of Castilla-La Mancha. Ian Lindsley said that the EU institutions should use these guidelines as a blueprint as they are comprehensive and there is no need for the Commission to ‘reinvent the wheel’.

Following these examples, there was a brief open discussion and Claude Rolin MEP reiterated that any legislation needed to go hand in hand with firm guidance, and that either one on its own would fail to provide adequate protection.

The meeting ended with an agreement from those involved that, whilst great strides had been made, particularly in the securing of the amendments to the CMD, the problems causing exposure to hazardous drugs were far from solved. It was agreed that sustained and ongoing work was required to ensure that practice across the EU was providing healthcare workers and patients with adequate protection via a sufficiently stringent legislative framework and clear guidance from the European Commission and other EU insitutions.  

The discussion throughout praised the Carcinogens and Mutagens Directive (CMD) which Yoline Kulpers of the European Commission stated would be formalised in April of 2019. It was recognised that it would accelerate the movement to adequately protect workers, but that it did not alone guarantee progress. In the wide-ranging discussion that was held, current examples of hazardous drugs guidelines were analysed and calls were made for stringent legislation and clear guidance on hazardous drugs.

Amongst the case studies presented was the recent Italian consensus document on the management of risk to healthcare staff, in relation to the handling of antineoplastic drugs and prevention and safety measures. Professor Francesca de Plato (Italian Society of Hospital Pharmacy) outlined the society’s work in cooperation with the nursing sector and the advances they had made through this, but assured those present that there was still far more to be done.

Ian Lindsley, Secretary of the EBN, speaks about the recent Carcinogens and Mutagens Directive

Ian Lindsley, Secretary of the EBN, emphasised that the USA was a good example to emulate with the success of NIOSH, but that it would have to be “Europeanised” to better fit its environment. Further, he emphasised that a list of hazardous drugs would need to be formalised and readily available for a clear and uniform approach to exposure prevention.

Discussion was then focused on Spain, at first on a national level. Representatives of bodies including the Spanish General Nursing Council and the National Institute of Health and Safety at Work emphasised that ongoing work has been making widespread improvements on a localised basis. Their ambition was now to bring different regulations and best practise guidelines into one place on a national level.

Strong regional efforts have been made in Castilla-La Mancha, whose guidelines have now come to be regarded as the “gold standard” in exposure prevention. These recent publications were presented by Dña Regina Leal Eizaguirre and D. Iñigo Cortázar Neira of the Health Service of Castilla-La Mancha. Ian Lindsley recommended that a future approach to hazardous drugs should use these guidelines as a blueprint.

Following these examples, there was a brief open discussion and concluding remarks from Ian Lindsley, who reiterated that any legislation needed to go hand in hand with firm guidance, and that either one on its own would fail to provide adequate protection. Claude Rolin MEP had been a particular advocate of this point throughout discussions.

The meeting ended with an agreement from those involved that whilst great strides had been made, particularly in the securing of the CMD, the problems causing exposure to hazardous drugs were far from solved. It was agreed that sustained and ongoing work was required to ensure that practice across the EU was providing healthcare workers and patients with adequate protection via a sufficiently stringent framework from the European Commission.