On 29 October 2019 the European Biosafety Network held a Summit at the Italian Ministry of Health in Rome to discuss the exposure of healthcare workers to hazardous drugs.

The Summit was split into three sessions including a keynote address from the Italian Under Secretary of Health, Sandra Zampa, and conclusions with closing remarks from Pasqualino Rossi from the Italian Ministry of Health.

Sandra Zampa, Under Secretary at the Italian Ministry of Health, opened the Summit with a keynote address explaining that Ministry of Health recognised that the exposure of hazardous drugs to healthcare works was a serious issue and one that the Ministry is looking at very carefully. Zampa stated that she was looking forward to seeing the evidence and conclusions from the Summit and that the Ministry of Health is committed to taking all necessary steps to improve safety for healthcare workers in Italy.

The first session which was chaired by former MEP Sion Simon was entitled, ‘Prevention of exposure to hazardous medicinal products, including cytotoxics, in the healthcare sector in Europe: Current framework and future actions’ and contained presentations from the following people/organisations:

  • Sion Simon, Former Member of the European Parliament
  • Zinta Podniece, Deputy Head of Health and Safety Unit, European Commission
  • Luca Scarpiello, Policy Officer, European Public Services Union
  • Ian Lindsley, European Biosafety Network
  • Olga Delgado, Spanish Hospital Pharmacists Association, SEFH

Sion Simon opened the session noting that in 30 years working in politics and formulating policy, this issue was one of the most urgent he had come across – he emphasised that the evidence is now clear of a link between sustained occupational exposure and serious health conditions, and it is high time that workers were properly protected.

Zinta Podniece, Deputy Head of Health and Safety Unit at the European Commission gave a presentation on the European Commission’s current framework for prevention of exposure to hazardous medical products as well as detailing the proposed work going forward to assess what further improvements could be made to European legislation to improve the situation for healthcare workers around hazardous drugs. She concluded that healthcare workers deserve proper protection and they are looking very carefully at the steps needed to deliver this but that it was not just a question of legislation or policy, but also about education and adherence to proper practice.

Ian Lindsley, Secretary of the European Biosafety Network (EBN) gave a presentation outlining how the EBN was formulated, offering an overview on the dangers of hazardous drugs, current legislation affecting the subject area, as well as the EBN’s historic and planned future activity and engagement in addressing the problems surrounding hazardous drugs.  He said that both new legislation and guidance in 2020 are necessary in order to drive behavioural change to protect healthcare workers.

Olga Delgado, Spanish Hospital Pharmacists Association, SEFH, finished the session detailing the work undertaken in Spain on this subject area, highlighting the guidance and procedures that have been put into practice in Spain which can provide a road map for the EU and national governments like Italy to follow. Luca Scarpiello also gave a speech advocating the need for protection of workers of hazardous drugs, as well as explaining this is an issue that EPSU perceived to be of the greatest importance to their membership.

The second session entitled, Raising awareness of the danger of exposure hazardous drugs and the need for closed systems to protect workers in the preparation, administration and disposal of hazardous drugs in Italy’, included a panel discussion with the following people/organisations:

  • Walter De Caro, President, Italian Nursing Association (CNAI)
  •  Maria Grazia Cattaneo Vice Presidente  SIFO
  • Maria Giuseppina Lecce , Ministero della Salute/Ministry of Health
  • Roberto Lombardi, Dip.to  INNOVAZIONI TECNOLOGICHE,  INAIL, Italian Institute for the Prevention of Accidents at Work                             
  • Emanuela Foglia, Centre for Health Economics, Social and Health Care Management, LIUC University
  • Francesca de Plato, SIFO
  • Ausilia Pulimeno, Vice President, FNOPI
  •  Diego de Merich, INAIL
  •  Giuseppe Campo  INAIL
  •  Prof. Alberto Firenze, President, Italian Society of Hospital & Clinical Risk Managers (HCRM)

Walter De Caro, President of CNAI argued that greater attention needs to be given for a strategy of training healthcare workers, stating that there needs to be improved education around the handling and risks of exposure to hazardous drugs. De Caro continued that the formation of an inter-institutional network between key stakeholders, such as the Ministry of Health, scientific associations and societies could help tackle the poor understanding around this. This network could then work together on joint initiatives as well as improve the dissemination of good practice which would in turn help drive up the standards of safety for professionals working in this field.

Ausilia Pulimeno, Vice President of FNOPI stated that the risk presented to healthcare workers from hazardous drugs was so great that it requires immediate initiatives to tackle the problem. Pulimeno proposed that the Ministry of Health create a document detailing the dangers of the drugs to be disseminated to healthcare professionals, as well as an easily accessible database of hazardous drugs and the correct protection procedures around the handling of these drugs. Further, Pulimero stated that a Technical Observatory at Ministerial level should be established which could provide oversight of the issue and drive solutions to helping protect workers at risk of exposure to hazardous drugs.

Maria Grazia Cattaneo, Vice President of SIFO, gave evidence highlighting the work they are involved in promoting the protection of healthcare professionals from chemical and biological agents. Further, she detailed the collaborative work being undertaken in conjunction with INAIL and HCRM in producing a technical document detailing a comprehensive list of hazardous drugs as well as setting out the correct safety measures and procedures around the handling and use of these drugs by healthcare workers.

The final session was a panel discussion, with representatives from social partners, employers and union representatives, as well as contributions from the audience. Speakers included:

  • Emanuela Omodeo Salè, Italian Society of Hospital Pharmacy (SIFO)
  • Maria Giuseppina Lecce , Ministero della Salute/Ministry of Health
  • Matteo Tripodina, Italian Association for Health Care Prevention & Protection (AIRESPSA)
  • Italian Federation of Local Health Care Units & Hospitals (FIASO)
  • Giancarlo Go, FP-CGIL

It was noted by many members of the audience that there was a generalised need to do more risk assessments, and that these needed to take advantage of the greater understanding people now had about the risk inherent in handling these substances. Technology was vital, but often would not be enough. Operators require training with an understanding of safety processes in clinical areas, and this needed to start at the beginning of their careers, but then continue throughout.

It was noted that there was a generalised lack of controls, and clinical engineers needed to be more involved in developing the solutions to this. In many cases, it was agreed that there is a need to refresh basic training given to healthcare workers in these situations. It was also agreed that there were opportunities for manufacturers in bringing forward new mechanisms to address this, and a chance for them to work in partnership with health systems to do so.

Participants agreed that this had to be done at a European level, given their centrality and role in developing the CMD, but that there was an equally integral role for Member States in tailoring the output to their own national health systems. To deliver this, coordination and integration at European national and local level will be vital. There is also a need to consider how this dovetails with chemicals regulation – such as Reach and other regulations impacting occupational safety.

Finally, it was agreed that this problem ultimately was not one just for one segment of staff in the workforce – training, understanding and involvement in the development of a safer environment needed to be an effort from the top down, with a competent doctor taking responsibility for safety in their specific work environment.

The event closed with remarks from Pasqualino Rossi from the Italian Ministry of Health who stated that the Ministry of Health recognised the seriousness of the issue, adding that he the issue would have the full attention of the Ministry and of the Minister of Health, the Hon. Roberto Speranza, in taking the necessary initiatives on the safety of health workers, with the active involvement of institutions, regulatory bodies, associations and scientific societies.  He also confirmed that the Ministry of Health would need to coordinate its work with the Italian Ministry of Labour as well as the EU institutions.