The European Biosafety Network believes that the plan also
has to consider the potential benefits for workers, the health-care
system, patients and their families, by what has already
identified as a preventive instrument in the plan’s roadmap,
namely further legislative measures to reduce exposure to
carcinogenic substances in the workplace.
Every year more than 12.7 million healthcare workers in Eu-rope
are potentially exposed to hazardous cytotoxic drugs,
which are mainly used to treat cancer and are carcinogenic,
mutagenic and reprotoxic. Studies show that hospital wor-kers
who handle cytotoxic drugs are three times more likely
to develop malignancy and that nurses exposed to cytotoxic
drugs are twice as likely to miscarry. Given that the roadmap
says that 40% of cancers are preventable, now is the time to
intervene to apply the control measures in the existing Car-cinogens
and Mutagens Directive 2004/37/EC (CMD) to the
preparation, administration and disposal of hazardous drugs
to prevent exposure.
In terms of the European legislative framework, the CMD is
the only effective and existing legislation which is regularly
reviewed to protect workers, patients and carers from ex-posure
to hazardous drugs. There are risks for the families
of patients who stay with them in hospital but also because
cancer treatment is increasingly being delivered in the home
and, with an ageing population, in increasing numbers. Most
patients and their families will be completely unaware of the
potential danger of exposure to carcinogenic drugs and how
to handle them properly and that includes the most vulnera-ble:
the young, the elderly and pregnant women.
The only way to change behaviour and practice and introduce
effective preventative and risk management measures is to
ensure that a list of hazardous drugs is included in the CMD.
These drugs must be manufactured, used and disposed of
in a ‘closed technological system’ as defined by the CMD.
Across the EU there is very little protection from exposure
in practice and there is institutional resistance to behavioural
change to prevent exposure.
On 5 June 2019, the third revision of the CMD (CMD3) in-cluded
amendments recognising and prioritising for the first
time the specific importance of protecting workers and pa-tients
who are exposed to such drugs through work involv-ing:
the preparation, administration or disposal of hazardous
drugs, including cytotoxic drugs; services related to cleaning,
transport, laundry or waste disposal of hazardous drugs or of
materials contaminated by such drugs; or personal care for
patients treated with hazardous drugs.
The European Commission is required by CMD3 to complete
a study and consultation on assessing the option of further
amending the Carcinogens and Mutagens Directive to include
hazardous drugs, including cytotoxic drugs, and then to pro-duce
a report including a potential legislative proposal.
The European Commission must accept Parliamentary
amendments for the fourth revision, called CMD4, in 2021
Together we can help
to create a much safer
place in hospitals that
we can be proud of for
the next 30 years that
will reflect the hard
work of the Association
over the last 30 years
that include hazardous drugs in Annex I, and in particular
the three pharmacotherapeutic groups of antineoplastics, an-tivirals
and immunosuppressants. Healthcare workers, pa-tients
and their families deserve to be protected by legislation
now with the best possible systems of work, technology and
education and training to avoid the risk of toxic and genetic
damage and deadly diseases that may result from exposure
to hazardous drugs.
We hope that APFH, its members and other healthcare or-ganisations
in Portugal will join with us to continue lobby
the European Commission, the Portuguese Government and
Members of the European Parliament to ensure that Europe-an
legislation is passed in 2021 to include hazardous drugs
and prevent exposure of pharmacists and other workers, pa-tients
and their families. Together we can help to create a
much safer place in hospitals that we can be proud of for the
next 30 years that will reflect the hard work of the Associa-tion
over the last 30 years.