1. Introduction to the topic

In the fight against cancer, chemotherapy remains one of the cornerstones to fight it, and often defeat it; however, by understandably focusing on patients, the risk to which healthcare workers are exposed during the preparation, administration and disposal of these infusion solutions is often overlooked.

The handling of antiblastic chemotherapy drugs (CA) is obviously a highly critical procedure, especially in the phase of reconstitution and dilution of the active ingredients, in relation to their cytotoxic nature. CAs carry out their main function by inhibiting the growth of tumor cells, either by generating alterations in their DNA, or by interfering in the cell division phase. However, they notoriously do not act selectively only on tumor cells, but on all dividing cells, on systemic or loco-regional basis depending on the therapy chosen, which evidently does not exclude a certain degree of mutagenicity, and paradoxically carcinogenicity and/or teratogenicity.

It can be deduced that accidental exposure to these agents can therefore cause a series of health problems for those who handle them, both in the short term, such as skin irritation, respiratory problems, nausea and vomiting, dizziness and other neurological effects, etc; as in the long term, with possible reverberations, as mentioned, in the spheres of fertility and fetal well-being, but also with a non-negligible increase in the risk of developing various chronic diseases, including cancer.

Operators can come into contact with these drugs through different methods, typically through inhalation and skin during manipulation and management of administration; in particular, skin contamination, probably the most frequent modality, occurs preferably when there is prolonged contact directly with the drugs or with polluted surfaces and work clothes, while involuntary oral intake and/or accidental inoculation are eventualities. quite residual.

2. Regulatory evolution and measures adopted

The Constitution and the Civil Code obviously protect workers generically, also defining obligations and guidelines for this purpose, but evidently given the inevitable complexity of the matter in question, specific additions and regulations are necessary, adequate for the conditions peculiar to the molecules involved and to the knowledge achieved on the risks associated with certain activities.

The reduction of the risk of exposure, therefore, must be guaranteed through the adoption of codified procedures of technical inspiration, compliance with which must be constantly verified and rectified in case of need or the introduction of ratified improvements; evidently the aforementioned protocol will have to amalgamate to suitable structural equipment, both in terms of premises and equipment.

To make a brief excursus on regulatory evolution, in 1995, the Ispesl Consensus Document took into consideration, for the first time in Italy, the topic of ‘Prevention of risks from exposure to antiblastic chemotherapy’, leading to the publication, in 1999, of the first provision which established the guidelines for the safety and health of workers exposed to antiblastic chemotherapeutics in a healthcare environment. The latter represented a real turning point in the regulatory framework, with the establishment of the Antiblastic Drugs Units ( UFA), i.e. environments, duly equipped, dedicated to the preparation of anti-tumor therapies, and outlined the first targeted operating procedures for the safe handling of this category of drugs.

Over the years, as can be imagined, further regulations and recommendations have been introduced, with the aim of further refining and improving safety measures. Ministerial Recommendation n°14 and the SIFO recommendations provide for the use of primary barriers, in detail, to protect the operator first and foremost (personal protective equipment, biological safety cabinet, etc.), but also the preparations , and the application of secondary barriers, in order to maintain air asepsis and the containment of potential contaminants (adequate systems and environments).

In parallel with national provisions, harmonization with European and international regulations has gradually been strengthened, such as Good Manufacturing Practices (GMP), the regulations of the International Organization for Standardization (ISO) and the Guidelines (Quapos) of the European Society of Oncology Pharmacy (ESOP). This virtuous process has helped raise safety standards at a national level and drive the adoption of more advanced operational practices compliant with global standards.

Some of the most significant guidelines to be respected, established by national and international regulations, can be listed below:

1. Organizational and structural centralization

As previously mentioned, the entire working cycle of chemotherapy drugs (preparation, transport, administration, disposal, elimination of contaminated excretions, maintenance of systems) must be contained in the “Anti-cancer Drugs Unit” (UFA), preferably located in the hospital pharmacy and below the coordination, responsibility and strict supervision of the authorized hospital pharmacist, trained for this purpose.

It is typically a “clean room” with a controlled atmosphere, i.e. a totally sterile and protected environment, in which the antiblastic chemotherapeutics but also all the galenic formulations intended for the hospital pharmacy are prepared daily in complete safety.

In the Measure of 5 August 1999, the priority characteristics that the UFA must possess are clearly indicated; it must be:

– Centralized: to facilitate the control of risky activities.

– Isolated: structurally well circumscribed and identifiable from the remaining healthcare environment.

– Closed: to offer greater guarantees of disposal and compliance with environmental protection and prevention criteria for the materials used in handling.

– Protected: access must only be granted to authorized personnel.

– Reported: with specific, visible and unequivocal risk signals.

2. Use of environmental and individual protection tools

The ministerial guidelines prescribe that the preparation of chemotherapy drugs must take place inside vertical laminar flow hoods (at least class II b). These are structures characterized by an air flow directed from top to bottom, which generates a barrier between the inside of the hood and the operator; they must also be equipped with special high efficiency filters (HEPA) and preferably of an air expulsion system towards the outside. The latter is a highly recommended condition for keeping the air clean and reducing the risk of inhaling toxic vapours.

Furthermore, they establish the use of Personal Protective Equipment (PPE) by operators, such as:

– Gloves

– Disposable gowns

– Filter face masks

– Safety glasses, where necessary

– Disposable caps for hair protection

– Disposable overshoes, if required

In the case of accidental spills, operators must have a special “emergency kit” available, which includes all the PPE mentioned, and instructions on the specific intervention procedure in the event of accidental contamination.

3. Adoption of certain procedures for the preparation and administration of anti-tumor treatments

In particular, reference is made to the adoption of “closed transfer” systems equipped with devices that protect the operator. For greater clarity, NIOSH has defined a closed transfer system as a “System that limits microbial and chemical contamination, as it mechanically prevents exchanges between the external environment and the internal environment of the system itself and vice versa”

4. Correct waste disposal

That is, the use of techniques and procedures compliant with what is established by the regulations, in order to prevent dispersions, contamination and environmental pollution.

5. Education and training of healthcare workers

Healthcare workers must receive specific education and training on the safe handling of chemotherapy drugs, including safety protocols and standard operating procedures.

In essence, the safety of healthcare workers who work with antiblastic chemotherapy drugs represents a priority, in some ways less visible and less “emotionally engaging”, but no less important than the other just causes, on which to focus, in the context of the fight against the cancer. Exposure to these cytotoxic agents, as we have briefly mentioned, can cause serious health problems in both the short and long term, underlining the importance of adopting effective preventive measures.

In this context, Infra presents itself as an important ally in the supply of closed system devices, intended for the safe handling and preparation of injectable drugs for chemotherapy. The Infra products, made in sterile packages and free of latex and phthalates, are designed to be used individually or in combination by adequately trained healthcare workers equipped with PPE, under a laminar hood, in perfect coherence with the abov The customization of the products according to the specific requests of the recipient, always in full compliance with current regulations, including the CE mark, gives the measure of our commitment to combining multiple clinical needs with the guarantee of maximum safety and quality in the handling processes of chemotherapy drugs.

In conclusion, it is clear that the adoption of qualitative closed-system devices allows healthcare workers to significantly improve the safety quotient during the preparation and administration of anti-tumor treatments, and also with these measures it increases, indirectly, also the protection of patients and the overall quality of the care they receive. Infra fits into this context with a contribution of research and development and with products consistent with this tension towards the optimal.