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European Union (EU)

Under article 5 of the Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work183, employers must ensure that the carcinogen or mutagen is manufactured and used in a closed system and, if this is not technically possible, that the level of exposure is as low as is technically possible.

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In 2011, the Austrian Ministry of Health published recommendations on standards for usage, application and disposal of cytotoxic drugs. These recommendations include the use of closed systems and needlefree drug transfer systems.

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In Belgium, the European Directive on Occupational Health Care from 2004 was transposed into a local law called Codex. Under this law the employer is obliged to prevent occupational exposure to hazardous drugs.

The Belgian Pharmacopeia, based on the European one, and the GMP & ISO guidelines are mandatory. Additionally, each hospital lists its own guidelines, mainly based on the international guidelines like ISOPP, USP and others.

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In France, regulations require pharmacies to equip themselves with a clean room and adequate equipment such as cabinets or insulators isolators for the handling and preparation of cytotoxic products. France's Regional Health Agencies (ARS) accept the use of closed systems as instructed in the referenced guidelines.

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Hungary’s National Centre for Public Health and Pharmacy (NNGYK) has issued a renewed position paper on the preparation of cytotoxic infusions recommending the use of CSTDs such as Chemfort™. The paper has been initiated and elaborated by the Professional Board of Hospital and Clinical Pharmaceutics.

Section states:

“The use of a needle-free and/or closed drug transfer device – approved by the competent European Authority or FDA (under ONB product code) - is mandatory when preparing and handling any cytostatic, cytotoxic, CMR substances listed in the international classification lists (IARC, NIOSH) and proven to be carcinogens.”

Note: The above regulation is extended to the preparation and handling of monoclonal antibodies as well. The position paper states that "We currently lack sufficient scientifically substantiated knowledge regarding their long-term toxicity (of MaBs). Until the "safety" of specific monoclonal antibodies is clearly demonstrated in a measurable, reproducible manner, considering all MaBs as potentially highly hazardous, akin to classical cytotoxics (L01), is necessary. Only through such precaution can we ensure the expected safety of the personnel."

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To date, Israel is the only country that has made the use of closed system drug-transfer devices (CSTDs) such as Chemfort™ mandatory for pharmacists during reconstitution and preparation of hazardous drugs.

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The Spanish Ministry of Employment and Social Security has issued guidelines recommending the use of CSTDs such as Chemfort™.

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In Sweden there is a mandatory guideline (law) since 1999, written by the Swedish Work Environment Authorities, called the “AFS 2005:5: Cytotoxic and Other Drugs with Permanent Toxic Effects”.

This regulation on hazardous drugs applies to all healthcare, pharmacy and veterinary medicine, as well as to dental activities, research and education. The regulation addresses risk assessment, handling, protective equipment and more. It applies to different classes of drugs (antibiotics, anesthetics, antivirals, cytotoxic, some monoclonal AB etc.)

The regulation does not describe specific instructions, but the core message is that exposure to hazardous drugs shall be reduced to a minimum. Each hospital provides its own rules, based on its interpretation of the AFS. Some hospitals have made specific rules for CSTD (cytotoxic and antibiotics). .

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