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 Awareness & Guidelines

 
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Drugs are classified as hazardous if studies in animals or humans indicate that exposures to them have a potential for causing cancer, developmental or reproductive toxicity, or harm to organs. They include drugs used for cancer chemotherapy, antiviral drugs, hormones, some bioengineered drugs, and other miscellaneous drugs.

 

 

 

The National Institute for Occupational Safety and Health’s (NIOSH) definition of a closed system:

 

“Closed System”

 

A device that does not exchange unfiltered air or contaminants with the adjacent environment

 

"Closed system drug-transfer device (Closed System)”

 

a drug transfer device that … - mechanically prohibits the transfer of environmental contaminants into the system - and the escape of hazardous drug or vapor concentrations outside the system. ​

 

 

 

 

 

 

 

Tevadaptor® meets the NIOSH definition that was issued and further clarified in publication of a Letter to Editor in Ann. Occup. Hyg., (Nygren, O., Olofsson, E., & Johannson, L. (2009). NIOSH definition of closedsystem drug-transfer devices. Annals of Occupational Hygiene, 53, 549) Tevadaptor® meets the requirements of the USP.

 
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USP800 by the US Pharmacopeia was published on February 1, 2016 in the First Supplement to USP 39–NF 34. The Expert Committee approved a delayed official implementation date of July 1, 2018 to allow entities additional time to implement the standard.The chapter describes practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety and environmental protection. Handling HDs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration and disposal of sterile and non-sterile products and preparations.

 

 

 

 

 

The International Society of Oncology Pharmacy Practitioner’s (ISOPP) definition of a closed system:

 

“Closed System”

 

The NIOSH definition is therefore the most comprehensive and complete.

 

“Closed system drug-transfer device (Closed System)”

 

Filters with a diameter of 0.22 mm and HEPA filters DO NOT retain the vapour of cytotoxic products. Filters with active ca​rbon can absorb vapours on a temporary basis only and therefore should be accompanied with studies indicating the maximum loading, working conditions and the minimum and maximum retention time of the filter capacity.​​​


 

 

 

 

Tevadaptor® meets the American Society for Hospital Pharmacists’ (ASHP) requirements published in Drug Distribution and Control: Preparation and Handling–Guidelines, American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs.

 

 

 

 
The Oncology Nursing Society (ONS) published guidelines for Safe Handling of Hazardous Drugs. Tevadaptor® meets the ONS requirements for a closed system drug transfer device. The document cross
references the NIOSH definition of a CSTD and then goes on to state the following: A clarification of the NIOSH definition, however, led these authors to conclude that compounding systems, like the ones they had studied, should all be regarded as meeting the NIOSH CSTD definition if they are shown to perform according to the specified performance criteria.
 
 

 

 
The Sharps directive by the European Agency for Safety and Health at Work.
The purpose of the Directive is to implement the Framework Agreement so as:
            - to prevent workers' injuries caused by all medical sharps
            (including needlesticks);
            - to protect workers at risk;
- to set up an integrated approach establishing policies in risk     assessment, risk prevention, training, information, awareness raising and monitoring;
 



 

 

 Veterinary safety and health

 

 

 



 

 


 

 Radiopharmacy safe handling

 
Current guidelines do not address the risk of exposure of radiopharmaceutical drugs to the HCW in terms of the drug activity or prevention of microbial contamination during their preparation and administration. They only address the risk of exposure to the radioactive isotope (see the attached link).

 

 Monoclonal Antibodies safe handling and guidelines

 
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 Local guidelines and recommendations

 

Italy

 

Israel

The only country that made the use of closed system transfer devices mandatory for pharmacist reconstitution and preparation of hazardous drugs.

 

Hungary

Guideline on preparation of cytotoxic infusions by the National Institute of Pharmacy and Nutrition

 

Sweden