Thursday, 16 December 2010

Israel mandates closed system drug transfer use

Israel becomes the first country in the world to make the use of closed systems for the preparation and administration of hazardous drugs mandatory.

Carmel Pharma, based in Gothenburg, Sweden, has welcomed the Israeli Ministry of Health’s decision to make closed systems a mandatory addition to the protective equipment requirements in all Israeli medical institutions that prepare and administer cytotoxic drugs.

"It’s a decision that will continue to improve the welfare of Israeli heathcare workers by providing them with a safer working environment," says Dan Pitulia, CEO, of Carmel Pharma, the manufacturer of the PhaSeal closed-system drug transfer device. "We will continue to monitor this and sincerely hope that other countries will follow this excellent initiative."

The Israeli Ministry of Health ruling stipulates that closed systems must be available in any place where cytotoxic drugs are prepared and administered; and as the first line of defence against hazardous drug contamination, healthcare workers must work with closed systems.

The ruling was made in relation to scientific studies proving that cytotoxic drug contamination can be found in preparation and administration areas, and that a closed system drug transfer device is able to minimize this contamination by mechanically controlling the transfer of the cytotoxic drugs.

The definitions used by the Ministry of Health regarding a closed system closely mirrors that of the American based National Institute of Occupational Health and Safety.

NIOSH defines a closed system drug transfer device (CSTD) as a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug vapour concentrations outside the system. The International Society of Oncology Pharmacy Practioners uses a similar definition, but includes the terms airtight and leakproof.

Carmel Pharma