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OncoSafe Arisure: Closed System for Drug Transfer - luxury or necessity?

Zeal for patient safety should be the top priority of health services. Nothing more just. Risk management must be the guiding thread of every movement of the health professional. Perfect. It is intriguing to say the least how we fight with unquestionable dedication for the safety of our patient, but on several occasions we neglect our own safety by not requiring minimization of the occupational risks to which pharmacists and nurses are exposed in their work routine.

Which oncology nurse has the courage not to have annual mammograms from the age of forty, as recommended by the Ministry of Health? We know the inherent risk. We have data, baggage, to analyze cost / benefit or, more appropriately, risk / benefit, and make a conscious decision.

But what about the use of a closed system for handling and administering antineoplastic drugs? We are lions to defend our patients, but who will fight for us so that we are not cancer patients in the future? Why do we deliberately choose to neglect such occupational risks?

Is there a lack of Brazilian data to support the need to use closed systems? Yes No doubt. However, the absence of Brazilian data does not mean the absence of valid and overwhelming data.

The United States National Institute for Occupational Safety and Health (NIOSH) is the US federal agency responsible for conducting research and producing recommendations for the prevention of work-related injuries and illnesses. NIOSH's mission is to develop new knowledge in the area of occupational health and safety and to transform this knowledge into practical actions.

NIOSH is part of the Center for Disease Prevention and Control (CDC), in the Department of Health and Human Services and has more than 1,300 employees from various fields of knowledge, including epidemiology, medicine, nursing, industrial hygiene, psychology, chemistry, statistics , economics and various engineering specialties.

In 2004, NIOSH published the document entitled Alert. Preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings (Alert - Preventing occupational exposure to antineoplastic and other dangerous drugs in health institutions). In the preface, the document defines its importance: “The Alert aims to make workers and employers more aware of the risks of exposure to antineoplastic drugs and the tools to prevent such risks.”

What risks are we specifically addressing? The document itself states that: “working with or near dangerous drugs in a health institution can cause skin rashes, infertility, spontaneous abortions, birth defects, leukemia, among other types of cancer.” In order to make these risks palpable, real for each of us, the Alert presents five real cases of workers who have suffered adverse effects from exposure to antineoplastic drugs in the workplace.

As for proving that occupational exposure is an unquestionable fact, the report presents evidence that professionals are being exposed to dangerous drugs and are experiencing important adverse events despite the guidelines in practice today.

In 1999, authors Sesink and Bos found that 11 of 12 studies reported cyclophosphamide in the urine of tested health professionals, demonstrating continued exposure even when safety precautions existed and were consistently adopted.

In a 2001 survey, Harrison reported that six different drugs (cyclophosphamide, methotrexate, ifosfamide, epirubicin, cisplatin / carboplatin) were detected in the urine of workers in 13 out of 20 investigations.

Petram et al. (2003) found antineoplastic drugs in the urine of pharmacists and nurses from 14 hospitals in Germany, evaluated over a three-year period. The drugs detected were cyclophosphamide, ifosfamide, doxorubicin, epirubicin and platinum. On the other hand, the investigation conducted by Wick et al. (2003) demonstrated that “the use of a closed system for drug transfer for six months reduced not only the concentration of cyclophosphamide and ifosfamide in the urine, but also the percentage of samples contaminated by these drugs.”

In a management mindset, we must reduce risks as much as possible. That is why the NIOSH Alert mindset is pertinent, which presents several recommendations that, taken together, reduce risks. “And this is the irrefutable justification for adopting closed systems for the transfer of medicines” - the addition of yet another stage of reducing occupational risk.

NIOSH defines the closed drug transfer system as a mechanically closed device that prevents the transfer of environmental contaminants into the system and the escape of dangerous aerosol drugs out of the system.

At this point, an appropriate debate regarding the proposed theme is worthwhile. Are there any risks? Yes and they are indisputable. Do workers fall ill due to these risks? Undoubtedly! Making decisions to take risks to our health is our right. But, what about spontaneous abortions and birth defects related to occupational exposure to antineoplastic agents? Are we aware of the impact of the decision we are making?

Certified microbiological control

As the definition of the device itself indicates, it is the basic task of the closed system to maintain the microbiological integrity of the drug, whether it is the leftover in the bottle or the ready-made dose. Sterility maintenance for up to seven days was verified for the OncoSafe Arisure line, using the OncoSafe Arisure Closed Vial Adapter vial adapters, and using samples of medication vials and unit doses. For a 95% confidence interval, 60 samples were handled in an ISO class 5 area and tested for sterility. Negative and positive microbiological controls were used. All 60 samples handled with OncoSafe Arisure Closed Vial Adapter maintained their sterility for seven days (168 hours). The reduction of losses of medicine remnants and ready-made doses can amortize the cost of the system, reverting to a reduction in risks for exposed professionals.

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