Guidelines

Guidelines on Safe Handling of Hazardous Drugs
Many agencies have developed guidelines to handle hazardous drugs.


Association of Pediatric Oncology Nurses (APHON)

APHON’s Pediatric Chemotherapy and Biotherapy Curriculum – Second Edition includes a chapter on the safe handling of chemotherapy that details the risks associated with handling cytotoxins and the measures that should be taken to prevent occupational exposure.

This resource refers to studies indicating that engineering controls and traditional handling practices do not prevent hazardous drug exposure, leading to the development of the closed-system drug transfer device (CSTD). The guidelines further specify use of a CSTD for the safe handling of hazardous drugs and reiterate the following recommendation from the National Institute for Occupational Safety and Health (NIOSH):

 

“When reconstituting drugs in vials, avoid pressure build up because it can result in aerosolization. Use a closed-system device (e.g. BD PhaSeal) if available.”
Source: The Pediatric Chemotherapy and Biotherapy Curriculum – Second Edition. Association of Pediatric Hematology/Oncology Nurses; 2007: 60.
View: APHON Homepage


The American Society of Health-System Pharmacists (ASHP)

ASHP Guidelines state the following with regard to safely handling hazardous drugs:

Contamination is Still Prominent While Using Current Ventilation Controls

“Studies have shown that (1) there is contamination on the outside of vials received from manufacturers and distributors, (2) work practices required to maximize the effectiveness of the Class II BSC are neglected or not taught, and (3) the potential vaporization of hazardous drug solutions may reduce the effectiveness of the high-efficiency particulate air (HEPA) filter in providing containment.”
“Workers must understand that the Class II BSC does not prevent the generation of contamination within the cabinet and that the effectiveness of such cabinets in containing hazardous drug contamination depends on operators’ use of proper technique.”

Needleless Devices Alone May Not Be Enough

“Many devices labeled as “chemo adjuncts” are currently available. Many feature a filtered, vented spike to facilitate reconstituting and removing hazardous drugs during the compounding process. However, none of these devices may be considered a closed-system drug transfer device, and none has been formally studied with the results published in peer-reviewed journals.”
“None of these devices has been tested for reduction of hazardous drug contamination. The appropriateness of these devices in the safe handling of hazardous drugs has not been determined.”
“As other products become available, they should meet the definition of closed-system drug-transfer devices established by NIOSH and should be required to demonstrate their effectiveness in independent studies. “

 

Source: American Society of Health-System Pharmacists. ASHP Guidelines for Handling Hazardous Drugs.
Download: ASHP Guidelines for Handling Hazardous Drugs
Accessed June 21, 2011


International Society of Oncology Pharmacy Practitioners (ISOPP)

ISOPP specifies that only “Airtight” and “Leakproof” devices prevent chemical contamination:

  • A product described as a closed-system must be “leakproof and airtight”—therefore vented, filtered devices are not closed. A product cannot be “semi-closed;”
  • the vapor of cytotoxic products are not retained by filters with a diameter of 0.22μm and HEPA filters;
  • to avoid confusion, it is strongly recommended that if a device claims to prevent chemical contamination it should be airtight and leakproof.

ISOPP stipulates that all manufacturers of transfer and administrative devices for chemotherapy should disclose the following to potential users of these products:

  • If the device covers all steps in the preparation process and in which routes of administration the containment is guaranteed. If the device covers only some of the steps, the manufacturer should clearly indicate where the closed properties are not retained;
  • if the device retains its closed characteristics when more than one vial is used for a particular preparation (i.e. over multiple manipulations);
  • studies that show that the device eliminates or reduces contamination in daily practice, can retain its closed characteristics when more than one preparation or administration is performed and to what degree.
  • To prevent exposure to hazardous drugs, ISOPP has created the following Hierarchic Order of Protection. It is imperative that the sequence of protection starts with Level 1 and ends at Level 4 (top to bottom):

Level 1: Elimination, substitution, replacement
Level 2: Isolation of the hazard/source containment (i.e. a CSTD)
Level 3: Engineering controls/ventilation
Level 3B: Administrative controls/organization methods
Level 4: Personal Protective Equipment (PPE)

Source: ISOPP Standards of Practice. Journal of Oncology Pharmacy Practice. 2007; 13 Suppl: 1-81.
View: ISOPP Homepage


National Institute for Occupational Safety and Health (NIOSH)

NIOSH ALERT Publication addresses workers in all healthcare settings and includes this warning:

nioshalert-1

“Evidence documents a decrease in drug contaminants when a closed-system transfer device is used.”

Source: National Institute for Occupational Safety and Health. The NIOSH Publication No. 2004-165 page.
Available at: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings
Accessed February 6, 2009


The Oncology Nursing Society (ONS)

According to ONS:

Using a closed system significantly reduces the exposure risk associated with spiking and priming tubing

  • “Clinical studies done with one CSTD, the PhaSeal® System (Carmel Pharma), showed significant reduction in surface contamination in hazardous drug compounding areas when the CSTD was used compared to the standard needle-and-syringe technique.”
  • “BD PhaSeal has been studied in the clinical environment.”

Source: Polovich M. Safe Handling of Hazardous Drugs, Second Edition. Oncology Nursing Society; 2011.
View: ONS Homepage


Occupational Safety and Health Administration (OSHA)
OSHA published this statement on the potential hazards of handling antineoplastic and hazardous drugs in 1996:

“Preparation, administration and disposal of hazardous drugs, may expose pharmacists, nurses, physicians and other health care workers to potentially significant workplace levels of these chemicals.”

Source: The Occupational Safety and Health Administration. The Hazardous Drugs – OSHA Standards page.
Available at: OSHA Hazardous Drug Guidelines
Accessed December 27, 2010


USP <797> United States Pharmacopeia (USP)

The revised USP <797> guidelines state that: “Occupational exposure to hazardous drugs can result in: (1) acute effects, such as skin rashes; (2) chronic effects, including adverse reproductive events; and (3) possibly cancer.”

With regards to safe handling, USP <797> also states:

  • “in order to ensure containment, especially in operations preparing large volumes of hazardous drugs, environmental sampling to detect uncontained hazardous drugs should be performed routinely (e.g., initially as a benchmark and at least every six months or more often as needed to verify containment).”
  • “The use of a CSTD [i.e., vial transfer systems that allow no venting or exposure of hazardous substance to the environment] is preferred because of their inherent closed system process.”
  • “in facilities that prepare a low volume of hazardous drugs, the use of two tiers of containment (e.g., CSTD within a biological safety cabinet [BSC] or a compounding aseptic containment isolator [CACI] that is located in the non-negative pressure room) is acceptable.”

Source: USP <797> Guidebook to Pharmaceutical Compounding – Sterile Preparations. United States Pharmacopeial Convention; 2008: 37-38.
View: USP Homepage