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Engineering Controls | CSTD Clinical Studies | PPE | Medical Surveillance |
Wipe Study Analysis | Hazardous Waste Handling
To help prevent occupational exposure to hazardous drugs, the use of engineering controls – including Class II or III biological safety cabinets (BSC), compounding aseptic containment isolators (CACI) and a clinically proven closed-system drug transfer device (CSTD) – is recommended by the National Institute for Occupational Safety and Health (NIOSH), the International Society of Oncology Pharmacy Practitioners (ISOPP), the American Society of Health-System Pharmacists (ASHP), the Oncology Nursing Society (ONS) and USP <797>.
Administrative controls such as implementing work practices, management policies, training programs to reduce worker risk and medical surveillance programs are also recommended.
ISOPP Hierarchic Order of Protection
To better understand the hierarchy of the aforementioned controls, ISOPP has created an Hierarchic Order of Protection, which is designed to begin with Level 1 and progress to Level 4 as necessary:
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)
Since it is not likely that the hazardous drug can be eliminated, substituted or replaced as outlined in Level 1 of ISOPP’s Hierarchic Order of Protection, one may need to consider complying with Level 2, which can be achieved via implementation of a CSTD. Additional guidelines relevant to use of a CSTD follow:
- NIOSH (2004) “Consider using devices such as closed-system transfer devices... closed systems limit the potential for generating aerosols and exposing workers…”
- ASHP (2006) “Consider using closed-system drug-transfer devices while compounding hazardous drugs…vented, filtered products are not closed”
- ONS (2005) “The PhaSeal System is the only documented closed system on the market. This system is designed to prevent leakage of drugs into the environment during preparation and administration”
- USP <797> (2008) “The use of a CSTD is preferred because of their inherent closed system process”
Defining a CSTD
Given the many recommendations to use a CSTD, it is important to understand the definition of this specific device. According to NIOSH and ISOPP, a CSTD is defined as:
“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.”
At this time, only one device – the PhaSeal System – has been clinically proven to meet this definition.
View: Details on the PhaSeal System
ISOPP notes that “manufacturers of special preparation devices must clearly indicate if studies have shown the device to fulfill the aim of eliminating or reducing the environmental contamination in daily practice and to what degree.”
At this time, more than 10 independent, peer-reviewed, published clinical studies exist to validate the efficacy of the only device proven to meet the NIOSH and ISOPP definition of a CSTD (the PhaSeal System).
View: CSTD Clinical Studies
Because surface contamination (on vials, counters, hoods and more) has been linked to the human uptake of hazardous drugs, personal protective equipment (PPE) plays a vital role in preventing exposure to hazardous drugs and should be a part of every safe handling program. Although individual institutions may vary slightly in their PPE protocol, NIOSH, ISOPP, ASHP, ONS and USP <797> all include guidelines relevant to the use of proper PPE.
Examples of PPE may include:
- Gloves
- Gowns
- Respirators
- Eye and face protection
- Sleeve, hair and shoe covers
View: ASHP Safe Handling Guidelines
View: NIOSH Workplace Solutions Page
Effective January 12, 2009, the Occupational Safety and Health Administration (OSHA) also issued a final rule clarifying that employers who fail to comply with PPE and training standards may be penalized on a per-employee basis.
View: Full Text of OSHAs Final Rule
View: OSHA PPE Webpage
Establishing a medical surveillance program is recommended by NIOSH and is key in monitoring the health and wellbeing of employees who may face occupational exposure to hazardous drugs. (This includes nurses, pharmacists and pharmacy technicians as well as those who may come into contact with hazardous waste such as nurses’ aides, maintenance staff or laundry workers.)
According to NIOSH, elements of a medical surveillance program for hazardous drugs should include (at a minimum):
- Reproductive and general health questionnaires (baseline and periodically following hire)
- Laboratory work, including complete blood count and urinalysis (baseline and periodically following hire)
- Physical examination completed at the time of hire and then as needed for any worker whose health questionnaire or blood work indicates an abnormal finding
- Follow-up for those workers who have shown health changes or have had a significant exposure (substantial skin contact, cleaning a large spill [a broken bag, leaking IV line], etc.)
Additional measures should be taken if the medical surveillance program reveals that health changes have occurred following exposure to hazardous drugs.
View: NIOSH Medical Surveillance Page
A wipe study analysis is a tool used to monitor the environment in which hazardous drugs are prepared, transported, and/or administered to evaluate surface contamination, which has been linked to human uptake. According to the revised USP <797> guidelines, wipe studies “should be performed routinely (e.g. initially as a benchmark and then at least every six months or more often as needed to verify containment.”
Typically, analyses are based on wipe samples from a variety of areas, including but not limited to biological safety cabinets (BSC) and adjacent areas, compounding aseptic containment isolators (CACI) and adjacent areas, countertops, floors, refrigerators, waste bins, carts, patient administration areas and prepared IV bags. These samples are then examined by a third-party laboratory to determine the risk level associated with contamination. To ensure consistent methodology and results, wipe study evaluations are currently conducted by Dr. Paul J.M. Sessink at Exposure Control, a monitoring agency located in The Netherlands that is accepted as the leader in environmental and biological monitoring analyses.
View: Exposure Control Homepage
After administration, hazardous drugs need to be disposed of properly. PharmEcology provides information and resources to dispose of hazardous pharmaceutical waste in a compliant and cost-effective manner.
View: PharmEcology
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