The United States Pharmacopeial Convention (USP) is looking into the
establishment of safety standards to be used when handling drugs that are
considered hazardous. While there are other organizations that have provided
standards on handling hazardous drugs, USP 800 addresses in detail the storage,
transportation, handling, compounding, administration as well as disposal of
hazardous drugs. The following are the objectives USP 800 is seeking to meet.
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Protect both the involved
personnel as well as the general environment.
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Proper handling of hazardous
drugs.
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Handling of both sterile and
non-sterile product preparation.
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Implementing all required
standards.
To be more specific, USP 800 refers to the primary and secondary
containment engineering controls which are in relation to the storage and
compounding of HDs. It therefore addresses the guidelines on facility design,
engineering controls, personal protective equipment as well as transportation
of hazardous drugs.
Engineering Controls, Facility
Design and Compounding
It identifies the primary and secondary containment engineering
controls, Containment Primary Engineering Control (C-PEC) and Containment
Secondary Engineering Control (C-SEC) which are in relation to the storage and
compounding of HDs. The C-PECs are devices that are ventilated to reduce the
risks of the workers and the environment from hazardous drugs. C-PECs there
include equipment such as:
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Biological Safety cabinets
(BSC).
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Compounding aseptic containment
isolators (CASIs).
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Containment ventilated
enclosures (CVEs).
On the other hand, the C-SEC is the room in which the containment
primary engineering control devices are kept. The rooms are negative pressure
which are ventilated externally. The rooms may come with a refrigerator in case
there are some hazardous drugs that require refrigeration. Depending on the
drug, you will be pushed to controlling air changes per hour (ACPH). In this,
it is evident that different hazardous drugs. There should be different areas designated
for different drug conditions.
The different engineering controls fulfill the desired standards.
The engineering controls for non-sterile HDs and those for sterile HD
compounding are different. Therefore, you need a professional who understands
the USP 800 chapter to put all the requirements in place. Every requirement
must be fulfilled to the very last bit and you need to meet them.
Personal Protective
Equipment and Personnel Training
It is not a compromise that all personnel must be in protective gear
at all times when handling hazardous drugs. Every protective gear is outlined
in the USP 800 and its use fully described to ensure that the company's
personnel is safe.
In addition, each institution for this category is required to offer
a training program that highlights what they are up against when handling
hazardous drugs and their contents. All the procedures regarding storage,
handling, as well as disposal must be well known to all personnel. After the
training, the staff should be assessed of their competency from time to time to
minimize on safety risks.
The above services cannot be complete and met without ensuring that
all standards are met. In this, professionalism and a better understanding of
this chapter must be looked into help implement the required requirements.