HD Facilities

December 2019 : USP <800> - Vol. 16 No. 12 - Page #1

Preparation for USP <800> compliance is an ongoing effort in pharmacy; results from PP&P’s USP <800> survey (pppmag.com/article/2416) demonstrate a strong concentration on facility upgrades. As a result, compliance rates are strong in areas such as external ventilation of sterile HD CPECs, continuous pressure monitoring, and HD storage segregation. Unfortunately, many facilities report significantly lower success rates in their quality control efforts surrounding HD handling; wipe analysis efforts and spill simulations, for example, have yet to be adopted by a majority of pharmacies.

Most facilities (61%) are unpacking their HDs in a neutral-pressure area with an increasing number of facilities utilizing a negative-pressure area for this task. Fortunately, those using a positive-pressure area for unpacking continue to diminish; just 7% are currently taking this approach, down from 12% three years ago.

Segregated storage for HDs is the norm in most facilities. Almost three-quarters of all facilities currently separate HDs from non-HDs in storage, and that number is projected to exceed 90% shortly. The largest facilities have been the fastest to adopt this storage requirement; nonetheless, facilities of all sizes are expecting to make significant progress toward this requirement over the next few months.

USP <800> requires the prominent display of signs designating the hazard at the entrance to HD handling areas. Signage should also be available to restrict access to areas in the event of an HD spill. Facility size impacts compliance to this requirement. While 90% of the largest facilities restrict access to the HD compounding areas, facilities with fewer than 400 beds have been less aggressive in their approach to date.

More than a third of facilities have yet to dedicate a refrigerator to antineoplastic HD storage in the cleanroom complex. Under USP <800>, antineoplastic HDs requiring refrigeration must be stored in a dedicated refrigerator located in a negative pressure area with at least 12 ACPH (eg, storage room, buffer room, or C-SCA). Location of these units is important; for refrigerators in negative buffer rooms, ideally there would be an exhaust adjacent to the unit’s compressor in order to minimize the impact of any particles. Facilities of all sizes need to take steps to get into compliance with the requirement, and this is particularly true for the smallest facilities.

There is a real risk of HD breakage or leakage during medication transport that must be considered as part of the facility’s risk assessment. Under no circumstances should liquid HDs or any antineoplastic HDs be transported via the pneumatic tube system, given the inherent possibility of breakage and contamination. While the honesty of these survey respondents is to be commended, the 2% who are using pneumatic tubes for liquid/antineoplastic HD delivery should discontinue the practice immediately.

There was a 20% jump this year in the number of facilities with the ability to track HD CSPs by lot number in the event of a recall; 7 out of every 10 facilities now have this capability. Facility size has a strong impact on this metric, as smaller facilities are less likely to have lot number tracking in place.

An impressive 90% of facilities already vent their HD sterile compounding CPECs externally.

Nonsterile HD CPECs are also typically vented outside, although by a smaller margin than CPECs used for sterile compounding. For those facilities with internal ventilation, many are relying on redundant HEPA filtration.

Pressure indicators are indispensable to ensuring that the room pressurization is maintained as expected in the HD SEC. Thus, it is heartening to see that the number of facilities utilizing a continuously monitored pressure indicator in the HD compounding area jumped by another 5% this year; 86% of all facilities now take this approach. Mounting indicators between the anteroom and HD compounding room, and again between the anteroom and the general pharmacy area, is a relatively simple task that can be quickly accomplished.


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