CASE STUDY
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changes to pharmacy and cleanroom operations. An example of
this type of significant change would be how restricted-access
barrier systems (RABS) can be used. In the 2008 version of the
chapter, the ISO 5 environment that can be achieved with these
systems alone was considered sufficient to apply extended Beyond-
use Dates (BUDs) for CSPs regardless of where the RABS was
located4. However, the 2023 version of USP <797> requires that
the RABS be located in an ISO 7 environment to apply Category
2 or 3 beyond-use dating5. Essentially, a RABS in an unclassified
space is now equivalent to a segregated compounding area.
In any case, whether the standards of the 2008 and 2023
versions of the chapter remain the same, or they receive minor or
significant updates, history tells us that they can be challenging
to consistently adhere to for many pharmacies. In the 2023
State of Pharmacy Compounding survey published in Pharmacy
Purchasing and Products, only 31% of respondents indicated
their facilities were in full compliance with standards that will
become effective in November of 20236. An even more alarming
statistic is that only 76% of respondents indicated their facilities
were in full compliance with the 2008 version of USP <797>6.
DISCUSSION
The compounded sterile preparation goals of ISMP and
USP are both rooted in ensuring that safe medications are
available to patients when they are needed, ISMP with the
Guidelines for Sterile Compounding and the Safe Use of Sterile
Compounding Technology, and USP with General Chapter <797>.
Although, in some ways, the two organizations approach the
goals differently, there is overlap in that they both focus on
processes to achieve the goals. It’s this process overlap that
can allow IVWFM systems with broad functionality such as the
DoseEdge system to support the needs of pharmacies in their
pursuit of compliance with both organizations’ guidelines.
From an ISMP perspective, the use of technology such as an
IVWFM system to improve the safety, efficiency, and prioritization
of compounding within the cleanroom is a well-known and frequent
topic of discussion. In fact, ISMP includes this in their 2022-2023
Targeted Medication Safety Best Practices for Hospitals and has
done so since 20167. These improvements can be achieved by
automating potentially error-prone processes that have traditionally
been performed manually. These error-prone processes can
include researching and following the correct and complete
compounding process, manually performing dose calculations
and determining appropriate BUDs, prioritizing urgently needed
products and using the ‘syringe pull-back’ or ‘proxy’ method for
indicating volumes of drugs injected into final containers.
Additionally, in 2022, “ISMP Guidelines for Sterile Compounding
and the Safe Use of Sterile Compounding Technology”
was published. It contains essential technology attributes,
safe pharmacy processes, safety gaps, and associated
best practices for various technologies such as automated
compounding systems, IV robotics and IVWFM systems.
The ISMP essential attributes for IVWFM systems are
listed below. Many align nicely to address the gaps
or issues associated with CSP preparation8.
ISMP Essential Technology Attributes
DoseEdge
System
Functionality
IV workflow management systems are interfaced
with the electronic health record to eliminate order
transcription from one system into another.
If a compounded sterile preparation has been
discontinued before initiation of the compounding
process, the system interface allows for the
removal of these products from the queue.
IV workflow management systems allow users
to create a master formulation record for non-
patient specific batch, stock solution, and patient-
specific compounded sterile preparations.
When master formulation records are
created, the IV workflow management system
prompts for an independent double check,
which is documented in the system.
Master formulation record changes are
timestamped, saved, and identify the
user who made the modification.
IV workflow management systems
provide an electronic log of changes
made to the database by users.
IV workflow management systems allow users to
customize the incoming order queue to prioritize work.
Machine-readable coding (e.g., barcode, RFID)
is used to verify source products, including
diluents, during the compounding process.
IV workflow management systems automatically
perform calculations or conversions.
IV workflow management systems guide users
through essential steps in the compounding
process including which steps require video
or still images or gravimetric analysis.
Image-capture pictures are clear such that syringe
graduation marks, drug and/or diluent names, lot
numbers, and expiration dates are easily visible.