Posted on September 27, 2018
Automation and technology have a long history in supporting pharmacy practice. Unfortunately, so too do unsafe medication practices. Compounding errors can be attributed to nearly 1,500 adverse drug events, including 114 deaths, between 2001 and 2017.[i] While sterile preparations are the primary focus, attention must also be paid to miscalculations and mistakes in filling prescriptions.
There is growing pressure to tighten requirements around sterile compounding as well as to provide the documentation from compounding and master formulation records. The 2018 proposed revision of USP <797> requires that all pharmacies that compound will need documentation for all the doses they prepare. Without the right systems and processes, encompassing automation within the cleanroom, tracing the data elements around the preparation of compounded sterile preparations (CSPs) is a very manual and tedious task.
Automation in support of sterile compounding provides a robust framework that is critical to ensure the patient safety objective of right drug, right dose, and right patient is achieved. While the reasons to automate are extensive, three key benefits of automation of the CSP process stand out.
1. Meet Requirements and Create Traceability
A compounding record, required in the proposed revisions of USP <797>, must be created for all CSPs, but paper documentation is unreliable and unsearchable when it comes to operational reviews, CSP traceability (recalls), and clinical assessments. Automating order management and documentation allows pharmacists to better manage the order queue and ensure CSPs are properly prepared and labelled, so the drug and dose of each medication is clear. Automation can also ease the management of discontinued or changed doses.
Standardized formulation records and standard operating procedures are also clear benefits of automation. Further, with the right documentation, it’s easier to eliminate or spot formulation process deviations and errors.
By automating documentation, hospitals are better equipped to meet State Board of Pharmacy regulations, USP Standards, and the American Society of Heath System Pharmacists (ASHP) guidelines, which place emphasis on accurate and appropriate labelling for ingredient identity, strength, purity and sterility.
2. Prevent Drug and Dose Verification Errors
Experience has taught us that drug and diluent selection errors can be eliminated with automated verification using barcode scanning. The importance of barcode verification is recognized as best practice by the Institute for Safe Medication Practices (ISMP), which has stated that “barcode scanning of base solutions and ingredients should now be considered the minimum requirement for pharmacy IV admixture services.”
Barcoding and other automation features for pharmacy IV admixture need to be the next priority within the IV cleanroom, once the USP standard requirements are met. Crucially, barcode scanning confirms that the right drug and dose is used to prepare the CSP and facilitates administration to the right patient.
3. Create a Better, More Efficient Cleanroom
Process automation can build quality into compounding procedures in the IV cleanroom by allowing the pharmacist to focus on formulation rather than constantly having to conduct process checks that can be done more seamlessly by technology. Accuracy can also be vastly improved, although it’s crucial that bad processes aren’t being automated. The selection of any technology solution in the cleanroom must be to eliminate poor manual processes and create optimized and accurate automated processes. One report found that error rates when compounding parenteral nutrition admixtures was as high as 37% when manually prepared and 22% when partially automated.[ii]
While sterility is paramount, equally important is accuracy, which must become a next priority in the IV cleanroom. Automating processes and enabling IV cleanroom staff to ensure accuracy will be integral to safeguarding the patient, the staff and the hospital.
[i] [i] The Pew Charitable Trusts, “National Assessment of State Oversight of Sterile Drug Compounding” (February 2016), http://www.pewtrusts.org/~/media/assets/2016/02/national_assessment_of_state_oversight_of_sterile_drug_compounding.pdf
[ii] Flynn EA et al. Am J Health-Syst Pharm. 1997; 54:904-12..