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Missing the mark with ISMP sterile compounding safety recommendations

BD Institute for Medication Management Excellence

Most health-system pharmacies admit missing the mark with ISMP sterile compounding safety recommendations. Technology can help support.

PUBLISHED: Feb 5, 2021

Shannon Johnson, PharmD, CPHIMSS
Associate Director, Medical Affairs, Becton, Dickinson and Company (BD)

Introduction

Errors related to pharmacy preparation of sterile injectable products and admixtures continue to be reported to the Institute for Safe Medication Practices (ISMP). A 2009 State of Pharmacy Compounding Survey showed that 30% of hospitals experienced a patient event involving a compounding error within the prior five years.¹ In response, ISMP published “Guidelines for Safe Preparation of Compounded Sterile Preparations” with best practice recommendations in 2013. These guidelines were revised in 2016 (Figure 1).2 Since many of the errors “repeatedly show that the manual inspection of IV admixture ingredients by pharmacy technicians and pharmacists is not a totally effective deterrent in preventing preparation and dispensing errors,” the guidelines call for “organizations to have a strategic plan for implementation of automation and technology for sterile compounding” that “augments manual processes for preparing and verifying” compounded sterile products (CSPs). Moreover, ISMP specifically advocates for technology “systems that include barcode scanning verification of ingredients, gravimetric verification of drug and diluent volumes, and/or robotic image recognition” and goes on to further delineate that “at a minimum both barcoding and gravimetrics are used…. [when] preparing chemotherapy and ideally, for pediatric CSPs.”²

To raise awareness and gauge adoption of these best-practice recommendations, ISMP recently surveyed 634 pharmacy practitioners (80% pharmacists, 18% pharmacy technicians) who prepare or oversee the preparation of CSPs. Results of this survey were published in the October 22, 2020 edition of ISMP’s Medication Safety Alert newsletter.³

Implementation of ISMP best practices

Participants gave input into nine questions for whether they “always,” “often,” “sometimes” or “rarely” follow best practices (Table 1). Aside from the best practice recommendation for ensuring sufficient workspace inside the IV room (“always” rating of 73%), the other eight questions fared much worse, with “always” compliant ratings ranging from 34% to 56%. A summary of some startling findings include:

Standard operating procedures are “always” followed just 56% of the time.
Staff can “always” identify with certainty the drugs & diluents used during a preparation only 52% of the time.
Dose volume information (to eliminate reliance on manual calculation) was “always” readily available only 49% of the time.

Challenges with adopting ISMP best practices

Survey respondents also ranked their biggest challenges with meeting the ISMP guidelines. As shown in Table 2, the top challenges cited were (1) lack of direct observation, (2) difficulty meeting USP<797> standards, (3) insufficient staff competency and training, and (4) insufficient technology, followed by a general theme of workload (staffing), time, efficiency and interruptions.

Top 10 ways IVWMS technology can support ISMP best practices

Wondering how technology can help support these critical compounding best practices? Here are the top 10 ways technology can help address some of the challenges:

With standardization comes reduction in variability—a fundamental tenet of patient safety and high reliability.^4,5,6 IVWMS aims to ensure all staff follow the same process for each CSP every time.
Eliminate the need for proxy methods of ingredient verification (e.g., syringe pull-back method) with remote verification enabled with image capture.
Remote verification also enables sharing of workload to more pharmacists without reliance on being physically near the IV room.⁷*

Remote verification reduces consumption of expensive personal protective equipment (PPE) and the labor (time) it takes to put it on and take it off before entering and after leaving the IV room where verification is typically done.⁷*

*The University of North Carolina Medical Center (UNCMC) showed how utilizing remote pharmacist verification for CSPs lead to increased efficiency in pharmacist time plus lower PPE consumption that equated to an annualized cost savings of $23,770 (7).

Eliminate reliance on potentially risky manual calculations thanks to software enabled gravimetric algorithms that automate calculations.
Gravimetric verification improves dose accuracy with a scale that makes errors (volumes outside preset tolerance levels) apparent to everyone and can stop them from being released. Dose accuracy is no longer limited by human performance.⁸
Gravimetric verification with hard stops can help users correct errors before they are committed. In addition to the safety benefits, this also helps avoid the expense of having to waste and remake an erroneous dose.
Barcode scanning and image capture ensures that each ingredient is correct. With the addition of gravimetrics, certainty that the volume was indeed transferred to the receiving container can be demonstrated.
Integrated task management software improves the likelihood that standard operating procedures aimed to maintain United States Pharmacopeia (USP) and board of pharmacy compliance are consistently followed. Before routine tasks (e.g., cleaning, environmental monitoring, competency, etc.) come due, on-screen reminders help remind users to complete the task. When tasks are overdue (representing noncompliance risk), administrators have options to employ hard-stops to ensure a compliant compounding state is never compromised.
Compounding errors (as a result of comingling or intermingling ingredients) can be reduced with barcode scanning and also by using a bin and a bin label to keep things separate during the workflow. IVWMS can support a labeled bin workflow by guiding the user to gather all the necessary parts (e.g., ingredients, supplies) for a single CSP.

Figure 1: ISMP sterile compounding process recommendations (2016)

The recommendations contained within the safe practice guidlines focus on the following process:

Policies and procedures for compounding sterile preparations
Order entry and verification
Drug inventory storage
Assembling products and supplies for preparation
Compounding
Drug conservation
Compounding performed outside the pharmacy IV admixture service
Preparation of source/bulk countainers
Technology/automation used for compouding sterile products
Automated compounding (pumping) systems
Quality control/final verification
Product labeling
Staff management

Table 1. Survey results, implementation of compounding best practices (October 2020)

Year	EHR (Complete or partial)	Inpatient CPOE w/ CDSS	BCMA	Smart infusion pumps
2005	24.5%	3.1%	4.4%	32.2%

Best Practice	Degree of Implementation (%)
Best Practice	Never/Rarely	Sometimes	Often	Always
There are enough workbenches in the cleanroom/sterile compounding area to support only one staff member working at a time per primary engineering control device (e.g., laminar airflow workbench, biological safety cabinet, isolator).	7	5	15	73
Standard operating procedures are defined and utilized by all staff during the compounding process (including the verification/checking process).	3	7	34	56
During the verification process, it is easy to identify with certainty which drugs, diluents, and volumes were used (including the number of vials/ampules/bags used) to prepare each CSP.	3	10	35	52
A standard workflow is followed for how final product labels are placed onto CSPs (e.g., location, flagging, label orientation).	7	12	32	49
Only one CSP is prepared in a workbench/laminar flow hood/bilogical safety cabinet at a time.	5	14	34	47
When compounding a CSP, dose volume information is available on a preparation label, master formula record, or other approved document, so there is no need for calculations.	9	11	31	49
There is sufficient counterspace to gather and stage each component needed to prepare CSPs without the risk of intermingling/overlapping or the need to stage/store items on top of each other.	9	18	31	42
Bins are used during the compounding of each CSP (or each batch of identical preparations) to permit segregation (separation) from other CSPs.	21	9	16	54
Lighting and noise in all locations where CSPs are prepared and verified have been measured and are consistent with USP standards (i.e., 1,000-1,500 lux, 50 dBA).	44	11	11	34

Key: Never/Rarely = 0 to 10% of the time; Sometimes = 11 to 50% of the time; Often = 51 to 95% of the time; Always = more than 95% of the time

Table 2. Challenges related to sterile compounding (October 2020)

Challenge	Percent of Comments	Brief Description
Lack of direct verification of the CSP process	13	No direct observation by a pharmacist of the compounding process; still using the post-production syringe pull-back method for verification; pharmacist cannot see the actual drug/volumes prepared; unable to observe aseptic technique
Difficulty meeting USP standards	11	Difficulty meeting USP <797> and USP <800> standards related to sterility, cleaning, environmental monitoring, beyond-use dating, garb worn during preparation, and safe handling of hazardous drugs
Insufficient staff training and competency	10	Technicians: Inexperienced; do not fully understand sterile compounding; no certification required (certain states); competencies not evaluated; high turnover Pharmacists: Inexperienced; supervising CSP process but have inadequate knowledge to properly verify; rotating staff not highly skilled
Insufficient technology	8	Lack of hardware, software, cameras, gravimetric systems, workflow systems, bar-coding technology; concerns about electronic health record capabilities
Space limitations	6	Lack of space; lack of required rooms; architecture/design issues
Insufficient staffing	6	Often related to staffing shortages, high turnover rate of pharmacy technicians
Variation in practices	6	Variations in workflow; not following standard operating procedures; lack of follow-through with details (e.g., putting product in light-protective bags, applying warnings)
Excessive workload	6	Increasing CSP numbers; demand and expected turnaround unsustainable; unrealistic expectations
Lack of time	6	Often rushed; focused on speed over safety
Technology limitations	5	Unreliable technology that requires frequent maintenance; automation downtime; lack of information technology (IT) support; specific limitations (e.g., workflow system gaps, images unclear, camera not wireless, unable to receive wireless signal in cleanroom)
Interruptions/distractions	2	Phones; music; frequent questions; multitasking
Bypassing available technology	2	Technology workarounds; bypassing warnings; not scanning each container; not utilizing workflow systems for required CSPs
Leadership failure	2	Failure of leadership to recognize and provide resources to reduce CSP risks
Lack of supervision	2	Pharmacist not always available to supervise/oversee the CSP process

Pharmacy Purchasing & Products. State of pharmacy compounding 2009: Survey findings. Pharm Purchasing Products. 2009;6(4):4–20.
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