Kenneth Maxik, MBA, MBB

MANY PHARMACIES HAVE implemented or considered implementing cleanroom automation or compounding systems.

Intravenous (IV) admixture automation is one of the newest areas of technology that has been applied to pharmacy workflow.

Manufacturers tout systems for reducing errors reaching patients.

 Clinical literature supports that cleanroom technology can aid in patient safety.

 Errors that occur during sterile product compounding can have significant consequences, from minor harm to the death of patients and expensive lawsuits.

 Pharmacies have attempted to achieve the following goals as part of tech justification: reducing errors and improving accuracy, productivity, and workflow. Based on a justification for financial approval, here are pre- and postimplementation checklists for evaluating or upgrading existing automation in the cleanroom and for justifying the investment, including financial considerations, medication safety, productivity, and quality.

Preimplementation AssessmentFinancial justification. 

Most facilities typically require some form of financial analysis and justification for capital expenditures. This information typically includes cost avoidance for medication errors, potential staffing adjustments, ability to handle growth, consumables for the auto-mated systems, and potential reduction in outsourcing. Our previous study suggested productivity and safety were overriding reasons for implementation, but a large number of facilities still required financial analysis.

 In addition, vendors often publicize that these systems reduce waste by creating more just-in-time dose preparation, decreasing lost and missing doses, and reducing rejected product and remakes.

Reporting tools for metrics and monitoring to document achievement of stated goals is also a consideration.

Most vendors project a reduction in medication errors pre-implementation. Error reduction can be achieved through automated calculations, barcode verification of ingredients, and use of standardized preparation steps.

 It is important to identify upfront how one will measure medication safety pre- and post- implementation as it relates to the automation technology. A brief meeting with the chief financial officer can help firm up how savings will be counted on analysis of the project. Promote dose preparation accuracy and safety. Cleanroom automation is advertised as highly accurate with auto-mated calculations, standardized concen-trations and preparation steps, which yields more consistently accurate results than the manual compounding process.

 Pharmacists evaluating these systems should request evidence-based data supporting any accuracy claims made by vendors related to the technology and validate it with a currently installed client. Before implementation, pharmacies should evaluate any additional regulations or governing approvals that are required, including being compliant for USP Chapter <797>. Consideration should be given to identify quality control processes and additional required equipment.

Pharmacy administrators must identify if staff workflow redesign is an implementation goal or part of the justification. The impact on pharmacist checking time is also a consideration, as many systems tout remote verification and suggest freed-up time. If increased volume is a concern, a metric should be identified to track any associated changes in staffing from baseline. Some vendors tout the reporting capabilities of their systems to allow analysis and trending of workloads and productivity.

Other matters to be addressed before implementation include compounding outside the automation, drug inventory storage, order entry and verification, policies and procedures for compounding sterile preparations in automated systems, preparation of source/bulk containers,product labeling and staff management,and workflow.

Facilities should report results and obtain a baseline for any metrics prior to implementation and associate reporting with the return on investment (ROI). Typically, results should be reported on an annual basis. Comparing annual metrics yields insight to improvements achieved with technology. Metrics to review include, as follows:

. Work with vendors to identify quality control procedures and measure accuracy at the recommended intervals and document results. If internal data exist, they should be compared with the automated systems.

. In our previous study, almost half the subjects indicated no savings were realized or documented related to IV room automation.

 This issue is likely because a precise measurement tool was not adopted with baseline information before implementation. Also, including a parameter to monitor missing doses or product remakes could yield significant savings to identify impact on supply cost reduction.

. Any documented improvements should be made with a specified error rate reduction associated with IV compounding.

. A baseline volume that accounts for seasonal variation for the cleanroom should be identified and used for comparison. This baseline should identify staffed hours, as well as a measurable volume.

IV room automation justification and analysis can be a complex process. Facilities that have implemented IV room automation have overwhelmingly indicated that there was not an ongoing assessment for justification of the achievement of the ROI.

 Identifying the metrics that will be assessed before implemen-tation and an associated reporting plan for the institution’s specific goals with this technology are critical to justifying an ROI and docu-menting improvements of this technology. ■

, is vice president of operations support at CompleteRx in Lexington, Kentucky.

, is director of experiential learning, manager of clinical support services, and associate professor of pharmacy practice at Marshall University School of Pharmacy in Huntington, West Virginia.

, is a professor of health care administration program at the Management and Healthcare Administration Division at Lewis College of Business at Marshall University.

, is a clinical assistant professor in the Department of Pharmacy Practice, Administration, & Research at Marshall University School of Pharmacy.

Schneider PJ, Pedersen CA, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and adminis-tration-2017. 

. 2018;75(16):1203-1226. doi: 10.2146/ajhp180151.

ARxIUM’s RIVA rated highest performing IV robot in pharmacy study. Winnipeg, Manitoba; March 31, 2016. ARxIUM website. arx-ium.com/arxiums-riva-rated-highest-performing-iv-robot-in-pharma-cy-study/. Accessed February 20, 2020.

Case study: Peninsula Regional Medical Center. Baxter website. https://www.baxtermedicationdeliveryproducts.com/pdf/111852_PeninsulaRegionalMedicalCenter_CaseStudy_FINAL.pdf. Published January 2013. Accessed February 19, 2020.

The intelligent platform to transform sterile compounding. Omnicell website. omnicell.com/solutions/central-pharmacy-iv-com-pounding. Accessed February 25, 2020.

Eckel SF, Higgins JP, Hess E, et al. Multicenter study to evaluate the benefits of technology-assisted workflow on i.v. room efficiency, costs, and safety. 

. 2019;76(12):895-901. doi: 10.1093/ajhp/zxz067.

Current state of IV workflow systems and robotics. ASHP Section of Pharmacy Informatics and Technology Workgroup website. ashp.org/-/media/assets/pharmacy-informaticist/docs/sopit-current-state-of-iv-workflow-systems-and-iv-robotics.pdf. Accessed February 20, 2020.

Hedlund N, Beer I, Hoppe-Tichy T, Trbovich P. Systematic evidence review of rates and burden of harm of intravenous admix-ture drug preparation errors in healthcare settings. 

. 2017;7(12):e015912. doi: 10.1136/bmjopen-2017-015912.

Failed check system for chemotherapy leads to pharmacist’s no contest plea for involuntary manslaughter. Institute for Safe Medication Practices website. ismp.org/resources/failed-check-system-chemother-apy-leads-pharmacists-no-contest-plea-involuntary. Published April 23, 2009. Accessed February 25, 2020.

Vivian JC. Criminalization of medication errors. 

. November 19, 2009. uspharmacist.com/article/criminalization-of-medi-cation-errors. Accessed February 25, 2020.

Kimble CA, Maxik K, Booth C, et al. Post implementation analysis: impact of intravenous automation systems on health-system pharmacy operations. Abstract presented at: ASHP 2018 Midyear Clinical Meeting; Anaheim, CA. December 2018.

Gabay M, Hertig JB, Degnan D, et al. Third consensus devel-opment conference on the safety of intravenous drug delivery systems-2018. 

. 2020;77(3):215-220. doi: 10.1093/ajhp/zxz277.

Guidelines for safe preparation of compounded sterile preparations. Institute for Safe Medication Practices website. ismp.org/guidelines/sterile-compounding. Published September 19, 2016. Accessed February 25, 2020.

Articles

Check out these pre- and postimplementation checklists, which also help to justify the investment.

How Do Pharmacies Evaluate Cleanroom Automation Systems?

Many pharmacies have implemented or considered implementing cleanroom automation or compounding systems.

Intravenous (IV) admixture automation isone of the newest areas of technology that has been applied to pharmacy workflow.

Clinical literature supports that cleanroom technology can aid in patient safety.

 Pharmacies have attempted to achieve the following goals as part of tech justification: reducing errors and improvingmaccuracy, productivity, and workflow. Based on a justification for financial approval, here are pre- and postimplementation checklists for evaluating or upgrading existing automation in the cleanroom and for justifying the investment, including financial considerations, medication safety, productivity, and quality.

 Most facilities typically require some form of financial analysis and justification for capital expenditures. This information typically includes cost

avoidance for medication errors, potential staffing adjustments, ability to handle growth, consumables for the automated systems, and potential reduction in outsourcing. Our previous study suggested productivity and safety were overriding reasons for implementation, but a large number of facilities still required financial analysis.

 Reporting tools for metrics and monitoring to document achievement of stated goals is also a consideration.

 It is important to identify upfront how one will measure medication safety pre- and post- implementation as it relates to the automation technology. A brief meeting with the chief financial officer can help firm up how savings will be counted on analysis of the project.

Promote dose preparation accuracy and safety.

 Cleanroom automation is advertised as highly accurate with automated calculations, standardized concentrations and preparation steps, which yields more consistently accurate results than the manual compounding process.

 Pharmacists evaluating these systems should request evidence based data supporting any accuracy claims made by vendors related to the technology and validate it with a currently installed client. Before implementation, pharmacies should evaluate any additional regulations or governing approvals that are required, including being compliant for USP Chapter <797>. Consideration should be given to identify quality control processes and additional required equipment.

 Pharmacy administrators must identify if staff workflow redesign is an implementation goal or part of the justification. The impact on pharmacist checking time is also a consideration, as many systems tout remote verification and suggest freed-up time. If increased volume is a concern, a metric should be identified to track any associated changes in staffing from baseline. Some vendors tout the reporting capabilities of their systems to allow analysis and trending of workloads and

Other matters to be addressed before implementation include compounding outside the automation, drug inventory storage, order entry and verification, policies and procedures for compounding sterile preparations in automated systems, preparation of source/bulk containers, product labeling and staff management, and workflow.

Facilities should report results and obtain a baseline for any metrics prior to implementation and associate reporting with the return on investment (ROI). Typically, results should be reported on an annual basis. Comparing annual metrics yields insight to improvements achieved with technology. Metrics to review

 Work with vendors to identify quality control procedures and measure accuracy at the recommended intervals and document results. If internal data exist, they should be compared with the automated systems.

 In our previous study, almost half the subjects indicated no savings were realized or documented related to IV room automation.

Any documented improvements should be made with a specified error rate reduction associated with IV compounding.

A baseline volume that accounts for seasonal variation for the cleanroom should be identified and used for comparison. This baseline should identify staffed hours, as well as a measurable volume.

 Identifying the metrics that will be assessed before implementation and an associated reporting plan for the institution’s specific goals with this technology are critical to justifying an ROI and documenting improvements of this technology. 

Schneider PJ, Pedersen CA, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration-2017. 

ARxIUM’s RIVA rated highest performing IV robot in pharmacy study. Winnipeg, Manitoba; March 31, 2016. ARxIUM website. arxium.com/arxiums-riva-rated-highest-performing-iv-robot-in-pharmacy-study/. Accessed February 20, 2020.

Case study: Peninsula Regional Medical Center. Baxter website. https://www.baxtermedicationdeliveryproducts.com/pdf/111852_ PeninsulaRegionalMedicalCenter_CaseStudy_FINAL.pdf. Published January 2013. Accessed February 19, 2020.

The intelligent platform to transform sterile compounding. Omnicell website. omnicell.com/solutions/central-pharmacy-iv-compounding. Accessed February 25, 2020.

Current state of IV workflow systems and robotics. ASHP Section of Pharmacy Informatics and Technology Workgroup website. ashp.org/-/media/assets/pharmacy-informaticist/docs/sopit-current-state-of-ivworkflow-systems-and-iv-robotics.pdf. Accessed February 20, 2020.

Hedlund N, Beer I, Hoppe-Tichy T, Trbovich P. Systematic evidence review of rates and burden of harm of intravenous admixture drug preparation errors in healthcare settings. 

Failed check system for chemotherapy leads to pharmacist’s no contest plea for involuntary manslaughter. Institute for Safe Medication Practices website. ismp.org/resources/failed-check-system-chemotherapy-leads-pharmacists-no-contest-plea-involuntary. Published April 23, 2009. Accessed February 25, 2020.

Vivian JC. Criminalization of medication errors. US Pharmacist. November 19, 2009. uspharmacist.com/article/criminalization-of-medication- errors. Accessed February 25, 2020.

Gabay M, Hertig JB, Degnan D, et al. Third consensus development conference on the safety of intravenous drug delivery systems-2018. 

In February 2016, the United States Pharmacopeia (USP) released General Chapter <800> to “provide standards for safe handling of hazardous drugs (HDs) to minimize the risk of exposure to health care personnel, patients, and the environment.” 

The rule provided much-needed codification around the handling of HDs, following research that found improper employee exposure may lead to both acute and long-term health effects. The scope of USP <800> represents standards that apply to all personnel who compound HD preparations and all production phases where this activity may occur, including receiving, storing, compounding, dispensing, administering, and disposal. As USP <800> has taken effect, one recommended step with which health care facilities have struggled is conducting risk assessments.

USP 800 has a provision for certain drugs on the National Institute for Occupational Safety and Health (NIOSH) list that do not have to follow all the containment requirements of this chapter if a risk assessment is performed and implemented. These drugs include final dosage forms of compounded HD preparations and conventionally manufactured HD products, including antineoplastic dosage forms that do not require any further manipulation other than counting or repackaging (unless required by the manufacturer). This rule allows organizations to decide which containment strategies and work practices they will enact for these medications.

This risk assessment should include an overview of how each drug is used and by whom; what the potential exposure is for those individuals; what the consequence of such exposure would be; containment strategies to minimize this risk; and contingency plans for how to best address exposure, if it were to occur. Through this process, organizations can understand how broadly USP <800> applies to them, then prioritize compliance actions. Facilities that decide not to conduct a risk assessment, no matter which HDs they use, must follow the full set of guidelines.

The first step for any organization that decides to conduct a risk assessment is to create a comprehensive list of HDs available in the facility. Included in this list, for each HD, is its type, name, and dosage form(s) in which it is available. At the beginning of this process, many facilities do not have a complete list of HDs in their facility. Per USP <800>, a HD is any drug identified as such by NIOSH on the basis of carcinogenicity, teratogenicity, or developmental toxicity; reproductive toxicity in humans; organ toxicity at low doses in animals or humans; genotoxicity; or being a new drug that mimics an existing HD in structure or toxicity. These drugs are listed in Tables 1, 2, and 3 in the NIOSH document.

After creating a list of HDs, a facility’s next step is to determine how an employee could get exposed to each of these drugs during various steps in the medication management process: receiving, storing, compounding, dispensing, administering, and disposal.

To give a broad example, during receiving and storage, exposure experienced by an employee could be via ingestion, inhalation, or injection, or through the skin or eye. Such exposure could be caused by contact with HD residues that are present on drug containers, individual dosage units, outer containers, work surfaces, or floors, either in the receiving or storage areas.

Once the medications and risks of exposure have been identified, the next step is to identify what practices should be undertaken so that the risk associated with handling the HD will be mitigated. One mitigation strategy, for instance, is the use of personal protective equipment, including gloves that meet American Society for Testing and Materials standard D6978. Organizations going through risk assessment have moved toward having only this type of glove available for use by nursing personnel, as they did not want to double the glove stock on the nursing units and they did want to eliminate the possibility of staff members selecting the incorrect glove. Another strategy entails facilities removing the process of crushing, cutting, or splitting Table 1 drugs out of the nursing units and into the pharmacy.

When risk assessment is complete, the final step in the process is to educate all staff members who could, potentially, come into contact with the HD, so they clearly understand their risk. After receiving the education and training, the trained staff members should sign an acknowledgment of risk to be maintained on file at the facility or other centralized location.

For some facilities, the prospect of completing a risk assessment may seem overwhelming. However, it should comfort them to know that, in addition to reaching the primary goal of improving worker health and safety, implementation of these best practices may also improve long-term operational efficiency.

For additional information, facilities may review free resources on USP’s website, including the organization’s overview and frequently asked questions sections for the chapter.

Home page. United States Pharmacopeia website. usp.org. Accessed January 2, 2020.

NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. CDC website. cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf. Published February 2016. Accessed January 2, 2020.

Although they seem overwhelming, implementation of these best practices may improve long-term operational efficiency.