Alberto Coustasse, DrPH, MD, MBA, MPH

The Drug Quality and Security Act was signed into law on November 27, 2013, and included the Title 2 Drug Supply Chain and Security Act (DSCSA).

This legislation was introduced to enact a federal prescription drug safety standard to decrease contamination, counterfeiting, diversion, and otherwise harmful illicit activities. It also improves the detection and elimination of potentially unsafe drugs from the drug supply chain to protect US consumers.

DSCSA required that several key initiatives be implemented and maintained to ensure supply chain safety. These have included building an interoperable system for the handling of suspected counterfeit products and product serialization, tracing, and verification. Components of this regulation have been phased in over time, and manufacturers and suppliers have spent unspecified funds relabeling, retooling, and working on the supply chain with the ultimate goal of unit-level traceability by November 27, 2023.

DSCSA was broad in scope, encompassing prescription drugs in finished form for administration (capsules, tablets, and lyophilized powder for reconstitution). It does not cover, or exempts, several items that are difficult to monitor, including blood or blood components for transfusion; compounded, homeopathic, and imaging drugs; intravenous and OTC products; medical gases; and radioactive biologics and drugs.

Critical components of DSCSA that pharmacists need to know and continuously monitor include the following:

Supply chain participants have been required to electronically share product transaction history with the next member of the chain (interoperable data) until the member is providing the medication to the final user.

 This part often has included significant documentation if the pharmacies are transferring medication between 2 locations. This can now be done electronically. Also, DSCSA required that the transaction, history, information, and statement be provided upon a change of ownership between trading partners.

 Therefore, if pharmacies loan products between pharmacies under different ownership, they would be accountable to provide the statements to the entity where the product is loaned and maintain records for 6 years. Exceptions include distribution among hospitals under common control, intracompany distributions, and public health emergencies dispensed under a prescription.

For serialization, a unique serial number is added to each saleable unit of each prescription product, which has been linked to the information about the product’s batch number, expiration date, and origin. This process allows end-to-end tracing and gives businesses the ability to manage and track many transactions and large data sets between trading partners. The key for pharmacies is that these systems are interoperable.

This is a product for which there is reason to think that it appears unfit for distribution because it could result in serious adverse health consequences or death or it is potentially counterfeit, diverted, stolen, or the subject of a fraudulent transaction. In case of any of these events, the pharmacy will need policies and procedures in place and a segregated area to store the product until a resolution is found.

This is a statement in electronic or paper form, including the information for each prior transaction going back to the product manufacturer.

This includes the names and addresses of the businesses from which and to which ownership was transferred, dosage form, established or proprietary name of a product, lot size, National Drug Code container size, number of containers, product strength, and shipment and transaction dates.

This is a document or electronic statement showing that the entity transferring ownership in a transaction did not deliberately provide false transaction information, knowingly alter the transaction history, or intentionally ship an illegitimate or suspect product; had processes and systems in place to comply with verification requirements under the law; received the product from an individual authorized as required under DSCSA; and received transaction information and a statement from the prior owner of the product, as mandatory under the law.

In the event of a suspect product inquiry, supply chain companies must be able to produce relevant transaction documentation within 24 hours (dispensers have 48 hours). Businesses need a storage and retrieval system that quickly supports these queries. The verification process requires a system be put into place to allow for the quarantine and investigation of suspect products and a mechanism to notify the FDA and trading partners if an illegitimate product is found.

DSCSA was enacted and phased in over the past several years with the intent to help secure the pharmaceutical supply chain. Pharmacy health-system managers should continue to work with FDA-approved partners to analyze their data requirements, operations, and technology and to understand their responsibilities around tracking and tracing.

is vice president of operations support at CompleteRx Ltd in Houston, Texas.

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

Alberto Coustasse-Hencke, MD, DrPh, MBA, MPH, 

is a professor of health care management and administration at Marshall University Lewis College of Business in Huntington, West Virginia.

Articles

Pharmacy health-system managers should understand the key components of the drug quality and security act.

Law Helps Ensure Safety of the Supply Chain

Intravenous (IV) workflow systems using technology have been available for years to those who compound sterile products. The Institute for Safe Medication Practices (ISMP) has emphasized the value of tech solutions applied to sterile compounding, including barcode scanning of ingredients and volumetric/gravimetric verification of drug and diluent volumes.

The ISMP has noted that these systems help reduce errors in the IV workflow process.

 Previous literature also documents the value of IV workflow and automation systems as related to medication safety, productivity, and standardizing IV compounding processes.

Even with results from several studies demonstrating the value of IV workflow systems, health systems have been slow in adopting these safety tools that help standardize the IV workflow and detect medication events.

 The adaptation rate is much different among large facilities with more than 400 beds. These facilities tend to use IV workflow systems at a rate greater than 50%, whereas 20% or less of smaller hospitals use these systems.

 Labor and safety continue to be emphasized through accreditation and regulatory bodies, and technology is touted as improving both. So what are the barriers hindering adoption? For those who have moved toward using these tools, have they obtained the benefit they had anticipated?

A survey was developed and sent to 200 recipients between May 2020 and May 2021 to determine barriers to implementation and results obtained from those who have implemented the IV workflow system. The survey was also distributed via direct email to 350 pharmacy administrators or pharmacy staff members with direct supervisory roles for IV rooms across the United States through targeted email invitations. Additionally, to increase participation, respondents were targeted using anonymous participation requests and links on the American Society of Health-System Pharmacists medication safety officer, pharmacy informatics, and pharmacy practice management discussion boards, and additional databases containing pharmacy management information for mid- to large-size hospitals were used. A survey question was included to identify whether respondents had adopted IV automation technology. Those who answered that they had not implemented the technology were asked questions about identifying barriers to adoption and why they did not embrace the technology. The survey instrument consisted of 24 questions targeting the following key areas: purchasing decision methodology, justifications for making a purchase or not, and considerations related to financial impact. Demographic information and the respondents’ practice settings were also included. The survey was administered using the Qualtrics survey platform and data were recorded anonymously. An Institutional Review Board approved the research.

A total of 68 responses were received, with a breakdown of compounding/outpatient pharmacy (5.88%); for-profit health system or hospital pharmacy (7.35%); nonprofit health system or hospital pharmacy (72.06%); state, Veterans Affairs, or other government-affiliated health system or hospital (7.35%); or other (7.35%).

Of note, 25% of respondents stated that they have not considered IV workflow systems previously and do not plan to. Although 20% had implemented IV workflow systems, another 7% had purchased but not completed implementation. In addition, 32% of respondents were considering making a purchase.

Of those that have implemented IV workflow products, 50% did not obtain any financial savings from the purchase, and 65% outsourced some portion of sterile compounding, whereas 35% did not. The majority of those who implemented IV workflow systems did not anticipate reducing outsourcing (68%).

Barriers identified toward purchasing IV workflow systems were based upon a 5-point Likert scale, with 1 being not a barrier and 5 indicating it prevents any movement on the project. The most frequently cited barriers and percentages stating a significant barrier toward or preventions of movement to purchase were the cost of automation (3.84, 76%), other competing capital projects (3.36, 60%), resources required for the project (3.12, 44%), lack of perceived return on investment (2.88, 36%), and time to take on project implementation (2.88, 16%). Other barriers reviewed that did not show a large impact on purchasing decisions were board of pharmacy approval, level of staffing or staff resistance to change, and upcoming renovation projects.

Medication safety is an essential driving factor in the implementation of IV room automation. However, the significant cost and difficulty of monitoring systems value has presented barriers for health systems to implement technology, even though these tools have been shown to reduce medication errors and streamline workflow. Facilities that wish to pursue technology for their IV rooms should engage in formal return on investment analysis and ensure that critical goals can be met and are monitored. In addition, health-system administrators should be engaged early and often with staff to build buy-in, consensus, and support for the project.

Alberto Coustasse-Hencke, DrPh, MD, MBA, MPH, 

1. Deng Y, Lin AC, Hingl J, et al. Risk factors for i.v. compounding errors when using an automated workflow management system. Am J Health Syst Pharm. 2016:73(12):887-893. doi:10.2146/ajhp150278

2. Moniz TT, Chu S, Tom C, et al. Sterile product compounding using an i.v. compounding workflow management system at a pediatric hospital. Am J Health Syst Pharm. 2014;71(15):1311-1317. doi:10.2146/ajhp130649

3. Current state of IV workflow systems and IV robotics. American Society of Health-System Pharmacists. Accessed June 23, 2021. https://www.ashp.org/-/media/assets/pharmacy-informaticist/docs/sopit-current-state-of-iv-workflowsystems-and-iv-robotics.pdf

4. Shah HM, MacDonald C. Implementing an IV workflow management system. Pharmacy Purchasing & Products. September 2020. Accessed June 23, 2021. https://www.pppmag.com/article/2626

5. Talley CR. Sterile compounding in hospital pharmacies. Am J Health Syst Pharm. 2003;60(24):2563. doi:10.1093/ajhp/60.24.2563

Institute for Safe Medication Practices advocates technology solutions, such as barcode scanning of ingredients

Maximize Benefits of IV Workflow Systems

Technology has changed the practice of pharmacy. Many systems are now part of an ever-increasingly interfaced or integrated health care system allowing the electronic exchange of prescriptions from electronic health records (EHRs) to the pharmacy information system and bidirectional data exchange for many items, such as lab results and test information. With meaningful use of automated distribution cabinet databases, EHR efforts, electronic data exchange, and smart pump technology, the availability of data to use for addressing and preventing adverse medication events has grown.

 Use of these systems has allowed a data-rich environment to store and retrieve reporting. Mining data is becoming easier and can be used as a tool to identify adverse medication events or potential events.

The EHR supports an enterprise-wide view of patient care delivered in both the inpatient and outpatient settings.

 Achieving meaningful use and interoperability with EHRs has improved 2 critical aspects of the medication management system: conducting a medication reconciliation and reducing transcription errors during medication ordering. However, even with increased legibility and transcription, EHRs can only be as good as the data entered, the review process, and their sources.

To catch potential medication errors using EHRs, pharmacy staff members generate reports to determine the number of profiles or identified patient populations who are high-risk. Employees review data to determine whether communication handoffs exist among the varying levels of care and whether data received at the time of admission or care were accurate.

An EHR can be built during the ordering process to include dose range, drug information resources, frequency, lab result limits, medication route, and required testing. In addition, a drug interaction screening system is often layered to prevent medication misadventures. Staff members can analyze data from the EHR to look at tool use, such as the number of times the standard orders were not being used and the number of required interventions allowed for education and quality improvement in the medication use system. Order sets should be maintained, and as such, a process for continual review and updating must be identified to ensure optimal value and prevent other issues from arising.

Other areas to review are medications being administered within the time frame set by policy and whether there is an associated reason for the change in medication administration time. A review can include documentation that an independent double-check was conducted when required by organization policy. 

Automated distribution cabinets (ADCs) decentralize and streamline the entire physician order and medication delivery process. The results have been better supply chain management, improved reporting, more effective communication between nursing and pharmacy staff, and timelier patient care.

 With the implementation of technology, pharmacy staff members load systems via barcodes, and nurses select the correct medication for the appropriate patient using barcode e-verification. The system is integrated with the medication administration record in the EHRs.

To prevent medication problems, pharmacists can monitor null transactions, wrong bin openings, returns, forced entry detection, and overrides. Pharmacy staff can review for documentation of independent double-check, if it is required by the organization, for medications that have been removed from the ADC using the override function.

Radiofrequency identification technology offers tools to help reduce errors in patient care, assisting with medication selection, facilitating tracing and tracking of equipment and patients, and promising better management of health care assets and improvement in the process of audits and forecasting capacity.

 These systems offer data mining and reporting capabilities when used in conjunction with an administration or dispensing system.

INTELLIGENT INFUSION (SMART PUMP) TECHNOLOGY

Computerized intravenous infusion pumps have become a standard method of improving medication safety.

 Software included in these pumps can alert the operator when a pump setting is put into the system outside approved organizational guidelines. However, the tool's effectiveness depends on creating a database to put in document alerts, rules, and safety "guardrails."

 Features must be kept up-to-date with continual maintenance of data when new medications are added or when there has been a change in concentrations or formulations. In addition, staff members must be educated about changes and determine pump use. Review of pump usage should include common medications excluded during the data build process, the number of overrides and guardrail warnings, and what medications have been programmed outside the data dictionary. Also, data transfer should be reviewed for accuracy during the most recent update to the pump.

Pharmacists must use data intentionally to prevent medication errors. Using technology in the medication use process in an increasingly interconnected system helps achieve the common goal of effective and safe medication use.

1. Reisman M. EHRs: the challenge of making electronic data usable and interoperable. P T. 2017;42(9);572-575.

2. Arzt NH. The interoperability of things. J Healthcare Information Manag. 2015;29(4):6-8.

3. Kellermann AL, Jones SS. What it will take to achieve the as-yet-unfulfilled promises of health information technology. Health Aff (Millwood). 2013;32(1):63-68. doi:10.1377/hlthaff.2012.0693

4. ASHP Section of Pharmacy Informatics and Technology Executive Committee, 2008-09. Technology-enabled practice: a vision statement by the ASHP Section of Pharmacy Informatics and Technology. Am J Health Syst Pharm. 2009;66(17):1573-1577. doi:10.2146/ajhp090073

5. Interoperability in healthcare. Healthcare Information and Management Systems Society. Accessed April 12, 2021. https://www.himss.org/resources/interoperability-healthcare

6. Federico F. 15 years after to err is human: the status of patient safety in the US and the UK. Institute for Healthcare Improvement. December 6, 2015. Accessed April 20, 2021. http://www.ihi.org/communities/blogs/15-years-afterto-err-is-human-the-status-of-patient-safety-in-the-us-and-the-uk

7. Gurwitz JH, Field TS, Harrold LR, et al. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 2003;289(9):1107-1116. doi:10.1001/jama.289.9.1107

8. Zhan C, Roughead E, Liu L, Pratt N, Li J. A data-driven method to detect adverse drug events from prescription data. J Biomed Inform. 2018;85:10-20. doi:10.1016/j.jbi.2018.07.013

9. Desselle S. Mitigating information chaos during prescription handoffs. McGraw Hill Medical. April 8, 2021. Accessed April 12, 2021. https://www.accessmedicinenetwork.com/posts/41355-mitigating-information-chaos-during-prescription-handoffs?channel_id=1754-pharmacy-management-tip-of-the-week

10. Braswell A, Duggar S. The new look of bedside technology. The point-of-care evolution drives providers to rethink nursing workflow and medication management. Nurs Manag. 2006;(suppl):14,16-18,32.

11. Pedersen CA, Schneider PJ, Ganio MC, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration-2020. Am J Health Syst Pharm. 2021;zxab120. doi:10.1093/ajhp/zxab120

12. ISMP issues updated guidelines for the safe use of automated dispensing cabinets. Institute for Safe Medication Practices. February

13, 2019. Accessed April 12, 2021. https://www.ismp.org/news/ismp-issues-updated-guidelines-safe-use-automated-dispensing-cabinets

13. Seckman C, Bauer A, Moser T, Paaske S. The benefits and barriers to RFID technology in healthcare. Healthcare Information and Management Systems Society. June 26, 2017. Accessed April 20, 2021. https://www.himss.org/resources/benefits-and-barriers-rfid-technology-healthcare

14. Lehr J, Vitoux RR, Zavotsky KE, Pontieri-Lewis V, Colineri L. Achieving outcomes with innovative smart pump technology. J Nurs Care Qual. 2019;34(1):9-15. doi:10.1097/NCQ.0000000000000326

15. Franklin BD. ‘Smart’ intravenous pumps: how smart are they? BMJ Qual Saf. 2017;26(2):93-94. doi:10.1136/bmjqs-2016-00530

 is vice president of operations support CompleteRx in Houston, Texas.

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

Alberto Coustasse-Hencke, MD, DrPh, MBA, MPH,

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

Digital tools can help pharmacists and other health care providers ensure effective and safe drug use.

Detect Adverse Events and Medication Errors Using Technology

During the coronavirus disease 2019 (COVID-19) pandemic, organizations have promoted concepts such as "We are in this together" to ensure buy-in and build communication with employees and the public.

However, we should consider post-pandemic times. We do not always have a crisis to solve or a critical body of evidence to point to when we need to change a work process, influence employees to support changes, improve products, or increase medication safety. As leaders, we should always ask ourselves: Is change necessary? How do we effectively implement the change? How do we articulate the benefits of the change? How do we sustain efforts after the change?

Change management (CM) is a well-organized framework for managing the people side of change.

 It includes practices, processes, and planned activities designed to facilitate and lead organizations to move from the present state to a desired state.

 The goal of CM is not to eliminate resistance but to anticipate it, proactively plan for it, continuously manage it, and mitigate the consequences.

In some settings, such as hospitals, there are important challenges to changing processes. Clinicians have high individual autonomy and show various degrees of professional dominance over management and patients, which gives them control and power.

 CM practices are often only considered retrospectively in practice after challenges or implementation difficulty occur.

STEP 1: IDENTIFYING WHAT NEEDS TO BE CHANGED

The first step in most CM models is identifying what needs to be changed. A good way to examine this in health care is the Swiss cheese model related to patient safety.

 Perhaps the task or item is not meeting expectations or there is a need to increase effectiveness, operational efficiency, patient safety, or productivity. In either event, the element that needs to be changed is identified. Then we recognize what exactly should change, who will be affected, and who the stakeholders are. Leadership must realize that change may not be positive for all stakeholders and may be perceived as negative by some.

An example is rationing products for personal protective equipment (PPE) during supply chain disruptions from the pandemic. Another is increasing telepharmacy use to provide care and education to patients while protecting clinicians and patients from unnecessary exposure to COVID-19 and advancing medication management and safety. In these cases, what needed to change was apparent to those involved. If a patient could not come to the clinic to get care or equipment was not available, an alternative was required.

STEP 2: DETERMINING THE NEW WAY OF DOING BUSINESS

Once a needed change is identified, a new process should be identified. One case in pharmacy practice is using alternative compounded products instead of commercially available products to address supply shortages caused by stressors during the pandemic. A matrix can be developed to aid in this process, such as the Six Thinking Hats, in which various points of view are considered to evaluate the best ideas.

 This type of thinking can help determine the best choice and provide feedback to stakeholders about why the option(s) being proposed are better. This will allow the proposed change to build critical mass to support the change.

To implement and sustain change, it must address who is going to do what and when. An example would be inventory-control functions for the COVID-19 vaccine supply. Everyone involved with the supply chain and planning needs to understand their role. The COVID-19 vaccine supply chain includes managing cold storage, thawing, and complex administration and scheduling processes.

Once a plan is in place, stakeholders need to be informed that the change is starting. Once implemented, it should be determined if the results were obtained. Depending on the change, a new policy may be written and employees trained accordingly to sustain the change. Step 3 is the point in which CM can fail and cause a new process to increase the number of errors in the short term, if the new standard work is not written clearly. Finally, there is a need to codify the change so the process does not backslide over time.

The pandemic has caused leadership to implement change more rapidly than usual and rethink how business and process operates, including managing the supply chain, deploying staff, ensuring medication safety, and using personal protective equipment. Additionally, to effectively manage identified change, CM should encompass a standardized procedure. Although CM can be a daunting process, a thoughtful application will reduce the resistance to change and improve overall operations, regardless of where it is applied if it follows consistent steps.

Change Management: The People Side of Change.

 Prosci Learning Center Publications; 2012.

2. Stouten J, Rousseau DM, De Cremer D. Successful organizational change: integrating the management practice and scholarly literatures. 

. 2018;12(2):752-788. doi:10.5465/annals.2016.0095

3. Erwin DG, Garman AN. Resistance to organizational change: linking research and practice. 

Leadership & Organizational Development Journal

. 2010;31(1):39-56. doi:10.1108/01437731011010371

4. Kotter JP, Schlesinger LA. Choosing strategies for change. 

. July-August 2008. Accessed March 8, 2021. https://hbr.org/2008/07/choosing-strategies-for-change

5. Gagnon MP, Godin G, Gagne C, et al. An adaptation of the theory of interpersonal behaviour to the study of telemedicine adoption by physicians. 

 2003;71(2-3):103-115. doi:10.1016/s1386-5056(03)00094-7

6. Reason J. Human error: models and management. 

. 2000;320(7237):768-770. doi:10.1136/bmj.320.7237.768

Organization Change: Theory and Practice.

Thoughtful application can reduce resistance and improve overall operations, if consistent steps are followed.