Automation and Information Technology

Rationale

Technological advances in medication delivery systems and administration devices frequently enable improved control of medication administration. Smart infusion pumps are becoming the standard of care for delivering intravenous fluids and medications because they allow for a greater level of control, accuracy, and precision with drug delivery. They are designed to provide users with clinical decision support for programmed doses and infusion rates in order to identify errors before medications or fluids are infused. Smart pump technology and data systems can help improve safety practices by recording and offering reports regarding pump-related errors, alerts, compliance to the institution’s drug library, and overrides. ASHP advocates that to enhance patient safety, medication delivery systems interface with information systems, allow interoperability with the electronic health record, and employ dose error reduction software, including but not limited to standardized medication drug libraries with dosing limits, clinical advisories, and other patient safety-enhancing capabilities.

The design, maintenance, monitoring, and continuous quality improvement of medication delivery systems is an interdisciplinary process that requires ongoing collaboration among many disciplines. The pharmacy workforce has an integral role in ensuring the safe and effective management of medication delivery systems, including advising the interprofessional care team on their use. Pharmacists are a resource for education, therapy selection, monitoring, and troubleshooting of smart pump and other drug delivery systems to help improve patient safety and reduce medication errors. In efforts to optimize drug use, pharmacists should participate in organizational and clinical decisions with regard to these systems and devices.

Rationale

The current Food and Drug Administration (FDA) barcode rule requires the National Drug Code (NDC), lot number, and expiration date on all saleable medication packages. FDA created an exception for immediate packages, which include unit dose packages and individual vials sold as lots in boxes. More than 90% of products dispensed in a hospital are immediate packages. The FDA exception requires that the barcodes on these immediate packages be linear (1D) barcodes. Due to the technology of 1D barcodes, it is difficult to fit the larger barcode containing additional characters needed to code lot number, expiration date, and NDC on labels of inner packages. As a result, the 1D barcodes required on inner packages only contain the NDC. 2D barcodes require less label space than 1D barcodes, and 2D scanners can read 1D and 2D barcodes. Many products dispensed are saleable packages that only contain 2D barcodes, and 2D barcode readers are significantly less expensive and more reliable than the 1D laser scanners used in the past. Hospitals have responded by widely adopting use of 2D scanners.

A proposed FDA rule will allow but not require 2D barcodes and require only the inclusion of the NDC in the barcode. The FDA states that the reason for these requirements is that the expansion of the NDC to 12 digits will create issues for manufacturers that code a 10-digit NDC number in the barcode and don’t have the label space to expand the 1D barcode to 12 digits. The proposed rule will not guarantee that barcodes on inner products contain lot number and expiration date. FDA has stated that they are addressing the immediate package requirements in the revised rule, but this is only true for the NDC 12-character expansion and not for the encoding of lot and expiration date.

Multiple state boards of pharmacy, including California and Texas, require hospitals to log the NDC, lot number, and expiration dates on all intravenous (IV) products that are compounded or repackaged. United States Pharmcopeia (USP) Chapter 797 is adding the same requirements, effective November 1, 2023. The logging of lot numbers and expiration dates is not a second check but an attempt to track medications all the way to the patient in the case of recalls and event reporting. With IV workflow systems and barcodes with lot number and expiration dates, an IV product can be prepared and documented with only two barcode scans. Current linear barcodes require scans of the NDC, multiple mouse clicks, and many keystrokes on a keyboard to enter the data. For example, a two-component IV product with a base solution and one additive was reported to require 22 keystrokes and 2 mouse clicks at a minimum if lot number and expiration date are not in the barcode. In addition, putting a keyboard into the sterile environment or pulling hands in and out of the sterile field threatens sterility. Dispersing this data entry work in the middle of a complicated IV workflow will not only create data entry or transcription errors but will increase the potential for computation errors, as the preparer keys in or handwrites a long series of seemingly random numbers while computing, measuring, and verifying doses.

Software vendors have acknowledged that their systems already have the functionality to capture lot number and expiration dates, if available, through barcode scanning, replacing numerous keystrokes. This functionality has not only been added to IV preparation functions but also to dispensing and medication administration functions as well. In addition, many systems allow barcode scans to be initiated by foot switches, permitting users to avoid touching scanners, therefore minimizing potential impacts on sterility. One vender has reported that they are in the process of adding automatic checks for expired medications and recalled lot numbers during all medication barcode scanning functions throughout the medication-use process. Significant safety improvements and time savings can be realized through automated checking of expiration dates and recalls throughout the medication-use process, including automated dispensing cabinet restocking.

Although state boards of pharmacy and USP are considering and implementing rules to track medications to the patient and validate expiration dates, there is a general lack of understanding how these rules impact IV preparation workflows and corresponding medication safety and sterility of IV preparation. It is important that rulemakers understand these impacts and implement rules to require the inclusion of lot number and expiration date on immediate product barcodes. Healthcare organizations should communicate the need for NDC, lot number, and expiration date on all immediate products, including repackaged products and investigational medications, to the FDA and GS1, the barcode standards organization that defines medication barcode standards, to assure the resulting barcodes meet the needs of health systems.

Rationale

Digital health technologies, including mobile health (mHealth) applications (apps), hold great potential to improve health and healthcare. There is nearly ubiquitous use of smartphones and an ever-growing and increasingly sophisticated suite of health apps. These apps are providing a wide range of medical functions that span the care continuum from prevention to diagnosis to care management. The adoption of these digital solutions is further amplified by their accessibility, low cost, and personalized features. In addition, their ability to provide practical functions such as health education, tracking of symptoms and side effects, appointment management, and social support make them compelling healthcare tools. With the proliferation of mHealth tools, clinical apps, and associated devices, healthcare organizations need to address the potential barriers and risks of application use. Particular concerns include (1) assessing the quality of mHealth tools, clinical apps, and associated devices; (2) standardizing choices and use across the organization; (3) ensuring the security of data and data storage; and (4) patient usability, acceptability, and usefulness (e.g., generational differences in acceptance of technology). To maximize the effectiveness of mHealth tools, clinical apps, and associated devices, they must be selected, approved, and managed with the goal of improving care and with input from representatives of all affected parties, including patients, physicians, pharmacists, and other healthcare professionals. In addition, their effectiveness is enhanced when they are interoperable (as described in ASHP policy 1302, Interoperability of Patient-Care Technologies) and the data stored within them can be incorporated into the patient’s electronic health record (EHR) and other essential clinical systems.

Providers and patients currently have little guidance regarding use of these resources or the management of the data they provide. The Food and Drug Administration and other regulatory agencies are just beginning to determine the scope of their oversight regarding standardized evaluation and validation processes. As medication-use experts, pharmacists can contribute to the regulatory evaluation and approval of mHealth tools, clinical apps, and associated devices that involve medications or medication management. For example, pharmacists can help assess the quality of information presented (e.g., incorrect or incomplete information, variation in content, incorrect or inappropriate response to patient needs) and mitigate inconsistencies with patient education resources provided by an organization (e.g., discharge education). ASHP is committed to fostering development of resources to help pharmacists ensure safe, accurate, supported, and secure use of mHealth tools, clinical apps, and associated devices. Patient engagement strategies include patient education and competency assessment and enhanced patient awareness of how to access and use validated sources of health information integrated with mHealth tools, clinical apps, and associated devices. Product customer assistance teams for mHealth tools, clinical apps, and associated devices should be leveraged to provide direct support to sustain these efforts. Patient engagement with these tools will: (1) increase communication between patient and providers, leading to increased patient satisfaction; (2) enhance sharing of health information using EHRs; and (3) enable patients to have access to their health data, which empowers them with the knowledge of their health conditions and helps them make informed treatment choices.

Rationale

The purpose of autoverification of medication orders is to improve medication-use safety and quality and more efficiently and effectively utilize pharmacy personnel. When autoverification functionality is used, medications ordered via computerized provider order entry (CPOE) are evaluated against predetermined parameters in electronic health records (EHRs). Orders that fall within set parameters are autoverified and available to be administered; those that fall outside the parameters require review by a pharmacist. Critical values, patient history, and clinical decision support tools are used to create the algorithm that determines whether a medication order is reviewed. The healthcare community has long recognized the importance of pharmacist verification of medication orders, and that role is no less important when developing and implementing systems for autoverification of select medication orders. Recent experience has shown that autoverification of medication orders, when done safely and efficiently, can allow more effective use of pharmacist resources by expanding access to pharmacist patient care.

In the 2016 ASHP survey of health systems, 51.6% of hospitals utilized the autoverification functionality in the CPOE system; this rose to 62.2% utilization by the 2019 survey. Of the health systems surveyed in 2019 that utilized autoverification, 52.9% autoverified in selected areas (e.g., all emergency department orders, perioperative orders); 50.2% identified selected medications for autoverification in specific areas (e.g., pain medications in the emergency department); and 17.1% of hospitals had autoverification for select medications (e.g., flushes, influenza vaccine) throughout the hospital. Between 2016 and 2019, overall use of autoverification and autoverification of select medications throughout the hospital and for select medications in certain areas increased. In contrast, the use of autoverification for all medications in a select area of the hospital decreased from 2016 to 2019.

According to the ASHP survey, the most commonly cited reasons for not implementing autoverification were patient safety concerns (40.4%); “our hospital has not discussed this” (23.2%); and requirements by law, regulation, or accreditors (22.9%). Less common reasons were that EHR software does not have the functionality (6.9%) and EHR limitations on criteria used for autoverification (4.6%). Healthcare professionals have also expressed a concern about medication optimization: medication appropriateness may not be the same as medication optimization. Pharmacy directors have also stated that staffing determinations based on pharmacist workload and other measurable metrics must be carefully considered; autoverification should not be a mechanism for reducing pharmacist hours, which would negate the potential to expand patient care services.

Rationale

The Joint Commission (TJC) Comprehensive Accreditation Manual for Hospitals includes standards that specify that healthcare professionals involved in the medication-use process should have access to and use patient and medication information important in the prescribing, dispensing, administration, and monitoring of medications. In addition to its accreditation standards, TJC’s 2022 national patient safety goals for hospitals include improved staff communication (getting important test results to the right staff person on time) and safe use of medications (recording and passing along correct information about a patient’s medications). It is important to recognize that medication indications are used not only by pharmacists, nurses, and physicians but also other important members of the healthcare team, including but not limited to respiratory therapists, social workers, physical therapists, and others who utilize this information to guide patient care.

The Institute for Safe Medication Practices (ISMP) has offered recommendations, including clearly specified dosage form, drug strength, and complete directions on all prescriptions; indication on all outpatient prescriptions and on inpatient PRN orders; with name pairs known to be problematic, reducing the potential for confusion by writing prescriptions using both the brand and generic names; listing both brand and generic names on medication administration records and automated dispensing cabinet computer screens; and, whenever possible, determining the purpose of the medication before dispensing or administering it.

Several well-known studies have demonstrated reductions in wrong-patient errors and adverse events with the inclusion of indication on the prescription order. In 2010, Equale (Drug Saf. 2010;33:559–67) described the accuracy of indication information in electronic health records (EHRs). Galanter (J Am Med Inform Assoc. 2013;20:477–81) focused on preventing wrong-patient medication errors with the use of indication-based prescribing. Indication-based alerts resulted in an interception rate of 0.25 interceptions per 1000 alerts. One team of investigators conducted a trial of inpatient indication-based prescribing using computerized provider order entry with drugs commonly used off-label (Appl Clin Inf. 2011;2:94–103). Off-label prescription drug use without strong scientific evidence has also been associated with increased rates of adverse drug events (JAMA Internal Medicine 2016;176:55–63). The authors suggested that use of and proper documentation of therapeutic indication can help improve surveillance and safety and decrease risk. This additional safety check is critical in limiting errors due to wrong and/or look-alike/sound-alike medications. In addition to error prevention, indication-based prescribing can improve patient engagement, patient education, and provide pharmacists with information that may be necessary for prior authorizations or claim processing. To foster successful implementation of indication-based prescribing in EHRs, several authors have documented the success of starting electronic prescriptions with a problem or indication list first before medications can be selected to reduce time and medication errors while maintaining clinician satisfaction.

In several countries, including Canada and Spain, the EHR includes indication as part of comprehensive documentation. ASHP first developed official policy on the importance of pharmacists’ access to indications in 1993. In 1996, the National Coordinating Council for Medication Error Reporting and Prevention recommended including the purpose of medication orders because of concerns about safety, unless considered inappropriate by the prescribers. In 1999, the Institute for Safe Medication Practices recommended including the purpose of prescribing on all written orders. In 2004, the National Association of Boards of Pharmacy (NABP) approved a resolution encouraging national and state medical associations to support legislative and regulatory efforts to require prescribers to include indications for all oral, written, and electronically transmitted prescriptions. In 2012, the United States Pharmacopeia made amendments to the standards for prescription container labeling to include “purpose-for-use” language. In 2015, the National Council of Prescription Drug Plans drafted language to recommend diagnosis and SNOMED indication be sent with any prescription. Despite these recommendations, few states have adopted any laws requiring inclusion of indication on all medication orders or prescriptions.

More recently, ISMP has recommended updating the five “rights” of patient, drug, dose, time, and route to include a sixth “right”: the right indication. They cite benefits of indication-based prescribing as (1) helping to prevent errors by narrowing medication choices; (2) empowering and educating patients, which helps increase patient adherence; (3) improving communications among the healthcare team, patients, and families; (4) facilitating medication reconciliation; (5) helping prescribers select the best medications for their patients; and (6) aiding in measuring drug effectiveness and learning from off-label use.

ASHP also has policy on off-label use that encourages the use of the three authoritative drug compendia, peer-reviewed literature, and consultation with experts in research and clinical practice to make specific coverage decisions. ASHP supports informed decision-making that promotes third-party reimbursement for drug products approved by the Food and Drug Administration (FDA) appropriately prescribed for unlabeled uses.

Implementation and use of interoperable clinical decision support systems with indications-based prescribing would be eased by agreement on a universal coding system for labeled therapeutic indications. The FDA, the National Council for Prescription Drug Programs, and other organizations should work collaboratively to select and implement such a system.

Furthermore, ASHP recognizes that there are circumstances in which it would be inappropriate to include diagnosis on a medication order, and encourages such exceptions in federal and state laws and regulations. One clear example of such an exception would be six protected categories of drugs (antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretrovirals, and antineoplastics), as including these may inadvertently result in breaches in patient privacy.

Rationale

ASHP recognizes that design, maintenance, and cyber-security of healthcare information systems (e.g., medication-use information systems, electronic health records, computerized provider order entry systems, e-prescribing systems) is an interdisciplinary process that requires ongoing collaboration across many disciplines. Maintaining the privacy of health information, in compliance with the Health Insurance Portability and Affordability Act (HIPAA), and ensuring patient safety in the face of cyber-attacks are essential concerns for every healthcare organization. Given the ever-evolving nature of pharmacist patient care, medication use, and health information technology, it is essential pharmacists have key decision-making roles in the planning, selection, design, implementation, and maintenance of such systems in order to help prevent and respond to cyber-attacks. To ensure the safe and effective use of medications, pharmacists must have accountability for strategic planning and direct operational aspects of the medication-use process, including the successful deployment of medication-use-related information systems by assessing vulnerabilities and vendor systems to validate the security and integrity of the data. Increased connectivity with vendor systems creates a mutual need to share access to patient information and other vital data, so risk mitigation must be considered at all points of access. This includes, for example, facilitating clinical decision support by assessing the minimum amount of patient health information vendors require to provide services, data analysis, education of users, and developing and implementing business continuity plans, to include fail-over testing of these plans, for when the systems are unavailable.

Rationale

For the past two decades, the U.S. health system has been racing to take advantage of the potential that digital health information offers for improved patient care. Each institution and practice has invested in information systems that work for its specific situation. These systems were developed by multiple vendors, each with their own proprietary structures and labels. Information was and continues to be found in silos, within health systems, within institutions, even within departments.

In 2004, an executive order created the Office of the National Coordinator for Health Information Technology (ONC). ONC is the primary federal entity charged with coordination of nationwide efforts to implement and advance health information technology and the electronic exchange of health information. The 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act provided the Department of Health and Human Services with additional authority to promote health information technology, including the secure exchange of electronic health information.

As defined by the Healthcare Information and Management Systems Society (HIMSS), interoperability is “the ability of different information systems, devices, or applications to connect, in a coordinated manner, within and across organizational boundaries to access, exchange and cooperatively use data amongst stakeholders, with the goal of optimizing the health of individuals and populations.” ONC has developed a roadmap for interoperability and created calls to action for entities with specific roles in our healthcare system (e.g., the Calls to Action for People and Organizations That Deliver Care and Services).

As government agencies, standards-setting organizations, and professional associations work toward interoperability of health information technology, it is important to ensure this includes the ability of healthcare providers and patients to securely access and use health information from different sources and settings relevant to medication use to ensure patient-centered continuity of care.

Along with secure access and sharing of health information, providers and health systems must be cognizant of how a vendor will handle data, how it plans to safeguard data, and whether and how data will be used for secondary purposes (e.g., research, advertising).

ASHP recognizes that continuity of care is a vital requirement in the appropriate use of medications. Pharmacists have responsibility for ensuring continuity of care as patients move from one setting to another (e.g., ambulatory care, inpatient care, community pharmacy, home care). Achieving information systems that have the ability to share relevant patient care data securely across care settings is a critical step in optimizing medication use across care settings.

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ASHP’s vision to make medication use safe, optimal, and effective includes supporting efforts to protect the public from unscrupulous website operators who illegally provide medications online. Patients are entitled to know whether the healthcare providers prescribing and dispensing their medications are licensed, and in which states they are licensed. ASHP supports legislation and regulations that would require online pharmacies to provide such information. To further guarantee patient safety, ASHP advocates mandatory accreditation of such sites by the National Association of Boards of Pharmacy (NABP) Verified Internet Pharmacy Practice Sites (VIPPS) and Veterinary-Verified Internet Pharmacy Practice Sites (Vet-VIPPS) accreditation programs for online pharmacies to assure the public that the pharmacies are compliant with federal and state regulations and NABP criteria. Education of consumers will be required to ensure that online pharmacies are used wisely, and use of online pharmacies should involve appropriate pharmacist counseling.

Rationale

The adoption of HIT in hospitals has been increasing at a quickening pace. The ASHP National Survey—2012 reports the adoption of the following: full paperless electronic health record (EHR) (18.6%), computerized provider order entry with clinical decision support (CPOE with CDS) (54.4%), bar-coded medication administration (BCMA) (65.5%), and smart pumps (77%). The adoption of HIT has undoubtedly been spurred by the American Recovery and Reinvestment Act (ARRA) and the Health Information Technology for Economic and Clinical Health Act (HITECH) provisions under Meaningful Use (MU) of the EHR. Hospitals have been incentivized to implement EHRs that meet the MU criteria by increased reimbursement through Medicare and/or Medicaid payments. Due to the strict guidelines and the rush to meet incentive payments, many providers are questioning whether some HIT is being implemented too quickly.

The implementation of HIT within the medication-use process has been proven to prevent and decrease errors, improve quality, and prevent waste. A key premise of the Office of the National Coordinator for Health Information Technology (ONC) report “Health Information Technology Patient Safety Action & Surveillance Plan” (July 2013) is that HIT, when fully integrated into health care delivery organizations, facilitates substantial improvements in health care quality and safety as compared to paper records. As hospitals and providers implement HIT within their institutions and practices, however, they often encounter new types of errors and problems. The medical literature is starting to see reports of these unintended consequences of HIT, so continuous monitoring of these systems is required. It has become increasingly important to properly assess the interface between HIT and users to identify whether any new risk has been introduced to the system and implement HIT appropriately, taking into account medication-use processes and human factors. Critical questions hospitals and health systems face include (1) when do HIT advances exceed the capacity for integration into workflow, (2) when does HIT begin to introduce risk into the medication-use process rather than improve patient safety, and (3) what are the accountabilities of HIT providers, regulators, and providers to ensure the necessary product development and assessments are made before implementation of new HIT.

ASHP advocates that the pharmacy department be part of the implementation team for any medication-related technology within an institution. Technology assessment tools should be applied by pharmacists and others to proactively determine gaps in function prior to implementation, during upgrades, and as part of the continuous evaluation of HIT performance. The use of failure modes effects analysis (FMEA) and other resources should be considered. Risk assessment should also be considered when implementing any new technology to ensure that unintended consequences are minimized.

Regulatory and accreditation organizations include components of risk assessment and quality improvement within their criteria, but hospitals need to incorporate these into their overall plans. Such risk assessments could result in less attention on some HIT implementations. Finally, federal law needs to recognize vendors’ accountability for the safety of their products as implemented.

Rationale

Clinical decision support (CDS) systems provide timely information, usually at the point of care, to help inform decisions about a patient’s care. CDS can effectively improve patient outcomes and lead to higher-quality healthcare. CDS systems are now commonly administered through electronic medical records and other computerized clinical workflows, which has been facilitated by increasing global adoption of electronic medical records with advanced capabilities. Despite these advances, there remain unknowns regarding the effect CDS systems have on the providers who use them, patient outcomes, and costs. There have been numerous published examples of CDS system success stories, but notable setbacks have also demonstrated that CDS systems are not without risks. Ongoing advocacy is needed for evidence-based improvements in CDS systems that minimize risk in design, implementation, evaluation, and maintenance; provide actionable data analytics; and support the medication-use process.

Rationale

Effective use of automation and technology solutions improves efficiency, allows more time for direct patient care, and ensures safe medication management. The Joint Commission Sentinel Event Alert published in December 2008 outlined patient safety concerns specific to technology implementation and recommended specific actions to reduce error and patient harm. The Institute for Safe Medication Practices (ISMP) has published related recommendations for specific technologies and noted recently that one drug delivery device was marketed to promote physician autonomy as a benefit of its use.