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ASHP Guidelines on the Safe Use of Automated Dispensing Devices

Purpose

The purposes of these guidelines are to (1) propose goals and objectives for the safe use of automated dispensing devices in the medication-use process, (2) provide guidance on the safe use of automated dispensing devices to pharmacists and others involved in the medication-use process, (3) advise vendors of automated dispensing devices about the safety needs of health care professionals who use their systems, and (4) recommend standardization for Health Level 7 (HL7) interfaces between pharmacy information systems and automated dispensing devices. The recommendations presented in these guidelines should be used in conjunction with other literature on the topic and information from prospective or selected automated dispensing device or system vendors, established guidelines, and state and federal regulations. Pharmacists should exercise professional judgment in assessing their health system’s needs regarding automated dispensing devices and systems and in adapting these guidelines to meet those needs.

Automated pharmacy systems are designed for centralized filling of individual patient prescriptions and unit-dose medication orders, decentralized dispensing, and other purposes. These guidelines address primarily computer-controlled decentralized medication-dispensing cabinets, which will be referred to as “automated dispensing devices.” Since many of the concepts discussed here may be applicable to related technologies, the term “automated pharmacy system” will be used generally and the term “automated dispensing device” will be used specifically. Automated dispensing devices are located in hospital patient care units, surgical suites, emergency rooms, long-term care facilities, physicians’ offices, and other settings. Several manufacturers produce automated dispensing devices with a variety of configurations and software capabilities that may interface with the pharmacy or health care organization’s information systems.^1,2

Background

The appropriate, accurate, and timely distribution of medications to patients is a well-established responsibility of pharmacists. In acute care settings in particular, distribution systems have been developed that enable pharmacists to review patient-specific medication orders and oversee the preparation and packaging or selection of these medication doses, as well as the delivery of these medication doses to patient care units. Automation has evolved to ease fulfillment of pharmacists’ distributive responsibilities, expand distribution system capabilities, and improve efficiency in distribution.

Automated dispensing devices are an increasingly prevalent component of the medication-use process in health care organizations today. The pharmacy profession’s transition to an emphasis on direct patient care, changes in health care systems, and pressures to reduce costs have all created interest in the availability and use of automated dispensing devices. ASHP supports the use of automated dispensing devices when it frees pharmacists from labor-intensive distributive functions, helps improve patient care by both pharmacists and nurses, improves accountability and storage of medications, and improves the accuracy and timeliness of medication product availability. Experience with automated dispensing devices suggests that, when used appropriately, these benefits can be realized.^3–11 When automated dispensing devices are not used appropriately, their complexity, design and function variations, maintenance and education requirements, and other factors can have undesirable effects and compromise patient safety.^12,13 The National Association of Boards of Pharmacy (NABP) includes language on automation in the NABP Model State Pharmacy Act and Model Rules.^14,15 The NABP Model Act uses the term “automated pharmacy systems” and defines them to include, but not be limited to, “mechanical systems that perform operations or activities, other than Compounding or Administration, relative to the storage, packaging, Dispensing, or Distribution of medications, and which collect, control, and maintain all transaction information.”¹⁴ Data processing and bar code technologies, although incorporated as integral components of some of these systems, are not considered in the NABP Model Act definition as automated drug distribution technology. The NABP Model Rules suggest specific requirements and options for helping individual states determine which automated pharmacy systems are appropriate for use.¹⁵ These ASHP guidelines reflect and expand on the requirements of the NABP Model Rules.

The use of automated dispensing devices continues to evolve. Some health care organizations deploy one or several devices in selected areas, such as emergency departments, that are floor-stock intensive and where lost charges can be substantial. Some devices are used for selected categories of medications, such as controlled substances, that have time-consuming tracking and documentation requirements. Some organizations deploy devices throughout patient care areas to cover nearly all medications used.

The rapid development of technology applications in health care, including automated dispensing devices, and pressures to expand their use have raised concerns about patient safety, access to medications, and possible legislative and regulatory barriers. While technologies can be designed to minimize opportunities for medication errors, that same design can create other, often unanticipated, opportunities for medication errors. Consideration of the use of automated dispensing devices, like consideration of any other technology, must include serious evaluation of existing and potential opportunities for error and the implementation of mitigating strategies to minimize or prevent such errors. Pharmacists have a professional responsibility to ensure that appropriate policies, procedures, and quality-assurance programs are in place to address the safety, accuracy, security, and patient confidentiality of automated pharmacy systems, including automated dispensing devices.

Goals and Objectives

Goals for the use of automated dispensing devices in the medication-use process should focus on improving patient care and resource use. Specific objectives related to these goals may include the following:

• Information necessary for appropriate medication management and patient care is accurate, accessible, and timely.
  
• Appropriate medications are readily available and accessible to meet patient needs within safety and security controls.
  
• Vulnerabilities to medication errors are minimized, and those that remain are identified, documented, and mediated.
  
• Staff members involved in the medication-use process are safety conscious, accurate, and productive.
  
• Patients are satisfied with the quality and delivery of care.
  
• Medication distribution services are facilitated across the continuum of practice settings in the health care system.
  
• Resource management is improved by linking supply ordering channels to the medication distribution system.
  
• Billing accuracy is improved by allowing charges and credits to post when medications are dispensed from or returned to the automated dispensing device.

Requirements

Automated dispensing devices should be regarded by users as tools for improving the medication-use process rather than inherent solutions to problems in that process. Consideration should be given to how the technology can be adapted to meet the goals and objectives of the user rather than how the user’s systems should be redesigned to fit the automated dispensing device. It is important to consider the recommended workflow for the automated dispensing device while simultaneously reviewing the facility’s current workflow and practices to ultimately determine the best practices that will provide safe and efficient patient care while maximizing the safety and efficiency advantages offered by the automated dispensing device.

Before deciding to deploy automated dispensing devices in the medication-use process, an organization should assess its logistical, financial, and cultural circumstances; the safety, patient care, and resource benefits it hopes to gain; and how these benefits would be observed and measured. The organization should also determine if the automated dispensing devices in consideration are capable of producing the desired benefits. Specific consideration should be given to

• Incorporating the use of automated dispensing devices into the organization’s strategic planning (i.e., ensuring that automation is compatible with the vision and mission of the organization).
  
• Assessing the use of automation from a complete systems perspective. Automated dispensing devices should integrate smoothly with other systems and processes, both manual and automated. Interfaces with overall patient care computer systems especially must be considered.
  
• Establishing performance standards for safety, accuracy, timeliness, and costs.¹⁶
  
• Determining the responsibilities of the automated dispensing device vendor and the organization for installation, validation, maintenance, education, operations, and troubleshooting.
  
• Assessing the impact of automation on organizational culture. Automation has a significant impact on employees, particularly pharmacy technicians and nurses. Optimal preparation and support should be considered.
  
• Ensuring effective education for the organization’s employees who use the automated dispensing device or whose responsibilities are affected by its use.
  
• Developing an ongoing support plan.

Since the medication-use process involves multiple health care disciplines, selection of automated dispensing devices and establishment of policies and procedures for their use will require decisions that meet the needs of all disciplines involved. However, since pharmacists have a professional and legal responsibility for the safety and integrity of the entire medication-use process, they should provide leadership in the development and maintenance of policies and procedures for the safe use of automated pharmacy systems. Any system or device adopted for drug distribution and control, including automated dispensing devices, should meet the intent of established professional standards and guidelines regarding patient safety. The automated system or device should provide the following inherent safety features of unit-dose drug distribution systems:

• Medications are contained in, and administered from, single-unit or unit-dose packages.
  
• Medications are dispensed in ready-to-administer form to the extent possible.¹⁷
  
• Medications are available for administration to the patient only at the time at which they are to be administered, according to the institution’s policy.
  
• An electronic patient medication profile is concurrently maintained in the pharmacy for each patient and made easily accessible to the pharmacist.
  
• Medications are accessible to different categories of health care professionals with the ability to limit access based on policy or law.

In addition, the automated systems or devices should ensure safe medication storage, distribution, access, and use wherever they are deployed, including meeting required environmental conditions for the storage and handling of medications. Plans for use of automated dispensing devices should include

• Sufficient quantity and appropriate location of devices to support intended use and efficient work processes,
  
• Selection of a location that minimizes distractions and interruptions during use,
  
• Consideration of surrounding work-space to allow efficient device operation and movement of staff,
  
• Ensuring appropriate ventilation and temperature control, including refrigeration for applicable medications,
  
• Ensuring adequate infection control policies and procedures are maintained when appropriate for the intended use and placement of the device,
  
• Ensuring appropriate and sufficient lighting to support the safe and accurate verification of medication orders, reading of medication labels, and administration documentation,
  
• Establishing proximity of the device to medication information and documentation systems,
  
• Selection of location or placement of the device that permits only the patient’s caregivers access to protected health information, and
  
• Ensuring power and data connections essential to the operation of the device are included in the facility’s emergency backup power and data management systems, so that support and information are provided in a reliable manner during power or data interruptions.

Finally, the automated system or device should comply with applicable federal and state consumer protection laws and regulations. State boards of pharmacy may have different requirements for the use of automated dispensing devices in various practice settings and for obtaining approval for their use.

Override Access to Medications Through Automated Dispensing Devices

All medication distribution systems have medication withdrawal functions that allow nurses and other caregivers limited access to certain medications before order review and approval by a pharmacist, especially in cases of patient emergencies. This function is typically referred to as an “override.” Clearly stated organizational policies and criteria for system overrides should be developed that limit access to medications before orders have been reviewed and approved by a pharmacist.^16,18,19 Override access to medications should be limited to cases in which the drug product has been approved by a multidisciplinary committee of physicians, pharmacists, and nurses as having a clinically urgent need for the medication that outweighs the potential risk of medication error.

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