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ASHP Guidelines on the Safe Use of Automated Compounding Devices for the Preparation of Parenteral Nutrition Admixtures
Purpose
Automated compounding devices are frequently used by pharmacists for the extemporaneous preparation of parenteral nutrition admixtures. This continuing shift from manual compounding procedures comes as a result of significant advances in automated technology, as well as in response to changing health care demands to provide admixture compounding in a safer, more efficient, and more accurate manner. Approximately 65% of the hospitals in the United States currently use automated compounding devices for parenteral nutrition admixtures on a daily basis.a Compounders are also used for other types of intravenous admixtures and in other settings, including home care and long-term-care facilities; therefore, the overall magnitude of their use may be substantial. As with other automated systems or devices, the benefits can be realized only when the technology is used appropriately. Significant patient harm may occur when safety and quality assurance measures are overlooked or circumvented.1
The purpose of these guidelines is to outline the key issues that should be considered to safely and cost-effectively incorporate this technology into the pharmacy operations of health care organizations. The guidelines focus on parenteral nutrition admixtures, but the safety issues are also applicable to the use of compounders for other types of i.v. admixtures. The term “health care organization” is used throughout the guidelines as a general descriptor and is intended to be inclusive of any of the practice settings and types of facilities in which compounders are used, including, for example, home infusion companies. These guidelines should be used in conjunction with the ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products and device manufacturers’ instruction manuals and training materials. Pharmacists should use professional judgment in assessing their health care organization’s needs for automated compounding devices and in adapting these guidelines to meet those needs.
Background
The act of extemporaneously compounding any parenteral formulation is complex and not without inherent risks; therefore, compounding tasks are best performed by personnel most qualified to do so. An incompatible, unstable, or contaminated i.v. infusion may induce significant patient morbidity and even mortality.1 Pharmacists are specifically educated and legally responsible for performing these tasks safely. Pharmacists are also responsible for training other personnel to perform relatively simple tasks with the least risk possible.
The extemporaneous preparation of multiadditive products, such as parenteral nutrition admixture compounding, should be performed under the direct supervision of a pharmacist and in the appropriate environment.2 The historical method of compounding these multicomponent admixtures has been to manually use gravity-driven transfers for large-volume additives, such as amino acids, dextrose, lipids, and sterile water. Small-volume additives, such as electrolytes, trace minerals, multivitamins, and drugs, have often been added manually and separately with a syringe. Thus, this compounding method is limited by the visual inspection of volumes transferred between stock containers, as well as by the precision of the calibrations marked on the stock containers or transfer devices.
The manual method of parenteral nutrition admixture compounding is labor-intensive and requires multiple manipulations of infusion containers, sets, syringes, needles, and so forth, which can lead to the extrinsic contamination of the final admixture with sterile and nonsterile contaminants. A sterile contaminant can be particulate matter from elastomeric vial enclosures (needle cores), and nonsterile contaminants can be bacteria and other infectious materials. Minimizing the number of extemporaneous manipulations of the parenteral infusion containers and supplies improves compounding efficiency and reduces the risk of extrinsic contamination and associated sequelae.3
The emergence of automated technology as an alternative approach to parenteral nutrition admixture compounding has led to potentially improved compounding accuracy with the use of fluid pump technology and software that controls the compounder pump. Fluid can be delivered from the source container to the final container by using either a volumetric or a gravimetric fluid pumping system. Volumetric systems transfer a specified volume of fluid from a source container to a final container via a rotary peristaltic pump. The tubing is stretched around a rotor and, as the rotor turns, solution is pulled from the source container and pushed toward the final container. Measurements are based on the theory that each rotor movement advances a constant amount of fluid through the system. The total volume delivered is calculated by the volume pulled into the tubing by each rotor movement multiplied by the number of movements. These systems usually incorporate a final check of the actual total bag weight by comparing it with a calculated expected weight.
In gravimetric systems, measurement of fluid volume delivered from the source container to the final container is determined by weighing the fluid transferred and dividing the weight by the solution’s known specific gravity, thereby converting weight to volume. Two types of gravimetric pumps are available: additive and subtractive. With an additive pump, a single load cell is positioned to measure each fluid as it is delivered to the final container. With a subtractive pump, load cells are positioned beneath the source containers to measure each fluid as it is being pumped from its source container. Weight is determined by subtracting the posttransfer weight from the pretransfer weight of the container for each source solution. When all transfers are completed, the system compares the actual total bag weight with a calculated expected weight.
In addition to the compounder, dedicated software may be used to electronically transfer information to the compounding device. Automated compounding software has additional features that can enhance the management of the parenteral nutrition program. Software issues and their integrity are additional critical components unique to compounder methods and require continuous monitoring to ensure that the operations are correct.4
Justification for the Use of Automated Compounding Devices
When is it appropriate to use compounders, and how will decisions affect others within and outside the pharmacy department? It is incumbent upon the pharmacist to ensure that the department is fully knowledgeable about the operation of the compounder and that a minimum acceptable standard of pharmacy practice is met. First, internal decisions need to be made to justify the expenses associated with this technology. Second, policies and procedures should be in place to assess workflow, establish training programs, and standardize compounder use in the specific pharmacy practice setting. Third, changing current compounder contracts may result in more cost than the savings that might appear in the new contracts. Specifically, the initial incorporation of an automated compounder into daily pharmacy practice is a labor-intensive effort, and such transitions can be disruptive and can even increase the risk of errors. This may be particularly true during staff orientation to new devices. Such changes must be carefully reviewed; if they are determined to be worthwhile, a well-coordinated transition plan should be devised beforehand. Whether transition costs (including the potential for unused sets and supplies) can be deferred to the new contract is another factor for consideration.
The principal emphasis associated with using automated compounding devices in health care organizations should be improving patient care and enhancing efficiency while remaining cost-effective. “Cost-effectiveness” is, therefore, a relative term with respect to personnel, as the labor saved is often redirected to other aspects of pharmaceutical care that could also improve patient safety. Time that was previously spent on operations associated with parenteral nutrition admixture compounding can now be aimed at other issues, such as optimization of drug and nutritional therapies, reorganization of product utilization, quality assurance programs, and augmentation of other core pharmaceutical services. Specific objectives related to cost justification of automated compounding devices may include the following:
- Enhanced efficiency and worker safety during the parenteral nutrition compounding process and patient safety with parenteral use.
- Reduction in labor associated with manually compounded parenteral nutrition admixtures. Assessment of the overall labor and material costs associated with the current manual compounding methods should include hidden costs such as pharmacists’ time to perform calculations, quality assurance checks, and compounder set-up, as well as staff training (initial and on-going).
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