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Computerised automated unit dose distribution systems allows an improvement of drug distribution in the clinical ward and pharmacists need to be prepared to get the most out of them
Mª Esther Gómez de Salazar
Hospital Ramón y Cajal
In the 1960s, unit-dose dispensing systems (UDDS) were developed in the USA as an effective way to decrease the existing error rates affecting drug prescription, dispensing and administration. However, some problems related to drug distribution still needed to be solved: delays in the arrival of the prescriptions, slowness in the response to the needs generated by new medical orders, frequent prescription changes necessitating the repetition of work, missed doses, increases in the number and amount of drugs kept on the ward, and communication breakdowns between the pharmacy and the clinical units. As more effective alternatives for the institutions were needed, both in clinical and economic terms, robotics, informatics and automation have been gaining ground and nowadays play an important role in the activities and services of pharmacy departments.
Medication use in hospitals is inherently complex, involving numerous steps from prescription to drug administration. Technology has the potential to reduce medication errors by reducing complexity, avoiding over-reliance on memory, simplifying key processes, and, if designed and implemented properly, increasing efficiency. It can also be a cost-effective tool for improving quality.
Hospital pharmacy practice around Europe differs between countries and so does the degree of implementation of automation and the systems in use. Focusing on Spain, in October 2004 the Working Group on New Technologies (TECNO) was set up within the Spanish Society of Hospital Pharmacy (SEFH). Its main objective is to establish the technical criteria to be met by the software and hardware applied to the safe use of medication in hospital practice. So far it has published documents dealing with automated storing, computerised prescribing, total parenteral nutrition, chemotherapy, outpatients, automated unit-dose dispensing, drug distribution and registration of pharmaceutical interventions.
New technologies allow us to improve patient care and they apply to the whole pharmaceutical scope of activity:
CPOE simplifies the medication circuit in the hospital. Direct input of information makes it available in real time for validation, eliminating intermediate processes such as transcription and collection and reception of medical orders. More advanced systems allow nursing staff to register drug administration online once it has been validated. All this, together with clinical decision support tools (alerts, protocols, dose adjustments, formulary restrictions and laboratory results) as well as informatics data records, are meaningful advantages compared to traditional prescribing. Moreover, CPOE brings pharmacy the opportunity to maintain a key role coordinating the process and actively participating in patient care. The benefits of CPOE on safety, prescription quality and institutional budgets have been confirmed in several publications, although evidence of new types of errors is emerging.
A descriptive study carried out in Spain in 2007 showed that CPOE was implemented in 22.4% of the hospitals that answered the survey, reaching 25% in hospitals with 400 or more beds. The fields with higher rate of CPOE implementation were medical (52%), oncology/chemotherapy and surgical (31.5% each).
Automated storage and dispensing devices
These concepts include heterogeneous technology. On the one hand, there are automated systems that simplify drug delivery and storage processes, and on the other, robotised systems that replace human activity in those procedures they have been especially designed for, mainly restocking and dispensing.
The USA National Association of Boards of Pharmacy (NBPA) in the Model State Pharmacy Act and Model Rules states that: ‘Automated Pharmacy Systems include, but are not 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.’
Finding the most suitable system for an institution is a major consideration. There are different systems that cover different areas and needs in the drug-use process and their efficiency and acceptance will depend on how well they fit into the current workflow and also on the ability of the institution and its members to achieve the cultural change required.
Horizontal and vertical carousels for storage and dispensing are more popular in some European countries such as Spain because they suit the unit-dose dispensing model prevailing there, compared to robotic systems, commoner in countries like the UK where ‘original pack dispensing’ is customary.
Horizontal carousels are automated storage and retrieval, computer-controlled devices with high storage capacity centralised in the pharmacy department, consisting of a series of shelving sections (bins) mounted on a horizontal, closed-loop oval track. Once activated, the bins rotate to bring requested items to the operator or automated picker. Refrigeration equipment can be integrated so that drugs requiring controlled temperature storage conditions can be managed by these systems. All the information generated by their activity is registered and with appropriate software it can be sent to the Pharmacy Information System in order to generate purchasing orders based on stock levels or to manage incoming ward ‘top-up’ orders. When interconnected with vertical carousels or automated dispensing machines they control and simplify the whole process of drug storage and distribution. Despite the initial investment required for their setting up, horizontal carousels increase efficiency and accuracy in stock and inventory management, improve productivity and manage space in an efficient manner.
Similar to horizontal, vertical carousels are automated storage and retrieval devices that consist of a series of carriers (pans) mounted on a vertical closed-loop oval track, inside a metal enclosure, that can be either refrigerated or non-refrigerated. Pans rotate to bring requested items to the operator, enabling a relatively large inventory to be directed to a picker at one fixed location. This results in a more efficient ‘parts to picker’ instead of ‘picker to parts’ workflow. Vertical carousels increase storage density, throughput and material handling while reducing picking, restocking and expiry date errors. These systems include software that keeps records of all the operations performed and which is able to retrieve data from other devices such as horizontal carousels and from processes such as CPOE, unit-dose dispensing and ward stock orders. They are used mostly to fill in unit-dose carts and to restock automated cabinets.
Other centralised storage systems are dispensary-based robots designed to eliminate pick errors, speed dispensing and increase storage capacity. Their primary functions are to dispense, pack labelled boxes and restock the robot inventory. There are two broad types of pharmacy robots: channel storage robots (less complex, predominantly used in community pharmacies where stock is manually loaded into predetermined channels); and robotic random storage devices (the most common type of robots used in hospital pharmacies across the globe). They can restock automated cabinets and fill in unit-dose trolleys similarly to carousels, however, their benefits are primarily with full pack dispensing and whether they will benefit individual patient dispensing remains to be seen.
The advantages regarding stock and inventory management, space sparing, productivity and software solutions are overall the same compared to the other pharmacy-based systems.
Decentralised systems, like automated dispensing machines (ADMs), appeared on the scene in the 1980s in the USA, reaching Europe at the end of the 1990s. Ward ADMs are drug storage devices or cabinets that electronically dispense medications in a controlled fashion and track medication use. On the one hand, they permit registered nurses (most systems require user identifiers and passwords) to obtain medications for inpatients at the point of use when they are needed and on the other, internal electronic devices track nurses accessing the system together with the patients for whom medications are administered, providing useful data about how medications are used and their cost. More advanced systems provide additional information support aimed at enhancing patient safety through integration into other external systems, databases and the internet. Some models use machine-readable code for medication dispensing and administration. There is the potential to reduce time to administration of first dose, particularly when interfaced with a CPOE system: however, as each machine can only have one user at a time, insufficient numbers of devices lead to lines in front of the machines and there is an increased likelihood that nurses will take medications for more than one patient at a time, or bypass the ADM.
‘Vending-machine’ style inventory storage and ADMs are becoming popular not only for ward storage, but also for pharmacy-controlled drug (CD) management. These systems of automated storage and electronic recording facilitate paperless CD management and remove the need for pharmacy CD registers, and potentially requisition books (if interfaced to ward CD ADM). They have a high level of accuracy, improving the security of CD management and reducing or eliminating CD discrepancies.
Some hospitals are provided with smart medication trolleys. These are electronic medication trolleys for temporary storage of medications and recording of medication administration to a specific patient on a nurse medication round. When connected to CPOE and ADM they can be used in an integrated manner closing the drug-use system and reducing medication errors. The nurse selects patient and medications to be given from the smart trolley computer, and the prescribed medication for a specific patient is transferred from the ward ADM to a specific drawer in the smart trolley. As soon as the patient’s barcode is scanned, the specific patient treatment drawer on the smart trolley opens. Administration can be recorded either manually in the computer or via barcode reading. As mentioned previously, insufficient smart trolleys can lead to queues and an increase in the likelihood of bypassing the smart trolley and reverting to conventional manual administration of medications.
The study by Bermejo et al showed that 93.4% of the Spanish hospitals that completed the survey had a centralised unit dose model, but only 18.4% of them were using automated cart filling. Unit dose based on automated dispensing systems (decentralised) was available in only 13.3% of the institutions that responded.
Automation of sterile and non-sterile compounding can benefit hospitals by creating a proper environment in which the pharmacy staff can be proficient, safe and efficient. Integration of automation into sterile compounding achieves greater efficiency, security and safety in handling and storage, and facilitates compliance with legislation.
New devices and software for small-scale non-sterile compounding are being developed to integrate compounding, conditioning, labelling, weight and volume control, and recording. Interconnection with precision digital scales and different databases providing information about patients, drugs, excipients, dose calculation and stability can be incorporated. This allows printing of individual manufacturing standard operating procedures (SOPs), labels and records. These records, if properly filled, could eventually replace the compounding record book.
Sterile compounding ranges from relatively simple filling devices to complex robotic systems. The former are volumetric peristaltic compounding devices designed for use in laminar flow cabinets and isolators, which accurately deliver a required volume of a solution to a final container. There are two main kinds: single ingredient (more affordable but does not allow interface with other systems); and multi-ingredient devices. These are used to prepare TPN and complex fluid admixtures and contain software that calculates quantities of ingredients and compatibilities.
Automated robotic systems are generally ISO Class 5 classified manufacturing cabinets, interfaced with a pharmacy information system with potential to be interfaced with CPOE software. These devices are able to perform almost all of the actions carried out by a pharmacy technician in the sterile or cytotoxic compounding process: product recognition, reconstitution, extraction from vial into syringe, loading volume into the final container, volume check, waste disposal and cleaning. However, there are still some functions that must be performed by technicians such as loading drugs and consumables into the robot, and removing and labelling completed products. Each product for a specific patient is identified with a barcode sticker – when scanned, it will indicate if the product has passed the quality assurance restrictions. If passed, then a second label is generated with patient- and product-specific information. If it fails, a second request will be sent to the robot. These robots reduce error and increase operator safety by minimising exposure to cytotoxic and hazardous medications, and reducing needle stick injuries, stress and excess workload and occupational overuse syndrome. They also have the potential to reduce drug wastage through the ability to store and reuse vials internally.
The five rights of medication administration (right patient, right drug, right dose, right route and right time) are principles taught to nurses as part of their education. However, they may not always adhere to them and they may also lack knowledge about the medication (indication, usual dose, route, actions, adverse effects, contraindications and interactions).
Barcode medication administration (BCMA) at the most basic level helps to verify that the right drug is being administered to the right patient at the right dose by the right route and at the right time. Some systems can also create an online medical administration record (MAR). Smart systems can also facilitate drug reference information and various alerts and reminders. Finally, data capture allows for retrospective analysis of administration records.
Delivery of i.v. medications via infusion devices has traditionally not been a major concern for pharmacists. The introduction of smart infusion technology has changed that paradigm by requiring pharmacist involvement in defining minimum and maximum doses for continuous and bolus infusions used within a health-care facility. This technology provides a software filter to prevent key-stroke errors in programming infusion devices for delivery of i.v. drugs, as well as a new source of data with which to measure medication errors at the bedside. Computerised i.v. infusion devices, known as ‘smart pumps’, include software that incorporates institution-established dosage limits, warnings to the clinician when dosage limits are exceeded, configurable settings by patient type and access to transaction data by direct cable downloads to a desktop computer. Smart infusion systems can also integrate barcode technology to provide additional checks and balances in the drug administration process. The involvement of pharmacists is essential for needs assessment, evaluation, selection, customisation and quality control.
When interfaced with the pharmacy department management software, both BCMA and smart pumps provide a closed-loop medication use process and an improved inventory control.
In 2007 only 5.4% of the hospitals were recording administration electronically and patient/drug identification via barcoding prior to drug administration was present in just 1.4% of the hospitals surveyed in Spain. The same study revealed that 63.7% of hospitals expected to implement new technologies in a short time period, principally CPOE, automated dispensing, vertical storage, electronic recording of drug administration and administration by barcode.
Although the authors recognise that they cannot assess whether the sample obtained is representative of the Spanish hospitals, the results reflect the interest of Spanish institutions in modernising and in getting up-to-date with new technologies, as these can improve drug safety and management. From the pharmacy department point of view, re-engineering some processes will enable pharmacists to devote more time to pharmaceutical care. The institutional cultural change and the initial high investment needed to carry out and succeed in the implementation of new technologies are the main drawbacks we presently face.
There are various systems and providers available, so the prioritisation of which technology or system to implement first is crucial, especially in times of economic restrictions. The decision will be based on factors such as feasibility, institution characteristics, timelines and economics. A good strategy is to focus on those parts of the medication use process where more medical errors occur and where the risk is higher, or those whose complexity makes them susceptible to be simplified in order to be more effective.
Although automation decreases the number and frequency of errors, they cannot be completely eradicated and even new types of errors can emerge. A six-month prospective study was carried out during 2008 in Ramón y Cajal Hospital, a third level, 1070-bed hospital in Madrid, to analyse errors and their contributing factors in the coexisting dispensing systems. Error rates were as follows: UDDS without CPOE, 3.7%; UDDS with CPOE, 2.2%; automated dispensing systems (ADS) without CPOE, 20.7%; and ADS with CPOE, 2.9%. Discrepancies when filling the drug carts accounted for most errors in UDDS, whereas ADS errors were mostly related to the ADMs filling. We found out that stock out and supply problems contributed mainly to ADS errors. Prime factors for errors in UDDS were inexperience and deficient communication between professionals. When calculating error rates in ADS without CPOE only the restocking lines were considered as error opportunities, thus explaining the higher value compared to ADS with CPOE, where the lines of drugs prescribed and validated were also included. These results are similar to those reported in the literature.
Provider(s) support is indispensable, above all at the early stages of implementation of a new technology, and this should not be neglected when contracting their services. Fluent communication between the hospital pharmacy and IT departments with the provider ensures a smoother performance. Not less important is the development of contingency plans for downtime that guarantee the working processes can continue safely and prevent data loss.
A ‘closed-circuit’ seamless system seems to be the future trend. This kind of system understands and records all data generated in the whole medication use process (from electronic prescribing to smart administration) and would be the ideal one to integrate solutions for issues such as patient safety and management needs. New technologies are here to stay and pharmacists need to be prepared to get the most out of them.
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