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Published on 4 November 2009

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Use of information technologies to improve the safety of small-scale preparations

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Information technology can have a positive impact on safety, traceability, efficiency and communication during the preparation of drugs. The experience of users at a local level illustrates the pros and cons of these new tools

Professor Pascal
Bonnabry
Head of pharmacy
Dre Sandrine
Fleury-Souverain
Head of quality control
Dr Farshid
Sadeghipour
Head of production
Pharmacy

Geneva University
Hospitals (HUG),
Switzerland

Drug production in the hospital pharmacy is a high-risk process, particularly when individual sterile preparations are compounded in an aseptic environment. Working methods are complex, with high-frequency of production, low probability to detect mistakes and potential for human error. This could have serious consequences for patients.

Research has shown the limits of reliability, indicating a 6.5% error rate during the preparation of syringes by anaesthetists[1] and demonstrating limited performance of human controls (only 85% of efficacy).[2] A 9% total error rate in admixtures within pharmacies was measured in five hospitals (2% with clinical significance), 59% of errors being committed during total parenteral nutrition (TPN) compounding.[3]

Information technology (IT), such as electronic files, weighing systems, scanning and automation, may be able to rectify this risky situation, improving:

  • Safety by reducing the rate of errors and increasing reliability of controls.
  • Traceability by facilitating registration of logs.
  • Efficiency by optimising working performance.
  • Communication by connecting the different steps of the process.

In our hospital pharmacy, in 2001, we decided to integrate IT systematically to support our production and quality control activities. We started to develop several modules to cover the whole process. In 2009, implementation is almost finished.

Global concept
To have a significant impact, computer-assisted production management should be as large as possible. It should support any type of preparation, including batch production, cytotoxics, TPN and other individualised prescriptions. In-process electronic controls and/or automated filling systems should be used for the all critical operations, from the prescription to the administration, without interruption of the information flow.

Figure 1 describes the global concept we followed for our developments. The central part of the scheme illustrates the workflow from raw materials analysis to production and quality control of end products. These steps are connected in a single system, ensuring a complete and integrated traceability of batch productions, as well as the follow-up of production environments and operators. Electronic prescription- computerised physician order entry (CPOE)-modules have been developed for each type of individualised preparation and the information given by the physician can be used directly without retranscription. Downstream, the electronic system can print labels and production/analysis protocols. It can also be connected to in-process control systems and automated filling systems.

In-process control systems increase performance. Verification of drug identity and correct weighing are essential to ensure the quality and safety of drugs- especially for individualised preparations that cannot be fully analysed before release. These systems work particularly well with cytotoxics preparation and a number of software options are available, such as Cato and Cypro. We decided to interface Cato, which receives orders from our CPOE system and gives back all the traceability information. We are also developing a similar system for batch production.

Automated filling systems reduce the risk of human error during this critical step. Their performance is good, but their installation can be time-consuming and complex. Several robots for cytotoxic preparation are in an advanced stage of development (such as Cytocare from B/Braun, Cytotoxics Formulation Machine (CFM) from Medical Dispensing Systems). This approach still presents a huge challenge but offers promise for the future. In other areas, like TPN (including MicroMacro 12 Compounder and ExactaMix from Baxa) and syringes filling (such as Smartfiller from Addedpharma and Rapid-Fill from Baxa), we have validation and implemented automated filling systems in our hospital.

To optimise safety, there is a real benefit in closing the loop, by implementing a bedside electronic verification of the prepared drug. For that purpose, a machine-readable identifier (such as Datamatrix) must be printed on the preparation’s label and on the patient wristband, and a scanning system implemented to help the nurse to perform the final control and to document the administration of the drug. In our case, we have developed such a system for cytotoxics, which allow a global and uninterrupted electronic management, from prescription to administration.

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Making use of IT systems can really improve the safety of small-scale preparations, by suppressing retranscriptions and calculations, and by supporting or replacing high-risk human tasks. They naturally integrate traceability and also improve efficiency- achieving a 60% reduction in human resources needed for TPN compounding. The communication between physicians and pharmacists or between production and quality control can be facilitated at different levels, with several positive outcomes. Workload can be anticipated and, therefore, scheduling can be improved. Important messages, such as a risk of incompatibility during the prescription of TPN, can be transmitted at the right moment with a suggestion to modify calcium or phosphate content, thereby avoiding phone calls later on. The management of the documentation associated with production and quality control is facilitated, procedures are homogenised and their updating simplified. The result is a global and integrated approach to process management.

However, this new technology can be successful applied only when numerous challenges have been overcome. In particular careful evaluation and monitoring throughout the project of: acceptability by users; users’ education; access to computers, reliability of IT infrastructure and appearance of new risks. The human-machine interfaces must be specifically evaluated by specialists because poor ergonomics can be a Figure 1. Global concept for the integration of IT in the production process source of new risk and also make people reluctant to use the system and hinder the development of workaround strategies.

Opportunity to improve
The arrival of these new IT tools is an opportunity to redesign the whole process of drug preparation from prescription to administration. Every hospital should define the scope for such technology as it can have a positive impact on safety, traceability, efficiency and communication. However, these projects are time-consuming during their development and implementation phases and it is important to set priorities and to dedicate the necessary financial and human resources.

References
1. Garnerin Ph, Pellet-Meier B, Chopard P, Pernegger TV, Bonnabry P. Measuring human-error probabilities in drug preparation: a pilot simulation study. Eur J Clin Pharmacol 2007;63:769-76.
2. Facchinetti NJ, Campbell GM, Jones DP. Evaluating dispensing error detection rates in a hospital pharmacy. Med Care 1999;37:39-43.
3. Flynn E, Pearson RE, Barker KN. Observational study of accuracy in compounding i.v. admixtures at five hospitals. Am J Health-Syst Pharm 1997;54:904-12.

Resources
HUG pharmacy: http://pharmacie.hug-ge.ch/
www.cato.eu
www.cypro.de
www.cytocare.com
www.medicaldispensing.nl
www.baxa.com
www.addedpharma.com



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