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Abstract: |
The Masaryk Memorial Cancer Institute (MMCI) is a state-owned, medium-sized hospital with more than 200 beds and over 80 years of experience, that specializes in the treatment of cancer. The institute focuses mainly on the treatment of solid tumours, namely breast cancer and colorectal cancer. Patients are either hospitalized during treatment, or receive treatment at the outpatient clinic which is less expensive and also has psychological benefits for the patient. The ratio between outpatients and inpatients receiving chemotherapy is approximately 3:2.
Administering the incorrect dosage of cytostatic agents can endanger the patient. Handling them also presents a potential safety hazard for hospital staff. In order to improve the quality and safety of cytostatic preparation for the benefit of both patients and hospital staff, the Pharmacy Department at MMCI designed and implemented a system that recorded who, where, when and how an individual was exposed to cytostatics. Furthermore, pharmacy staff wanted to introduce active support software that would help them during the whole process, thus reducing the possibility of error. The outpatient clinic was also included in this project so that the administration of cytostatics could be recorded and supported there too.
Although there are several ways to monitor the preparation and administration of cytostatic drugs, radio-frequency identification (RFID) was chosen because it appeared to offer greater advantages than other systems, i.e. various bar code systems.
Prior to the introduction of RFID technology, there were several steps in the preparation and administration of cytostatics during which an error could potentially have occurred. However, because the pharmacy at MMCI has a quality control system in place, and is regularly inspected and audited following EN ISO 9001:2008, no significant errors have ever occurred. Other safety and quality control mechanisms included personnel watching each other during drug preparation, and strict adherence to standard operation procedures. The possibility of a patient receiving a drug intended for another patient was excluded. However, the person preparing the infusion could accidentally take the necessary volume twice and unknowingly double the dose. It was not possible to identify such an error prior to the introduction of RFID. Furthermore, in some cases, it was also not possible to track the drug batch number during the process; this information is important with respect to unexpected adverse reactions.
As the patients or their relatives had to carry the prescription to the pharmacy in person, and sometimes did not want other people to know they were undergoing chemotherapy, they often folded the prescription and put it away. In some cases, they would forget to give the prescription to the pharmacy resulting in delayed treatment.
Since cytostatic drugs have limited stability, the date of first use was recorded on the vial. However, if the incorrect date was written on the vial, or the date became smudged and illegible, there was a risk that a drug of compromised quality may be administered to a patient. Furthermore, access of personnel to the drug preparation room was recorded in written form. Looking for particular entry in the records or counting annual sums for individuals was difficult. Further, erroneous entries were difficult to identify.
RFID technology is based on the communication between a unique carrier of information, i.e. a RFID tag, and a suitable reader. Widely used for identification and tracking purposes in industry, warehouses and supermarkets, this technology has recently found its use in health care [1-3]. A report prepared by RAND in 2009 [4] for the European Commission described seven cases of the use of RFID technology within the healthcare setting. In one case, the project fundingfailed completely. In two other cases, RFID was replaced by another technology for financial reasons. In both cases, RFID was used in hospital pharmacies—one of which was at the University Hospital in Geneva, Switzerland—to control the preparation and administration of drugs [5]. The RAND report praised RFID technology for its ability to increase the quality of health care, however, the report highlighted its high cost as compared with other technologies such as bar coding. RFID technology has also been used in a hospital pharmacy in Akita University Hospital, Japan. It is used in two other hospitals in the Czech Republic for the management of laundry and medical devices. Another hospital in the Czech Republic has announced its plan to introduce RFID identification in the management of blood and blood products.
Whether to employ bar codes or RFID technology was discussed at the beginning of the project at MMCI. RFID was ultimately chosen because the use of radio frequency provides better reliability than systems based on visible light. Moreover, an RFID tag is not as prone to incidental damage as a bar code which can become smudged or may be printed illegibly. Additionally, RFID tags can be placed on vials already possessing a bar code without the risk of having two different bar-coding systems on one vial. Drug manufacturers put bar codes on their labels; however, these are batch-unique, not vial-unique and this was not the case at the start of our project. Increased precision in drug labelling also allows more information to be stored.
In the course of the project, tags of other standards such as I-CODE and other working frequencies were tested. However, staff at MMCI chose passive RFID tags, ISO standard 15693, frequency 13.56 MHz. These cannot be used at distances greater than 50 cm. The proposal that evidence of staff entry into the preparation room could be tracked by finger rings with RFID tags and recorded by a walk-through frame with RFID reader working with UHF (800–900 MHz) frequency was abandoned. The system in use at MMCI may require more input from staff; however, it is clear whether personnel are entering or leaving the room, or simply checking whether the reader is functional. Staff can clearly see if their entry was recorded correctly, or who is inside the drug preparation room without having to go and look.
The pharmacy at MMCI uses RFID tags in two different ways: adhesive labels for vials and infusion bags (on which the RFID printer prints further information), and identification cards for pharmacists, nurses, and patients.
Although there is evidence [6] to suggest that interference between the tag and the infusion bag is possible due to the conductive nature of the infusion medium in the bag, we have never experienced this. We have also never encountered any problems with interference between RFID tags and medical equipment such as infusion pumps. Such interferences are known with frequencies other than 13.56 MHz [7]. In Japan, the shortest distance permitted between a 13.56 MHz tag and medical equipment is 22 cm; however, testing has shown that the risk of interference is significant in high-output antennas only, and these are rarely used [8].
Cost is the main disadvantage of the RFID system. Although initial costs are comparable to bar code systems, running costs are higher. An RFID tag costs approximately Euros 0.25 which is more expensive than a bar code label (Euros 0.05). Because of inherent difference between these two systems, RFID tags will never be cheaper than bar code. Our determination to continue with the RFID system depends on the finances of both the pharmacy and the hospital. However, if necessary, the bar code system could easily be reinstated. The change could be complete or partial, e.g. RFID tags could be used to label vials but infusion bags could be labelled with a bar code, thus saving money but retaining many of the advantages of RFID.
Three different information systems are involved in the preparation and administration of cytostatics at MMCI:
These three information systems exchange and store information and are also available as test versions, which are used for training purposes and for the development of new functionalities.
The whole system produces various data, as most operations are recorded to some extent. This enables retrospective control and also means the individual responsible for performing a particular step, and details regarding and how and when a procedure was undertaken, to be traced. These data can be further processed and analyzed and the results used to improve the process of preparation and administration of cytostatics.
On entry to the drug preparation room, staff identify themselves with their personal RFID ID card. In this way, the identity of personnel who prepared cytostatic drugs is recorded. Recorded data are exported monthly and stored in defined folders where they may be accessed for internal and external audits. The number of entries as well as the total length of stay in the preparation room is recorded. The former meets the requirements of law; the latter is more quantitative and may provide insight into the incidence of any occupational disease. Another important quantitative value is the number of drug preparations per person. This shows whether an individual was directly involved in the drug preparation process or had simply entered the room. Data for both number of entries and number of preparations for 2011 is shown in Figure 1.
*Figure 1 pending to upload.
The isolators are equipped with RFID readers and touch screens, see photograph below, the computers themselves being outside the preparation room allow easier access. During drug preparation, the user reads the tag from the infusion bag and checks the data on the screen against the information printed on the label. Then, as individual vials are used, the user reads them thus deducting the volume that is needed to finish the preparation. The system remembers when a particular vial was first used thereby preventing the use of expired material.
The system allows for repeated preparation in case the infusion bag is damaged during or after preparation. If the infusion bag is not administered, it can be used for another patient since the amount of drug in the bag is known. Any material necessary for the preparation is defined in the system and can easily be charged to a particular ward. In case of clinical trials, invoice for drugs and/or preparation is done automatically.
Figure 2 shows the time of day at which drug preparation was most frequently performed in 2011. During the day, the amount of work is not divided evenly between particular shifts. Most drug preparations are processed in the morning. This is because prescriptions for inpatients, whose treatment protocols cover several days, arrive in the pharmacy first thing in the morning. Furthermore, outpatients usually arrive for treatment at around 9 a.m. Most outpatients like their infusions to be prepared in a very short timeframe, flooding both the pharmacy and the outpatient clinic with their requirements. An unwritten agreement between the pharmacy and the outpatient clinic states that patients should wait for their medication for an average of one hour (including the 15-minute recall period reserved for the physician).
*Figure 2 pending to upload.
Since the project was implemented in October 2009, there have been no recorded incidences of erroneous preparation or administration of cytostatic drugs. Within the Czech Republic, MMCI is the only hospital that employs RFID technology in the preparation and administration of cytostatics, and is an example of a multidisciplinary solution tailored to the needs of the hospital. However, the general principle is robust enough to allow for implementation in other hospitals. The goal, i.e. the reduction of the human factor in the process of preparation and administration of cytostatics, was fulfilled.
From 2006 to 2009, the system was co-financed by Czech Ministry of Education, Youth and Sports (grant 2C06024). Currently, however, the costs are covered by MMCI, and form a standard part of the hospital budget.
Roman Goněc, MSc
Sarka Kozakova, PharmD, MBA
Pharmacy
Masaryk Memorial Cancer Institute
7 Zluty kopec
CZ-65653 Brno, Czech Republic
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