A Smart RFID Device for Drugs Administration

In this work a device is described that can be used in hospitals to lower the risk of Adverse Drug Events (ADE) due to the incorrect link between patients and drugs. The device is a container that can be handled by the patient himself of by the caregivers. It is provided with an internal lock that prevents any openings when there is a mismatch

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Introduction
In this paper we will show the design of a device that is intended as a solution for reducing the number of Adverse Drug Events (ADEs) related to drugs administration to patients. e device is a container that incorporates an RFID (Radio Frequency Identi cation) reader in order to perform a check on patient's identity and to allow the administration of medications only to the right patient.
Many studies can be found in literature on this subject, assessing the problem of human factors in medication administration errors. Part of them are based on data coming from incident-reporting, others apply proactive analysis tools such as FMEA (Failure Modes and E ects Analysis) or HTA (Hierarchical Task Analysis). e National Coordinating Council for Medication Error Reporting and Prevention de nes a medication error as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labelling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."[1] Adverse Drug Events (ADEs) are de ned as injuries resulting from the use of a drug. Under this de nition, ADEs include damages caused by the drug (adverse drug reactions and overdoses) and damages from the use of the drug (including dose reductions and discontinuations of medication therapy) [2]. According to [3,4], the 28% of all the ADEs come from the medication administration step.
Technological solutions, such as radio frequency tagging has been widely suggested as a solution to the problem of the wrong identi cation of patients and of the incorrect association between patient and medications.
In this work we are focusing on the error in the administration step, de ned as the change between what the physician's prescription and the actual medication administered to the patient. Medication errors that originate from mistakes during prescribing can be signi cantly reduced by using CPOE (Computerized Physician Order Entry) so ware, thereby solving problems related to incomplete orders, bad calligraphy, misunderstandings in abbreviations, incompatible drugs etc. Nevertheless, CPOE use itself cannot prevent that the medication that is actually given to the patient is di erent from what the doctor prescribed. We can notice a lack in patient's safety in the last step of the whole therapeutic process: the administration step.
Some authors claim that use of Barcode Point-of-Care Technology (BPOC) to reduce medication errors is a patient-safety approach that hospitals can implement within a short time frame and obtain immediate bene ts [5]. Some claim that the integration of bar codes and radio frequency identi cation tags are viewed as critical in achieving e ective and safe patient care although systems using these capabilities must be carefully planned to achieve optimal outcomes [6][7][8].

Materials and Methods
We propose a custom device based on passive RFID (Radio Frequency Identi cation) technology, able to check the correct relation between patient and drug containers and to trace every step of the drugs administration process.
Many di erent technologies are gathered under the acronym RFID, each optimized for some particular tasks. Factories can take advantage of RFID for managing and optimizing their supply-chains, inspecting the content of a pack without actually opening it. Stores use RFID as a substitute to barcode labels because it works even without any lines of sight. Many o ces and car parks use some RFID based solutions to allow the access for authorized people only. Recently, RFID technology has been used to implement fast and secure payment services, using disposable wristbands that stop functioning once removed from the wrist and cannot be put back together.
Nowadays, also the healthcare world is rapidly approaching to RFID, both for increasing the automation level and for reducing the overall clinical risk for patients. Following, are few examples.
Passive RFID tags are used on surgical tools to read the composition of a sterile surgical kit prior to start the operation.
RFID wristbands can be worn by patients for reducing identi cation errors and for tracking their therapies or treatments. If the wristbands are equipped with active RFID tags, the patient position inside the hospital can also be easily monitored and tracked: this is particularly useful to caregivers for managing children or patients with reduced cognitive functions.
Blood transfusion errors can be heavily reduced by using RFID in the blood supply chain: patients and bags of blood can be tagged to make sure every patient receives the right blood product.
Similarly, the pharmaceutical supply chain could take advantage of RFID technology both for replacing barcodes and for implementing single-dose delivery automated systems [9].
An RFID system is typically composed by at least two components: tag and reader. In the simplest functioning mode, when the reader "wakes up" the tag (forward link), this responds by transmitting its own unique ID code (reverse link). If the tag is passive, i.e. is not provided with a battery power, the reader itself must energize the tag. e communication between the reader and the tag can hence be only initiated by the reader (Figure 1).

Results
We started the design process by spotting 28 requirements to which our device must respond (see Table 1) and generating 20 corresponding technical speci cations (see Table 2). e identi ed requirements relate to aspects of process safety as well as to procedural aspects and usability. Also a ordability is an issue, to guarantee the widest dissemination of our device in hospitals. e device, based on above requirements and technical speci cations, is a container with an electronically operated lock that opens only when the opening attempt is performed by the patient to whom the drugs are destined (or by healthcare sta ), thus dramatically reducing the chance of wrong administrations. e device integrates a custom miniaturized RFID reader operating at 13.56 MHz for the recognition of the patient and/or operator that must wear a simple and cheap passive ISO 15693 compatible wrist band. e compliancy to this standard guarantees maximum compatibility to bracelets commercially available.    As shown in gure 2, the device incorporates an internal tag that will contain information about the patient's identity and his drug therapy. is solution has been preferred to ash memories because in this way we can read/write on this "internal memory" using the onboard electronic card or a standard external RFID reader without any wired connections. Each attempt to open the device (successful or not) and each consequent alarm is logged using this internal tag as an on-board memory. e device is also provided with an USB port, but this is used just for battery recharge and for rmware maintenance.
As stated in speci cation S.5 (see Table 2), the container is provided with two LEDs, a red one and a green one, to give feedback to the user about the correct patient-drugs matching. e technical speci cation S.15 is satis ed by providing a small 16 Pharm Anal Acta ISSN: 2153-2435 PAA, an open access journal × 2 display. is is used to show the name of the patient for which the device has been prepared for, and to display the list of drugs prescribed to the patient. e rmware is also able to read the drugs inserted into the device (provided that they are tagged with RFID) and to prevent its opening if some un-prescribed drug is found inside the container, alerting the patient/operator using the on-board display (Figure 3).
A functioning stand-alone prototype device has been realized and tested. It still lacks a mechanical prototype.

Discussion
e patient himself can easily operate the presented device, since its input interface consists of a single button, to be pressed a er placing the device in proximity of the RFID wristband. It is also possible, for caregivers, to force the opening by using their own RFID badge. All these operations are logged in the internal tag and can be wirelessly sent to a central HIS (Hospital Information System).
By logging the number of granted/denied openings, the device could feed a Hospital Risk Management System, providing the risk manager with some valuable data to assess the quality of the medication service. If inserted in a CEP (Complex Event Processing) system the proposed device could signi cantly increase the patient's safety as well as the knowledge of the process by the hospital executives. e ideal usage scenario provides an interface between the device and the hospital information system and CPOE and with an automated pharmacy that provides single dose RFID-tagged medications. In this setting, the device can easily signal mistakes in the preparation before the wrong drugs can reach the patient. It will also prevent openings in this case.
Future works include improving the performance of the antenna, realizing a mechanical prototype and analysing the domestic scenario for possible use of the device at home.