A NMIS can try to integrate radiopharmaceutical management functions, such as radiopharmaceutical preparation and dispensing. But the complexity of comprehensive radiopharmacy management is large enough to require an exclusive software application, that is, a RPIS. It is necessary to manage a great deal of processes and tasks, namely, management of orders and stocks of radipharmaceuticals, cold kits and disposable materials, elutions and disposal of generators, labelling of cold kits and autologous radiopharmaceuticals, quality controls, doses dispensing, management of radioactive waste, etc. The correct management of all those data make possible a correct traceability of all radiopharmaceutical products and their waste, which is of utmost importance.
Our RPIS (Radiolab) fulfils all these functions in a quite flexible way, that is, easy to adapt to the needs of any radiopharmacy. Because, let’s face it, although all radiopharmacies perform basically the same processes, the rate and extent of interpretation and adoption of international directives, such as cGRPP (Elsinga et al. 2010), varies among each country, and may introduce changes, provided the general scope and limits of each directive are maintained. Besides, even within the same country we can find differences in this respect. For instance, in our country NMDs are supplied with radiopharmaceuticals from various ways. One way is from their own hospital radiopharmacy, which generally is integrated into the NMD and whose staff is also from the same NMD. Another way is from an external or centralized radiopharmacy, which generally supplies doses of radiopharmaceuticals to several NMDs of different hospitals. And other ways can be some hybrid mix of the two above. For instance, in our case the radiopharmacy is inside our NMD, but the staff is from an external company, which prepare and supply the doses of all radiopharmaceuticals, and whose work is conducted under the supervision of a radiopharmacy specialist, who is staff of the NMD.
A hospital radiopharmacy must have a radiopharmacy specialist responsible, among other things, for the assurance of traceability. So, when I had to assume this responsibility, I found out that our RIS does not include essential data, such as the activity of the radiopharmaceutical administered to the patient for diagnosis or treatment, nor the batch of the radiopharmaceutical. Therefore, our RIS does not have any traceability capability. I also found that I had to deal with a radiopharmacy information system developed by the external company that supplies us with the radiopharmaceuticals. And it turned out that that software has deficiencies, which seriously hindered correct traceability. Since that software does not communicate in any way with our RIS, the introduction of radiopharmaceutical prescriptions must be performed manually, that is, by means of the keyboard with the subsequent inevitable typos, which seriously hindered the correct traceability.
Facing with this problem, I developed and implemented our own RPIS (Radiolab). And of course, it would be ideal if it were possible the data transfer between our RIS and our RPIS through the standards of HL7 (Health Level Seven International. https://www.hl7.org).
But in this respect, I encountered two impediments. Firstly, implementing HL7 is not possible unilaterally. Even if our RPIS was able to send and receive HL7 messages, it is necessary assistance of the IT department of the hospital with the intranet server. And secondly, the other software application, the RIS in this case, must be able as well to send and receive HL7 messages. But when I tried to contact with the technical support service of the hospital and with the developer of the RIS, in both cases I hit a brick wall, because I did not find any interest in collaboration by either of the two parties. Only one thing was for sure, RIS does not contemplate, nor does it seem that it intends to contemplate, the possibility of recording information regarding the activity and the batch of the radiopharmaceutical administered. So, it is impossible to have traceability from this RIS. However, taking advantage of the fact that this RIS can issue an Excel file with data of the daily prescriptions, I designed in our RPIS the capacity of importing the necessary data from the RIS via an intermediate XLS or XLSX file. With those data, the RPIS issues the daily radiopharmacy worksheet with the scheduled prescriptions. Since the activity of the dose is not contemplated by the RIS, our RPIS assigns an activity to each radiopharmaceutical based on the radiopharmaceutical, the study or treatment, and the patient's age.
Our RPIS is compliant with the standards of good practice established in the guidelines on current good radiopharmacy practice (cGRPP) (Elsinga et al. 2010). It has user-friendly and intuitive interfaces which make it very easy to use (Figs. 4 and 5). And it can work both as a single-user desktop application, and as a multi-user network system, sharing and updating data without overwriting each other’s work.
After installing and before starting to work with this RPIS, it must be customized for each radiopharmacy, entering into the database their data: activimeters, radioactive calibration sources, mobile and stationary phases for chromatography, equipment, materials, staff, catalogue, radionuclides, radioactive products, cold kits, suppliers, protocols, etc. After all that has been done, the software is customized and ready to work.
Logically, for as long as we have been using this RPIS its database has been growing. For this reason, it was necessary to foresee a possible need for migrating the MS Access database to SQL Server. But eventually it seems that this is not necessary, and we are going to see why.
According the specifications of MS Access, their databases can support up to 255 concurrent users and it supports up to 2 GB in size (https://support.microsoft.com/en-us/office/access-specifications-0cf3c66f-9cf2-4e32-9568-98c1025bb47c).
Regarding the number of concurrent users, if MS Access databases can support up to 255 concurrent users, it means that there will be no problem with 50 concurrent users, that is, five times less than the stated limit. And the staff number of a hospital radiopharmacy, and even of a NMD, is below that figure. And regarding the size of the back-end of the database, the initial size of the just installed back-end file of Radiolab is 2 MB. It was predicted that with the daily work routine of our hospital radiopharmacy, the database would grow around 6 MB per year (Gómez-Perales 2013). Ten years later, the size of our database file was 59 MB. Therefore, that prediction was quite accurate. Therefore, it would take more than 165 years for the database file reaches a size of 1 GB, which is half the size supported by MS Access.
A standard radiopharmacy can generate thousands of printed papers a year (radiochemical quality controls, reports, etc.). A total of 23,144 radiochromatograms have been performed in our radiopharmacy between January 2011 and December 2021 (about 2,100 per year), which represents 46 file cabinets of 500 pages (about 4 file cabinets per year). But with our RPIS there is no need to print the reports of radiochemical purity control or radiochromatograms, since they are stored in digital format (pdf) and they can be located easily from the RPIS at any time. In addition, the validation signature of the control by the radiopharmacy specialists can be done digitally through their user password. Therefore, this software is eco-friendly, because not being necessary to print it saves paper, ink, storage space and time.
Because of the expiration dates of cold kits and the continuous radioactive decay of radiopharmaceuticals, it is critical to properly control their stock. And this is also easily performed with the various alerts of this RPIS.
A very useful functionality of this RPIS is that all the reports and system data can be converted into common formats (pdf, word, excel), with all the advantages that this entails.
This RPIS can be connected to printers and barcode readers, as the labels it issues contain barcodes. But it cannot be connected to other devices, such as dose calibrators, radio thin layer chromatography scanners or dose dispensers or injectors.
One example of how our RPIS has incorporated new functionalities according to new requirements, is the problem generates form shortages of 99mTc generators supply, which occasionally happens when there is some problem of production or some problem with the transport. Recently has occurred an important shortage in Europe over two weeks, when one of the world's largest medical isotope manufacturers in the Netherlands had shut down due to a water leak in its cooling system. In these cases of shortage of 99mTc it is necessary to optimize the use of the elutions of the generators for the labelling of the cold kits. And to do that, two new functionalities have been added to our RPIS: the instant prediction of the theoretical activity available on every generator in the Generators module (Fig. 6), and an assistant for labelling of cold kits with 99mTc in the Labelling module (Fig. 7).
Software validation in hospital pharmacy is generally not formalized. But just recently it has been published a consensual tool for validating radiopharmacy software (Léa et al. 2020), proposed by a panel of experts of the French Society of Radiopharmacy (SoFRa) and following the Delphi method (McPherson et al. 2018). Therefore, to improve our RPIS it has been followed some of the specific requirements of this publication.
A European conformity (CE) marking on any prescription support software is imposed. And, in this regard, it has been published that software in radiopharmacy will eventually acquire medical device status (Blondeel-Gomes et al. 2020). But for now, a RPIS is not a medical software, because it does not comply with any of the conditions mentioned in the European regulation in this regard. A medical software must comply with the definition of a medical device and is considered as such when it fulfils one or more of the functions specified in the Regulation (EU) 2017/745 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745). The only software that can carry the CE marking are those that fall into the category of medical device. Software that is not a medical software cannot and must not bear the CE marking.