Department of Clinical Pharmacy
Department of Clinical Pharmacy
Department of Clinical Pharmacy
Information Systems Direction
39 rue Camille Desmoulins
94805 Villejuif Cedex – France
T:+33 1 42114807
F:+33 1 42115277
The Institut Gustave-Roussy (IGR), on the outskirts of Paris, is the European leader in providing cancer treatment. It has approximately 400 beds and employs 2,400 medical professionals. Each year the IGR sees 11,500 new cases of cancer, and approximately 55,000 patients are treated at any time.
Doctors have password-protected access to patients’ computerised files via the hospital network and the patient management software, SIMBAD® (Système d’Information Mèdicale et Bureautique Appliquée au Dossier patient – medical information software applied to each patient’s file). This database is one of the largest in the world, with more than 410,000 files online.
The Department of Clinical Pharmacy (DCP) employs 70 professionals and, among its many responsibilities, manufactures 25,000 injectable conventional chemotherapy formulations (not including those needed for clinical trials) each year. These are prescribed via the SIMBAD(®) chemotherapy prescription module and transferred to the Production Functional Unit (FU) for pharmaceutical validation (dosage, solvent nature and volume, cytotoxic drug interactions, and so on) and manufacture according to the administration schedule. Each preparation corresponds to a sole batch number.
The PFU has been involved in a quality assurance programme – the ISO 9001 (2000) certification process – since November 2000. This is not only due to the considerable number of therapeutic agents manufactured each year and their highly toxic nature, but also because of the French government’s wishes to make cancer a national health priority through the five-year “Plan Cancer 2001–2005”.(1)
This quality assurance programme not only consists of standard operating procedures (SOPs) and staff training, but also includes analytical postproduction quality control involving the use of high-performance thin-layer chromatography (HPTLC) to assess each chemotherapy preparation’s identity, purity and concentration.(2–4) This analytical platform is part of the Quality Assurance and Research FU and is also located in the DCP, which facilitates communication with the PFU.
The integrated chemotherapy tracking programme
Since 1999, the DCP Tracking and Medical Devices PFU has been equipped with tracking software, SIMBAD-TRACE(®), interfaced with SIMBAD(®) patients’ records, allowing effective follow-up of approximately 19,000 implantable medical devices and blood-derived products each year. This has proved very effective, with a tracking score of approximately 100%.(5)
As Figure 1 shows, once the chemotherapy formulations have been dispensed to the clinical units, it is impossible to know if the preparation has been administered to the right patient, and whether any problems occurred during administration. Considering the cytotoxicity of these drugs, and even though tracking is not compulsory under the French Health Code of Regulations, we decided a tracking process would be very useful. The desired tracking process we are aiming for is described in Figure 2. It uses data implementation using SIMBAD-TRACE at each step. This tracking process uses two barcodes – one for the preparation batch number (BC1) and one for the patient’s identification number (BC2).
Each fabrication sheet for a chemotherapy preparation prescribed for a particular patient will contain both barcodes that will be indefinitely associated (ie, a patient is associated with a treatment, and vice versa). The association between BC1 and BC2 also opens a tracking file in SIMBAD-TRACE. At the beginning of the manufacturing process the operator will read BC1 with an appropriate barcode reader, and will do the same at the end of the manufacturing process to indicate that the preparation was carried out without any problem. BC1 will be read again when dispensing the chemotherapy.
In the clinical units, BC1 and BC2 on the chemotherapy label and BC2 on the patient’s wrist will be read by the nursing staff before administration, to ensure that it is the appropriate chemotherapy. If there is a problem at this step, error messages may appear on the barcode reader, such as “Administration date/time expired – do not inject” or “Wrong patient – do not inject”.
Once the preparation has been administered, the nursing staff will again read both barcodes, which lets the system know that administration is complete and that the track file can be closed; messages may be entered at this stage, such as “Adverse event during administration”.
This project, involving IGR Information Systems Direction (ISD), is a major one for the institution and required a prelaunch testing phase. The first step of the testing programme was carried out in five clinical units using handwritten tracking documents, one copy being kept in the PFU, and a second sent with the chemotherapy to the clinical unit. On receiving the preparations, the nurses were supposed to check the match between the preparations and the tracking document and send the latter back to the PFU with a signature. The SIMBAD-TRACE database could be implemented once both documents were put together. In this way, a complete tracking file could be generated for each patient.
This system has been in practice since June 2001, and during the first six-month period (June–December 2001) 3,378 preparations were manufactured for the five clinical units and 3,310 were tracked. Among these, 3,183 (96.2 %) completed the tracking process (see Table 1). Of the 127 chemotherapy formulations that did not complete the tracking process, 61 tracking sheets were not returned to the PFU and 66 tracking sheets were returned but had not been signed by the nursing staff.
The tests are still being carried out, and a barcode printer that can print both codes on the labels is being evaluated. According to the joint ISD–DCP operational planning, the fully computerised tracking process is due to be in place by May 2002. Patients will need to be informed as to why they will need to wear a barcode on their wrist as, although such tagging is a common procedure in other countries, it is not common in France except for newborns.
Chemotherapy tracking has been well accepted by the medical and nursing staff and is considered to be extra security for the administration of these products. It is a pioneering process as it affects patient care and security and should reduce legal issues that arise from incorrect administration of these agents. It is also an improvement in patient care as it contributes to the currently ongoing accreditation procedure.(6)
- Circulaire DHOS-0-F2/DGS/DSS-1A/2000 no. 603 du 13 Décembre 2000.
- Sethi PD. High performance thin-layer chromatography. Quantitative analysis of pharmaceutical formulations. Anal Chem 1994;66:27A-37A.
- Treiber LR. Utility of thin-layer chromatography as an analytical tool. J Chromatogr Sci 1986;24:200-24.
- Xiang Y, Wang B. The principles of quantification in scanning thin-layer chromatography. Chinese J Univ Chem 1993;8:34-8.
- Bourget P, Barath V, Guntz JP, Bourgain JL, Demirdjian S, Rongeat S. Tracabilité pharmaceutique intégrée au dossier patient. Développement d’une application informatique hospitalière. Pathol Biol 2001;49:624-33
- Ordonnance no. 96-346 du 24 Avril 1996 portant réforme de l’hospitalisation publique et privée. J Officiel République Française 1996;98:6324.
Federation of European Cancer Societies