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Abstract: |
Introduction
The management of people with cancer is complex and hazardous. Chemotherapy administration is one of the most risky activities of modern medicine, because many of the antineoplastic agents have a narrow therapeutic index, and the consequences of, and error with, these drugs can be devastating. Many chemotherapy drugs have safety limits that cannot be exceeded. Additionally, in cancer chemotherapy, the dosage, and even the route of administration, have to be taken into account, because they may vary as a function of the tumour type and stage of disease.
Clinical oncology involves many interconnected care processes provided by several medical specialties, including medical oncology, radiotherapy, surgical oncology, and pathology. Other healthcare professionals, i.e. oncology nurses, and pharmacists, are involved in diagnostic and therapeutic decisions, see Figure 1.
*Figure 1 pending to upload.
Strategies to reduce medication errors and improve the quality and efficiency of cancer pharmacotherapy care have been suggested by several organizations. These include the implementation of information technology, particularly computerized physician order entry (CPOE) in hospitals and health systems as a consistent recommendation.
To achieve the best outcomes, it is essential to use information technologies to coordinate and integrate all the activities related to cancer care. Examples of electronic data generated fering needs and who work in different functional scenarios, and manage large amounts of online data. Every thing must be coordinated and work simultaneously, with enough fluency that the tool does not become an obstacle within the clinical process. In this way, reliable, safe and reproducible data can be maintained. For all these reasons, software that integrates the whole clinical process of a cancer patient, from diagnosis to death or recovery, remission, or death is difficult to find.
The main objective of the OncoBASS (OBss) project was to develop, implement and maintain an integral oncology patient information system (IOPIS) for use by cancer-care providers, and to amalgamate all the information pertaining to individual cancer patients, from diagnosis to the end of the treatment process. We present five-year results from inception of OBss in a general hospital.
Materials and methods
Clinicians, pharmacists, nurses, technicians and computer programmers worked in conjunction to develop and implement OBss as an IOPIS.
The functional philosophy of OBss as an IOPIS was based on three basic principles: (1) it should be user-friendly, requiring little, if any, training for clinicians; (2) it should allow clinical data to be updated while attending the patient on a clinical visit, but at no extra time cost to the patient or clinician; and (3) it should give as many (functional) rewards as possible, adding value to its implementation.
Four types of users were defined: (1) clinicians (oncologists, haematologists, paediatricians, and other clinicians responsible for cancer care patients); (2) pharmacists; (3) chemotherapy preparation personnel (technicians); and (4) nurses (responsible for chemotherapy administration). Each role is assigned a specific area within the system, with different functions and utilities. This prevents unauthorized actions by specific users. All the updated information is available to all users for consultation. A colour code was defined for each step in the process, to make it visible at a glance.
Clinician
The clinician is responsible for registering diagnosis, stage, surgery and biological markers. They are also responsible for updating clinical status, evaluating and registering response to treatment, and designing or incorporating pre-designed therapeutical strategies.
Some specific considerations about the role of clinicians, and clinical management within the entire process, are presented below.
Tumour type
Once data on personal medical history and symptoms have been added, clinicians must select the type of tumour, e.g. solid tumour, leukaemia or lymphoma. This selection takes the clinician to different functionalities for each type of tumour. Clinical, pathological, and surgical information necessary for each tumour type is presented to the clinician. The software was designed to filter data to be shown on the screen depending on the tumour selected. The information is sufficiently dynamic to allow the clinician to work only within the parameters needed to manage one specific type of tumour.
Original data from other software systems can be linked to OBss and updated. The estimated median time needed for introducing all the clinical information for a new patient is about seven minutes.
Tumour response
During the clinical process, it is possible to register the assessment of tumour response according to ‘response evaluation criteria in solid tumours’. It allows the evaluation response for each tumour, stage, or histology during the clinical visit, and can be seen in terms of ‘overall survival’ or ‘disease-free survival’.
Toxicities
It is also possible to register toxicities according to National Cancer Institute Common Toxicity Criteria during the clinical evaluation of the patient.
Integrated software
The software was designed to connect with other electronic hospital patient records within the hospital information system, to allow the management of integrated information about admission and discharge of patients to be undertaken. Additionally, other clinical software, i.e. laboratory software, pharmacy software, has been integrated, providing essential continuously updated online information, see Figure 2.
*Figure 2 pending to upload.
Treatment plan
Finally, the clinician can select, prescribe, and make the necessary adjustments to chemotherapy treatment for each patient through the drug-ordering software developed. This takes into account the specific clinical conditions the patient has at the time the prescription is dispensed, e.g. renal, hepatic or blood disorders, and any other circumstances that might modify the treatment plan, e.g. drug allergies, drug–drug and drug–disease interactions.
Pharmacist
The pharmacist is responsible for ensuring that chemotherapy is used rationally and safely. They work within a multidisciplinary team, and are involved in the following: developing treatment strategies; definition and validation; design of the CPOE system; follow up of treatment plans; definition of alert system for drug allergies; drug–drug and drug–disease interactions; and drug dosing in special clinical conditions. Pharmacist responsibilities are discussed below.
Policies and procedures
Pharmacists are responsible for defining policies and procedures for conditioning the drug in a solution mix to be ready for use in the safety area by technicians. They must also establish and validate cytotoxic compounding procedures according to good manufacturing practices for reconstituting, diluting, mixing, packaging, labelling, and delivering antineoplastic agents in the most appropriate conditions to prevent errors.
Policies and procedures have already been developed to manage the quality-assurance programme of the mixed drug (gravimetric control) and the whole process of traceability for all products used.
Chemotherapy order validation
Pharmacists are responsible for chemotherapy order validation. They must take into account established alerts for allergies, interactions and doses according to clinical condition, and defined alerts for stability of drugs in solution and storage conditions. Additionally, the pharmacist must ensure that the schedule is maintained as planned and contribute to managing the circumstances for failure to maintain it, see Figure 3.
*Figure 3 pending to upload.
Adjusting drug doses and selecting brand-name drugs
At this point, pharmacists can adjust drug doses under some security limits previously defined by consensus (2.5%), and can select the most suitable brand-name drug for compounding that particular mix.
Monitoring plans
As part of the team, the pharmacist is responsible for the error-prevention programme and established monitoring plans for the whole process.
Technicians
Once the pharmacist validates the chemotherapy cycle, technicians can begin to compound the cytotoxic drug according to procedures of good manufacturing practices established. A procedure to trace all the products used to prepare the admixture has been established: labels are printed for each different vial of drug and for each diluent needed in the preparation, so that the traceability of the whole compounding process can be assured.
Technicians select the vial of drug and diluents proposed by the software according to some pre-established parameters of expiration, efficiency, and the way that every residual amount of cytotoxic drug is used.
The solution bag with the drug mix is weighted for quality control, the software sends an alert and does not permit continuation if there is any anomaly in the quality parameters previously established. All the data resulting from this process are registered for any later processing, see Figure 4.
*Figure 4 pending to upload.
Compounded antineoplastic medications are labelled immediately after preparation. Labels are automatically printed. The following information is automatically generated and included on the label: patient’s name, location, generic drug name, dose, route of administration, storage specifications, other specific information for a particular admixture.
The naming of the patient for whom the admixture has been prepared, and details of hospital location, can prevent errors being made when delivering the chemotherapy to the hospital facilities where the patient is waiting.
The ready-to-administer dosage is dispensed immediately after preparation, to assure minimum waiting time for the patient to be attended. They are dispensed according to the internal established procedures for maintaining appropriate storage conditions and preventing errors.
Nurses
When a preparation is completed, a nurse is notified through the colour code established for every step in the process, and may begin to prepare the patient, i.e. beginning the infusion of IV premedication.
The software allows the nurse to notify the pharmacist if the patient is ready to receive chemotherapy in cases of preprescribed cycles, i.e. cycles prescribed days before the date of administration, and preventing wasted preparations in advance should the patient miss the appointment.
In the process of delivering chemotherapy, nurses can check the software for information on starting and finishing times, including every single drug that is prescribed in any step, e.g. hydration, and any other concomitant drug to chemotherapy, see Figure 5.
*Figure 5 pending to upload.
To follow up the implementation of the OBss project, the multidisciplinary team defined users, number of patients, department responsible for the prescription of a patient, and results from activity in the safety area, e.g. number of admixtures prepared to deliver antineoplastic drugs ready to use, as quality outcomes to be evaluated.
Results and discussion
The OBss software, designed as an IOPIS, was implemented in January 2007, and has been continuously updated over the past five years.
A multidisciplinary team composed of physicians, pharmacists, nurses, technicians and computer programmers was created to follow up the implementation of the OBss project. This team has been working together during that time to review, modify, and implement new functionalities in response to different needs requested.
The usage rate among clinicians for OBss was 100% in January 2012, and integration with other health-information technologies, e.g. laboratory, radiology and pharmacy, available in the hospital has been completed.
Users
The OBss software is used by over 157 different healthcare providers: 23 oncologists, 13 haematologists, 18 pharmacists, 24 technicians, and 79 nurses, see Figure 6.
*Figure 6 pending to upload.
In the past five years, the number of users has progressively increased. The group of cancer-care providers that has grown the most is nurses, see Figure 7.
*Figure 7 pending to upload.
Chemotherapy treatments
OBss has been used for about 98% of all chemotherapy treatments, including those that do not have to be conditioned in a safety area, e.g. antineoplastics for oral administration.
One-hundred per cent of diagnostic and clinical data are registered on the system, including essential data required for prescribing specific drugs, e.g. human epidermal growth factor receptor 2 status. One-hundred per cent of biochemical data necessary to prescribe new chemotherapy cycle are also integrated online at the point of prescription.
Admixtures
Admixtures are used in over 4,031 patients, with 46,612 preparations delivered: oncology patients (40,944 units; 88%); haematology patients (5,688 admixtures; 12%).
Patients
During the past five years, 4,031 patients have been treated, 3,960 (98%) were oncology patients and 71 (2%) were haematology patients.
Attendance figures for oncology and haematology patients between 2007 and 2012 are presented in Figures 8 and 9.
*Figures 8 and 9 pending to upload.
Conclusion
The OBss project has achieved a 100% clinician usage rate, and has become a safe, fully-automated, integrated tool. Development is ongoing to support the delivery of best practices, improve quality of care and patient safety, and use data to improve accountability and enable better system planning and policymaking.
Authors
Ana Rosa Rubio Salvador, BPharm
Specialist in Hospital Pharmacy and Oncology Pharmacy
(Board Certified Oncology Pharmacist)
Department of Pharmacy
José Manuel Martínez Sesmero, BPharm, PhD
Specialist in Hospital Pharmacy
Department of Pharmacy
Izaskun Alonso Aldama, MD
Specialist in Haematology
Department of Haematology
Concepción Cornejo Castro, BN
Department of Oncology
Víctor Arellano de la Vega, BSc(Eng)
Department of Information Technology
Fernando José Rodríguez García, BSc(Eng)
Toledo-Soft
Miguel Angel Cruz Mora, MD
Specialist in Oncology
Chief of Department of Oncology
Paloma Moya Gómez, BPharm
Specialist in Hospital Pharmacy
Chief of Department of Pharmacy
José Ignacio Chacón López-Muñiz, MD, PhD
Specialist in Oncology
Department of Oncology
Complejo Hospitalario de Toledo
30 Avda Barber,
ES-45004 Toledo, Spain
