Abstract
Background: Oncological therapy is based on multidimensional therapy protocols. The requirements for standardized protocols and digitation are high. These protocols are created through several complex development stages to ensure standardized recording. The process involves analyzing original publications published in international journals and extracting key content. Standardized supportive therapy is then added, and compatibility with current guidelines and quality controls is checked. Summary: The Onkopti® website is based on the WordPress content management system and provides protocols in a variety of formats, generated through the use of a relational SQL database (www.onkopti.de, www.onkopti.com, www.oncopti.com). It is continuously updated to include new therapeutic developments or changes to standard therapy. The protocols are stored in a relational database and can be exported to various application systems via a standardized XML format or other formats. The website and protocols are available in both German and English. As of January, 2025, there are over 2,700 protocols for parenteral and oral therapies for all oncological specialties. Key Messages: The digitalization of protocol selection, prescription, pharmacy preparation, hospital or practice information system documentation, billing, and prescription creation can accelerate, standardize, and streamline these processes. This optimization can significantly reduce personnel costs, resulting in cost savings, and improved quality.
Plain Language Summary
The Onkopti® website is based on a comprehensive relational database for digitized treatment plans in oncology (www.onkopti.de, www.onkopti.com, www.oncopti.com). It is continuously updated to include new therapeutic developments or changes in the standard of care for malignant diseases. Protocols are generated from the modules of the database and can be exported to various application systems in standardized XML or other formats. The website and the protocols are available in English and German. As of January, 2025, there are over 2,700 protocols for parenteral and oral therapies for all oncology specialties. Therapy is prescribed using electronic prescribing systems to ensure the highest quality standards. The use of standardized, digitized therapy protocols and an electronic prescribing system minimizes the error rate in antineoplastic therapy. The rapid and ubiquitous availability of protocols accelerates the implementation of oncology treatment guidelines. By digitizing protocol selection, prescribing, pharmacy preparation, hospital or practice information system, documentation, billing, and prescription generation, these processes can be accelerated, standardized, and streamlined. This optimization can significantly reduce personnel costs, resulting in cost savings and improved quality.
Introduction
The pharmacological treatment of malignant neoplastic diseases relies on the implementation of evidence-based treatment protocols. These protocols are multimodal. In addition to anticancer drugs, concomitant and supportive therapies are included to ensure the best possible tolerability and safety.
Online protocol, standard view, number 1920. Pola-R-CHP – Polatuzumab Vedotin 1.8/rituximab 375/cyclophosphamide 750/doxorubicin 50/prednisolone 100, diffuse large B-non-Hodgkin lymphoma, cycle 1–6 [2], see example on website: https://onkopti.de/diseases-protocols/?lang=en&view=2&pid=1920. Designation: name of the protocol from the substance names with dose information, usually in the order of application, possibly also the established protocol acronym or study name, main indication, cycle information, protocol number (PID), version number (V). Protocol acronym: abbreviations from substance names for the file name of the protocol, etc. Indication(s): disease(s), from publications, guidelines, approval; ICD-10-code. Classification of the therapy: standard, alternative, etc., according to guidelines, intensity, therapy phase and intention. Cycles: duration and number of cycles from publication. Sequences of protocols: therapy plan with different protocols, link to graphic on Onkopti® server. Risks: febrile neutropenia, neutropenia, anemia, thrombocytopenia, nausea and vomiting, and other relevant risks from publication. Therapy divided into color-coded sections: hydration, allergy prophylaxis, antiemetics, supportive therapy, antineoplastic therapy (oral, parenteral), hematopoietic growth factors, infection prophylaxis, etc. Possible changes in therapy, warnings etc. Relevant controls to be performed before and during therapy. Original indication from the study in the original publication. Author of the original publication. Origin of the protocol, study group, clinic, etc. from publication. Reference for literature used in the protocol link to PubMed and if available, directly to the original publication via Digital Object Identifier (DOI). Recommendations from medical professional societies.
Online protocol, standard view, number 1920. Pola-R-CHP – Polatuzumab Vedotin 1.8/rituximab 375/cyclophosphamide 750/doxorubicin 50/prednisolone 100, diffuse large B-non-Hodgkin lymphoma, cycle 1–6 [2], see example on website: https://onkopti.de/diseases-protocols/?lang=en&view=2&pid=1920. Designation: name of the protocol from the substance names with dose information, usually in the order of application, possibly also the established protocol acronym or study name, main indication, cycle information, protocol number (PID), version number (V). Protocol acronym: abbreviations from substance names for the file name of the protocol, etc. Indication(s): disease(s), from publications, guidelines, approval; ICD-10-code. Classification of the therapy: standard, alternative, etc., according to guidelines, intensity, therapy phase and intention. Cycles: duration and number of cycles from publication. Sequences of protocols: therapy plan with different protocols, link to graphic on Onkopti® server. Risks: febrile neutropenia, neutropenia, anemia, thrombocytopenia, nausea and vomiting, and other relevant risks from publication. Therapy divided into color-coded sections: hydration, allergy prophylaxis, antiemetics, supportive therapy, antineoplastic therapy (oral, parenteral), hematopoietic growth factors, infection prophylaxis, etc. Possible changes in therapy, warnings etc. Relevant controls to be performed before and during therapy. Original indication from the study in the original publication. Author of the original publication. Origin of the protocol, study group, clinic, etc. from publication. Reference for literature used in the protocol link to PubMed and if available, directly to the original publication via Digital Object Identifier (DOI). Recommendations from medical professional societies.
In the drug therapy of malignant diseases, several anticancer drugs are often combined to improve efficacy and are administered in specific sequences and time intervals. Combination chemotherapy is an important part of the treatment of most cancers and hematologic neoplasms. Almost all curative chemotherapy consists of combinations of several agents. Its use requires precise instructions with information on the exact composition, necessary concomitant and supportive therapies, sequence and type of application, which are recorded in treatment plans, here called treatment protocols. Scientific publications, in which the results of the conducted studies have been published, serve as a source. The assessment of whether a therapy is suitable for routine use is usually published by professional societies in the form of guidelines, such as the European Society for Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO), the German Cancer Society (DKG), the National Comprehensive Cancer Network (NCCN), and others. Complex protocols may include 4 or more agents, such as atezolizumab, bevacizumab, paclitaxel, and carboplatin in non-small cell lung cancer [1] or even 5 agents in the Pola-R-CHP protocol for diffuse large cell non-Hodgkin lymphoma [2] (see Fig. 1). Each individual substance is associated with side effects, requiring specific concomitant and supportive therapy. In addition to antineoplastic therapy, drugs for side effect prophylaxis are integrated into the protocol as essential supportive therapy. The latter Pola-R-CHP protocol includes the addition of 6 drugs. This therapy protocol is administered in several cycles at specific intervals. Different therapy protocols or variants can be combined into a comprehensive protocol.
Retrieving therapy protocols is not centralized, so each clinic, practice, or user must convert the protocols into specific prescriptions themselves or transfer them from protocol directories. This is done manually using PC keyboards with protocol forms, electronic worksheets, or electronic prescription systems. Hundreds of electronic health records (EHRs), in addition to numerous cancer-specific subsystems, including, e.g., chemotherapy treatment management systems are available [3].
In a more limited sense, the term “chemotherapy treatment management systems” refers to a digitized record database with the potential for exportation to application programs for pharmacies or EHR, and electronic medical records, as well as computerized physician order entry (CPOE). A database of this nature was identified in Sweden [4].
Much of the literature focuses on the electronic prescribing of antineoplastic therapy, yet there is a paucity of research examining the process of actual record creation [5‒7]. A review from 2022 evaluated the impact of CPOE on the prescribing process. The analysis included 19 publications that utilized 18 distinct CPOE programs [8]. A review on the management of hazardous substances in pharmacy highlighted 21 different systems [9].
There is a clear need for all oncologists to have a central location for defined standard protocols in digitized form that can be directly transferred to application programs. Onkopti®, an online database available in both German and English, meets this requirement and enables digitalization in oncology.
Onkopti® – The Database of Digitized Therapy Protocols
The digitized therapy protocol database, Onkopti® (Onkodin GmbH, Kaiserslautern, Germany), provides a professional solution for obtaining standardized protocols in XML format and other data formats for import into your own software application via the Onkopti® website (www.onkopti.de). The protocols cover all areas of drug-based antineoplastic therapy, including those for children. The database is developed in collaboration with the Fraunhofer Institute for Experimental Software Engineering (IESE) in Kaiserslautern since 2008 and has since been continuously expanded by the Onkopti® clinical team. The protocols are based on the original publications and guidelines for supportive therapy from various sources, including the German Cancer Society, Onkopedia, ESMO (European Society of Medical Oncology), NCCN (The National Comprehensive Cancer Network, USA), ASCO (American Society of Clinical Oncology), and expert commissions. The substances used in Onkopti® therapy protocols are sourced from regulatory authorities, typically the European Medicines Agency (EMA).
The protocols are typically selected in accordance with the guidelines set forth by the NCCN, ESMO, ASCO, and Onkopedia (Hematological and Oncological Societies of Germany, Austria, and Switzerland). This also applies to supportive therapy. In addition, current publications from peer-reviewed journals are taken into account, if considered highly relevant. A systematic review of the literature is conducted on a regular basis, with the journals of ESMO and ASCO being screened on a continuous basis. The guidelines are consulted within approximately 3 to 4 months. Furthermore, new drug approvals are considered, and corresponding protocols are developed. Additionally, study protocols can be created on a per-study group basis.
The protocols are therefore classified as standard or alternative. The original publications and, if available, the underlying study protocols serve as a detailed starting point. When guidelines or approvals are updated, existing protocols are checked to see whether changes or additions are necessary. Modifications are made if relevant changes result from subsequent publications or drug approvals. In such cases, new versions are published, e.g., V2.0 for changes to antineoplastic therapy and V1.1 for supportive and concomitant therapy. The protocols are standardized and consist of self-contained components that are defined in a consistent manner. These components include information on substances, diseases, application methods, literature references (if available, linked to PubMed and Digital Object Identifier – DOI), and supportive therapy, among others.
Individual modules can be combined to form more complex modules that are managed in a relational database. Additionally, there are modifiable predefined protocol structures into which the components and modules can be inserted and supplemented with further relevant information.
Sequences of different therapy plan protocols are displayed graphically. The protocols are then checked for compatibility with guidelines and subjected to quality control by hematologists, oncologists and pharmacists.
Due to the modular structure, protocols can be easily modified and updated as needed, such as dose changes or supportive therapy updates. The protocols are generated dynamically from the database content and exported in a structured form to the respective application via existing interfaces in XML format or other formats. More details can be found below.
The Relational Database
The treatment protocols are developed, reviewed, and regularly updated according to quality criteria specified in the ASCO 2016 and 2024 standards [7, 10]. Quality assurance is ensured through review processes by pharmaceutical and medical experts of the database and data output. The protocolsʼ individual versions are reviewed by experts in different time cycles and released for use again, if necessary, after modification.
The process of developing a therapy protocol can be simplified into four steps:
- 1.
Selecting the protocol from guidelines, original papers, and study groups.
- 2.
Analyzing the original data with regarding the predefined database structures in a standardized manner.
- 3.
Creation of the digital therapy protocol based on the structures specified by the database.
- 4.
Reviewing and approving the protocol by pharmaceutical and oncological experts.
After receiving official approval, the digital protocol is available for export to digital oncology prescription and administration software, CPOE, hospital information systems, and other systems. Additionally, there are many protocols for prepared drugs that do not require compounding in the pharmacy, so these can also be prescribed via CPOE.
Relational SQL Database
Onkopti® is based on a relational SQL database, which was designed by Fraunhofer IESE in Kaiserslautern and is continuously being developed in cooperation with the Onkopti® clinical team, both in terms of structure and content. A relational database is a type of database that organizes data into structured formats using tables, which consist of rows and columns. This model allows for easy access and management of data points that are related to one another. Each table represents a specific entity, such as a protocol or a substance, and the relationships between these tables are established through unique identifiers known as keys.
A row in a table describes one entity by a set of attributes. For instance, the substance table has 300 rows, each describing a single pharmaceutical substance. Each row has 28 attributes, such as SubstanceID, SubstanceName, Acronym, and SubstanceGroupID that provide detailed information about the substance. “SubstanceGroupID” is the identifier or foreign key for a row in the “SubstanceGroup” table, indicating a 1:n relationship where several substances belong to exactly one substance group. As of January, 2025, the Onkopti® database contained 180 tables with over 200 relations, storing more than 2,700 distinct therapy protocols. Figure 2 displays a section of the Onkopti® database schema as a Unified Modeling Language (UML) diagram.
Author Portal
Using the basic tables and the stored modules, the authors generate the protocols in the online portal by first inserting and linking the literature reference via the identification number of the PubMed database of the National Center for Biotechnology Information (NCBI) of the USA (https://www.ncbi.nlm.nih.gov/pubmed). This is followed by the indication (diseases) with ICD-10 (International Statistical Classification of Diseases and Related Health Problems) code, MeSH (Medical Subject Headings) code and the corresponding MeSH term in German and English for the international version. The substances are stored with the required dosages and the codes of the Anatomical Therapeutic Chemical classification system (ATC) in basic tables, which can be supplemented as required. The protocols are then created from the substances and predefined modules according to the specifications of the internally stored original publication. The toxicity of the protocols is standardized, with the risks of emesis, febrile neutropenia, anemia, thrombocytopenia and other relevant information from the corresponding original publication. Essential are the predefined modules of supportive therapy, which are based on national and international guidelines, such as antiemesis and prophylaxis of febrile neutropenia, which are then inserted according to the risks. Further information and therapy implementation such as time intervals, checks, etc., are also schematized and taken from the database.
The protocols can be composed of these different elements. For example, a typical protocol for diffuse large B-cell lymphoma contains 5 lymphoma-specific and 6 supportive therapy substances (see Fig. 1 [2]).
It is important to add links to relevant websites such as guidelines, specialist information, EMA (European Medicines Agency), study information, etc. Study protocols can also be created and selectively released for authorized persons.
Online Publication, Download, Import into Software for Use in German and English
Protocols can be found on the Onkopti® website (www.onkopti.de, www.onkopti.com, www.oncopti.com) through a detailed search by disease groups, diseases, substances, supportive therapy, authors, MeSH codes, etc. (as shown in Fig. 3). The content of a standardized protocol is structured schematically, as seen in Table 1. The therapy protocols stored in the Onkopti® database can be exported in various data formats, which can then be imported and displayed or processed by other applications. Protocols can be exported completely or individually for other applications. Registered users can choose whether they wish to be informed about new, amended and withdrawn protocols and new substances by e-mail in the monthly newsletter. Corresponding lists of these protocols are also published on the initial page of the website.
Onkopti® website protocol search for breast cancer, https://onkopti.de/protokollsuche/?lang=en.
Onkopti® website protocol search for breast cancer, https://onkopti.de/protokollsuche/?lang=en.
Sections and standardized content of the Onkopti® protocols, see also Figure 1
1. Designation: Name of the protocol from the substance names with dose information, usually in the order of application, possibly also established protocol acronym or study name, main indication, cycle information (C) Protocol number (PID) Version number (V) |
2. Protocol acronym: Abbreviations from substance names for the file name of the protocol etc. |
3. Indication(s): Disease(s), from publications, guidelines, approval; ICD-10-Code(s) |
4. Classification of therapy: Standard, alternative etc. According to guidelines Intensity, therapy phase and intention |
5. Cycles: Duration and number from publication |
6. Sequences of protocols: Therapy plan with different protocols, link to graphic on Onkopti® server |
7. Risks: Febrile neutropenia, neutropenia, anemia, thrombocytopenia, nausea and vomiting and other relevant risks clinically relevant data from publication |
8. Therapy divided into color-coded sections: Hydration, allergy prophylaxis, antiemesis, supportive therapy, e.g., mesna, antineoplastic therapy (oral, parenteral), hematopoietic growth factors, infection prophylaxis, etc. |
9. Adjunctive therapy supplements: e.g., osteoporosis prophylaxis, on-demand therapy |
10. Notes: Possible therapy modifications, warnings etc. |
11. Cycle diagram: Graphical representation of the medications in a cycle |
12. Controls: Relevant controls for implementation before and during therapy |
13. Pharmacokinetics: Relevant clinical information for the implementation of the therapy |
14. Original indication: From the study in the original publication |
15. Original author: From original publication |
16. Origin of the protocol: Study group, clinic, etc. from publication |
17. Literature reference: For protocol used literature, link to PubMed; if available directly to the original publication via digital object identifier (DOI) |
18. Links: Relevant publications, EMA, study groups, etc. |
19. Recommendations: Recommendations by medical professional societies such as NCCN, DGHO (Onkopedia), German Cancer Society, ESMO, ASCO etc. |
20. Status: Date of the start of validity of the protocol |
1. Designation: Name of the protocol from the substance names with dose information, usually in the order of application, possibly also established protocol acronym or study name, main indication, cycle information (C) Protocol number (PID) Version number (V) |
2. Protocol acronym: Abbreviations from substance names for the file name of the protocol etc. |
3. Indication(s): Disease(s), from publications, guidelines, approval; ICD-10-Code(s) |
4. Classification of therapy: Standard, alternative etc. According to guidelines Intensity, therapy phase and intention |
5. Cycles: Duration and number from publication |
6. Sequences of protocols: Therapy plan with different protocols, link to graphic on Onkopti® server |
7. Risks: Febrile neutropenia, neutropenia, anemia, thrombocytopenia, nausea and vomiting and other relevant risks clinically relevant data from publication |
8. Therapy divided into color-coded sections: Hydration, allergy prophylaxis, antiemesis, supportive therapy, e.g., mesna, antineoplastic therapy (oral, parenteral), hematopoietic growth factors, infection prophylaxis, etc. |
9. Adjunctive therapy supplements: e.g., osteoporosis prophylaxis, on-demand therapy |
10. Notes: Possible therapy modifications, warnings etc. |
11. Cycle diagram: Graphical representation of the medications in a cycle |
12. Controls: Relevant controls for implementation before and during therapy |
13. Pharmacokinetics: Relevant clinical information for the implementation of the therapy |
14. Original indication: From the study in the original publication |
15. Original author: From original publication |
16. Origin of the protocol: Study group, clinic, etc. from publication |
17. Literature reference: For protocol used literature, link to PubMed; if available directly to the original publication via digital object identifier (DOI) |
18. Links: Relevant publications, EMA, study groups, etc. |
19. Recommendations: Recommendations by medical professional societies such as NCCN, DGHO (Onkopedia), German Cancer Society, ESMO, ASCO etc. |
20. Status: Date of the start of validity of the protocol |
The protocols are accessible globally in both German and English via the Internet. The digital import into the BD Cato program (in some countries BD Pyxis™ IV Prep) has been tested for both languages and found to be effective. The protocols and the websites for desktop and the progressive web app for mobile devices are published in both languages. The underlying relational SQL database, the translation technology, the content management system, and the website have been technically prepared in such a way that the publication and export of website content in other languages can be achieved with a defined level of effort. Users can make an individual decision regarding the import of the numerous protocols as their local standard, in accordance with the ASCO Antineoplastic Therapy Administration Safety Standards 2024 Domain 3 [7].
Online and PDF Format
The online and PDF representations (PDF: Portable Document Format) are available in different levels of detail, with 5 so-called views, which can also be downloaded as PDF (shown in Fig. 1) for the standard view.
Import into Application Software
For efficient resource utilization, the protocols can be imported into software for oncological treatment planning, treatment monitoring, cytostatic preparation, and hospital information systems. The protocols are exported in a standardized XML format, allowing the respective software to easily adapt its import interface. Other export formats, such as JSON, are also available.
The interfaces for import into the application programs are defined by the software manufacturers. In order to accept the Onkopti® files in XML format, it is necessary to establish detailed agreements on the definitions in each case. This may include, for example, the specifications for drug names, time sequences, mixed infusions, definitions of the carrier solutions, and the representation of oral medications. Based on our experience, it is possible to achieve these without any problems.
BD Cato™
BD Cato™ (BD Austria GmbH, Austria) is an integrated software solution that supports all phases of therapy, including long-term prescription planning and the preparation and administration of cytotoxic drugs and other critical substances. However, it is important to note that all therapy protocols in BD Cato™ must be created manually. The program has an import interface that can be configured to import Onkopti® protocols for the prescribe module.
In combination with Onkopti®, BD Cato™ offers a comprehensive solution. The Onkopti® protocol import provides the necessary protocols, while the BD Cato™ program with its modules for prescription, preparation, and administration facilitates communication between physicians, pharmacists, and nursing staff. The software solution can function as a stand-alone application in both small pharmacies and large hospital networks or compounding centers that connect multiple wards and facilities (https://www.bd.com/en-uk/products-and-solutions/solutions/bd-cato-medication-workflow-solutions). The combination of Onkopti® with BD Cato™ is currently in routine use in numerous pharmacies and hospitals.
OptiTemplate
OptiTemplate is a Microsoft Excel 2016 application developed by Fraunhofer IESE for creating standardized oncological protocols, including all supportive and concomitant therapies, as Excel documents with individual daily medication schedules for patients. The application is user-friendly and currently available only in German, utilizing the familiar Microsoft Excel interface. A context-sensitive plausibility check is already in place to indicate input errors during data entry. To use the Onkopti® protocols, the user must first register on the Onkopti® website and download the desired protocol for further use in OptiTemplate. Application protocols created with OptiTemplate can be saved as an Excel workbook, modified, and printed out at any time for daily use.
Import into Other Software Applications
Individually defined database exports are available in XML, JSON, or other formats for various application programs for antineoplastic therapy preparation and application, as well as information systems in hospitals and practices. The interfaces for importing the Onkopti® protocols have been developed for several therapy software systems used in Germany.
Discussion
Digitalization is currently a top priority and politically relevant in medicine, particularly in oncology. The volume of data, growth in knowledge, and rapid medical progress must be constantly and directly applied. Intelligent digital application tools are necessary to meet the requirements of state-of-the-art antineoplastic therapy in the long term. Digitization and standardization are essential for creating, managing, and maintaining a large number of oncological therapy protocols with the necessary quality and incorporating them into the prescription process. Due to its ability to export protocols, the Onkopti® database allows the transfer of such data to any other software system. Electronic prescription systems are currently the standard for prescribing and implementing drug-based antineoplastic therapy [11‒14]. Several studies have shown that using electronic prescriptions significantly reduces the error rate, especially in prescribing chemotherapy, and therefore decreases the potential risk to patients compared to handwritten or pre-printed protocol prescriptions [7, 12, 13, 15‒18].
Additionally, there are subsystems specific to the administration of chemotherapy. With the exception of a few, the majority of special prescription systems for chemotherapy lack the functionality to generate therapy plans, necessitating the creation of these plans through manual processes. Some of the EHRs import protocols, e.g., as order templates from the NCCN in PDF format (www.nccn.org) or have their own protocols [3, 19, 20]. It is imperative to ascertain from the software manufacturers whether direct digital protocol importation in standard formats is feasible. Our successful imports into the German software programs J-MED (wp.mdigmbh.de/j-med-software), omniplaner (https://omnicare.de/de-de/page/home/apotheker-und-apothekenteams/omniplanerund-apothekenteams/omniplaner), and oncotrace (oncotrace.org), which are used in medical practices, demonstrate that this is a viable approach. However, these programs must be linked to the pharmaciesʼ manufacturing software for the import process to be fully functional.
The ASCO-ONS guidelines for administering antineoplastic therapy require the use of standardized, protocol-related, pre-printed, or electronic forms for parenteral therapy. The protocol should also specify the supportive therapy required for the regimen, including premedication, hydration, growth factors, and allergy prophylaxis [7]. Deficits in the implementation of guideline-based supportive therapy in everyday practice can significantly impair patientsʼ quality of life and fail to reduce the risk of complications unnecessarily [21, 22]. Clinical-pharmacological control of the treatment plan, plausibility checks, and interaction checks can be significantly accelerated and made more efficient [23, 24].
However, the use of CPOE alone is insufficient to meet these requirements. A combination of CPOE and digitized protocols is necessary. Additionally, the protocols for CPOE must be manually entered, which requires significant personnel effort for selecting, analyzing, creating, managing, and updating. Onkopti® can help avoid this issue.
A study published by the University of North Carolina Medical Center, Chapel Hill, showed that “the breadth of information available to support the use of an EHR in the management of chemotherapy treatment plans, the biggest hurdle was to finally implement the new electronic order entry process” [14]. The entire process of transferring paper protocols into an EHR was very labor intensive [14].
By utilizing digital protocols in the CPOE, physicians and pharmacists no longer need to spend a considerable amount of time creating and maintaining their own therapy protocols, resulting in tremendous time and human resource savings. On average, it takes around 210 min to create a new combination therapy protocol, including supportive and concomitant therapy, while considering the total personnel costs, including literature search and evaluation, as well as the review process.
The empirical evidence from the Medical Center Dept. Hematology and Medical Oncology in Kaiserslautern, Germany indicates that the implementation of Onkopti® protocols has resulted in a notable reduction in time compared to both the traditional “classical” development approach and the manual transcription of data from existing directories. When utilizing imported digital therapy protocols in a CPOE system, approval can be obtained in as little as 10 min, which is only 5% of the time required for in-house creation. Even though protocols can be transcribed from other sources, a minimum of 60 min is required. However, by using imported digitized protocols, the time required can be reduced by 83% with a maximum of 10 min of effort (see Table 2).
Average time required to prepare one protocol, comparison of the different methods
Average time required with the use of digitized Onkopti® protocols. Comparison when creating a new treatment protocol, min . | |||
---|---|---|---|
. | new classical . | transcription from directory . | Onkopti® . |
Literature selection | 30 | 0 | 0 |
Literature search, PDF-download | 10 | 0 | 0 |
Literature evaluation – analysis, data extraction | 60 | 0 | 0 |
Data entry, protocol generation, plus supportive and concomitant therapy | 60 | 12 | 0 |
15 | 15 | 0 | |
Review, correction, release | 30 | 30 | 8 |
Administration | 5 | 5 | 2 |
Total in minutes | 210 | 62 | 10 |
Time saving with Onkopti® protocol in minutes | 200 | 52 | |
Time reduction in % with Onkopti® protocols | 95% | 84% |
Average time required with the use of digitized Onkopti® protocols. Comparison when creating a new treatment protocol, min . | |||
---|---|---|---|
. | new classical . | transcription from directory . | Onkopti® . |
Literature selection | 30 | 0 | 0 |
Literature search, PDF-download | 10 | 0 | 0 |
Literature evaluation – analysis, data extraction | 60 | 0 | 0 |
Data entry, protocol generation, plus supportive and concomitant therapy | 60 | 12 | 0 |
15 | 15 | 0 | |
Review, correction, release | 30 | 30 | 8 |
Administration | 5 | 5 | 2 |
Total in minutes | 210 | 62 | 10 |
Time saving with Onkopti® protocol in minutes | 200 | 52 | |
Time reduction in % with Onkopti® protocols | 95% | 84% |
It can be reasonably assumed that 200 new protocols are required annually for an oncology clinic covering all specialist disciplines. This results in a time saving of approximately 666 working hours, that can be converted into avoidable personnel costs or into enhanced direct patient contact. By optimizing the further clinical workflow, e.g., with the BD Cato program, additional personnel can be relieved, as also recommended by Levy (see p. 53, [3]).
The benefits and increased efficiency of this digitization should convince everyone, especially given the dramatic shortage of staff in the healthcare sector. Additionally, costs in the entire prescription and compounding process can be saved through process optimization [15].
To meet the demands for digitization in hospitals, it should be standard practice to work with a CPOE and electronic therapy protocols like Onkopti®. Table 3 summarizes the advantages of combining a CPOE with a digitized therapy protocol database. Many clinics and practices already use this combination and cannot imagine working any other way [25]. The accessibility via online publication can accelerate the implementation of therapy guidelines [26]. Adherence to guidelines is crucial for patientsʼ survival [27‒29].
Possible advantages using digitized Onkopti® treatment protocols
Standardization of drug therapy for hematological neoplasms and solid tumors, including pediatrics |
Protocols for parenteral and oral therapies |
Continuous addition of new protocols |
Updating existing protocols |
Integrated supportive and concomitant therapy according to guidelines |
Risk classification such as febrile neutropenia, anemia, nausea and vomiting, etc. |
Quality-assured guideline-based therapy protocols |
Linked PubMed and DOI literature references |
Compliance with ASCO standards |
Clinical evidence in clinics and practices |
Contributes to increased efficiency |
Time savings through accelerated processes |
Process optimization |
Reduced workload for staff |
Eliminates the need to create own protocols |
Contributes to adherence to therapy guidelines |
Contributes to cost savings |
Digital standardized export to application software (XML and other formats) |
Standardization of drug therapy for hematological neoplasms and solid tumors, including pediatrics |
Protocols for parenteral and oral therapies |
Continuous addition of new protocols |
Updating existing protocols |
Integrated supportive and concomitant therapy according to guidelines |
Risk classification such as febrile neutropenia, anemia, nausea and vomiting, etc. |
Quality-assured guideline-based therapy protocols |
Linked PubMed and DOI literature references |
Compliance with ASCO standards |
Clinical evidence in clinics and practices |
Contributes to increased efficiency |
Time savings through accelerated processes |
Process optimization |
Reduced workload for staff |
Eliminates the need to create own protocols |
Contributes to adherence to therapy guidelines |
Contributes to cost savings |
Digital standardized export to application software (XML and other formats) |
The slow implementation of innovations and guidelines in chemotherapy is a well-known problem that has been shown in several studies [30‒33]. Experts in the field suggested that increasing the efficiency of oncology care by improving the functionality and efficiency of EHRs “may be the only solution that will allow clinicians to care for more patients without extending work hours” [3].
Conclusion
The use of an electronic prescription system is standard in the antineoplastic therapy of solid tumors and hematological neoplasms. Standardized, digitized therapy protocols from the central Onkopti® database in German or English can increase efficiency, reduce personnel workload, and optimize protocol quality.
Conflict of Interest Statement
Hartmut Link – Last DOI update: August 27, 2024. Financial interests: Pharmacosmos, advisory board, and personal. SIGAL SMS GmbH: advisory board, personal. Takeda: advisory board, and personal. Teva: advisory board, personal. Teva, invited speaker, personal, vision plus Mailand, invited speaker, personal. Apogepha, advisory board, and personal. G1 Therapeutics, advisory board, personal. Lindis blood care: advisory board, personal. Octapharma: invited speaker, personal. Onkodin GmbH: ownership interest, Personal, onkopti.de. Viatris: licensing fees, institutional, Onkodin GmbH, onchemo.com. Biocon, Licencing Fees, Institutional, Onkodin GmbH, onchemo.com. AMGEN: research grant, no financial interest, institutional, study with German Cancer Society. MMF GmbH, Coordinating PI, financial interest, personal. Pharmacosmos: research grant, no financial interest, institutional, grant to German Cancer Society. Teva – Xcenda: Steering Committee member, financial interest, and personal. Takeda: research grant, no financial interest, institutional, Grant to AIO German Cancer Society. Non-financial interests: Onkodin GmbH, project lead, digitized oncological treatment protocols. Other: Ethics Committee at the Rhineland-Palatinate Medical Association, Mainz, Other, Expert Testimony. Axel Wickenkamp, Annika Dresel, Migle Link, Cornelia Link-Rachner, and Rolf H. van Lengen have no conflicts of interest to declare.
Funding Sources
The development of Onkopti® has been supported in part by grants of: State of Rhineland-Palatinate, Ministry of Economic Affairs, Transport, Agriculture, Viticulture Digiboost No. 81080823, Innovation voucher No. 81105841-2149. The funder had no role in the design, data collection, data analysis, and reporting of this study.
Author Contributions
H.L. drafted and prepared the manuscript, A.W. and R.v.L. contributed the methods and database development part, A.W., R.v.L., A.D., M.L., and C.L.R. revised and completed the manuscript.