© ISO 2016 Health informatics — Requirements for medicinal product dictionary systems for health care Informatique de santé — Exigences pour les systèmes de dictionnaires de produits médicaux pour les[.]
Boundary between MPD-systems and IDMP
IDMP Standards regulate medicine processes in specific jurisdictions with comprehensive detail, but not every aspect needs to be included in an MPD-system as per ISO IDMP Standards Elements from IDMP that do not align with the use cases in this Technical Specification are excluded Additionally, the MPD-system can incorporate locally necessary concepts and data fields, such as a historic identifier for patient medication history or to support ongoing trend analysis For more information on the relationship between the MPD-system and IDMP, refer to Clause 6.
Boundary between MPD-systems and ancillary information to build an MPD-system
This Technical Specification outlines the MPD-system provided by the MPD maintenance organization to hospitals, pharmacies, software vendors, and other stakeholders To effectively maintain the MPD-system, ancillary information such as lists of substances, dosage forms, and routes of administration from the databases specified in the ISO IDMP Standards implementation guides may be required While these lists are not integral to the MPD-system, they are essential for deploying its concepts.
Boundary between MPD-systems and local implementation
The MPD-system must be integrated into health, clinical, and pharmacy information systems, resulting in a localized version of the MPD-system This local implementation may include specific components of the MPD-system based on the supported use cases It is deemed compliant with the MPD-system's functional requirements as long as the utilized subset aligns precisely with the MPD-system and adheres to ISO IDMP standards.
— It can use a certain subset of the medicines included in the MPD-system.
— It can use a certain part of the structure (e.g only the pharmaceutical or medicinal product part but not the packaged medicinal products).
For specific use cases requiring additional elements beyond those defined in the MPD system, local implementations should have the flexibility to utilize separate elements This allows them to create a customized view tailored to the unique needs of the particular use case.
Content of the MPD-systems in terms of product coverage
The MPD-system encompasses all authorized medicinal products and may also include unapproved products, such as extemporaneous preparations It is essential for the MPD-system implementations to clearly define the types of products included and the extent of their coverage To promote international harmonization, the ISO IDMP Standards will be consistently adopted for authorized medicinal products, potentially leading to a unified reference source managed by a consortium of stakeholders, including regulatory bodies and pharmaceutical manufacturers Furthermore, all concepts, characteristics, relationships, and data elements outlined in the IDMP standards should be integrated into the MPD-system If the ISO IDMP Standards are not fully implemented, any missing data will not be reflected in the MPD-system but can be incorporated by its maintainer.
Authorized medicinal products should utilize identifiers based on the ISO IDMP Standards within the MPD-system It is essential to avoid creating new identifiers for concepts already defined in IDMP For products not covered by IDMP but required in the MPD-system, IDMP elements should serve as a model for information creation In cases where identifying characteristics or concepts are absent in the IDMP standards, new identifiers, such as package IDs, may need to be established.
Definition of Medicinal Product Dictionary MPD-systems
An MPD-system provides a standardized representation of medication concepts through a set of identifiers, ensuring meaningful relationships among these concepts This structure supports various healthcare use cases where medication is essential.
Benefits of the Technical Specification
The Technical Specification for MPD-systems clearly outlines the functional requirements, categorizing them into core and supporting sections, while also defining the relationships between MPD-systems and other health information systems This clarity enables the assessment of how well MPD-systems meet these requirements, thereby aiding in their ongoing development, maintenance, and selection.
Target users for the Technical Specification
The target users of the Technical Specification for MPD-systems include:
• healthcare professionals with responsibilities for their practice ICT systems, such as for selection, application governance,
• those responsible for health informatics systems in their environment.
6 Positioning of Medicinal Product Dictionary Systems for Healthcare
Base materials for MPD-systems
Relation with ISO IDMP standards
Global medication regulations are tightening, making it essential to implement a standardized methodology for the consistent identification of medicinal products The IDMP standards aim to encompass a diverse range of medications, including locally prepared pharmacy products, by applying core concepts, relationships, and data specifications.
The relationship between this Technical Specification for functional requirements for MPD-systems and the ISO IDMP Standards is as follows:
• This Technical Specification uses existing terminology, concepts and relationships as specified in the ISO IDMP Standards, in particular ISO 11615, ISO 11616 and ISO 11238.
• This Technical Specification assumes that the MPD is created and maintained in accordance with the IDMP series In particular the following IDMP standards shall be used
— The substance referred to in an MPD shall be described in accordance with ISO 11238 Further, it should use the implementation specifications from ISO/TS 19844, and its resulting terminology
A term and a term identifier shall be used
The MPD must define the administrable dose form in line with ISO 11239, utilizing the implementation specifications from ISO/TR 20440 and the associated terminology Additionally, both the term and its identifier should be clearly specified.
— The MPD shall specify data elements and units of measurement according to ISO 11240.
— The MPD shall define the concepts required to associate Medicinal Products with an appropriate set of MPIDs in accordance with ISO 11615.
— The MPD shall define the concepts required to associate Pharmaceutical Products (authorized) with an appropriate set of PhPIDs in accordance with ISO 11616.
— The MPD shall support electronic prescription systems in accordance with ISO 17523.
— The MPD shall refer to machine readable coding of medicinal product package identifiers in accordance with ISO/TS 16791.
This Technical Specification utilizes and restricts the ISO IDMP terminology and concepts to enhance clinical practice use cases for an MPD-system It defines a subset of ISO IDMP concepts and their corresponding identifiers, tailored to meet the specific use cases outlined Additionally, it acknowledges that various users of MPD-systems may access different levels of data detail, allowing them to view more or fewer characteristics based on their specific needs.
The IDMP standards aim to encompass core concepts, characteristics, relationships, and data models within an MPD-system to accommodate various use cases However, since the clinical practice use case does not necessitate the full specificity of IDMP, the MPD-system may only include a relevant subset of IDMP concepts and data elements It is essential that any utilized IDMP components remain fully compatible and consistent with the applicable IDMP specifications To cater to specific user needs, it is recommended to implement different views of the data fields for different users.
This Technical Specification outlines the implementation of IDMP concepts, characteristics, relationships, and data elements within an MPD-system, utilizing classification terms such as "Shall" for mandatory concepts, "Should" for important concepts, and "May" for optional concepts MPD-system providers are prohibited from creating overlapping identifiers with IDMP identifiers for the same products However, for products not covered by IDMP, such as extemporaneous preparations, the core IDMP concepts, characteristics, and data elements should be employed to generate identifiers for these medicinal products.
The development of MPD-systems must consider existing systems in various jurisdictions, which may need to comply with local requirements and implementation practices To address this, the Technical Specification will outline a migration strategy for transitioning to full ISO IDMP regulation adherence in MPD-systems Additionally, the specification will accommodate local requirements and medicinal product preparations not covered by existing regulations, allowing for flexibility and adaptability in its implementation.
Relation with health/clinical/pharmacy information systems, decision support, EHR and dose instructions
An MPD-system is integral to health, clinical, and pharmacy information systems, encompassing various functions and types of information Key components include the MPD-system itself, decision support information, electronic health records (EHR), and dosage instruction systems To ensure the correct prescription or dispensing of medication, these systems utilize the MPD-system to identify the appropriate medicine, while decision support and EHR data are employed to verify the safety and efficacy for individual patients Additionally, dosage instructions are crucial for determining the correct dosage and cross-referencing it with decision support data.
Relation with EHR-S FM
Health Level 7 International's work on the Electronic Health Record System Functional Model (EHR-S FM) serves as a foundational guide for this Technical Specification The 2nd Release outlines seven key sections of functional requirements for EHRs, each depicted in a distinct color in the accompanying figure (Figure 2 EHR-S FM sections) These sections encompass headers, functions, and conformance criteria essential for effective EHR implementation.
Figure 2 — Sections of the Electronic Health Record System Functional Model
The MPD-system functional requirements are presented following a similar approach as the EHR-S
Use cases for requirements for an MPD-system
Prescribing use case
An MPD-system must deliver detailed descriptions of medicinal products to ensure that the subsequent actions, whether dispensing or administration, can accurately identify the correct product to be used.
Depending on the domain of use, this might be to describe:
• a product in full – an actual manufactured product (brand named or not) and the relevant pack size;
• a product in some degree of abstraction, e.g an abstraction level that contains elements like active substance, dose form and strength but no brand name.
The product can be described without specifying its dose form, strength, or presentation unit, which differs from merely listing its active substances Patients receive a formulated product containing the substance rather than just an "amount of substance."
Dispensing use case
An MPD-system must effectively describe medicinal products in detail, enabling dispensers to accurately select the correct product for dispensing.
Effective local implementation requires availability information for both prescribing and dispensing use cases Prescribers should only receive descriptions of products that are available for dispensing, and any restrictions on availability must be clearly communicated Dispensers should exclusively select products that are confirmed to be available for dispensing.
This requirement may be expanded to encompass formulary information for prescribers and stock control data for dispensers, ensuring that each has access to a curated list of products for selection.
Administration use case
Administering a prescribed medicinal product involves delivering a specific pharmaceutical dose to the patient through a defined method and route, while also documenting the administration's occurrence, including the exact date and time.
Recording medication history use case
Recording a patient's medication history is essential for various reasons, including understanding the duration of their current treatment and identifying any previously attempted medications that were discontinued for specific reasons.
Reconciling medication list use case
When multiple healthcare providers supply medication lists for the same patient, it is crucial to reconcile these lists to accurately determine the patient's current medications, especially during patient transfers To streamline this reconciliation process, medications should be presented with consistent granularity, or if differing levels are used, they must be translatable to a comparable standard This approach is essential for identifying shared medications and any omissions in the patient's medication list.
Ordering and supply chain (logistics) use case
This use case focuses on the ordering, transport, delivery, and storage of medicinal products in a pharmacy It is essential for this process to enable tracking and tracing throughout the various stages of logistics To facilitate this, each medicinal product requires a unique identifier.
Analysis, statistics, and pharmacoepidemiology use case
Analytics in the pharmacological domain often involve retrospective analyses of medicinal product usage Pharmacoepidemiology focuses on studying the effects and utilization of drugs across large populations To effectively gather data on drug use, it is essential to aggregate information from various sources Consequently, a well-structured medicinal product database (MPD) that aligns with standard pharmacoepidemiology classifications, such as the Anatomical Therapeutic Chemical (ATC) classification, is highly beneficial.
Electronic data exchange of medicinal product information between
The MPD-system supports interoperability between systems, across care settings and across jurisdictions Data that are exchanged will be based on the ISO IDMP Standards.
The MPD-system offers a comprehensive framework for health information technology applications focused on medication management, including prescription, dispensing, and administration details It encompasses Electronic Health Records (EHRs) that maintain patient information, Clinical Decision Support systems that aid in prescription processes, and Drug Knowledge databases that provide essential information on medications, their relationships, and interactions.
Clinical Decision Support systems play a crucial role in enhancing drug safety by generating alerts for improper medicine usage and supply shortages To maximize their effectiveness, these systems must be integrated with a Medication Processing and Dispensing (MPD) system, which provides essential data on prescribed and dispensed medications, as well as the patient's medication history Additionally, an MPD system offers various levels of granularity, ensuring a reliable connection between clinical decision support and medications, thereby minimizing the risk of errors This integration is vital for effective pharmacovigilance reporting.
Reimbursement use case
This use case focuses on reimbursements for dispensed medicinal products An MPD system must provide essential medicinal product information to facilitate secondary uses, including pricing transparency and procurement, where applicable.
Clinical research use case
Clinical research involves direct interaction between investigators and human subjects, focusing on studies that utilize human-derived materials such as tissues and specimens This type of research often includes protocol-driven clinical trials aimed at evaluating medications, where the investigational medicinal product is assessed in relation to authorized medicinal products.
Types of clinical research may include:
Patient-oriented research focuses on specific individuals or groups and utilizes human materials This research encompasses therapeutic interventions and clinical trials, often employing an MPD-system to enhance analysis.
Epidemiological and behavioral studies focus on the distribution of diseases, health-affecting factors, and individuals' health-related decision-making processes When these studies incorporate medicinal product variables, an MPD-system can be utilized to enhance the analysis.
Outcomes and health services research aims to determine the most effective and efficient interventions, treatments, and services When medicinal product variables are involved, an MPD-system can be utilized to enhance the analysis.
Accurate information regarding current and past medicinal products used by patients is crucial for secondary uses of data, especially in clinical research Consequently, clinical research should provide use cases that support the requirements for a Medicinal Product Database (MPD) system.
Recruitment of subjects for clinical trials is challenging, with success rates varying significantly Eligibility criteria, documented in study protocols, guide the selection process To enhance recruitment efforts, innovative strategies are being developed, including clinical trial recruitment support systems that assess protocol feasibility and patient eligibility These systems utilize eligibility criteria to query clinical data warehouses, identifying potential candidates for trials Accurate medication descriptions are crucial, as many criteria reference medication use Standardizing medication data across clinical care, data warehouses, and research eligibility criteria can significantly improve the effectiveness of recruitment support systems.
Tracking and tracing for patient and public safety use case
The MPD-system must provide essential medicinal product information to ensure traceability throughout the prescribe-ordering-dispense-supply-administration cycle, which can be achieved through effective linking Additionally, it plays a crucial role in reducing fraudulent activities, such as false dispensing and grey imports, while also incorporating post-dispense follow-up measures.
• Parallel imports – Medicinal products licensed by a regulator for import, these products have no therapeutic difference from the equivalent products on the market within the same territory.
• Grey imports – Imported medicinal products without authorization.
• Specials – Medicinal products without authorization manufactured in a territory for use by individual patients in that territory.
Pharmacovigilance use case
Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Pharmacovigilance primarily targets adverse drug reactions (ADRs), defined as harmful and unintended responses to medications, including instances of lack of efficacy Additionally, it encompasses medication errors such as overdoses, misuse, and abuse, along with drug exposure during pregnancy and breastfeeding, as these factors can also lead to ADRs.
Healthcare professionals, including doctors, pharmacists, and nurses, as well as patients, can report PV events related to medications The detail of drug information can range from limited, as seen in spontaneous and patient-reported events, to more comprehensive data collected in controlled settings like hospitals and clinical trials.
PV events are analysed to determine ‘signals’ and to confirm the ‘suspect drug’ and cause of the event
An MPD-system can deliver detailed information about a 'suspect drug,' including active substances, dosage, dosage form, route of administration, product trade name, packaging, administered product, manufacturer, and batch This comprehensive data aids in identifying the root cause of adverse events related to specific substances, manufacturers, or batches.
Patient safety through linking personal data with the decision support
Effective medication relies on matching the right treatment to the patient's specific condition; otherwise, it may be harmful or ineffective To ensure accurate prescriptions, decision support information is essential, as it offers insights into potentially harmful or ineffective scenarios When this information is integrated with personal data from Electronic Health Records (EHR), it enables healthcare providers to prescribe the most suitable medications.
The MPD-system serves as a framework for linking decision support information, which includes critical data such as drug-drug interactions, contraindications, duplicate therapy, dose verification, and patient label instructions It also supports risk minimization activities, including pregnancy prevention programs, educational initiatives, and controlled access programs Additionally, the system aids in selecting the appropriate medication based on a formulary that aligns with therapeutic guidelines and the specific characteristics of the patient.
Migration use case
Migration represents the gap between the current state and the desired future state It involves assessing existing systems, such as MPD-systems, which vary in their compliance with the functional requirements outlined in this Technical Specification While some systems may already fulfill most of these requirements, others may only address a limited number of functions tailored to specific use cases.
In the future, it is anticipated that the evolving landscape will result in stricter regulations to ensure that MPD systems comply with established requirements Immediate changes in these systems are not feasible, and the same applies to the current medicinal terminology The objective of mapping to existing terminologies, as outlined in section 7.3.1.2, is to ease the transition from traditional terminology to MPD terminology.
This Technical Specification outlines the necessary functions for existing MPD systems to eventually fulfill all requirements A reasonable timeframe for undisputed functions, which pose no implementation or usage issues, aligns with the duration of this Technical Specification However, for functions that may lead to challenges in the coming years, an extended grace period may be necessary to transition this Technical Specification to a full International Standard (IS) in the future.
This Technical Specification outlines the required functions using the 'shall' statement for immediate implementation, while functions that may be implemented later are indicated with 'should' statements The 'may' statement refers to optional components However, it is important to note that not all statements will guarantee compliance, as some may retain a 'should' designation, particularly for functions dependent on the availability of underlying data In such cases, it is acceptable to forgo usage, but if the data is present, it must meet the specified criteria.
7 The Functional Requirements for MPD-systems
Introduction
This subclause outlines the functional requirements for an MPD-system, utilizing a structure similar to the HL7 EHR-S FM with sections, headers, functions, and criteria The criteria are defined using normative language: "shall" indicates mandatory features, "should" refers to features that are recommended if available, and "may" denotes optional features.
The ISO IDMP Standards define key concepts and elements that serve as the foundation for the MPD-system These concepts are interrelated and can be organized into various hierarchical layers based on their granularity The relationships among ISO IDMP concepts provide a framework for structuring the subsequent sections of the article.
The Technical Specification mandates the maintenance of globally unique IDs within any MPD system, with further details provided in the subsequent clauses.
Goal of an MPD system
The MPD System aims to provide a comprehensive overview of available medicinal products for various healthcare stakeholders, ensuring that the concepts, descriptions, and identifiers can be integrated into diverse healthcare information systems It relies on ISO IDMP concepts to uniquely identify specific characteristics of medicinal products, which may vary in granularity and exhibit hierarchical interrelations This approach accommodates different use cases requiring varying levels of detail while maintaining the interconnections between layers and concepts to support all users effectively.
The Technical Specification outlines the functions of the MPD system that facilitate mutual understanding and the interpretation of concepts This normative content is derived from the data model established by IDMP.
Normative content
Content of regulated medicinal products
7.3.1.1 The MPD-system provides identified content according the ISO IDMP Standards
The MPD-system shall, should or may provide the following content and functions to pharmacy information systems, to health and clinical systems and to pharmacovigilance systems:
The local MPD system must include globally unique medicinal product identifiers based on the essential elements of ISO IDMP standards, particularly ISO 11616 and ISO 11615 If the MPD system includes local, unauthorized medicines lacking an IDMP identifier, these identifiers will be omitted.
• The MPD-system shall provide a listing (inventory or catalogue) of medicinal products concepts for use in health, pharmacy and clinical applications.
• The MPD-system should provide both human understandable and machine readable identifications for the medicinal product concepts, according to ISO IDMP terminology and approved regulated products.
• The MPD-system may provide corresponding words/phrases in alternative languages, depending on target audience and localization.
• The MPD-system should offer synonyms for medicinal products.
• The MPD-system shall provide the separate characteristics of the concepts as separate discrete elements.
7.3.1.2 The MPD-system provides data specification according to the ISO IDMP Standards The MPD-system shall, should or may include the following data according to the ISO IDMP Standards:
The MPD-system is designed to differentiate between various hierarchical layers of concepts in accordance with the ISO IDMP Standards, specifically ISO 11615 These layers include substances found in medicinal products, pharmaceutical products, medicinal products themselves, and packaged medicinal products.
Concerning the substance (as present in the medicinal products):
• The MPD-system shall provide the Substance and it may provide data about the specified substance which contains more details about the substance;
• The MPD-system shall provide the confidentiality indicator;
• The MPD-system shall provide the Ingredient role;
• The MPD-system shall provide the reference to the identifier of substances as provided by the source that contains the ISO 11238 identifiers.
The MPD-system will include pharmaceutical products and their characteristics in accordance with ISO 11616, focusing on both 'substance' and 'specified substance' categories Additionally, it may offer information on the concentration range of these products.
The MPD-system must reference the pharmaceutical product identifier as specified by the source containing ISO 11616 identifiers If a sublevel of the pharmaceutical product is utilized according to ISO 11616, the identifier for this sublevel must also be included.
The MPD-system may include multiple classifications of medicinal products, specifying the classification system name, such as ATC or a local medicinal terminology While the classification system name is not a defining element, it provides additional information about the pharmaceutical product This classification also applies to levels below the pharmaceutical product, as outlined by ISO 11615.
The MPD-system offers essential information regarding Medicinal Product Information, including a cross-reference between authorized medicinal product identifiers and investigational medicinal product identifiers from the development and clinical investigation phases It provides indicators for 'additional monitoring' and 'special measures,' unless this data is available through a linked decision support system The system grants access to the Summary of Product Characteristics (SPC) and package insert, along with their identifiers, and includes the medicinal product name and approved routes of administration It may also specify off-label routes, clearly distinguishing between approved and off-label uses Additionally, the MPD-system can include medical indications and attributes detailing the approved indications and the color of the medicinal product.
The MPD-system offers essential details regarding marketing authorization, including the country where the authorization is granted, the current status and date of that status, and potentially the validity period of the authorization Additionally, it identifies the marketing authorization holder and may include information about the marketing status and its corresponding date.
The MPD system will offer details about the organizations supplying data, including their names and additional information as outlined in ISO 11615.
The MPD-system delivers essential information regarding the manufacturer of the medicinal product, including the type of operation involved, such as production, re-labelling, or re-packaging This information encompasses the manufacturer's name and additional details as outlined in ISO 11615.
• The MPD-system shall provide the reference to Medicinal Product Identifier as provided by the source that contains the ISO 11615 identifiers.
Concerning the packaged Medicinal Product:
The MPD-system delivers essential information about the Packaged Medicinal Product, including a detailed package description It specifies the package item, container type, and container quantity, encompassing all components of the package, such as the outer and inner packaging, like boxes and blisters, in accordance with each regional ISO IDMP implementation.
• The MPD-system provides the following information concerning the data carrier identifier: o The MPD-system shall provide the data carrier identifier code system and the data carrier identifier value.
The MPD-system delivers essential information about the package, including the type and material of the component, as well as the option to provide alternate material for the component.
The MPD-system offers essential details regarding shelf life and storage, including the specific type of shelf life and the corresponding time period, as well as important precautions for proper storage.
The MPD-system delivers essential information about the device, including its type, material, and quantity It also specifies the device's trade name and may offer details on alternate materials Additionally, the system provides a sterility indicator for the device.
The MPD-system delivers essential information about the manufactured item, including the manufactured dose form, the unit of presentation, and the quantity of the manufactured item.
• The MPD-system provides the following information concerning the physical characteristics: o The MPD-system may provide the, height, width and depth of the package.
• The MPD-system provides the following information concerning the marketing authorization: o The MPD-system shall provide the legal status of supply.
The MPD-system offers crucial information to aid in the identification of falsified medicines, including an indicator for package serialization and details about the distinguishing features that manufacturers incorporate to differentiate between authentic and counterfeit packages.
• The MPD-system shall provide the reference to the Medicinal Product Package Identifier as provided by the source that contains the ISO 11615 identifiers.
Some characteristics used in the concepts represent a nomenclature of themselves, like the dosage form or route of administration.
7.3.1.3 The MPD-system provides data about relationships and cardinality of the ISO IDMP concepts
The MPD-system shall, should or may provide the following content and functions to pharmacy information systems, to health and clinical systems and to pharmacovigilance systems:
Prescription
The MPD-system facilitates the prescribing use case by ensuring the identification of the appropriate medication However, it does not encompass decision support functions, such as checking for drug-drug interactions or composing dosage instructions, which are outside the scope of the MPD-system.
Prescribing medications can occur at both a generic and a brand-specific level, with regulations governing these practices differing across various jurisdictions.
Describing a specific set of data and their characteristics for medicine prescription is challenging due to varying needs across jurisdictions However, it is essential to provide guidance that connects to decision support and the documentation of dispensable packages.
An MPD-system defines a level at which a prescriber can prescribe a drug generically, typically at the pharmaceutical product level or between the pharmaceutical and medicinal product levels.
The MPD system must provide comprehensive descriptions of all available medicinal products at varying levels of detail, from specific to generic, to effectively support the prescribing use case, ensuring clear relationships between these levels.
• In case the MPD-system does NOT have a fixed prescription level, it shall be possible to compose a prescription based on the identifiers of the different layers of concept.
The different levels of concepts facilitate connections to decision support systems When the MPD system aids in prescribing through distinct identifiers, the medications prescribed using these identifiers enhance the integration with the decision support system.
The MPD-system will facilitate the integration of medication records by allowing the storage of prescribed medicine names, identifiers, and other pertinent information within the medication record.
• The MPD-system may support the linkage to the dose instructions in such a way that choosing a medicine to describe leads to the applicable dose instructions to be used.
An MPD-system aids prescribers in finding the necessary medicinal product descriptions by offering various features, including navigation tools, grouping concepts, and search strategies such as shortcuts, abbreviations, and synonyms to enhance usability and implementation.
Dispensing
This subclause handles the interactions between the MPD-system and clinical systems that pharmacies use to keep record of dispensed medicinal product(s):
The MPD-system must provide comprehensive descriptions of all available medicinal products, ranging from detailed to generic levels, along with appropriate relationships between these levels This structure is essential for selecting the correct packaged medicinal product for dispensing when a higher level of abstraction is prescribed.
An MPD-system can assist dispensers in selecting the appropriate product by offering additional features like navigation tools, grouping concepts, and search strategies, including shortcuts, abbreviations, and synonyms to enhance usability.
The MPD-system is designed to accommodate local and national regulations regarding the dispensability of products, ensuring that patients are eligible to receive specific items, determining reimbursement options, and identifying suitable alternatives when necessary.
• The various levels of concepts shall support the linkage to the decision support system.
• The MPD-system shall support the linkage to the medication record in such a way, that a dispensed medicine can be saved in the dispense record.
• The MPD-system may support the linkage to the dose instructions in such a way, that choosing a medicine to describes leads to the applicable dose instructions to be used.
Administration
This subclause addresses the interactions between the MPD-system and clinical systems responsible for recording administered medications The MPD-system typically lacks the capability to log actual medications, a function usually managed by Electronic Health Records (EHR), medication records, or increasingly, personal health records and mobile applications Consequently, this section focuses solely on the interactions between the MPD-system and these external systems.
Healthcare organizations are expected to meticulously monitor the medicinal products they administer In the future, this practice may extend to patients tracking their own prescribed and over-the-counter medications This aspect is crucial for the proper management of medicinal products in healthcare; however, it remains incomplete due to the ongoing advancements in personal health records, devices, and smartphone applications.
The MPD-system will provide comprehensive descriptions of all available medicinal products, ranging from detailed to generic levels of abstraction This structured approach ensures that the appropriate packaged medicinal product can be selected for administration, especially when a higher level of abstraction is prescribed.
The MPD-system is designed to support the administration use case by providing the licensed routes of administration for specific medicinal products, which may include various accepted methods such as oral intake, inhalation, or injection, allowing patients to receive the product effectively.
Recording and reconciliation
The MPD-system will enhance the documentation of prescribed medications within electronic and personal health records by ensuring accurate reconciliation of all medications a patient has been prescribed, dispensed, and administered Different healthcare providers often maintain separate medication lists for the same patient, necessitating reconciliation to determine the patient's actual medication regimen, especially during patient transfers The MPD-system will provide standardized naming, identifiers, and concepts from the IDMP standards to support these other systems in achieving effective medication reconciliation.
The MPD-system is designed to enhance the recording and reconciliation of medicinal products by providing detailed descriptions at various abstraction levels, from specific to generic This structure facilitates the accurate documentation of dispensed medications in electronic health records (EHR) and allows for effective grouping of medicines Such organization aids in conducting medication reviews and offers a comprehensive overview of a patient's medication usage Additionally, this standardized grouping and insight into dispensed packages assist healthcare providers in reconciling multiple medication lists for the same patient.
An MPD-system facilitates the recording of medication data, presenting it in an easily understandable format This system enhances the medication history section of electronic health records by aggregating medication use data at the desired level.
• An MPD-system should present the medicinal product information in a standardized way to different medication record systems at different levels of presentation.
The MPD-system must enable the connection of stored data in electronic health records or personal health records related to specific medicinal products administered to individuals with the IDMP identifying data provided by the system.
To ensure effective reconciliation of medication lists, the MPD system must present medicinal products with consistent granularity If varying levels of presentation are used, the system should support translation to comparable levels for clarity.
In other words, the MPD-system should facilitate in detection of the shared and missing medicinal products on the medication history:
The MPD-system must provide essential medicinal product information to facilitate the review and reconciliation of medication profiles within Electronic Health Records (EHRs) This information is also crucial for various applications and systems related to medications, including prescription management, dispensing, clinical decision support, drug knowledge databases, and administration details.
To enhance medication reconciliation in healthcare, the MPD-system must enable the integration of data from various electronic health records, personal health records, and pharmacy systems, specifically linking information about prescribed, dispensed, and administered medications for each individual.
Order and supply chain and logistics
Effective logistics in medication management is crucial for ensuring that medicinal products are readily available at the point of care This process relies heavily on the accurate identification of products according to the IDMP standard Key logistics activities encompass production, storage, transportation to pharmacies, stock management, timely reordering of supplies, physical handover to patients, and the secure disposal of waste medications.
The MPD-system is designed to streamline logistic processes related to the storage, distribution, inventory management, ordering, and disposal of medicinal products It plays a crucial role in managing data about packaged medicinal products, enhancing efficiency in handling and waste disposal.
• The MPD–system should facilitate in tracking and tracing during the various stages of the logistics process.
• The MPD-system should include machine readable barcode identifiers for any medicinal product for tracking and tracing throughout the logistics process.
Analysis, statistics, pharmacoepidemiology, and clinical research
The demand for data analysis in healthcare is increasing, particularly with a shift towards utilizing observational data alongside traditional clinical trial data This section focuses on the MPD-system in healthcare, highlighting how the application of IDMP medicinal product identifiers can enhance specific data uses Four primary data uses are identified: analysis, statistics, pharmacoepidemiology, and clinical research For clarity, the term "analysis" will be used in normative statements unless a specific type of analysis is referenced.
The MPD-system must facilitate the exchange of linked personal medication administration data from electronic health records or personal health records, specifically identifying medicinal products, to a clinical data warehouse for comprehensive analysis.
• Various data aggregations, based on personal data on medicinal product administration and IDMP identification data should be facilitated, including continuity of care, ICSR, pharmacological usage research, and more.
The first category of analysis in medicinal product data are simple kinds of analysis, often performed at the pharmacy for internal managerial purposes as stock keeping:
The MPD system must enable comprehensive analysis of medicinal product data, either directly within the system or through integration with a supply chain system This includes critical aspects such as inventory management, lead times, and usage patterns.
Statistics is a broad concept, particularly in the context of MPD-systems, where it involves calculating the baseline frequencies of specific medicinal products and generating tables and trends based on this data.
The MPD-system must facilitate the exchange of linked personal medication administration data from electronic health records or personal health records, specifically identifying medicinal products from IDMP, to a clinical data warehouse for comprehensive statistical analysis of medicinal product data.
• The results of the statistical analysis should be obtained from other applications than the MPD-system.
According to Strom [24] pharmacoepidemiology is the study of the uses and effects of drugs in well- defined populations:
To enhance pharmacoepidemiology, the MPD-system must enable the storage and exchange of essential linked data regarding medicinal products within electronic and personal health records This includes comprehensive descriptions of all available medicinal products, ranging from detailed to generic levels, along with appropriate relationships between these levels, facilitating their use in clinical data warehouses for pharmacoepidemiological research.
Linked data for pharmacoepidemiology must encompass a variety of essential elements, including stored demographic information, comprehensive details on administered medicinal products with their IDMP identifiers, procedural data related to administration, as well as data on symptoms, diseases, and both desired and adverse effects.
Clinical research is essential for evaluating the effectiveness, efficiency, and safety of healthcare treatments, providing the evidence needed for practical application Medicinal products are a primary focus of this research, which typically involves multiple phases The MPD-system enhances clinical research by streamlining the accurate recording of medicinal product data into electronic health records and clinical trial reporting systems, including clinical trial management systems and electronic case report forms (eCRF).
The MPD-system must facilitate the integration of essential linked data regarding medicinal products within electronic health records, personal health records, and clinical trial reporting systems This includes comprehensive descriptions of all available medicinal products, ranging from detailed to generic levels, while ensuring appropriate relationships between these levels Such data should be stored and exchanged to a clinical data warehouse to support further research in pharmacoepidemiology.
Linked data for clinical research must encompass comprehensive descriptions of all available medicinal products, ranging from detailed to generic forms, while establishing appropriate relationships between these levels This data should connect to records that include demographics, specifics of administered medicinal products with their IDMP identifiers, applied administration procedures, symptoms, diseases, trial-defined data, and both desired and adverse effects.
Ensuring patient safety through linking personal data with the decision
The MPD-system serves as a framework that integrates decision support information with EHR data, enhancing the effective use of medication and minimizing potential harm This decision support information plays a crucial role in optimizing patient care.
The article emphasizes the importance of monitoring drug-drug interactions, contraindications, and duplicate therapies, along with verifying dosages and providing clear patient label instructions It also highlights the role of risk minimization activities, such as pregnancy prevention programs, educational initiatives, and controlled access programs, in ensuring patient safety and effective medication management.
• Information that supports the choice of the right drug according to a formulary, which is based on therapeutic guidelines combined with the characteristics of the patient.
To ensure the safe use of medications, it is crucial to have decision support during the prescribing and dispensing processes Ideally, a decision support system should be integrated with the MPD system, allowing for real-time access to vital information when medications are prescribed or dispensed Consequently, the MPD system must serve as the foundational framework for linking the decision support tools effectively.
The MPD-system will enhance decision support by providing comprehensive descriptions of all available medicinal products, ranging from detailed specifics to general overviews, while ensuring appropriate relationships between these levels and the decision support system.
This approach facilitates decision support at a generic level for all medicines within that category, or it can be tailored to provide specific decision support for individual products when necessary.
The MPD-system enables the categorization of characteristics to enhance decision support connections beyond traditional hierarchical levels For instance, it allows for linking decision support specifically to all ibuprofen products administered orally and rectally, while excluding cutaneous products.
• The MPD-system shall relate medicinal product concepts together within the inventory or catalogue in such a way as to support some reasoning (even if very basic).
Every country has reimbursement systems in place as part of their healthcare system It is obvious that often quite expensive medicinal products fall under such a regime.
This use case focuses on reimbursements for dispensed medicinal products An MPD system must provide essential medicinal product information to facilitate various secondary applications, including pricing transparency, appropriate procurement links, and research opportunities.
An MPD system is essential for submitting accurate information required by the organization responsible for reimbursing medication It must accommodate various levels of granularity to meet diverse informational needs.
An MPD-system must enable the inclusion of supplementary data beyond the IDMP data fields for submission to reimbursement systems This additional information should encompass the medicine's price, value-added tax, reimbursement status, and the specific reimbursement class, whether it is covered by the government, an insurance company, or other entities.
Interaction of MPD-systems with pharmacovigilance systems
Pharmacovigilance primarily targets adverse drug reactions (ADRs), defined as harmful and unintended responses to medicinal products, including instances of lack of efficacy Additionally, it encompasses medication errors such as overdoses, misuse, and abuse of drugs, along with drug exposure during pregnancy and breastfeeding, as these factors can also lead to ADRs.
An MPD-system is essential for delivering detailed information about a 'suspect drug' at various levels, including active substance, dosage, dosage form, route of administration, product trade name, packaging, administered product, manufacturer, and batch This comprehensive data is crucial for identifying the root cause of adverse events related to the drug, such as issues linked to a specific substance, manufacturer, or batch.
An MPD-system facilitates electronic interactions among diverse electronic health record systems, personal health record systems, and pharmacy systems, ensuring accurate specification of administered medicinal products.
An MPD-system enhances pharmacovigilance reporting by facilitating the submission of medicinal product identifiers and relevant information to national and international reporting systems This enables healthcare professionals and others to report adverse drug reactions to a central agency in compliance with Individual Case Safety Reports (ICSR) guidelines.
Data exchange and technical functions
The MPD-system is designed to benefit both human users and health information systems, facilitating interactions through a human-computer interface for users and technical interfaces for other computer systems This section outlines the functional requirements for both interaction levels.
7.3.11.1 Human interface to the MPD-system: multiple views
The MPD-system must cater to a diverse range of users, including regulators seeking to assess its completeness, developers aiming to maintain its currency, physicians using it for prescriptions, pharmacists during dispensing, and patients desiring clear information Each user group has distinct perspectives on the system's content, with some preferring a broad overview while others require detailed, granular insights.
This leads to the following criteria for MPD-systems:
• An MPD-system should provide a function which allows defining different views on the data fields inside, and a selective choice of what is presented to which target audience.
• An MPD-system should provide the option to change such views on demand.
• An MPD-system should have a role based access system to control the content Minimum roles are based on the CRUDE matrix: Create, Read, Update, Deprecate and Exchange.
• The role based access to the MPD-system shall be defined at individual database field level, on record level and on view level.
• An MPD-system’s Deprecate function shall not actually destroy the contents about medicinal products, but will define policies around a products end of life.
• An MPD-system should facilitate the creation of views, based on a flexible set of fields to be shown, however, taking into account the limits set.
7.3.11.2 Technical interfaces with various Health IT systems
The MPD-system must interface with multiple healthcare information systems, accommodating various human roles While this Technical Specification does not detail every possible interface, it will highlight some core systems as examples based on generic criteria.
• An MPD-system should provide a function which allows defining different technical interfaces to other health information systems.
• An MPD-system should provide a function which allows deploying standards for electronic interchanges to other health information systems An example can be a Health Level 7 interface.
An MPD system must include a user-friendly feature that enables the definition of trigger events for electronic data interchange For instance, a physician can initiate a pull request to access necessary data for a prescription, which is then stored in the patient's electronic health record (EHR).
• An MPD-system should provide a function which allows such a trigger event to automatically carry out the specified data exchange task(s).
An MPD system must enable users to define diverse data exchange tasks, including retrieving relevant data from the medicinal products database with varying degrees of generality or specificity It should also format this data for compatibility with the receiving system or messaging platform, facilitating seamless data exchange.
An MPD-system offers functionality for managing application roles, enabling the tracking and tracing of exported data to various systems, including details on when and where the data was sent Additionally, it can automatically dispatch updated information or alerts when new data regarding a specific medicinal product becomes available.
• An MPD-system shall provide a function which allows exchanging data with electronic health record systems.
• An MPD-system shall provide a function which allows exchanging data with clinical decision support systems.
• An MPD-system shall provide a function which allows exchanging data with clinical data warehouse systems.
• An MPD-system shall provide a function which allows exchanging data with pharmacovigilance case reporting systems, i.e ICSR based systems.
• An MPD-system shall provide a function which allows receiving data from national regulatory systems, distributing market authorization data and IDMP based data.
• An MPD-system shall deploy a technical interface that allows regular updates from the (inter) national IDMP database.
Governance
Developers of MPD-systems must adhere to the principles and processes outlined in ISO/TR 12309:2009 to ensure the proper application of international healthcare terminology standardization These principles are essential for effective implementation and compliance.
ISO/TR 14872 provides essential guidelines for the governance and maintenance of the ISO IDMP Standards, with principles that may also be relevant to the governance and maintenance frameworks for MPD systems.
The information models representing the MPD-system must adhere to principles of governance, due process, transparency, impartiality, and balance, ensuring they are safe and sustainable This Technical Specification, while focused on other topics, applies similar approaches to the information model of MPD-systems.
A well-defined governance model is essential for an MPD-system to maintain the quality, consistency, usability, security, and availability of information This governance body should oversee the development of the dictionary and maintain a business plan, ensuring input from Subject Matter Experts (SMEs), Data Stewards, Dictionary Users, and Management representatives Additionally, the model must facilitate collaboration with governance organizations related to terminologies, such as ISO IDMP Standards, to enhance consistency, interoperability, and minimize redundancy.
• The governance mechanism for a body distributing an MPD-system should apply an established and proven governance model.
NOTE Examples would include the Plan Do Check Act process, or another example could be ISO 9001 based procedures.
The governance framework for an organization managing an MPD system should incorporate international standards when relevant, particularly concerning the marketing authorization of medicinal products, the use of identifiers, detailed descriptions at both generic and specific levels, and the reporting of adverse reactions.
• The governance mechanism for a body distributing an MPD-system should apply clear lines of communication with regulators.
• The governance mechanism for a body distributing an MPD-system should apply safety procedures.
• The governance mechanism for a body distributing an MPD-system should apply links of communication to vendor communities both for medicinal products and for electronic healthcare systems.
Maintenance
Regular maintenance processes of the MPD-system
• Maintenance processes should be fully documented, communicated and appropriately maintained, with approved Standard Operating Procedures (SOPs) and Service Level Agreements.
• Controlled terms, versions and whole vocabularies shall not be deleted, but instead should be designated as “retired” or “deprecated” and should be traceable at every time point.
Requests for new terms, modifications to existing terms, or the retirement of terms should be handled promptly, taking into account the specific use cases as well as the frequency and complexity of the maintenance activities involved.
• Decisions should be communicated, including publication of the new, modified or retired term, within the time frame specified in approved service level agreements.
• Requests for new terms, term changes or term retirement should be supported with appropriate levels of information, details of which should be specified in the approved service level agreements.
Effective evaluation and approval of change requests require proportionate procedures, appropriate security measures, and quality control, all conducted by qualified personnel Additionally, the consideration of independent audits can enhance the integrity of the process.
• Electronic means for receiving, processing and communicating the outcome of change requests should be used where possible.
To maintain the integrity of the MPD-system, it is essential to implement mechanisms that ensure timely updates of elements and vocabularies mastered by other organizations Any modifications to these elements and vocabularies must originate from the master source before being reflected in the MPD-system Requests for changes should be directed to the mastering organization to ensure proper management and accuracy.
• The MPD-system owner should deploy a strict and transparent versioning approach to guarantee up to date content to the various MPD-system users.
• Appropriate advanced notice and sufficient detail should be given to stakeholders for any major data or structural changes or releases of the MPD-system.
Interaction with regulatory information
This subclause encompasses two primary regulatory categories: the approval of new medicinal products and the withdrawal of existing products for various reasons, each categorized under distinct headers.
The interaction with regulatory authorities / pharmaceutical industry to submit new approved medications with all details that need to be included in the MPD-system.
• To support the availability of new medicines for the several use cases, the MPD-system shall synchronize regularly with regulatory master information services to obtain newly registered medications data.
The identifiers for marketing status in the local MPD-system ensure that new medicines can only be prescribed and dispensed if they are available in the specific country or area where the system is implemented.
7.5.2.2 Withdrawn marketing authorization and discontinued medicinal products
This subclause outlines how the MPD-system interacts with regulatory authorities and pharmaceutical industry databases to withdraw medications It emphasizes the necessity of addressing all relevant details that must be removed, inactivated, or marked as not available in the MPD-system, while also acknowledging that certain medications may no longer be distributed but still exist in historical records.
• The MPD-system shall synchronize regularly with regulation master databases to obtain data about withdrawn medicinal products that have lost their marketing authorization.
In implementing the MPD system, it is essential to ensure that withdrawn medicinal products can still be prescribed and dispensed, provided they are available from the marketing authorization holder or wholesaler during any legal transition period that allows for their lawful prescription and sale.
• In the implementation of the MPD-system it shall be guaranteed that withdrawn medicinal products can be kept in the medication history of an individual.