ISO/TC 215/WG 6 - Pharmacy and medicines business

This document specifies the requirements for medication safety alert systems and the topics which are relevant to alert system vendors. This document applies to clinical decision support systems (CDSSs) whether or not these are medical devices. This document addresses: — requirements for terminology used in medication safety alerts; — requirements for choosing a knowledge base for medication safety alert systems; — requirements for the proper functionality of CDSSs as related to medication safety alert systems; — requirements for medication safety alert display; — requirements for quality measurements to improve the effectiveness of medication safety alerts. The following are out of the scope of this document: — the development of content (rule-based knowledge base) for CDSS; — the development of algorithms for generating medication safety alerts in CDSS; — the development of alert processors for medication safety alerts in CDSS.

This document provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product. This document outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency Identification (RFID).

This document specifies the requirements for developing a knowledge base for drug-related problems that cohere with the intended drug use, to be used in rule-based clinical decision support systems (CDSS), such as the criteria for selecting a raw data source and the quality criteria for the development and maintenance for the rules or clinical rules for drug safety. It also describes the process of how to develop a knowledge base, the topics to be considered by the developers of a knowledge base, and it gives guidance on how to do this. This document gives guidelines for the development of a knowledge base: — with rules to enhance decisions and actions in drug-related problems that cohere with the intended drug use; — which can be used by all kinds of healthcare professionals, such as those who prescribe, dispense, administer or monitor medicines; — which can be used in every care setting, including chronic and acute care, primary and specialized care; — which is a repository of evidence/practice bases rules, assessed by experts; — which is meant to be used in conjunction with a medicinal product dictionary; — whose knowledge is structured in rules and therefore to be used in the type of rule-based CDSS. This document does not: — describe the exact content of a knowledge base i.e. the outcome of the process of developing rules. — provide the requirements for a clinical decision support system, the software that uses the knowledge base combined with the patient's data, and presents the outcome of the rules to the healthcare professional. These requirements are described in ISO/DTS 22703[1]. — give the requirements for non-medication knowledge bases. Some aspects of the requirements in this document are general in nature and applicable to other kinds of knowledge bases, but this document does not address all of the requirements of non-medication knowledge bases. [1] Under preparation. Stage at the time of publication: ISO/DTS 22703.

The purpose of this document is to describe the core principles and proposed service delivery model for supporting implementation and ongoing maintenance of IDMP terminologies. The information provided in this document can be used as evaluation and/or design criteria when considering current or future operations and service level agreements for systems and terminology support services in conformity with IDMP.

This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.

This document is used in the implementation of ISO 11238. This document defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production. ISO 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high-level model for the structuring of information for substances. This document provides detailed explanations of each type or grouping of substance information, an element-by-element description for implementation of ISO 11238, and examples for a variety of Substances and Specified Substances. This third edition of the document addresses Substances Groups 1 to 3 of the Specified Substances as defined in ISO 11238 and Annexes A, B, C, D, E, F, G, H, I, J and K. It is anticipated that Specified Substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of this document. Some information that would typically fall under Specified Substances Group 4 is covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, might be essential to distinguishing substances. This document addresses the following: - data elements necessary for defining Substances and Specified Substances Groups 1 to 3; - the logical use of data elements as defined in ISO 11238; - Substances and Specified Substances Groups 1 to 3 business rules for: - determining necessary data elements, - distinguishing and defining materials according to ISO 11238, - triggering the assignment of identifiers. This document does not address the following: - business processes for data management; - implementation of a specific data information system (e.g. a relational database schema); - normative messaging standards for substances; - the maintenance of controlled vocabularies; - the specific global identifier system that should be used; - nomenclature standards for substances.

ISO/TS 19293:2018 specifies requirements for a record of a dispense of a medicinal product. It is intended to be adopted by detailed, implementable specifications, such as interoperability standards, system specifications, and regulatory programs. ISO/TS 19293:2018 applies to information systems in which a dispense of a medicinal product is registered, and the systems that consume such information. These systems are usually in pharmacies or other healthcare institutions. This document does not necessarily apply to non-pharmacy shops or other non-clinical systems (e.g. supermarket cashiers). The scope of ISO/TS 19293:2018 includes the activities relating to the dispensing of a medicinal product and the information content for the capture of structured information produced in those events. These activities include any actual dispense, cancellation or other outcome that may have occurred at the time of planned or actual dispense. In other words, the dispense record also contains information that medication was expected to be dispensed but was not dispensed.

ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017. Medicinal products for veterinary use are out of scope of ISO 11616:2017.

ISO/TS 20443:2017 defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in ISO/TS 20443:2017 to support successful information exchange.

ISO/TS 20451:2017 defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616. Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of ISO/TS 20451:2017. Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7 Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured Product Labelling (SPL) can be applied for pharmaceutical product information in the context of ISO/TS 20451:2017.

ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

The purpose of ISO/TR 20831:2017 is to define the various concepts and terminologies used in the pharmacy domain when applied to the topic of creating medication lists from existing data.

ISO 17523:2016 specifies the requirements that apply to electronic prescriptions. It describes generic principles that are considered important for all electronic prescriptions. ISO 17523:2016 is constrained to the content of the electronic prescription itself, the digital document which is issued by a prescribing healthcare professional and received by a dispensing healthcare professional. The prescribed medicinal product is to be dispensed through an authorized healthcare professional with the aim of being administered to a human patient. Other messages, roles and scenarios (e.g. validation of a prescription, administration, medication charts, EHR of the patient, reimbursement of care and dispensed products) are out of scope of this International Standard, because they are more or less country or region specific, due to differences in culture and in legislation of healthcare. However, requirements and content of electronic prescriptions within the context of jurisdictions have a relationship with these scenarios. The way in which electronic prescriptions are made available or exchanged also fall outside the scope of this International Standard. ISO 17523:2016 is applicable to electronic prescriptions of medicinal products. Although other kinds of products (e.g. medical devices, wound care products) can be ordered by means of an electronic prescription, the requirements in this International Standard are aimed at medicinal products that have a market authorization and at pharmaceutical preparations which are compounded in a pharmacy. An electronic prescription is an information object that authorizes a healthcare professional to legally dispense a medicinal product. ISO 17523:2016 specifies a list of data elements that can be considered as essential for electronic prescriptions, depending on jurisdiction or clinical setting (primary healthcare, hospital, etc.).

ISO/TS 19256:2016 defines the required characteristics for any MPD-system to support use cases in healthcare. These characteristics include the medication concepts, identifiers and relationships to form a kind of structure that supports the use cases.

ISO 11240:2012: specifies rules for the usage and coded representation of units of measurement for the purpose of exchanging information about quantitative medicinal product characteristics that require units of measurement (e.g. strength) in the human medicine domain; establishes requirements for units in order to provide traceability to international metrological standards; provides rules for the standardized and machine-readable documentation of quantitative composition and strength of medicinal products, specifically in the context of medicinal product identification; defines the requirements for the representation of units of measurement in coded form; provides structures and rules for mapping between different unit vocabularies and language translations to support the implementation of ISO 11240:2012, taking into account that existing systems, dictionaries and repositories use a variety of terms and codes for the representation of units. The scope of ISO 11240:2012 is limited to the representation of units of measurement for data interchange between computer applications.

ISO 27953-1:2011 seeks to establish an international framework for data exchange and information sharing by providing a common messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that can occur upon the administration or use of one or more products. The messaging format is based upon the HL7 Reference Information Model (RIM) and can be extended or constrained to accommodate a variety of reporting use cases. ISO 27953-1:2011 will be harmonized over time with other HL7 public health and patient safety reporting standards to help ensure that messaging constructs and vocabulary are harmonized in the HL7 Public Heath and Regulatory Reporting domains. The data elements used in ISO 27953-1:2011 were identified as consistent across many of the use cases and can be applied to a variety of reporting scenarios. Specific reporting requirements within organizations or regions might vary.

ISO 27593-2:2011 seeks to create a standardized framework for international regulatory reporting and information sharing by providing a common set of data elements and a messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that can occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination.

ISO/TS 19844:2016 is used in the implementation of ISO 11238. This document defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production. ISO 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high level model for the structuring of information for substances. This document provides detailed explanations of each type or grouping of substance information, an element-by-element description for implementation of ISO 11238, and examples for a variety of Substances and Specified Substances. This second edition of the document addresses substances, Groups 1 to 3 of the Specified Substances as defined in ISO 11238 and Annexes A, B, C, D, E, F, G and H. It is anticipated that Specified Substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of this document. Some information that would typically fall under Specified Substances Group 4 may be covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, may be essential to distinguishing substances. This document addresses the following: · Data elements necessary for defining Substances and Specified Substances Groups 1 to 3; · The logical use of data elements as defined in ISO 11238; · Substances and Specified Substances Groups 1 to 3 business rules for - determining necessary data elements, - distinguishing and defining materials according to ISO 11238, - triggering the assignment of identifiers. ISO/TS 19844:2016 does not address the following: · Business processes for data management; · Implementation of a specific data information system (e.g. a relational database schema); · Normative messaging standards for substances; · The maintenance of controlled vocabularies; · The specific global identifier system that should be used; · Nomenclature standards for substances.

ISO/TS 17251:2016 specifies the business requirements for the structured content of structured or semi-structured dose instructions for recording dose instructions in the electronic health record (EHR), supporting clinical decision support, and in exchanging medication orders, as applicable to primary, secondary and tertiary care. NOTE See 2.9, note to entry, regarding the use of "medication order" and "prescription". Comprehension of dose instructions by the patient is an overarching consideration for patient safety and the best patient outcomes. Related factors are discussed, but are not part of the primary scope. It does not define an information model, except to the extent that those information model concepts are necessary to define business requirements. Outside the scope of ISO/TS 17251:2016 are: - the functionality of health, clinical and/or pharmacy systems; - other kinds of content of health, clinical or pharmacy systems that are needed to support the whole process of health care providers, such as: - wide range of knowledge about medicines that would be handled in drug knowledge databases and decision support systems; - the complete medical record (EHR); - a medicinal product dictionary.

ISO/TS 20440:2016 describes data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging. Based on the principles outlined in this Technical Specification, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those concepts. ISO/TS 20440:2016 is intended for use by: - any organisation that might be responsible for developing and maintaining such controlled vocabularies; - any regional authorities or software vendors who wish to use the controlled vocabularies in their own systems and need to understand how they are created; - owners of databases who wish to map their own terms to a central list of controlled vocabularies; - other users who wish to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept. The terminology to be applied in the context of this Technical Specification and set out in ISO 11239 is under development. All codes, terms and definitions used as examples in this Technical Specification are provided for illustration purposes only, and are not intended to represent the final terminology.

ISO/TS 19844:2015 is used in the implementation of ISO 11238. ISO/TS 19844:2015 defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production. ISO 11238 provides the conceptual framework for defining substances and specified substances and for assigning unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high level model for the structuring of information for substances. ISO/TS 19844:2015 provides detailed explanations of each type or grouping of substance information, an element-by-element description for implementation of ISO 11238, and examples for a variety of substances and specified substances. This first edition of ISO/TS 19844:2015 will only address substances, and Groups 1 to 3 of the specified substances as defined in ISO 11238 and Annexes A, B, C, and D. It is anticipated that specified substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of ISO/TS 19844:2015. Some information that would typically fall under specified substances Group 4 may be covered in the Annexes of ISO/TS 19844:2015. This information, although not defining of either a substance or a specified substance Group 1, may be essential to distinguishing substances. ISO/TS 19844:2015 addresses the following: Data elements necessary for defining substances and specified substances Groups 1 to 3; The logical use of data elements as defined in ISO 11238; Substances and specified substances Groups 1 to 3 business rules for - determining necessary data elements, - distinguishing and defining materials according to ISO 11238, - triggering the assignment of identifiers.

ISO/TS 16791:2014 provides guidance on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product. ISO/TS 16791:2014 outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies e.g. Radio Frequency Identification (RFID).

ISO 11616:2012 is intended to provide specific levels of information relevant to the identification of a medicinal product or group of medicinal products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2012 is essential to ensuring that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders. This ensures interoperability and compatibility for both the sender and the recipient.

ISO 11615:2012 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of medicinal products.

ISO 11239:2012 specifies: · the structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items related to medicinal products; · a mechanism for the association of translations of a single concept into different languages; · a mechanism for the versioning of the concepts in order to track their evolution; · rules to allow regional authorities to map existing regional terms to the terms created using ISO 11239:2012 in a harmonized and meaningful way.

ISO/TS 22224:2009 encompasses the electronic reporting of adverse reactions caused by drugs for human uses. Thus, other businesses relating to adverse events caused by blood transfusion, medical devices and veterinary drugs are excluded from the scope of ISO/TS 22224:2009.

ISO/TR 22790:2007 provides a common conceptual model of information management related to the process of prescribing or ordering medication. This Technical Report provides a set of optional business requirements that could be selected by the buyer in a procurement process to be responded to by a tendering supplier. This report shall not provide any mandatory requirements but, as an informative document, give a common expression of various possible functions meeting different objectives for the health care system. ISO/TR 22790:2007 is intended to be used as a guide for a specific organization in formulating and prioritizing a subset of characteristics tailored to national or local needs. The complete list here is thus not intended to be a minimum set of requirements that all systems must comply with. There may also be good reasons to further specify the generic characteristics presented here and to add other characteristics. This Technical Report contains the following sections: introduction to concepts with agreed definitions and recommended terms; overview of the relationships between different actors and information flows; overview of the functional model taking as its starting point the objectives of the health care system; overview of the different information resources needed to achieve the requirements; a list of detailed characteristics to select from in a procurement process.