Jim Case

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Jim Case

Victor Medina 

Jim Case 

Discussion:

Jim Case 

Disorders or conditions caused by a drug or medicinal product are variably modeled as subtypes of either 281647001 |Adverse reaction (disorder)| or a variety of other Disorder concepts. This inconsistency has led to many disorders that should be subtypes of 281647001 |Adverse reaction (disorder)| to not classify as subtypes.  Based on definitions of adverse reactions from multiple sources, it is proposed that all disorder concepts with a CAUSED BY relationship value from the Pharmaceutical/biological product hierarchy be modeled as a subtype of Adverse reaction.  In some cases this parent assignment will be in addition to other proximal primitive parents assigned in the concept model.

Definitions:

Glossary of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, for Adverse Drug Reaction (ADR):

--In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.

The phrase "responses to a medicinal products" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out.

--Regarding marketed medicinal products, a well-accepted definition of an adverse drug reaction in the post-marketing setting is found in WHO Technical Report 498 [1972] and reads as follows: A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function. 
The old term "side effect" has been used in various ways in the past, usually to describe negative (unfavourable) effects, but also positive (favourable) effects. It is  recommended that this term no longer be used and particularly should not be regarded as synonymous with adverse event or adverse reaction.

Pg 9 of 205: Adverse drug reactions, as established by regional regulations, guidance, and practices, concern noxious and unintended responses to a medicinal product. The phrase “responses to a medicinal product” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. A reaction, in contrast to an event, is characterized by the fact that a causal relationship between the drug and the occurrence is suspected. For regulatory reporting purposes, if an event is spontaneously reported, even if the relationship is unknown or unstated, it meets the definition of an adverse drug reaction.

Downloaded from https://cioms.ch/publications/product/glossary-of-ich-terms-and-definitions/#description. Referenced by MedDRA. 

US Regulatory Definition (21 CFR 201.57(c)(7)): •“An undesirable effect, reasonably associated with use of a drug… − that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence” •“Does not include all adverse events observed… −only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event” •Causal relationship need not have been definitively established (see also §201.57(c)(6)(i))

Discussion:

Jim Case 

Expansion of the prior briefing note to inactivate the Navigational concept hierarchy to include its parent 370115009 |Special concept (special concept)|, as it only has one subtype.  See link to briefing note above.

Decision:

Jim Case 

Nicola Ingram 

Issue with positioning non-pharmaceutical products (e.g. nicotine, environmental products) as there is not generic Product top level hierarchy. The proposal is to create this new top-level concept, and make the current 373873005 |Pharmaceutical / biologic product (product)| a subtype.  This would also allow the movement of many of the current substance concepts under 312412007 |Substance categorized functionally (substance)|, most of which are not pharmaceutical, to be reclassified as products.

Decision:

Feikje Hielkema-Raadsveld 

Inconsistent representation of "No known...(situation)" with proposed remodeling.  See attached document.

Different resolution depending on whether the Situation is a "Finding with explicit context" (allowed range = <<  410514004 |Finding context value (qualifier value)|) or a "Procedure with explicit context" (allowed range - <<  288532009 |Context values for actions (qualifier value)|)?

Proposed definition for "No known" after consultation with EAG members.  Differs from "unknown" in that it implies a reasonable effort to acquire the information, or a lack of evidence to support the issue at hand as opposed to a general lack of information for any reason.  Agreed in the last meeting in Atlanta that it should be a sibling of "Unknown".

Latest proposed Definition:

Subsequent to a reasonable attempt to acquire information, there is no evidence or information that proves the presence of a particular finding, therefore assuming its absence without objective proof.

11/27/2023 Decision:

Topic table for now.  EAG members encouraged to review Monique's document and add comments in preparation for a later meeting. Review the attached document:

Context_No known_MvB_Short_20231127.docx

Decision:

Feikje Hielkema-Raadsveld Daniel Karlsson 

Jim Case 

• A request from multiple member countries to enhance the MRCM in the Physical object hierarchy to support the definition of specimen containers.
• A request to add a new attribute to the Specimen hierarchy MRCM to support the container in which a specimen is "contained".
• Briefing note attached 

11/27/2023 Discussion:

Requirements were developed with lab specialists to meet their needs.  There needs to be some more specific use cases to make the effort worth it other than just making the hierarchy more manageable.

Meetings will continue on the fourth Monday of the month and may be cancelled if necessary.