Jim Case

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Jim Case

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Peter G. Williams 

Jim Case 

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 to make changes as described.

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.

Jim Case 

April business meeting