With the major and complex MedDRA update (version 19.0) coming on 02 May 2016, here is the summary of key changes:
New 27th SOC: ‘Product issues’
The ICH MedDRA Management Board endorsed the creation of a new 27th SOC, called ‘Product issues’, to be implemented. Currently there exists 26 SOCs which have been in place since the creation of MedDRA SOCs.
‘Product issues’ SOC will cover manufacturing and quality systems, product quality, devices, supply and distribution and counterfeit products.
14 new PTs have been added in this new SOC and other existing PTs are relocated from other SOCs, mainly from “General disorders and administration site conditions” SOC. Medical devices HLGT and HLTs from the General disorders SOC are also relocated.
Specifically there are two subsections (HLGT) that make up SOC 27:
Device issues: Currently there is one existing HLGT and 8 existing HLTs. No new HLT or HLGTs are added in the update of SOC 27. These, however, will be moved from SOC ‘General disorder’ to this SOC 27. Six new PTs are also added.
Product Quality (quality, supply, manufacturing, distribution): 5 exiting HLTs moved from SOC General disorders to this SOC 27, 8 new HLTs added and 7 existing PTs moved from SOC ‘General disorders’ to this SOC 27.
Implications in the PSUR:
SOCs are referenced within appendix 2.1 and 2.2 of the PSUR. SOC 27 will only show up in the summary tabulations if there are any cases for the SOC (not all SOCs appear in every tabulation – if no cases or AEs are coded for a particular SOC then the SOC will not appear in the summary tabulation).
The potential exists for an increase in total reported events due to the newly added PTs specific to SOC 27, or a noted change in the total AEs within other SOCs due to the change in the redistribution of some events between SOCs (regrouping of PTs, HLGT, HLTs to SOC 27). Therefore, an increase in the number of cases/events, or their distribution, may be apparent when compared to the previous PSUR and may necessitate a discussion in the PSUR.
New SMQs:
Three new SMQs will be released into production in MedDRA Version 19.0:
• SMQ Medication errors
• SMQ Drug reaction with eosinophilia and systemic symptoms syndrome
• SMQ Hypoglycaemia
Medication errors: With the recent guidelines from EMA on “Medication Errors”, new SMQ will also be launched in the new MedDRA version 19.0.
The SMQ is not mandatory for a company to use. Each company has a choice to continue to use their own search criteria (updated with any new PTs in the MedDRA update), or switch to the new SMQ. The new SMQ includes 123 PTs.
Additional PTs in the SMQ for ‘potential” medication errors - circumstances or information capable of leading to the occurrence of a medication error (terms which do not specifically represent a medication error, but have a significant potential to identify medication errors for their frequent association with them, such as product label issue terms, product exposure terms, and terms referring to administration of contraindicated drugs or other unapproved uses, for example ‘Product lot number issue’)
Implications in the PSUR:
Search criteria from 02 May 2016 with the MedDRA update may capture more data compared to the previous PSUR due to broad SMQ. This significant change needs to be explained in the medication error section of the PSUR.
Where PTs are duplicated in this new SMQ (as it includes overdose and devise issues problems) when compared to the other standard LLs such as “overdose’ and “devise issues’, the writer may want to filter these out and refer to the appropriate section of the PSUR where these are discussed.
New 27th SOC: ‘Product issues’
The ICH MedDRA Management Board endorsed the creation of a new 27th SOC, called ‘Product issues’, to be implemented. Currently there exists 26 SOCs which have been in place since the creation of MedDRA SOCs.
‘Product issues’ SOC will cover manufacturing and quality systems, product quality, devices, supply and distribution and counterfeit products.
14 new PTs have been added in this new SOC and other existing PTs are relocated from other SOCs, mainly from “General disorders and administration site conditions” SOC. Medical devices HLGT and HLTs from the General disorders SOC are also relocated.
Specifically there are two subsections (HLGT) that make up SOC 27:
Device issues: Currently there is one existing HLGT and 8 existing HLTs. No new HLT or HLGTs are added in the update of SOC 27. These, however, will be moved from SOC ‘General disorder’ to this SOC 27. Six new PTs are also added.
Product Quality (quality, supply, manufacturing, distribution): 5 exiting HLTs moved from SOC General disorders to this SOC 27, 8 new HLTs added and 7 existing PTs moved from SOC ‘General disorders’ to this SOC 27.
Implications in the PSUR:
SOCs are referenced within appendix 2.1 and 2.2 of the PSUR. SOC 27 will only show up in the summary tabulations if there are any cases for the SOC (not all SOCs appear in every tabulation – if no cases or AEs are coded for a particular SOC then the SOC will not appear in the summary tabulation).
The potential exists for an increase in total reported events due to the newly added PTs specific to SOC 27, or a noted change in the total AEs within other SOCs due to the change in the redistribution of some events between SOCs (regrouping of PTs, HLGT, HLTs to SOC 27). Therefore, an increase in the number of cases/events, or their distribution, may be apparent when compared to the previous PSUR and may necessitate a discussion in the PSUR.
New SMQs:
Three new SMQs will be released into production in MedDRA Version 19.0:
• SMQ Medication errors
• SMQ Drug reaction with eosinophilia and systemic symptoms syndrome
• SMQ Hypoglycaemia
Medication errors: With the recent guidelines from EMA on “Medication Errors”, new SMQ will also be launched in the new MedDRA version 19.0.
The SMQ is not mandatory for a company to use. Each company has a choice to continue to use their own search criteria (updated with any new PTs in the MedDRA update), or switch to the new SMQ. The new SMQ includes 123 PTs.
Additional PTs in the SMQ for ‘potential” medication errors - circumstances or information capable of leading to the occurrence of a medication error (terms which do not specifically represent a medication error, but have a significant potential to identify medication errors for their frequent association with them, such as product label issue terms, product exposure terms, and terms referring to administration of contraindicated drugs or other unapproved uses, for example ‘Product lot number issue’)
Implications in the PSUR:
Search criteria from 02 May 2016 with the MedDRA update may capture more data compared to the previous PSUR due to broad SMQ. This significant change needs to be explained in the medication error section of the PSUR.
Where PTs are duplicated in this new SMQ (as it includes overdose and devise issues problems) when compared to the other standard LLs such as “overdose’ and “devise issues’, the writer may want to filter these out and refer to the appropriate section of the PSUR where these are discussed.
Please feel free to provide your feedback.
Regards,
Dr. Gaurav Arora
