Use of MedDRA: Focus on the New Scope of Adverse Event Reporting · 2013-07-20 · 7/19/2013 1...
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7/19/2013 1 Patrick Revelle MedDRA MSSO 5 February 2013 Use of MedDRA: Focus on the New Scope of Adverse Event Reporting 2 Overview • The new EU pharmacovigilance legislation broadened the definition of an adverse event • Now includes terms in MedDRA for off label use, overdose, misuse, abuse, medication errors, and occupational exposure • Preview of relevant changes in MedDRA Term Selection: Points to Consider (MTS:PTC) document
Transcript of Use of MedDRA: Focus on the New Scope of Adverse Event Reporting · 2013-07-20 · 7/19/2013 1...
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Patrick Revelle
MedDRA MSSO
5 February 2013
Use of MedDRA: Focus on the New Scope of AdverseEvent Reporting
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Overview
• The new EU pharmacovigilance legislation broadened the definition of an adverse event
• Now includes terms in MedDRA for off label use, overdose, misuse, abuse, medication errors, and occupational exposure
• Preview of relevant changes in MedDRA Term Selection: Points to Consider (MTS:PTC) document
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EU Pharmacovigilance Directive
Chapter 17Member States should operate a pharmacovigilance system to collect information that is useful for the monitoring of medicinal products, including information on suspected adverse reactions arising from use of a medicinal product within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisation, including overdose, misuse, abuse and medication errors, and suspected adverse reactions associated with occupational exposure.
EU Pharmacovigilance Directive (cont)
Drug Information Association www.diahome.org 4
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• There are two PTC documents– Term Selection– Data Retrieval and
Presentation
• Using MedDRA is a big step forward
• Using MedDRA the same way is a leap toward harmonization
MedDRA PTC Documents (1)
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MedDRA PTC Documents (2)
• Developed by a working group of the ICH Steering Committee– Regulators and industry representatives– EU, Japan, USA– Canadian observer, MSSO, JMO
• Updated twice yearly with each MedDRA release• Current version available on MSSO Web site
– English and Japanese– Summary of Changes document– Microsoft Word ®, Adobe ® PDF, and web-based formats
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Revisions Related to New EU PV Legislation
• Significant revisions to MedDRA Term Selection: Points to Consider for Release 4.5, based on MedDRA v16.0 (1 April 2013)– Definitions added (consistent with international
regulatory authorities’ definitions)– Examples added– New section on Misuse, Abuse and Addiction
• MedDRA Introductory Guide v16.0 (1 March 2013)– Definitions added (consistent with MTS:PTC definitions)
• MedDRA v16.0 (1 March 2013)– Added new HLT Occupational exposures
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Off Label Use – Terms in MedDRA
• Currently in MedDRA
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Off Label Use – MTS:PTC (1)
3.27 – Off Label Use
The concept of “off label use” relates to situations where the product is intentionally used for a medical purpose not in accordance with the authorized product information.
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Off Label Use – MTS:PTC (2)
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Off Label Use – MTS:PTC (3)
Example from the PTC
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Off Label Use – MTS:PTC (cont)
Off Label Use – MTS:PTC (4)
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Off Label Use – MTS:PTC (cont)
Off Label Use – MTS:PTC (5)
Example from the PTC
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Overdose – Terms in MedDRA (1)
Current Overdose terms in MedDRA
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Overdose – EMA Definition
OverdoseThis refers to the administration of a quantity of a medicinal product given per administration or cumulatively, which is above the maximum recommended dose according to the authorised product information. Clinical judgement should always be applied.
EMA. Guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products.
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Overdose – MTS:PTC (1)
If overdose, poisoning or toxicity is explicitly reported, select the appropriate term.
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Overdose – MTS:PTC (2)
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Overdose – MTS:PTC (3)
If an overdose report specifically states that there were no clinical consequences, select LLT Overdose and the additional LLT No adverse effect can be selected.
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Misuse, Abuse and Addiction New MTS:PTC section
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Misuse – Terms in MedDRA
• Current Misuse terms in MedDRA
• Note that misuse is considered intentional
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Misuse – MTS:PTC (1)
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Misuse – MTS:PTC (2)
Example from PTC
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Abuse – Terms in MedDRA (1)
Current Abuse terms in MedDRA
Abuse – Terms in MedDRA (2)
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Abuse – MTS:PTC (1)
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Abuse – MTS:PTC (2)
Example from PTC
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Addiction – MTS:PTC (1)
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Addiction – MTS:PTC (2)
Example from PTC
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Expansion of Medication Error Terms
• Prior to MedDRA Version 8.0, only one term existed - PT Medication error
• Medication error section expanded in v8.0– Added HLGT Medication errors in SOC Injury,
poisoning and procedural complications• HLT Maladministrations
• HLT Medication errors due to accidental exposures
• HLT Medication monitoring errors
• HLT Overdoses
• HLT Medication errors NEC
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Concept Descriptions
• Appendix B in MedDRA Introductory Guide• To assist in understanding and appropriate
use of medication error and product quality issue terms in regulatory reporting
• Medication error descriptions developed by FDA and MSSO
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Medication Error Concept Description Example
• Documented hypersensitivity to administered drug: This medication error refers to the situation when a patient is administered a drug that is documented in the patient's medical file to cause a hypersensitivity reaction in the patient. Example: Despite the fact that the patient's medical record indicated "sulfa allergy," the physician prescribed a sulfa antibiotic. Subsequently, the patient took the antibiotic and experienced hives.
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Medication Errors – Terms in MedDRA
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•Approx. 160 LLTs under HLGT Medication errors- Examples
•LLT Intramuscular formulation administered by other route•LLT Wrong drug dispensed
•Note: Includes“overdose” terms
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Medication Errors – MTS:PTC (1)
Note that Occupational Exposures has been added to section name
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Medication Errors – MTS:PTC (2)
• 3.15.1 Medication/Administration Errors– 3.15.1.1 Medication errors reported with clinical
consequences– 3.15.1.2 Medication errors and potential medication
errors reported without clinical consequences– 3.15.1.3 Medication errors in the context of labeled
interactions– 3.15.1.4 Do not infer a medication error
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Medication Errors and Product Quality Issues
• There can be overlap between product quality issues and medication errors
• An example of both a product quality issue and a medication error is provided
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Accidental Exposures – MTS:PTC
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Occupational Exposure – Terms in MedDRA
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Current Occupational Exposure terms in MedDRA
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Occupational Exposures – MTS:PTC (1)
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Occupational Exposures – MTS:PTC (2)
Example from PTC
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Summary
• There is regulatory interest in “special situations”– Off label use– Overdose– Misuse– Abuse– Medication errors– Occupational exposure
• MedDRA covers most such concepts and can expand as needed through Change Requests
• MTS:PTC provides definitions and coding examples. Feedback welcome!
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Thank You
