MedDRA Term Selection: Latest activities of the Points to Consider Working Group

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1 MedDRA Term Selection: Latest activities of the Points to Consider Working Group Patrick Revelle MedDRA MSSO 23 May 2013 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 MedDRA Term Selection: Points to Consider (MTS:PTC) document changed as a result Drug Information Association 2 1

2 EU Pharmacovigilance Directive Chapter 17 Member 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. Drug Information Association 3 MedDRA PTC Documents 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 Drug Information Association 4 2

3 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 Definitions added (consistent with international regulatory authorities definitions) Examples added New section on Misuse, Abuse and Addiction MedDRA Introductory Guide v16.0 Definitions added MedDRA v16.0 (March 2013) Added new HLT Occupational exposures Drug Information Association 5 Off Label Use Terms in MedDRA Currently in MedDRA Drug Information Association 6 3

4 Off Label Use MTS:PTC (1) 3.27 Off Label Use Relates to situations where the product is intentionally used for a medical purpose not in accordance with the authorized product information Reported as an indication Reported with an AR/AE Drug Information Association 7 Off Label Use MTS:PTC (2) Reported as an indication Medical condition reported as an indication along with off label use Preferred option is to select terms for the medical condition and LLT Off label use Alternatively, select a term for the medical condition/indication alone. Select LLT Off label use alone only if it is the only information available. Drug Information Association 8 4

5 Off Label Use MTS:PTC (3) Reported with an AR/AE Preferred option is to select LLT Off label use and a term for the medical condition in addition to a term for the AR/AE Alternatively, select a term for the medical condition and a term for the AR/AE Drug Information Association 9 Overdose Terms in MedDRA (1) Current Overdose terms in MedDRA Drug Information Association

6 Overdose EMA Definition Overdose This 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. Drug Information Association 11 Overdose MTS:PTC 3.18 Overdose, Toxicity and Poisoning If overdose, poisoning or toxicity is explicitly reported, select the appropriate term. Guidance provided for cases with and without clinical consequences Drug Information Association

7 Misuse, Abuse and Addiction New MTS:PTC section 3.16 Misuse, Abuse and Addiction Closely related and can pose challenges for coding given overlap in meaning PTC includes a table to help provide guidance based on several factors Drug Information Association 13 Misuse Terms in MedDRA Current Misuse terms in MedDRA Drug Information Association

8 Misuse MTS:PTC Misuse Within MedDRA, misuse is the intentional and inappropriate use of a product (Over-thecounter or prescription) Other than as prescribed or not in accordance with the authorized product information Drug Information Association 15 Abuse Terms in MedDRA (1) Current Abuse terms in MedDRA 16 8

9 Abuse Terms in MedDRA (2) Drug Information Association 17 Abuse MTS:PTC Abuse Within MedDRA, abuse is the intentional, nontherapeutic use of a product (over-the counter or prescription) For a perceived reward or desired non-therapeutic effect including (e.g., getting high ) Abuse may occur with a single use, sporadic use or persistent use Drug Information Association

10 Addiction MTS:PTC (1) Addiction Within MedDRA, addiction is an overwhelming desire to take a drug for non-therapeutic purposes together with inability to control or stop its use despite harmful consequences. Addiction can occur because drug induces physical dependence Addiction can occur because of a desire to experience the drug's psychological, behavioral or physical effects. Drug Information Association 19 Addiction MTS:PTC (2) Example from PTC Drug Information Association

11 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 Drug Information Association 21 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 Drug Information Association

12 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. Drug Information Association 23 Medication Errors Terms in MedDRA Approx. 160 LLTs under HLGT Medication errors - Examples LLT Intramuscular formulation administered by other route LLT Wrong drug dispensed Note: Includes overdose terms Drug Information Association

13 Medication Errors MTS:PTC (2) Medication/Administration Errors Medication errors reported with clinical consequences Medication errors and potential medication errors reported without clinical consequences Medication errors in the context of labeled interactions Do not infer a medication error Drug Information Association 25 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 Drug Information Association

14 Occupational Exposure Terms in MedDRA Current Occupational Exposure terms in MedDRA Drug Information Association 27 Occupational Exposures MTS:PTC (1) Accidental exposures and occupational exposures Within MedDRA, occupational exposure encompasses the chronic exposure to an agent during the normal course of one s occupation Can include additional scenarios in specific regulatory regions Occupational exposure may additionally relate to a more acute, accidental form of exposure In some regions, occupational exposure for healthcare workers could be of particular interest. Drug Information Association

15 Occupational Exposures MTS:PTC (2) Example from PTC Drug Information Association 29 Summary Many changes in PTC document driven by new PV legislation 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! Drug Information Association

16 Acknowledgement Thanks to Dr. Patricia Mozzicato and Dr. Judy Harrison for their support in developing this presentation Drug Information Association 31 Thank You 16