EU MedDRA Industry User Group
Kathy Manzetti, RN, CMC
October, 2013
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• Coding Challenges
• Medication errors: Terms in MedDRA v16.1
• Product quality issues: Terms in MedDRA v16.1
• Medication errors vs. Product quality issues
• Medication errors and Device issues
• Medication errors vs. Off-label use
• Medication errors vs. Drug misuse
• Summary and Reporting
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The pill looked like it had disintegrated but the patient took all remnants of the pill
The patient has been taking the medication out of the capsule and putting it in food
Patient received all 18 units of the medication at once due to a faulty pen
He re-dosed himself by estimating how much medication leaked out of the syringe
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Reports are unlike the terms in clinical trial data
Often cannot search MedDRA dictionary by a key word that may be found in the verbatim term – unlike a sign, symptom, diagnosis, procedure
Coders need to be knowledgeable regarding the types of terms available in MedDRA and the guidance provided in MedDRA PtC
May require top-down searching in MedDRA for most accurate classification
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MedDRA v8.0 – a significant number of specific medication error terms were added
HLGT = Medication errors SOC = Injury, poisoning and procedural complications MedDRA v16.1 has 55PTs/166 LLTs in this HLGT
Coding of Medication errors is addressed in MedDRA
Term Selection: Points to Consider
Medication error term concept descriptions are incorporated in Appendix B of the MedDRA Introductory Guide
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Medication errors are defined as any preventable event that may cause or lead to inappropriate
medication use or patient harm while the medication is in control of the health care professional, patient or
consumer. Such events may be related to professional practice, health care products,
procedures and systems, including prescribing, order communication, product labeling, packaging and
nomenclature, compounding, dispensing, distribution, administration, education, monitoring
and use.
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HLT Accidental exposures to product
PT Accidental exposure to product
PT Accidental exposure to product by child
HLT Maladmistrations
PT Accidental use of placebo
PT Booster dose missed
PT Counterfeit drug administered
PT Drug administered at inappropriate site
PT Drug administered in wrong device*
PT Drug administered to patient of inappropriate age
PT Drug administration error
PT Drug dose omission
PT Expired device used**
PT Expired drug administered
PT Inappropriate schedule of drug administration
PT Incomplete course of vaccination
PT Incorrect dose administered
PT Incorrect dose administered by device*
PT Incorrect drug administration duration
PT Incorrect drug administration rate
PT Incorrect drug dosage form administered
PT Incorrect route of drug administration
PT Intentional underdose
PT Intercepted drug administration error
PT Lack of injection site rotation
PT Multiple use of a single-use product
PT Poor quality drug administered
PT Prescribed underdose
PT Radiation underdose
PT Underdose
PT Wrong drug administered
PT Wrong technique in drug usage process
HLT Medication errors NEC
PT Circumstance or information capable of leading to medication error
PT Drug dispensing error
PT Drug label confusion*
PT Drug name confusion*
PT Drug prescribing error
PT Incorrect storage of drug*
PT Intercepted drug dispensing error
PT Intercepted drug prescribing error
PT Intercepted medication error
PT Medication error
PT Product dosage form confusion*
PT Vaccination error
HLT Medication monitoring errors
PT Documented hypersensitivity to administered drug
PT Drug administration monitoring procedure incorrectly performed
PT Drug administration monitoring procedure not performed
PT Labelled drug-disease interaction medication error*
PT Labelled drug-drug interaction medication error*
PT Labelled drug-food interaction medication error*
PT Therapeutic drug monitoring analysis incorrectly performed
PT Therapeutic drug monitoring analysis not performed
HLT Overdoses
PT Accidental overdose
PT Intentional overdose***
PT Overdose
PT Prescribed overdose
PT Radiation overdose
MedDRA v16.1 September, 2013
* Secondary SOC = General disorders and administration site conditions
** Primary SOC = General disorder and administration site conditions *** Secondary SOC = Psychiatric disorders
PT Accidental use of placebo PT Counterfeit drug administered PT Drug administered to patient of inappropriate age PT Expired drug administered PT Incorrect drug dosage form administered PT Poor quality drug administered PT Multiple use of a single-use product PT Wrong drug administered
PT Booster dose missed PT Drug dose omission PT Incomplete course of vaccination PT Incorrect dose administered PT Incorrect dose administered by device PT Intentional underdose PT Prescribed underdose PT Radiation underdose PT Underdose
PT Drug administered at inappropriate site PT Drug administered in wrong device PT Expired device used PT Incorrect route of drug administration PT Lack of injection site rotation
PT Drug administration error PT Intercepted drug administration error PT Wrong technique in drug usage process
PT Inappropriate schedule of drug administration PT Incorrect drug administration duration PT Incorrect drug administration rate
PATIENT + DRUG
DOSE
ROUTE/SITE/DEVICE
TIME
OTHER TERMS
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The patient was wrongly administered Drug A Dispersible tablets instead of Drug A CR capsules LLT/PT Incorrect drug dosage form administered Reconstituted the medication in 0.5 ml sterile water instead of 1.0 ml LLT Inappropriate dilution of medication PT Wrong technique in the drug usage process The pill looked like it had disintegrated but the patient took all remnants of the pill LLT Deteriorated drug administered PT Poor quality drug administered Administered Drug B Adult instead of Drug B Paediatric by mistake LLT/PT Drug administered to patient of inappropriate age The patient has been taking the medication out of the capsule and putting it in food LLT Inappropriate removal of drug from capsule PT Wrong technique in the drug usage process
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PT Overdose PT Accidental overdose PT Intentional overdose PT Prescribed overdose PT Radiation overdose
What medication(s)? ◦ LLTs include multiple drug overdose terms
Important to distinguish accidental vs. intentional vs. prescribed overdose
What was the consequence of the overdose?
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Definition (Introductory Guide MedDRA Version 16.1)
More that the medically recommended dose (in quantity and/or concentration) is administered. An excessive dose.
Definition (Guideline on Good Pharmacovigilance Practices (GVP) – Module VI EMA/873138/2011)
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.
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The patient unintentionally took 20 mg of Drug C instead of 10 mg
LLT/PT = Accidental overdose
LLT/PT = Incorrect dose administered
Coding convention to handle consistently
◦ Based on drug/amount administered vs prescribed?
◦ Based on recommended maximum dose on the label?
◦ Based on verbatim term report?
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Drug D IV solution was administered simultaneously while patient was receiving Ringer’s lactate Drug D
DOSAGE AND ADMINISTRATION
Drug D may be administered intravenously or intramuscularly.
Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute Drug D vials or to further dilute a reconstituted vial for IV administration because a precipitate can form.
LLT/PT= Labelled drug-drug interaction medication error
PT Documented hypersensitivity to administered drug
PT Labelled drug-disease interaction medication error
PT Labelled drug-drug interaction medication error
PT Labelled drug-food interaction medication error
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Proper drug administration includes monitoring for effectiveness and adverse effects. This may require activities such as monitoring of vital signs, performing lab tests, etc.
In order for some drugs to be effective and non-toxic, therapeutic drug monitoring testing is required to ensure a blood concentration of a drug is within the established therapeutic range. ◦ Examples: dilantin, phenytoin, theophylline
PT Drug administration monitoring procedure incorrectly performed
PT Drug administration monitoring procedure not performed
PT Therapeutic drug monitoring analysis incorrectly performed
PT Therapeutic drug monitoring analysis not performed
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PT Accidental exposure to product
PT Accidental exposure to product by child
Who was exposed?
What product were they exposed to?
What was the pathway of the exposure?
Is this an occupational exposure?
Is there a known consequence?
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Occupational exposure
Pathways of exposure
Patient’s 3 year old grandson swallowed one of her 600 mg Drug D pills
LLT/PT Accidental exposure to product by child
LLT/PT Exposure via ingestion
Drug E solution splashed onto my colleague’s lips and mouth as the injection was being prepared
LLT Accidental exposure while preparing drug for administration
PT Accidental exposure to product
LLT/PT Exposure via direct contact
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OTHER EVENTS
DISPENSING
PRESCRIBING
PT Drug dispensing error PT Intercepted drug dispensing error
PT Circumstance or information capable of leading to a medication error PT Drug label confusion PT Drug name confusion PT Product dosage form confusion PT Incorrect storage of drug
PT Medication error PT Intercepted medication error PT Vaccination error
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PT Drug prescribing error
The patient received the eye medication as a gel instead of a solution from the pharmacy and returned it
LLT/PT Intercepted drug dispensing error
The patient forgets if she has taken her medication
LLT/PT Circumstance or information capable of leading to a medication error
The medication was stored on the kitchen counter instead of in the refrigerator
LLT/PT Incorrect storage of drug
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MedDRA v12.0 – Product Quality terms were added
HLGT = Product quality issues SOC = General disorders and administration site conditions
MedDRA v16.1 has 72PTs/197 LLTs in this HLGT
Product quality issues are addressed in MedDRA Term
Selection: Points to Consider
Product quality term concept descriptions are incorporated in Appendix B of the MedDRA Introductory Guide
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Product quality issues are abnormalities that may be introduced during the
manufacturing/labeling, packaging, shipping, handling or storage of the products.
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HLT Product label issues
PT Drug label confusion* PT Physical product label issue PT Product barcode issue PT Product expiration date issue PT Product identification number issue PT Product label confusion PT Product label counterfeit PT Product label issue PT Product label on wrong product PT Product lot number issue
HLT Product packaging issues
PT Failure of child resistant mechanism for
pharmaceutical product PT Product blister packaging issue PT Product closure issue PT Product closure removal difficult PT Product commingling PT Product container issue PT Product container seal issue PT Product dropper issue PT Product outer packaging issue PT Product package associated injury* PT Product packaging counterfeit PT Product packaging issue PT Product packaging quantity issue
HLT Product physical issues
PT Capsule physical issue PT Liquid product physical issue PT Product coating issue PT Product colour issue PT Product deposit PT Product dosage form issue PT Product friable PT Product gel formation PT Product odour abnormal PT Product physical consistency issue PT Product physical issue PT Product reconstitution issue PT Product shape issue PT Product size issue PT Product solubility abnormal PT Product taste abnormal PT Tablet physical issue
HLT Product quality issues NEC
PT Drug name confusion* PT Incorrect product storage PT Incorrect storage of drug* PT Out of specification test results PT Product adhesion issue PT Product compounding quality issue PT Product counterfeit PT Product distribution issue PT Product dosage form confusion* PT Product formulation issue PT Product measured potency issue PT Product name confusion PT Product origin unknown PT Product process control issue PT Product quality control issue PT Product quality issue PT Product raw material issue PT Product substitution issue PT Product tampering PT Suspected counterfeit product
* Primary SOC = Injury, poisoning and procedural complications ** Primary SOC = Infections and infestations
MedDRA v16.1 September, 2013
HLT Product contamination and sterility issues PT Exposure via body fluid* PT Exposure via contaminated device* PT Inadequate aseptic technique in use of product PT Product cleaning inadequate PT Product contamination PT Product contamination chemical PT Product contamination microbial PT Product contamination physical PT Product contamination with body fluid PT Product sterility lacking PT Suspected transmission of an infectious agent
via product** PT Transmission of an infectious agent via a
medicinal product**
Medication Errors Product Quality Issues
PT Product expiration date issue
LLT Product expiration date illegible
LLT Product expiration date incorrect
LLT Product expiration date issue
LLT Product expiration date missing
PT Expired drug administered
PT Drug dispensing error
LLT Expired drug dispensed
PT Product label counterfeit PT Product counterfeit PT Product packaging counterfeit PT Suspected counterfeit product
PT Counterfeit drug administered
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Medication Errors Product Quality Issues
PT Capsule physical issue LLT Capsule separation
PT Wrong technique in drug usage process LLT Inappropriate removal of drug from
capsule
PT Product reconstitution issue
PT Wrong technique in drug usage process LLT Wrong solution used in drug
reconstitution
PT Wrong technique in drug usage process
LLT Tablet crushed incorrectly
LLT Tablet split incorrectly
PT Tablet issue LLT Scored tablet splitting issue LLT Tablet chipped LLT Tablet clumping LLT Tablet cracked LLT Tablet damaged
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Medication Errors Product Quality Issues
PT Product label on wrong product
PT Drug dispensing error LLT Wrong directions typed on label LLT Wrong label placed on medication
during dispensing
PT Product dosage form issue
PT Incorrect drug dosage form administered PT Drug prescribing error LLT Drug dosage form prescribing error PT Drug dispensing error LLT Wrong dosage form dispensed PT Product dosage form confusion
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Patient received all 18 units of the medication at once due to a faulty pen
LLT/PT Incorrect dose administered by device
The drug pump stopped working and the patient did not receive the medication within the 30 minute prescribed infusion period
LLT Pump not infusing/PT Device infusion issue
LLT Drug administration rate too slow
PT Incorrect drug administration rate
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Off Label Use is the intentional use of a product for a medical purpose not in accordance with the authorized product information. (Introductory Guide MedDRA Version 16.1) ◦ May be related to the indication for the medication
◦ May be related to the patient (adult vs. child)
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Medication error -
Patient’s 3 year old grandson swallowed one of her 600 mg Drug D pills
LLT/PT Accidental exposure to product by child
LLT/PT Exposure via ingestion
Administered Drug B Adult instead of Drug B Paediatric by mistake
LLT/PT Drug administered to patient of inappropriate age
Off-label use -
The eye doctor intentionally administered an intra-ocular injection of Drug F to treat the patient’s age-related macular degeneration (off-label use)
LLT Intentional use for unlabeled indication
PT Off label use
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“Misuse” is the intentional and inappropriate use of a product – over-the-counter or prescription – other than as prescribed or not in accordance with the authorized product information. (Introductory Guide MedDRA Version 16.1, Section 3.16.1)
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Medication error -
The patient has been taking the medication out of the capsule and putting it in food
LLT Inappropriate removal of drug from capsule
PT Wrong technique in the drug usage process
Misuse -
The patient intentionally snorted the entire contents of the prefilled syringe
LLT Intentional use by incorrect route
PT Intentional drug misuse
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Medication errors, product quality issues and device issues are being reported to pharmaceutical/device companies
Do you have a strategy within your organization for handling these reports?
Coding challenges
◦ Do you have internal coding conventions based on the need to detect signals and trends?
Was there a medication error – drug, dose, route, time, prescribing, dispensing, etc.?
Was there a product quality issue?
Was there a device failure?
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How often is analysis of medication errors, product quality issues and device issues performed?
How are trends and findings communicated internally?
How is it determined if additional actions need to be taken?
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