EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial...

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EU MedDRA Industry User Group Kathy Manzetti, RN, CMC October, 2013 1

Transcript of EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial...

Page 1: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

EU MedDRA Industry User Group

Kathy Manzetti, RN, CMC

October, 2013

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Page 2: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

• 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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Page 3: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 4: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 5: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 6: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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

Page 8: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 9: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 10: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 11: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 12: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 13: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 15: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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

Page 17: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 18: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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

Page 19: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 20: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 21: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 22: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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**

Page 23: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 24: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 26: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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Page 27: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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Page 28: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 29: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 30: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 31: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

“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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Page 32: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 33: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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Page 34: EU MedDRA Industry User Group Kathy Manzetti, …...Reports are unlike the terms in clinical trial data Often cannot search MedDRA dictionary by a key word that may be found in the

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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