1. Medication Error and Product Quality Issue Concepts in MedDRA
MedDRA® is a registered trademark of the International Federation
of Pharmaceutical Manufacturers and Associations (IFPMA)

2. Course Objectives To provide an understanding of:
Background of medication error (ME) and product quality issue (PQI) concepts in MedDRA
Definitions and concept descriptions
Practical approaches to coding and analysis of these concepts

3. Medication Errors and Product Quality Issues Background Information

4. Medication Errors – Background Information
48,000 to 98,000 people die yearly due to medical errors - December 1999 Institute of Medicine (IOM) report
7,000 of which are related to Medication Errors
Important to capture and report these events

5. 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
New 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

6. Product Quality Issues – Background Information
FDA requested addition of product quality terms into MedDRA
Allows FDA to use a single coding system for adverse events and product quality issues
FDA requires manufacturers to report contamination, packaging issues, other product quality issues
Solicits voluntary reports from lay and medical community

7. MedDRA Expert Panel Review of Product Quality Issue Terms
Generally favorable to FDA proposal
Some issues over meaning of “product” (medicinal vs. devices)
Concern about overlap with some existing medication error terms
Recommended addressing issues in Term Selection: Points to Consider document
Each term should be distinct and self-explanatory

8. Product Quality Issues Hierarchy
New HLGT Product quality issues in SOC General disorders and administration site conditions added in MedDRA v12.0
Five new HLTs:
HLT Product contamination and sterility issues
HLT Product label issues
HLT Product packaging issues
HLT Product physical issues
HLT Product quality issues NEC

9. Definitions

10. Medication Error Definition
Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the 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.
National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)

11. Medication Error Definition (cont)
A preventable event
Intentional action is NOT an “error”
Includes intercepted and not intercepted errors, because
Patient harm is NOT required
Inappropriate use of the medication is NOT required
Applies to all stages of medication handling and process

12. Product Quality Issue Definition
Product quality issues are abnormalities that may be introduced during the manufacturing/labeling, packaging, shipping, handling or storage of the products

13. Product Quality Issue Definition (cont)
“Product” refers to regulated entities such as drugs, devices, food, etc.
To address concerns about the concept of “quality issue”:
The word “issue” for the purpose of MedDRA is used as a general term, which does not necessarily point to a failure or defect when paired with a product or a device

14. Concept Descriptions

15. 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 and product quality issue descriptions developed by FDA and MSSO

16. Medication Errors – Concept Description Examples
Overdose: More than medically recommended dose (in quantity and/or concentration) is administered. An excessive dose.
Overdose: More than medically recommended dose (in quantity and/or concentration) is administered. An excessive dose.

17. Medication Errors – Concept Description Examples (cont)
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.

18. Product Quality Issues – Concept Description Examples
Coring: A small piece of the stopper is sometimes sheared off (known as coring); an example could be after a needle is inserted through the stopper of a medication vial

19. Product Quality Issues – Concept Description Examples (cont)
Product coating incomplete: Refers to the outer coating of a product when it does not entirely cover the product and can appear blotchy, splattered or speckled

20. Practical Coding Approaches

21. Term Selection: Points to Consider
Medication/administration errors and accidental exposures
Section 3.15
Explanations and examples
Product quality issues
Section planned for next release of TS:PTC based on MedDRA v13.1 (Release 3.15, October 2010)

22. Medication Errors and Product Quality Issues – Useful Information
Helpful hints:
Less likely to find exact – or even close – verbatim matches for these types of reported concepts
If you think it is a medication error or product quality issue concept, browse through these parts of MedDRA carefully

23. Browser Demonstration of Medication Error and Product Quality Issue Terms

24. Examples

25. Types of Medication Errors
Actual (patient exposed)
With harm
Without harm
Potential (patient not exposed)

26. Medication Errors
Example: Medical record indicated allergy to penicillin; patient accidentally received amoxicillin and experienced severe rash attributed to known allergy Which LLT is correct? Penicillin allergy Rash Documented allergy to administered drug Drug rash

27. Medication Errors (cont)
Example: Drug given by mouth instead of IV. No sequelae. Which LLT is correct? Intravenous formulation administered by other route Incorrect route of drug administration Inappropriate dose of drug administered No adverse effect

28. Medication Errors (cont)
Example: Nurse noted that the medication was the wrong drug strength; she did not give the medication to the patient Which LLT is correct? Wrong drug dispensed Intercepted wrong drug strength selected Wrong drug strength dispensed

29. Medication Errors (cont)
Example: Written patient instructions attached to the prescription were difficult to understand and could cause confusion in administering the correct dose Which LLT is correct? Confusion Intercepted drug administration error Circumstance or information capable of leading to medication error

30. Medication Errors (cont)
Example: A pharmacist was concerned that the trade names of two products for different disorders were very similar and could be easily confused Which LLT is correct? Drug label confusion Product name confusion Drug name confusion

31. Overdose
More than medically recommended dose (in quantity and/or concentration) is administered. An excessive dose.
To code LLT Overdose, the word “overdose” must be in the report verbatim to avoid misinterpretation

32. Medication Errors (cont)
Example: Patient intentionally took an additional dose of drug to get high (not to commit suicide) Which LLT is correct? Intentional overdose Drug overdose Drug abuse

33. Medication Errors (cont)
Example: 3 year old boy accidentally ingested the remaining tablets of drug X Which LLT is correct? Drug overdose accidental Accidental ingestion Accidental drug intake by child

34. Medication Errors (cont)
Example: Did not receive full prescribed dose of gamma radiation for brain tumour Which LLT is correct? Brain tumour Gamma radiation therapy to brain Radiotherapy to brain Radiation underdose

35. Medication Errors (cont)
Example: Nurse splashed drug A in her eye while preparing to administer to the patient Which LLT is correct? Accidental exposure while preparing drug for administration Accidental exposure while administering drug Superficial injury of eye

36. Medication Errors (cont)
Example: Patient took medication once every two weeks instead of once a month as prescribed Which LLT is correct? Once monthly dose taken more frequently Medication error Inappropriate schedule of drug administration

37. Medication Errors (cont)
Example: Baby’s antibiotic solution was inadvertently stored at room temperature instead of being refrigerated Which LLT is correct? Incorrect product storage Incorrect storage of drug Temperature regulation disorder

38. Product Quality Issues
Example: Drug bottles were unsealed in manufacturer’s boxes Which LLT is correct? Product container seal issue Product container damaged Product closure issue

39. Product Quality Issues (cont)
Example: Tablets have a strong smell Which LLT is correct? Tablet issue Product container damaged Product odo(u)r abnormal

40. Product Quality Issues (cont)
Example: Catheter was contaminated with Candida spp Which LLT is correct? Exposure to contaminated device Catheter related infection Product contamination fungal Candidal infection NOS

41. Product Quality Issues (cont)
Example: Sterile lumbar puncture kit received in broken packaging (sterility compromised) Which LLT is correct? Product sterile packaging disrupted Traumatic lumbar puncture Reversal of sterilization Product sterility lacking

42. Product Quality Issues (cont)
Example: Product label missing from contact lens cleaner package Which LLT is correct? Product label missing Product label issue Off label use

43. Product Quality Issues (cont)
Example: Pharmacist noted that the labeling information on Drug A was confusing Which LLT is correct? Physical product label issue Product label issue Drug label confusion

44. Product Quality Issues (cont)
Example: Bottle of cough medication noted to be leaking Which LLT is correct? Product container leak Device leakage Product container damaged

45. Product Quality Issues (cont)
Example: Complained that “child proof” cap is difficult to remove Which LLT is correct? Failure of child resistant mechanism for pharmaceutical product Product container issue Product closure removal difficult

46. Product Quality Issues (cont)
Example: Patient noted that some pills in the bottle were a darker blue colour than others Which LLT is correct? Product colour issue Product colour variation Product discolouration

47. Product Quality Issues (cont)
Example: Powder did not dissolve well in water Which LLT is correct? Product solubility decreased Product dissolution decreased Product coating issue

48. Product Quality Issues (cont)
Example: Pills do not split correctly along score Which LLT is correct? APACHE II score Tablet issue Scored tablet splitting issue Tablet damaged

49. Product Quality Issues (cont)
Example: Drug X patch does not stick to skin Which LLT is correct? Patch test negative Medicinal patch adhesion issue Leaking patch

50. Medication Error or Product Quality Issue or Both?
Example: After applying an acne cream, the patient noted that the expiration date on package was misleading Which LLT is correct? Incorrect product storage Product expiration date issue Medication error Expired drug used

51. Analysis of Medication Error and Product Quality Issue Data

52. Analysis of ME/PQI Data
An important part of pharmacovigilance
Medication errors and product quality issues may be associated with adverse effects
Keep this in mind when retrieving data
E.g., PT Multiple drug overdose intentional also in SOC Psychiatric disorders
Follow key terms to their secondary locations

53. Analysis of ME/PQI Data (cont)
Medication error terms
All in HLGT Medication errors (SOC Injury, poisoning and procedural complications)
Product quality terms
All in HLGT Product quality issues (SOC General disorders and administration site conditions)
Three terms are both types:
Drug label confusion
Drug name confusion
Incorrect storage of drug

54. Summary In this course, we:
Reviewed the background behind the inclusion of medication error and product quality issue terms in MedDRA
Learned about the definitions and descriptions of these concepts
Reviewed practical approaches to coding and analysis of these concepts

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