How to Use this Document The MTS:PTC document does not address every potential term selection situation. Medical judgment and common sense should also be applied. This document is not a substitute for MedDRA training. It is essential for users to have knowledge of MedDRA’s structure and content. For optimal MedDRA term selection, one should also refer to the MedDRA Introductory Guide (see Appendix, Section 4.2). Users are invited to contact the with any questions or comments about this MTS:PTC document. Preferred Option In some cases, where there is more than one option for selecting terms, a “preferred option” is identified in this document. Designation of a “preferred option” does not limit MedDRA users to applying that option. Users should always first consider regional regulatory requirements. An organisation should be consistent in the option that they choose to use and document that option in internal coding guidelines. MedDRA Browsing Tools The MSSO and JMO provide two browsers (a Desktop browser and a Web-Based browser) that allow for searching and viewing the terminology (see Appendix, Section 4.2). Users may find these browsers useful aids in term selection. GENERAL TERM SELECTION PRINCIPLES Quality of Source Data The quality of the original reported information directly impacts the quality of data output. Clarification should be obtained for data that are ambiguous, confusing, or unintelligible. If clarification cannot be obtained, refer to Section 3.4. Quality Assurance To promote consistency, organisations should document their term selection methods and quality assurance procedures in coding guidelines consistent with this MTS:PTC document. Clear initial data can be promoted through careful design of data collection forms, and training of individuals in data collection and follow-up (e.g., investigators, drug sales representatives). Term selection should be reviewed by a qualified individual, i.e., a person with medical background or training who has also received MedDRA training.
MULTIPLE DIAGNOSES DEFINITIVE DIAGNOSES PROVISIONAL DIAGNOSES Multiple definitive diagnoses without signs/symptoms Multiple diagnoses (only possible option) Multiple provisional diagnoses without signs/symptoms Multiple provisional diagnoses (only possible option) Multiple definitive diagnoses with signs/symptoms Preferred: Multiple diagnoses only Alternate: Diagnoses and signs/symptoms Note: Always include signs/symptoms not associated with diagnosis SEE EXAMPLE 3 Multiple provisional diagnoses with signs/symptoms Preferred: Multiple provisional diagnoses and signs/symptoms Alternate: Signs/symptoms only Note: Always include signs/symptoms not associated with diagnosis SEE EXAMPLE 4 EXAMPLES Example Reported LLT Selected Preferred Option 1 Anaphylactic reaction, rash dyspnoea, hypotension, and laryngospasm Anaphylactic reaction Anaphylactic reaction Rash Dyspnoea Hypotension Laryngospasm 2 Possible myocardial infarction with chest pain, dyspnoea, diaphoresis Myocardial infarction Chest pain Dyspnoea Diaphoresis Chest pain Dyspnoea Diaphoresis
Congenital Terms “Congenital” = any condition present at birth, whether genetically inherited or occurring in utero (see the MedDRA Introductory Guide). Congenital conditions Select terms from SOC Congenital, familial and genetic disorders when the reporter describes the condition as congenital or when medical judgment establishes that the condition was present at the time of birth. Example Reported LLT Selected Comment Congenital heart disease Heart disease congenital Child born with heart disease Newborn with phimosis Phimosis A “congenital” term is not available but LLT/PT Phimosis links to primary SOC Congenital, familial and genetic disorders Acquired conditions (not present at birth) If information is available indicating that the condition is not congenital or present at birth, i.e., it is acquired, select the non-qualified term for the condition, making sure that the non-qualified term does not link to SOC Congenital, familial and genetic disorders. If a non-qualified term is not available, select the “acquired” term for the condition. Example Reported LLT Selected Comment Developed night blindness in middle age Night blindness LLT/PT Night blindness links to primary SOC Eye disorders. Do not assume the condition is congenital (LLT/PT Congenital night blindness).
Reported LLT Selected Preferred Option Medication was given intravenously instead of intramuscularly but the patient did not experience any adverse effects Intramuscular formulation administered by other route Intramuscular formulation administered by other route No adverse effect Example Reported LLT Selected Comment Pharmacist notices that the names of two drugs are similar and is concerned that this may result in a medication error Drug name confusion Circumstance or information capable of leading to medication error Note: this example is a potential medication error and LLT Drug name confusion provides additional information about the nature of the potential medication error
Accidental exposures and occupational exposures Accidental exposures The principles for Section 3.15.1 (Medication errors) also apply to accidental exposures. Example Reported LLT Selected Comment Child accidentally took grandmother’s pills and experienced projectile vomiting Accidental drug intake by child Vomiting projectile Father applying topical steroid to his arms accidentally exposed his child to the drug by carrying her Accidental exposure to product by child Exposure via skin contact The “exposure to” term captures the agent of exposure, i.e., a product, and the “exposure via” term captures the route/vehicle of exposure, i.e., skin contact Occupational exposures For the purposes of term selection and analysis of MedDRA-coded data, occupational exposure encompasses the “chronic” exposure to an agent (including therapeutic products) during the normal course of one’s occupation, and could include additional scenarios in specific regulatory regions. For example, occupational exposure may additionally relate to a more acute, accidental form of exposure that occurs in the context of one’s occupation. In these regions, occupational exposure for healthcare workers could be of particular interest. Example Reported LLT Selected Comment Physical therapist developed a photosensitivity rash on hands after exposure to an NSAID-containing pain relief cream that she applied to a patient Occupational exposure to drug Exposure via skin contact Photosensitive rash Pathologist chronically exposed to formaldehyde developed nasopharyngeal carcinoma Occupational exposure to toxic agent Nasopharyngeal carcinoma Exposure to formaldehyde is a known risk factor for this type of malignancy
Nurse splashed injectable drug in her own eye resulting in excessive tearing Inadvertent exposure to drug Excess tears An additional term for occupational exposure – e.g., LLT Occupational exposure to drug – could also be selected, if applicable to regional requirements Misuse, Abuse and Addiction The concepts of misuse, abuse and addiction are closely related and can pose challenges for term selection since the terms may overlap to some extent; the specific circumstances of each case/reported event may help in consideration for term selection of these concepts. Medical judgment and regional regulatory considerations need to be applied. It may also be useful to consider these concepts as shown in the table below: Concept Intentional? By Whom? Therapeutic Use? Additional Sections in this Document Misuse Yes Patient/consumer Yes* 3.16.1 Abuse Yes Patient/consumer No 3.16.2 Addiction Yes Patient/consumer No 3.16.3 Medication error No Patient/consumer or healthcare professional Yes 3.15 Off label use Yes Healthcare professional Yes 3.27 * Definitions of misuse may not always include the concept of therapeutic use; misuse may be similar to the concept of abuse in some regions. Select the most specific term available and always check the MedDRA hierarchy above the selected term to be sure it is appropriate for the reported information. In some cases,
because of a desire to experience the drug's psychological, behavioral or physical effects. Example Reported LLT Selected Patient became dependent on crack cocaine Dependence on cocaine Patient became addicted to a deliberately ingested topical medication for its psychoactive effect Drug addiction Intentional use by incorrect route See Section 3.24.1 for additional references to “addict/addiction” terms in MedDRA. Drug diversion For the purposes of term selection and analysis of MedDRA-coded data, drug diversion means that a drug is diverted from legal and medically necessary uses toward illegal uses. Example Reported LLT Selected Pharmacist stole medications from the pharmacy and sold them to others for recreational use Drug diversion The patient sold his controlled drug prescription to another person Drug diversion Transmission of Infectious Agent via Product If a report of transmission of an infectious agent via a product is received, select a term for the transmission. If the infection is identified, select a second term for the specific infection; if appropriate, a product quality issue term can also be selected (see Section 3.28). Example Reported LLT Selected Patient received a nasal spray product and later developed a severe nasal infection with Burkholderia cepacia. Cultures of unopened containers of the nasal spray grew B. cepacia Transmission of an infectious agent via product Product contamination bacterial Burkholderia cepacia infection