To perform coding of individual cases for data entry, training in MedDRA is needed. MedDRA coding will be easy for people with a medical background as the knowledge on medical terminology is important for coding. Each person who handle safety reporting must be trained in MedDRA which will be taken care by companies.
As we learned earlier, two major uses for MedDRA are data entry coding for cases and case retrieval by AEs. We will talk briefly about each.
Coding of Individual Cases for Data Entry into a Safety Database
Once the adverse event report or case is received to safety team, the case is triaged and reviewed and the medically most important or “primary event” is chosen. The case will be sent for data entry. The received report will be reviewed and the terms which require coding with MedDRA browser will be assessed. Below are the terms from adverse event report must be coded with MedDRA browser.
- Patient’s/parent medical history
- Lab data/investigations
- Product indication
- Events
1. Coding of Patient’s/parent medical history:
All medical events and problems a person had experienced prior to start of suspect medication is considered as medical history in Pharmacovigilance.
A medical history may include information about allergies, illnesses, surgeries, immunizations, and results of physical exams and tests.
It may also include information about medicines taken and health habits, such as diet and exercise.
A family medical history includes health information about a person’s close family members (parents, grandparents, children, brothers, and sisters).
Although social circumstances are not usually regarded as medical terms, they fall within the “medical” scope (examples are: Foreign travel, Occupational exposure to toxic agent, Tobacco use, Bereavement issues, alcohol use).
These medical events must be coded with MedDRA browser. While coding these conditions we need to select LLT which most accurately reflects the reported verbatim information and we need to remember there are coding options available for each type.
For example, if report states a patient has a medical history of having gastric ulcers then we can directly search in MedDRA with reported term.
If any gender specific terms are reported then we need to search LLT which are gender specific, for example Infertility female/Infertility male/ Breast cancer female.
If allergy reported as medical history then we need to make sure if it is drug allergy or food allergy and code accordingly.
If report states patient mother has cardiac problem then we need to select terms with family history of cardiac disorder.
2. Coding of lab data/investigations:
For MedDRA, an “investigation” is a clinical laboratory test concept (including biopsies), radiologic test concept, physical examination parameter, and physiologic test concept (e.g., pulmonary function test).
MedDRA has options to code names or investigation procedures – e.g., Electrocardiogram, liver functions tests (SGOT, SGPT, ALT, AST, etc..), blood pressure, blood glucose, urine pH etc.. and qualitative results of investigations -e.g., increased, decreased, normal, abnormal, present, absent, positive, and negative.
Only PTs representing investigation procedures and qualitative results (e.g., Blood sodium decreased, Blood glucose) appear in SOC Investigations. Terms representing conditions (e.g., hyperglycemia) or mixed concepts of conditions with an investigation are excluded from this SOC and can be found in the respective “disorder” SOCs.
The point that we need to consider here is when we are using MedDRA browser for lab data coding not event, then we must select code for names not the qualitative results of investigation.
3. Coding of product indication:
Therapeutic indications can be signs, symptoms, diseases, diagnoses, diagnosis or prophylaxis of disease, and modification of physiologic function. These terms must be coded with MedDRA browser and mostly direct coding options will be available.
Some browsers have autoencoders where a word or sentence is typed into the browser (cut and paste) and the browser provides a list of one or more terms for each medical idea in the words or sentences entered. The computer program picks what it perceives to be the “best fit” for each concept. This mechanical choice must be verified to ensure that the chosen term makes sense, is in the proper SOC and is the best choice if multiple choices are offered. MedDRA has lots of choices for some medical concepts making coding tricky.
….. Next post in MedDRA learning series will be about coding of events with MedDRA, rules we need to follow and tricky coding issues…..
