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Assets of Pharmacovigilance, Its Necessity and Future in INDIA in coming five years.


MedDRA (Medical Dictionary for Regulatory Activities)

What is MedDRA?
MedDRA
is a second most important tool as Assets of Drug safety Pharmacovigilance system.

In 1997 the first version of MedDRA was born.[10]

It was developed from the European Union system, under the auspices of the ICH (International Conference on Harmonization).    

It was developed to standardise regulatory communication between the authorities responsible for the authorization of medicinal products as well as the exchange between authorities and biopharmaceutical companies; data related to safety, quality or efficacy of medicinal products.

MedDRAhas been developed for “Medical Coding” as an internationally, clinically validated medical terminology for utilization in data entry, retrieval, evaluation and presentation, in both pre-and post marketing phases of regulatory processes.

Why knowledge of MedDRA is Important?
The coding of patient data is critical in the grouping, analysis, and reporting of data. Coding decisions directly impact submissions for New Drug Applications (NDAs), safety surveillance, and product labeling.[10]The success of a submission to the FDA can be significantly impacted by the analysis of adverse events, medical history and concomitant medications. The analysis relies on the interpretation of what has been transcribed from the subject CRF (Case Report Form).[10]

The original clinical term is referred to as the clinician’s term or verbatim term. This term needs to be re-interpreted or coded into a preferred term in order for it to be used during analysis. This is because different verbatim terms can have the same meaning such as in the example of the term “pain in head” or “headache”. In this case, the two distinct verbatim terms are coded to one synonymous preferred term. The identical terms and the consistent classification of the term allow the analysis to draw valid statistical conclusions pertaining to the subject’s experience. The coding process can therefore affect the statistical interpretation of the adverse events or medications in which the subject is taking during the clinical trial.[10]

Structure of MedDRA:
MedDRA is a five level multi-axial terminology. [11] The relationships between terms fall into one of three categories:
Hierarchical - provides vertical links between superordinate (broad grouping) terms and subordinate (higher level of specificity) descriptors.
1.    System Organ Class (SOC)
2.    High Level Group Term (HLGT)
3.    High Level Term (HLT)
4.    Preferred Term (PT)
5.    Lowest Level Term (LLT)

Equivalence - grouping of synonymous terms. This is only exemplified in the relationship between the LLT and the PT.
Associative - allows terms to be linked horizontally, which are neither equivalent, nor hierarchically related but have a strong relation by sign, symptom, disease and diagnosis. This in only exemplified in the Special Search Categories.
The 26 System Organ Classes (SOC) in MedDRA represents parallel axes, which are not mutually exclusive. This allows terms to be represented in more than one SOC, and therefore grouped by different classifications. One single medical concept can be represented in more than one medical discipline. For example, the term Congenital HIV infection is represented in the following SOCs:
•    Congenital and familial/genetic disorders
•    Pregnancy, puerperium and perinatal conditions
•    Infections and infestations
•    Immune system disorders

Scope & Purpose of using MedDRA:
Terms found in MedDRA [11]
•    Diseases
•    Diagnosis
•    Signs & Symptoms
•    Therapeutic indications
•    Investigation names and qualitative results
•    Medical and surgical procedures
•    Medical, social, family history
•    Terms from: COSTART, WHO-ART, ICD-9 (some), ICD-9CM and HARTS.
Terms NOT found in MedDRA [11]
•    Population level qualifiers (e.g. rare and frequent fail to focus on the individual patient)
•    Numerical values for results (you cannot universalise numeric representations, especially in terms of the measurement parameter)
•    Severity descriptors (typically, terms such as severe or mild are not found in the terminology, some exception when their presence is medically relevant, e.g. aggravated conditions are different than the condition its self)
•    Medical product terms (except a very small number pertaining to clinical lab tests)
•    Patient demographics (aside from very few occasions where sex is a pertinent descriptor, terms like age, race and religion are not included in the terminology
•    Equipment, device and diagnostic product terms (e.g. the term catheter would not be include in the terminology where as the failure and its health effects would be)

Purposes of Using MedDRA [12]
•    To aggregate reported terms in medically meaningful groupings for the purpose of reviewing and/or analyzing safety data.
•    To facilitate identification of common data sets for evaluation of clinical and safety information.
•    To facilitate consistent retrieval of specific cases or medical conditions from a database.
•    To improve consistency in comparing and understanding “safety signals” and aggregated clinical data.
•    To facilitate electronic data interchange of clinical safety information.
•    To report adverse reaction/adverse event (ADR/AE) terms via individual case safety reports.
•    To include ADR/AEs in tables, analyses, and line listings for reports
•    To identify frequency of medically similar ADR/AEs.
•    To capture and present product indications, investigations, medical history and social history data.


udayvenkatmateti's picture
udayvenkatmateti
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Joined: 2011-02-13
Nice article

Nice Article.

Can you please give the information regarding how to publish the articles in Pharma Tutor.

Thanking You,

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