Definitions

ADR - Adverse Drug Reaction

Brand names (Product Brand Generic/PBG) – this means the drug brand name e.g. Amoxil is a brand name for the drug substance amoxicillin

MedDRA - this stands for Medical Dictionary for Regulatory Activities, which is the internationally agreed list of terms used for Medicines Regulation. MedDRA groups related ADR terms in a hierarchical structure whereby the 'Preferred Term' (PT) (e.g. tunnel vision) is grouped under the broader heading 'High Level Term' (HLT) (e.g. visual field disorders). 'High level terms' are contained within the 'System Organ Class' (SOC) (e.g. eye disorders). The 'Preferred Term' is the most specific term on the interactive Drug Analysis Profile, while the 'System Organ Class' is the most general

SOC - System Organ Class - this is the highest level in MedDRA which groups together reactions that affect similar systems/organs in the body

HLGT - High Level Group Term – grouping of one or more HLTs

HLT - High Level Term - see definition of MedDRA

PT - Preferred Term - see definition of MedDRA

NEC - appears in MedDRA and stands for ‘Not Elsewhere Classified’

NOS - appears in MedDRA and stands for ‘Not Otherwise Specified’

Multiple constituent – these contain the drug substance of interest plus one or more other drug substances (e.g. co-codamol contains paracetamol and codeine)

Multiple constituent brand names - this is a list of the brands for which at least one suspected ADR report has been received that specifies that brand as a 'suspected drug' (i.e. suspected causal association with the reaction). It does not provide an exhaustive list of the brands which contain the named drug substance

Reports processed up to - shows reports committed to the database up to this date

Seriousness - A suspected ADR report is considered ‘serious’ according to two criteria; firstly, whether the original reporter considers the report to be serious. The seriousness criteria for ADR reporting were determined by a working group of the Council for International Organizations of Medical Sciences (CIOMS) and are defined as 6 possible categories which are documented on the Yellow Card. We ask reporters to select one of the following criteria by ticking the appropriate box on the Yellow Card.

The criteria are:

1. patient died due to reaction

2. life threatening

3. resulted in hospitalisation or prolonged inpatient hospitalisation

4. congenital abnormality

5. involved persistent or significant disability or incapacity

6. if the reaction was deemed medically significant. In addition to this, seriousness of reaction terms has also been defined by the MHRA in our medical dictionary. Therefore, an ADR report can be serious because the reporter considers the reaction to be serious or because the reaction term itself is considered serious in our medical dictionary.

Single constituent - contain only the drug substance of interest

Single constituent brand names - this is a list of the brands for which at least one suspected ADR report has been received that specifies that brand as a 'suspected drug' (i.e. suspected causal association with the reaction). It does not provide an exhaustive list of the brands which contain the named drug substance

Spontaneous - suspected ADR reports sent in to the Yellow Card Scheme are called spontaneous reports

Substance - is an active ingredient in a drug