Disclaimer: This website does not include all the adverse drug reactions (ADRs) that may occur in practice. At present, the database only contains ADRs affecting 5 system organ classes. Thus, a search for a particular ADR may not yield any results. A negative search result should not be interpreted to mean that no drugs cause that particular ADR. The data was sourced from Summary of Product Characteristics (SPCs) of Medicinal products present in Malta. Thus, other drugs (available outside Malta), besides those enlisted may also be responsible for a particular ADR. This work was carried out by Stephanie Bezzina under the supervision of Dr. Maurice Zarb Adami as part of her submission for the degree of Master of Pharmacy.
One ADR term may be described using different jargon. To standardise these ADR terms, a single recognised term was needed. Therefore, the Medical Dictionary for Regulatory Activities (MedDRA) was used. The MedDRA is a collection of standard medical terminology and a classification system for events associated with medicinal products. Harmonisation of terms aids authorities and the industry to exchange and analyse data, related to the safe use of medicine, more efficiently (MedDRA MSSO, 2010). Structural Hierarchy of the MedDRA Terminology: System organ class High level group term High level term Preferred term Lowest level term
The Preferred Term is used as the standard term. Lowest level terms are synonyms, lexical variants, quasi-synonyms or sub-elements (containing more detailed information) of the Preferred term (MedDRA MSSO, 2010). Most of the terms found in literature are lowest level terms. The corresponding MedDRA Preferred term (PT) is written alongside these ADR terms within the database. “A PT is a distinct descriptor (single medical concept) for a symptom, sign, disease, diagnosis, therapeutic indication, investigation, surgical, or medical procedure, and medical, social, or family history characteristic. PTs should be unambiguous and as specific and self-descriptive as possible in the context of international requirements.” (MedDRA MSSO, 2010)
MedDRA Maintenance and Support Services Organisation. Introductory Guide to MedDRA Version 13.1. Chantilly, Virginia. September, 2010. *MedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).