Adverse Drug Reactions Database
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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.
   The World Health Organisation defines an adverse drug reaction (ADR) as “a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.” [WHO Technical Report No 498 (1972)]. This description implies that individual factors may play an important role in drug response, and that the effect is harmful to the patient.
   
   EU directive 75/319/EEC gives the following definitions for ADRs which comply with the WHO terminology:
   “Adverse reaction means a reaction which is harmful and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function.”
   A “serious adverse reaction means an adverse reaction which is fatal, life-threatening, disabling, incapacitating, or which results in or prolongs hospitalization.”
   These definitions exclude overdose since overdosing may cause fatalities with drugs which are normally safe at their therapeutic dose.

   Several classification methods have been proposed to describe ADRs such as by their severity (mild, moderate or severe), source of reported data (reported by patient, observer or machine), by reaction time (acute or latent) and whether the reaction is localised or systemic. However the pharmacological classification which classifies ADRs into Types A-F is the most commonly used:

Type A (Augemented): An exaggeration of the drug's normal pharmacological actions
Type B (Bizarre): Unexpected reactions (Rawlins and Thompson, 1977)
Type C (Chronic): Occur with long term use
Type B (Delayed): Occur after a period of time has elapsed from cessation of medication
Type E (End of use): Result from sudden stopping or immediate cessation of use (Aronson and White, 1996)
Type F: Failure of therapy (Edwards and Aronson , 2000)

   An ADR may result from both drug related factors (drug effects, drug use, synergistic effects between a drug and a disease or between two drugs) & also non-drug related factors (abnormal pharmacokinetics due to genetic factors, age or disease states).

   The World Health Organisation defines Pharmacovigilance as the "science and activities relating to the detection, education, understanding and prevention of adverse drug reactions or other drug related problems."

   Pharmacovigilance is an essential activity since clinical trials do not always involve large enough samples of patients and these patients are not normally treated for a sufficiently long period of time to guarantee the detection of all the adverse effects of the medication undergoing the study. Other adverse reactions may be rare or delayed or result from interactions with other drugs, or may only affect a subgroup of patients (Bénichou, 1994). It is therefore crucial to monitor drugs post marketing.

   
With the help of spontaneous reporting systems, rare or delayed adverse reactions, which would have otherwise gone unnoticed, have become known thanks to HCPs who were able to correlate an adverse symptom with the use of a particular drug and transmitted the information to regulatory bodies. This discernment and correlation of adverse reactions may not always be easy and obvious to identify. This project aims to help clinicians and other health-care professionals to be able to identify drug-induced adverse events via the use of an online ADR database.

   An ADR report involves completing a Case Report Form (CRF) which is different for each country but includes at least four common sections being: the patient information, suspected medication, adverse event and reporter information.

   HCPs are obliged to report ADRs through their national reporting system. The agency in Malta which receives such reports is the Malta Medicines Authority. The ADR report form is easily accessible to all HCPs from the Post-licensing/ Pharmacovigilance section within their website
http://www.medicinesauthority.gov.mt


Aronson JK, White NJ. Principles of Clinical Pharmacology and Drug Therapy. In: Oxford Textbook of Medicine. London: Oxford University Press; 1996.
Bénichou C (editor). Adverse Drug Reaction: A practical guide to Diagnosis and Management. Chichester: John Wiley & Sons; 1994
Edwards I, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. The Lancet 2000; 356(9237): 1255-1259.
EU. Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products. The Institute: 1975.
Rawlins MD and Thompson JW. Pathogenesis of adverse drug reactions. In: Davies DM, editor. Textbook of Adverse Reactions London: Oxford University Press: 1977. P.44.
WHO. Technical Report No 498: International Drug Monitoring, The Role of National Centres. Geneva: The Institute; 1972.
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