Adverse Drug Reaction reporting

EMA, the European Medicines Agency, has recently launched a new website giving public access to the European database of suspected adverse drug reaction (ADR) reports. The website provides an A-Z list of reports that have been submitted to EudraVigilance by national medicines regulatory authorities. The list is classified by product and substance.

For medical translators the new website offers a good opportunity to brush up on terms and definitions used in ADR reporting, so the rest of this post is a brief review of ADR terminology in the form of a Q&A section. 

What’s an adverse drug reaction?

• An ADR is defined as “a response to a medicinal product which is noxious and unintended” (Article 1 of Directive 2001/83/EC).
• In layman’s terms: a side effect.

Are seriousness and severity the same thing? → No.

• Seriousness refers to the patient outcome. If the ADR results in death or is life-threatening, it is serious. The antonym is non-serious.
• Severity is the intensity of the reaction. It can be mild, moderate or severe.

What’s the difference between an ADR and an adverse event?

• As mentioned above, an adverse drug reaction is an undesirable response to a medicinal product.
• An adverse event is any untoward medical occurrence experienced by a patient whilst taking a medicine, regardless of whether or not the medicine is suspected to be related to the event.

How is an ADR classified?

• An ADR is classified by reaction group, using the MedDRA system organ class. The table below shows suspected ADR reports for Insulatard, classified by reaction group and age. Logically, the highest incidence of adverse reactions in this case is found in the ‘metabolism and nutrition disorders’ group. (Click on the image to enlarge.)

What does ‘benefit-risk balance’ mean?

• The benefits (desired effects) of a medicine are weighed up against its risks (adverse reactions). The balance or ratio is continually monitored to confirm that the benefits outweigh the risks.

What’s the difference between the effectiveness and the efficacy of a medicine?

• Effectiveness is the ability of a medicine to produce the desired therapeutic effect when used in real-life conditions.
• Efficacy is the ability of a medicine to produce the desired therapeutic effect under ideal conditions (usually in a clinical-trial setting).

What are Type A and Type B reactions?

• Type A reactions – or augmented reactions –  result from an exaggeration of a drug’s normal pharmacological actions when given at the usual therapeutic dose. They are normally dose-dependent, e.g. hypotension with an antihypertensive agent.
• Type B reactions – or bizarre reactions – are novel responses that are not expected from the known pharmacological actions of the drug, e.g. an anaphylactic reaction with penicillin.

When are suspected ADRs reported?

• At any time during the pre-authorisation stage when there is a suspected unexpected serious adverse reaction (SUSAR) and also later, post-authorisation, through spontaneous reporting, post-authorisation studies, scientific literature, etc. Reports are submitted to EudraVigilance, the EMA suspected ADR reporting system.

The new EMA website is a small but welcome addition to a medical translator’s resources. Make sure you bookmark it now!

1. EMA ADR Reports Glossary
2. MHRA information about Adverse Drug Reactions
3. CPMP/ICH/377/95 Definitions and Standards for Expedited Reporting

Update on 24 June 2012: The EMA has just announced that it has translated its new website into all EU languages. The ADR database itself is still only in English, but the actual website and the brief ADR glossary is now in 23 different languages, offering a more comprehensive resource for translators.

Image attribution: oddharmonic