What to Report

Any suspected ADRs to any medicine, vaccine or complementary medicine should be reported. This should include those that are self-medicated as well as those prescribed. We also encourage reports to Psychoactive Substances

Established medicines and vaccines
Healthcare professionals and coroners are asked to report all serious suspected reactions and other reactions of clinical concern to established medicines (including over-the-counter, complementary and alternative products, and medicines used off-label) and vaccines. Serious reactions include those that are fatal, life-threatening, disabling, incapacitating, or which result in or prolong hospitalisation; they should be reported even if the effect is well recognised. Examples include anaphylaxis, blood disorders, endocrine disturbances, effects on fertility, haemorrhage from any site, renal impairment, jaundice, ophthalmic disorders, severe CNS effects, rhabdomyolysis, severe skin reactions, reactions in pregnant women, congenital abnormalities and any drug interactions.

Newly introduced medicines and vaccines
Spontaneous reporting is particularly valuable for recognising possible new hazards rapidly. For newly introduced medicines and vaccines, or those being used for new indications or being delivered by a different route CARM asks that all suspected reactions (including minor reactions) are reported.
An adverse reaction should be reported even if it is not certain that the drug has caused it, or if the reaction is well recognised, or if other drugs have been given at the same time.
Even if you only thought it could be an ADR, report it
If in you are in doubt, report!
In summary, please report:
– all adverse reactions of clinical concern
– all adverse reactions to new medicines
– all reactions for which a warning about future use would be appropriate especially serious allergic reactions (see Medical Warning System)
– drug interactions