Identifying and reporting adverse drug reactions

Clinically relevant Side-effects for most drugs are included in the monographs. However, if a class of drugs (e.g. tetracyclines, p. 346) share the same side-effects, these are presented in the prescribing notes while those unique to a particular drug in that class are included in its individual drug monograph. Occa sionally, side-effects may be included within a preparation record if they are specific to that preparation or if the preparation is not accompanied by a monograph.

Side-effects are generally listed in order of frequency and arranged broadly by body systems. Occasionally a rare side-effect might be listed first if it is considered to be particularly important because of its seriousness. The frequency of side-effects is described in fig. 1.

An exhaustive list of side-effects is not included for drugs that are used by specialists (e.g. cytotoxic drugs and drugs used in anaesthesia). Recognising that hyper-sensitivity reactions can occur with virtually all medicines, this effect is generally not listed, unless the drug carries an increased risk of such reactions. The BNF also omits effects that are likely to have little clinical consequence (e.g. transient increase in liver enzymes). The prescribing notes in the BNF may highlight important safety concerns and differences between drugs in their ability to cause certain side-effects. Safety warnings issued by the Commission on Human Medicines (CHM) or Medicines and Healthcare products Regulatory Agency (MHRA) can also be found here or in the drug monographs.

Adverse Reactions to Drugs (p. 12) provides advice on preventing adverse drug reactions, and guidance on reporting adverse drug reactions to the MHRA. The black triangle symbol ▼ identifies those preparations in the BNF that are monitored intensively by the MHRA.

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