BNF for Children 2011-2012

BNFC 2011–2012 Adverse reactions to drugs 13medicines depends on the availability of informationfrom routine clinical practice.The black triangle symbol (T) identifies newly licensedmedicines that are monitored intensively by the MHRA.Such medicines include new active substances, biosimilarmedicines, medicines that have been licensed foradministration by a new route or drug delivery system,or for significant new indications which may alter theestablished risks and benefits of that drug, or thatcontain a new combination of active substances.There is no standard time for which products retain ablack triangle; safety data are usually reviewed after 2years.Adverse reactions to medical devices Suspectedadverse reactions to medical devices including dental orsurgical materials, intra-uterine devices, and contactlens fluids should be reported. Information on reportingthese can be found at:www.mhra.gov.uk.Side-effects in the BNF for Children The BNF forChildren includes clinically relevant side-effects formost drugs; an exhaustive list is not included fordrugs that are used by specialists (e.g. cytotoxic drugsand drugs used in anaesthesia). Where causality has notbeen established, side-effects in the manufacturers’ literaturemay be omitted from the BNF for Children.In the product literature the frequency of side-effects isgenerally described as follows:Very common greater than 1 in 10Common 1 in 100 to 1 in 10Uncommon [‘less commonly’ in 1 in 1000 to 1 in 100BNF for Children]Rare 1 in 10 000 to 1 in 1000Very rare less than 1 in 10 000Special problemsSymptoms Children may be poor at expressing thesymptoms of an adverse drug reaction and parentalopinion may be required.Delayed drug effects Some reactions (e.g. cancersand effects on development) may become manifestmonths or years after exposure. Any suspicion of suchan association should be reported directly to the MHRAthrough the Yellow Card Scheme.Congenital abnormalities When an infant is bornwith a congenital abnormality or there is a malformedaborted fetus doctors are asked to consider whether thismight be an adverse reaction to a drug and to report alldrugs (including self-medication) taken duringpregnancy.. allergy and idiosyncrasy are important causes ofadverse drug reactions. Ask if the child has hadprevious reactions to the drug or formulation;. prescribe as few drugs as possible and give veryclear instructions to the child, parent, or carer;. whenever possible use a familiar drug; with a newdrug be particularly alert for adverse reactions orunexpected events;. consider if excipients (e.g. colouring agents) may becontributing to the adverse reaction. If the reactionis minor, a trial of an alternative formulation of thesame drug may be considered before abandoningthe drug;. obtain a full drug history including asking if thechild is already taking other drugs including overthe-countermedicines; interactions may occur;. age and hepatic or renal disease may alter themetabolism or excretion of drugs, particularly inneonates, which can affect the potential for adverseeffects. Genetic factors may also be responsible forvariations in metabolism, and therefore for theadverse effects of the drug;. warn the child, parent, or carer if serious adversereactions are liable to occur.Defective medicinesDuring the manufacture or distribution of a medicine anerror or accident may occur whereby the finished productdoes not conform to its specification. While such adefect may impair the therapeutic effect of the productand could adversely affect the health of a patient, itshould not be confused with an Adverse Drug Reactionwhere the product conforms to its specification.The Defective Medicines Report Centre assists with theinvestigation of problems arising from licensed medicinalproducts thought to be defective and co-ordinatesany necessary protective action. Reports on suspectdefective medicinal products should include the brandor the non-proprietary name, the name of the manufactureror supplier, the strength and dosage form of theproduct, the product licence number, the batch numberor numbers of the product, the nature of the defect, andan account of any action already taken in consequence.The Centre can be contacted at:The Defective Medicines Report CentreMedicines and Healthcare products Regulatory Agency151 Buckingham Palace RoadLondon, SW1W 9SZTel: (020) 3080 6588info@mhra.gsi.gov.ukAdverse reactions to drugsPrevention of adverse reactionsAdverse reactions may be prevented as follows:. never use any drug unless there is a good indication.If the patient is pregnant do not use a drugunless the need for it is imperative;