Adverse drug reactions

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Chapter: Hospital pharmacy : Risks with medicines

When a medicine is first licensed and marketed there will be limited information about its side-effects and potential to cause adverse drug reactions.


Adverse drug reactions

 

When a medicine is first licensed and marketed there will be limited information about its side-effects and potential to cause adverse drug reactions. For a medicine to be safe the benefits to the patient of taking the medicine should be greater than the risks of harm to the patient. The marketing authorisation for the drug is granted on the basis of a balance of benefits and risks. Once a drug is used more widely and more doses are taken by patients, more side-effects will become evident, and less common and potentially more serious side-effects will emerge. Table 12.1 provides a classification of adverse drug reactions.

 


 

To protect patients from the risks of medicines a system must be in place to be able to collect information about, and identify trends in, the adverse drug reactions these medicines may cause. Pharmacovigilance is a process for monitoring the use of medicines once they have been licensed for use to ensure information about adverse effects not identified prior to the drug being marketed can be collected and collated. It is also a means of identi-fying changes in the patterns of adverse effects to drugs already widely used. By understanding these patterns and the frequency of adverse effects, risks and benefits can be assessed to determine whether action needs to be taken to improve their safety, for example, by providing additional infor-mation to prescribers and patients about cautions and contraindications. The ultimate aim of pharmacovigilance is to ensure medicines have a positive impact on patients and the risk of harm from those medicines is minimised.

 

In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for monitoring medicines safety. It does this by col-lecting data about the use of medicines from a wide variety of sources, includ-ing clinical studies, published medical literature, pharmaceutical companies and from individual case reports submitted to the MHRA as part of a spon-taneous reporting system, the Yellow Card scheme.

 

The Yellow Card scheme is a mechanism by which patients and healthcare professionals can report actual and suspected adverse drug reactions to new and established medicines. The reports are evaluated alongside other infor-mation to identify whether any action needs to be taken to minimise the risk and maximise the benefits of the drug to the patient by changing product information, restricting the indications for using the medicine or, in extreme situations, removing the product from the market completely.

 

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