Pharmacovigilance Study Resources

Summaries of product characteristics (SPC)- description of medicinal products properties and conditions attached to use How to use & prescribe used. By healthcare professionals available by EMC Patient information leaflets should be provided in every medicine pack- info on how to use medicine safely based on SPC info Pharmacovigilance Concerned with monitoring adverse effects of medicines and aims to detect, assess and understand and prevent problems Clinical trials must occur before medicines reach the market and once it reaches, the safety is monitored for new side effects or concerns Initially tested on animals then trialed on a patient group usually young healthy men Type B rare type adverse effect Yellow card scheme Reporting suspected side effects set up inn 1964 following thalidomide Run by MHRA collecting and monitoring info suspected safety concerns involving healthcare products Reliant on voluntary reporting Medicines, vaccines, herbal medicines, e-cigarettes, medical devices Adverse drug reactions (ADRs) All suspected marked as black triangle drugs in BNF Serious suspected in established medicines and vaccines including unlicensed OTC and herbal Black triangles intensively monitored and assigned if new active substance, biological medicine, vaccine, plasma, conditional approval Once the product has been well established, no longer black triangle Previously unrecognised side effects i.e. rare or delayed may be unidentified i.e. Reye’s syndrome aspirin Classification of adverse drug reactions: Usually type A or B but has been extended A- augmented resulted from exaggeration of drugs pharmacological actions when given therapeutic dose usually dose dependant i.e. respiratory depression with opioids B- bizarre reactions expected from the known pharmacological actions of drug. Less common may be discovered after some time i.e. anaphylaxis penicillin C- continuing persistent for a long time i.e. osteonecrosis of jaw with biphosphonates D- delayed reactions become apparent after some time E- end of use associated with medicine withdrawal i.e. insomnia, anxiety, depression from benzodiazepine withdrawals Serious reactions from life-threatening fatal disability incapacitating resulting in prolonged hospitalisation congenital abnormalities medically significant ADRs suspected in children, elderly over 65, biological medicines/ vaccines, delayed drug effects and interactions, complementary remedies i.e. homeopathic Herman; remedies Children aren’t fully developed i.e. kidneys and livers enzymes m,any not be created to metabolise drugs Drugs actions and pharmacokinetics different from adults so may effect growth and development causing adverse reactions not found in adults Post-marketing evaluation Variations and renewal of marketing authorisations Extending license from second to first line treatment Change of classification Change of license to permit usage in different age groups Regulation product regulation Regulation medicines advertising and promoting Interactions Effects produced when 2 or more drugs given at the same Time Some interactions may be beneficial Some may be harmless or little impact on patients wellbeing day to day Others may be severe or harmful should be avoided or monitoring effects I.e. elderly, patients with renal/kidney impairments or patients with hepatic/liver impairments Pharmacodynamic interactions Interactions between drugs which have similar potentiating or opposing antagonistic pharmacological effects Due to competition at receptor sites or drugs acting on the same physiological system Some can be predictable Pharmacokinetic interactions Occur when one drug alters the way the body handles movement of another drug in the body and dresses or increases amount of drug available to produce pharmacological effects Absorption Distribution Metabolism Elimination Importance of interactions Most given a severity describing effect of an unmanaged interaction of patient Severe- result may be life threatening or have permanent detrimental effect Moderate- considerable distress of result or partially incapacitate a patient unlikely to be life threatening Mild- result unlikely to cause concern or incapacitate the majority of patients Unknown- interactions predicted, insufficient evidence to hazard a guess at outcome