Pharmacovigilance and monitoring medicines use

Question 1

MHRA

Answer 1

• are responsible for regulating all medicines, medical devices and blood components for transfusion in the UK by ensuring they work and meet standards for safety and quality
• they secure the safe supply chain for medicines, medical devices and blood components
• educate the public and healthcare professionals about the risks and benefits of medicines

Question 2

What is an SPC ( summaries of product characteristics )

Answer 2

• a description of a medicinal products properties and the conditions attached to its use. it explains how to use and prescribe a medicine.

Question 3

Pharmacovigilance

Answer 3

• concerned with monitoring adverse effects of medicines
• aims to detect, access, understand and prevent problems.

Question 4

Yellow card Scheme

Answer 4

• scheme for reporting side effects
• the scheme was set up in 1964 following the thalidomide scandal
• run by the MHRA

Question 5

What should be reported in the YCS ?

Answer 5

SAFETY ISSUES AND CONCERNS ABOUT ANY HEALTHCARE PRODUCT INCLUDING :

• medicines
• vaccines
• blood factors and immunoglobins
• herbal medicines
• Ecigs

Question 6

What adverse drug reactions should be reported ?

Answer 6

• all suspected ADRS in marked as black triangle in the BNF
• all suspected serious ADRS in established medicines and vaccines including unlicensed, OTC and herbal medicines.

Question 7

Why report serious reactions to older drugs ?

Answer 7

• no longer require intensive monitoring as black triangle products because the safety of the product has been well established. However previously unrecognised side effects may still be unidentified when a medicine has been available for many years

Question 8

Classification of adverse drug reactions

Answer 8

• Type A reactions result from an exaggeration of a drugs normal pharmacological actions when given at the usual therapeutic dose and are normally dose dependent
• Type B = these are reactions that are not expected from the known pharmacological actions of the drug. These are less common and so may also be discovered after a drug has been for some time
• Type C = continuing reactions persist for a relatively long time
• Type D = delayed reactions become apparent some time after the use of medicine
• Type E = end of use reactions are associated with the withdrawal of a medicine

Reporting in children is important because the drug and its pharmacokinetics in children may be different from that in adults.

drugs many not have been extensively tested in children

Question 9

Pharmacodynamic interactions

Answer 9

these are interactions between drugs which have similar or opposing pharmacological effects or side effects. They might be due to competition at receptor sites or occur between drugs acting on the same physiological system

Question 10

Pharmacokinetic interactions

Answer 10

• these occur when one drug alters the way the body handles the movement of another drug in the body so increasing or decreasing the amount of drug available to produce pharmacological effects.