Pharmacology - the use of medicine Flashcards
what does the MHRA (medicines and healthcare products regulatory agency) do?
Ensures that human medicines meet acceptable standards on safety, quality and efficacy. Ensures that the sometimes difficult balance between safety and effectiveness is achieved. A license from the MHRA is required before any medicine can be used to treat people in the UK..
pharmacovigilance
The process involving detection, assessment, understanding and prevention of adverse drug reactions (ADRs). Provides continual assessment of the risks and benefits of each drug resulting in the best drug therapy for the patient.
what is the yellow card scheme?
main method for post-marketing surveillance of ADRs in the UK.
The Scheme collects information on suspected problems or incidents involving:side effects (also known as adverse drug reactions or ADRs);
medical device adverse incidents;
defective medicines (those that are not of an acceptable quality);
counterfeit or fake medicines or medical devices;
safety concerns, e.g. for e-cigarettes or their refill containers (e-liquids).
Healthcare professionals should report all suspected adverse drug reacitons to:
new drug on market and black triangle drug
children (Mostly off license)
Serious ADRs for established drugs and vaccines, e.g. anaphylaxis, events that have led to significant harm, those which are fatal.
what info should be included in a yellow card report?
side effects, info of person wo expericnced side effects, name of thhe medicine, your name and full address.
what does unlicensed mean?
no marketing authorisation
whaht does off-label mean?
licensed but prescribed outwith the terms of marketing authorisation
what does specials mean?
special formulations of medicines made for clinical reasons when an exisitinf formulation of an available liscensed product is not suitable for the patient= unlicensed
gmc view on unlicensed mredicines.
GMC expects you to carefully consider any treatment that you prescribe, and to be able to justify your decisions and actions when prescribing, administering and managing medicines regardless of whether they are licensed or unlicensed.
how are controlled durgs prescribed?
5 Schedules – e.g. Opiates - Schedule 2, Temazepam, tramadol - Schedule 3
Specifies import, export, production, supply, possession, prescribing, record keeping activities.
See BNF for further information Schedules 2, 3, and 4 limited to supply of up to 30 days’ treatment.
general prescribing rules
write mg if you need mg, do not used decimal points. Write out micrograams and nanograms.
