Use of Medicine Flashcards
What are the medicine regulation aims (6)
- to ensure medicines have required quality, safety, efficacy
- to ensure medicines are appropriately manufactured, stored, distributed and dispensed
- allows detection of illegal manufacturing and trade
- provides health professionals/patients with information to enable safe use of medicines
- ensures promotion and adverting is fair
- provides framework to allow access to new medicines
Who is the main medicine regulator in the UK
MHRA
what is the MHRA’s tasks (4)
- approves and licenses meds in the UK - issues clinical trial authorisations and marketing authorisations
- has power to withdraw meds from the market
- monitors safety
- issues manufacturers and wholesale dealers licences
what is the MHRAS main role
ensure medicine meets the standards of safety, quality and efficacy.
what is meant by an unlicensed drug
no UK marketing authorisation
imported drugs, chemicals and bespoke formulations
what is meant by off-label or off-licence
has a marketing authorisation but is prescribed outwit the terms of the licence:
- dosage
- age of patient
- indication
- route
- contra-indication
What do you have to be aware of as a prescriber in regards to off-licence drugs
ensure sufficient evidence for use
benefits will outweigh the risk
ensure adequate monitoring and follow up
what’s a key example of off-licence drug use
thalidomide:
morning sickness but was intended as a sedative
caused malformations of the limbs however is used now to treat skin conditions such as leprosy
Medicine Act 1968
Provided legal framework regarding control of medicines in the uk
Medicine of Drugs Act 1971
Prohibits activities around certain drugs
to prevent misuse of potencially dangerous drugs by applying penalties to their manufacture, supply or possession
also separates the drugs into three classes
A cocaine
B cannabis
c anabolic steroids
Misuse of drugs regulations 2001
to allow for possession and supply of “controlled drugs” for legitimate purposes
import, export, production, supply, possession and record keeping activities for controlled drugs
there are five different schedules
Human Medicines Regulations 2012
simplified set of rules, introduced pharmacovigilance requirements
modernised rules in line with EU guidelines
reduced regulatory burden
clearer pharmacovigilance routes
what are the three categories of medicines
GSL = general sales list P = Pharmacy only POM = Prescription Only Medicine
GSL = general sales list
can be sold in registered pharmacies but also in other retail outlets
OTC - over the counter like PARACETAMOL
Pharmacy only
sold from registered pharmacy premises by a pharmacist
can also be over the counter
POM = Prescription Only Medicine
has to be written by an appropriate before it can be sold or supplied
Good medical Practise 2013
describes what is expected of all doctors
good practise in prescribing and managing medicines and devices
says prescriber should report adverse drug reactions, medical advice incidents and other patient safety incidents
what are the general principles of legal, safe and effective prescribing
prescriber is responsible for prescriptions signed for
work within limits of competence
keep up date
report adverse events
what are the legal considerations when writing a prescription
signed in ink name and address of patient dated if patient is under 12 you must state name of drug, strength, quantity, dose, frequency controlled drugs
what are the 5 R’s of medicine safety
RIGHT PATIENT RIGHT DRUG RIGHT DOSE RIGHT ROUTE RIGHT TIME
MHRA yellow card scheme
report suspected adverse reactions to any therapeutic
why report medicine incidents
improves medicine safety
to share the learning
identify trends and areas of concern
Local report system
DATIX
National report system
National Reporting and Learning System
Scottish guidelines
SIGN
English guidelines
NICE
Northern island guidelines
Dept for health, social services and public safety
Wales guidelines
All-wales medicine strategy group
What is the role of medicine formalities
this is a list of prescription drugs used by practitioners to identify drugs that offer the greatest overall value in terms of safety, efficacy and cost
SMC
Scottish Medicines Consortium offers individual country medicine adice by analysing the health benefits of meds
