clinical pharmacology: the use of medicines Flashcards
who gives licenses to medicines?
Medicines and Healthcare products Regulation Agency (MHRA)
what are criteria for new medicines to be awarded license?
- safe
- effective
- high quality
what are different types of licenses awarded by MHRA?
product
- clinical trial authorisation
- marketing authorisation (product licence)
company
- company licences
(manufacturing and wholesaler dealer licences)
what is pharmacovigilance?
continual assessment of risks and benefits of each drug
- detection, assessment, understanding and prevention of adverse drug reactions (ADRs)
what is the main method of post-marketing surveillance of ADRs in UK?
yellow card scheme
what information does the yellow card scheme collect?
- side effects (ADRS)
- medical device adverse incidence
- defective medicines
- counterfeit or fake medicines or medical devices
- safety concerns
what information is included when reporting ADRs to yellow card scheme?
- reporter’s details (name and full address)
- patient’s details (initials, sex, age)
- name of medicine
- side effects
what are different status of licenses a medication can be?
unlicensed: no marketing authorisation
off-label: licensed but prescribed outwith terms of marketing authorisation
specials: special formulations of medicines made for clinical reasons when an existing formation of an available licensed product is not suitable for patient (unlicensed)
licensed
describe unlicensed medication
no marketing authorisation
describe off-label medication
licensed but prescribed outwith terms of marketing authorisation
describe special medication
special formulations of medicines made for clinical reasons when an existing formation of an available licensed product is not suitable for patient (unlicensed)
what does the GMC expect you to do in regards to unlicensed medication?
carefully consider any treatments you prescribe
be able to justify decisions and actions regardless of whether they are licensed or unlicensed
What are different classifications of medicines by Human Medicines Regulation 2012?
prescription only medicines (POM): all new medicines
over the counter (OTC)
who can POMs be prescribed by?
- doctor
- dentist
- supplementary prescriber
- nurse independent prescriber
- pharmacist independent prescriber
- community practitioner nurses (limited)
- optometrist independent prescribers (limited)
when medicines are just given licensing, what are they classed as?
POM not OTC
what are the different kinds of OTC medications?
pharmacy (P) medicines: sold from registered pharmacy
general sales list (GSL): sold from registered pharmacy + other retail outlets
examples of things that must be on a prescription?
patient: name, address, age (if <12)
drug: name, formation, dose, frequency, quantity to be dispensed
prescriber: signature, date, type and address
what are controlled drugs?
subjected to additional regulations due to being associated with dependence (Misuse of Drugs Regulations 2001)
- 5 schedules
- specifies import, export, production, supply, possession, prescribing, record keeping activities
what legislation control controlled drugs?
Misuse of Drugs Regulations 2001
what are some rules for when writing doses?
avoid decimal points
- if less than 1g – write as mg (500mg not 0.5g)
- if less than 1mg – write as micrograms (500micrograms not 0.5mg)
avoid Latin abbreviations
- do not abbreviate micrograms or nanograms to other symbols
what should be done before inpatient prescribing?
ensure good medicine reconciliation (accurate drug history)
discuss with seniors if medicine it to continue, change dose/frequency, be with-held or stopped
check BNF if unsure of drug, dose, frequency
general principles of inpatient prescribing?
all patients must have a PAR (‘kardex’); maximum of 2 PARs at a time
permanent black ink, legible, block letters, don’t use dittos, use 24 hour clock, sign for each medicine and print name
use generic name of drug (except use brand name for insulin), all routes of administration
write down allergies - NKDA
in what units should liquids be prescribed?
do not prescribe in mL, must be mg of active ingredient such as:
125mg/5mL
