clinical pharmacology: the use of medicines

Question 1

who gives licenses to medicines?

Answer 1

Medicines and Healthcare products Regulation Agency (MHRA)

Question 2

what are criteria for new medicines to be awarded license?

Answer 2

• safe
• effective
• high quality

Question 3

what are different types of licenses awarded by MHRA?

Answer 3

product

• clinical trial authorisation
• marketing authorisation (product licence)

company

• company licences

(manufacturing and wholesaler dealer licences)

Question 4

what is pharmacovigilance?

Answer 4

continual assessment of risks and benefits of each drug

• detection, assessment, understanding and prevention of adverse drug reactions (ADRs)

Question 5

what is the main method of post-marketing surveillance of ADRs in UK?

Answer 5

yellow card scheme

Question 6

what information does the yellow card scheme collect?

Answer 6

• side effects (ADRS)
• medical device adverse incidence
• defective medicines
• counterfeit or fake medicines or medical devices
• safety concerns

Question 7

what information is included when reporting ADRs to yellow card scheme?

Answer 7

• reporter’s details (name and full address)
• patient’s details (initials, sex, age)
• name of medicine
• side effects

Question 8

what are different status of licenses a medication can be?

Answer 8

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

Question 9

describe unlicensed medication

Answer 9

no marketing authorisation

Question 10

describe off-label medication

Answer 10

licensed but prescribed outwith terms of marketing authorisation

Question 11

describe special medication

Answer 11

special formulations of medicines made for clinical reasons when an existing formation of an available licensed product is not suitable for patient (unlicensed)

Question 12

what does the GMC expect you to do in regards to unlicensed medication?

Answer 12

carefully consider any treatments you prescribe

be able to justify decisions and actions regardless of whether they are licensed or unlicensed

Question 13

What are different classifications of medicines by Human Medicines Regulation 2012?

Answer 13

prescription only medicines (POM): all new medicines

over the counter (OTC)

Question 14

who can POMs be prescribed by?

Answer 14

• doctor
• dentist
• supplementary prescriber
• nurse independent prescriber
• pharmacist independent prescriber
• community practitioner nurses (limited)
• optometrist independent prescribers (limited)

Question 15

when medicines are just given licensing, what are they classed as?

Answer 15

POM not OTC

Question 16

what are the different kinds of OTC medications?

Answer 16

pharmacy (P) medicines: sold from registered pharmacy

general sales list (GSL): sold from registered pharmacy + other retail outlets

Question 17

examples of things that must be on a prescription?

Answer 17

patient: name, address, age (if <12)
drug: name, formation, dose, frequency, quantity to be dispensed
prescriber: signature, date, type and address

Question 18

what are controlled drugs?

Answer 18

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

Question 19

what legislation control controlled drugs?

Answer 19

Misuse of Drugs Regulations 2001

Question 20

what are some rules for when writing doses?

Answer 20

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

Question 21

what should be done before inpatient prescribing?

Answer 21

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

Question 22

general principles of inpatient prescribing?

Answer 22

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

Question 23

in what units should liquids be prescribed?

Answer 23

do not prescribe in mL, must be mg of active ingredient such as:

125mg/5mL