The Use of Medicines Flashcards
Who gives licenses to medicines?
Given by Medicines and Healthcare products Regulation Agency (MHRA)
What does MHRA stand for?
Medicines and Healthcare Products Regulation Agency
What are criteria for new medicines to be awarded license?
- Safe
- Effective
- High quality
How is the safety and efficay of potential new medicines proven?
- Pre-clinical testing
- Clinical trials
What are different types of licenses awarded by MHRA?
- Product
- Clinical trial authorisation
- Product licence (marking authorisation)
- Company
- Company licences (manufacturing and wholesaler dealer licences)
What is pharmacovigilance?
Is the process of detection, assessment, understanding and prevention of adverse drug reactions (ADRs):
- Provides continual assessment of risks and benefits of each drug
- Yellow card scheme is the main method for post-marketing surveillance of ADRs in UK
What is the main method of post-marketing surveillance of ADRs in UK?
Yellow card scheme
What information does the yellow card scheme collect?
Collects information on suspected problems involving:
- Side effects
- 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?
- Side effects
- Information about person (initials, sex, age)
- Name of medicine
- Your name and full address
What are different status of licenses a medication can be?
- Unlicensed
- No marketing authorisation
- Off-label
- Licensed by prescribed outwith the 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
What are off-label medications?
- Licensed by prescribed outwith the terms of marketing authorisation
What does the GMC expect you to do in regards to unlicensed medication?
- Carefully consider any treatments you prescribe
- Be able to justify to decisions 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
- Can be prescribed by – doctor, dentist, supplementary prescriber, nurse independent prescriber, pharmacist independent prescriber, community practitioner nurses (limited), optometrist independent prescribers (limited)
-
Over the counter (OTC)
- New medicines can be re-classified as this
- Pharmacy (P) medicines
- Sold from registered pharmacy by pharmacist or person acting under supervision of pharmacist
- General sales list (GSL)
- Can be sort in registered pharmacies but also other retail outlets like a shop
What does POM stand for?
Prescirption only medicines
Who can POMs be prescribed by?
- Can 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 does OTC stand for?
Over the counter
What are the different kinds of OTC medications?
- Pharmacy (P) medicines
- Sold from registered pharmacy by pharmacist or person acting under supervision of pharmacist
- General sales list (GSL)
- Can be sort in registered pharmacies but also other retail outlets like a shop
What are examples of things that must be on a prescription?
- Name and address of patient
- Age of patient if under 12
- Details of – drug name, formation, dose, frequency, quantity to be dispensed
- Signed in indelible ink
- Date on which was signed
- Type of prescriber and address
What are controlled drugs?
- They are subjected to additional regulations due to being associated with dependence (Misuse of Drugs Regulations 2001)
- Drugs divvied into 5 schedules
- Regulates import, export, production, supply, possession, prescribing, record keeping
- Must specify formation and strength, dose, total amount must be in words and figures
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 – 500mg not 0.5g
- Less than 1mg – 500mg not 0.5mg
- Avoid Latin abbreviations
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
What are some general principles of inpatient prescribing?
- All patients must have a PAR
- Use permanent black ink
- Legible
- Block letters
- Maximum of 2 PARs at a time
- Use 24 hour clock
- Route of administration on chart
- Generic name of drug
- Branded prescribing of insulins
- Sign for each medicine and print name
- Write all allergies
- If none write NKDA (no known drug allergies)
- If only taking on alternative days, cross of the days
- Write micrograms in full
