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Specialities > The Use of Medicines > Flashcards

The Use of Medicines Flashcards

1
Q

Who gives licenses to medicines?

A

Given by Medicines and Healthcare products Regulation Agency (MHRA)

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2
Q

What does MHRA stand for?

A

Medicines and Healthcare Products Regulation Agency

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3
Q

What are criteria for new medicines to be awarded license?

A
  • Safe
  • Effective
  • High quality
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4
Q

How is the safety and efficay of potential new medicines proven?

A
  • Pre-clinical testing
  • Clinical trials
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5
Q

What are different types of licenses awarded by MHRA?

A
  • Product
    • Clinical trial authorisation
    • Product licence (marking authorisation)
  • Company
    • Company licences (manufacturing and wholesaler dealer licences)
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6
Q

What is pharmacovigilance?

A

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
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7
Q

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

A

Yellow card scheme

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8
Q

What information does the yellow card scheme collect?

A

Collects information on suspected problems involving:

  • Side effects
  • Medical device adverse incidence
  • Defective medicines
  • Counterfeit or fake medicines or medical devices
  • Safety concerns
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9
Q

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

A
  • Side effects
  • Information about person (initials, sex, age)
  • Name of medicine
  • Your name and full address
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10
Q

What are different status of licenses a medication can be?

A
  • 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
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11
Q

What are off-label medications?

A
  • Licensed by prescribed outwith the terms of marketing authorisation
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12
Q

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

A
  • Carefully consider any treatments you prescribe
  • Be able to justify to decisions regardless of whether they are licensed or unlicensed
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13
Q

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

A
  • 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
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14
Q

What does POM stand for?

A

Prescirption only medicines

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15
Q

Who can POMs be prescribed by?

A
  • Can be prescribed by – doctor, dentist, supplementary prescriber, nurse independent prescriber, pharmacist independent prescriber, community practitioner nurses (limited), optometrist independent prescribers (limited)
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16
Q

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

A

POM not OTC

17
Q

What does OTC stand for?

A

Over the counter

18
Q

What are the different kinds of OTC medications?

A
  • 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
19
Q

What are examples of things that must be on a prescription?

A
  • 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
20
Q

What are controlled drugs?

A
  • 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
21
Q

What legislation control controlled drugs?

A

Misuse of Drugs Regulations 2001

22
Q

What are some rules for when writing doses?

A
  • Avoid decimal points
    • If less than 1g – 500mg not 0.5g
    • Less than 1mg – 500mg not 0.5mg
  • Avoid Latin abbreviations
23
Q

What should be done before inpatient prescribing?

A
  • 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
24
Q

What are some general principles of inpatient prescribing?

A
  • 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
25
Q

Should 12 or 24 hour clock be used for inpatient prescribing?

A

24 hour clock

26
Q

Should generic or brand name of drugs be used for inpatient prescribing?

A
  • Generic name of drug
    • Branded prescribing of insulins
27
Q

What should be written if the patient has no known allergies?

A
  • If none write NKDA (no known drug allergies)
28
Q

How should micrograms be written on inpatient presciption?

A
  • Write micrograms in full
29
Q

In what units should liquids be prescribed?

A

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

  • 125mg/5mL

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