Uses of Medicine Flashcards

1
Q

What are the aims of medicine regulation ?

A

• To ensure medicines have required quality, safety and efficacy
• To ensure medicines are appropriately manufactured, stored, distributed and dispensed
• Allowsdetectionofillegalmanufacturingandtrade
• 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

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2
Q

What is the meaning of off-label and licence medicine ?

A

Off-label medicine : has a marketing authorisation
but prescribed outwith the terms of licence (different dose, age of patient, indication, route, contra-indication)

Off-licence medicine : no Marketing Authorisation, includes “Special/Bespoke” formulations, imported drugs, chemicals

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3
Q

What are the legal categories of medicine in the UK according to the Misuse of Drugs Act 1971 ? Give 2 examples for each.

A

Class A– cocaine, heroin
Class B– cannabis, mephedrone
Class C– anabolic steroids, benzodiazepines

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4
Q

What are the legal categories of medicine in the UK based on, according to the Misuse of Drugs Act 1971?

A

How harmful would this drug be if it were misused?

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5
Q

What are the punishments for possession and supply of class A, B, and C drugs respectively ?

A

Class A: POSSESSION: 7 years + fine SUPPLY: Life + fine
Class B: POSSESSION: 5 years + fine SUPPLY: 14 years + fine
Class C: 2 years + fine SUPPLY: 14 years + fine

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6
Q

What does the Misuse of Drugs Regulation (2001) do ?

A

Specifies import, export, production, supply, possession, prescribing, record keeping activities for controlled drugs (CDs)
Divides Controlled Drugs into 5 Schedules

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7
Q

Give an example of a controlled drug in each schedule according to the Misuse of Drugs Regulation (2001).

A
Schedule 1: Lysergide
Schedule 2: Some opiates
Schedule 3: Some benzodiazepines
Schedule 4: Anabolic steroids
Schedule 5: Codeine
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8
Q

What are the 3 legal categories of medicine according to the Human Medicines Regulations 2012 ?

A

General Sale List (GSL)
Pharmacy Only (P)
Prescription Only Medicine (POM)

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9
Q

What are general sale list medicines ? Give an example.

A

Can be sold in registered pharmacies but also in other retail outlets that can ‘close so as to exclude the public’.
Paracetamol

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10
Q

What are Pharmacy Only Medicines ?

A

Sold from registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist.

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11
Q

Which of the 3 legal categories of medicine according to the Human Medicines Regulations 2012 are considered over-the-counter medications ?

A

General Sale List Medicines and Pharmacy Only Medicines

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12
Q

What are some considerations to be taken by a pharmacist before giving a Pharmacy Only medicine ?

A

Check for contra-indications, and give appropriate advice

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13
Q

What are prescription only medicines ?

A

Written by an “appropriate practitioner” before it can be sold or supplied

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14
Q

How may some medicines have more than one category of classification ?

A

Depending on formulation, strength, quantity, indication or marketing authorisation

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15
Q

Give examples of ‘appropriate practitioner’ which can prescribe POMs, in the UK.

A
  • doctor
  • dentist
  • supplementary prescriber
  • nurse independent prescriber
  • pharmacist independent prescriber
  • EEA and Swiss doctors and dentists (limited)
  • community practitioner nurses (limited)
  • optometrist independent prescribers (limited)
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16
Q

What does the GMC Good Medical Practice 2013 say about prescribing medicines ?

A

Says prescriber should report adverse drug reactions, medical device incidents and other patient safety incidents

17
Q

What are some general principles of legal, safe, and effective prescribing ?

A
  • Prescriber is responsible for prescriptions signed for
  • Must be able to explain and justify your decision to prescribe, including if “unlicenced” /”off-label” use.
  • Work within limits of competence
  • Keep up to date
  • Take account of evidence-based, clinical guidelines
  • Report adverse events
18
Q

What are some legal considerations of prescription writing ?

A
  • Signed in ink by appropriate practitioner
  • On proper stationary
  • Name and address of patient
  • Address of eg. GP practice
  • Dated
  • If patient under 12, specify age
  • Name of drug, strength, quantity, dose, frequency
19
Q

What are some specific precautions taken when prescribing controlled drugs ?

A
  • Some schedules limited to supply of up to 30 days’ treatment.
  • Specify formulation and strength
  • Total amount in words and figures
  • Specify dose
20
Q

What are the 5 Rs of medicine safety ?

A
  • Right patient
  • Right drug
  • Right dose
  • Right route
  • Right time
21
Q

What are some routes available to report adverse events involving medicines ?

A
  1. MHRA Yellow Card Scheme
    – report suspected adverse reactions to any
    therapeutic agent

2 .“Black triangle” drugs
– newly licenced medicines that require intensive monitoring

  1. MHRA Drug Alerts
    – to communicate problems to all healthcare professionals
22
Q

Why is it important to Report any errors OR near misses in prescribing ?

A
  • Improves medicine safety

- To share the learning, look for trends, target areas of concern.

23
Q

Give examples of local, and national Medicine incident reporting systems.

A

Local: “DATIX” – NHS Fife reporting system
National: National Reporting and Learning System

24
Q

Where do evidence based guidelines come from ?

A

From a systematic review of literature

25
Q

What is the aim of evidence based guidelines ?

A

Recommend management and treatment options for specific conditions

26
Q

What are the pros of evidence based guidelines ?

A
  • Support practitioners
  • Maximise efficacy
  • Reduces variation in practice
  • Maximise safety
  • Advise on best value
27
Q

What are examples of UK bodies publishing guidelines ?

A

NICE (National Institute for Health and Clinical Excellence)
SIGN (Scottish Intercollegiate Network)

28
Q

What are medicine formularies and what is their role ?

A

A list of prescription drugs

Used by practitioners to identify drugs that offer the greatest overall value in terms of safety, efficacy and cost

29
Q

What is the NHS Fife Formulary ? Is it still allowed to prescribe outwith the formulary ?

A

List of medicines which are approved to be prescribed by hospitals and primary care in Fife
Non-formulary prescribing strongly discouraged