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Medicine Year 1 - Semester 2 - Part 1 > The Use of Medicines > Flashcards

The Use of Medicines Flashcards

1
Q

List aims of medicine regulation

A

To ensure :

  • Medicines have required quality, safety and efficacy
  • Medicines are appropriately manufactured, stored, distributes and dispensed
  • Promotion and advertising is fair
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2
Q

What does medicine regulation allow ?

A

Detection of illegal manufacturing and trade.

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3
Q

What does health regulation provide ?

A

Health professionals/patients with information to enable the safe use of medicines.

Framework to allow access to new medicines

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4
Q

What % of medicines in the world are counterfeit ?

A

Up to 10% of medicines in the world are counterfeit.

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5
Q

State the Medicine Regulator in the UK

A

MHRA - Medicines and Healthcare products regulatory agency

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6
Q

What is the function of the MHRA ?

A

Approves and Licences meds in the UK - issues clinical trial authorisations and marketing authorisations

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7
Q

Describe the role of MHRA

What does MHRA have the power to do ?

A

Has the power to withdraw meds from the market

Monitors safety

Issues manufacturers and wholesale dealers licenses.

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8
Q

What are marketing authorisations ?

A

Granted for a period of 5 years.

Ensures that the medicine meets the standards of safety, quality and efficacy.

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9
Q

What is the Summary of Product Characteristics ?

A

The terms which specifies what sort of conditions and patients the medicine is licensed for.

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10
Q

SmPC

A

Summary of product characteristics

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11
Q

Where can you find the SmPC ?

A

Electronic Medicines Compendium

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12
Q

Describe unlicensed medicines

A

No marketing authorisation, includes “special/bespoke” formulations, imported drugs, chemicals.

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13
Q

“special/bespoke formulations “

A

Crushing a tablet

(tablet is the licensed form not crushed form)

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14
Q

Describe off-label medicines

A

Has a marketing authorisation but prescribed outwith the terms of licence.

(different dose, age of patient, indication, route, contra-indication)

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15
Q

Off-label medications

A

Using a licensed medicine for an indication thats not on the summary of product characteristics.

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16
Q

Understand the significance of prescribing medicines unlicensed or off-label

A

There is an increased prescriber responsibility.

You must document and justify reasons for prescribing

Benefits outweigh risk ?

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17
Q

When prescribing unlicensed or off-label medicines, what are some things you need to ensure ?

A

Ensure :

  • Sufficient evidence for use
  • Adequate monitoring and follow-up
  • Patient is aware the medicine being used is outwith license (“label”)
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18
Q

Describe off-label thalidomide use

A

Marked as a sedative - became over-the counter

Resulted in tragedy - caused malformation of limbs and other developmental problems

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19
Q

Medicine Act 1968

A

Provided legal framework regarding control of medicines in the UK

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20
Q

Misuse of Drugs Act 1971

A

Prohibits activities around certain drugs

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21
Q

Aim of the misuse of drugs act 1971

A

To prevent misuse of potentially dangerous drugs by applying penalties to their manufacture, supply or possession.

Separated drugs into 3 classes

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22
Q

Class A drugs examples

A

Cocaine, Heroin, Methadone, Magic Mushrooms

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23
Q

Consequences for possessing/supplying Class A drugs

A

Possession : 7 years + fine

Supply : Life + Fine

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24
Q

Class B drugs examples

A

Cannabis, Mephedrone

25
Q

Consequences for possessing/supplying Class B drugs

A

Possession : 5 Years + fine

Supply : 14 years + fine

26
Q

Class C drugs examples

A

Anabolic steroids, Benzodiazepines

27
Q

Consequences for possessing/supplying Class C drugs

A

Possession : 2 years + fine

Supply : 14 years + fine

28
Q

Misuse of Drugs Regulations 2001

A

To allow the possession and supply of controlled drugs for legitimate purposes

29
Q

Describe the misuse of drugs regulations

State the schedules of controlled drug

A

5 Schedules of Controlled Drug :

  1. Lysergide
  2. Opiates
  3. Some benzodiazepines
  4. Anabolic steroids
  5. Codeine
30
Q

Human Medicines Regulations 2012

A

Simplified set of rules, introduced pharmacovigilance requirements.

31
Q

Describe human medicines regulations 2012

A

Information on labelling of medicines and patient group directions.

32
Q

Controversies of drugs

A

Just because a drug is legal to supply and use doesn’t mean it is safe.

33
Q

FRANK

A

Honest information about drugs

34
Q

State the 3 legal categories of medicines in the UK

A

GSL
P
POM

35
Q

GSL

A

General Sales List

36
Q

P

A

Pharmacy Only

37
Q

POM

A

Prescription only medicine

38
Q

Describe General Sale List

A

Can be sold in registered pharmacies but also in other retail outlets :

e.g. paracetamol
- over the counter

39
Q

Describe pharmacy only medicines

A

Not for public self-selection
Additional legal/professional considerations

Check for contra-indications, and give appropriate advice.

40
Q

Describe prescription only medicine

A

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

An increasing number of medicines are reclassified from POM to P - improving access to medicines with safety net of pharmacists.

41
Q

Who are appropriate practitioners ?

A

Doctor
Dentist
Supplementary Prescriber
Nurse independent practitioner
Pharmacist independent prescriber

42
Q

Describe the GMC 2013

A

Describe what is expected of all registered doctors

43
Q

Summarise general principles of safe and legal prescribing

A

Prescriber is responsible for prescriptions signed for

Must be able to explain and justify your decision to prescribe, including if unlicensed/off-label use.

44
Q

General principles of safe and legal prescribing (in terms of prescriber)

A

Keep up to date
Report adverse events
Work within limits of competence

Take account of evidence-based, clinical guidelines

45
Q

Legal considerations of prescription writing

A

Name and Address of patient
If patient is under 12, specify age

Name of drug, strength, quantity, dose, frequency

46
Q

Describe controlled drugs

A

Valid for 28 days from the appropriate date

Specify formulation and strength

Total amount in words and figures

47
Q

State the 5 R’s of medicine safety

A

Right patient
Right drug
Right dose
Right route
Right time

48
Q

State some important parts of safe prescribing

A

Legible writing
Unambiguous
No abbreviations
No latin

49
Q

Summarise the routes available to report adverse events involving medicines

A

MHRA Yellow Card Scheme

MHRA Drug Alerts

50
Q

MHRA yellow card scheme

A

Report suspected adverse reactions to any therapeutic agent

51
Q

“Black triangle” drugs

A

Newly licensed drugs that require intensive monitoring

52
Q

MHRA Drug Alerts

A

To communicate problems to al healthcare professionals

53
Q

Why use incident reporting systems ?

A

Improves medicine safety

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

54
Q

Explain the role of evidence based guidelines

A

Maximise safety and efficacy
Reduce variation in practice
Advise on best value
Support practitioners

55
Q

What are evidence based guidelines ?

A

Result of a systematic review of literature by multi-disciplinary teams.

56
Q

What do evidence based clinical guidelines do ?

A

Recommend management and treatment options for specific conditions

57
Q

UK Guidelines

A

SIGN - Scottish
NICE - English

58
Q

Explain the role of medicine formularies

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.

59
Q

Individual country medicine advice
(SMC)

A

Independent, multi-professional
Analyses health benefits of meds
Compares to other treatment

Medicine Year 1 - Semester 2 - Part 1 (51 decks)

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