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Pharmacology MD2002 > The Use of Medicines > Flashcards

The Use of Medicines Flashcards

1
Q

List the aims of medicine regulation

A
  • To ensure meds have required quality, safety and efficacy
  • Ensure meds are appropriately manufactured, stored, distributed and dispensed
  • Allows detection of illegal manufacturing and trade
  • Provides health professional/patients with info to ensure safe use
  • Ensures promotion/advertising is fair
  • Provides framework to allow access to new meds
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2
Q

What is the Uk’s main medication regyulator

A

MHRA

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3
Q

What is the role of the Medicines and Healthcare products Regulatory Agency? (MHRA)

A
  • Approves and Licences meds in the UK
  • Ability to withdraw meds from the market
  • Monitors Safety
  • Issues manufacturers and dealers licences
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4
Q

What does an unlicenced drug mean?

A

It has no UK marketing authorisation

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5
Q

What does off-label or off-licence mean?

A

It has marketing authorisation but is perscribed outwith the terms of licence

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6
Q

What is the significance of prescribing unlicensed or off-licence drugs (what must you ensure doing when perscribing off-licence)

A

it increases perscriber responsibility
You must ensure patients knows it is being perscribed without licence
Must ensure there is significant evidence for use
Ensure follow ups
Document and justify reasons

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7
Q

What did the Human Medicines Regulations 2012 Act introduce?

A
  • A new set of modernised rules in line with EU laws
  • Info on labelling of meds and patient group directions
  • Reduced regulatory burden
  • Clearer pharmacoviligance routes
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8
Q

What does pharmacoviligence mean?

A

The monitoring of the effects of a drug after it has been licenced

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9
Q

What are the three legal categories of medicines in the UK

A

GSL - General Sales List
P - Pharmacy only
POM - Percription only medicine

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10
Q

What are General Sales List medication?

A

These are medications that can be sold to registered pharmacies but also other retail outlets. E.g. Paracetamol or other over the counter drugs

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11
Q

What are Pharmacy Only drugs

A

Drugs sold from registered pharmacy premises by a pharmacist or persons acting under a pharmacist. These can also be considered as over the counter medication

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12
Q

What are prescription only medications?

A

These are meds which must have a prescription written by an appropriate practitioner before it can be supplied. Medications can be in more than one category depending on factors such as formulation, strength, quantity ect.

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13
Q

What are some of the general principles of legal, safe and effective perscribing

A
  • Prescriber is responsible for prescriptions signed for
  • Must be able to justify and explain decision for prescription
  • Work within limits of competence
  • Keep up to date
  • Take account of guidelines
  • Report adverse side effects
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14
Q

What must be on a perscription?

A

Signature written in ink, name and address of patient, address of GP practice, Date, Name of drug, strength, quantity, dose and frequency

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15
Q

What is different with a prescription of a controlled drug?

A
  • Limited supply of up to 30 days
  • Must specify formulation and strength and dose
  • Total amount in words and figures
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16
Q

What are the 5 R’s of perscribing?

A 
Right Patient
Right dose
Right drug
Right route
Right time
17
Q

What is a post marketing survalence scheme?

A

The MHRA Yellow Card Scheme - It is used to report suspected adverse reactions to any agents, devices, fake drugs.
Black Triangle drugs - Newly licences meds that require intensive monitoring
MHRA drug alerts

18
Q

What are some medicine incident reporting schemes?

A

DATIX and National Reporting and Learning System. Report any errors or near misses.

19
Q

What are the roles of evidence based clinical guidelines?

A
  • Recommend management and treatment options for specific conditions
  • Support practitioners
  • Maximise efficacy
  • Reduces variation on practice
  • Maximise safety
  • Advice on best value
20
Q

What are the main guidelines used in scotland?

A

SIGN and NICE

21
Q

What is the role of medicine formularies?

A

It is a list of prescription drugs used by practitioners to identify drugs that offer the greatest overall value in terms of safety, efficacy and cost. e.g. BNF

Pharmacology MD2002 (12 decks)

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