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3rd year > Medicine Regulations > Flashcards

Medicine Regulations Flashcards

1
Q

How and why are medicines licensed?

A

Medicines and healthcare products regulatory agency. (MHRA)
Ensures that human medicines meet acceptable standards on safety, quality and efficacy.
Ensures difficult balance between safety and effectiveness is achieved.

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2
Q

What is used in the UK for detection, assessment and understanding and prevention of adverse drug reactions.

A

Yellow Card Scheme.

- Side effects, safety concerns.

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3
Q

How is the yellow card scheme used?

A

By both healthcare and public.

Healthcare professionals should report all suspected adverse reactions.

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4
Q

Can you give unlicensed medication?

A

Yes if you carefully consider any treatment that you prescribe.

Be able to justify your decisions and actions when prescribing, administering and managing medicines regardless of whether they are licensed or unlicensed.

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5
Q

What do you need to make sure of when prescribing?

A

It is legible
The right dose (BNF)
Signed
Route is mentioned and how often.

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6
Q

What is osmolarity?

A

The measure of solute concentration per unit volume of solvent.

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7
Q

What is the difference between hypoosmotic and hyperosmotic?

A

Hypoosmotic = lower solute concentration, higher free water conc.

Hyperosmotic = higher solute concentration, lower free water conc.

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8
Q

What is osmolality?

A

The measure of solute concentration per unit MASS of solvent.
Same in ICF and ECF.

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9
Q

What is tonicity?

A

The measure of the osmotic pressure gradient between two solutions.
Influenced by what cant cross the membrane.

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10
Q

What fluids are needed daily in people?

A

Water - 25-30ml/kg/day
Sodium - 1mmol/kg/day
Potassium - 1mmol/kg/day
Glucose - 50-100g/day

NOT EVERYONE NEEDS THE SAME.

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11
Q

How do you decide what fluids are needed?

A

What is the patients volume status? (ABCDE)

Does the patient need IV fluids? (hypo, euvo, hyper)

How much fluid do they need?

What types of fluid do they need?

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12
Q

If someone is 1. Euvolaemic, 2. hypovolemic and 3. hypervolemic do they need fluids?

A
  1. No fluids.
  2. Resuscitation fluids, rehydration fluids, “plug the leak”
  3. No more fluids, possibly diuretics (if resp compromise)
    Haemofiltration if anuric.
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13
Q

How do you know if someone is 1. Euvolaemic, 2. Hypovoleamic, 3. Hypervolaemic?

A
  1. Feels well, not thirsty.
    Veins well filled, mild sweat, warm extremities, normal BP and HR, normal urine.
  2. Feels nauseous, thirsty.
    Flat veins, cool peripheries, no sweat, low or postural BP, high HR, concentrated oliguria, Responds to SLR.
  3. Feels breathless, not thirsty. Veins distended, warm and oedematous extremities, sweaty, high BP and HR, Dilute urine.
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14
Q

How do you work out water deficit?

A 
Catheters, drains. 
Input charts
Vomit bowls
Sputum pots 
Stool charts and stoma losses. 
Sepsis (sweat)
Ventilation 
Open wounds 
Burns 
Bleeding
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15
Q

What types of fluids should be given in chronic dehydration hypernatraemia?

A

Dextrose - moves through all compartments, isotonic.

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16
Q

When are crystalloids useful?

A

Acute
Dehydration
AKI
Resuscitation

Remain in ECF - High Na load usually.

17
Q

When are plasma expanders used?

A

Liver patients
Select intra-operative.

Stays in IVS. Blood and TPN are collids.

18
Q

What are the 5 Rs?

A

Resucitation - IV fluids urgent.
Routine maintenance - Iv if cannot be orally taken.
Replacement - IV additional to maintain correction.
Redistribution - Abnormal internal fluid.
Reassessment.

19
Q

What types of errors are the most common in healthcare?

A

Surgery
Complications from drug treatment
Therapeutic mishaps
Diagnostic errors were the most common non-operative events.

20
Q

What patients are most at risk?

A 
Cadiothoracic, vascular or neurosurgery. 
Complex conditions 
Emergency room
Inexperience doctors
Older patients.
21
Q

What are the 5 Rs in prevention of medical errors?

A 
Right Patient 
Right Drug 
Right Dose
Right route 
Right time
22
Q

Why is drug production monitored? (CSM)

A

Standard of the drug
Does the drug work
Pharmacovigilance
QUALITY, SAFETY, EFFICACY.

23
Q

Who decides whether a drug can be used in Scotland?

A

Scottish Medicines Consortium (SMC)

3rd year (22 decks)

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