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CPT - Summary > S1 - Safe Prescribing And Medicine Errors > Flashcards

S1 - Safe Prescribing And Medicine Errors Flashcards

1
Q

What are some patient - related prescribing problems ?

A

Drug interactions
Increased drug use
Sicker/older patients vulnerable to side effects

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2
Q

What are some population prescribing problems ?

A

Increasing numbers

Elderly patients with co-morbidities

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3
Q

What are some pharmaceutical prescribing problems ?

A

New drugs

Side effects only seen later as trails usually on healthy patients

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4
Q

What are some doctor related prescribing problems ?

A

On call/junior doctors can be sleep deprived and not know patients very well
Bad handwriting on prescriptions

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5
Q

What do you need to confirm before writing a prescription ?

A 
Drug name 
Dose 
Strength 
Frequency 
Allergies 
Adherence(more likely to adhere to fewer drugs)
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6
Q

What are the legal prescription requirements ?

A

Black ink
Patients and DRS name and address
DOB
Signed and dated

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7
Q

What are black triangle drugs

A

Intensively monitored drug which may be newly released or have changed formulas

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8
Q

Basic checklist for Drugs:

A 
The right drug
Drug distribution/elimination
Alternatives
Non- prescription medications
The route 
The dose
The frequency
Duration
SE
Monitoring 
Infromation
Special requirements
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9
Q

How long does it take to develop a medicine ?

A

12 years

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10
Q

What are the first 4 years of development for ?

A

Discovery research (medicinal chemistry , pharmacology and toxicology )
There are patent regulations
>5000 compounds used

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11
Q

What are the stages of drug development ?

A 
Research
Healthy volunteers 
Patients
Testing efficacy and safety
Testing different formulas
H/e, throughout each stage, the number of drugs eventually decrease to only 1
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12
Q

What does the Research stage comprise of ?

A

Idea
Feasibility
Target validation (screening)
Identification of potential compounds (PK and potency optimised)
Selection of candidate drug (toxicology studies)

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13
Q

What screening is used in the research stage ?

A

High through-put screening - helps to identify compounds that may work as the drug and it is usually automated
Identifies if compound has correct structure, is chemically stable and is selective for the target

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14
Q

What is lead identification ?

A

Allows us to identify candidate drug
Drug tested on smaller animals
Measure ADME

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15
Q

What are the aims of lead identification ?

A

Increase potency
Optimise selectivity and pharmacokinetics
Ensure efficacy

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16
Q

What do phase 1 studies comprise of ?

A

First administered to humans - single or multiple ascending doses
Small number of healthy volunteers
Requires MHRA ethical and regulatory approval
1 year

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17
Q

What are the 4 principles of ethics ?

A

Justice : being fair
Beneficence : doing good
Non- maleficence : not doing harm
Autonomy : allowing individual to determine what happens to them

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18
Q

What do phase 2 studies comprise of ?

A

Targets patient with disease but few other complications - 200 - 400 patients
2 years
Evaluates pharmacology in disease
Phase 2a : pilot study to find the correct dose
Phase 2b : measures therapeutic action and determines dose for phase 3
Proof of concept/principle

19
Q

What do phase 3 studies comprise of ?

A

Targets patient with disease
Large randomised controlled trial
Determines efficacy against placebo
4 years

20
Q

What occurs after Phase 3 ?

A

Regulatory review (1 year )- submitted to national body (MHRA), if it is to be marketed , a product license is required

21
Q

What does MHRA do ?

A

Give approval for clinical trials and issues licenses, can also remove products from the market

22
Q

What does phase 4 studies comprise of ?

A

Seeks new indications ( valid reason to use the drug )

Outcome - based

23
Q

What is a clinical trial ?

A

Any form of planned experiment which involves patients and is designed to find the most appropriate method of treatment for future patients with a given medical condition

24
Q

What is its purpose ?

A

To provide reliable evidence of treatment efficacy and safety

25
Q

What is efficacy ?

A

The ability of healthcare to improve the health of a defined group

26
Q

What is safety ?

A

The ability of a healthcare to not harm a defined group

27
Q

Explain the significance of the 95% confidence interval

A

If the null hypothesis value is consistent with the observed data, then any observed difference from the null hypothesis may be due to chance. The observed value is always within the 95% confidence interval. Null hypo inside 95% CL - p>0.05, Null hypo outside 95% CL - p<0.05

28
Q

What are disadvantages of non- randomised clinical trials ?

A

Allocation bias

Confounding variables

29
Q

What are disadvantages of using historical controls ?

A

Comparison with historical control involves the comparison of a group of patients who had the standard treatment with a group receiving a new treatment but this is often flawed for the standard treatment group as :
Selection process is less rigorous
Treated differently to a new treatment group
Unable to control confounders

30
Q

What are steps involved in a RCT ?

A

Definition of factors- disease of interest, treatments to be compared, outcomes to be measured
Conduct of trial - identify source of eligible patients , gain consent
Allocate participants to the treatment fairly
Follow up in identical ways
Minimise losses to follow up
Maximise compliance with treatments
Comparison of outcomes - is there an observed difference ? How big is it ?

31
Q

What are some suitable outcomes for clinical trials ?

A

Pathophysiological - tumour size
Clinically defined - death ( mortality ), disease
Patient - focussed - quality of life

32
Q

What does the benefits of random allocation ?

A

Minimal allocation bias : equal chance of being allocated to each of the treatments
Minimal confounders : treatments groups likely to be similar in size and characteristics
Applies to both known and unknown confounder factors

33
Q

Methods of random allocation

A

Coin toss

Computer generated

34
Q

What are disadvantages of open label allocation ?

A

Behaviour effect and non- treatment effect

35
Q

Purpose of blinding ?

A

Don’t know the treatment allocation to prevent bias

36
Q

What is a placebo ?

A

A placebo is an inert substance made to appear identical to the active formulation which it is meant to be

37
Q

What is the aim of a placebo ?

A

Cancel out any placebo effect that may exist in the active treatment

38
Q

What are the ethical implications of a placebo ?

A

Should only be used where no standard treatment is available

Participants should be informed that they may receive a placebo

39
Q

How do you deal with losses to follow up and non compliance ?

A

Some participants need/are made to withdraw

Maintain contact with patients and simplify instructions

40
Q

What is explanatory trial ?

A

As treated analysis
Analyses only those who completed follow up and complied with treatment which allows comparison of psychological effects of treatment but loses effects of randomisation

41
Q

What is a pragmatic trial ?

A

Intention to treat analysis
Analyses according to original allocation regardless of whether they completed follow up or complied with treatment. This preserves the effects of randomisation.

42
Q

What are the ethical principles involved in medical research involving human subjects ?

A

Declaration of Helsinki
Collective ethic
Individual ethic

43
Q

What issues should be considered for a clinical trail to be regarded as ethical ?

A

Clinical equipoise : where there is uncertainty about the better treatment
Scientifically robust
Ethical recruitment : no inappropriate exclusion or inclusion
Valid consent : written

44
Q

What is the purpose of a research ethics committee ?

A

Conduct of study
Recruitment and protection of participants
Informed consent

CPT - Summary (8 decks)

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