Drug Safety Flashcards

1
Q

Classify attitudes to risk

A
  • Plan A: Avoid (ultra-safe)
  • Plan B: Accept risk but manage through preperation (high reliability)
  • Plan C: Embrace risk fully (ultra-adaptive)

all concerned with safety

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2
Q

safety 1

A

takes accidents as the focus point and tries to prevent bad things from occurring

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3
Q

safety 2

A

emphasizing on ensuring that as much as possible goes right, expanding much more than the area of incident prevention and promoting a real safety management over a simple risk assessment

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4
Q

simple, complicated, complex, chaotic…

A
  • simple - easily knowable and predictble
  • complicated - not simple, but still knowable and predictable
  • complex - not fully knowable but not always predictable
  • chaotic- unknowable and unpredictable
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5
Q

SEIPS

A

Systems Engineering Initiative for Patient Safety

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6
Q

SEIPS diagram

A

see sheet

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7
Q

Risk management

A

Focus on things can control (e.g. PPE stop virus)

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8
Q

Factors/interactions affecting medication safety

5

A
  1. Person
  2. Tool and technology
  3. Task
  4. Environmental
  5. Orginisational
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9
Q

Person factors affecting medication safety

1

A
  • weight
  • age
  • liver/kidney function
  • compliance
  • literacy
  • motivation
  • capabilities
  • socail class
  • Polymorphic variationg in enzymes that metabolise drugs
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10
Q

Tool and technology factors affecting medication safety

2

A
  • formulation of drugs
  • routes of administration
  • equipment required to administer drugs
  • labelling and packaging (placement)
  • names
  • user interface of electronic medicines management systems (e.g. safety alerts)
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11
Q

Task factors affecting medication safety

3

A
  • Diagnosing
  • Prescribing
  • Dispensing
  • Administering
  • Storage
  • Procuring
  • Monitoring/counselling
  • Working with patient
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12
Q

Environmental factors affecting medication safety

4

A
  • policy, legislation
  • safety alerts
  • cost
  • availability, procureemnt
  • failure of cold chain
  • temperature, humidity
  • healthy environments
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13
Q

Organisational factors affecting medication safety

5

A
  • Leadership
  • Management
  • Culture
  • Values
  • Teamwork
  • Communication…

dont really bother learning… ;)

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14
Q

one of single biggest challenges facing modern healthcare

A

safe care of patients

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15
Q

what does safety require, and at what levels

A

Active management at personal and strategic (organisational) level

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16
Q

define “safety” in a systems context

LO

A

System safety is the application of engineering and management principles, criteria and techniques to achieve acceptable mishap risk within the constraints of operational effectiveness and suitability, time and cost throughout all phases of the system life cycle

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17
Q

A systems approach to ADME

specific framework

A

System:
* Poeple
* Tools
* Tasks
* Organisation
* Environment

Process: ADME

Outcomes:
* Theraputic response
* Side effects
* Adverse events
* Sequalae
* Impact on life

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18
Q

System (ADME)

5 things

A
  • People
  • Tools
  • Tasks
  • Organisation
  • Environment
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19
Q

List relevant ADME factors under SEIPS headings

A

see sheet

20
Q

define adverse drug reaction

A

appreciably harmful or unpleadsant reaction resulting from an intervention related to the use of a medicinal product - warrants change/withdrawal/alterations of dosage

21
Q

Classifications of adverse drug reactions (ADR)

A
  • Onset: acute (within 60mins), Sub-acute (1 to 24 hours), Latent (>2days)
  • Severity: Mild (annoying), Moderate (requires change in therapy/additional treatment/hospilisation), Severe (disabiling or life-threatening)
22
Q

ADR types

A
  • A: augmented
  • B: bizzare
  • C: chronic
  • D: delayed
  • E: end of treatment
  • F: failure of treatment
23
Q

Predisposing factors to ADR

A
  • Multiple drug therapy (polypharmacy)
  • Inter-current disease
  • Renal/hepatic impairment
  • Race/genetic polymorphism
  • Age (elderly/neonates)
  • Sex (more common in women)
24
Q

ADR type A: augmented

A
  • normal but augmented response to pharmacological actions of drug
  • predictable and dose dependent
  • due to excess pharmacological action
  • easily reversiable on cessation of treament/dose reduction
  • secondary effects
25
Q

Reasons for type A (ADR)

A
  • too high or low dose
  • Pharmacokinetic varitation (ADME)
  • pharmacodynamic variation
26
Q

ADR: type B - bizzare

A
  • unpredictable
  • rare
  • cause serious illness/death
  • go unidentified for months/years
  • unrelated to dose
  • no readily reversed

e.g. hypersensitivity

27
Q

ADR: type C - chronic

A

related to duration and dose

28
Q

ADR: type D delayed

A

carcinogenesis or teratogenesis

29
Q

ADR: type E - End of treatment

A

Rebound effects - e.g. seizures after cessation of anti-epileptics)

30
Q

ADR: type F - failure of therapy

A

Common, dose related, drug-drug interactions

31
Q

diagnosis ADRs

A

manifest in multiple ways:
* drowsiness
* confusion
* kidney injury
* biochemical derangements
* bleeding
* GI disturbances
* +less common

need copmprehensive medical history

32
Q

pharmacovigilance

A

science and activites relating to detection, assessment, understanding and prevention of adverse events or any other drug-related problem —> reporting

33
Q

Surveillance methods for ADRs

A
  • reporting (patients as well as healthcare professionals) - yellow card
  • Integrated healthcare (records including data on ADRs direct to central agencies)
  • Drug saftey studies
  • published data
  • pharma company data (PSURs)
  • Social media
34
Q

Medical importance of adverse drug reactions (ADRs)

A

can cause morbidity and mortality

35
Q

Drug interactions

A

modification of a drug’s effect by prior concomitant administration of another drug, herb, foodstuff, drink…

36
Q

object drug, precipitant

A
  • Object drug: drug whose activity is altered by action
  • Precipitant: agent which precipitates such interaction
37
Q

are drug-drug interactions undesirable

A

Not always… sometimes increase action of drug

think synergism/addition of antibiotics

38
Q

one of major causes of ADRs

A

drug-drug interactions

39
Q

risk factors to people getting drug-drug interactions (ADRs)

A
  • Age, polymorphism, polypharmacy, co-morbidities, dose, therapeutic index
  • Multiple prescribers
  • self-prescription
  • length of hospital stay
  • potent drugs with narrow therapeutic index
  • change in blood levels —> profound toxicity
  • One drug alter the ADME of another
40
Q

what do drug-drug interactions have an effect on

A

morbidity and mortality

41
Q

Effect of drug-drug interactions on ADME

A
  • Absorption: effect rate rather than extent
  • Distribution: displacemnt of drug from plasma protien binding (free drug = active)
  • Metabolism: to do with CYP405s - competition (e.g. statins and grapefruit juice)
  • Elimination:changes to GFR or tubular secretion will result in altered drug levels
42
Q

what happens if CYP450 is inhibited

drug-drug interactions

A

metabolism of many drugs is stopped

43
Q

pharmacodynamic interactions

A

pharmacodynamic actions of a drug are changed due to another drug acting directly (same receptor) or indirectly (different receptors)

44
Q

classes of drug interactions

A

duplication, opposition (antagonism), and alteration of what the body does to one or both drugs

45
Q

Therapeutic drug monitoring

A
  • Focus on adverse drug events: constructing therapeutic ranges reduced incidence of toxicity
  • Linking mathematical therois to pateint outcomes
  • drug concentration-response relationships
  • Measurement and adjustment of drug concentrations in the body to optimise drug efficacy and minimise toxicity
  • Personalised

wtf bro?

46
Q

What to do after drug-drug interactions

A
  • consider normal range and exposure target
  • apropriate adjustment of dose… for as long as necessary
  • drugs/patients have a narrow therapeutic indices
  • assessing compliance
  • Diagnosing failed therapy