Drug Safety Flashcards
Classify attitudes to risk
- 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
safety 1
takes accidents as the focus point and tries to prevent bad things from occurring
safety 2
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
simple, complicated, complex, chaotic…
- 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
SEIPS
Systems Engineering Initiative for Patient Safety
SEIPS diagram
see sheet
Risk management
Focus on things can control (e.g. PPE stop virus)
Factors/interactions affecting medication safety
5
- Person
- Tool and technology
- Task
- Environmental
- Orginisational
Person factors affecting medication safety
1
- weight
- age
- liver/kidney function
- compliance
- literacy
- motivation
- capabilities
- socail class
- Polymorphic variationg in enzymes that metabolise drugs
Tool and technology factors affecting medication safety
2
- 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)
Task factors affecting medication safety
3
- Diagnosing
- Prescribing
- Dispensing
- Administering
- Storage
- Procuring
- Monitoring/counselling
- Working with patient
Environmental factors affecting medication safety
4
- policy, legislation
- safety alerts
- cost
- availability, procureemnt
- failure of cold chain
- temperature, humidity
- healthy environments
Organisational factors affecting medication safety
5
- Leadership
- Management
- Culture
- Values
- Teamwork
- Communication…
dont really bother learning… ;)
one of single biggest challenges facing modern healthcare
safe care of patients
what does safety require, and at what levels
Active management at personal and strategic (organisational) level
define “safety” in a systems context
LO
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
A systems approach to ADME
specific framework
System:
* Poeple
* Tools
* Tasks
* Organisation
* Environment
Process: ADME
Outcomes:
* Theraputic response
* Side effects
* Adverse events
* Sequalae
* Impact on life
System (ADME)
5 things
- People
- Tools
- Tasks
- Organisation
- Environment
List relevant ADME factors under SEIPS headings
see sheet
define adverse drug reaction
appreciably harmful or unpleadsant reaction resulting from an intervention related to the use of a medicinal product - warrants change/withdrawal/alterations of dosage
Classifications of adverse drug reactions (ADR)
- 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)
ADR types
- A: augmented
- B: bizzare
- C: chronic
- D: delayed
- E: end of treatment
- F: failure of treatment
Predisposing factors to ADR
- Multiple drug therapy (polypharmacy)
- Inter-current disease
- Renal/hepatic impairment
- Race/genetic polymorphism
- Age (elderly/neonates)
- Sex (more common in women)
ADR type A: augmented
- 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
Reasons for type A (ADR)
- too high or low dose
- Pharmacokinetic varitation (ADME)
- pharmacodynamic variation
ADR: type B - bizzare
- unpredictable
- rare
- cause serious illness/death
- go unidentified for months/years
- unrelated to dose
- no readily reversed
e.g. hypersensitivity
ADR: type C - chronic
related to duration and dose
ADR: type D delayed
carcinogenesis or teratogenesis
ADR: type E - End of treatment
Rebound effects - e.g. seizures after cessation of anti-epileptics)
ADR: type F - failure of therapy
Common, dose related, drug-drug interactions
diagnosis ADRs
manifest in multiple ways:
* drowsiness
* confusion
* kidney injury
* biochemical derangements
* bleeding
* GI disturbances
* +less common
need copmprehensive medical history
pharmacovigilance
science and activites relating to detection, assessment, understanding and prevention of adverse events or any other drug-related problem —> reporting
Surveillance methods for ADRs
- 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
Medical importance of adverse drug reactions (ADRs)
can cause morbidity and mortality
Drug interactions
modification of a drug’s effect by prior concomitant administration of another drug, herb, foodstuff, drink…
object drug, precipitant
- Object drug: drug whose activity is altered by action
- Precipitant: agent which precipitates such interaction
are drug-drug interactions undesirable
Not always… sometimes increase action of drug
think synergism/addition of antibiotics
one of major causes of ADRs
drug-drug interactions
risk factors to people getting drug-drug interactions (ADRs)
- 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
what do drug-drug interactions have an effect on
morbidity and mortality
Effect of drug-drug interactions on ADME
- 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
what happens if CYP450 is inhibited
drug-drug interactions
metabolism of many drugs is stopped
pharmacodynamic interactions
pharmacodynamic actions of a drug are changed due to another drug acting directly (same receptor) or indirectly (different receptors)
classes of drug interactions
duplication, opposition (antagonism), and alteration of what the body does to one or both drugs
Therapeutic drug monitoring
- 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?
What to do after drug-drug interactions
- 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
