Clinical Pharmacology and Pharmacotherapy (lesson10)
AIM: Translation theoretical concepts of… into a research project.
- Determinants of behaviour
- Behaviour change
- Intervention development
- Intervention evaluation
RATIONAL USE OF MEDICATION: EVIDENCE BASED PRACTICE
Without Clinical Expertise Without Current Best Evidence
Practice risks being tyrannized by evidence Practice risks becoming rapidly out of date
Even excellent external evidence may be This is to the detriment of patients
inappropriate for individuals
WHICH SCIENTIFIC EVIDENCE?
- Systematic summaries of evidence
- Systematic reviews
- Practice guidelines
Key Features:
- Clear Population, Intervention, Comparator, Outcome (PICO) framework
- Systematic and transparent search strategy to find relevant studies
- Systematic and transparent evaluation of the evidence quality
- Information about the magnitude of effect
- Information about the quality of evidence
QUALITY OF EVIDENCE: GRADE
High Very confident that the true effect is close to the estimate.
- Randomized controlled Trial
Moderate Moderately confident; true effect likely close but may be substantially different.
- Randomized controlled Trial
Low Limited confidence; true effect may be substantially different from the estimate.
- Observational study
Very low Very little confidence; true effect is likely substantially different from the estimate.
- Observational study
Belgian practice guideline rational medication use: “BCFI”.
CHALLENGES OF IMPLEMENTATION
There is still a gap between knowing and doing.
CHALLENGES OF MEDICATION IN THE NURSING HOMES
- More vulnerable population
- There are several aspects that are typical for nursing homes residents
- There is not always a good collaboration between
stakeholders: resident nurse and nurse aid
pharmacist who deliver expert management
general practitioner (PG) coordination physician
FOCUS ON RATIONAL PRESCIRBING
A call from the Belgian government: optimize medications of the
nursing home (bcs the high use of medication and inappropriate
use).
, COME-ON design: cluster Randomized Clinical Trial
3 components:
- Training and education
- Interdisciplinary case conferences
- Local concentrations
Effectiveness: Potentially inappropriate
prescriptions (PIPs)?
- Potentially inappropriate
medications (PIMs): overuse/
misuse
• 88.3% of NHRs (1245/1410) had at least 1 PIM
• Median/ resident= 2
- Potentially prescribing
ommissions (PPOs): underuse
• 85.0% of NHRs (1199/1410) had at least 1 PPO
• Median/ resident= 2
Primary outcome: Positive study effect: positive result for primary endpoints A and B.
- Primary endpoint A: Proportion of residents with at least one PIM/PPO at baseline, for whom at least one of
these PIMs/PPOs were solved at the end of the study. => Positive result (‘yes’) = at least one problem solved
- Primary endpoint B: Proportion of residents for whom no new PIM/PPO was present at the end of the study,
compared to baseline. => Positive result (‘yes’) = no new problem
Conclusions:
- Practice-based intervention
- Evaluation of effectiveness in cluster Randomised Clinical Trial
- Small positive effect on rational prescribing in nursing homes
PITFALLS WITH PRACTICE-BASED APPROACH
- Preventing a problem that is not important/widespread
- Changing the “wrong” behavior
- Target the “wrong” determinants
- Intervention methods do not fit with determinants
- Problems with implementation/uptake
- Uninformative evaluation
COMINANDO
COMplex INtervention to support appropriate prescribing of ANtimicrobial Drugs for Older people in
nursing homes
APPROPRIATE USE OF ANTIBIOTICS
Balance: treat the patients (QoL is guaranteed) & the use of antibiotic drugs (bcs it increases the risk of
antimicrobial resistance)
Antibiotic use in BE compared to the EU average?
- In eastern and southern of EU and also the use in BE is on the high side.
- So the higher use of antibiotics is also linked in this countries with an higher prevalence of
resistant microorganisms.
Antibiotic use in BE ambulatory sector compared to the hospital sector?
- In the ambulatory sector the consumption is 10X higher than in the hospital sector.
In which patient population is antibiotic use the highest?
AIM: Translation theoretical concepts of… into a research project.
- Determinants of behaviour
- Behaviour change
- Intervention development
- Intervention evaluation
RATIONAL USE OF MEDICATION: EVIDENCE BASED PRACTICE
Without Clinical Expertise Without Current Best Evidence
Practice risks being tyrannized by evidence Practice risks becoming rapidly out of date
Even excellent external evidence may be This is to the detriment of patients
inappropriate for individuals
WHICH SCIENTIFIC EVIDENCE?
- Systematic summaries of evidence
- Systematic reviews
- Practice guidelines
Key Features:
- Clear Population, Intervention, Comparator, Outcome (PICO) framework
- Systematic and transparent search strategy to find relevant studies
- Systematic and transparent evaluation of the evidence quality
- Information about the magnitude of effect
- Information about the quality of evidence
QUALITY OF EVIDENCE: GRADE
High Very confident that the true effect is close to the estimate.
- Randomized controlled Trial
Moderate Moderately confident; true effect likely close but may be substantially different.
- Randomized controlled Trial
Low Limited confidence; true effect may be substantially different from the estimate.
- Observational study
Very low Very little confidence; true effect is likely substantially different from the estimate.
- Observational study
Belgian practice guideline rational medication use: “BCFI”.
CHALLENGES OF IMPLEMENTATION
There is still a gap between knowing and doing.
CHALLENGES OF MEDICATION IN THE NURSING HOMES
- More vulnerable population
- There are several aspects that are typical for nursing homes residents
- There is not always a good collaboration between
stakeholders: resident nurse and nurse aid
pharmacist who deliver expert management
general practitioner (PG) coordination physician
FOCUS ON RATIONAL PRESCIRBING
A call from the Belgian government: optimize medications of the
nursing home (bcs the high use of medication and inappropriate
use).
, COME-ON design: cluster Randomized Clinical Trial
3 components:
- Training and education
- Interdisciplinary case conferences
- Local concentrations
Effectiveness: Potentially inappropriate
prescriptions (PIPs)?
- Potentially inappropriate
medications (PIMs): overuse/
misuse
• 88.3% of NHRs (1245/1410) had at least 1 PIM
• Median/ resident= 2
- Potentially prescribing
ommissions (PPOs): underuse
• 85.0% of NHRs (1199/1410) had at least 1 PPO
• Median/ resident= 2
Primary outcome: Positive study effect: positive result for primary endpoints A and B.
- Primary endpoint A: Proportion of residents with at least one PIM/PPO at baseline, for whom at least one of
these PIMs/PPOs were solved at the end of the study. => Positive result (‘yes’) = at least one problem solved
- Primary endpoint B: Proportion of residents for whom no new PIM/PPO was present at the end of the study,
compared to baseline. => Positive result (‘yes’) = no new problem
Conclusions:
- Practice-based intervention
- Evaluation of effectiveness in cluster Randomised Clinical Trial
- Small positive effect on rational prescribing in nursing homes
PITFALLS WITH PRACTICE-BASED APPROACH
- Preventing a problem that is not important/widespread
- Changing the “wrong” behavior
- Target the “wrong” determinants
- Intervention methods do not fit with determinants
- Problems with implementation/uptake
- Uninformative evaluation
COMINANDO
COMplex INtervention to support appropriate prescribing of ANtimicrobial Drugs for Older people in
nursing homes
APPROPRIATE USE OF ANTIBIOTICS
Balance: treat the patients (QoL is guaranteed) & the use of antibiotic drugs (bcs it increases the risk of
antimicrobial resistance)
Antibiotic use in BE compared to the EU average?
- In eastern and southern of EU and also the use in BE is on the high side.
- So the higher use of antibiotics is also linked in this countries with an higher prevalence of
resistant microorganisms.
Antibiotic use in BE ambulatory sector compared to the hospital sector?
- In the ambulatory sector the consumption is 10X higher than in the hospital sector.
In which patient population is antibiotic use the highest?
