Palliative care new challenges and opportunities for ...€¦ · CAMPUS GROSSHADERN CAMPUS...
Transcript of Palliative care new challenges and opportunities for ...€¦ · CAMPUS GROSSHADERN CAMPUS...
CAMPUS GROSSHADERN
CAMPUS INNENSTADT
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
Palliative care – new challenges and opportunities for pharmacist
Evidence vs. experience – Clinical
Practice Constanze Rémi MSc
Pharmacist
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Symptom management
Carl Carlo Carlton
pixar.wikia.com
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Symptom Management – Scenario 1
• 85 year old patient
• Prostate Cancer, metastases
• Pain (bone, abdomen)
Morphine p.o.
pain relieved
Carl
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Symptom Management – Scenario 2
• 85 year old patient
• COPD
• Dyspnea
Morphin
dyspnea relieved
Carlo
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Symptom Management – Scenario 3
• 85 year old patient
• Diabetes, stroke, MI
• Painful decubitus ulcer
Morphine topical
pain relieved
Carlton
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Find the difference
Carl Carlo
Oral morphine for pain Morphine for dyspnea
Liscensed treatment Unliscensed treatment
Carlton
Topical morphine for pain
Unliscensed treatment
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Find the difference
Carl Carlo
Oral morphine for pain Morphine for dyspnea
Evidence-based treatment
Evidence-based treatment
Carlton
Topical morphine for pain
Evidence-based treatment
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
What is EBM?
Evidence based medicine is the conscientious, explicit, and
judicious use of current best evidence in making decisions
about the care of individual patients.
The practise of evidence based medicine means integrating
individual clinical expertise with the best available external
clinical evidence from systematic research.
Sackett DL, Rosenberg WM, Gray JA, et al.Evidence based medicine: what it is and what itisn’t. BMJ 1996;312:71–2.
Applying evidence using clinical judgement!
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
EBM
…is a systematic approach to clinical problem solving which
allows the integration of the best available research
evidence with clinical expertise and patient values
Sackett DL, Strauss SE, Richardson WS,et al. Evidence-based medicine: how to practice and teach EBM. London: Churchill-Livingstone,2000
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
What is EBM?
www.luhs.org
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
What is EBM?
Source: Florida State University, College of Medicine. Retrieved 29.08.14
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Therapeutic Options in Palliative Care
High Evidence
Experience and unconventional
treatment strategies
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Evidence
ExperienceExtra-
polation
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Drug licensing – why bother?
www.zeit.dejcx1.wordpress.com
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Licensing Process
ensures that:
Efficacy, safety and quality have been thoroughly tested
the benefits outweigh the potential risks
Research & Developement
Post marketingdevelopment
Clinical Experiences
Add-on treatment for partial-onset seizures
with or without secondary generalisation for patient
from 16 years of age
Patients from one month of age
Levetiracetam (Keppra®)
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Mind the Gap
The MA does not limit what the medicine could
be used for (i.e. off-label use)
clinical experience may reveal other indications.
BUT: for these to receive MA, additional evidence would
need to be gathered and submitted.
Barriers to MA extensions:
• expenses
• small market for a new indication
• high level evidence difficult to generate
• …Adapted from: British Pain Society: Use of medicines outside of their UK marketing authorisation in pain management and palliative medicine. 2012
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Off Label Drug Use
Off-label describes the use of a medicine beyond the
specifications of its Marketing Authorisation, e.g.:
• an unlicensed indication
• doses,
• preparations,
• patient population,
• route of administration not covered by the MA.British Pain Society: Use of medicines outside of their UK marketing authorisation in pain management and palliative medicine. 2012
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Problems and consequences
General
No information in Patient Information Leaflet
Communication with other health care providers
…
Specific
Legal liability
Reimbursment
…
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Off-label use in palliative care
To et al Pall Med 2012
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
From theory to practice
52 y/o lady, cared for at home
Malignant bowel obstruction
Unable to take oral medication
Distressed by severe reflux
Only subcutaneous access
Does not tolerate H2-Antagonists (e.g. ranitidine)
Omeprazol (?)
Route of administration (?)
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
From theory to practice
Omeprazol
Oral and intravenous formulations available
Alternative routes of drug administration
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
From theory to practice
Personal experiences withalternative routes• in general• for PPI
Identification & appraisal of available evidence on alternative routes of administration
• Patients views on different routes.
• Wish to stay at home.
• etc.
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Best external evidence
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Patient views and expectations
Symptom burden
Preferred route of administration
Onset of action
Prefererred place of treatment
…
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Individual clinical expertise
Experiences with rectal/subcutaneous route of drug
administration
„Pharmafacts“
Pharmakokinetic & pharmacologic considerations
Characteristics of available formulations (modified release, pH,
osmolarity)
What are the big unknowns?
Local tolerability
Bioavailability
What is the worst thing to expect?
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Close the Gap
First, do not harm („primum non nocere“)
© Mikael Damkier - Fotolia.com
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
First, do not harm
Potential risk from an untested medication
Best treatment
© Sebastian Kaulitzki - fotolia
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Close the Gap
First, do not harm („primum non nocere“)
Structured off-label use (decision framework)
Monitoring
Generation of new evidence
© Mikael Damkier - Fotolia.com
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®Framework for off-label use
1. Identification of off label use2. Consideration of alternatives (liscensed
or with better evidence)3. positive risk-benefit ratio (for individual
patient)4. Qualification of the doctor5. Patients‘ right for information6. Monitoring parameters7. Documentation8. Publication
© suzannmeer - fotolia
KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN
KLINIKUM DER UNIVERSITÄT MÜNCHEN®
Evidence vs. ExperienceEvidence + Experience
www.teradatamagazine.com