Palliative care new challenges and opportunities for ...€¦ · CAMPUS GROSSHADERN CAMPUS INNENSTADT KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN Palliative care –new challenges

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


KLINIKUM DER UNIVERSITÄT MÜNCHEN®

Symptom management

Carl Carlo Carlton

pixar.wikia.com



Symptom Management – Scenario 1

• 85 year old patient

• Prostate Cancer, metastases

• Pain (bone, abdomen)

Morphine p.o.

pain relieved

Carl





• COPD

• Dyspnea

Morphin

dyspnea relieved

Carlo





• Diabetes, stroke, MI

• Painful decubitus ulcer

Morphine topical

pain relieved

Carlton



Find the difference

Carl Carlo

Oral morphine for pain Morphine for dyspnea

Liscensed treatment Unliscensed treatment

Carlton

Topical morphine for pain

Unliscensed treatment



Find the difference

Carl Carlo

Oral morphine for pain Morphine for dyspnea

Evidence-based treatment


Carlton

Topical morphine for pain




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!



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



What is EBM?

www.luhs.org



What is EBM?

Source: Florida State University, College of Medicine. Retrieved 29.08.14



Therapeutic Options in Palliative Care

High Evidence

Experience and unconventional

treatment strategies



Evidence

ExperienceExtra-

polation



Drug licensing – why bother?

www.zeit.dejcx1.wordpress.com



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®)



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



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



Problems and consequences

General

No information in Patient Information Leaflet

Communication with other health care providers

…

Specific

Legal liability

Reimbursment

…



Off-label use in palliative care

To et al Pall Med 2012



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 (?)




Omeprazol

Oral and intravenous formulations available

Alternative routes of drug administration




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.



Best external evidence



Patient views and expectations

Symptom burden

Preferred route of administration

Onset of action

Prefererred place of treatment

…



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?



Close the Gap

First, do not harm („primum non nocere“)

© Mikael Damkier - Fotolia.com



First, do not harm

Potential risk from an untested medication

Best treatment

© Sebastian Kaulitzki - fotolia



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


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



Evidence vs. ExperienceEvidence + Experience

www.teradatamagazine.com

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Palliative care new challenges and opportunities for ...€¦ · CAMPUS GROSSHADERN CAMPUS INNENSTADT KLINIK UND POLIKLINIK FÜR PALLIATIVMEDIZIN Palliative care –new challenges