Palliative care new challenges and opportunities for pharmacist Evidence vs. experience Clinical Practice Constanze Rémi MSc Pharmacist

Transkript

1 CAMPUS GROSSHADERN CAMPUS INNENSTADT Palliative care new challenges and opportunities for pharmacist Evidence vs. experience Clinical Practice Constanze Rémi MSc Pharmacist

2 Symptom management Carl Carlo Carlton pixar.wikia.com

3 Symptom Management Scenario 1 85 year old patient Prostate Cancer, metastases Pain (bone, abdomen) Morphine p.o. pain relieved Carl

4 Symptom Management Scenario 2 85 year old patient COPD Dyspnea Morphin dyspnea relieved Carlo

5 Symptom Management Scenario 3 85 year old patient Diabetes, stroke, MI Painful decubitus ulcer Morphine topical pain relieved Carlton

6 Find the difference Liscensed treatment Unliscensed treatment Unliscensed treatment Carl Oral morphine for pain Carlo Morphine for dyspnea Carlton Topical morphine for pain

7 Find the difference Evidence-based treatment Evidence-based treatment Evidence-based treatment Carl Carlo Carlton Oral morphine for pain Morphine for dyspnea Topical morphine for pain

8 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. Applying evidence using clinical judgement! Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: what it is and what it isn t. BMJ 1996;312:71 2.

9 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

10 What is EBM?

11 What is EBM? Source: Florida State University, College of Medicine. Retrieved

12 Therapeutic Options in Palliative Care High Evidence Experience and unconventional treatment strategies

13 Evidence Extrapolation Experience

14 Drug licensing why bother? jcx1.wordpress.com

15 Licensing Process ensures that: Efficacy, safety and quality have been thoroughly tested the benefits outweigh the potential risks

16 Research & Developement Post marketing development Levetiracetam (Keppra ) 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

17 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

18 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

19 Problems and consequences General No information in Patient Information Leaflet Communication with other health care providers Specific Legal liability Reimbursment

20 Off-label use in palliative care To et al Pall Med 2012

21 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 H 2 -Antagonists (e.g. ranitidine) Omeprazol (?) Route of administration (?)

22 From theory to practice Omeprazol Oral and intravenous formulations available Alternative routes of drug administration

23 From theory to practice Personal experiences with alternative routes in general for PPI Patients views on different routes. Wish to stay at home. etc. Identification & appraisal of available evidence on alternative routes of administration

24 Best external evidence

25 Patient views and expectations Symptom burden Preferred route of administration Onset of action Prefererred place of treatment

26 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?

27 Close the Gap First, do not harm ( primum non nocere ) Mikael Damkier - Fotolia.com

28 First, do not harm Best treatment Potential risk from an untested medication Sebastian Kaulitzki - fotolia

29 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

30 1. Identification of off label use 2. Consideration of alternatives (liscensed or with better evidence) 3. positive risk-benefit ratio (for individual patient) 4. Qualification of the doctor 5. Patients right for information 6. Monitoring parameters 7. Documentation 8. Publication Framework for off-label use suzannmeer - fotolia

31 Evidence + vs. Experience