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Transcript
Atlernate Routes of Medication
Administration for End of Life
Symptom Management
CHOOSING THE RIGHT ROUTE AT THE END OF
LIFE - COMPARING EFFECTIVENESS,
VERSATILITY, COST, AND EASE OF USE IN THE
HOME SETTING
Brad Macy RN, BA, BSN, CHPN
Potential Conflict of Interest Statement
I am a co-founder of Hospi Corporation and the inventor of the Macy
Catheter. I may benefit financially from sales of the Macy Catheter,
which is discussed in this presentation.
Outline
1.
Current Challenges with Symptom Management
2.
Analyzing Current Standards of Practice at Home
3.
Indentifying the Best Alternative Route
4.
Various Routes of Medication Delivery
5.
Comparing Alternate Routes of Delivery
Symptom Management
How are we doing?
Kehl et al. (2013) – Large lit review -dyspnea (56.7%), pain (52.4%),
respiratory secretions/death rattle (51.4%), and confusion (50.1%) [₁]
Doing better than this but have room for improvement
SUPPORT Study (1998) - >80% patients reported the desire to die
at home – only 50% died at home[₂]
₂
NHPCO Facts and figures (2013- 2014) [₃,₄]
GIP days increased from 2.2% (2011) to 2.7% (2012) to 4.8%
(2013) – (>100% increase)
>33% of hospice patients still dying in an inpatient facility
Symptom Management
Institute of Medicine Report - State of End of Life
Care in America (2014)[₅₅]
Patients not dying in the environment of choice
“Falling short of our goals of providing end of life care based
on the needs, values and preferences of our patients”
Spending too much for end of life care
Of the> 1.5 million hospice patients:
• 1/3rd die in inpatient at ~$700 per day
• 2/3rd die in home setting at ~$160 per day
Analyzing Current Standards of Practice
Typical Home Hospice End of Life Scenario:
The oral route fails for a patient who wishes is to die
comfortably at home
Most oral medications stopped (except SL morphine, lorazepam,
atropine)
For many patients this is all that is needed
Not adequate for complex symptom management patients
When symptoms worsen
Many
commonly utilized alternate medication routes or
formulations often do not work well
• Transdermal, Sublingual, tablets given PR
Analyzing Current Standards of Practice
When alternative routes fail
Symptoms
continue to worsen
Patient continues to suffer
Family/CG are burdened significantly
Placement in Higher Acuity Setting
Often
more invasive and costly medication options are utilized
Patient loses choice of environment of death
Analyzing Current Standards of Practice
Many medications stopped in last days
Typically
revert to sublingual-only meds
• Morphine
• Ativan
• Atropine
These
work well in low volumes - mild to moderate
symptoms.
For
more severe symptoms another route must be
considered proactively
Issues with Current Standards of Practice
Medications many times stopped - need careful
consideration
NSAID’s
Bone, inflammatory pain, fever
Antiepileptics
Rebound seizures, neuropathic pain, withdrawal (phenobarbital,
valium, clonazepam)
Anti-depressants
Withdrawal, neuropathic pain
Steroids
Metabolic disturbances, return of numerous symptoms including
pain (Liver, Bone, Inflammatory) dyspnea, fever, nausea and
vomiting, seizures, bowel obstruction
Analyzing Current Standards of Practice
Use of potentially ineffective transdermal route
Transdermal Gels
Avoid compounding for systemic drugs
Skin is very effective barrier for chemical penetration
No evidence base – most drugs
Growing evidence - no efficacy
Decreased peripheral circulation – decreased bio-availability
NSAIDs – some work locally, little systemic absorption
Ativan, Benadryl and Haldol Gel Study- Very little absorption [6]
Analyzing Current Standards of Practice
Use of Sublingual Route
SL excellent route for continuing low dose morphine, lorazepam,
atropine only
Very few drugs actually absorb sublingually
•
•
•
•
Morphine (9% - 51% bio-availability)[7]
Ativan
Atropine (variable absorption)[8]
Intensols – These are NOT sublingual
Copious oral secretions inhibit absorption
Large volumes will not stay under tongue
• May be swallowed
• Silent aspiration with larger volumes - adds to respiratory distress
• Crushing tablets = (bad taste + unlikely absorption+ aspiration risk)
Analyzing Current Standards of Practice
Use of Tablets or Capsules Rectally
Rectum is dry, especially near death
Dry tablets = difficulty dissolving = Decreased T-max and C-max
Unable to spread over rectal mucosa without water
Lubricating jelly adds very little water
Increased burden of care - Caregivers usually don’t like giving
suppositories much less pills
Literature shows micro-enemas tend to absorb better
than suppositories[9,10]
Indentifying the Best Alternative Route(s)
What is the best alternative route?
Scenario: The oral route fails for a patient who wishes to die
comfortably at home.
Answer depends on the patients wishes, active symptoms, and
symptom history.
Ongoing assessment / proactive planning key to good transition
Does the patient wish to die at home?
What is the history of symptom types and their severity
Will patient experience withdrawal if any medications are stopped?
Is the patient on high doses of opioids?
Are adjuvants for pain and symptom control being utilized?
Based on this assessment decide;
Which medications should be stopped and which continued?
Identifying the Best Alternative Route(s)
An optimal route would have these qualities
Clinical
Effectiveness- Evidence base for
effectiveness
Easy Use- Home Setting
• Easy for caregivers
• Comfortable and safe
• Rapid initiation and availability
• Minimum supply coordination.
Identifying the Best Alternative Route(s)
A optimal route would also be:
Versatile
- All medications needed could be given via
this route - scheduled and break through dosing
Cost Effective -Low comparative cost
• Not always obvious
Per diem pharmacy costs
Delivery costs
Supply costs
Nursing time to implement and problem solve
Alternate Routes of Medication Delivery
Sublingual
Benefits
Easy,
Comfortable,
Low cost
Downsides
Limited medications
Limited surface area
Copious secretions inhibit
absorption
Limited dose volume - potential
aspiration
Alternate Routes of Medication Delivery
IV
Benefits
Fast (once placed)
Very Effective
Versatile medications
Downsides
High CG burden
Difficult/delayed access to
supplies/meds
High cost
Some limited medications (NSAIDS)
Higher complications
Alternate Routes of Medication Delivery
SQ
Benefits
Usually fast (once placed)
Usually effective
Mostly comfortable
Downsides
Difficult/delayed access to
supplies/meds
High cost
Limited medications
Higher complications
<SQ fat-wasting
Higher CG Burden
Decreased peripheral
circulation at EOL
Alternate Routes of Medication Delivery
Transdermal
Benefits
Easy
Comfortable
Downsides
Poor absorption
Delayed/difficult access
(compounding/delivery issues)
Moderate cost
Very Limited medications
Decreased peripheral circulation EOL
No break through dosing potential
Alternate Routes of Medication Delivery
Intranasal
Benefits
Very rapid onset
Easy
Comfortable
Downsides
High cost
Very limited drugs
Buildup of residue
Alternate Routes of Medication Delivery
Rectal (Suppositories)
Benefits
High medication versatility
Effective absorption most
meds used at end of life⁴
Some are inexpensive
Less CG education
Downsides
Higher CG Burden
Uncomfortable (requires repeated movement)
Ongoing invasion of privacy
Low dose versatility – usually one drug, one dose
Availability and cost if specially compounded
Time to onset of effect
An Emerging Alternate Route
Rectal micro-enema (Macy
Catheter)
•
•
•
•
•
•
Device placed by the clinician
Medication port on leg or abdomen
Discreet delivery of medications in
suspension via syringe to rectal
mucosa
Oral medications crushed and
suspended or dissolved in water
Stays in place for ongoing
medication administration
Small, soft balloon defecated when
patient has bowel movement (or
removed prior to)
An Emerging Alternate Route
Rectal micro-enema (Macy Catheter)
Benefits
High medication versatility
Effective absorption most
meds used at end of life[8]
Easy, Comfortable
Utilizes oral medications
Discreet, no caregiver invasion
of privacy
Quick alternative – no
compounding
Downsides
Moderate Device Cost
Device is expelled with
defecation
Nurse needs to reinsert
Comparing Alternate Routes of Delivery
Rectal
SQ
IV
SL
Transdermal
Intranasal
Opiates - (Morphine, fentanyl, Hydromorphone, methadone, more)
X
X
X
X
Fentanyl
Fentanyl
NSAIDS - (Ibuprofen, Indomethacin, ASA, Ketoprofen)
Benzodiazepines (Lorazepam, Diazepam, Midazolam, Clonazepam)
Antinauseants- (Metoclopramide, Prochlorperazine, Odansetron,
X
-
-
-
Local
X
X
X
Ativan
-
Midazolam
X
X
X
-
-
-
Anti Seizure - (Valproic Acid, Carbamazepine)
X
-
X
-
-
-
Sedatives - (Phenobarbital, Pentabarbital,
X
X
X
-
-
-
Anti-depressants - (Trazadone, Doxepin, Imipramine, Clomipramine)
X
-
-
-
-
-
Neuroleptics - (Haldol, Thorazine)
X
X
X
-
-
-
Anti-cholinergics -
X
-
X
X
-
-
X
X
X
-
-
-
Antibiotics - (Amoxicillin, Erythromycin, Metronidazole, Fluconizole)
X
-
X
-
-
-
Acetaminophen
X
-
X($$)
-
-
-
Furosemide
X
-
X
-
-
-
Medication Versatility
promethazine)
Steroids -
(Atropine, Dimenhydrate, Oxybutinin)
(dexamethasone)
Pharmacokinetic studies have been done on the above drugs. Absorption has been found to be effective in the routes
marked in green. For specific absorption via rectal route, see Davis et al. (2002)[8]
-
Comparing Alternate Routes of Delivery
Route/Formulation
Rectal – Suppository
Rectal - Macy Catheter
Sublingual
Subcutaneous
Intravenous
Intranasal
Transdermal
Dosing Versatility
Drug Class Versatility
Ease of Use
Cost
Comparing Alternate Routes of Delivery
Route/Formulation
Dosing Versatility
Rectal – Suppository
Rectal - Macy Catheter
Sublingual
Subcutaneous
Intravenous
Intranasal
Transdermal
Green - Easy and Effective
for Break Through
(Immediate) Symptom.
and ongoing Symptom
Control
Yellow – More difficult for
Immediate and/or
ongoing Symptom Control
Red – Not effective for
immediate symptom
control
Drug Class Versatility
Ease of Use
Cost
Comparing Alternate Routes of Delivery
Route/Formulation
Dosing Versatility
Drug Class Versatility
Rectal – Suppository
Rectal - Macy Catheter
Sublingual
Subcutaneous
Intravenous
Intranasal
Transdermal
.
Green - 80%+ drug classes
listed (slide 24)have drugs
effective via route
Yellow - 50% drug classes
listed have drugs effective
via route
Red - 20% or less of drug
classes listed have
drugs effective via route
Ease of Use
Cost
Comparing Alternate Routes of Delivery
Route/Formulation
Dosing Versatility
Drug Class Versatility
Ease of Use
Rectal – Suppository
Rectal - Macy Catheter
Sublingual
Subcutaneous
Intravenous
Intranasal
Transdermal
Green - Minimal Training,
Easy set up, non-sterile,
comfortable for CG/Pt., low
complications
Yellow - Minimal Training,
uncomfortable for CG/Pt.,
repeated invasiveness
Red - Greater training
needs, delivery/supply
management, sterile
technique, more
complications
Cost
Comparing Alternate Routes of Delivery
Route/Formulation
Dosing Versatility
Drug Class Versatility
Ease of Use
Cost
Rectal – Suppository
$$
Rectal - Macy Catheter
$$
Sublingual
$
Subcutaneous
$$$
Intravenous
$$$
Intranasal
$$$$
Transdermal
$$
$ ~ $10 dollars/day
$$ ~ $20 dollars/day
$$$ ~ $50 dollars/day
$$$$ ~ $100/day
Comparing Alternate Routes of Delivery
Route/Formulation
Dosing Versatility
Drug Class Versatility
Ease of Use
Cost
Rectal – Suppository
$$
Rectal - Macy Catheter
$$
Sublingual
$
Subcutaneous
$$$
Intravenous
$$$
Intranasal
$$$$
Transdermal
$$
Green - Easy and Effective Green - 80%+ drug
for Break Through
classes listed (slide
(Immediate) Symptom. 24)have drugs effective
and ongoing Symptom
via route
Control
Yellow - 50% drug
Yellow – More difficult for classes listed have
Immediate and/or ongoing drugs effective via
Symptom Control
route
Red – Not effective for
Red - 20% or less of
immediate symptom
drug classes listed have
control
drugs effective via route
Green - Minimal Training,
Easy set up, non-sterile,
comfortable for CG/Pt., low
complications
Yellow - Minimal Training,
uncomfortable for CG/Pt.,
repeated invasiveness
Red - Greater training
needs, delivery/supply
management, sterile
technique, more
complications
$ ~ $10 dollars/day
$$ ~ $20 dollars/day
$$$ ~ $50 dollars/day
$$$$ ~ $100/day
Review - Planning a Good Patient-centric Death
1.
Provide ongoing assessment and proactive care-planning
• Identify which meds can be stopped and which continued
2. Avoid symptom crises that lead to loss of patient choices and increased
caregiver burden.
• Quickly respond to symptom return
• Consider adding back adjuvants
3. Choose the medication route that meets the needs and wishes of the
patient in the easiest, most versatile, and most cost effective way
possible.
Cited References
1.
Kehl, KA et al. A systematic review of the prevalence of signs of impending death and symptoms in the last 2 weeks of life.
Am. Journal of Hospice and Palliative Care 2013 Sep;30(6):601-16
2.
Pritchard RS, Fisher ES, Teno JM, Sharp SM, Reding DJ, Knaus WA, Wennberg JE, Lynn J. Influence of patient preferences and
local health system characteristics on the place of death. SUPPORT Investigators. Study to Understand Prognoses and
Preferences for Risks and Outcomes of Treatment., J Am Geriatr Soc. 1998 Oct;46(10):1242-50.
3.
NHPCO Facts and Figures (2014); http://www.nhpco.org/sites/default/files/public/Statistics_Research/2014_Facts_Figures.pdf
4.
NHPCO Facts and Figures (2013); http://www.nhpco.org/sites/default/files/public/Statistics_Research/2013_Facts_Figures.pdf
5.
Institute of Medicine Report (2014); Dying in America: Improving Quality and Honoring Individual Preferences Near the
End of Life; http://www.iom.edu/Reports/2014/Dying-In-America-Improving-Quality-and-Honoring-Individual-Preferences-Near-theEnd-of-Life.aspx
6.
T. J. Smith, J. K. Ritter, P. J. Coyne, G. L. Parker, P. Dodson, D. S. Fletcher, Testing the cutaneous absorption of lorazepam ,
diphenhydramine , and haloperidol gel used for cancer-related nausea., Journal of Clin Oncol 2011 29:
7.
Gary M. Reisfeld, M.D., George R. Wilson, M.D., Rational Use of Sublingual Opioids in Palliative Medicine, Journal of Palliative
Medicine, 2007; 10:465-475,
8.
Davis, MP, Walsh D, LeGrand SB, Naughton M. Symptom control in cancer patients: the clinical pharmacology and
therapeutic role of suppositories and rectal suspensions. Support Care Cancer, 2002 Mar;10(2): 117-38.
9.
De Boer AG, Moolenaar F, de Leede LG, Breimer DD. Rectal drug administration: clinical pharmacokinetic considerations. Clin
Pharmacokinetics, 1982 July-Aug;7(4):285-311
10.
Van Hoogdalem EJ, de Boer AG, Breimer DD. Pharmacokinetics of rectal drug administration, Part 1. Clin Pharmakokinet.1991;21:11-26.
Related References
•
Coyle N, Adelhardt J, Foley KM, Portenoy RK. Character of terminal illness in the advanced cancer patient:
pain and other symptoms during the last four weeks of life. J Pain Symptom Management 1990; 5:83-93.
Cooper J. Stepping into palliative care; a handbook for community professionals; Radcliffe Press;
2000; Chapter 7: 105-116.
Letizia M, Shenk J, Jones TD. Intermittent subcutaneous injections of pain medication: effectiveness,
manageability, and satisfaction. Am J Hosp Palliative Care 1999;16(4):585-92
Crane RA. Intermittent subcutaneous infusion of opioids in hospice home care: an effective,
economical, manageable option. Am J Hosp Palliative Care 1994;11(1):8-12.
David S Weinberg BA, Charles E Inturrisi PhD, Bruce Reidenberg MD, Dwight E Moulin MD, Tony J
Nip BS, Stanley Wallenstein MS, Raymond W Houde MD and Kathleen M Foley MD. Sublingual
absorption of selected opioid analgesics. Clinical Pharmacology and Therapeutics1988; 44:335–342
Coyne PJ, etal. Compounded Drugs – Are customized prescription drugs a salvation, snake oil or both?
Journal of Hospice and Palliative Nursing 2006;8:222-226
Moolenaar F, Koning B, Huizinga T. Biopharmaceutics of rectal administration of drugs in man.
Absorption rate and bioavailability of phenobarbital and its sodium salt from rectal dosage forms,
Laboratorium voor Farmacotherapie en Receptuur, Ant. Deusinglaan, 2, Groningen, The Netherlands
Related References
Warren DE. Practical use of rectal medications in palliative care. Journal of Pain and Symptom
Management 1996;11:378-387.
Nee, Douglas PharmD, MS. Rectal Administration of Medications at the End of Life.; HPNA
Teleconference December 6, 2006. http://www.hpna.org. Accessed January 2012
F. Moolenaar, S. Bakker, J. Visser, T. Huizinga, Biopharmaceutics of rectal administration of drugs in
man IX. Comparative biopharmaceutics of diazepam after single rectal, oral, intramuscular and
intravenous administration in man. International Journal of Pharmaceutics Volume 5, Issue 2, April
1980, Pages 127–137
Graves NM, Kreil RL Rectal administration of antiepileptic drugs in children. Pediatr Neurol.,1987;
3:321-326
Web References and Resources
http://www.hpna.org/DisplayPage.aspx?Title=2012 CPF Poster
Presentations “A Quality Improvement Study: Use of a Rectal Medication
Administrative Device, an Intervention to Manage End-Stage Symptoms in Hospice
Patients when the Oral Route Fails “- Brad Macy, RN, BA, BSN, CHPN®; Debi Clancy,
RN, BSN, CHPN®