1. WELCOME!!

2. Challenges of Symptom Management when the Oral / SL Routes Fail and the Macy Catheter
Brad Macy RN, BA, BSN, CHPN
President and Co-founder, Hospi Corporation

3. My Experience and the Invention Story
19 years after hours 6 days a week 12 hour shifts
Three large counties in SF bay area
1000s of patients
Terminal agitation patient
Saw everything – found about 20% of patients need an alternative to SL to avoid symptoms and aspiration from medications
Agitation, Pain, Severe Resp. symptoms, high fever, seizures, medication withdrawal, continuing medications

4. Managing Symptoms at The End of Life
For 80% of patients symptoms are controlled well oral and sublingually with good results. But Symptoms cannot be controlled SL in about 10% to 20% of patients due to severe symptoms. When this happens, we switch to alternatives such as IV/SQ/suppository which all cost an additional amount in medication and delivery cost and even worse, cause a delay in symptom control for hours or even days leaving the patient to suffer. Many times, because agencies have no other alternative, they continue trying sublingual and raising the dosage which causes poor outcomes such as uncomfortable death and choking on medication, and a burden on patient, family, clinician time, and the agency and quality outcomes. The Macy Catheter solves this problem completely in a more cost effective easy and safe way. Now the patients symptoms can be immediately controlled in the same nursing visit, saving nursing time and medication and delivery costs.
Terminal Agitation
Seizures
Severe pain
Respiratory distress

5. Non-Oral Options We need a route that is; Fast Proven (evidence base)
Comfortable
Easy to use and teach
Safe (minimal complications)
Readily available
Comparatively cost effective

6. Sublingual Route Benefits Downsides Immediate Easy Comfortable
Lowest cost
Downsides
Limited medications absorb
Limited surface area
Copious secretions inhibit absorption
Limited dose volume
Potential for aspiration

7. Intravenous Route Benefits Downsides Fast Onset (once in place)
Very Effective
Versatile medications
Downsides
Delayed symptom control (Delivery/setup)
High CG burden
Highest cost
Some limited medications (NSAIDS)
Higher complications
Can be uncomfortable and invasive
Parenteral shortages
Turned one benefit line into two, clarified speed is AFTER placement.

8. Subcutaneous Route Benefits Downsides Usually fast (once placed)
Usually effective
Mostly comfortable
Downsides
Delayed symptom control (Delivery/setup)
Higher cost
Higher complications
< SQ fat – wasting at EOL
Higher CG Burden
Decreased peripheral circulation at EOL

9. Transdermal Route Benefits Downsides Easy Comfortable
Delayed symptom control (delivery)
Delayed onset of action
Very few medications absorb
Moderate to high cost
Decreased peripheral circulation EOL
No break through dosing potential

10. Rectal Route - Suppositories
Benefits
High versatility
Effective absorption most meds used at EOL(11,12)
Downsides
Delayed symptom control (delivery/teaching)
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
High absorption variability between patients
Edited a bit to make them even less desirable. I know we are trying not to stack the deck too much, but still, suppositories suck also due to time to onset and availability stuff. Tried to make more consistent with the messages on our video…

11. The Macy Catheter Concept
Benefits
Discreet, comfortable, easy to use
Quick placement
Use medications already at beside
No delay for delivery of alternatives
No turning / bothering patient for medications
EOL meds quickly / effectively absorbed
Lower cost than IV/SQ, no delivery charges
Downsides
New technology
Can come out with stool
Communicating benefits of “rectal catheter”
Nurse carrying = upfront cost

12. Macy Catheter General Information
FDA Indication: Macy Catheter provides rectal access to administer liquids and medications
Guidelines
MD/NP order for use
Can remain in place up to 28 days
Non-sterile placement
Latex free
Focus on patient and caregiver

13. Rectal Anatomy and Physiology
Inferior
vena cava
Inferior mesenteric vein
Mucosa is highly vascularized
High % absorptive cells
Liquid medications absorbed more quickly than suppositories
Rapidly enters the circulation
Distal 1/3 of the rectum (Venous return bypasses liver)
Balloon
Rectal
sphincter

14. Versatility of Routes of Delivery

15. The Macy Catheter Placement Marker Lines Balloon
Balloon Inflation Port
Medication Delivery Holes
Here is overview of the device. Note the two simple ports and medication delivery holes.
Medication Administration Port

16. Catheter Placement Step 1: Lubricate Step 2: Insert Step 3: Inflate
Step 4: Secure

17. The Macy Catheter in the Home Setting
Enables continuation of medication at the bedside when oral/SL fails
Facilitates same-visit symptom relief
Eliminates delay R/T delivery and setup
Empowers caregivers to easily and safely medicate patient
Eliminates costs associated with;
other medication alternatives
increased nursing time
delivery

18. The Macy Catheter in the Inpatient Setting
More cost-effective than parenteral options
Hospices reporting equivalent or more rapid symptom relief vs SubQ
More comfortable and safer vs. needles
Easier set up, maintenance and drug disposal
More home-like atmosphere
Easy discharge patients back into the home
Large IPU’s using the MC
Hospice of the Western Reserve, OH
Suncoast Hospice, FL
Hope Hospice, FL
Hospice of Dayton, OH
Hospice of Buffalo, NY
Hospice of the Treasure Coast, FL
JourneyCare, IL

19. Review of Common Palliative Medications
Morphine - Oral vs. ME (1)
Bioavailability – Same as oral
Significant pain relief in 10 min (p=.03) via ME vs 60 min oral
Pain intensity continued significantly lower only by rectal route at 180 min
Methadone – Oral vs. ME (2,3,4)
Bioavailability 88% oral
T-max 1.4 hr rectal vs. 2.8 oral
Significant pain relief took 10 minutes (rectal) vs. 60 minutes (oral)
Phenobarbital - Suppository vs. ME (5)
Phenobarb blood levels 8X to 12x higher for MC-20 compared to suppository.
Concentrations achieved in 30 minutes via MC-20 took 4 hours to achieve by supp.
Variability between subjects much less with ME vs Supp
Two suppositories failed to produce ANY blood level of Phenobarbital
(c) Hospi Corp MAC [B]

20. Review of Common Palliative Medications
Quetiapine (seroquel) – Rectal vs. Oral (6)
Rectal bioavailability of Quetiapine = 189% compared to oral
T-max comparable but less variable for rectal
102min±21 (rectal) vs 93min±68.5 (oral)
Lorazepam Oral, SL, IM, ME (7,8)
Bioavailability = 86%
T-max = 1.12 hr ME vs. 1.15hr (IM), 2.37hr (oral), 2.35hr (SL)
Diazepam – Oral, IM, ME (9)
T-max 17 min (rectal ME) vs. 52 min (oral) vs. 95 min (IM) vs. 82 min (supp.)
Rectal ME absolute bioavailability = 100%
Intra-subject variability lowest via ME and highest orally

21. $2k 64 Hospice Buffalo saved $40 patients
Paper publishing in Journal of Pain and Palliative Care Pharmacotherapy(10)
Written by Director of Pharm, CMO, and Nursing Leadership(12)
Looked at the challenges facing all hospices
Reviewed the Clinical, quality and cost benefits their agency has experienced utilizing the Macy Catheter. 64
patients
$2k
saved
Cost Savings Experienced
Total 2017 Savings $92,000
Total Patients in IPU = 640
MC Patients = 230 (36%)
$401 savings per MC placed
I am glad to report that the Macy Catheter can indeed save you money!!!
Hospice Buffalo projects $111,000 in gross savings for 2017 with not quite 20K in cost for the MC for a net savings of 92K. Even if there were no savings in home care this pays for the entire MC program there with $80K in savings! Especially now with the parenteral drug shortage, the Macy Catheter can be an extremely effective tool in improving care and decreasing cost.
$40
saved per MC

22. Ohio’s Hospice of Dayton
Had opioid shortage crisis at end of 2017
Switched in mid-November 2017
Used in > 1000 patients to date
Using Macy instead of SQ in almost all patients
Except patients that have contraindications for rectal delivery
Finding Macy Catheter faster, easier and more cost efficient

23. Ohio’s Hospice of Dayton Testimonial Video

24. Macy Catheter Information and Educational Resources Research Articles Training platform and videos Testimonial videos and stories

25. ?
Q & A

26. References
De Conno F, et al. Role of rectal route in treating cancer pain: a randomized crossover clinical trial of oral versus rectal morphine administration in opioid-naive cancer patients with pain. J Clin Oncol. 1995 Apr;13(4):
Dale et al. Bioavailabilities of rectal and oral methadone in healthy subjectsBr J Clin Pharmacol. Aug 2004; 58(2): 156–162.
Bruera et al. Custom-made capsules and suppositories of methadone for patients
on high-dose opioids for cancer pain. Pain, 62 (1995)
Ripamonti C. et al. Rectal methadone in cancer patients with pain. A preliminary clinical and pharmacokinetic study. Ann Oncol. 1995 Oct;6(8):841-3.
Lam Y, Lam A, Macy B. Pharmacokinetics of phenobarbital in micro- enema via Macy Catheter versus suppository. J Pain Symptom Manage. 2016;51(6):
Leung, J. G., Nelson, S., Cunningham, J. L., Thompson, V. H., Bobo, W. V., Kung, S., ... Lapid, M. I. (2016). A Single-Dose Crossover Pharmacokinetic Comparison Study of Oral, Rectal and Topical Quetiapine in Healthy Adults. Clinical Pharmacokinetics, 1-6. 

27. References
Graves et al. Bioavailability of Rectally administered Lorazepam. Bioavailability of Rectally Administered Lorazepam. Clinical Neuropharmacology: December Volume 10 - Issue 6 - ppg
Greenblatt DJ, Shader RI, Franke K et al. Pharmacokinetics and bioavailability of intravenous, intramuscular, and oral lorazepam in humans. J Pharm Sci 1979;68:57–63.
Moolinaar et al. 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, 5 (1980)
Davis M, Walsh D, LeGrand S, Naughton M. Symptom control in cancer patients: the clinical pharmacology and therapeutic role of suppositories and rectal Suspensions. Support Care Cancer. 2002;10(2):
Moolenaar F, de Leede LG, Breimer DD., Rectal drug administration: clinical pharmacokinetic considerations. Clin Pharmacokinet Jul-Aug;7(4):
Latuga et al. Improving Care and Decreasing Costs; Utilizing the Macy Catheter for End of Life Symptom Management. accessed 9/24/18