Improved Care Delivery and Responsiveness: A Non-parenteral Option for Hydration and Medication Delivery

Introduction We would like to take this opportunity to thank the Commission for Safety and Quality in Nursing Homes. There is a serious need for developing best practices, regulations and procedures for handling both current and future challenges and emergencies in the skilled nursing setting. The technology presented in this brief relates in particular to the Commissions Objective 3: Identify best practices for improved care delivery and responsiveness to the needs of all nursing home residents in preparation for, during, and following an emergency.

Background The inability to administer parenteral fluids and medications in the skilled nursing setting is a major barrier to effectively caring for patients in place during emergencies when access to supplies, emergency transport, hospitals, or employees with IV training are limited. Even during “non-emergency” times parenteral access is a major issue impacting a facilities responsiveness to patient’s clinical needs leading to hospital transfers or poor outcomes. Intravenous access demands skillsets a facility may not have, or patients may have difficult venous access due to age or morbidities causing delays in care or unnecessary hospital transfers. During emergencies these challenges are amplified. After hurricane Maria hit Puerto Rico in 2017, the US experienced a significant parenteral medication shortage. These shortages are becoming a chronic phenomenon worldwide and COVID 19 has exacerbated the problem significantly. This brief introduces a new best practice alternative for a non-parenteral medication and fluid delivery catheter that is less invasive, safer, and requires minimal skillset and supplies. While this alternative does not replace the need for parenteral therapy in certain emergent medical situations, it can serve as an immediate option while awaiting delays in parenteral placement and many times can replace the need for parenteral therapy altogether.

The Macy Catheter® Description The Macy Catheter is a specialized rectal Figure 1: The Macy Catheter administration catheter (Hospi Corporation,) designed and FDA cleared for fluid and medication delivery. The catheter consists of a 14fr silicone body with a 15ml retention balloon on one end with ports to inflate the balloon and administer medication/fluid on the other (figure 1). The catheter is placed in the distal 1/3rd of the rectum, immediately adjacent to the internal rectal sphincter. This particular placement allows for maximal absorption of medication while blocking injected fluids from Improved Care Delivery and Responsiveness: A Non-parenteral Option for Hydration and Medication Delivery

Figure 2: Placement of the Macy Catheter exerting pressure on the rectal sphincter. (figure 2). The catheter can remain in the rectum up to 28 days for ongoing fluid and medication delivery. The catheter can be removed prior to defecation (in a continent patient) or is easily expelled automatically with defecation in an incontinent patient. Being a non-sterile catheter, it can be reinserted as many times as necessary during the 28-day period following the specified guidelines. Insertion of the catheter is a simple procedure that takes less than 5 minutes and can be performed by both RNs and LVN/LPNs with minimal training. Sterile parenteral medications and fluids are not needed. Oral forms of medications are crushed, and 10 ml water is added to produce a “micro-” . For hydration, tap water or an oral rehydration fluid such as pedialyte® can be used. As emergency preparedness plans currently mandate having several days of water on hand in their emergency supplies, the Macy Catheter can be added to the emergency preparedness supply closet allowing for hydration and medication of all patients, even those too obtunded to take PO medications and fluids.

Current Use of the Macy Catheter The Macy Catheter is being used in hundreds of hospices throughout the US and is currently being adopted in skilled nursing facilities and some acute inpatient facilities. In 2019 Genesis Health Care added the Macy Catheter to their national formulary. The Valley Hospital in New Jersey recently implemented the Macy Catheter for the treatment of COVID 19 patients due to parenteral drug shortages. The Macy Catheter is currently being used in several VA Hospitals as an alternative to parenteral medications and fluids for treatment of hospice and patients.

Summary A recommendation to skilled nursing facilities by the Commission to consider inclusion of this intervention into emergency preparedness plans would empower facilities with information on a method to immediately treat patients in place with medications and fluids on hand even during the most severe emergency circumstances. A further recommendation to the government to add the Macy Catheter to the Strategic National Stockpile would further enhance the safety of the national community during disasters such as earthquakes, fires, severe weather or other disasters. Lastly if the Commission were to recommend skilled nursing facilities adopt this intervention into expanded non-emergency practice for treatment of patients in place either as a bridge to parenteral access or a replacement of parenteral access when appropriate it could lead to a decrease in unnecessary hospital transfers, , decrease cost and staff burden and provide a more patient centric approach to care.

Improved Care Delivery and Responsiveness: A Non-parenteral Option for Hydration and Medication Delivery

Macy Catheter Features and Benefits Review • MD/NP order • No needles, pumps, parenteral fluids, or medications needed • No needle sticks, infections, occlusion, infiltration associated with parenteral • Faster infusion vs hypodermoclysis (up to 250ml/hr – 1500ml/day) • Quickly and easily placed by RN/LVN/LPN • Minimal training needed; easy to implement • Treat changes in condition immediately pending IV placement or as a substitute when able • Discreetly accessible on the patient’s leg or abdomen • Small, soft balloon (the size of a quarter) o NOTE: Not like balloons on bowel management devices that are large and uncomfortable • Comfortable delivery of fluid/medication. More comfortable than IV/SQ • Expelled comfortably and easily with defecation (or removed prior to defecation in continent patients) and can be reinserted for up to 28 days

Quick links to Macy Catheter Information

Frequently Asked Questions: https://www.macycatheter.com/skilled-nursing-facility-faq/

Download for policies and procedures: https://www.macycatheter.com/skilled-nursing-facility-faq/

Skilled Nursing Implementation Portal: https://www.macycatheter.com/skilled-nursing-facility-faq/

Macy Catheter Informational and Training Video Links:

Macy Catheter Patient and Caregiver Teaching Panelist Webinar: Managing Hospice and Palliative Care Through COVID-19 Challenges Using the Macy Catheter for Hydration Using the Macy Catheter

Literature links

Use of the Macy Catheter in the skilled nursing setting: 1. Decreasing Hospital Transfers in the Skilled Nursing Setting Utilizing a Catheter for Treatment of Changes in Patient Condition

Macy Catheter Hydration 1. Decreasing Hospital Transfers in the Skilled Nursing Setting Utilizing a Rectal Administration Catheter for Treatment of Changes in Patient Condition 2. An alternative for rapid administration of medication and fluids in the emergency setting using a novel device. American Journal of Emergency Medicine 3. Journal of Online Video Education A Novel Approach for the Administration of Medications and Fluids in Emergency Scenarios and Settings 4. Expert Review of Medical Devices: Evaluation of the Macy Catheter®: a rectal catheter for rapid medication and fluid administration

Macy Catheter and Rectal Micro-enema Medication Administration 1. Journal of Pain and Symptom Management: Pharmacokinetics of Phenobarbital in Microenema Via Macy Catheter Versus Suppository 2. Journal of Hospice and Palliative Nursing. Promoting Excellence in Symptom Management Case Series Case Study: A New Intervention for Rapid End-of-Life Symptom Control in the Home Setting 3. Journal of Pain and Palliative Care Pharmacotherapy. A Cost and Quality Analysis of Utilizing a Rectal Catheter for Medication Administration in End-of- Life Symptom Management 4. American Journal of Emergency Medicine. Safe and effective administration of lactulose retention enema in the ED using specialized rectal medication administration catheter