1. Ambulatory infusion pumps in oncology settings
Dr. Sameh Awwad, Pharm D. RPH. BCNSP
Consultant Clinical Pharmacist
Pediatric Oncology / TPN
King Fahad Medical City

2. Financial Disclosure
I have no conflict of interest or financial interest in any service or product mentioned in this program

3. Objective Discuss types of ambulatory infusion pumps
Review safety concern related to ambulatory infusion pumps
Review pharmacist/health care provider role in educating patients on infusion pumps

4. Background
Ambulatory care applies to patients who require treatment with close monitoring but are stable enough to stay out of the hospital
Historically high dose chemotherapy is given in the inpatient setting
Using ambulatory device chemo regimes can be safely delivered in the home setting
Development of smart ambulatory infusion pumps helped in reducing errors
using dose-error-reduction software and drug-infusion libraries

5. Types of infusion pumps
IV Infusion pump is advice that delivers measured amounts of fluids or medications into the bloodstream over a period of time
Types of infusion pumps
Elastomeric
Electronic
Patient-controlled analgesia (PCA)
Syringe
Implantable
At first glance, the elastomeric pump appears simple. Using a balloon inside a plastic covering, the unassuming device has the capability to infuse a variety of medications at different rates. It has no buttons to program it; rather, it relies on an elastomeric membrane to generate pressure that moves the fluid out of the membrane. The rate of infusion is controlled by an inline orifice or flow restrictor. 

6. Why ambulatory pumps? Improve patient quality of life
Evidence suggest that caring for cancer patients at home can improve symptom and decrease social dependency
Decrease healthcare cost
Home care resulted in a 53% decrease in healthcare costs
There is a market for offering such services
90% of hospitalized patients receive medications through IV route
Market research study suggests that the use of ambulatory pumps will continue to grow at an annual rate of about 9%
Lüthi et al The study included 46 home-based treatments with the majority of study participants receiving multiple cycles of chemotherapy. 53 % decrease

7. Medication commonly administered via ambulatory pumps
Antineoplastic agents
Biologics
Factor therapy
Parenteral nutrition
Analgesics
Blood products
Hydration
Antimicrobial, antifungal, antiviral agents

8. Desired features in infusion pumps
Continuous delivery
allows the infusion of drug/fluid at a constant programmed rate continuously
Intermittent delivery
allows the infusion of a specific volume of drug/fluid at a regular programmed interval
Step delivery
allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume
Taper delivery
allows a plateau rate of infusion with the option of tapering at the beginning and/or end and has a programmable KVO rate at the end of the infusion
Special delivery
used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patient controlled analgesia (PCA)

9. Desired features for infusion pumps
Ability to reduce common infusion hazards (SMART technology)
Integration
Barcoding
Wireless technology
Patient monitoring
Real time access to infusion status
Reduce programing steps

10. Types of infusion pumps
Elastomeric
Pumps deliver a low steady dose of medication until it is empty
Fluid is held in a stretchable balloon reservoir, and pressure from the elastic walls of the balloon drives fluid delivery
Require no programming
User friendly (minimal patient involvement)
Enhances patient compliance
Decrease risk of contamination
Very easy to teach, reducing nursing time
Increase workload over gravity methods (pharm tech)
the energy in an elastic membrane to provide the force for fluid delivery according to Poiseuille-Hagen’s law, independently of gravity.

11. Elastomeric pumps
The fill port is where the chemotherapy is put into the balloon
The balloon has two layers: an inner membrane that holds the chemotherapy and an outer cover that protects the inner membrane.
The infusion line carries chemotherapy from the balloon to CVC tubing.
The clamp is used to start and stop the flow of chemotherapy
The filter filters the chemotherapy before it’s infused
The flow restrictor helps to control how quickly the chemotherapy is infused
The patient connector
At first glance, the elastomeric pump appears simple. Using a balloon inside a plastic covering, the unassuming device has the capability to infuse a variety of medications at different rates. It has no buttons to program it; rather, it relies on an elastomeric membrane to generate pressure that moves the fluid out of the membrane. The rate of infusion is controlled by an inline orifice or flow restrictor. 

12. Elastomeric pumps Flow restrictor
Manufacturer recommends that the flow restrictor NEEDS to be next to the patient’s skin for rate accuracy
Design to operate at 31.5°C- 33°C ( °F)
For every 1 °F decrease or increase in temperature the flow rate can be affected by ~ 2%
Increase in temp result in increase in flow rate while decrease in temp decrease in flow rate

13. Elastomeric pumps Pump placement
As a general rule, keep the pump placement level with the luer-lock connector
0.5 % rate increase or decrease for every inch above/below
Diluent type ( dextrose vs normal saline)
Using the wrong solution in the bag will change the flow rate approximately by 10% ( viscosity)

14. Continuous ambulatory delivery devices (CADD)
Electronic
Made to supply a continuous dose of medication to patients at different rates
Allows for dosing schedules, such as bolus, tapering, step therapy, etc.
Rates are programmed by nurse (provider)
Audible and visual alarms to alert users
Has safety features such as air bubble, occlusion, low battery etc.
Can be SMART
Risk of pump malfunction as a result of radiation exposure
Electronic pumps require a power source and usually operate via peristaltic mechanisms that propel the infusion forward via appendages that move in waves (similar to peristalsis of the bowel). Rates are programmed into the pump as either intermittent or continuous infusions. Many come with audible and visual alarms to alert users to errors such as occlusion, low battery, and pump malfunction.

15. CADD programing Human factor Multi steps programing 11-17
Safety vs. risk
Among IV-related errors, medication administration was the most commonly reported type (represented 36.9% )
Electronic pumps require a power source and usually operate via peristaltic mechanisms that propel the infusion forward via appendages that move in waves (similar to peristalsis of the bowel). Rates are programmed into the pump as either intermittent or continuous infusions. Many come with audible and visual alarms to alert users to errors such as occlusion, low battery, and pump malfunction.

16. Patient-controlled analgesia (PCA)
An infusion pump intended for the delivery of analgesics medication
Equipped with a feature that allow for additional limited delivery of medication upon patient demand
Lockable /secure
Real time monitoring such as respiration rate

17. Syringe Pump
An external infusion pump which utilizes a piston syringe as the fluid reservoir and to control fluid delivery
They can operate at very small volumetric flow rates 0.1 ml /hr ( mg micro, nano , etc.

18. SFDA Training: Medical Device Accident Investigation 11-14 Feb, 2007
Implantable Pumps
Site specific drug delivery where the drug is needed most
Dose control
Require surgical procedure
Free flow refilling in wrong spot (into tissue or into vessel)
Catheter/pump separation
Gliadel® wafer pump polymer implant wafer is a biodegradable compound containing 3.85% carmustine (BCNU, bischloroethylnitrosourea) implanted in the brain at the time of planned tumor surgery, which then slowly degrades to release the BCNU chemotherapy directly into the brain thereby bypassing the blood–brain barrier.
20 micro liter tubing volume; 5 psig loading pressure
©2007 ECRI

19. Manual vs electronic –patient prospective
Patients indicated their preference for elastomeric devices over electronic pumps
Light weight and size
No bells or whistles
less interference with daily activity and sleep
User friendly

20. Smart portable pumps
Smart pump technology has been evolving since late 1990s,
Utilize dose-error-reduction software
Built in drug-infusion libraries and protocols
Wireless technology linked with dispensing systems
Incorporate barcode technology
Evidence show decrease in medication error
Supported by major safety organization (ISMP)

21. Safety
FDA recall database for large volume IV smart pumps between the January 1, 2015, and October 9, 2017
ISMP estimated that 2/3 of preventable death are due infusion therapy and attributable to manual programming errors when using infusion pump
37 recalls of large volume IV infusion pumps, tubing and/or software for Alaris, Baxter and Hospira
Class I: a situation in which there is a reasonable probability that the use of, or exposure to, a violate product will cause serious adverse health consequences or
death.
Class II: a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the
probability of serious adverse health consequences is remote.
Class III: a situation in which use of, or exposure to, a violative product is not likely to
cause adverse health consequences
5 are class I

22. Safety
The National Institutes of Health reports that more than 250,000 Americans receive fluorouracil annually
A Swedish study of medication errors involving cytotoxic drugs between 1996 and 2008 found that fluorouracil was most commonly involved drug
Errors with fluorouracil are often caused by
dose miscalculations
infusion pump programming errors
confusing pharmacy labels
lack of pump programming safeguards
use of the wrong type of infusion pump in outpatient settings
Class I: a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or
death.
Class II: a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the
probability of serious adverse health consequences is remote.
Class III: a situation in which use of, or exposure to, a violative product is not likely to
cause adverse health consequences

23. Fluorouracil incidents
Patient was to receive 4,000 mg of fluorouracil by IV infusion at 2 mL per hour over 4 days
Mix-up between elastomeric infusion pump that infuses 2 mL per hour with one that infuses 250 mL per hour
Patient received four-day dose in less than one hour
Similar incidents with CADD pump

24. Pharmacist role Involve in decision making on type of pumps selected
Medication use process include administration
Pharmacy are the primary user and programmer of the pumps
Patient and nursing education

25. Patient education
Check clamps, patient has the ability to identify that pump is “running”
Avoid hot/cold temperature extremes and keep out of direct sunlight
Observe the patient’s ability to maintain flow regulator next to skin
Keep pump level with the LuerLock Connector
Review the use of the provided chemotherapy spill kit
Review safe management of chemotherapy at home
When / who to call with questions and/or issues r/t chemotherapy administration.
Electronic pumps require a power source and usually operate via peristaltic mechanisms that propel the infusion forward via appendages that move in waves (similar to peristalsis of the bowel). Rates are programmed into the pump as either intermittent or continuous infusions. Many come with audible and visual alarms to alert users to errors such as occlusion, low battery, and pump malfunction.

26. Patient education Review CADD pump education sheet with patient
Verify programing before infusion starts
Verify having good batteries and that patient demonstrate battery change appropriately
Read the alarm and follow instructions
Keep the pump from getting wet
Patient verbalize understanding as well as demonstrate proper use of pump
Emergency contact numbers.
Electronic pumps require a power source and usually operate via peristaltic mechanisms that propel the infusion forward via appendages that move in waves (similar to peristalsis of the bowel). Rates are programmed into the pump as either intermittent or continuous infusions. Many come with audible and visual alarms to alert users to errors such as occlusion, low battery, and pump malfunction.

27. References
Accessed 9/2019
US Food and Drug Administration (FDA). Medical device recalls Availableat:
Lüthi, F., Fucina, N., Divorne, N., Santos-Eggimann, B., Currat-Zweifel, C., Rollier, P., ..., Leyvraz, S. (2012). Home care—A safe and attractive alternative to inpatient administration of intensive chemotherapies. Supportive Care in Cancer, 20(3), doi: /s
Capdevila, P. Macaire, P. Aknin, C. Dadure, N. Bernard, S. Lopez. Patient-controlled perineural analgesia after ambulatory orthopedic surgery: a comparison of electronic versus elastomeric pumps. Anesth Analg 2003;96:414-7
Grissinger M. Accidental Overdoses Involving Fluorouracil Infusions. P T. 2018;43(6):316–335.
National Institutes of Health. Public teleconference regarding licensing and collaborative research opportunities for: methods and compositions relating to detecting dihydropyrimidine dehydrogenase (DPD). Fed Regist 2008;73(129):38233
Fyhr A, Akselsson R. Characteristics of medication errors with parenteral cytotoxic drugs. Eur J Cancer Care 2012;21(5):606–613.
McCorkle, R., Benoliel, J. Q., Donaldson, G., Georgiadou, F., Moinpour,C., & Goodell, B. (1989). A randomized clinical trial of home nursing care for lung cancer patients. Cancer, 64(6),
Institute for Safe Medication Practices. Fluorouracil error ends tragically, but application of lessons learned will save lives. ISMP Medication Safety Alert 2007;12(19):1–3.
Bak, K., Gutierrez, E., Lockhart, E., Sharpe, M., Green, E., Costa, S., … Warde, P. (2013). Use of Continuous Infusion Pumps During Radiation Treatment. Journal of Oncology Practice, 9(2), 107–111.doi: /jop

28. Questions