A – In some venues nurse practitioners and physician assistants may execute orders for
the MOD® device as well as physicians. The preprinted order sheet or CPOE order will
be similar to that of the IV-PCA. You will be asked to specify the drug name, dose,
lockout interval in hours, and when to start the first dose. You can also indicate
additional or “bolus doses” for pain not relieved with a prn dose of medication or prior to
physical therapy, if part of the treatment plan. Extra doses can be ordered in the device
program. Nursing will obtain the filled medication tray from the automated dispensing
cabinet on the unit and program the device according to your order. The patient will be
instructed on how to use the device and should be required to agree to their
responsibilities for the device prior to beginning its use.
Q – Why do you recommend a lower lockout interval in hours than the usual four hour
interval?
A – Similar to the IV-PCA logic, the device allows single, more frequent doses of
medication. For usual dosing it is recommended that the patient be able to access a
dose of medication every two hours if needed. This is in contrast to manual dosing by
nursing which is usually one or two tabs every four hours as needed. By allowing access
more frequently, the patient can avoid the peaks and troughs of medication levels within
the blood stream and achieve a more consistent blood level of medication with better
pain control. For a detailed discussion of this topic, see the Avancen White Paper
entitled “A Better Way to Deliver Oral PRN Pain Medication in Today’s Hospitals” on the
Avancen website under Resources and Healthcare Professionals.
Q – Does the MOD® device deliver medication according to the pain score?
A – With manual dosing, the amount of medication delivered, i.e., one or two tabs,
usually is determined by the patient-reported pain level. It has been reported when using
this system, that patients may elevate their pain score in order to obtain an adequate
dose of medication. The MOD® device works differently. The patient is notified by a
green light on the device when the lockout interval has passed. The medication will be
available for the patient when the green light illuminates. In order to obtain the
medication, the patient enters a pain score by pressing one of the numeric pain score
buttons on the device. This action activates the Radiofrequency Identification (RFID)
reader inside the device. The patient then holds their registered RFID wristband within
an inch of the front of the device. If the reader recognizes the wristband, the device
dispenser wheel turns to expose a single dose of medication for the patient to remove
and self-administer. Patients are encouraged to enter an honest pain score at the time of
medication delivery since with any score they will be able to obtain a dose of medication.
This allows the patient to manage their own pain when they feel they need the
medication. It puts them in charge of the process and generates high levels of patient
Q – Which patients are eligible to use the device?
A – An individual hospital’s policy and procedure will describe the criteria for patient
selection. Appropriate patients must be:
Alert and able to understand how to use the device. Able to demonstrate to the nurse’s satisfaction that they understand how to use the device.
Without any swallowing problems.
Have no physical limitations that would prevent them from taking the tab out of the device and self-administering the medication.
Able to agree to be responsible for the device security and rules of use described by nursing.
Nursing Questions
Q – Isn’t there a ruling that the nurse must observe a patient take a pain pill?
A – There is no Joint Commission (TJC) requirement that the patient must be observed
while taking the medication. TJC states that under the 2014 accreditation standard MM
06.01.03 hospitals should have a policy for self-administered medications to be safely
and accurately administrated. Under that guideline the patient must receive training and
appropriate information regarding the nature of medication, how to administer the
medication and the expected action and side effect of the medication. In the policy there
should also be a plan as to how to monitor the patient. Patients taking medication from
the MOD® device must also be determined to be competent before being allowed to use
the medication. The MOD® Hospital Sample Policy provided with MOD® support
materials addresses these areas. All patients should complete a simple teaching module
and demonstrate that they are capable of using the device before the device can be left
at the bedside.
Q – How does the MOD® device save nursing time?
A – A published study at a well-known academic medical center showed that each
manual delivery of oral pain medication took a minimum of 10.9 minutes of nursing labor
time per dose including documentation and reassessment. In a patient unit with frequent
prn oral pain medication dosing, this task can take up to 30% of the shift time. With the
MOD® device, it is estimated that the nursing time will be less than half of that recorded
with the manual delivery of medications. An ongoing study is now determining the time
savings using the wireless MOD® device as compared to the manual delivery of
medications. With this time saved, more nursing time will be freed up for other critical
tasks and patient satisfaction with pain management will increase.
Q – How do you prevent diversion of pain medication when using the MOD® device?
A – Narcotic control and medication reconciliation is an important part of the nursing and
pharmacy process. In addition to having security features on the device itself, the
workflow process using a MOD® device has several checkpoints required to aid in
preventing diversion. The following steps of the MOD® device process require a dual RN
signature within the device program as part of the programming software:
Programming the device and loading the pill tray
Wasting medication at the time of discharge
Order change in medication (new medication or dose change)
Order change in a time interval between doses
Replacing an empty tray of medication
The nurse identifier that programs the device and the second sign-in nurse identifier are
recorded in the device database for review at any time. The Avancen White Paper
entitled “The MOD® Experience after 1,000 Patients” highlights current users’ findings
and can be found on the home page of www.avancen.com. To date no staff or patient
diversion of medications from the device have been reported as noted in the White
Paper.
Q – Do we need a special IV pole for the MOD® device?
A – No. The MOD® device and its IV pole clamp may be locked to any IV pole in the
facility and moved to the patient bedside for easy reach and access by the patient.
Q – Is the MOD® device locked onto the IV pole?
A – Yes, the MOD® device clamp has a unique locking mechanism. The device is locked
onto its steel tray support and the attached IV pole clamp is locked onto the IV pole. A
proprietary tool is required to lock and unlock the MOD® device from the IV pole. The
tool (wrench) is supplied with each MOD® device and should be stored in a safe, secure
location.
Q – Where do I get a filled MOD® tray to place into the device as part of the initial
patient programming step?
A – Medication trays for use in the device are prepared in the central pharmacy and
placed for storage into the automated dispensing cabinet on the unit. Trays are not
usually patient specific – only medication specific, e.g., a tray will be labeled with the
name of the medication, dose, and lot number and any other identifiers applied by
pharmacy.
Q – Will the trays be barcoded?
A – Yes. Your central pharmacy may affix a barcode label to each medication tray. The
nursing staff will scan the medication trays during the validation process, which will
match the medication to the specific patient. The barcode will signal that you are
verifying a multidose tray of medication containing eight identical pills in the filled tray.
This step is identical to barcode validation of a multidose syringe or pre-filled medication
IV bag that will be loaded into an IV-PCA pump.
Q – What do we do about our usual orders, since the physician usually writes for 1-2
tabs q 4 hours?
A – Orders that provide one or two tabs cannot be used with the MOD® device as each
slot in the medication tray contains only one dose of medication. In order to achieve the
ability of the patient to receive up to two doses within four hours we recommend that the
lockout interval be set at two hours on the MOD® device. See on the Avancen website
under Resources/Healthcare Professionals the white paper which discusses this topic,
entitled “A Better Way to Deliver Oral PRN Pain Medication in Today’s Hospitals.”
Allowing a patient a dose every two hours is equivalent to two doses every four hours if
needed. The medication is dispensed by time and not by pain score although the device
captures that score with each patient request for medication. If additional clinician doses
are needed at any time to provide adequate pain control, this option is available within
the MOD® program so that all doses of medication are delivered and recorded from the
device itself.
Q – If a patient records a pain number of 0 or 1, will they be able to get a dose of
medication when the green ready light comes on?
A – Yes. The pain scale number that is entered is for documentation only. It does not
make a decision regarding the dose of medication. Patients are educated regarding this
fact and a zero or one score is very rare because of this. The same dose will be
dispensed regardless of the pain scale. This allows the patient to self-regulate and
obtain the dose when they need the pain medication. Entered pain scores are available
to monitor overall how well the patient’s pain is being controlled not only from the
medications from the device but from all the medications and procedures ongoing for
patient pain control.
Q – Does the MOD® device record how many attempts have been made to remove a
dose of medication from the device? This is recorded in some IV PCA devices.
A –The MOD® device does not have this function. Patients learn very quickly that if the
bright green ready light is not on, then it is futile to try to obtain a dose of medication
from the device.
Q – How does the device capture a pain reassessment score after each selfadministered
dose of medication?
A – One hour after each self-administered dose, an audible reminder asks the patient to
“enter your pain score now.” The patient is instructed that this is only to better
understand if the pain medication is adequately managing their pain. If they do not
respond to the reminder, it repeats intermittently for 20 minutes or until a pain number is
entered. If the patient does not reassess his/her pain within that time frame, the audible
reminder will stop and it will be the clinician’s responsibility to obtain the reassessment
score, when/as applicable.
Q – How do we clean the MOD® device between different patient uses?
A – FDA standards require that medical devices be evaluated for proper cleaning
procedures as designated in the Association for the Advancement of Medical
Instrumentation document AAMI TIR 12:2004. The MOD® has been formally reviewed by
North American Science Associates, Inc. (NAMSA), for cleaning requirements. The
MOD® has been judged to be a reusable device with a disposable clean tray of
medications supplied for each patient. Because the tray is disposable, the risk of cross
contamination is minimized. Therefore, the MOD® can be cleaned using a simple wipedown
of all the exposed surfaces between patients or when soilage occurs. A low level
disinfectant is acceptable. A detailed cleaning protocol is available as part of the MOD® Device User Manual provided with each purchased unit, or as a separate document from
Avancen.
Q – Does a bell ring to remind the patient when they are able to get a pill out of the
MOD® device?
A – No. However, any time the patient sees the bright green ready light, the appropriate
time has passed and the patient is allowed access to get their pain medication. The
visual queue (green light) is easily recognizable by all patients, especially those who are
hearing impaired. If the patient does not need medication when the green light comes
on, the device will stand ready until the patient requests and obtains a dose of
medication. Once a dose is obtained, the green light will not illuminate again until the
lockout interval has passed.
Q – How does the memory keep up with the time of the drug administration since
there is no clock to set on the MOD® device
A –The MOD® device obtains the correct time from the computer platform or network
that is used for the MOD® device programming, similar to most medical devices that
have programming ability and database capture.
Q – Can the data from the wireless MOD® device be integrated into the electronic
medical record (EMR)?
A –Since there is no standard hospital EMR, different hospitals use different EMR
systems, so this is done on an institution-by-institution basis. The wireless MOD® device
can be used alone before EMR integration takes place. Even without EMR integration,
the MOD® device still provides a detailed database of each patient’s medication use from
the device including a graphic pain scale chart which reflects all the patient pain scores
at the time of medication administration and the reassessment pain scores patients are
reminded to enter usually one hour after self-administration of a medication. MOD® device data is stored in an MS Sequel database, and relevant MOD® device data can be
integrated into an EMR system using open platform tools or interface engines used by all
EMR providers to integrate devices.
Q – Why is the wristband a security feature of the device?
A – The programmed RFID wristband only recognizes the device to which it was
programmed; it is the only wristband that will activate the device for that particular
patient. Therefore, two people in the same room or unit cannot access another person’s
device with their wristband. Only their device will respond to their wristband.
Q – What if a patient is discharged before all the medication in the MOD® device’s tray
is used?
A – If this occurs the medication is disposed of according to the hospital policy for the
disposal of controlled substances. The facility pharmacy dictates how that procedure is
accomplished and as part of each facility’s medication reconciliation policy.
Q – What are the advantages of the device from a nursing standpoint?
A – The device is a tool to improve nursing workflow efficiency by reducing the time and
number of trips necessary to deliver prn pain medication. With the MOD® device, instead
of the patient waiting on the busy nurse to deliver the medication, the medication is
available at the bedside and waiting on the patient to dispense when they need it
according to the scheduled lockout intervals. In no way is the device use intended to
replace nursing staff. It is a technology to free up time so nursing can spend more time
providing quality bedside patient care.
Q – What if a patient drops a pill or loses a pill while using the MOD® device?
A – The MOD® device is ergonomically designed to make removing a pill from the pill well
easy to do. When the dispenser wheel turns to expose a dose of medication for selfadministration,
the pill is available for removal for 45 seconds, a sufficiently long period of
time so that the patient does not need to rush with removing the medication. However,
there is always the chance that a patient will drop or lose a dose of medication. Should this
occur, follow your hospital guidelines for dropped/lost pills. If you have any doubt the
patient who has dropped or lost the pill is not a good candidate for the device, remove the
device from that patient’s room, discharge the patient from the device, and return to
manual delivery.
Pharmacy Questions
Q – How are the MOD® device trays loaded in central pharmacy?
A – Avancen vends a “quad” manual loader to prepare up to four trays at a time. The
clear disposable medication trays are placed into holders that precisely fit each tray.
Each well is hand-loaded with a single dose of medication. A tray label is applied in the
center of the tray with the appropriate medication information. A barcode is applied if in
use to indicate that an eight-dose tray of the medication is dispensed. Trays are most
often not patient specific – only medication specific so that trays can be stored and used
as needed.
An adhesive seal that comes with the trays is peeled off its backing and applied to the
top of each tray to prevent spillage. If multiple filled trays are prepared at one time, they
can be stored in the CII safe in central pharmacy and then delivered to the unit where
they are stored in the automated dispensing cabinet on the patient unit. The nurse
removes a tray for loading a device as part of a new patient programming process. A
limited formulary of medications is suggested for each unit in order to limit the variety of
trays needed. The medication stored in each tray can be seen through the clear tray
seal. When the nurse who programs the MOD® device loads the tray into the device, the
clear seal is removed and the device cover is closed and locked. The medication label
information can always be read through the clear device top. See “A Pharmacist’s
Guide” on the Avancen website under Resources and Healthcare Professionals.
Q – How does the MOD® device save pharmacy time?
A – There are no projected savings in pharmacy time. However, the trays can be quickly
loaded and labeled after a brief practice session. The time savings for the hospital will
come from increased nursing efficiency and time savings for better patient care. With a
bulk bottle of 200 tabs, 25 MOD® trays can be quickly loaded and stored prior to delivery
to the inpatient unit.
Q – What is the tray material?
A – The tray material is a pharmaceutical grade thermoformable rigid PVC film coated for
pharmaceutical packaging that is commonly used for blister packaging of medications.
Tray seals are a Mylar material with a 3M adhesive suitable for pharmacy use. Additional
specs on the materials for the trays and seals are available upon request.
Q – What expiration date do we put on the medication tray label once it is repackaged?
A – According to U.S. Pharmacopeia Chapter <1146> on Packaging Practice,
repackaged medications can be marked with a one year expiration date provided the
date of expiration is not earlier than one year. Additional discussion of this topic is
available if requested.
Q – What if a patient is discharged without using all the medication contained in the tray?
A – The nurse is responsible for discharging the patient from the device using the MOD® programming software. It is recommended that patients be offered the MOD® device only
if they are anticipated to have at least a 48-hour hospital stay. On average, loaded
medication trays last from 16 to 48 hours depending upon the frequency of medication
removal by the patient. As part of the patient discharge from the device, the device top opens and any remaining medication doses are “wasted” according to the pharmacy’s disposal and medication
reconciliation policy. The empty disposable tray is removed and discarded. This is a
process similar to the “wasting” of opioid medication contained in intravenous syringes or
IV bags removed from the IV PCA device when the device is discontinued. The MOD® Discharge program screen provides for two nurses to witness and document the
discharge from the device and the waste step, and this data is recorded in the MOD® record.
Oral pain medications are usually generic and very inexpensive as compared to the
value of the nursing time saved during the MOD® device use. This time can be directed
towards better patient care.
Q – The device is not tethered to the patient. Is the device jeopardized when the patient ambulates or leaves for physical therapy?
A – Access to the medication in the device can only occur through the patient wristband
registered to the patient-specific device. Someone walking into a room cannot get
access to the medication inside the device. The device can remain in the room if the
patient leaves the room. The device has an on/off switch which also disables it from
being used.
Q – How do you prevent diversion of pain medication when using the MOD® device?
A – Narcotic control and medication reconciliation is an important part of the nursing and
pharmacy process. In addition to having security features on the device itself, the
workflow process of using a MOD® device has several checkpoints required to aid in
preventing diversion. The following steps of the process require a dual RN signature.
Programming the device
Wasting medication at the time of discharge
Replacing a medication tray
Order change in medication (new medication or dose change)
Order change in the lockout interval between doses
The Avancen White Paper entitled “The MOD® Experience after 1,000 Patients”
highlights current users’ findings and can be found on the home page of
www.avancen.com. No medical staff diversion of medication from the device has been
reported to date.
Q – We use several different analgesics, depending on the patient, because different drugs work better for different patients. Will using the MOD® device increase our inventory?
A – Each inpatient unit has a small formulary of oral pain medication ordered prn. The
initial step requires working with nursing in a specific unit, encouraging the use of only
one or two different strengths of a single analgesic or, at most, two medications. Usually,
the problem is not the drug, but sustaining a therapeutic serum level. Implementing the
MOD® system will likely reduce the need for large inventory variety.
Q – How do you know the patient took the drug?
A – Much like an IV PCA, the device is provided to patients who can demonstrate the
cognitive and physical requirements to manage it responsibly. If the nurse has doubts
that the device is not being used responsibly, the device can be removed. See the
Avancen White Paper entitled “The MOD® Experience after 1,000 Patients” which
highlights current users’ findings and can be found on the home page of
www.avancen.com.
Q – We use several different analgesics, depending on the patient, because different drugs work better for different patients. Will using the MOD® device increase our inventory?
A – Each inpatient unit has a small formulary of oral pain medication ordered prn. The
initial step requires working with nursing in a specific unit, encouraging the use of only
one or two different strengths of a single analgesic or, at most, two medications. Usually,
the problem is not the drug, but sustaining a therapeutic serum level. Implementing the
MOD® system will likely reduce the need for large inventory variety.
Q – How do you know the patient took the drug?
A – Much like an IV PCA, the device is provided to patients who can demonstrate the
cognitive and physical requirements to manage it responsibly. If the nurse has doubts
that the device is not being used responsibly, the device can be removed. See the
Avancen White Paper entitled “The MOD® Experience after 1,000 Patients” which
highlights current users’ findings and can be found on the home page of
www.avancen.com.
Q – Does the DEA need to approve the device use?
A – The DEA does not rule on the use of devices that dispense opioids. The FDA is the
ruling agency for medical devices.
Q – Does the device have a double locking mechanism?
A – A double locking mechanism is a specific DEA regulation required for narcotic
storage devices, whereas the MOD® device is a dispensing device as ruled by the FDA.
However, there are several design features that secure the medication including the
double top design that prevents medication theft from the device, use of an RFID
wristband for the patient which precludes anyone else obtaining medication from the
device and dual nurse sign-in recorded in the device program database for any steps
that provide exposure to the medications within the device during tray loading or
discharge from the device.
Q – Do any state pharmacy associations or boards or state boards of health need to
rule on the use of the MOD® device?
A – No – The appropriate agency for the device approval and regulation is the FDA. A
legal opinion in this regard was obtained for the State of New York Department of Health
and the device approval in general. These documents are available upon request.
Regulatory Issues
Q – What is the FDA status of the device?
A –The MOD® device has been classified as a Class I device by the FDA, 510 (K) Exempt. The MOD® device can be found on the FDA website under the listing Establishment Registration & Device Listing or Product Classification: as a Dispenser, Solid Medication, Product Code NXB, Regulation Number 890.5050 and Registered Establishment Name, Avancen MOD Corporation.
Q – Does Avancen have a patent on the MOD® device?
A – The first MOD® device patent was granted by the United States Patent Office in 2006. To date there are five US patents issued on the device, the device medication tray and the device design.
Q – Does The Joint Commission (TJC) have to approve the use of the MOD® device?
A – TJC is aware of the MOD® device and has visited hospitals with the device in use; but the Joint Commission does not have regulatory authority to approve medical devices. As long as the facility maintains a policy and procedure for the safe use of the device, the device can be used with appropriate patients for whom a clinician order is written. The MOD® device is similar to an IV PCA, and policies must be generated to reflect the management of a PCA device.
Q – Does Medicare or Medicaid pay for the MOD® device and/or the medication trays?
A – When the MOD® device is used in the hospital, it is included as an expense of the patient’s hospital stay coded for charges as a piece of equipment used for patient care such as an IV pump or a ventilator. Therefore, Medicare and Medicaid will pay for the MOD® device as part of the bill from the hospital depending upon the Diagnosis Related Group (DRG) for the stay. For other insurance companies, the device is part of the overall bill and does not need individual approval by the insurance company. Medication trays that fit into the device are usually billed as a single charge for the entire tray similar to the billing for a multidose syringe loaded into an IV-PCA pump. From what we understand, most hospitals can only bill for the medications, whether for a PCA pump or an IV pump or the MOD® device. The medication is charged for and the hospital effectively amortizes the cost of the delivery system as part of overhead in treating patients. This would be similar to the use of a Hoyer lift or bariatric commode.
Device Design Functions and Logistics
Q – What kind of battery is in the MOD® device and how long will the rechargeable battery last?
A – Devices should be plugged into a power source during use. If devices need to be unplugged for any reason, there is a battery inside the device that can maintain power until the device is again plugged into power. As a reminder, when a device is unplugged from power a warning beep occurs at spaced time intervals to remind the user to attach the device to power. A second MOD® battery serves as a backup battery to maintain the database within the MOD® until it can be sent to the wireless server which holds all the data for devices within a facility.
Q – How does the Radiofrequency Identification (RFID) system work in the device?
A – RFID technology uses radio signals to exchange data between a reader and an electronic tag. The RFID reader is behind the pain scale on the device and the tags are in the patient wristbands. When the patient wristband is registered into the device during the programming steps, the reader collects the data and stores it to provide exclusive recognition of only that patient for the use of that device. The RFID system used in connection with the device is a low-energy passive system that does not interfere with any other wireless or RFID systems that may be in use in the hospital. The maximum range of the RFID reader is only two inches from the pain scale on the device. The advantage of RFID is that a “line of sight,” which is necessary for barcode validation, is not needed for the tag recognition with RFID use.
Q – How does the wireless MOD® device interact with our computer system?
The MODtrac™ enterprise software is loaded onto a server behind the firewall of the computing network within the facility. This allows access to any device within the facility by signing onto the computer system and then accessing the MOD® programming software according to instructions from the information technology (IT) group within the facility. This software provides the wizard program for programming devices and connecting to any devices to gather information or execute other programs needed for the device use. For integration of data into the Electronic Medical Record (EMR), specific MOD® data elements are uploaded into the EMR database and populate each patient record with medication administration data and pain scores.