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
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
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
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
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
Q – Does a bell ring to remind the patient when they are able to get a pill out of the
- 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
- 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