Pharmacy Questions

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.