B) Stack Type Medication Monitor for Global Drug Facility Packages (In development)
Figure 1 shows the 4x7 package of the four drug combination caplets distributed by the WHO’s Global Drug Facility (GDF) and how it can be broken into strips of 2, 3, 4, or 5 packages.
Figure 2 shows the back side of the medication monitor and Figure 3 the front side.
As shown In Figure 2, the back of the monitor has a hole at its lower right hand corner which offers access to one end of a strip of medication packages. This strip contains the next dose to be dispensed. To begin dispensing this dose, the patient inserts one finger into the hole . This pushes one portion of this strip of medication packages forward part of the way out of the dispenser through the medication removal slot in the front side of the monitor, as shown in Figure 3.
As shown In Figure 2, the back of the monitor has a hole at its lower right hand corner which offers access to one end of a strip of medication packages. This strip contains the next dose to be dispensed. To begin dispensing this dose, the patient inserts one finger into the hole . This pushes one portion of this strip of medication packages forward part of the way out of the dispenser through the medication removal slot in the front side of the monitor, as shown in Figure 3.
The four-drug combination used in the initial phase of therapy is oblong and oriented diagonally in the package leading to a stable stack. The two-drug combination tablet distributed by the GDF used in the continuation phase of therapy is ovoid and may not lead to a stable stack. Furthermore, the two-drug combination comes in smaller packages.
Figure 6 shows how an adapter could be used to use the device for the two drug combination during initial clinical trials. The adapter has a slot for the package blisters and a recess for the flat portion of the strip. Strips that are 2, 3, 4, and 5 packages long can be placed in this slot.
Figure 6 shows how an adapter could be used to use the device for the two drug combination during initial clinical trials. The adapter has a slot for the package blisters and a recess for the flat portion of the strip. Strips that are 2, 3, 4, and 5 packages long can be placed in this slot.
Since the thickness of the two drug combination is only slightly more than ½ the thickness of the four drug combination the device could dispense a 28-
If field trials with adapters show that the device improves clinical results, the drug companies that provide the medications for the GDF could be asked to place their medication in rectangular packages like that shown in Figure 7.
In Figure 3 a strip of packages partially protrudes from a horizontal slot that is long enough that five packages of the four-drug GDF combination caplet could be removed through the slot. In this image one side of a strip of four packages has been pushed forward. This allows the patient to grasp the exposed portion of the package and completely remove it.
It should be noted that this means of removing medication may be less likely to attract a child to play with the device and create an inaccurate record of pill removal than devices that have covers, knobs, sliders, or tabs for medication removal.
Figure 3 also shows a vertical slit which allows the patient to see how much medication remains in the dispenser. This will help the patient return on time for a refill before he runs out of medication.
Figure 4 shows the inside of the device with a stack of strips containing the four drug GDF caplets with four caplets per strip. The device will hold a 16-day supply of the four drug GDF packages. This is an appropriate supply for the initial phase of therapy. On top of the stack is a compression plate that is forced downward with a spring located over a fixed guide rod on the left hand side of the image.
It should be noted that this means of removing medication may be less likely to attract a child to play with the device and create an inaccurate record of pill removal than devices that have covers, knobs, sliders, or tabs for medication removal.
Figure 3 also shows a vertical slit which allows the patient to see how much medication remains in the dispenser. This will help the patient return on time for a refill before he runs out of medication.
Figure 4 shows the inside of the device with a stack of strips containing the four drug GDF caplets with four caplets per strip. The device will hold a 16-
On the right hand side of the image is a positionable guide rod that runs through a slit that extends the length of the compression plate. The rod is used to adjust the space in the monitor for strips of 2, 3, 4, or 5 GDF packages.
To make this adjustment the compression plate would be rotated forward, toward the viewer in this image. The rod would then be moved in the slot in the compression plate until it overlies the appropriate vertical slots at the top and bottom of the device corresponding to the length of the medication strip being dispensed. The rod is then moved into the appropriate slots by rotating the compression plate into the position shown in figure 4.
The compression plate has a tab extension, which engages a hole in the top of the case to hold the compression plate at the top of the device while it is being filled with medication. This makes it easier to fill the device. To ensure that the compression plate acts on the stack during use, the case cannot be assembled while the tab is engaged in the hole.
To make this adjustment the compression plate would be rotated forward, toward the viewer in this image. The rod would then be moved in the slot in the compression plate until it overlies the appropriate vertical slots at the top and bottom of the device corresponding to the length of the medication strip being dispensed. The rod is then moved into the appropriate slots by rotating the compression plate into the position shown in figure 4.
The compression plate has a tab extension, which engages a hole in the top of the case to hold the compression plate at the top of the device while it is being filled with medication. This makes it easier to fill the device. To ensure that the compression plate acts on the stack during use, the case cannot be assembled while the tab is engaged in the hole.
At the bottom left hand corner is a hinged plate, which acts on a switch (not shown) to detect the removal of medication. As a strip of medication is removed the hinged plate jumps up briefly to close the switch until it is pushed down by the next overlying strip.
Figures 2 and 4 demonstrate how the two portions of the case are kept together after the device is filled. Figure 2 shows 8 tabs on the outer case of the device. These tabs interact with rounded projections on the inner case to keep the two halves of the case together. Two of these rounded projections can be seen at the bottom of Figure 4. For the caregiver to open the device all medication would first have to be removed. Then, while grasping the top of the device with one hand, the caregiver could insert a finger into the hole on the backside of the device and push on the front portion of the case to separate the two halves. While a patient could use this sequence of steps to open the case, it is unlikely that they would learn how to do it, especially since this would require removing all medication from the dispenser.
The height of the fully compressed spring in the prototype dispenser shown above adds significantly to the overall size of the dispenser. The dispenser could be made smaller by using a constant force spring, as shown in Figure 5, to apply force to the compression plate rather than using the coil spring.
Figures 2 and 4 demonstrate how the two portions of the case are kept together after the device is filled. Figure 2 shows 8 tabs on the outer case of the device. These tabs interact with rounded projections on the inner case to keep the two halves of the case together. Two of these rounded projections can be seen at the bottom of Figure 4. For the caregiver to open the device all medication would first have to be removed. Then, while grasping the top of the device with one hand, the caregiver could insert a finger into the hole on the backside of the device and push on the front portion of the case to separate the two halves. While a patient could use this sequence of steps to open the case, it is unlikely that they would learn how to do it, especially since this would require removing all medication from the dispenser.
The height of the fully compressed spring in the prototype dispenser shown above adds significantly to the overall size of the dispenser. The dispenser could be made smaller by using a constant force spring, as shown in Figure 5, to apply force to the compression plate rather than using the coil spring.
TITLE PAGE and ABSTRACT
Background and Optimal Requirements for Medication Monitors for TB Treatment
I. Cover and Cap Opening Monitors
II. Dose Removal Monitors
Background and Optimal Requirements for Medication Monitors for TB Treatment
I. Cover and Cap Opening Monitors
II. Dose Removal Monitors
A) Stack Monitor for Packaged Medication
As of July 2010 we believe this will prove to be the most practical Medication Monitor
B) Strip Package Monitor
C) Clip Monitor for WHO's Packaged Medication
D) Multi-
E) Trace Sheet Monitors
F) Alternate Means for Providing Moisture Protection
III. Dose Removal Monitors Developed by Other Groups
A) E-
B) U-
IV. Devices That Prove or Come Close to Proving Medication Ingestion
A) X Out TB
B) Necklace Monitor
C) Fluorescent Pill Wrist Watch Monitor (In development)
D) Networked Pill
E) E-Tect
F) Video Phone to Monitor DOT
B) Necklace Monitor
C) Fluorescent Pill Wrist Watch Monitor (In development)
D) Networked Pill
E) E-
F) Video Phone to Monitor DOT
V. Display incorporated into the monitor
VI. Means to instruct and remind the patient
VII. Retrieval of the adherence record
A) Direct Communication with Computers
B) Using a Dot Matrix Display to determine the battery status
C) Using a Dot Matrix display to retrieve the adherence record
D) Using a single red/green LED for summary adherence record and battery status
E) Use of 2-digit display for reviewing battery status and adherence record
F) Communicating by Mobile Phones
B) Using a Dot Matrix Display to determine the battery status
C) Using a Dot Matrix display to retrieve the adherence record
D) Using a single red/green LED for summary adherence record and battery status
E) Use of 2-
F) Communicating by Mobile Phones
Assuming that clinical trials show the device to be practical, the drug companies should be willing to do this, in order to keep the GDF business. Furthermore, this type of package should be easier to adapt to HIV drugs and any new TB drugs which are introduced in the future.
The electronic and display elements have been described in the section
Display incorporated into the monitor
Newer display elements are being developed.
Display incorporated into the monitor
Newer display elements are being developed.
