The purpose of this website is to present the status of development of a wide variety of portable electronic medication monitors that could be used to supervise the self-administered treatment of tuberculosis and perhaps AIDS. The discussion includes both commercially available devices and various designs of potential medication monitors, to allow investigators and funding sources to chose the optimal device for their needs and encourage inventors to develop improvements.

For those with limited time we suggest you click on the link Cover and Cap Opening Monitors and scroll down to Figures 1 and 2, which depict the simplest medication monitor.

After viewing the device, scroll up to the written material entitled 'Use of the Display by the Caregiver' which describes how an inexpensive  (16¢) built in LED display could be used to retrieve the adherence record in any location without computers or PDAs.

One company, Applied Minds, is particularly interested in developing these devices.  The contact person is:

Abstract:

In contrast to previous recommendations New International Standards no longer require directly observed therapy (DOT) for all TB patients, but state practitioners must be capable of assessing adherence and addressing poor adherence when it occurs. This removes much of the burden that DOT imposes on both patients and treatment delivery systems. However, the new recommendations may lead to treatment failures and drug resistance because consistent accurate assessment of adherence is at best problematic. Electronic medication monitors, devices that determine when medication is removed from a container, could significantly help overcome this problem even in poor developing countries. For extensive use in developing countries, monitors could be further refined and mass-produced to reduce cost. Both health facilities and community workers could dispense drugs for self-administered treatment (SAT) in medication monitors and retrieve the adherence record with inexpensive built-in displays. These devices could keep the adherence record from the beginning of therapy for managing patients who move. Pharmacists using medication monitors could provide surveillance of SAT prescribed by private physicians with less adherent patients referred to health departments. Health departments could oversee Family Member DOT with these devices.  Less adherent patients could be managed with focused counseling, DOT when necessary, and extensions in treatment duration. Removal of the DOT burden would encourage patients to seek free, high quality supervised pubic care and help expand effective TB treatment services.  If the resources saved by giving less DOT were focused on less adherent patients and defaulters, medication monitor based programs should create less acquired drug resistance than programs that attempt but are overwhelmed by giving DOT to all patients.

For a more detailed discussion of these issues go to the last section in the website entitled.

Adapting to New International TB Treatment Standards with Medication Monitors and DOT given selectively

or contact Dr.Moulding at: tmoulding@earthlink.net

Key Words:
Adherence Monitors, Compliance Monitors, Medication Monitors,  Tuberculosis Treatment,  Directly Observed Therapy (DOT), Self Administered Therapy (SAT),
Self Supervised Therapy (SST)
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Considerations in Choosing the Optimal Medication Monitor Design
 
This website describes a variety of medication monitors for TB medications. The choice of a preferred design will depend on a variety of factors:
 
1) It is very desirable for the device to be compatible with the packaged medication dispensed by WHO's Global Drug Facility (GDF).
 
The packaged medication it distributes protects the medication against ambient moisture and is becoming the standard for what should be distributed worldwide.
 
The GDF distributes Fixed Dose Combinations (FDCs) of several different drugs in one pill. The ratio of the individual drugs within the combination is chosen so the dose can be appropriate for individuals of varying weights by providing the patient with the appropriate number of pills (2, 3, 4, or 5) to be taken at each dosing time based on his or her weight.
 
Except when toxicity forces the clinician to use a non standard regimen, a four drug fixed dose combination of isoniazid (INH), Rifampin (RMP), pyrazinamide (PZA), and ethambutol (EMB) is usually given in the initial phase of therapy, and a two-drug combination of INH and RMP in the continuation phase of therapy. If the dispenser that is chosen does not use the GDF's moisture proof packaging, there would need to be another means to exclude moisture at least when dispensing the four drug combination which incorporates the hygroscopic medication ethambutol.
 
The Cover Opening Monitor and the Clip Monitor for WHO's packaged medication were designed for to accommodate strips of medication derived from GDF's standard blister pack cards for all regimens.
 
The Stack Monitor could use strips derived from GDF's standard blister pack cards for the initial phase of therapy, but would require a different package for the medications given in the continuation phase of treatment.
 
The Strip Packaged Monitor, which has certain advantages, would require a different type of package.
 
2) It would be best to have a device, which determines when each dose of medication is removed.
 
The Clip Monitor, the Stack Monitor, and the Strip Monitor achieve this.  However, a less complex device which determines when the cover of a container is opened may prove to be adequate even though it does not tell how many doses are removed when the cover is opened.  The Cover and Cap Opening Monitor described in this material should be the least expensive of all devices to construct, easier to fill than other dispensers, and mechanically robust.
 
3) The device should minimize the likelihood that children or adults will play with it.
 
4) It should be possible for the caregiver to obtain information from the monitor without additional hardware.
 
In many settings, especially in remote rural settings or at the patients home it would be desirable if the adherence record could be read by the caregiver without a computer or PDA, since these devices are often not available, non-functioning, lost or stolen. Various types of built-in-displays are described in the section, Displays Incorporated into Compliance Monitors. The least expensive would be a 16¢ red/green LED.

Still, it will also be desirable for the monitor to have the capability of transferring data to a computer or PDA.  This would permit the health care delivery system to readily keep the adherence data on all of their patients.  This could be accomplished by some type of port, by RFID transmission, or through an optical coupler using the monitor's red/green LED.
 
5) It would be desirable for the monitor to provide a convenient reminder function.
 
It is often suggested that a medication monitor should have a beeper to remind the patient to take medication. However, if the patient is not home and the beeper annoys the family, a family member could remove medication to turn off the beeper, creating a record of adherence even though the patient failed to take the medication. Providing the beep tone infrequently, like every 15 minutes could minimize the chance that the family would be annoyed. Arranging for the beeper to not beep during the day and start beeping in the evening abound 10:00 PM if the patient had not taken medication that day would increase the chance that the patient would be home to take the medication and reduce the chance that the family would be annoyed.

Using the LED as a reminder would be less obtrusive.  Having it flash for short period of time, like 1/2 second every 5 seconds, would  increase the chance that the patient would notice it. The LED would only work if the monitor were within sight of the patient, rather than in a drawer or a different room. Both the beeper and the LED would require additional power possibly requiring a larger battery or more frequent changing of the battery. Intermittent beeping and intermittent flashing of the LED would reduce the power requirements.
 
6) The monitor should be simple in order to minimize cost.
 
7) The monitor should be robust to minimize mechanical failure.
 
8) The device should be easy to fill by the caregiver.
 
9) The batteries should have a long life.
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TABLE OF CONTENTS

TITLE PAGE and ABSTRACT

POTENTIAL AND EXISTING MEDICATION MONITOR DESIGNS

 I.   Cover and Cap Opening Monitors

 II.  Dose Removal Monitors

DISPLAYS INCORPORATED INTO COMPLIANCE MONITORS