A) Optimal Medication Monitor(s) and Method of Retrieving  Adherence Record.

or



Alternative Communication Means are found in Alternative displays for Retrieval of Data from the Monitor This includes Retrieval of  Clinical Data on the Patient.

B) Other Dose Removal Monitors.






Devices That Prove or Come Close to Proving Medication Ingestion

Introduction

A series of devices have recently been developed with the objective of proving the patient has ingested the medication.  While this would overcome the limitation of all previously mentioned medication monitors, that the patient could remove pills from the device on time and ingest none of them, most of these devices have limitations, or would appear to be excessively expensive for use in the developing countries.

Furthermore, the problem of removal without ingestion is probably a relatively minor problem compared with the effort needed to mobilize the resources required for managing the poorly adherent patient detected by any medication monitor. Nevertheless, these devices need to be considered.


X Out TB

In this method, which was designed to “prove” that medication is ingested

1) Patients are given a unique urinalysis test strips that are dispensed every 24 hours from a special dispenser.

2) The strips contain 4 printed numbers with embedded chemicals that turn one of the numbers a new color when they react with the urine of a patient who has taken TB medication.

3) Patients use cell phones to send an SMS to a database reporting the numbers on their strip.

4) They are rewarded with free cell phone minutes for a good record.



Apparent Limitations
 
     1) The system requires that the patient have a functioning cell phone.

    2) Patient must check the urine during the time interval when the
          drug or its metabolites are in the urine (not too soon or not too
          late)
  
      3) Once patient has a positive urine he could keep the urine and
           retest it every day; get repeated positive results without ingesting
           any more medication.

For more details contact Elizabeth Leshen  elesh@mit.edu


Necklace Monitor (In development)

Magnets are embedded in pills. Patient wears a necklace that detects the magnet when the pills are ingested and sends a signal to a cell phone that  the patient wears. The cell phone relays the signal to the caregiver. The system is in development.  

Contact: Mark.Braunstein@innovate.gatech.edu


Fluorescent Pill Wrist Watch Monitor (In development)

A Fluorescent substance is ingested along with the pills. A device worn on the wrist emits a lazar that causes the fluorescence substance to light up. The device on the wrist detects the light and proves medication ingestion.

Contact Leo Einck - leoeinck@sequella.com or
Gary Horwith GaryHorwith@Sequella.com
Sequella Inc.
9600 Medical Center Drive
P.O.Box 1067
Rockville MD 20852
301 762 7776

Networked Pill

Tiny (1mm) digestible microchips are added to each pill. Each microchip transmits a brief distinctive electronic signal when exposed to the moisture in the stomach. This signal is conducted through the body in a manner similar to an EKG signal.  A disposable, “smart band-aid” worn in the epigastric area detects what medication was ingested and the time of ingestion. Data from the “smart band aid” is communicated by wireless technology to the health care system. www.proteusdigitalhealth.com


Limitation.  This Device is probably too expensive for use in most developing countries.

Contact:  athompson@proteusbiomed.com


etect

A Company called etect (http://etectbio.com/) has developed state-of-the-art in vivo telemetry and biocompatible antenna technol­ogy and integrated them into a novel medication adherence monitoring “tag.” This “tag,” called ID-Cap, can be easily attached to existing pills or capsules, and, once ingested by the patient, can be read via a small, wearable or hand-held reader until the ID-Cap dissolves and passes harm­lessly through the patient’s digestive system. The ID-Cap is designed to separate from the drug once it is in the digestive system and to have no effect on the formulation of the compound. The ID-Cap combines ultra-low power integrated electronics and advances in biocompatible materi­als. The reader may use a personal area network such as Bluetooth to connect to a mobile phone or computer, allowing real-time patient data to be integrated into electronic medical records and clinical trial databases. Two key technological innovations make this possible. The first is a novel integrated circuit that utilizes a proprietary, patent pending communications and energy harvest­ing technique to enable a link to external detectors and communication architectures from deep inside the GI tract without an on-board power source. The second is a patent-pending flexible and biocompatible engineered substrate and ink formulation. These innovative materials enable ingest­ible and flexible antennas so that the resulting ID-Cap tag may be wrapped around the outside of a finished capsule to maximize antenna radiation efficiency while minimizing any effect on the pharmaceutical manufacturing.

Limitation.  It will probably be too expensive for developing countries.

Contact
Eric Buffkin, President
eTect
4817 SW 34th St., Ste. 4
Gainesville, FL 32608
Phone: (352) 367-8328 ext. 102
E-mail: eric@etectbio.com


Supervising Medication Ingestion with Videophones

Trials in Washington State, USA (1) (2) and San Diego County, California, USA have demonstrated the feasibility of videophone monitored DOT using landline videophones. While videophones make it possible to visualize that the patient has placed the pills in his mouth, one cannot be sure he has swallowed the medication. However, these trials appear to show that this approach is effective, well received by patients, and substantially less costly than conventional DOT in a developed country like the United States.

A small study in Kenya (3) entitled Mobile Direct Observation Treatment (MDOT) of Tuberculosis Patients Pilot Feasibility Study in Nairobi, Kenya, supported by the Danya International Inc. of Silver Springs, Maryland, USA has extended this approach using video-capable mobile phones. Some technical difficulties and problems with network reliability were encountered in this study and are likely to occur in other developing countries, as well. In addition, video-capable mobile phones are more expensive than simple mobile phones for voice or text messaging. These factors probably limit the practicality of this method of supervising TB medication ingestion in developing countries, but with advances in technology this approach to the adherence problem may become more applicable.
1) Krueger K, et. al, Videophone utilization as an alternative to directly observed therapy for tuberculosis. Int J Tuberc Lung Dis. 2010 Jun;14(6):779-81.
2) DeMaio J, Schwartz L, Cooley P, Tice A., The application of telemedicine technology to a directly observed therapy program for tuberculosis: a pilot project. Clin Infect Dis. 2001 Dec 15;33(12):2082-
3) Hoffman JA, Cunningham JR, Suleh AJ, Sundsmo A, Dekker D, Vago F, Munly K, Igonya EK, Hunt-Glassman, Mobile direct observation treatment for tuberculosis patients: a technical feasibility pilot using mobile phones in Nairobi, Kenya.  J.Am J Prev Med. 2010 Jul;39(1):78-80. Epub 2010 May 26.