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.






Using the Monitor Record to Improve Treatment Outcomes

Use of Monitor Record to Improve Adherence

After hearing the adherence record, the person listening to the record would normally speak to the patient giving praise for a good adherence record or mild reprimands for a poor record while stressing the importance on uninterrupted treatment and letting the patient express his concerns. While this process takes staff time and transmission time that must be paid for, the maintenance of human contact with the patient even though it is only voice contact should prove to be helpful in maintaining rapport and improving adherence of most patients. Furthermore, phone reinforcement of instructions for patients with minor defects in the adherence record would take far less staff time and expense than a home visit

In addition to listening to the adherence record at each transmission session, the clinic would want to keep a permanent adherence record from the beginning of therapy for each patient to decide on the best way to manage patients with good, modestly poor and bad adherence records. Such management could include 1) free mobile phone minutes for good adherence records in addition to praise, 2) mild reprimands for patients with minor adherence defects, 3) periodic home visits to re-instruct the less adherent patient and family, 4) extending the duration of therapy based on the adherence record, and 5) changing the treatment to DOT.

The previous description of using the monitor record to supervise patients is intended primarily for uncomplicated drug susceptible TB patients being treated for the first time. However, as explained in the later section Use of Monitor Record to Supervise DOT Given by a Neighbor, the same medication monitor could be used to supervise DOT given by a neighbor when a neighbor is responsible for observing the DOT. The monitor also has the potential  to improve private sector treatment as discussed in the section immediately below.

Improving Private Sector Treatment

Convincing private physicians to supervise TB therapy is very difficult. Probably this could be more readily achieved if health departments provided FREE medication that was placed in medication monitors by trained and subsidized pharmacists.

Many different persons, such as the pharmacist, the physician, the physician’s assistant or a health department employee could listen to the monitor record sent by mobile phones and counsel the patients as described above. The monitor record could be used to advise the physician, to warn the patient when the adherence was inadequate, and to extend the duration of therapy if necessary.

Furthermore, a grossly inadequate adherence record would provide strong evidence that the health department officials could use in convincing reluctant physicians that the health department should take over the management of the patient and give DOT. If it was found to be necessary, the health department could be given legal power to take over the treatment of a patient that has a grossly inadequate monitor record. The fact that most private patients have cell phones makes this approach to the private physician problem particularly attractive.

Use of Medication Monitor Record to Supervise
Medication Given by a Neighbor

For those patients whose adherence does not improve with counseling or for a patient taking a critical re-treatment TB regimen, strict DOT will be needed. When DOT is given for previously untreated drug susceptible patients, it is usually given at clinics two or three times per week rather than daily to make it easier for the patients to cooperate.  With these regimens multiple problems have still occurred including 1) patients who don’t come in regularly or don’t come in at all for treatment, 2) health workers who record that they gave DOT when in fact they gave the patient a supply of medication to take at home, and 3) patients who send someone else to the clinic to pick up the medication for them.

Most re-treatment regimens for drug resistant disease will have to be given daily. For some re-treatment regimens the DOT needs to be given twice a day.  In view of the alarming increase in rates of drug resistant disease, these re-treatment regimens given by DOT are going to put a heavy load on almost all health departments in developing countries and become very difficult if not impossible for some patients.

To overcome these problems biometric DOT given at various stations surrounding clinics in high population density areas in Delhi India is being investigated. The patients’ fingerprint is recorded with an electronic finger print reader each time he or she is given DOT and sent to the supervising clinic as described in V Biometric DOT.  The cost of the equipment, $500, would be prohibitive in rural areas and probably too high for lesser density urban areas.

In less populated areas the clinics often arrange for a neighbor or community worker to give the DOT to make it easier for the patient to cooperate. However, if paid clinic workers give the patient medication to take home and falsify the record that they give DOT, the same practice could readily occur with Neighbor Supervised DOT. To avoid this problem Monitor Supervised Neighbor DOT could be given.  

Monitor Supervised Neighbor DOT involves a representative from the clinic, together with the patient, choosing a reliable authoritative neighbor to give the DOT from a medication monitor. If the health department had a community worker in the area, the community worker could give the DOT from a monitor.

The process would consist of the monitor being kept at the neighbor’s home, the patient going to the neighbor’s home daily, removing a dose of medication from his or her medication monitor, and ingesting it in the presence of the neighbor. At periodic intervals, the adherence record in the monitor could be transmitted to the clinic in charge of the patient by the neighbor using his or her mobile phone with beeps and tones in the same way a patient taking self-administered medication sends the adherence record to the clinic. For every transmission the neighbor would initially provide the patient’s number that is on the monitor to make sure the adherence record is recorded for the proper patient. When the monitor is empty or almost depleted of all medication, the patient would take the monitor to the supervising clinic for a refill of medication.

This process would provide considerable assurance that the patients came to the neighbor’s and took DOT as prescribed and would provide a record of their adherence. It would provide more evidence than the current practice of simply trusting the neighbor or community worker to give DOT and record that it was given,

However, despite the effort to choose a reliable treatment observer, a few of them may not give the patient DOT.  For instance, the neighbor might let the patient keep the monitor at his or her home.  If the clinic had a phone with ‘”Caller ID,” it should be obvious to the clinic staff that the neighbor was not keeping the monitor if the phone that was used to send the adherence record was the patient’s phone. If the clinic did not have caller ID it should still be evident that the neighbor was not sending the record when the patient identified himself or herself.

While unlikely the patient might keep the monitor and return periodically to the neighbor’s home to send the adherence record. To detect this type of deception, the clinic could make random calls to the neighbor and request that the adherence record be sent. If the patient had the monitor, the neighbor could not send the record and this type of deception could be detected.

Despite all these possible ways the neighbor and patients could avoid giving DOT, using a monitor to provide Neighbor Supervised DOT would create more assurance that DOT was actually given than simply trusting the neighbor or community worker to give DOT, which is now being practiced.

Confidentiality Problem

The use of a neighbor to give DOT will probably be noticed by members of the community, who are likely to conclude that the patient has TB. This would result in an undesirable breach of confidentiality that would be hard to avoid. However, the community’s right to be protected against TB probably outweighs the downside of a breach in confidentiality. Furthermore, informing patients who are taking self-administered treatment that if they are not adherent they may have to go to distant clinic or a neighbor each day to get a dose of medication could serve as a motivation to be more adherent.

Use of Monitor Record to Reduce Defaulting

Patients who default or fail to complete treatment represent a major problem that increases the risk of treatment failure. Finding and returning such patients to treatment can take excessive resources. Medication Monitors could help solve this problem. First, avoidance of multiple visits for DOT will make it easier for patients to continue treatment and reduce the motivation to default. Second, not giving DOT to reliable patients would free up staff time to retrieve defaulters. Third, evidence from several studies shows that poor early adherence records created by medication monitors appear to predict patients who are more likely to default (1), (2), (3). This data could be used to direct additional counseling to potential defaulters and their families, together with careful use of Monitor Supervised Neighbor DOT. Fifth, if a defaulting patient moves to a new location, the data in the monitor would help in planning further treatment.

1) Moulding T S, Caymittes M. Managing medication compliance
of tuberculosis patients in Haiti with medication monitors.
Int J Tuberc Lung Dis 2002; 6: 313–319.

2) Menzies D, Dion M J, Francis D, et al. In closely monitored
patients, adherence in the fi rst month predicts completion of
therapy for latent tuberculosis infection. Int J Tuberc Lung Dis
2005; 9: 1343–1348.

3) Trajman A, Long R, Zylberberg D, Dion M J, Al-Otaibi B,
Menzies D. Factors associated with treatment adherence in a
randomized trial of latent tuberculosis infection treatment. Int
J Tuberc Lung Dis 2009; 14: 551–559.