Pharmaceutical Safety Tracking (PhaST): Managing Medications for Patient Safety

This project evaluated the Pharmaceutical Safety Tracking (PhaST) system, which monitors medication safety in children and adolescents who are taking antidepressants. The use of these medications in this group has grown as significant benefits have been recognized. With known risks of suicidality and manic activation, close monitoring of these individuals is critical. Because of the lack of availability of an automated monitoring system such as PhaST, clinicians are forced to rely on frequent face-to-face office visits to accomplish this. Many families, however, are unable to visit their clinicians at the desired frequency due to financial, organizational, and geographic barriers. These children and adolescents may not receive adequate medication safety monitoring, since those with the least access to services have the least supervision.

A main feature of PhaST is an interactive voice response (IVR) telephony component that automates the monitoring of adherence, side effects, and symptoms. If a problem with a medication is reported by a patient on an IVR call, the system automatically alerts a nurse trained to triage issues who will counsel the patient or their family, contact the patient’s physician, or activate emergency services as warranted. The main objectives of this project were to:

• Determine whether PhaST is superior to usual care on measures of system process.
• Determine whether PhaST is superior to usual care on measures of patient and provider outcomes.

The project evaluated PhaST via a randomized clinical trial that compared the use of the automated system to usual treatment. Participants included families with children aged 6-17 years who were newly prescribed an antidepressant. On average, those families randomized to the PhaST arm received approximately seven IVR screening calls over a period of 3 months. During the calls, respondents were asked eight screening questions that focused on potential side effects of their medication, medication adherence, worsening of clinical state, suicidality, and unusual changes in behavior.

The PhaST system was able to reach its targeted rate of followup supervision. Significantly higher rates of mental health problems were reported by study families to PhaST. The information collected increased the amount of information available to clinicians on the mental health condition of their patients without burdening them with additional tasks.