e-Pharmacovigilance II - Surveillance for Safety and Effectiveness - Calling for Earlier Detection of Adverse Reactions

The study team has wide experience surveying primary care patients about medication
problems, and has established that this is an important component of detecting and
understanding ADEs among ambulatory patients. In the first study, 18% of primary care
patients reported a problem due to a medication during the previous year, but this was
documented in only 3% of medical records. A subsequent study found that 27% of patients
reported a medication-related symptom, but that only 69% of patients discussed this symptom
with their physician. Upon being notified via this automated pharmacovigilance, physicians
changed therapy in response to 76% of these symptoms, and 21% symptoms that had not been
previously discussed resulted in a preventable ADE and 2% resulted in a preventable ADE.

During the prior CERT, the investigators developed an interactive voice response system
(IVRS) that interoperates with the health system EHR, and demonstrated that IVRS can be used
to monitor ambulatory patients to assess adherence, medication related symptoms, and ADEs.
This study builds on that initial work.

The safety of prescription drugs represents an ongoing public health concern. A study by the
US General Accounting Office (GAO) found that 51% of all approved drugs have at least one
serious ADE that was not recognized during the approval process, reflecting the careful
selection and limited number of patients who participate in pre-approval trials. While
pre-market studies detect commonly occurring ADEs and efficacy in rigorously selected
participants, they are not designed to assess safety and effectiveness in the broader
population of eventual users. While the FDA maintains a passive adverse event reporting
system, it is estimated that only about 1% of all ADEs and 10% of serious ADEs are reported,
and these case reports lack accurate denominators to estimate incidence. While efforts are
underway to substantially expand capacity for active surveillance using electronic health
records and claims data, these data may not fully capture the patient experience, as
clinicians often do not fully document patients' symptoms.

Accurate ascertainment of ADEs and effectiveness in clinical practice requires real-time
systems that integrate patient-reported information with clinician decision-making.
Telephonic IVRS are a low-cost, sustainable way of reaching out to primary care populations,
independent of a visit. In addition to monitoring for ADEs, this technology could be used to
systematically assess treatment outcomes that are not commonly documented in the medical
chart such as functional status, sleep, and mood.

This 5 year project will have three phases: (1) development and pilot testing of the
integrated pharmacovigilance system; (2) implementation; and (3) assessment of the
translation and dissemination of the system, including data collection from both patients
and providers. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance)
conceptual model provides a framework to examine the success of translation and
dissemination of this system, and will be used for the third phase of the project.

Inclusion Criteria:

- receives primary care at one of the Brigham-affiliated ambulatory care clinics

- has received a new prescription for an oral agent to treat diabetes, hypertension,
depression, or insomnia

- prescribed new target drug within last month by a provider at one of the
participating clinics

Exclusion Criteria:

- not a true "new start," i.e. patient new to clinic/health system

- patient prescribed the drug for short term use, i.e. less than a week's dose

- patient prescribed same drug less than 2 years prior