Posted 05 February 2016
By Michael Mezher
A recent study funded by the US Food and Drug Administration (FDA) found that an iPod Touch-based platform and FDA's Sentinel system could be used to accurately track the safety of drugs and vaccines dispensed during public health emergencies.
The platform, called the handheld automated notification for drugs and immunizations (HANDI), uses an application running on an iPod touch, fitted with a card reader and barcode scanner, to record patients' information from a driver's license.
The goal of the study was to determine whether information gathered using the platform could be matched to electronic health records (EHR) within FDA's Sentinel database as a means of monitoring the safety of medical products used in public health emergencies.
FDA refers to products, including drugs, biologics, medical devices and diagnostics, used in public health emergencies (both manmade and naturally occurring) as medical countermeasures (MCM).
During a public health emergency, MCMs may be deployed before there is sufficient evidence for them to be approved for a specific use. For example, a vaccine that has only been studied in adults may be used to treat children, or an experimental drug could be used to treat patients when no approved treatments exist.
FDA has specific powers to authorize medical products for emergency use under the Food, Drug and Cosmetic Act (FD&C Act), and has recently granted emergency use authorizations to experimental products to treat or diagnose diseases including Ebola, H7N9 Influenza, Anthrax and Middle East Respiratory Syndrome (MERS).
When MCMs are used, health authorities have to monitor their use so that safety and efficacy can be determined. However, because MCMs may be dispensed outside of traditional healthcare settings, recording accurate patient information can be challenging.
To test whether HANDI could be used effectively, researchers recorded patients' information by scanning their driver's licenses and photographing their insurance cards when they checked in for appointments or arrived to get their seasonal flu shot. For patients receiving a vaccination, researchers also collected detailed information, such as vaccine type, lot number, dose, and manufacturer, for the vaccine they received.
The study found that nearly 90% of patients could be matched to their EHRs. Additionally, it took just over a minute on average (62 seconds) for researchers to collect the data in a timed sample for 25 patients.
All 21 patients who received a vaccination were matched with their EHRs, and the data collected about the vaccine they were given was 86% accurate.
In total, 431 patient participated in the study, while 33 who were asked to participate declined. Of the 431 participants, 10 were excluded because the pictures taken of their insurance cards were illegible.
Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance