When docs go electronic, they report more side effects

Electronic patient records have been hailed as a way to control healthcare costs and improve care. They might help the FDA do a better job, too. A small, Pfizer-sponsored study at two Boston hospitals found that, over a five-month period, a group of doctors reported 217 drug side effects to FDA using electronic records, compared with none the previous year.

The patient-record system used at Massachusetts General and Brigham & Women's hospitals was set up to help. When one of the doctors recorded that a patient had stopped using a drug because of a side effect, the system generated an alert. That alert prompted the doctor to describe the side effect, and then submitted a report to regulators.

About one-fifth of those reports involved serious side effects, such as hospitalization, the Wall Street Journal reports. Lead researcher Dr. Jeffrey Linder is trying to expand use of the alert system throughout both participating hospitals, and to other medical systems as well.

Adverse event reporting is questionable right now. It relies on doctors, patients and drugmakers to take the initiative and report a side effect voluntarily. Regulators have tried to encourage reports by requiring pharma ads to include the FDA's side-effects hotline. The agency also has launched efforts to scour insurance databases for potential drug side effects. Electronic patient records aren't yet in widespread use--and as Linder's efforts show, they don't all prompt docs to report those side effects.

- read the WSJ piece

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.