86% of Medical Error Goes Unreported

Hospital incident reporting systems were informed of only 14% of errors that harmed Medicare patients, according to this report on a recent survey undertaken by the Department of Health and Human Services Office of Inspector General. Hospital staff didn't perceive 61% of adverse events as reportable. Another 25% were classified as of a type commonly reported, but somehow not reported this time.

Remember what the Institute of Medicine told us, back in 1999, about how we ought to be dealing with medical errors? We're supposed to report them all, in a blame-free atmosphere, in order to gather information that will help us change the systems which give rise to them. The idea was that we'd make more progress by reporting error in this blame-neutral way than by either a) covering the error up or b) blaming error on particular human beings. The basic assumption was that most medical error resulted from flawed systems (training systems, oversight systems, information systems, and so on) which put hospital staff at predictable and preventable risk of making mistakes.

Some progress has been made. But this latest report shows how very far we have to go. A 14% reporting rate is absolutely dreadful, particularly because this is the report-rate for events that actually harmed Medicare patients. The IOM's goal was that not only harmful errors, but also "near-misses"--events that could have harmed patients, but luckily didn't--should be reported.

The Inspector General recommends that the government establish a list of reportable events, so that there's clarity about what needs to be reported and what doesn't; and that CMS (the Medicare agency) cooperate with accrediting bodies like the Joint Commission to establish review of hospital reporting procedures. Accrediting bodies currently tend to concentrate on what's done with reported information, rather than on the accuracy and breadth of the reporting process itself. That clearly needs to change.

Plan B Availability Blocked by Sebelius

FDA Commissioner Margaret Hamburg has just released a statement on the FDA's plan to allow the emergency contraceptive Plan B to be sold over-the-counter to women and girls of all ages. FDA found the drug safe and effective for emergency contraceptive use, over-the-counter, for all women and girls of child-bearing potential. But then--this morning--came the politics. From Hamburg's press release:

"[T]his morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17."