Imagine you're a pediatrician. As you check on some of your patients waiting to see you, they all seem healthy and happy. You answer their questions and find out that they aren't sick, despite what the charts tell them. A new medical resident walks in and tells you that this is due to an error: The medical records database has been transferred to a new system so it is wrong about one of the patients' allergies — but because it's your shift change, things will stay as-is until tomorrow morning at 8am when the shift changes again. Now, here's the kicker: If you go ahead and treat the patient regardless of theerror, you could be breaking federal law . You can get in serious legal trouble for treating a patient without their consent after the transfer. Sounds like a crazy scenario? A recent regulation by the U.S. Food and Drug Administration (FDA) makes it even crazier. The FDA just imposed new restrictions on physicians that may result in many of them being unable to legally provide care to patients without forming written consent after they get off shift. The regulations are oddly named "The Physician Consent Requirement Policy. " The new policy was originally created in 2000, but has been rewritten with the tightening of regulations on pediatricians. Many of these regulations are based on the Physician's Desk Reference (PDR) of 1996, where they are called "Mandated Reporting Subpoenas" . This is a classic example of making things more complicated rather than getting them done . It is particularly tough on pediatricians because there are still many patients who don't have their medical records transferred over to the new electronic system. As you can imagine, those records include agreements about medications, allergies and other conditions that might not be found in the computer files. The most notable part of the regulation is an example: It is determined that the following medication is to be administered to a patient with a known hypersensitivity: vancomycin. The patient's medical records show an allergy to vancomycin. A physician treating the patient in the physician's office at any time on or after 8 a.m., on May 1, 2003, must obtain written informed consent from the patient or from a person who is authorized by law to provide consent for the patient before administering vancomycin. This means that if you are treating a patient based on the chart's information, you could get into big trouble. The FDA has even included specific instructions to physicians about how to handle this situation: A physicians can treat or provide services to a patient after 8 a.m., on May 1, 2003, without written informed consent if one of the following applies: \t If this seems like an extreme move by the FDA, think again. They state that it is their policy to "protect patients" . One way they will supposedly accomplish this is by requiring prior permission for "sensitive procedures" (such as the above-mentioned vancomycin).
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