State moves to regulate high-dose painkillerApril 03,2014
Gov. Peter Shumlin announced today that the Health Department has issued an emergency rule to tightly restrict how health care providers prescribe certain hydrocodones such as Zohydro, a high-dose narcotic painkiller approved last year by the Food and Drug Administration.
The approved drug is manufactured without an abuse-deterrent formulation or other tamper-proofing technology, according to a press release issued Thursday by the governor's office, adding, abuse-deterrent formulation make drugs less likely to be abuse or diverted.
Shumlin made the announcement at a press conference this morning in Barre alongside Health Commissioner Harry Chen and several mayors from across Vermont.
Among other restrictions, the new rule requires prescribers to:
* Conduct and document a thorough medical evaluation;
* Conduct and document a Risk Assessment;
* Document in the medical record that the prescription of a hydrocodone without an ADF is required for the management of pain (i.e. nothing else will effectively manage the severe pain);
* Receive a signed Informed Consent form including information from the drug insert;
* Receive a Chronic Controlled Substance Treatment Agreement that shall include conditions such as urine screening, pill counts, safe storage and disposal, and other appropriate conditions as determined by the prescriber;
* Query the Vermont Prescription Monitoring System;
* Determine a maximum daily dose, or a “not to exceed value” for the prescription to be transmitted to the pharmacy; and
* Schedule and undertake periodic follow-up visits and evaluations and referrals.
Last week, Gov. Deval Patrick of Massachusetts declared a public health emergency in his state and issued an outright ban on the prescription and dispensing of on such drugs until the Commissioner has determined that safeguards against diversion are in place.
Chen said Vermont would closely monitor the situation in Massachusetts, but for now, "We are looking to our health professionals to be thoughtful and judicious in their use of such prescriptions."
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