Joined by a contingent of Vermont mayors and Health Commissioner Harry Chen, MD, Governor Peter Shumlin announced Thursday 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 in a form without abuse-deterrent formulation, in controversial decision by the Food & Drug Administration (FDA). The approved drug is manufactured without an abuse-deterrent formulation (ADF) or other tamper-proofing technology. ADFs make drugs less likely to be abuse or diverted.
In addition, the governor released a letter signed by all six New England Governors to Canadian Ambassador Gary Doer, strongly urging Canada to adopt abuse-deterrent formulations of prescription opioid pills like oxycodone. Those deterrent formulations, which make such drugs significantly more difficult to crush or liquefy, and therefore less prone to abuse, are in place in the United States. The governors are concerned about the potential for abuse of the Canadian drugs that make their way into the US.
“It is critical that we locally, at the state level, across the US, and even across national borders do everything within our power to stem the growing opiate and heroin addiction that is now acknowledged to be a national challenge,” Governor Shumlin said.
“At a time when our governments are working toward mutual recognition of regulatory frameworks, this step would greatly aid our work together to confront the problem of opioid addiction,” the governors wrote to the Ambassador. “(Abuse deterrent formulations) measures are proving to be an effective tool and, in combination with comprehensive approaches to prevent and treat opioid addiction, these measures could lead to better control of this tragic epidemic that is affecting both our nations.”
The letter was signed by Connecticut Governor Dannel Malloy, Maine Governor Paul LePage, Massachusetts Governor Deval Patrick, New Hampshire Governor Margaret Hassan, Rhode Island Governor Lincoln Chafee, and Governor Shumlin.
Vermont’s Mayors, sharing the commitment to protect their residents from the deadly effect of drug addiction and their communities from the crime that accompanies drug abuse, have led the fight against hydrocodone drugs like Zohydro, which can be up to 10 times more powerful than other opiates. Hydrocodone is an opioid derivative of codeine; the FDA approved the drug over objection of its own scientific advisory committee without requiring that it be made tamper-proof or in a form that deters abuse.
In March, Shumlin and the state’s mayors called on Food and Drug Administration Commissioner Margaret Hamburg to withdraw the FDA’s approval of Zohydro ER. While the Governor and mayors said today they continue to support a ban on these powerful and potentially dangerous drugs, they wanted to ensure immediately that Vermont would have in place stringent rules to control the prescribing of hydrocodone and educate physicians about the potential for abuse.
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.
“This is a powerful and effective painkiller, but experience tells us that the potential for abuse and diversion is a great danger to those who take this drug, here and elsewhere,” Shumlin said. “We urge the FDA to take a much harder look at whether this drug should deserve approval at all. These drugs can easily be manufactured to minimize the danger, and there is no reason to accept less. Today we are sending a message to drug manufacturers and the FDA to do everything possible to reduce the risks of addiction for our citizens."
“In the midst of this public health crisis, there is every reason to take action,” said Dr Chen. “Hydrocodone may be the best hope for managing severe pain for a minority of patients but, in its current formulation, is also easily abused or accidentally taken, with deadly consequences. The purpose of this rule is to ensure that physicians prescribe only when there is no reasonable alternative, that they fully inform patients of the risks and use the Vermont Prescription Monitoring System to prevent misuse, abuse and diversion.”
Last week, Governor 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.”
To read the complete text of the rule, visit: http://healthvermont.gov/regs/documents/hydrocodone_emergency_rule.pdf
Source: Shumlin's office 4.3.2014