More drugs.

According to the Philadelphia's "The Inquirer", Medical advisers to the FDA have recommended approval of a new abuse-deterrent formulation (ADF) opioid named Arymo ER by Egalet Corp. In fact, the vote was overwhelming; 18-1. This new painkiller is an extended-release morphine that comes in 15mg, 30mg and 60mg doses. A final decision by the FDA on that recommendation is expected by mid-October.
When compared to MS-Contin, a pharmacologist with the FDA reportedly said ...
The numerical difference or outcome in the data was less than 5 percent, raising a question about Arymo's "clinical relevance"
I applaud the concept of abuse-deterrence formulations of opioids and other dangerous drugs that can be abused. I appreciate the fact there truly are some people that need opioids for "before/during/immediately after surgery, cancer, AIDS/HIV, end-of-life care" (my broadbrush interpretation of appropriate use of opioids). I agree abuse (non-medical use) is rampant with opioids (and other dangerous drugs). I am an "all of the above" (all options on the table) kind of person when it comes to resolving our painkiller epidemic, and I do think ADF has a part to play.
But to me the bigger problem is ... legitimate prescriptions by legitimate prescribers used legitimately by patients that are clinically inappropriate. Especially for the mostly inappropriate treatment of chronic pain.
So is the introduction of a new drug just propping up bad practice? Is Big Pharma using ADF to maintain their revenues (will Arymo be a money-maker)? Will we see abuse of non-ADF drugs decline? Will we see prescriptions change from non-ADF to their ADF equivalents? Will we see generics (the majority of drugs prescribed & dispensed) also become ADF? As usual, I have more questions than answers.

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Contact Neil O'Toole and John Sbarbaro

at the Law Office of O'Toole & Sbarbaro, P.C.

Phone: 303-595-4777

Located in the Denver Metro area.

226 West 12th Avenue Denver, Colorado 80204

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Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.

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Bill Creating Clear Guidelines In Dispensing of Opioid Medications to Be Introduced in New Jersey Senate

By National Workers Compensation Defense Network (NWCDN) 10/02/2013 12:39:00

Opioid medications have become a major problem in the New Jersey workers’ compensation system.  The number of workers being prescribed opioids has increased dramatically along with other attendant issues, such as addictions to the medications, excessive periods of use, and large numbers of unused opioid pills.  Every workers’ compensation professional can attest to these and other problems with opioid medications, including cases where urine testing shows no trace of opioids in the system despite repeated renewals of prescriptions.

            A draft of a bill to be introduced in the New Jersey Senate proposes that medical expenses shall not include coverage of opioid drugs unless the prescribing doctor does the following:

            1) takes a thorough medical history and physical examination focusing on the cause of the patient’s pain;

            2) does a complete assessment of the potential addiction of the patient to opioids, which would include a baseline urine test and assessment of past and current depression, anxiety disorders and other mood disorders associated with risk of opioid abuse;

            3) provides a written treatment plan with measurable objectives, a list of all medications being taken and dosages, a justification for the continued use of opioid medications, a description of the pain relief from the medications, documentation of attempts at weaning, a description of how the patient responds to the medication, and alternative treatments under consideration;

            4) provides a description of either sustained improvement in function and pain reduction or consultation with a pain management specialist (if the dosage exceeds 120 mg morphine-equivalent dose or if the duration of treatment exceeds 14 days);

            5) provides an explanation to the patient of the risks and benefits of the prescribed medications and expected duration of treatment.

            The Act will allow an employer, carrier or TPA to disqualify any physician from its network who fails to provide such documentation.  If approved, this Bill would be a major step forward for the New Jersey workers’ compensation system.  New Jersey is a member of the National Prescription Drug Monitoring program, which allows physicians to check on an electronic database for prior or current prescriptions for controlled substances before dispensing narcotic pain medication to a patient. 

The PDMP program along with this proposed bill would go a long way to curb the abuse of opioid medications in workers’ compensation, often among patients who have a history of problems with opioids and other controlled substances.  The bill simply establishes a list of best practices that physicians would need to follow in order to prescribe opioids in the workers’ compensation system, as well as in personal injury protection coverage in automobile insurance. It would not prevent the dispensing of medications to those with chronic or short term pain; it would simply require the physician to undergo careful written analysis before making the decision to prescribe opioid drugs.  Many pain management doctors already engage in these practices and require their patients to sign pain management contracts allowing for urine testing.  However, not all physicians who prescribe opioid medications follow these practices, and this Bill is aimed squarely at those physicians.

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Let attorneys: Neil O'Toole and John Sbarbaro help you with your case today!
Contact them at the Law Office of O'Toole & Sbarbaro, P.C.

Phone: 303-595-4777

Located in the Denver Metro area.

226 West 12th Avenue Denver, Colorado 80204

Disclaimer 

Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.

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