Wednesday, October 30, 2013

Interesting article says drug safety bill puts urgent treatment in jeopardy. I thought bad compounders like necc who refuse to follow the rules cause far greater jeopardy


There are a lot of illness for which there are no treatments or cures so I am not sure I am completely convinced with this argument although I am sure there will be some such cases.  What is the solution if not what is proposed?  Is there a way to fix the current draft without having to start over?  There have been issues with the eye med named in article. I guess it comes down to a balancing and weighing. No legislation will be perfect.  Just as there never has been  assess to meds for every person for every illness... harsh but true.

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Drug Safety Bill Puts Urgent Treatment in Jeopardy

By Craig H. KligerOct. 30, 2013, 3:30 p.m.We all remember the scenes in the film “Willy Wonka & the Chocolate Factory” where Gene Wilder nonchalantly warns, “Stop. Don’t,” as various characters try unknown products and experience unanticipated effects. Of course, each instance ends with predictably unfortunate results.Congress’ attempt to regulate compounded medications poses a Wonka-esque scenario in which potentially well-intentioned legislation may have the unintentional side effect of harming patients and adding unnecessary costs to the health care system.

read here

1 comment:

Kenneth Woliner, MD said...

It appears that Dr. Kliger, an ophthalmologist, wants to have repackaged compounded drugs (such as Avastin) included in this bill, to ensure that non-patient specific doses of compounded Avastin could be in his clinic, so he could inject them on any day, rather than waiting for a compounding pharmacy to send him a patient-specific prescription. There are a few flaws in Dr. Kliger's argument, however.

1. Perhaps "the best compounding pharmacy" for ophthalmic drugs, Leiter's, is located in his state of California. Prescriptions from a pharmacy in his state could arrive within one day, two days max, if expedited shipping is used. For chronic conditions such as macular degeneration (the condition that Avastin and Lucentis is used for), there is no urgency to inject "right away". It does make it more convenient to both the doctor and patient to have these drugs "on hand" in the doctor's office, and less expensive too (less shipping fees and/or waste due to unused product), but it is not a "health issue" for the example he cited.

2. Nonetheless, I agree that doctors should be able to have compounded and repackaged drugs on hand for office use. Why is this not specifically laid out in the Federal bill? The answer is that doctors (the American Medical Association, the California Medical Association, the Ophthalmology Societies, etc - sat on the sidelines while this bill was being worked on.

3. Doctors could have said, "We will agree to ONLY use compounded/repackaged drugs from FDA-registered outsourcing facilities in exchange for the continued ability to have "office-use" compounded drugs. That is what Florida doctors are doing as the State laws and rules are being written.

Instead of this doctor crying Chicken Little, perhaps he should be more proactive, lobbying for laws and rules that protect patients from rogue compounders, but also don't interfere with legitimate medical practices.

One last thought, there are cases of blindness in humans from repackaged and/or compounded drugs, including cases in California. Doing nothing is not an option.

Kenneth Woliner, MD
www.holisticfamilymed.com