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Pepin's Pharmaceutical Prattle for 09-21-2009

 Quote of the day: Experience is not what

                      happens to a man;

                      it is what a man does with

                      what happens to him.

                     Aldous Huxley (1894 - 1963)

Good Morning!

Homeowners III

 Jeff was my next door neighbor at my first house. He developed a system of classifying the level of irritation a home owner experiences. It is like a Homeland Security system without the colors. More like the DEFCON (DEFense readiness CONdition) rating system in reverse. Homeowner I  would include normal maintenance items such as mowing, snow removal, raking, seeding, weeding and washing windows. The Homeowner II  level of frustration/irritation includes painting, electrical, pests, and appliance failure. Homeowner III  is the top of the heap and includes ANYTHING related to plumbing or water. A leaky roof, window wells full of water from a broken hose that floods the basement, and clogged drains all qualify. This week my son experienced his third sewer backup since buying his home 3 years ago. If there is a Homeowner IV then this is probably it.

 It started me thinking (at least something did). There could be a similar system within the pharmaceutical world. Pharmacy I  might include “missing” antibiotic bags, wholesale price hikes, rejection of PBM claims, and drug/vaccine shortages. Pharmacy II  might be anything from an irate patient or family member to technicians calling in sick, authors/reviewers missing deadlines to phlebologists who miss drawing vanco/gent/tobra concentrations. Anything related to computers would automatically go into Pharmacy III  be it a crash, lost data, or an “upgrade gone wild”. Increased antibiotic resistance or drug recalls also would qualify. I recently read about a rare Pharmacy IV event. An Ohio pharmacist checked an IV that a technician had made for a child and missed the tech’s error which resulted in a tragic death. The pharmacist will spend time in jail, pay a big fine and be required to perform 400 hours of community service. In addition the pharmacist lost his license to practice PERMANENTLY. While I do not know the specifics of the case this type of scorched earth approach to medication errors will not encourage the type of reporting behavior needed to make systems safer for patients. It did come out in this case that staffing was woefully inadequate and further stressed by sick employee absenteeism. As healthcare reform goes forward I expect that the pressures to “do more with less” will only make systems fail more often and even more dramatically. It is only by learning from sentinel events and the repair of flawed systems using root cause analysis that we will make patients safer. The punitive approach will only encourage cover-up and perpetuation of serious safety flaws.

 It is fortunate for my son that he learned from his sentinel event (the first backup) and purchased additional home owner’s "plumbing backup" insurance. It will cost him much less to replace the elm clogged line connecting his house to the city’s line in the street. I guess you could say he did intense “ROOT” cause analysis and will make PIPELINE changes to eliminate obstacles to FREE FLOW.

Have a GREAT week!

Steve

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ps. Best answer this week to the question "How are you?" was "I'm feeling just like Superman... all I need is a cape!"

pps. Please note that some of the links may not be up for very long and that

     you should capture or print anything that you may wish to keep.

  ------------

 

1) CDC and H1N1 influenza vaccine (nasal)

Looks like the first batch of vaccine will be the Flumist type that can’t be given to those under 2 or over 49 years of age. A scant 3.4 million doses are expected in the first round.

http://www.comcast.net/articles/news-health/20090915/US.MED.Swine.Flu/

but this just in…

Injections of the first 4 FDA approved vaccines could start in 2 weeks. Four product approved on 9-15.  Expect healthcare workers, women and children to get the first wave of shots.  http://www.bloomberg.com/apps/news?pid=20601082&sid=amY06qFxgL.s

 

2) France and the USA agree on something?!!!

Both countries have agreed to donate 10% of their allotted H1N1 (swine) Flu vaccine to poor countries. Italy, Norway, the U.K., Brazil, Australia, and New Zealand will also make donations to third world countries.

http://www.bloomberg.com/apps/news?pid=20601202&sid=alWYCWdPqZPE

 

3) Old nausea drug gets new black box warning

Promethazine injectable (approved in 1956 As Phenergan) receives a BLACK BOX WARNING requirement from the FDA. Intraarterial administration or extravasation of IV administered solution can result in gangrene. Deep IM administration or infusion of a diluted solution via a good IV line are the only legitimate routes.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182498.htm

 

 

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4) Senate wants disclosure of ANYTHING of value given to doctors

Any “gift” (drug samples, meals, etc) of over $10 would have to be reported is the Senate gets their way. I wonder if political finance reform will ever require reporting of $10 donations to Senatorial campaigns… (just wondering….)

http://www.bloomberg.com/apps/news?pid=20601202&sid=abpS2w4Zf2QU

 

5) Less than $200 per dialysis session (inclusive of all lab tests and drugs)

Expect shares of all companies that make erythropoietin stimulating drugs to plunge as reimbursement is cut for dialysis patients. CMS wants to bundle dialysis, lab tests and all drugs related to dialysis into a flat fee of $198.64 per session. The AWP of an average dose of Aranesp now exceeds that number so guess who won’t get the drug anymore. The only alternative is to increase the number of transfusions given to patients. With a limited supply of donated blood and an expanding appetite for it we will get a miniature view what ‘Bamacare will do to all services as demand increases but supply stays the same.

http://www.reuters.com/article/marketsNews/idINN158649420090915?rpc=44

 

6) No Moths in Sepracor’s wallet

Since Sepracor has all but stopped advertizing Lunesta using the famed moth commercials their sales have soared (2% up). Their $100 million TV ad budget from last year has been trimmed to $1 million for 2009.   

http://industry.bnet.com/pharma/10004298/sepracor-has-stopped-advertising-lunesta-but-sales-still-go-up/

 

7) The Coughing Swine

Sounds like an English pub but not so. A “piggery” in Northern Ireland has 4,500 coughing pigs who are infected with the H1N1 virus. The source of the infection is still under investigation. Look for Egypt and other such nations to use this as an excuse to exterminate any remaining pigs within their borders.

 http://www.bloomberg.com/apps/news?pid=20601202&sid=aS0MziA2El20

 

 

Have a SUPER-FANTASTIC week.

Steve

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Disclaimer: "Pepin's Pharmaceutical Prattle" (AKA "The Prattle") is the property of PHARMWORKS, LLC and Steven M. Pepin, Pharm. D, BCPS. The opinions expressed are those of the bald-headed author. To start or stop any drug without the advice and supervision of your physician would be stupid. So don't do anything based upon what you read here without professional advice.  To be added to or removed from the distribution list please e-mail your request to spepin@pharmworks.com . All insightful comments from readers are thoughtfully considered (the rest are callously discarded). Copyright 1998-2009 PHARMWORKS,LLC all rights reserved.

Copyright 1998-2009 PHARMWORKS, LLC all rights reserved