Compounding This Week Newsletter from www.CompoundingToday.com
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November 22, 2013 Volume 10, Issue 47
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The International Journal of Pharmaceutical Compounding
 
Loyd V. Allen, Jr., Ph.d., R.Ph  Letter from the Editor

Editorial: Polypill: Something New or History Recycling?

Recent headlines promote the advantage of a "Polypill," a single dosage unit of a fixed-dose combination of aspirin, a statin, and two antihypertensives. The advantage is that patients taking this single dosage form improve medication adherence since the patient does not have to remember to take all the different medications throughout the day.

I remember back in the 60s there was a concerted effort to remove "fixed-dose" combinations in favor of "individual drug" dosage forms. The rationale was that fixed doses remove the ability to respond to individual variations. However, over the years, a number of multiple-component fixed-dosage forms started coming back onto the market. Also, the "Polypill" concept has been coming on stronger especially for cardiac patients. But, it should not be limited to just those classifications. Polypills can be prepared by compounders using many different variations to meet the needs of specific patients and individualize their dosing to enhance compliance.

Again, this is nothing new, but just a recycling of what was common practice in the 1950s and 1960s from manufacturers. Today, however, it can involve both manufacturers and compounders.

One of the issues in 2014 of IJPC will cover this topic in depth and provide many opportunities for compounding pharmacists to assist in enhancing patient compliance through compounding involving the Polypill concept.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

 
News

NOTE: Due to the Thanksgiving Holidays, there will be no newsletter next Friday, 11/29/13. The IJPC staff wishes you and your family and friends a very Happy Thanksgiving!

Senate Passes Drug-compounding Bill
A bill to increase federal oversight of large-scale compounding pharmacies and establish a national prescription drug track-and-trace system was passed by the Senate and is now on its way to the President. The bill encourages large-scale compounding pharmacies to register with the FDA. This bill gives the FDA the authority to inspect and close down large-volume compounders, but it doesn't require the pharmacies to register with the FDA. It attempts to clarify the FDA's authority over high-volume compounding pharmacies that mass-produce medications, rather than fill doctors' prescriptions.

"Nobody will be required to register in this new category," said Allan Coukell, drug safety expert with the Pew Charitable Trusts, which lobbied to pass the bill. "The success of the voluntary category will depend on hospitals, clinics and doctors choosing to buy from these FDA-registered facilities."
http://www.politico.com/story/2013/11/senate-passes-drug-compounding-safety-bill-100011.html

http://www.washingtonpost.com/politics/congress/congress-putting-compounding-pharmacies-under-more-federal-scrutiny-after-meningitis-outbreak/2013/11/18/96e42d1e-5081-11e3-9ee6-2580086d8254_story.html

http://www.washingtonpost.com/politics/federal_government/senate-moves-ahead-with-bill-to-bring-stricter-oversight-to-specialty-pharmacies/2013/11/12/23b04af0-4bf7-11e3-bf60-c1ca136ae14a_story.html

Editor's Note: The bill will be discussed in detail over the next several issues of the International Journal of Pharmaceutical Compounding.

Alkermes to Produce Both Addictive Drug and Treatment!
Critics of the pharmaceutical industry have been known to accuse the industry of making drugs that cause side effects and then making more drugs to treat those side effects. A new example is the drug Zohydro, a new analgesic approved by the FDA last month. Concerned that the drug will result in more addicts, doctors point out that the company will also market Vivitrol, a medication designed to treat those very addicts.
http://www.nytimes.com/2013/11/16/business/addiction-specialists-wary-of-new-painkiller.html?_r=2&

Unapproved Meningitis-B Vaccine Requested by Princeton University for Students
Pending approval, Princeton University will offer students a meningitis vaccine not currently approved or available in the U.S. This is because a seventh case of meningitis-B was reported this year. The U.S. CDC is preparing to recommend that all undergraduate students, as well as graduate students living in dormitories, get the vaccine. The CDC requested and received permission from the FDA last week to import the vaccine.
http://www.bloomberg.com/news/2013-11-18/princeton-to-offer-meningitis-b-vaccine-after-new-case-reported.html

 
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Did You Know ...

�that the first Thanksgiving Proclamation was made by Governor Bradford three years after the Pilgrims settled at Plymouth?

"To all ye Pilgrims:
"Inasmuch as the great Father has given us this year an abundant harvest of Indian corn, wheat, peas, beans, squashes and garden vegetables, and has made the forests to abound with game and the sea with fish and clams, and inasmuch as he has protected us from the ravages of the savages, has spared us from pestilence and disease, has granted us freedom to worship God according to the dictates of our own conscience; now I, your magistrate, do proclaim that all ye Pilgrims, with your wives and ye little ones, do gather at ye meeting house, on ye hill, between the hours of 9 and 12 in the day time, on Thursday, November ye 29th, of the year of our Lord one thousand six hundred and twenty-three, and the third year since ye Pilgrims landed on ye Pilgrim Rock, there to listen to ye pastor and render thanksgiving to ye Almighty God for all his blessings.

William Bradford, Ye Governor of Ye Colony."

 
Tip of the Week

Not everyone will have a meaningful Thanksgiving holiday. Why not financially support or take time and help out in a "rescue mission" or church-sponsored meal for the needy. They really appreciate a hot meal!

 
Looking Back

The cream one hears
The most of now,
Comes from a jar
Not from a cow!
      Burma Shave

 
Accreditations

PCAB is proud to announce the accreditation of the following pharmacies:

Pharmacy Solutions, Arlington, Texas; Tom Siegenthaler, RPh, Owner, tesieg@sbcglobal.net. Initial Accreditation for Sterile & Nonsterile Compounding

ProCompounding Pharmacy, Johnson City, Tennessee; Perry Ripple, PharmD, perryr.rx@procompounding.com. Initial Accreditation for Sterile & Nonsterile Compounding

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