Compounding This Week Newsletter from www.CompoundingToday.com
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July 18, 2014 Volume 11, Issue 28
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Loyd V. Allen, Jr., Ph.d., R.Ph  Letter from the Editor

Editorial: What is Compounding Pharmacy, Part IX: Cutting Edge

We hear it all the time. "There is a new breakthrough in the treatment of "XXXX" using a drug that has been around for years! Let's go to "YYYY" and get the latest story!" And then, you don't hear anything for many years, and patients continue to suffer and die without the "new breakthrough" while waiting for the drug to be further developed by a manufacturer and the drug approved. Not so with compounding. Physicians keeping up on the latest and most innovative approaches to clinical treatment can often work with their local compounding pharmacist to provide this "new breakthrough" immediately with all the benefits to the patient.

Also, prescribers and pharmacists work together to develop new or alternative dosage forms to meet the needs of patients to relieve their suffering and, in many cases, to save their lives.

Many pharmacists are involved in clinical studies either by compounding the medications or working with investigators in conducting the clinical trials.

Compounding pharmacists work with equipment companies in the development of new equipment for compounding and for drug administration using new devices.

Yes, it is all in a day's work for a compounding pharmacist; there are many ways that compounding pharmacists are on the "cutting edge" of pharmacotherapy today!

Note: Regarding the Editorial and the news item in last week's edition, the numbers presented did not reflect the total picture of compensation of Express Scripts personnel. It appears that Paz made about 100 million dollars in the past 18 months in options alone! It is hard to understand why Express Scripts wishes to deprive patients that depend upon compounded medications while their personnel receive such exorbitant incomes. For more detailed, public information, see and evaluate the following website:
http://finance.yahoo.com/q/it?s=ESRX+Insider+Transactions



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

Tamoxifen May Produce Fewer Side Effects in Gel Form
Tamoxifen may be more efficacious for women if applied in gel form to their breast. In a small study, the blood levels were much lower when it was administered as a gel, reports a study in the journal Clinical Cancer Research. Dr. Seema Khan, a professor of surgery at the Northwestern University Feinberg School of Medicine, and her team found that applying the gel form directly to the breast caused lower levels of the drug to show up in blood tests, suggesting that side effects could be avoidable.

Editor's Note: It is not unusual to have lower blood levels with some transdermally administered drugs but still have effectiveness. We should review the therapeutic window concept as it may not apply in all cases.
http://www.nydailynews.com/life-style/health/tamoxifen-produce-side-effects-gel-study-article-1.1867526

Compounding Pharmacists Have a Solution to Painkiller Overuse
Compounding pharmacists may offer a possible answer to the continuing overuse of opioid painkillers across the country; however, decisions from PBMs to limit coverage of some individually prepared medications could eliminate the solution before it is extensively tried.

Earlier this month Express Scripts announced that it was dropping coverage for 1,000 drug ingredients found in many compounded medications, beginning September 15. David Whitrap announced that the move would lower treatment costs for employers on those medications by 95% while affecting just 0.6% of their patient consumer base.

Proponents say the idea of compounding for pain management has garnered increased interest from health practitioners in recent years. For example, while a powerful oral pain medication has the potential of being abused by a patient to use for non-medical reasons, converting a painkiller into a topical skin cream lowers the risk of abuse.
http://www.modernhealthcare.com/article/20140711/NEWS/307119958/compounding-pharmacists-battle-for-solution-to-painkiller-overuse

State Denies Kalydeco, a $300,000-a-Year Cystic Fibrosis Drug
A $300,000-a-year cystic-fibrosis drug has sparked a legal battle where the state's Medicaid program is restricting access to the expensive therapy. A lawsuit filed in Arkansas federal court by three people suffering from the fatal lung disease allege Medicaid officials have for two years denied them access to Kalydeco because of its cost. The plaintiffs allege state officials have violated their civil rights under federal law governing Medicaid, the government-run insurance plan for the poor.
http://online.wsj.com/articles/costly-drug-vertex-is-denied-and-medicaid-patients-sue-1405564205?mod=WSJ_article_EditorsPicks&cb=logged0.5824781362865685

Senators Question Gilead on Sovaldi's $80,000-a-year Extreme Cost
Two members of the U.S. Senate Finance Committee have asked Gilead Sciences Inc. to defend the more than $80,000 cost per patient of its breakthrough treatment for hepatitis C, citing the expense to federal healthcare programs. Gilead has defended the price saying Sovaldi reduces overall treatment costs for hepatitis C by lowering the number of required healthcare visits and sidestepping the need for other medicines that treat side effects of older therapies.

Editor's Note: It is evident the cost of Sovaldi is NOT based on the cost of production but rather the potential savings projected by having to use other treatments. However, this is not allowed in pricing compounded medications as payors want to reimburse based on cost of ingredients plus a compounding fee.
http://www.reuters.com/article/2014/07/11/us-gilead-sciences-sovaldi-senators-idUSKBN0FG1JV20140711

CDC Shutting Down Some Labs
The CDC has announced that following a list of public-safety scares, the Centers for Disease Control and Prevention will be shutting down two research labs, temporarily stopping all transfers of samples from high-level biosafety labs and strengthening its laboratory safety precautions. These new precautions came following an internal review of the CDC after three separate incidents of possible exposure to dangerous diseases at CDC labs and an FDA lab at NIH were all disclosed in the past three months. The latest, reported for the first time on Friday, involved the cross-contamination of an animal flu strain with a highly dangerous strain of bird flu. CDC said its review found the three incidents were among a total of five cases of mishandled biological material over the past decade. One incident in 2006 occurred at the same lab where the recent problem with anthrax samples occurred.
http://www.usatoday.com/story/news/nation/2014/07/11/cdc-centers-for-disease-control-prevention-anthrax-smallpox-influenza-contamination-lab-safety/12531081/

 
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Did You Know ...

�how interesting it is that even though we know the news media and the Internet are not always truthful and continually distort and misrepresent the "news" as "fact" that many citizens repeat what is said as "fact" to others in discussions and debates, furthering the distortions and misrepresentations?

 
Tip of the Week

Question everything! What you have been "taught" via the media (and even textbooks) is not always true, but we often base our opinions and actions on those untrue statements.

 
Looking Back

Brother Speeder,
Let's Rehearse.
All Together,
Good Morning, Nurse!
     Burma Shave

 
Accreditations

PCAB is pleased to announce the accreditation of the following pharmacy:

Wickliffe Veterinary Pharmacy, Lexington, Kentucky; Jackie Bernard, jbernard@wicklifferx.com. Re-Accreditation for Sterile & Nonsterile Compounding

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