Compounding This Week Newsletter from www.CompoundingToday.com
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June 29, 2012 Volume 9, Issue 26
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Loyd V. Allen, Jr., Ph.d., R.Ph  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.

Editorial: CMS Clarifies Position on Single-Dose Vials

On June 15, the Centers for Medicare and Medicaid Services (CMS) issued a new memorandum on the Safe Use of Single-Dose/Single-Use Medications to Prevent Healthcare-associated Infections. Referring to shortages of critical pharmaceuticals, the CMS has told surveyors not to cite facilities for noncompliance if they reuse single-dose vials under certain circumstances. It states the following:

"Under certain conditions, it is permissible to repackage single-dose vials or single-use vials (SDVs) into smaller doses, each intended for a single patient: The USP has established standards for compounding which, to the extent such practices are also subject to regulation by the FDA, may also be recognized and enforced under "501" and "502" of the FDCA. These USP compounding standards include USP General Chapter 797, Pharmaceutical Compounding - Sterile Preparations. Under USP <797>, healthcare facilities may repackage SDVs into smaller doses, each intended for use with one patient."

The memorandum goes on to say:
"Administering drugs from one SDV to multiple patients without adhering to USP <797> standards is not acceptable under CMS infection control regulations."

The Memorandum Summary concludes with:
"Deficiency Citation Policy: Healthcare facilities that do not adhere to USP <797> standards but reuse SDVs for multiple patients must be cited for deficiencies under the applicable infection control standards for each type of provider/supplier. On the other hand, healthcare facilities that utilize appropriately stored medications, derived from repackaged SDVs and prepared in accordance with USP <797> must not be cited solely on the basis of this practice."

More information can be found at:
http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-12-35.pdf


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

 
News

Cytarabine Importation by a Hospital
Early in 2011, a hospital pharmacy at an acute care hospital was struggling to supply cytarabine for four specific patients, all of whom needed critical maintenance therapy after induction. The product was not available from any source in the U.S., and they had no realistic projected release dates for back orders. A pharmaceutical distributor eventually found an unrestricted source of cytarabine in Switzerland. Investigation was made to carefully ensure that the drug, strength, dosage form, and any other ingredients listed were indeed what were expected. The involved patients provided consent to treatment with the unapproved product, and the necessary documentation was completed and included with the shipment. This entire importation process took 21 days.
http://www.ashp.org/DocLibrary/AJHP/Cytarabine.aspx

Veterans' Health Care Plans Paying Twice for Same Benefits: VA and Medicare
The VA spent an estimated $13 billion to care for veterans whose health coverage was already paid for by Medicare; in other words, taxpayers are paying twice for the same services, according to research published Tuesday. "They pay once to Medicare Advantage, they pay again to the VA to deliver comprehensive care to the same veterans."

Records for 1.3 million veterans who were enrolled simultaneously with the VA program and the Medicare Advantage managed-care program between 2004 and 2009 were studied. They found that the number of veterans enrolled in both programs increased during that time frame from 486,000 to 925,000. Also, the amount of VA medical care provided to those patients grew from $1.3 billion to $3.2 billion. Veterans who are entitled to VA care are also entitled to Medicare after age 65.
http://www.usatoday.com/NEWS/usaedition/2012-06-27-Double-BilledART_ST_U.htm

Roche to Close New Jersey Facility and Cut 1,000 U.S. Jobs
Roche announced it is overhauling its research operations by closing the 80-year-old New Jersey facility where Valium was discovered, cutting 1,000 jobs. Roche is closing its 127-acre Nutley, N.J.-based campus and moving those activities to Germany and Switzerland, a consolidation aimed at curbing drug development costs.
http://www.chicagotribune.com/business/sns-rt-us-roche-jobsbre85p130-20120626,0,5188759.story

Spanish Citizens Now to Pay for Drugs as Cuts Bite
Patients in Spain will pay the full price for some prescription medicines under a new measure to cut healthcare costs. Patients will pay 100 percent for 456 drugs for "minor ailments," including migraines. Patients will have to pay 100 percent of the cost for codeine, some anti-inflammatories, and laxatives, among other drugs.

The goal is to save more than 440 million euros ($549 million) with the new measure to cut state support; this is a part of 7 billion euros of savings already announced in April. Spain is in the midst of a painful recession that has left one in four unemployed and has vowed to make a total 45 billion euros of public sector cuts this year.
http://www.reuters.com/assets/print?aid=USL6E8HR5S720120627

FDA to Generate $6 Billion in Fees Through PDUFA
PDUFAs approved this year will generate $6 billion in fees over five years for the FDA. Even though FDA gets money from Congress each year, a significant chunk of its budget comes from fees the agency negotiates with the makers of brand-name drugs and medical devices. The bill, for the first time, requires payments from companies that make generic drugs and from other firms in the industry.
http://www.washingtonpost.com/business/economy/measure-to-increase-fda-funds-through-new-company-fees-goes-to-obama/2012/06/26/gJQAo0QW5V_story.html

 
IJPC Now on Facebook

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding

 
Did You Know ...

�that the IACP CCH meeting held this past week in Washington, DC was a great meeting? Excellent speakers and topics were on the program, especially those on (1) What's going on in the courts, (2) The FDA and efforts to regulate the dietary supplement industry, and (3) The role of USP in setting compounding standards. Also, the Exhibit Hall was FULL with the most exhibitors ever!

 
Compounding Tip of the Week
Summertime!

Summer is here and thermometers are rising! Remind your patients to keep their medications (Rx and OTC) out of their cars unless transporting them home, etc.

 
Looking Back

A guy who drives
A car wide open,
Is not thinkin',
He's just hopin'
      Burma Shave

 
PCAB Accreditations

PCAB is very proud to announce the 150th PCAB Accredited Pharmacy:

Phusion Pharmacy; Coventry, RI; David Hughes, Pharm.D. CEO/President; hughes.david@phusionrx.com; Initial Accreditation for Sterile and Non-Sterile Compounding

Please join us in congratulating Phusion Pharmacy on achieving their milestone.

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