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Editorial: New USP <800> May Have Greater Impact than USP <797>

On Monday of this week, the USP introduced the new USP General Chapter <800>Hazardous Drugs—Handling in Healthcare Settings. This new general chapter has been created to establish standards for the receipt, storage, mixing, preparing, compounding, dispensing, and administration of hazardous drugs to protect the patient, healthcare personnel, and environment. This version is out for comment until July 31, and pharmacists are encouraged to take the time to read it and comment. It can be downloaded at:

http://usp.org/usp-nf/notices/compounding-notice

Also, see the NIOSH website for a sample list of hazardous drugs at:
http://www.cdc.gov/niosh/docs/2012-150/pdfs/2012-150.pdf

In addition to most oncology drugs, other example drugs from this list that are covered include the following:

Special facilities, garb, training, and other requirements will be necessary to handle some dosage forms and compounded preparations involving hazardous drugs. At the website, there is also a 38 minute webinar presentation that is a good summary of the chapter.


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

In the report last week concerning the Student Pharmacist Compounding Competition, the students from Washington State University won third place, not the University of Washington. We apologize for the misprint and congratulate the WSU students!

Group Calling for Testosterone Study to be Retracted
The Androgen Study Group, a large group of physicians and researchers, is calling for the retraction of a paper linking testosterone and cardiovascular risks. The group state that the study's credibility was compromised by at least two corrections and should be pulled from the journal; there appears to be no misconduct, no one faked any data, it's just sloppy and has been called gross data mismanagement. The paper was published in JAMA in November by Michael Ho, MD, PhD, of the Eastern Colorado VA, and colleagues. Two corrections have since been published; first was a clarification that the results were based on Kaplan-Meier estimates and not raw data and the second involved reclassification of patients who were excluded from the study.
http://www.medpagetoday.com/Endocrinology/GeneralEndocrinology/44952

IV Nitroglycerin During the Shortage
For the last month, the Emergency Department team at Somerset Medical Center in New Jersey has struggled with a shortage of nitroglycerin. "IV nitroglycerin is really our workhorse for myocardial infarction, hypertensive crisis, and acute decompensated heart failure," Dr. Awad says. "Alternatives are scant and often associated with adverse events." Last week, Baxter International cut shipments of the drug because it could not keep up with demand. So what are the alternatives? The following are provided:

1. Nitroglycerin Paste
2. Nitroglycerin Spray
3. Nitroglycerin Sublingual
4. Drip ACE Inhibitors
5. Try Nitroprusside
6. Consider Nicardipine

Unapproved Imported Saline Ok'd by FDA to Offset Shortage
Moving to offset shortages of a common saline used in hospitals and dialysis centers, the U.S. FDA will temporarily allow Fresenius Kabi to distribute normal saline from its manufacturing facility in Norway. The initial shipments will help but not resolve shortages of 0.9% sodium chloride injection. The FDA said it is continuing to work with Baxter, B. Braun, and Hospira to restore their supplies to hospitals and health clinics.
http://uk.reuters.com/article/2014/03/28/fda-drugs-shortage-idUKL1N0MP1LT20140328

Turkish Drug Exporter Ships Illegal Cancer Medications
Ozay Pharmaceutical Co., of Istanbul, is an exporter of drugs, cosmetics, and medical devices to 70 countries. In recent years, according to U.S. federal prosecutors, Ozay has been shipping illegal cancer medications to the U.S. Federal officials report they have traced much of the illicit cancer medication from U.S. doctors' offices in recent years to this company; with many shipments being smuggled into the U.S. by Ozay employees in small parcels disguised as gifts, prosecutors say.
http://online.wsj.com/news/articles/SB10001424052702303546204579435692215579758?mg=reno64-wsj

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�that a mechanic told a client, I couldn't repair your brakes, so I made your horn louder?

�so called "work-arounds" are dangerous, especially in pharmacy. Things must be done correctly to ensure patient safety!

If these signs blur,
And bounce around,
You'd better park,
And walk to town!
     Burma Shave

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

Hopewell Pharmacy, Hopewell, New Jersey; Gene Ragazzo, RPh, gragazzo@aol.com. Re-Accreditation for Sterile & Nonsterile Compounding

Abrams Royal Pharmacy II, Plano, Texas; Justin Triesch, justin@arp-rx.com. Initial Accreditation for Nonsterile Compounding

For Sale: Nuaire NU-SNR 797-400 Negative Pressure Recirculating Aseptic Containment Compounding Isolator. Contact John by email at johnrx52@hotmail.com