To place a classified advertisement please contact: Lauren Bernick lbernick@ijpc.com or 405-513-4236

Editorial: United States Pharmacopeia 101, Part II

This is the second in the series on the United States Pharmacopeia (USP). The first part discussed the mission of the United States Pharmacopeia (USP), the object of the first USP, and a description of how the USP has grown from inception (1820) to the present (2012). This part will briefly discuss part of the formal governance of the USP.

The USP consists of (1) Officers, (2) Board of Trustees, (3) Council of Experts, (4) Council of Experts Executive Committee, (5) Expert Committees, and (6) Ad Hoc Advisory Panels. There are additional personnel as needed.

The officers include a President, Treasurer, Past President, and Secretary; the first three are elected for a 5-year term and the Secretary is Chief Legal Counsel of the USP.

The eight Board of Trustee members are elected for a 5-year term and also include the Chief Executive Officer as an ex-officio member.

Each of the Council of Experts (CoE) is elected for a 5-year term (20 elected and the CEO serves as the Chair). The individual members of the CoE serve as chairs of the 20 respective Expert Committees.

All the above elections occur at the USP Convention held every 5 years (2005, 2010, 2015, etc.). This formal meeting is held in Washington, DC.

The Chairs of the respective Expert Committees populate their committees from experts in their respective fields; there are approximately 10 to 20 members on each expert committee. These committees generally serve the 5-year term for the cycle.

Ad Hoc Advisory Panels are occasionally appointed to obtain the desired expertise in various aspects of health care; they may have a defined time or term limit. They are related to a specific Expert Committee to provide informational support so the Committee can make more informed decisions.

The elected positions and Expert Committees are made up of volunteers. Next week we will look at the remaining general governance structure of the USP.


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

Drug Shortages
Drugs updated this week include Amikacin Injection, Amino Acid Products, Bupivacaine HCl Injection, Chloroprocaine Injection, Fosphenytoin Sodium Injection, Hydromorphone HCL Injection, Lidocaine HCl Injection, Morphine Sulfate Injection, and Sodium Bicarbonate Injection.

For the latest updates on drug shortages, go to:
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm?source=govdelivery#amikacin

Criminal Charges and the Injectable Colchicine Error
Federal criminal charges have been filed against a Texas pharmacy making a lethal error in making injectable colchicine. The error was reportedly a breach in protocol that apparently resulted in the batch being more potent than was indicated on the label. Deaths occurred in Oregon and Washington.

The Justice Department filed criminal charges at the request of the FDA Office of Criminal Investigations. The charges stem from the pharmacy's shipment in February 2007 of 72 vials of "compounded colchicine," some of which contained 640% of the amount declared on the label, resulting in three patient deaths from that shipment. The Texas State Board of Pharmacy stated that Apoth�Cure personnel, in January 2007, prepared 175 mL of colchicine solution at a concentration of 3.2 mg/mL, put 5-mL portions into 35 vials, and affixed labels stating the vials contained 1 mg of colchicine per 2 mL. About 15 days later, the pharmacy dispensed and delivered pursuant to an order for Colchicine 0.5 mg/mL for office use about 34 of the vials to a physician in Oregon.
http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=3700

Fentanyl Sublingual Spray
Aptar Pharma has developed a customized sublingual unit-dose spray device for the delivery of SUBSYS�, fentanyl sublingual spray. It is indicated for the treatment of breakthrough cancer pain in opioid-tolerant adult patients who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Fentanyl has been available in many dosage forms including nasal, sublingual dissolving tablets, and oral transmucosal. SUBSYS� marks the arrival of the first ever unit-dose sublingual spray for fentanyl.
http://www.fiercedrugdelivery.com/press-releases/aptar-pharma-sublingual-unit-dose-spray-delivers-insys-therapeutics-subsys?utm_medium=nl&utm_source=internal

(Editor's note: The authors of the above article do not mention the fact that fentanyl sublingual spray has been compounded for years!)

Drugs and Doctor Visits Being Cut-back by Americans
Still struggling to pay for health care, patients cut back on prescription drugs and doctor visits last year. The IMS Institute for Healthcare Informatics report said 2011 was also a breakthrough year for the drug industry, with 34 new drugs introduced, the most in a decade, to treat various diseases including cancer, multiple sclerosis, and hepatitis C. The number of prescriptions issued to patients declined by 1.1 percent compared with 2010, and visits to the doctor fell by 4.7 percent, according to the report. ER room visits increased by 7.4 percent in 2011, an increase that was linked to the loss of health insurance resulting from long-term unemployment.
http://www.nytimes.com/2012/04/05/business/americans-struggle-with-medical-care-despite-economic-recovery.html?_r=1

Study Finds Doubled Cancer Risk with Recent Use of Depo-Provera as a Contraceptive for a Year
There appears to be a link between Depo-Provera, a progestin-only birth control, and an increased risk of breast cancer in young women. The increased risk appeared to diminish within months after women stopped using the contraceptive, and women who used the contraceptive for less than a year or who had stopped using it more than a year earlier did not have any increased risk of breast cancer; the findings will be published in the journal Cancer Research.
http://consumer.healthday.com/Article.asp?AID=663475

�that you can apply to the USP for consideration for participation in committees, panels, etc. at http://www.usp.org/council-experts-expert-committees-overview/call-candidates

Compounding Students
View the 2012 student compounding competition in the YouTube video below:
http://www.youtube.com/watch?v=dAWBkRUXwdk&feature=youtube_gdata_player

Heroes of Pharmacy: Professional Leadership in Times of Change
2nd ed.
Worthen DB
American Pharmacists Association
496 pages; Hardcover; 6"� 9"; $39.95

Includes historical information about fifty-two heroes of pharmacy that were statesmen, reformers, activists, educators, ethicists, editors, and pioneers along with the 20 founders of the American Pharmaceutical Association (APHA). The book contains dozens of photographs from the APHA Foundation archives, this volume presents insights into two centuries of professional progress in education, community and institutional practice, manufacturing, government, publishing, association leadership, and military service. This is a great addition to the library of those interested in the history of pharmacy.

Her chariot
Raced 80 per
They hauled away
What had Ben Her.
      Burma Shave

PCAB is proud to announce the accreditation of the following pharmacy as of March 23, 2012:

Custom Prescriptions, Bellevue, Washington; Dr. Emily Chen, Pharmacist; Emily1987224@gmail.com; Initial Accreditation for Sterile and Nonsterile Compounding

Please join us in congratulating them for their achievement.

NU-VIAL Fill-N-STATION
A �New� NU-VIAL Fill-N-STATION from RDI , Foley, Al. 2 vial trays, Foot Switch with spare parts sitting in storage. Best Offer
Bill Loftin, RPh whl@frii.com 719-761-3302