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April 20, 2012 Volume 9, Issue 16
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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: United States Pharmacopeia 101, Part IV

This is the fourth in the series on the United States Pharmacopeia (USP). In this part, we will introduce the publications of the USP. The primary publications (print and/or electronic) of the USP that are of interest to pharmacists include the USP-NF, FCC, DSC, USAN and the PF. Now let's look at what those abbreviations mean.

  1. The United States Pharmacopeia and The National Formulary (USP-NF) is a book of public pharmacopeial standards. It contains standards for (chemical and biological drug substances, dosage forms, and compounded preparations), excipients, medical devices, and dietary supplements. It is a combination of two official compendia, the USP and the NF. Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP. Excipient monographs are in the NF. Also included are the General Notices and General Chapters.

  2. The Pharmacopeial Forum (PF) FREE!!! Online Resource. PF is the bimonthly online journal in which the USP publishes proposed revisions to USP-NF for public review and comment. To encourage and broaden participation in the standards-setting process, USP transitioned PF from a subscription-based print and online publication to a free, online-only resource. New issues are posted online every two months at the beginning of the month. The comment period is 90 days and ends on the last day of the month. To make it easier for users to identify and respond to proposed changes to USP-NF standards, PF now contains only proposals for which USP is seeking public comment and information, including:

    • In-Process Revisions (Monographs and General Chapters)
    • Proposed Interim Revision Announcements (IRAs)
    • PDG Harmonization Proposals (Stage 4)
    • Stimuli Articles

    Other information previously in the PF, including official text (final IRAs), is now published on the USP website or in other publications.

Next week, we will look at other publications of the USP.


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

 
Other News

Intravenous Compounding Robots May Harbor Bacterial Contamination
Intravenous medication compounding robots may harbor dangerous bacteria, according to a report in Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America. During a routine screening in 2010, personnel at Wake Forest Baptist Medical Center in North Carolina discovered Bacillus cereus bacteria in samples dispensed by their machine, the Intellifill IV. Personnel discovered the contamination through quality-assurance measures recommended by the manufacturer before any patients were harmed by the contaminated drugs. While any adverse events were avoided, it appears that the current cleaning and maintenance recommendations may need to be strengthened.

Source: Cluck D, Williamson JC, Glasgo M et al. Bacterial contamination of an automated pharmacy robot used for intravenous medication preparation. Infect Control Hosp Epidemiol 2012; 33(5): 517-520.
http://www.shea-online.org/View/smid/428/ArticleID/149.aspx

Concern Raised Over Painkiller's Use in Sports
Some medical experts are concerned about the ways sports teams are using ketorolac (Toradol) because so little is known about its possible long-term effects on athletes. Since data is not really available on the use of the drug by athletes, it is unclear how frequently Toradol injections are provided and for what ailments, and whether players are told of the potential side effects. This concern has compelled at least two team doctors to stop using it.
http://www.nytimes.com/2012/04/14/sports/wide-use-of-painkiller-toradol-before-games-raises-concerns.html?_r=1&ref=todayspaper

Gelatin Capsule Contamination in China-produced Capsules
The gelatin capsules in question are said to have been made using industrial- rather than pharmaceutical-grade gelatin which results in excessive levels of chromium, according to a report from the state-run Xinhua news agency. The products include 11 traditional Chinese medicines and two antibiotics. A total of 22 people are reported to have been detained for questioning by police in connection with the incident.

The capsules were reportedly made at four factories in the Zhejiang region of China from gelatin derived from scrap leather. Chromium is used in the tanning process for leather, and repeated exposure to excess levels is linked to the development of cancer.
http://www.inpharm.com/news/172235/china-bans-medicines-formulated-toxic-capsules

New Delivery System for Buprenorphine with Naloxone
As drug addiction specialists seek new ways to treat opioid dependence, a new product called BEMA Buprenorphine will be administered via a small piece of film that dissolves in the mouth. But the company making it (BDSI) believes differences in its drug delivery technology would give it the edge over RB's Suboxone. BDSI will need an advantage to take on RB's blockbuster drug, which generated more than $1.2 billion in 2011 sales.

RB's Suboxone combines buprenorphine with naloxone, another drug that deters drug abuse. Suboxone was first developed as a tablet and now is available as a film. However, it has an unpleasant taste. Like Suboxone, BEMA Buprenorphine combines buprenorphine and naloxone in a single transmucosal product.
http://www.medcitynews.com/2012/04/opioid-dependence-treatment-from-bdsi-aims-to-challenge-rbs-suboxone/?edition=north-carolina

Physicians That Buy Medications from Unapproved Sources Warned
Clinicians in several states have been warned by the FDA to stop purchasing medications from foreign or unlicensed suppliers that sell illegal prescription medications. "These medical practices are putting patients at risk of exposure to medications that may be counterfeit, contaminated, improperly stored and transported, ineffective, and dangerous," the FDA said.

The Agency further said that "The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering such offers." http://www.medscape.com/viewarticle/762250

Drug Shortages Causing Deaths
Shortages of prescription drugs have been a growing concern for the past six years (2005 to 2010), nearly tripling and reaching record levels of 267 drugs in 2011 as manufacturers ceased operations or ran into production problems. In some cases, lifesaving treatments have been delayed, sending patients on desperate searches for needed medicines. Shortages have also caused injuries from mistakes and at least 15 deaths around the country since mid-2011, according to the ISMP. The mistakes included confusion about dosing and preparation of substitutes. Handling the shortage problem is very, very time consuming and involves a lot of people. It has a tremendous impact on pharmacy operations. Of the drugs in short supply, the majority are generic injectable medications.
http://www.washingtonpost.com/national/health-science/hospitals-scramble-on-the-front-lines-of-drug-shortages/2012/04/10/gIQAUQLN9S_story.html

 
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Book Review

APhA's Immunization Handbook
2nd Edition
Angelo LB
March 2012; $41.95; 225 pages; 5" � 8" spiral bound

This book is divided into 5 sections (1) Program Development and Management, (2) Immunization Administration and Delivery Options, (3) Safety Measures, (4) Enhanced Roles and Responsibilities, and (5) Immunization and Vaccine Product Information. It has been thoroughly revised and updated and is written in a very concise and easy-to-use format. There are many guidelines, tips, and resources for building and maintaining a successful immunization practice. It can serve as a great resource for pharmacy students and pharmacists.

 
Looking Back

Ben met Anna,
Made a hit,
Neglected beard
Ben-Anna split!
      Burma Shave

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