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Editorial: USP Salt and Base Nomenclature, Part 1

NOTE: There are two types of monographs in the USP; "drug substance" monographs and "drug product" monographs. Drug substance monographs are labeled as to their actual composition, base, or salt. The nomenclature presented here applies to the drug product monographs.

Why do we have some drugs that are dosed on the "base" form of the drug (whether they be weak acids or weak bases) and some drugs that are dosed on the total weight of the "salt" form of the drug. Let's look at two examples.

Diphenhydramine Hydrochloride Capsules USP are based on the total molecule (i.e., diphenhydramine hydrochloride). The USP states" Diphenhydramine Hydrochloride Capsules USP contains 90.0 to 110.0 percent of the labeled amount of diphenhydramine hydrochloride (C₁₇H₂₁NO.HCl). As one can see, the weight of the "HCl" is considered in the dose of the drug.

Albuterol Tablets USP contain an amount of albuterol sulfate [(C₁₃H₂₁NO₃)₂.H₂SO₄] equivalent to 90.0 to 110.0 percent of the labeled amount of albuterol (C₁₃H₂₁NO₃). In this example, the weight of the "sulfate" is not considered in the dose of the drug.

This inconsistency has been an issue for many years with no apparent basis for which way the salts are dosed. However, both the official USP drug product monographs and the FDA-approved drug products appear to be inconsistent in how they determine how a drug is dosed. Pharmacists involved in compounding must be aware of the correct use of the terms, as significant errors can result with potential patient harm, as shown below.

For example, fentanyl (C₂₂H₂₈N_2O) has a molecular weight of 336.47 and fentanyl citrate (C₂₂H₂₈N_2O.C₆H₈O₇) of 528.59. In other words, 1 mg of fentanyl is contained in 1.57 mg of fentanyl citrate. Fentanyl citrate injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of fentanyl (C₂₂H₂₈N_2O), present as the citrate. If the compounding pharmacist received an order for 50 mcg fentanyl and only weighed out 50 mcg of fentanyl citrate, the patient would only receive 31 mcg of fentanyl instead of the requested 50 mcg. Other examples could be given, but the point is made. We have a major potential for error which is being addressed by the USP.

Part 2 of this new series will provide the new policy and discuss its practical implementation.


Loyd V. Allen, Jr., Ph.D., R.Ph.
Editor-in-Chief

Ranbaxy Laboratories Closes Plant in the U.S.
Ranbaxy Laboratories has closed a unit in the U.S. that was under scrutiny by U.S. authorities for violation of regulatory norms. The company said the liquid-manufacturing plant in Gloversville, NY has been shut down as it was operating at a "sub-optimal level". A company spokesman said only one item of several manufactured at the plant had been manufactured for commercialization since March 2010.
http://articles.economictimes.indiatimes.com/2011-08-09/news/29867324_1_plant-
closure-arun-sawhney-ranbaxy-laboratories

State OKs Rules to Foil Spread of Chlamydia
No prescription is now required for sex partners of patients infected with chlamydia, the most commonly reported sexually transmitted disease in Massachusetts and the U.S., for antibiotic treatment under regulations approved yesterday by state health regulators. The change in rules is designed to thwart the rapid spread of the disease, which is especially prevalent among people under 25 and endemic in some Boston neighborhoods. In Massachusetts, chlamydia cases have more than doubled, from roughly 8,700 in 1999 to more than 21,200 in 2010.
www.boston.com/news/local/massachusetts/articles/2011/08/11/massachusetts
_oks_rules_to_foil_spread_of__chlamydia/

Drug Shortages Also Affecting Pets
With nearly 200 drugs approved (for humans) currently in short supply, veterinarians are also affected, as they are allowed to use FDA-approved human drugs off-label in pets under certain conditions. Also, there are sometimes shortages of specific veterinary drugs.

A veterinarian at an animal medical center in Manhattan said there were four drugs the center didn't have in stock, with no idea of when they'd become available. The shortages include acetylcysteine inhalation solution, used in both humans and animals to break up mucus and as a partial antidote to acetaminophen poisoning (Pets often eat medication off the floor or their owners may give a drug to them without a vet's supervision).

Also in short supply are doxorubicin and mechlorethamine. It is difficult to know the effect of these shortages and how they have compromised care. There are substitutes for some drugs.
http://blogs.wsj.com/health/2011/08/10/fido-needs-his-meds-drug-shortages-affect-veterinary-care/

Botox Gets Green Light for Bladder Problem in European Union
Botox has been approved in Europe for treating certain patients with urinary incontinence; patients with overactive bladder problems caused by multiple sclerosis and spinal cord injury. This action clears the way for the approval of the drug in 14 countries, under the European Union's mutual recognition procedure.
www.reuters.com/article/2011/08/08/idUSL6E7J808N20110808

Odd Chemicals Turn Up in Drinking Water
Chicago drinking water has been shown to contain trace amounts of sex hormones, prescription drugs, flame retardants, and herbicides. In the latest round of testing, city officials discovered that more than two dozen pharmaceutical drugs and other unregulated chemicals pass through Chicago's massive treatment plants.

Like other cities, Chicago must notify the public if its drinking water is shown to contain regulated contaminants, including lead, pesticides, and harmful bacteria; however, there is no such requirement if pharmaceuticals and other unregulated substances are detected.

EPA's position is that it doesn't yet have sufficient evidence to limit pharmaceuticals and many other unregulated chemicals in drinking water. Water officials say not enough is known to justify spending millions of taxpayer dollars to upgrade treatment plants.
www.pharmacistelink.com/index.php/drugs-and-treatment/31046-odd-chemicals-turn-
up-in-drinking-water

�that this month's edition of the free Science and Technology Newsletter will feature the topic "Documentation of Potential Problems in Compounding with Manufactured Products"? If you do not receive it, sign up for your free subscription at http://compoundingtoday.com/newsletter/Subscribe.cfm.

Safely Compounding Quality Medications - Understanding Revisions to USP General Chapter <1163>
August 16, 2011 1:00 - 2:30 (ET); Registration: US $25
Presented by Lisa D. Ashworth, BS Pharm, RPh, Vice-Chair Pharmacy Compounding Expert Committee

This 90-minute webinar will highlight the official changes that went into effect May 1, 2011 as the first revision of this chapter. This chapter contains information on what is required for the quality of a pharmaceutically compounded medication to meet USP standards. To learn more, visit:
www.usp.org/education/pe/courses/moreInfo.html?courseID=238

Safely Compounding Quality Medications - A Review of USP General Chapter <795>
August 23, 2011 1:00 - 2:30 (ET); Registration: US $25
Presented by Linda F. McElhiney, PharmD, RPh, FIACP, FASHP

This 90-minute webinar will highlight the official changes that went into effect on May 1, 2011. It will emphasize the role that USP has in standards setting for nonsterile compounded preparations along with responsibilities of the compounder and pharmacy personnel. To learn more, visit:
www.usp.org/education/pe/courses/moreInfo.html?courseID=239

For additional information on either of the above courses, please contact USP Pharmacopeial Education at pharmed@usp.org.

2011 Pediatric Formulations Initiative (PFI) Workshop
November 1-2, 2011; No charge
Bolger Center, Potomac, MD

The Eunice Kennedy Shriver National Institute of Child Health and Human Development is hosting the 2011 Pediatric Formulations Initiative Workshop on November 1-2, 2011 in Potomac, Maryland. This workshop will address scientific, regulatory, and economic barriers to the development of pediatric formulations, as well as focusing on current gaps in knowledge and new technology developments. To learn more, visit:
PFIworkshop@circlesolutions.com or 2011 PFI Workshop Web Site.

Observation
If one doesn't know when something wrong is being done, it is up to the trained to inform them. Please routinely observe your compounding personnel to eliminate any potential problems.