Compounding This Week Newsletter from www.CompoundingToday.com
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August 19, 2011 Volume 8, Issue 33
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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: USP Salt and Base Nomenclature, Part 2

Last week we discussed that some drugs are dosed on the "base" form of the drug (whether they are weak acids or weak bases), and some drugs are dosed on the total weight of the "salt" form of the drug and how this occurred. This is potentially a very dangerous situation in health care today, and especially in compounding pharmacy. The USP has a new salt nomenclature policy that covers drug substances, drug products and drug preparations. We should note again that there are two types of monographs in the USP/NF; "drug substance" monographs and "drug product/drug preparation" monographs. Drug substance monographs are labeled as to their actual composition, base or salt. The nomenclature presented here applies to the drug product/drug preparation monographs.

The USP nomenclature policy for salt drug substances in drug products and compounded preparations is followed by USP in naming drug products and compounded preparations that are newly recognized in the USP. It is not the intent to revise existing monographs unless the USP Council of Experts determines that a change is warranted for reasons such as safety.

The USP 34/NF29 policy states:

"The titles of USP monographs for drug products and compounded preparations formulated with a salt of an acid or base use the name of the active moiety, as defined below. The strength of the product or preparation also is expressed in terms of the active moiety. An active moiety is the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance, without regard to the actual charged state of the molecule in-vivo."

The USP provides an example of the active moiety of a hydrochloride salt of a base which will be the free base and not the protonated form of the base. The active moiety of a metal acid salt will be the free acid.

Practically, a new salt drug substance would be named as "Drug Salt" but a product or preparation would be named as "Drug Product" or "Drug Preparation". It is not the intent to go back and change existing names but to implement this policy over time in a manner to minimize any confusion with current drugs/drug salts already approved. Manufacturers with a "family" of products already on the market can request a continuation of that name for new products/dosage forms, etc.

Will this help immediately? Not much as it will continue to be confusing for awhile. However, it will help over the long run as new drug products and drug preparations are named according to their active entity and current products/preparations are no longer used.

Next week's Editorial will be about "about".


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

 
Other News

Illegal Online Pharmacies Using Consumer-Search-Engine Manipulation to Redirect Shoppers to Unauthorized Drug Sites
Consumers attempting to buy prescription medications over the Internet may fall victim to one of the many illegal online pharmacies popping up on the web according to cyber-security experts at Carnegie Mellon University. Their report says that infected websites are redirecting online shoppers to dangerous unauthorized pharmacies.

The study reported the top results for 218 drug-related web searches over the course of nine months in 2010 and 2011. They found the search results were being manipulated to promote unauthorized pharmacies. In the past, it has been known that unauthorized online pharmacies have been using email spam to take advantage of unwary online consumers; however, this did not cover enough customers so now the online thieves are infecting websites to redirect unwary consumers to hundreds of illegal online pharmacies http://consumer.healthday.com/Article.asp?AID=655839

Drug Shortages Lead to Price Gouging
Scalping tickets to a sporting event or a rock concert can get you arrested; but reselling drugs in short supply at a hefty markup is a thriving business. As an example, Propofol is in short supply at a cost of 3,161% more than regular price.

Being in the midst of a record shortage of prescription drugs, unscrupulous marketers are stockpiling hard-to-find drugs and attempting to sell them back to hospitals at up to 50 times their normal prices. However, even though pharmaceutical price gouging isn't illegal, it is unethical and potentially dangerous.

Among backordered drugs with the biggest markups are (1) Labetalol-4,533%, (2) Cytarabine-3,980%, (3) Dexamethasone-3,857%, (4) Leucovorin-3,170 %, (5) Propofol- 3,161%, (6) Papavarine-2,979%, (7) Protamine-2,752%, (8) Levophed-2,642%, (9) Sodium chloride concentrate-2,350%, and (1) Furosemide-1,721%.

Looking at the labetalol example that is reported to cost $25 a dose, hospitals have been asked to pay $1,200. The FDA has listed 180 drugs in short supply. Hospitals have responded, in some cases, by delaying surgeries or turning to less-effective drugs. Purchasing from unauthorized dealers can put patients at risk by circulating counterfeit or stolen medications; also these drugs may not have been stored and handled properly, which can adversely affect their stability.
http://yourlife.usatoday.com/health/healthcare/story/2011/08/Drug-shortages-lead-to-price-gouging/50028148/1

PHARMA Doesn't Want the FDA to Select Brand Names for Drugs
PHARMA told the FDA that name reviews should be overhauled or repealed; the reason given is that there are no validated measures or processes to define or determine when two proprietary names are similar.

Drug-name mix-ups, sound-alikes and look-alikes are problematic. The Institute for Safe Medication Practices (ISMP) says they are among the most common causes of medication errors. ISMP maintains a list of almost 800 confused-name pairs, most published more than a decade ago.

PHARMA agrees with ISMP Director Cohen that industry and other stakeholders should meet with the FDA to improve the process. They should determine how often name confusion contributes to medical errors and make the agency's review process quicker and more transparent.
http://articles.boston.com/2011-08-16/business/29893236_1_medical-errors-drug-names-phrma

Study Finds Slim Isn't Always Best
York University has published a study in Applied Physiology, Nutrition and Metabolism showing that obese people who are otherwise healthy live just as long as their slim counterparts, and are less likely to die of cardiovascular causes.

These findings challenge the idea that all obese individuals need to lose weight according to lead author Jennifer Kuk, assistant professor in York's School of Kinesiology & Health Science, Faculty of Health. "Moreover, it's possible that trying - and failing - to lose weight may be more detrimental than simply staying at an elevated body weight and engaging in a healthy lifestyle that includes physical activity and a balanced diet with plenty of fruits and vegetables," she says.

The study looked at 6,000 obese Americans over a 16-year span, comparing their mortality risk with that of lean individuals finding that obese individuals who had no (or only mild) physical, psychological or physiological impairments had a higher body weight in early adulthood, were happier with this higher body weight, and had attempted to lose weight less frequently during their lives. These individuals were also more likely to be physically active and consume a healthy diet.
http://pharmalive.com/news/index.cfm?articleID=798750&categoryid=9&newsletter=1

Inspection Deal Aims to Improve Generic Drugs
An agreement between pharmaceutical manufacturers and the FDA will force the scrutiny of overseas plants. Over 80 percent of the active ingredients for drugs sold in the US are made overseas, mostly in a network of facilities in China and India that are rarely visited by government inspectors, who sometimes cannot even find the plants.

After decades of failed attempts, the federal government and the generic drug industry have reached an agreement that should pass Congress and will lead to routine inspections of these overseas plants. Under this agreement, expected to be completed within weeks, generic drug companies (which make 75 percent of the prescription medicines sold in the US) would pay $299 million in annual fees to underwrite inspections of foreign manufacturing plants every two years, the same frequency required of domestic plants.

At the present rate of inspection, the FDA would need more than 13 years to inspect every foreign drug plant exporting to the US. Some plants have never been inspected, saving huge sums in cleanup and other compliance costs. This is one reason that drug manufacturing is disappearing from the United States.

OTC medications and vitamins are not affected. Aspirin and vitamin C supplements, among others, are now made almost entirely in uninspected plants in China.
http://www.charlotteobserver.com/2011/08/13/2524933/inspection-deal-aims-to-improve.html

 
Did You Know...

�that the USP has no enforcement power? It sets standards that are enforced either by the FDA or the State Boards of Pharmcy.

 
Upcoming Event

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 the above course, please contact USP Pharmacopeial Education at pharmed@usp.org.

 
Compounding Tip of the Week

The Useful USP
Become familiar with the USP/NF. There is a lot of information that is beneficial in promoting and ensuring quality compounding.

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