Compounding This Week Newsletter from www.CompoundingToday.com
Brought to you by the International Journal of Pharmaceutical CompoundingHeader
January 28, 2011 Volume 8, Issue 4
  In This Issue
 
  Classifieds

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

 
  About
  CompoundingToday
 
  Free Resources
 
  Subscriber
  Resources
 
IJPC Calculations CD

Letco Medical - Your Complete Source for Compounding Chemicals, Equipment, and Supplies
 
Loyd V. Allen, Jr., Ph.d., R.Ph  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.


Editorial: Drug Shortages

Drug shortages are increasing in frequency and severity. In the past, when shortages occurred, the company could relatively quickly obtain additional API and manufacture the product to ease the shortage. Things are not so easy now as the API in 80% of the cases comes from other countries. If, for some reason, the API, after it is received, does not meet the standards for the API, then more time is wasted. If the API gets held up in customs, etc., then the shortage continues for a longer period of time. Transportation delays and many other factors can result in delays in getting the API to the manufacturing facility. Other reasons include noncompliance by the manufacturer to FDA regulations that result in a hold on manufacturing activities. There can be many reasons for delays in production that result in drug shortages.

As of January 25 on the FDA website, there were almost 50 drug products in short supply. This lists includes many different injections as well as several oral solid dosage forms. The current list can be seen at:

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

Drug shortages also include higher concentrations of sodium chloride injection products that now can be compounded. Drug shortages are a great opportunity for compounding pharmacies to "fill in the gap" during the time period the shortages are in effect.

Next week, we will look at "Discontinued Drugs," the problems that might arise, and how compounding pharmacists can contribute to this increasing problem.


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

 
Other News

Sodium Thiopental Discontinued
Sodium thiopental, a drug used in executions, will soon no longer be available. Hospira has stated it did not intend for the drug to be used in executions. It planned to start making sodium thiopental at a plant in Italy, but Italian authorities required the company to guarantee the chemical would not be used in executions; capital punishment is outlawed in Italy and throughout Europe. With the issues surrounding the product along with the requirements and challenges of bringing the drug back to market, Hospira has decided to discontinue the product.

In addition to its use in executions, sodium thiopental is used as an anesthetic for brief surgical procedures and some kinds of hypnosis. Many state prison systems have run out of the drug and some states have turned to pentobarbital.
http://news.blogs.cnn.com/2011/01/21/sole-maker-of-execution-drug-says-its-pulling-out-of-market/

Using Small Syringes to Prepare Small Doses of Medication from Syringes May Be Inaccurate
Preparing small doses of medications from syringes can be inaccurate and lead to dangerous dosing errors for infants and small children. The problem addressed in a recent study is that small doses of potent drugs for young patients are often prepared using volumes of less than 0.1 mL; however, the syringes often used do not permit the accurate measurement of volumes that small. Medications often involved include narcotics and sedatives such as morphine, lorazepam, and fentanyl, as well as immunosuppressants.

In both hypothetical and clinical studies, the investigators looked at 71,218 intravenous doses given to 1,531 infants and children admitted to an intensive care unit in 2006. Of those, 7.4 percent required volumes of less than 0.1 mL of stock solution, and 17.5 percent required volumes of less than 0.2 mL.

The small volumes are required because of the relatively low doses needed for infants and young children and the relatively high concentrations of commercially available products. This study appears in the current issue of the Canadian Medical Association Journal.

(Editor's Note: Compounding pharmacists can assist by preparing more dilute preparations where larger volumes can be measured more accurately.)
http://consumer.healthday.com/Article.asp?AID=649085

Pharmacy Blows Whistle on Fraud
One of the most successful whistleblowers of recent years has been a pharmacy. The pharmacy is Ven-A-Care, a Florida pharmacy that appears to have whistleblowing as its primary business, not a sideline. The majority of its revenue is reported to come from PHARMA settlements; amounting to about $168 million last December alone.

The pharmacy investigates drug-pricing data, looking for major discrepancies between the prices it paid for drugs with the prices drugmakers report to the federal government. When large differences are found, it sues. Since 2000, the pharmacy has won 18 fraud suits, and its share of those settlements amounted to about $380 million. The individual states and the federal government received $2.2 billion.

The deputy attorney general for California says that Ven-A-Care has played a key role and possibly the predominant role in alerting state and federal governments about fraud. The article also states that the government recaptured a record $4 billion last year from pharmaceutical companies, hospitals, doctors, nursing homes, and other providers of care that defrauded federal healthcare programs.
http://www.fiercepharma.com/story/tattletale-pharmacy-blows-whistle-pharma-fraud/2011-01-25?utm_medium=nl&utm_source=internal

 
Did You Know...

�that you don't have to be a licensed manufacturer to compound commercial products that are not available due to drug shortages during the time period they are in short supply? Pharmacies must abide by state laws and regulations governing pharmacy practice.

 
Compounding Tip of the Week

Shortage Info
Keep up with drug shortages by joining the e-mail subscription service available from the FDA at: https://service.govdelivery.com/service/subscribe.html?code=USFDA_22 .

Copyright 2011
International Journal of Pharmaceutical Compounding, Inc.
122 N Bryant Ave, Edmond OK 73034
Reprints & Permissions: Reprints@ijpc.com
Manage my Email:
Subscribe / Un-Subscribe
Comments or Questions:
info@compoundingtoday.com