Editorial: Trends in Drug Shortages; Opportunities for Compounding, Part 2

Parenteral drugs, according to the article, account for between 53% and 60% of all drug shortages. Most commonly used categories of these drugs are anti-infective agents, central nervous system agents, hormone/synthetic substitutes, autonomic drugs, cardiovascular drugs and serums, toxoids, and vaccines.

An issue that is beginning to precipitate drug shortages is the attention being given by the FDA to the issue of "unapproved drugs," which generally fall into one of three categories.

Category 1: Drugs considered "DESI" drugs that were approved between 1938 and 1962; Congress requested that the FDA ensure that these agents are both safe and effective.

Category 2: Drugs considered "wrap-up" drugs that were marketed prior to 1962 and were never approved

Category 3: Drugs marketed after 1962 that were never approved

The FDA has agreed to remove unapproved manufactured drugs from the market gradually to prevent shortages of the products that they have categorized as medically necessary.

As mentioned last week, these shortages may provide opportunities for compounding pharmacies to fill in the gap until the shortages are resolved.


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

Swine Flu Vaccine: First Batch Produced
Novartis AG, a Swiss company, announced it has produced a first batch of experimental swine flu vaccine, a day after the World Health Organization declared the disease a pandemic. The vaccine hasn't yet been tested and cannot be used in humans yet.

This vaccine was made using cell cultures, rather than grown in eggs as is usually the case with vaccines, the company said. Vaccines grown in cells currently account for less than 5% of the world's vaccine production.
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1920421&contentType=sentryarticle&channelID=33e

Feeling sick? If so, the cause might have been bad chicken.
In 2006, poultry was the most commonly identified source of food poisoning in the U.S. It was followed by leafy vegetables and fruits and nuts.

Even though poultry is the most common source of illnesses among the 17 different foods tracked by federal officials, the Communicable Disease Center found that two-thirds of all food-related illnesses traced to a lone ingredient were caused by viruses, which are often added to food by restaurant workers who fail to wash their hands. These viruses often cause what many people refer to as a "stomach flu," and include nausea and vomiting that is unrelated to the flu virus.

Most of the poultry-related illnesses, the centers found, were associated with Clostridium perfringens, a bacterium that commonly causes abdominal cramping and diarrhea usually within 10 to 12 hours after ingestion. The spores from this bacterium often survive cooking, so keeping poultry meat at temperatures low enough to prevent contamination during processing and storage is critical.

Researchers counted leafy vegetables, fungi, root vegetables, sprouts, and vegetables from vines or stalks as separate categories; the Center for Science in the Public Interest, an advocacy group, noted that if all of the produce categories were combined, outbreaks associated with vegetables would have far exceeded those in poultry.

The centers found that salmonella, the bacteria found in nationwide outbreaks of contaminated peanut butter, spinach, and tomatoes, was the second-leading cause of sole-source food illnesses.

Researchers found that while dairy products accounted for just 3% of traceable food-related outbreaks, 71% of these cases were traced to unpasteurized milk.
http://www.nytimes.com/2009/06/12/health/research/12cdc.html?_r=1

Minor Illness or Major Disease? The Clinical Pharmacist in the Community
4th Edition
Edwards C, Stillman P
London, UK: Pharmaceutical Press; 2006

A physician and a pharmacist have joined together to write a very interesting book. This is a book that is interesting to just pick it up and start reading. It is divided into two sections: Part A-Responding to symptoms, and Part B-Preventative self-care. The 20 chapters in the book are interesting, well-illustrated, and easy to understand. Included in Part A are chapters on headache, cough, sore throats and colds, ear disorders, skin disorders, childhood ailments, and others. Part B discusses smoking cessation, travel health, and other topics. There are clinical case studies throughout the book. The format, appearance, and colorful illustrations make this a great addition to one's professional library.

�there are at least a dozen clinical trials of estriol registered with the government? More next week.

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