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Editorial: Does a "Limited Distribution System" fit the definition of "Commercially Available"?

There are a number of manufactured drug products today that are made available via limited distribution systems. The manufacturer selects certain pharmacies or facilities to handle the drugs and this procedure serves to limit access to the drug and may tend to increase prices charged for it.

The FDA Compliance Policy Guideline 460.200 Pharmacy Compounding, relating to what the FDA feels should not be compounded, item #8 in part states:

"Compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products."

The question to be addressed is "What does 'commercially available' mean? "Commercially available" is not the same as "commercially manufactured". We have generally looked at a manufactured product and its "reasonable availability" from wholesalers, direct from manufacturers, etc. If it is not available, then it can be compounded. For example, in the Tamiflu instructions on the FDA website, we read:

"These directions are not intended to be used if the FDA-approved, commercially manufactured TAMIFLU for Oral Suspension is readily available from wholesalers or the manufacturer."

Here we see FDA labeling about "readily available" as referring to the availability of the commercially manufactured Tamiflu for Oral Suspension. This means that if a pharmacist cannot get the product from wholesalers, distributors, etc., it can be compounded.

However, what about "limited distribution systems"? Some new drug products on the market are in this category and they are actually new chemical entities. However, the hydroxyprogesterone caproate injection was manufactured and marketed for years by E.R. Squibb as "Delalutin". After being discontinued, it has been prepared by compounding pharmacists. The new approval of Makena with a price of $1500 per dose (about 100 times what the compounded preparation cost) is ludicrous as well as it being offered through a limited distribution system.

A limited distribution system does not qualify for "commercially available" as it is NOT commercially and readily available to all. This is similar to a drug being unavailable in one part of the U.S. but stock still remains and it is still available in another part of the U.S. Compounding is appropriate where it is not readily available.

The question remains, "Is a limited distribution system commercially available or readily commercially available?" It doesn't appear to be if all pharmacists and other health professionals do not have access to it!


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

Editor's Note: We occasionally announce surveys through this newsletter to assist vendors in obtaining practical information to enhance their products from pharmacists that are interested in participating. This survey will be used to enhance products used in compounding pharmacies.

"We want to adapt our popular unit dose software so it can be used to label and bar code IV bags and compounded IV medications. Since the process and requirements of labeling IV medications is different than for unit dose medications, we need your advice. One completed survey will be drawn at random and awarded a $50 Amazon Gift Card on 3/31/2011!"
http://www.kwiksurveys.com/online-survey.php?surveyID=IHEIHH_6230fb60

FDA Cracks Down on Unapproved Cold and Allergy Drugs
The FDA has announced a crackdown on the sale of prescription cold, cough and allergy products that were never approved by the FDA to be safe and effective. Approximately 500 products have not been formally evaluated by the FDA and will be removed from the market. This is the latest in a series of actions by the FDA to stop the sale of a variety of products that are being sold without FDA approval.

With some reports of complications from the products, such as irritability and over-sedation, the FDA is unaware of how widely the products might cause problems or even how commonly the products are used.

Companies must stop manufacturing the indicated products within 90 days and stop shipping the products within 180 days. The FDA lists the products on its website, www.fda.gov. FDA officials stated that they were confident that consumers could get whatever relief they needed from cough, cold and allergy medications on the market by using the many over-the-counter and prescription products that had been approved by the FDA.
http://www.washingtonpost.com/wp-dyn/content/article/2011/03/02/AR2011030203206.html?moreheadlines

Editor's Note: This may provide additional compounding opportunities for compounding as these products become commercially unavailable.

Prescriptions for Truvada Slower than Projected
From sizzle to fizzle; Doctors are not prescribing Truvada for preventive use, at least not at the rate some predicted. Physicians say they're reluctant to treat healthy people with a drug that not only costs $12,000 per year, but also has potential side effects.

The drug was in the spotlight late last year when a study published in the New England Journal of Medicine showed that healthy men taking the drug regularly were 92 percent less likely to contract HIV than patients who received a placebo or who took the drug only irregularly.
http://www.bloomberg.com/news/2011-02-28/gilead-s-12-000-a-year-hiv-prevention-pill-fails-to-win-physician-support.html

J&J CEO Performance Bonus Cut to $1.98 Million in Light of Product Recalls; Base Salary to be $1.9 Million
The J&J Board cut the 2010 performance bonus of its chief executive, William Weldon, by 45 percent from 2009 levels to $1.98 million, according to a regulatory filing. The reduced bonus comes after a year in which the company experienced an endless stream of recalls of consumer health products (over 250 million bottles of widely used consumer products), medical devices and other products.

Weldon has said the company hopes to have all its affected products back on pharmacy and supermarket shelves by the end of this year after conducting quality-control inspections of its plants. It was explained that the Board's Compensation & Benefits Committee evaluates all their executive officers against a set of both financial and strategic objectives.
http://www.reuters.com/article/2011/02/25/jandj-ceo-idUSN259588620110225

Ibuprofen May Reduce Risk of Getting Parkinson's Disease
People who take ibuprofen regularly have a 38% lower risk of developing Parkinson's compared to those who don't use it, a new study suggests. The study is one of the largest to investigate the possible benefits of ibuprofen on Parkinson's. It was found that people who take ibuprofen regularly have a 38% lower risk of developing the condition, compared with those who don't use it.

The study, involving data from 136,197 nurses and other health professionals, suggests ibuprofen could be a potential neuroprotective agent against Parkinson's and was published in the online edition of the journal Neurology.
http://www.usatoday.com/yourlife/health/medical/2011-03-03-parkinsons03_ST_N.htm

PPIs Can Lower Magnesium
Nexium will soon carry a new warning that long-term use may cause low magnesium levels. Low magnesium can lead to complications, including muscle spasms, irregular heartbeat and seizures. If magnesium supplements do not help, patients may need to stop taking the drugs.

About 21 million U.S. patients filled prescriptions for the drugs in 2009; sales of Nexium, the market leader, topped $5 billion in 2010. The agency said there was little risk of low magnesium with lower-dose over-the-counter ulcer medicines if they are taken short term as directed.
http://www.reuters.com/article/2011/03/02/us-ulcer-drugs-idUSTRE7216AL20110302

Sampson's Textbook of Radiopharmacy, 4th Edition
Anthony Theobold
December 2010. Hardback, 768 pages, $129.99

This is a well-established text in nuclear pharmacy and has been completely revised and updated to incorporate new developments in the science and practice of nuclear pharmacy, or radiopharmacy. The demand for nuclear pharmacists continues to increase and this book is a great training resource.

The book is divided into (1) physics applied to radiopharmacy, (2) medicinal radio-elements, (3) radiopharmacology and radiopharmacokinetics, (4) radiopharmaceutics: formulation, preparation and quality assurance, (5) radiopharmacy practice, and (6) new techniques for design and testing of radiopharmaceuticals. These sections contain 37 chapters written by authors from different countries.

This book is well-illustrated and referenced and would be invaluable to those practicing radiopharmacy.

...that it's best to never cut what you can untie?

Legacies
Two thoughts about one's legacy:

1. It's not how you're buried; it's how they remember you.
2. If it's true you can't take it with you, then maybe it's about what you leave behind.

Pharmacies Wanted
Integrated Care Pharmacy (ICP) is acquiring compounding pharmacies nationwide. We are looking to purchase pharmacies with annual revenue in excess of $5 million annually and good margins. We offer competitive terms for the right pharmacy.
Contact CEO Cameron Horan 303.304.6347