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Editorial: Looking Forward 2012, Part II

This is the second in our series on issues involving pharmacy compounding. In this issue, we will briefly discuss "How many prescriptions are compounded today?"

I routinely get calls from the press, from venture capitalists, from pharmacists, etc. asking the simple question, "What percent of prescriptions are compounded today?" The answer is very simple, "Nobody knows!" There is no organization that keeps track of compounded prescriptions. The State Boards of Pharmacy do not, the pharmacy organizations do not, the third-party payors can't, etc. So, let's briefly look at the history of compounding to see if we can get a handle on where we are.

1. Prescriptions have been compounded since antiquity! From plants, animals, and the earth, early medicines were compounded. This continued, and it progressed from very rudimentary to a more sophisticated practice, until the 1900s.
2. In the late 1800s and early 1900s, the industrial revolution brought in large-scale production of compounded medications.
3. In the 1930s, about 75% of prescriptions required some compounding by a pharmacist.
4. In the 1950s, about 25% of prescriptions required some compounding.
5. In the 1970s, the extent of compounding was "estimated" to be about 1% (however, this only included retail pharmacies). Remember that in the 1960s and 1970s, intravenous admixture programs were implemented in pharmacy departments in hospitals.
6. In the 1970s and 1980s, compounding began an upward climb with the introduction of bioidentical hormone replacement therapy, pain management, veterinary compounding, etc.
7. The growth was sufficiently significant that the USP again looked to its roots in compounding and began setting standards for patient safety that state boards of pharmacy could use.
8. At the turn of the millennium, compounding continued to increase as a percentage of the total number of prescriptions dispensed.
9. A survey was performed by NCPA and some of the results were:
• Over 75% of community pharmacies compound
• Virtually 100% of hospitals do some type of compounding (IV admixtures, pediatric formulations, in-syringe admixtures, etc.)
• Veterinary compounding is now a full-time specialty in many locations
• Chain pharmacies now have compounding centers in their organization
• Home health care has been instituted and continues to grow
• Specialty compounding centers have been developed to serve the needs of some hospitals that did not have the facilities or expertise to compound
• Nuclear pharmacy continues to grow
10. Today, drug shortages have escalated compounding to a new contemporary all-time high, as well over 250 drugs have been in short supply this year and the problem may continue for many years to come. Pharmacy continues to serve and "fill-in-the-gap" during these times of drug shortages.

So, in answer to the question, "How many prescriptions are compounded today?" A reasonable estimate would be somewhere in the vicinity of 10%, which is significant. That number really has no scientific basis but is just an estimate from observing the practice for many years, looking at the growth of the number of compounding pharmacies, the number and growth of compounding support companies, and the general observation and discussion with leaders in this area of pharmacy practice. It is frightening to think of where we would be without compounding!


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

Millions of Dollars in New Drug Fees to Go to the FDA
Under an agreement between the FDA and industry, the FDA would collect hundreds of millions of dollars in new fees from pharmaceutical companies to help speed up the review of generic drugs.

The user-fee proposal is being submitted to Congress for approval by lawmakers. The agreements would each charge drug manufacturers application fees for traditional drugs, generic drugs, and generic biotech drugs. The FDA plans on collecting $299 million in fees annually to hire additional generic drug reviewers starting in fiscal year 2013.
http://www.washingtonpost.com/politics/fda-would-collect-299m-fees-annually-to-speed-up-review-and-clear-backlog-of-generic-drugs/2012/01/13/gIQAjepbwP_story.html

FDA Fines the American Red Cross $9.6 Million
The American Red Cross, the biggest U.S. supplier of donated blood, was fined $9.59 million by the FDA after they found that 16 of its facilities failed to comply with blood-safety rules. The FDA inspectors found "significant violations" from April 2010 to October 2010, including inadequate "managerial control," record-keeping, and quality assurance.

The FDA found no evidence that the lapses led to serious health consequences for blood recipients. The fines result from an inspection conducted 15 months ago at the organization's Donor & Client Support Center in Philadelphia. Red Cross officials state that "We are disappointed that the FDA believed it necessary to issue a fine for an inspection conducted so long ago, and it is important to know we have already taken corrective steps to address those matters and that improvements in operations have been made."
http://www.businessweek.com/news/2012-01-18/american-red-cross-fined-9-6-million-over-blood-safety.html

[Editor's note: This appears to mean that the FDA is now supported by our (1) taxes, (2) by user fees from the pharmaceutical industry, and (3) by our donations to charities.]

J&J Pushed Risperdal for Kids without Approval
In 2004, Johnson and Johnson marketed its Risperdal drug to doctors working with troubled children even though regulators hadn't approved the drug for those patients. J&J's Janssen unit pushed its salespeople in Texas to "flood clinics with Risperdal stuff" as part of a 2004 campaign to increase prescriptions for the anti-psychotic drug written for children and adolescents. The FDA did not approve Risperdal for any pediatric use until 2006.

Texas officials contend that J&J defrauded the state Medicaid program by promoting Risperdal for uses not approved by the FDA, including for children with psychiatric disorders.
http://www.bloomberg.com/news/2012-01-17/j-j-unit-pushed-risperdal-for-kids-without-approval-jury-learns-from-memo.html

Research Chemist Steals Trade Secrets and Sells to Chinese
A Sanofi-Aventis research chemist pleaded guilty to stealing trade secrets from the pharmaceutical giant and making them available for sale through a Chinese company.

Yuan Li, 29, of Somerset, New Jersey, pleaded guilty to one count of theft of trade secrets. A Chinese national, Li worked as a research scientist at Sanofi's U.S. headquarters in Bridgewater, New Jersey, from August 2006 to June 2011, where she directly helped develop a number of compounds that could possibly serve as building blocks for future drugs. Simultaneously, Li also was a 50 percent partner in Abby Pharmatech Inc., a U.S. subsidiary of a Chinese chemical company engaged in the sale and distribution of pharmaceuticals. Li faces up to 10 years in prison and a $250,000 fine. http://in.reuters.com/article/2012/01/17/sanofi-chemist-idINDEE80G0NN20120117

�that in the January/February 2012 issue of IJPC there are two articles related to the decline in the teaching and emphasis on science in pharmacy education and practice at a time when compounding is significantly growing and is based on the "science" of pharmacy?

Education Efforts
We need to reverse the trend of the decline of the sciences in pharmacy education and work with our colleges of pharmacy to make a concerted effort to enhance the science basis of the practice of pharmacy.

Cautious rider
To her reckless dear,
Let's have less bull
And a little more steer.
      Burma Shave

PCAB is proud to announce the accreditation of the following pharmacies:

AmEx Pharmacy, Melbourne, Florida - Initial Accreditation: Mark Sangree, BS, President; sangree@amexpharmacy.com; Sterile and Nonsterile Compounding (January 13, 2012)

Apothecary Shop of Tucson, Tucson, Arizona - Initial Accreditation: Mark Boesen, PharmD, Vice President, Regulatory and Government Affairs; mboesen@theapothecaryshop.com; Sterile and Nonsterile Compounding (January 13, 2012)

Central Compounding Center South, Durham, North Carolina - Reaccreditation: Jon Pritchett, PharmD; Pharmacy Manager; customrx@gmail.com; Sterile and Nonsterile Compounding (January 1, 2012)