Editorial: Freedom Celebration (including the freedom to compound)
At what price, Freedom? Most of us probably wake up without much thought given to the costs to those who have provided us with one of the most fantastic gifts any society can experience; freedom! I am often reminded of the last scene in "Braveheart" where Mel Gibson, as he is being tortured to death, instead of giving in, yelled at the top of his lungs, "Freedom!!!!" And, we must remember, respect and pay tribute to all the veterans that have served so admirably; some at great cost to their bodies and some even giving their lives.
When one looks over history and the founding of this great nation, it was so the citizens could experience freedom, away from the oppressive influences of the state, the political-state-church, political wannabes and those with a drive for power and money in England.
It's interesting when we look at the founding of the United States and the basis of its laws, government, etc. Our forefathers had the vision to establish a government that would allow all to be free, work, play, worship, grow and excel, if they desired; and it has worked for the most part. One interesting observation is that as I have traveled over most of the world, the same as many of you, I have not really found a country that has experienced the financial, social and economic success that the U.S. has along with the freedom that we enjoy. We are truly fortunate and should strive to keep all that has made this nation great from changing. It seems that we are losing many of our freedoms because of the actions of a few; this needs to be stopped so we can re-gain the freedom upon which our nation was founded.
How does this relate to pharmacy compounding? It's easy. Pharmacy compounding has historically been the mechanism for providing individualized medications for patients. Despite the industrial revolution in the late 1800s and 1900s, pharmacy compounding is still very, very important and growing rapidly. Pharmaceutical manufacturers have grown and serve a great purpose; but they cannot serve all patients. Related to the pharmaceutical manufacturers, the U.S. government, in 1938, established the Food and Drug Administration to oversee the pharmaceutical manufacturers to ensure that safe and effective drugs are marketed; this was good and proper.
However, as with many "good" things that come from the government, there sometimes tends to be expansion of various agencies and some associated problems. For example, the FDA has been impacting pharmacy compounding for the past several years; HIPAA has grown far beyond what it was intended to be; OSHA and EPA regulations have driven most chemical/drug synthesizers out of the U.S. due to the high costs of compliance; most oil refineries have closed down and left the U.S. for the same reason, etc. These are examples of good intentions gone awry resulting in higher costs of drugs and other commodities, and even gasoline. Why is it that many simple laws are expanded far beyond what they were originally intended to be? Why is it not possible to restrain expansion of the government into areas in which it has not really been given authority and the citizens no longer have much say? Kind of reminds you of the way things were back in England the 1700s at the time of the American Revolution.
What's the point of all this? The point is that for pharmacists that are involved in compounding (and it involves thousands and thousands of us), including hospital intravenous admixture services, home healthcare, etc., to continue doing what needs to be done for the patient's benefit, we, too, must work to retain the freedom that we have and keep it from being taken away.
I'm not talking about poor quality, inappropriate compounding, dangerous activities, etc., as those issues must be appropriately addressed. I am referring to conscientious pharmacists that work day after day with physicians providing quality compounded prescriptions for their patients. Can we lose this freedom? Yes, it is possible. To retain it we must all work to educate and inform our patients, elected officials and be active in our profession. The days are past when we can sit back and think that, as Pollyanna said, "it will all work out okay", because it won't. One only has to look at the U.S. to see what happens when we sit back and let things ride. We need to all get involved and help protect patients rights to individualized medications through pharmacy compounding.
We at IJPC wish you all a Happy July 4th, or Happy Freedom Day!
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief |
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This Regulatory Update has been provided by the International Academy of Compounding Pharmacists. For more information, www.iacprx.org.
USP Appropriations Request for Compounding Monographs
On June 21, the Senate Appropriations Agriculture Subcommittee held a mark-up hearing for the Fiscal Year 2006 Agriculture Appropriations bill, which includes funding requests for FDA among other departments. The FY 2006 Appropriations bill also included a request by USP for $2 million to fund development of monographs for compounded formulations. The subcommittee ultimately approved $750,000 for the USP proposal. The full Senate Appropriations committee approved the FY 2006 Agriculture Appropriations bill on June 23, which also included the $750,000 award to USP. More informatiion on the monograph initiative is provided on IACP's website. Read the committee's press release here.
FDA Update on Domperidone
On May 18, FDA published a webpage entitled, "How to Obtain Domperidone." It appears that FDA has recognized a medical need for domperidone indicated for treatment of gastrointestinal disorders. However, FDA encourages that domperidone prescribed for these purposes be obtained via an Investigational New Drug application (IND). FDA continues to express concerns with domperidone associated with lactation. For more information, visit http://www.fda.gov/cder/news/domperidone.htm
Oklahoma Adopts VAWD & Pedigree Requirements for Wholesalers
In early June, Oklahoma governor, Brad Henry, enacted SB 640/HB 1347, which codifies NABP's Verified Accredited Wholesale Distributor (VAWD) program and mandates that the Oklahoma State Board of Pharmacy establish drug pedigree regulations. The content of these regulations will be critical, as they may specify whether the law will be applied only to distribution of finished, FDA approved drug products or include the ingredients used in compounding.
Crawford Nomination Update
In mid-February, Acting FDA Commissioner Lester Crawford was nominated to permanently fill the post of FDA Commissioner. The confirmation process for this nomination has been ongoing and has encountered several delays. On Wednesday, June 15, Crawford's nomination was approved by the Senate Committee on Health, Education, Labor and Pensions (HELP). The nomination will now move forward for a full floor vote in the Senate. No date has yet been set for full Senate consideration and further delays in the confirmation are likely.
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