More research required
I just wanted to give you some feedback regarding your editorial on CSPs. It seems as though you have not done much research regarding the subject. I manage a compounding lab in Redding, California, and am required to have several pharmacy licenses, including one for sterile compounding. I am also JCAHO accredited. Our licensing is by the California State Board of Pharmacy. The inspections are rigorous and meticulous. We are held to a strict standard, and are required to be compliant with USP 797, which is enforceable. We do extensive environmental and end-product testing. We have an outstanding record, and the implication of our danger to society is inappropriate. I am not sure of your agenda, but your editorial is inaccurate, misleading, and poorly researched.
-Rob Gussenhoven, Lab Manager
Owens Compounding Pharmacy, Redding, CA
The madder the better
Just a word of thanks for your glorious outrage in your June editorial.
It wasn’t long ago that a previous editor at your publication lamented the torture of his grandfather at the hands of an out-of-control CSP compounding operation. In the too-many years since, nothing has changed. The next time you’re unfortunate enough to find yourself in a hospital, you’ll no doubt stare askance at the IV being pumped into your bloodstream or the bloodstream of a loved-one, and wonder. And hope. As an educated, responsible, and unafraid member of the lay public, you have responded predictably upon finding out that you and your loved ones have only the protections that the hospital’s administrator feels like springing for; that practitioners are inadequately trained for this task; that 50 states are hopelessly meandering as to the level of USP 797 compliance they might, or might not, expect their pharmacies to achieve; and that FDA and the FD&C Act that is supposed to protect us have no jurisdiction here…and were actually bounced from this very special club in 2002 by a federal court.
But, you also know that, sooner or later, the horror is likely to find you, or a family member, or a friend. And it’s going to be terrible. Like Lincoln, NE, and Walnut Creek, CA, where a pharmacist tried to use 70 percent IP alcohol to sterilize a vial to be used in an intrathecal (Betamethasone; direct into the spinal column) preparation. Three people died, and thirteen were injured. The ongoing horror stories are endless and deliberately obfuscated with euphemisms like “medication errors” used to hide the fact that nobody-practitioner, technician, or nurse-is adequately trained or skilled for this life-and-death job; that, in hundreds of hospital, home-healthcare, and clinical pharmacies, marginal high-school graduates with attitudes are making sterile products for $7.50/hr. And they hate their bosses and coworkers because they’re always finding all these damned errors. Frankly, if there were any other source of 45 to 90 thousand needless deaths a year (IOM Report, 2000), why, you’d have determined senators shaking their fists on TV; but, not so here. It’s business as usual. And the public? Well, I guess they’re just the trusting public. The problem is that what they don’t know kills them, routinely. And the really sad part: It’s not that tough to fix.
-Greg Peters, President
Lab Safety Corporation, Cumberland, WI
Flawed facts
I am the compounding pharmacist for the largest medical facility-consisting of three main hospitals (soon to be four)-in Indianapolis, Indiana. Some of your “facts” in your commentary are flawed concerning pharmacists compounding sterile preparations and you seem to be confused on the roles of the FDA, PCAB, JCAHO, IACP, and the state boards of pharmacy.
Let’s start with the FDA. The FDA is a federal agency that monitors the food and pharmaceutical drug industry. The key word here is “industry.” The FDA has jurisdiction over the pharmaceutical manufacturers, not individual pharmacists or pharmacies. The FDA approves new drugs that are developed by the pharmaceutical manufacturers and sets the standards for this industry. The standards are based on the standards published in the United States Pharmacopeia/National Formulary. The USP is recognized by federal law in several acts concerning pharmacy law. Again, the FDA regulates pharmaceutical manufacturing; it has never had the authority and should never have the authority to govern individual pharmacists and pharmacies.
The state boards of pharmacy regulate individual pharmacists and pharmacies. They write the laws for pharmacy practice and enforce them. You are wrong in stating that pharmacists and pharmacies are “not legally required to conform to any sterility standard.” Almost all of the state boards of pharmacy (and possibly all) recognize the USP as the standards of practice for pharmacists and pharmacies and it is written into the state laws. Pharmacists and pharmacies are legally required to follow the USP standards and legal action can be taken if the pharmacists or pharmacies do not comply.
PCAB and JCAHO are accreditation organizations, but they are not legal bodies and they are not connected with the government. They do not have the legal jurisdiction to enforce the law. They do inspect facilities that apply for accreditation and perform thorough, tedious inspections before granting accreditation. This is not a process that anyone concerned takes lightly. Accreditation by these organizations ensures that the accredited facilities are meeting their high standards. If a facility is not meeting the high standards set by JCAHO or PCAB, it will not be accredited. This helps consumers and patients make decisions on whether to use the facility or not.
IACP is a professional organization for compounding pharmacists, as the AMA is a professional organization for medical doctors. IACP is also not a legal body and is not connected with the government, so it does not enforce pharmacy laws. IACP does have a code of ethics and writes policies concerning compounding pharmacy practice. IACP promotes the practice of compounding pharmacy through lobbying and provides education and support for compounding pharmacists and their patients. Professional organizations do expect their members to adhere to their code of ethics and policies and, like the PCAB and JCAHO, can deny membership to anyone who does not comply with the code of ethics or policies. Professional organizations do not have legal jurisdiction to enforce the law. Only the state boards regulate professionals, such as pharmacists, doctors, nurses, and other health professionals.
Compounding is not the same as manufacturing. Compounding meets the needs of individual patients who cannot take the commercial drug products. Over 80 percent of the FDA-approved drug products are not approved for pediatric use, so there are very few commercial drug products that are available in dosage forms that children can take. If the FDA had jurisdiction over compounding, a child would have to wait ten years for an NDA (New Drug Application) to be approved by the FDA before getting the oral suspension that he needs. The child needs to be treated now and cannot wait. Would you want one of your family members to be in that situation? If compounding were banned or made illegal, thousands of patients would suffer or die on a daily basis.
No one is asking the FDA to get involved in regulating pharmacy compounding except ignorant individuals and organizations who are misinformed about the practice of compounding pharmacy.
-Linda F. McElhiney, Compounding Pharmacist
Clarian Health Partners, Inc., Indianapolis, IN
Clear and courageous
Congratulations! Thank you for your courage and for so clearly defining the issue. I hope this leads to the regulatory scrutiny that will ensure the safety of patients receiving CSPs.
-Russell E. Madsen, President
The Williamsburg Group, LLC, Gaithersburg, MD
Further study suggested
Your misinformation about compounding, made evident in your editorial is going to come back to bite you.
Who do you think your customers are? I’m connected to a network of hospital, home-infusion and sterile-compounding pharmacists across this nation and on several continents. I plan to share your views with my network of colleagues. I am sure they will “vote with their dollars.” I hope you get their message. Maybe after more study you might print a retraction/correction to some of your misstatements. They are legion.
-Mark Burger, Pharm.D.
Health First! Pharmacy, Windsor, CA