Questions Being Asked By Boards of Medical Examiners to Doctors About Compounded Medications /Potential Questions to Ask During Investigations

Sue Tuck Richmond

June 11, 2013

Various sources are reporting to the blog that State Boards of Pharmacy (BOPs) have begun requesting very specific information, such as pre-printed prescription pads, office-use, from physicians about compounded medications. Physicians are normally governed by state Boards of Medical Examiners with BOPS having no direct jurisdiction over them.  Nonetheless, when BOPs begin questioning physicans about compounded medications this can strain the relationship a pharmacist and a pharmacy has with a physican.   Both the Pharmacist and the Pharmacy should be aware of some of the question be asked by the BOP.  Some of the questions pharmacists and pharmacies should be aware of are:

1. What percentage of the drugs you prescribe are compounded medications?
2. What percentage of the drugs you prescribes are compounded pain medications?
3. What percentage of the drugs you prescribe are compounded medications for patients in state?
4. What percentage of the drugs you prescribe are compounded medications for patients in state?
5. If a pharmacy supplies your office with a pre-printed prescription pad listing the compounded products that you would prescribe for a patient, once a prescription pad is completed with the what does your office do with this? Please explain all scenarios that have taken place.
6. After a pharmacy fills the compounded drug, how does the compounded product reach the patient? Are drugs sent to your office for the patient to pick up? If so, what is the process? Please explain.
7. If compounded products are sent to your office for patient pick up, please explain what is displayed on the outside of the prescription vial?  If there is a label, what information is on this label? Please explain.
8. Has a pharmacy sent any of the compounded products to your office for "office use"? Please explain.
9. What other ways besides pre-printed prescription pads do you prescribe compounded products for patients? Please explain.
10. What are the percentage and the actual number of the prescriptions issued by your office using a pharmacy pads that are for patients residing in state?

Note these are also potential questions that Boards of Medical Examiners and Boards of Pharmacies can use during their investigations.  These questions could also be asked of the veterinarians using compounding medications and compounding veterinarian pharmacies.

A View of This Blog : A Year Ago, At This Very Moment in Time, And A Year From Now

By Sue Tuck Richmond                                      

Country	Pageviews
United States	27
Germany	25
China	8
Afghanistan	1
France	1
Japan	1

Russia                                                        1

Vietnam                                                   1

As a former Appellate Chief/Assistant United States Attorney, I like to see what areas of law are developing and have potential issues.  Over a year ago I ran across a case that caught my eye involving compounded medications and the death of 21 polo horses. At the same time, I was talking to a friend from college and had learned that he worked in the compounded medication world.  The idea for this blog came to me one night after realizing this was a hot new area of law and there were no blogs that exclusively addressed the law of compounding. I also wanted to help my friend by providing a go-to source of knowledge for the compounding world.  

I discussed my idea with no one.  I didn't even know how to set up a blog, but taught myself.  I loved learning how to create the blog.   I found the area  of law exciting and interesting. I felt it was going to be quickly developing in light of the Francks case. My second blog post-- right after the first explaining what compounding was--involved  the Facts of the Francks Case.  I soon learned it was being appealed to the 11th Circuit Court of Appeals.  I wrote a post explaining the appellate process, Franks case:  Appellate Process Explained.  I posted the documents--the briefs, the declarations, the record for the case.  I soon learned of and discussed another case from Dallas--Apothecure and Gary Osborn, where the Department of Justice/United States Attorney's Office had brought criminal charges in a case involving the death of humans from bad compounding.  I found more and more interesting story the more I researched and the more I talked to my friend who answered my questions.

The blog grew so rapidly at one point I thought I would need several assistants just to do the research, post and free me up to write. But instead I decide to forge ahead doing the research and writing as I had time and could. Nonetheless, experts and friends helped by pointing out topics, areas of interest, writing comments, posing questions, and helping search for solutions.  I thank all those who continue to provide me with sources of information, answers, knowledge and encouragement.

Today the blog has over 3000 posts.  It has almost 68000 views in less than a year.  It is viewed by well over 80 countries.  Above is a snapshot taken moments a go, of the countries viewing the blog as I write this post. Everyday I am still amazed at the work being done to help make compounding safer and to prevent future deaths of both humans and animals. Not all agree on the solution, but all should agree that these deaths are tragic.    Something must be done.  Something must change. Not all compounders are bad.  There are good compounders who play by rules, but they are getting overlooked by the number of bad compounders who haven't played by the rules.  I do believe that the more people who discuss and debate the issues, the better chance of a workable and effective remedy--whatever that remedy may end up being.

In any event,  there are more post to write, more news to report, and more laws rules and regulations to analyze. Thank you for reading over the past year.  May we find solutions that save lives during this next year.

Rebuttal to "Just Say No To (Unapproved) Drugs for Horses"--Why You Can't Just Say No to Compounded Preparations

by Sue Tuck Richmond

Last night I posted an article entitled " Just Say Not to (Unapproved) Drugs for Horses."  Some might questions why I would post this, but as I have stated before I try to present all views on the blog and not just advocate one position.  After thinking about this article overnight, I felt the need to post a response to it. In the legal world we call this playing devil's advocate--presenting or arguing the other side.  And, I woke  up feeling the need to present  the other side of the argument.  First, I must state a disclaimer.  I am not an expert at all on drugs for horses nor do I pretend to be.  However, I feel certain that there are drugs or medicines that must be compounded for the treatment of horses, thus again making compounding essential and necessary in the veterinary world.  I will leave it to the readers who are experts about horse medications to tell the readers when the essential and necessary times are.  It is true that animals have died from bad compounds.  This can be blamed on a lack of enforcement of the rules and regulations, a lack of proper testing, lack of stopping those who cut corners and use substandard powders, don't have sterile rooms, and really don't care whether their preparations are any good or not.  Ultimately it is about allowing bad compounders to remain in business and compete against the good compounders, who are following the rules and regulations--who are doing the testing, who do have clean, sterile rooms, who don't cut corners or use substandard powders, who do care and take ever step to make sure their preparations are what they say they are.  It is easy for a manufacturer of FDA approved drugs to say "just say no." However, just saying no to unapproved drugs for horses or any animals cannot be the answer as this article suggests.