Showing posts with label Doletta Sue Tuck-Richmond. Show all posts
Showing posts with label Doletta Sue Tuck-Richmond. Show all posts

Tuesday, June 11, 2013

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 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.

Friday, March 1, 2013

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.

Sunday, January 27, 2013

Damage Control 101: What Does the Compounding Industry Need to Do?


While serving as the appellate chief at the United States Attorney's office one of my main responsibilities was damage control or working to prevent issues on appeal.  In other words, when there was an emergency issue or problem my department dropped everything we were working on, pressed full steam ahead and found a solution or resolution to the emergency.  Most of the time we had less than 30 minutes to understand a complex issue, research it, and reach a decision.  Sometimes the emergency came in the middle of the night.  Sometimes it came when we had numerous other deadlines. Sometimes it was a federal judge waiting on us for advice. Sometimes it was a federal agent waiting on us for advice.  Sometimes it was defense counsel waiting to see what position we would take with regard to a client.  Sometimes we were not allowed to make the ultimate decision because we represented the Department of Justice.  Thus, we had to represent their views and positions, even if contrary to our individual views. However, contrary to what the public might think, the position was never about winning; the position was always about justice and doing what was right even if it meant confessing error and admitting our mistakes.

There is currently a push to do "damage control" in the pharmacy world and more specifically in the compounding world.  For example, in Forbes magazine dated 1/18/13 there is an article entitled, Pharma's Reputation Continues to Suffer -- What Can Be Done To Fix It?,  The article concludes with:

The pharmaceutical industry plays a valued and unique role in healthcare. The discovery and development of new drugs is largely driven by it. Any major treatment or cure for Alzheimer’s disease will likely come from these companies. Unfortunately, the importance of this industry is lost on the vast majority of patients due to the attacks on the industry’s credibility. It is time to take the necessary steps to change this negative perception.
Do you think the compound world has unfairly received a negative image after cases such as NECC and Franks?  If the compounding world has a negative image, what steps do you think the compounding world needs to take to change its negative perception after the NECC outbreak?  Do you think the compounding world has tried to take responsibility for the errors and mistakes made or do you think they have tried to shift blame to places like the FDA and state boards of pharmacies?  Do you have more trust and respect for compounding pharmacies and pharmacists when they admit there are mistakes in the industry and they work to find a solution rather than blaming the mistakes on others?  What type of damage control do you think needs to happen in both the pharmaceutical industry and more specifically in the compounding industry?