Tuesday, September 30, 2014
Question of the Day September 30, 2014 Who makes the decision regarding how much or what percentage of a drug a patient needs to take? In reading a recent post of a compounding discussion group the compounding pharmacist indicated she was having trouble getting the amount of the drug that needed to go into the compounded medication correct.
First, as I have pointed out before, this is very troubling to me that a compounding pharmacist seems willing to take advice on such a question from a discussion group. This shows the huge problem of compounding pharmacists not being properly trained or educated in order to be able to compound prescriptions. It also started me thinking about how the process of prescribing drugs works and should work. When it is a manufactured drug that has been through the FDA-approval process, the doctor determines the dosage of that manufactured drug. The amount of the api has already been determined by going through the trials and studies. However, from reading the question posed in the discussion groups, it is appears that in a number of compounded drug cases it maybe the compounding pharmacist determining the dose and the percentage of api to give to the patient, which again points to the fact that these are new drugs that have not been through the FDA-approval process. This is different from taking out fillers and additives of a commercially available because it is medically necessary. This poses a number of issues. Should this be happening? Are doctors educated on compounded medications and knowledgeable enough to make these calls? Isn't this scary to the patient to think your compounded medication may be made from a recipe on the Internet? Should there be more training and education of doctors on compounded medications and their use? Do new ethical guidelines between doctors and pharmacists need to be adopted? These lines seem very blurring and ones where compounding pharmacists found a way to make profit, focused on that, and didn't really think through all the legal and ethical issues. Speaking of legal issues, if pharmacists are crossing over into a defined area of "practicing medicine without a license" --then this could be a criminal act that could be prosecute and of course there are also the possibility of civil liability. What is clear is that this area of law is still developing in the courts.