Is this legal in Texas

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romaniangirl

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So, I came across a cancer facility here in the suburbs of Houston. They provide chemotherapy directly from their office. I went with a family member for their treatment and was able to talk to the staff. The pharmacy technician told me that she compounds all of the chemotherapy by herself. There is no pharmacist supervising her work or in the near vicinity. The room where they compound is not a sterile room, and she is not sterile when she compounds. The room is highly traveled in and out by other nurses and staff and does not have a door or anything. Just one hood with a fridge containing the drugs.

Is this legal in Texas? I tried to look up the law on TSBP, but couldn't find anything that states that she can fill these medication orders herself or that this facility can dispense the chemo without a pharmacist. Could I be missing something? Robotic compounding or something that makes this legal?

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That office is just asking for trouble one day over the sterility issues. I would not want to get my cancer treatment there. The highest level of protection is expected for chemo compounding; i.e. vertical hood, sterile room, etc. What you are describing is not compliant with USP 797. They could potentially get into trouble with the state board of pharmacy over this.

Since it is in a physician's office, my guess is that the physician is doing the actual dispensing. He/she would be liable if the tech made a mistake. The physician is supposed to check the chemo before giving it to patient.
 
Yeah there is definitely no physician checking the chemo when the tech compounds it. I also thought that physician dispensing in the state of Texas (minus emergent cases and samples) was illegal at this time. No pharmacist checking for appropriateness, and as an almost P1, I have to take it upon myself to figure out if there are any interactions and such. It is a major office here in the Houston area with multiple locations, so I thought they would have known better, especially with MDACC only 20 minutes away.
 
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It's not okay:

Immediate-Use CSPsThe immediate-use category should be reserved for emergent use or situations in which adhering to low-risk compounding procedures would add additional risk due to delays in patient care. Examples of such situations may include cardiopulmonary resuscitation, diagnostic procedures, or short-stability medications that must be prepared immediately before ad- ministration outside health care facilities (e.g., in home infu- sion or emergency care at the accident site or in an ambu- lance). Immediate-use CSPs do not need to be compounded in an ISO Class 5 environment and garbing and gowning are not required, as long as all of the following criteria are met:• • • ••• •Hand hygiene per CDC recommendations46;Aseptic technique is followed;No hazardous drugs are used;Only simple transfer of no more than three sterile, non-hazardous drugs in the manufacturer’s original containers are involved in the compounding, and no more than two entries into any one container occur; No more than 1 hour elapses from the time compound- ing commences to the time administration to the pa- tient begins (although best practice dictates that there are no intervening steps between compounding and administration);No batching or storage of CSPs occurs; andThe preparation is labeled with patient identification, names and amounts of all ingredients, name or initials of preparer, and exact 1-hour BUD and time.

From http://www.ashp.org/DocLibrary/BestPractices/PrepGdlCSP.aspx
 
Yeah there is definitely no physician checking the chemo when the tech compounds it. I also thought that physician dispensing in the state of Texas (minus emergent cases and samples) was illegal at this time. No pharmacist checking for appropriateness, and as an almost P1, I have to take it upon myself to figure out if there are any interactions and such. It is a major office here in the Houston area with multiple locations, so I thought they would have known better, especially with MDACC only 20 minutes away.

The physician is not "dispensing" unless he is sending them home with a labeled bag of chemo. He is "administering" which is almost certainly legal. Doesn't mean it is a good idea.
 
Not sure about TX law, in IL, it is legal for a pharmacy tech (or a nurse) to prepare chemo for administration by the physician in his office (even if he isn't checking it, he would still be legally liable if something went wrong, because he is supposed to check it.) As Chalupa said, not really a good idea, but legal. However, the non-sterility of the whole situation, is bad, bad, bad. That is against all standards and could/should get the physician in big trouble. Hopefully he gets in trouble and/or changes his ways before deaths occur.
 
I just can't believe these facilities get past OSHA. Don't they come in yearly or every few years and do an inspection? This facility has been open for 20 years. I'm just curious if they have a law they use to get around USP 797 standards. I'm really worried about my mom who is getting her treatment there.
 
I would hope if this is legal, that the board of pharmacy is able to inspect and regulate it. Isn't it against USP 797 to not have a vertical hood for hazardous compounding like prepping chemo drugs? Not only is a non-sterile environment dangerous for patients but lacking protection may also be dangerous for the tech/nurse preparing it. In all honesty if this is somehow legal, it shouldn't be.
 
I would hope if this is legal, that the board of pharmacy is able to inspect and regulate it. Isn't it against USP 797 to not have a vertical hood for hazardous compounding like prepping chemo drugs? Not only is a non-sterile environment dangerous for patients but lacking protection may also be dangerous for the tech/nurse preparing it. In all honesty if this is somehow legal, it shouldn't be.

I think I've seen the hood. I couldn't see the front of it, but the back certainly looks like a vertical hood to me (not that I'm an expert or anything). But the tech goes in and out of the room, doesn't gown up, and uses the same gloves she compounds in to touch other things like the computer, desk, etc. I mean there isn't even a door to this area and it's smaller than the average closet. I just have no idea how they get around USP 797, and I've tried asking some different questions but to no avail.
 
Legal or not it sounds insane for the patients and the poor tech having to prep the chemo. OSHA would prob **** a brick with a laminar flow hood and chemo drugs
 
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