Why Are IV Drugs So Expensive- Part 1

Why are IV drug so expensive?
Why are IV drug so expensive? Not surprisingly, that’s a question I often hear when people must pay for their therapy.
Well, the answer is both simple and complex. Simple, because many of the raw ingredients are expensive! Complex because there is a lot that goes into the manufacture of your IV preparation. If you saw us mix your drug you’d think our staff was walking into an operating room. We are literally covered from head to foot, with a cap then face mask, a gown, and booties worn over our shoes. Our hands are covered with sterile gloves, and then sprayed with sterilized alcohol! All of those body coverings cost something! While not a lot, over the course of the days and weeks they add up, especially when there are 4 or 5 people using going into the clean room.
The Procedure
Before a medication is even mixed there’s a lot of preparation that goes into procedure. Every morning one of our staff gown up and go into both our clean rooms and scrub the room with a special antibacterial solution. The floors are scrubbed, the counters and the walls. Once a week the ceiling is scrubbed with that solution too!
Why two clean rooms? Because we mix chemotherapy agents, and the hood (that device that is used to mix drugs) is different when mixing chemo than the one for antibiotics. Chemo therapeutic agents can actually cause cancer if an individual is exposed to those agents. So we don’t want any possibility of cross contamination. Not only do we use different hoods, we separate them in two different rooms.
Bookkeeping and pharmacy technicians prepare paperwork, making sure all the necessary supplies to properly administer the drug are entered. We want to make sure that if you have an IV that is going to be mixed and placed in a bag, there is tubing to connect that bag to your access site (a PICC line or whatever type of catheter you have inserted)
Before mixing we have to calculate the shelf life, delivery system, and diluent! If the drug has a short shelf life, we can’t deliver more than perhaps a weeks supply, or, if it’s very short, we may have to use special connectors and attach an IV bag with saline to a vial with powdered drug. If the patient has difficulty infusing, we must be creative in the products we use. We might need ball pumps for that individual.(elastomeric devices) If someone is severely challenged financially, we must become even more creative and balance patient safety with inexpensive infusion procedures.
Determining the shelf life we use publications, computer software and monthly publications. Keeping current is very important and can have a great impact on the products we use. We pay one software vendor for a clinical pharmacology program close to a thousand dollars a year. We pay another almost that for two hard copy publications of books that detail shelf life, stability, how to mix a preparation, and compatibility (what drugs can be mixed in what other drugs) All of those publications are expensive, but necessary for us to insure that when products are prepared and delivered to the end user, the patient, are proper and won’t cause a problem in the field. At times when two drugs are mixed they precipitate or fall out of solution. Many times that occurs immediately, other times it happens over time. This knowledge is very important because you wouldn’t want small particles falling out of solution just as you start your infusion! Those publications, pharmacy software and years of experience guide us through the preparation of safe intravenous pharmaceuticals
Once the paperwork is generated a person in the warehouse gathers the supplies needed to compound your prescription. Those items are placed on a counter for a pharmacist to review. The drugs are put on top of the paperwork that has four signature blocks on the form. The first is for the signature of the person that gathers the medication and supplies. When that person signs the form, they certify that the products gathered are correct. The second is for the pharmacist to verify the products are indeed what the prescription called for, and that the correct lot number and expiration date have been recorded on that form. The next signature block records the person who compounded the product, and the last, a final check is done by the pharmacist before the product can leave the pharmacy. Each of these boxes with signatures are part of our Quality Assurance Process. We know who has been involved in your product, EVERY step of the way.
Once two people have signed off on the products they are lightly sprayed with sterile alcohol and are moved into the "clean room". But before that happens, the person compounding the medication has to scrub, cap gown and prepare for the mixing. Scrubbing is a process prescribed by professional standard, using antibacterial soap, for a specified period of time. Also gowns must be donned, a cap, mask, and shoe covers, all of which cost something and must go into the cost of the final preparation.
Once in the clean room, the "hood" where the drugs are mixed must be sprayed with sterilized alcohol. (Cost of a pint of that stuff is about twelve dollars) You might ask, if alcohol kills bacteria, why does it have to be sterilized? Good question, and the reason is, because some spores can live in alcohol (a very few, but there are some that can) so we have to insure that we’re not introducing those spores to the clean room. You might also ask why clean the hood again, after all, first thing in the morning the clean room was already cleaned. But protocol calls for cleaning the hood where we mix medication before and after every single IV is prepared, with that twelve dollar bottle of sterile alcohol.
Once the hood is prepped the product is mixed. Many times we use a plastic device that goes into the drug product and has a vent on the side to allow air out as sterile water is forced in (or normal saline, or dextrose in water) to dilute the product and get it into a liquid state. If you’ve ever tried to introduce water into a vial (or take out liquid from a vial) without a vented needle you will quickly see the reason a vent is needed. The first time I tried, I pulled on the plunger, and the liquid came into the syringe, but as soon as I let go of the plunger it rapidly went back to it’s original state. That happened because of the vacuum that’s created. I learned very quickly that either use a vented system or inject air into the closed system before trying to get something out of it. The point is, those vented needles cost somewhere in the neighborhood of $2.00 EACH!
Of course all of this is done in a "class 100" area (the clean room ) under a hood. Those areas must be certified every six months (costs somewhere around a thousand dollars to do that, and when they find a problem and you have to fix it. In a past inspection the person certifying our clean rooms detected a problem with a HEPA filter. (High efficiency particulate air filter) That filter, can cost several thousand dollars, our last filter was more than five thousand. But those filters insure airborne bacteria and viruses are kept to a minimum.
OK you say, they’re done. Well not quite yet. Once the product is mixed it is placed either in the refrigerator in a "quarantined area" or in the anteroom in a quarantined area. It’s quarantined until another pharmacist reviews the medication to insure it was properly mixed, that there is no debris floating around in the bag (yes we’ve seen it happen.
Once the pharmacist signs off on the product it’s ready to be shipped. Ah, just throw it in the box and off it goes right? No, not that easy. We now have a list of supplies. Just like the drug mixing procedure there is a procedure to pack the box. One person gathers the supplies and lays them out, and other person double checks to make sure they were correct. (There are two signature areas on the bottom, and both the person that gathered the supplies, and the person double checking have to sign off to certify the supplies and drug are correct) We also list the lot number and expiration date of each product. All of this takes time, but insures accuracy.
Now the medication and supplies are finally ready to ship. If the products are to be refrigerated a Styrofoam box is used along with ice packs. I don’t know how a light Styrofoam can be so expensive, but those special formed boxes can be very expensive. In one drug study, we were required to purchase validated boxes at a cost of sixty five dollars each!
Each of those steps has associated costs, all of which must be rolled into the cost of the final product. If they weren’t the company supplying the IVs would soon be out of business.
At our company, we work very hard to find quicker, more efficient ways of producing the products we produce. Of course, we don’t compromise quality for cost. Sure we could get the products out faster, with less manpower costs of we just threw the things together and didn’t double check everything, but then we might use the wrong drug, or use the wrong diluent. People are human and errors happen, that’s why we have so many checks and balances. There are even errors when automated systems are used.
Written by David Kazarian.
David Kazarian has practiced pharmacy for over 4 decades! He as been president of a national pharmacy organization and currently sits on the board of a public company that produces products for the pharmaceutical industry. He has started two IV companies and currently is president of Infuserve America, a home IV company located in Saint Petersburg Florida.
Edited and posted by Dean A. Pedalino, HCC Pharmacy Business Solutions