New Bill: Compounding vs Manufacturing

The US Senate
 HELP Committee link
 

     I have been following the NECC meningitis outbreak since
it was first identified in the fall of 2012. I even attended a 5 hour
long meeting in January about this topic held by the Iowa College of Pharmacy. That event really helped answer a lot of my questions about how
something like this could happen. What it couldn't answer was, "Where do we go from here?" and "What does this mean for the future of compounding pharmacy?" I knew that regulations would change and their enforcement would be stricter, but I was anticipating a change for the worse. I was afraid that this would be such a negative blow to the world of pharmacy that it would force smaller, independent compounding pharmacists out of business.
     While looking around for any updates about the meningitis outbreak and its effect on pharmacy law, I found news that a new bill is being drafted addressing these issues. I was very pleased to see it included a point I thought about from the onset of the tragic events: the NECC was not acting as a compounding pharmacy. It was acting as a manufacturer and therefore should be subject to inspection and oversight by the FDA not the state of Massachusetts. Also, compounding pharmacies in general should not get a bad reputation for what this one greedy company did.

•      A compounding pharmacy by law operates as such:
• receives specific written order for a drug product from a licensed prescriber
• this drug product is for a specific patient
• this drug product is not made until the pharmacy receives the order to make it (some products that are shown to "move" in the pharmacy may be made ahead of time in limited quantities)
• they DO NOT produce large amounts of drug products to sell and ship all over the country!

If a "compounding" pharmacy is making huge batches of injectable steroids without doctor's orders or for a specific patient, selling and shipping them all over the country they cease to be a compounding pharmacy and are now a drug manufacturing facility.
     The HELP committee is writing this bill to help define "compounding" versus "manufacturing" and who is responsible for overseeing each of these entities. The bill will see to it that compounding pharmacies are still held up to the highest standards and answer to the state. Compounding pharmacies that stray into the area of manufacturing will answer to the FDA and must uphold the even more strict standards of a drug manufacturing facility.

http://www.help.senate.gov/imo/media/Compounding_Draft_One_Pager_FINAL.pdf

Side note: Iowa's own Senator Tom Harkin serves on the HELP committee. Go Iowa!

Compounding in the News

Image Source: Wikipedia
Entry: New England Compounding
         Center meningitis outbreak link

     Recently the field of compounding pharmacy was put in the national news spotlight. This was, for many people, the first time they had even heard of compounding pharmacy and what it entailed. Unfortunately, compounding pharmacy was not shown in a good light. For those of you not familiar with the New England Compounding Center and its involvment in a recent meningitis outbreak please see the link below the image. This link will take you to a Wikipedia page that gives the basic rundown of events that occurred without too much of a media bias.
     In October of 2012 there was an outbreak of fungal meningitis that affected patients in 23 different states. When the CDC began checking into possible causes of the meningitis outbreak they discovered all of the patients had received epidural steroid injections. The methylprednisolone acetate for injection had been produced at the NECC. The NECC immediately recalled this product and two others that may have been contaminated. As of March 2013, 48 patients had died from meningitis and over 700 people were injured or currently being treated for meningitis and other injection related infections.
     Like I said before, for many people in the public this was their first time learning about compounding pharmacies. The NECC has since closed its doors and is facing hundreds of lawsuits from families effected by their error and penalties from the US government. This tragedy was not only a huge blow against the NECC, but all pharmacists. It took away a level of trust the public has in our profession.
     Also, with the way the media presented the findings many people were terrified that any injection or any medication they received could kill them. True, all medications have their risks, but I really disagree with the media always using sensationalism and fear tactics to whip the public into a frenzy over any little thing. Simply by surfing around the internet and reading various message boards I see the paranoia and misinformation about this issue. Many people are asking, "Where was the FDA? Aren't they the ones supposed to be protecting us from the pharmaceutical companies?" Of course people demanded that compounding pharmacies now be inspected and subject to harsher laws. The NECC debacle lead to several other compounding pharmacies being shut down in Massachusetts and other states. This really scared me. I knew that soon every compounding pharmacy would be scrutinized and looked upon as a potential problem. The public would lose trust in pharmacy and the government would respond by driving independent compounding pharmacists out of business.
     I completely agree that compounding pharmacies should be held to high standards of safety as patients health and even lives are on the line. Unfortunately, the NECC was not operating as a compounding pharmacy in the true definition. In my next post I will get into the details of what constitutes "compounding" versus "manufacturing".  I think the NECC should be harshly punished to make an example for other pharmacies who may try to stray into the area of manufacturing.  I don't agree that more laws and regulations will necessarily prevent future tragedies of this nature. Case in point: the New England Compounding Center was violating tons of compounding pharmacy laws and this was not brought to light until they killed or injured hundreds of people.

What is Compounding Pharmacy?

     So, why am I interested in compounding pharmacy? I suppose the place to start would be to first look at what exactly compounding pharmacy entails. The following is taken from the Professional Compounding Centers of America's (PCCA) website: "Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are “made from scratch” – individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs."
     Before attending pharmacy I was a little undecided in my career path. Right out of high school I went to college for fashion design. I also graduated from cosmetology school and worked in a salon for awhile. Most recently I have worked as a bartender. What is the one thing all these very different jobs have in common? Creating something. I have always been more interested in fields that allow me to be creative or make a product.
     When I started pharmacy school I did not have experience working in retail pharmacy or hospital pharmacy, so I didn't really know what I was getting into. Our first year we were introduced to compounding in PPL and I also did an IPPE rotation at Care Pro in Cedar Rapids which has a compounding pharmacy on its premises. "This is something I'm familiar with", I thought. There are so many parallels I could draw between compounding pharmacy and my past careers. Compounding involves working with patients and doctors to make a product that will satisfy the needs of everyone. As a hairdresser I loved customizing color formulas to use on clients and bartending definitely involved measuring and combining different ingredients to make the perfect cocktail. Compounding is also a mixture of art and science. A good compounding pharmacist must know what ingredients should be mixed together to achieve the desired product, but care must be taken to also prepare an attractive product that the patient wants to use.
     Compounding pharmacy also reminds me of a bygone era when pharmacists compounded practically everything they sold. Or even further back to the roots of pharmacy when people used various natural products to create cures for illnesses. There's just something about it that is exiciting and mysterious to me. I'm sure once you've worked in compounding pharmacy for years it becomes more routine to you, but I think I would still appreciate the fact that I'm doing things the "old fashioned way".



Here is the link to the PCCA website: http://www.pccarx.com/
and the What is Compounding? page: http://www.pccarx.com/what-is-compounding/