Wednesday, November 7, 2012

What's a compounding pharmacy anyway, and how did all these people get sick?

You may have heard about the fungal meningitis outbreak that's happening all over the US.  At last count, at least 30 people have died and over 400 are infected (although not all have meningitis, some have fungal infections elsewhere that are still serious).  Its epicenter is a compounding pharmacy in Massachusetts that made lots of contaminated "sterile" injections.

There are a few things I think most people have no idea about, so I figured I'd explain.  And if there's stuff that doesn't make sense to non-healthcare/pharmacy types, leave a comment and I'll address that stuff too.

1) Why do we have compounding pharmacies? What do they do anyway?

Compounding pharmacies take various commercially-available medications and mix them together to prepare special prescription preparations for specific patients.  All pharmacies do some compounding, be they hospitals or community locations.  For example, one I've compounded a fair bit is a mouthwash for patients getting chemo.  It involves me getting a bottle of an antacid, benadryl, and lidocaine liquid from the shelf and mixing them as the doctor requests based on the needs of the patient (or the oncologist's favorite recipe).  Patients then gargle with the stuff and spit it out.  I saw this made in the hospital too, and saw the recipe for something similar at a long-term-care pharmacy (that's the pharmacy that serves nursing homes and other inpatient but not a hospital places like jails and group homes).  There are regulations about compounding on the professional level and states have their own laws and regulations too.  That basic mixing of commercial products that aren't sterile (not for injection that is) is much less heavily regulated than sterile compounding because it's much less dangerous if you do it wrong and because the products used usually have preservatives in them to prevent scary stuff from growing.  You have to use these in a timely manner though.

Sterile compounding is further split into high risk and low risk compounding (and you might add very high risk and medium risk to the list).  Low risk is what happens in hospitals most of the time when you make an IV - a sterile IV bag gets a single injection of sterile medication.  To make it safer we do this in an environment that reduces risk (a clean room) and wearing the full garb to prevent contamination.  For people who need infusions (that's IVs) often, home infusion pharmacies exist.

High risk sterile compounding is when you mix lots of things into one bag because there's more risk for contamination OR things getting injected into a place in the body with no immune system (eyes, spinal column/brain).  An example of this is a patient who can't eat or keep anything down who gets all their nutrition from a daily IV with all the nutrients added according to their needs (think pregnant folk with hyperemesis or people lacking a stomach).  Another high risk item is something that gets injected into the spinal column or an organ itself (epidurals, steroid shots for back pain caused by joint degeneration, stuff we use during open heart surgery).  Many of these products are made from non-sterile ingredients (think a jar of a powder that gets added to water) as well as sterile ingredients.  Because they are going into a place that won't tolerate preservatives, these products have to be made and then used pretty quickly.  It's also tough to get something to be sterile if you aren't using fancy, hard to clean equipment that's really expensive.

We have compounding pharmacies because of the shortage of commercial drug products that are cheap to make (especially injectables) and because commercial products don't work for everyone.  Some people are allergic to gluten so they need gluten-free medications made for them, others need a topical version of something (aspiring cream for arthritic elbows).  Drug shortages are a big part of why compounding pharmacies are making so many high risk things.  Cost is another factor.  If you use a brand name sterile product it can cost 10 or more times more than the compounded version that will do the same thing (but can't be identical because that's in violation of the brand name patent).  A good example of this cost factor is Makena, the progesterone injection used to prevent preterm labor.  It came on the market costing $1,500 a dose and patients need up to 21 doses (now it's down to $700 a dose) and you can compound it from the raw drug and sterile ingredients for more like $20-40 a dose.

We also have compounding pharmacies because it's hard for every pharmacy to be equipped to make all these sterile high risk products.  It's extra training, extra space, extra liability insurance that most places aren't big enough to afford investing in.  The tactic has been to find a large compounding pharmacy and pay them to make the high risk (sometimes medium risk or low risk things too) because it saves money in the big picture.  Big systems of hospitals and clinics often have their own compounding pharmacy or pharmacy that does compounding and other stuff, but hospitals and clinics without a big system to support the demand for one contract out.

2) How did all these people get sick then?

Because the compounding pharmacy in question wasn't following their own cleaning procedures within clean rooms and surrounding their equipment.  It's a pain in the tailfeathers to do all the cleaning required to make sterile products and it feels like you're cleaning stuff that's already clean all the time (but that feeling is a lie!).  Nobody was following their auditing procedure to check that the staff was doing what they were supposed to do.  Despite state warnings and fines, things hadn't improved and the board of pharmacy wasn't back to follow up on their progress.  If the state board of pharmacy had been on top of this, they would have probably closed this place down a lot sooner.  When you add in that one of the board members was CEO of this company, it gets stickier.

The compounding pharmacy was furthermore doing a number of illegal or at least very unethical things.  They crossed the line into manufacturing this steroid injection (and other products too) because they routinely made the injection, sent it out to various pharmacies and clinics, and then got prescriptions (if ever) from the doctors.  Manufacturing is making a bunch of a drug or drug product (the difference is that a product is a mixture of things) and selling it to pharmacies while never getting a prescription for a particular person.   Furthermore, they were shipping products to a variety of states without being licensed as a pharmacy in many (most?) of them.  To be licensed as a pharmacy in my state you have to be inspected annually by the state board of pharmacy.  Few states besides Massachusetts (maybe even none) had licensed this pharmacy, and yet they were selling drugs within the state.  Pharmacists also have to be licensed in each state where they work (so the national mail order chains license pharmacists either within a region or in all the states), and I'm not sure this place had licensed their pharmacists properly either.

In this specific case, some equipment was contaminated with a common fungus found in most dirt.  When it got into the steroid injections, it survived long enough to get injected, and with no immune cells to kill the spores, it grew and is inflaming brains across the country.

3) Do we need more legislation and federal oversight to keep this from happening?

I'm not convinced we need more legislation.  I think we need to work harder to fix the sterile drug shortage.  If you could just buy this steroid injection somewhere, most pharmacies and clinics would buy that rather than compounding it or paying someone to compound it.  We also need to actually enforce the best practices that we have on the books now and take serious (and timely) action when things are out of line.  It is important that we have compounding pharmacies because they fill an important role, and if we legislate about ALL compounding, even the non-sterile stuff that's done all over the place, we set ourselves up for a big headache.  Not all compounding requires the same level of oversight because not all of it is equally risky.

I do think we need a change in regulation from a state-based and state-exclusive system into one where we have a federal network of oversight (and licensing for all healthcare professionals).  Example: a doctor loses their license in one state, moves across the country, gets licensed there, and does something bad.  Or this lab tech who has hepatitis C and stole injectable drugs from hospitals (and using needles that got transferred back to patients) in several states, always getting caught and fired but because he wasn't licensed (why don't we license lab techs in every state?) there was nobody to report him to and no way to find out his history across state lines.  The same sort of federal-span oversight of pharmacies and pharmacists (and pharmacy technicians!) is also important for the same reasons.  When we confine things to one state we lose out on the big picture, so I say we let states keep doing their own thing but reporting to a national database that all other states have access to in real time.  If I'd been on the imaginary national board of pharmacy, I'd be inspecting extra often any pharmacy selling sterile products in multiple states because it's extra high risk and therefore needs extra oversight.  Because nobody knew this pharmacy was selling to so many states (as far as I can make out at least), nobody knew to look closely enough and we have an expensive and tragic scenario.

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