For the next few weeks I’m going to take a look back at how I started in compounding. There are some important lessons that I think everyone will benefit from by reading what happened when I first started working in the business I now co-own.
In July 2014, I started working only part-time as a pharmacist with BET Pharm. At the time, I was working full-time in retail about an hour away from where I live and some nights I didn’t get home until 1 am. Oh, and by the way, my wife was pregnant with our first son Seth. Needless to say, she didn’t really like me being that far from home. So she was ecstatic when I found the position at BET. It was only a few months later that in January (2015) I stepped up to become the pharmacist in charge; and only 3 months later was our first “real” <797> compliance inspection from Kentucky BoP. I say real in quotes because prior to that Kentucky wasn’t really performing true compliance inspections.
Now, full disclosure…I was aware of many of the non-compliance issues. It wasn’t my first time ever doing any kind of sterile compounding and I was already fairly familiar with USP <797>. Like I said, I had only been there a few months and we were ramping up to start our busy season (we’re somewhat seasonal because we make sterile injections for equine reproduction; from December through August is when we’re in full swing).
When the Board of Pharmacy arrived I have to say I was really nervous. Again, I already knew about many of the compliance issues and realized I had an uphill battle ahead of me. It was the first time meeting the pharmacist that heads the inspections, Katie Busroe. This isn’t me brown-nosing but I have to say that I really have a great respect for Katie. She is gracious and tactful in her approach to compliance and the Board is actually a group of very reasonable, caring people. Truly.
After it was all said and done she handed me a 17 page compliance report that had enough marks on it that if I was a school-aged boy, I’d probably go home crying to my Mom. Nonetheless, I pulled up my socks and got to work. Honestly, the best part about getting one of these reports is that it gives you a checklist of what you need to work on. Speaking for someone who loves checklists, this was the best thing that ever happened!
By the way, if you’d like a good checklist for YOU to improve your own compliance, I highly suggest downloading my action plan for getting up to speed with compliance from our 2015 inspection…. Use it as a guide to attack the low hanging fruit within <797>.
It was a little disheartening since I started this new position and already felt like I had a mark against me. After all, I really LOVED sterile compounding (and still do obviously), and didn’t like the idea of not doing the best I could be doing.
Many of the items on the list were things that I could just start implementing immediately; and others not so much. One of the biggest items on the list was our compliance with the engineering controls since we were compounding reproductive hormone injections. The pharmacy since its inception was using positively pressured laminar flow hoods. While we did take extra precautions to try to keep from being exposed, at the end of the day you’re potentially having hormones sprayed right at you if there ever was a spill.
Now, another thing to mention here is that we’re not just licensed in Kentucky. In fact. the pharmacy is licensed in just about every state where we’re required to (including me personally as pharmacist in charge – I think my license count will be at 18 by the end of the year). California actually visited only a few weeks after Kentucky to perform their own inspection.
As part of renewals we needed to send any home state inspection reports to the state that’s asking for them. Quite a few asked for them including Florida, Nebraska, Virginia and Indiana. Each of the states previously mentioned actually held up our renewal until we were in compliance. A few of these states even requested for the pharmacist in charge (that’s me) to appear before the board. Uh oh.
Actually, I have to admit, in hindsight, it wasn’t all that bad. The most nerve racking was Florida. I had to appear before the board not once but twice! The first time was a bit of a wasted trip as we just basically scheduled a time to meet at the next meeting. But what I did take away from that first Florida trip is that there were some very knowledgeable people on the board that were well versed in compounding; not all but a couple.
The most troubling thing about getting compliant is that I didn’t feel like there were too many REALLY good resources out there that gave out really specific answers to the compliance questions I had (not to mention that many of the continuing education programs for compounding is test in powerpoint clicking torture to sit through). So I did the next best thing…I reached out to people who I knew would have the answers. Only problem was they were board members…but was that really a problem? I really felt like I was stranded on an island for a little bit and honestly I was willing to try to get help anywhere it could be found.
One of the board members in Florida, Michael Mikhail, seemed like one of those who really knew his stuff. It turns out that he worked for a large compounding pharmacy at one point in his career. He spoke with me on the phone at length a couple times and it helped me tremendously. Michael if you’re reading this: Thank you, again.
Back to compliance…So, with Boards not allowing us to renew, we decided that we just need to build out a new pharmacy. A new, fresh start. Excellent. I was able to design the space, the cleanroom and make some decisions that would have an effect, good and bad, on my for months to come…
To be continued…
In my next post I’ll be talking about what compliance issues we had, getting compliant with USP <800> and everything I learned from the mistakes we made.