Your Practice Made Perfect
This podcast series provides support, protection, and advice for today’s medical professionals. Brought to you by SVMIC, a mutual insurance company that is 100% owned and governed by our policyholders.
Nov. 09, 2018
Episode 041: Controlling Controlled Substances
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Speaker 1: You are listening to Your Practice Made Perfect. Support, protection and advice for practicing medical professional brought to you by SVMIC.
Brian: Hello and welcome to this episode of our podcast. My name is Brian Fortenberry and today we're going to be talking about opioids and prescriptions and all of the issues that come along with that. And joining us today is Dr. Walter Fitzgerald. Dr. Fitzgerald thanks for being with us!
Dr. Fitzgerald: Well, thank you, Brian. It's a pleasure to be with you today.
Brian: Before we really get into this discussion on this hot topic why don't you tell us a little bit about yourself and your experience and your background.
Dr. Fitzgerald: Okay, I'd be glad to. I am a pharmacist and an attorney. I attended Mercer University School of Pharmacy and the University of Memphis School of Law, was on the faculty of the University of Tennessee Health Science Center for a couple of decades before becoming Dean of the South College School of Pharmacy in Knoxville.
Brian: Pharmacy and law, quite a combination. It's probably served you well though.
Dr. Fitzgerald: It has been. It's been a great opportunity to do things in both of the professions, but also to be someone that can help practitioners with issues of law and ethics and things that I like to research and talk about.
Brian: Well, I certainly imagine that's gonna be helpful today as we get in to this discussion. Opioid's big issue out there in the news today and in the country really. We often hear about this opioid abuse and how it starts with someone other than the patient gaining the access to the opioids and the medications themselves. What are some strategies out there to really help with this problem and get a handle on it?
Dr. Fitzgerald: Well, you're correct. There's more and more information that is in the literature telling us about how patients who do not protect their opioids are a source of allowing for opioid abuse to occur and so family members taking medications of other family members as one example. Some of the strategies, a couple of them actually are relatively new. There were two federal laws enacted in 2016 that created two strategies. One of those is to allow more sites to be available for disposal of unwanted and unneeded controlled substances and so, important distinction to make is that while opioids are a big focus of the media today and the coverage about overdose deaths, the things we're talking about apply to all controlled substances, not just opioids so...
Brian: I gotcha.
Dr. Fitzgerald: ...stimulants as well as all schedules. Not just schedule 2 but also schedule 3, 4 and 5. But one of the strategies I noted was to allow more disposal sites. Historically, it's only been where we've had drug take back days that have been sponsored by the Drug Enforcement Administration or by local sheriff or police department office where they've got a collection station set up and people drive by and hand them bags of controlled substances. Now we have these collection stations available in various sites including retail pharmacies. So, pharmacies now can be a collection station for controlled substances.
We've not seen a lot of growth in that because of the regulatory requirements that are associated with maintaining that disposal box but I think that overtime we'll see that grow. Hospitals are another place where you can have a disposal collection station and then the Drug Enforcement Administration has written rules and regulations about how those collections stations have to be emptied, who can empty them. In other words, what happens to all that unwanted controlled substance after it's put into that box. And that's part of the context why I think we haven't seen a huge expansion. In fact, the GAO, the General Accounting Office recently issued a report of a study that it completed about the need to stimulate the industry to open more collection stations, so hopefully that'll happen in the near future.
Brian: So, they are making an effort to get new sites and try to find more ways of having these unwanted or unneeded controlled substances to be dispensed on?
Dr. Fitzgerald: Yes, and I think that one of the issues is they have not publicized that very well. So, for example, a medical clinic which has an on site pharmacy could have disposal collection station in that clinic because it has an on site pharmacy. I think that one of the areas for targeting expansion would be to provide more information about this. I think there are a lot of places that do not realize there could be a collection station, so I think that as we think about ways to get unwanted controlled substances out of the excess by whoever may access them, more publicity about opening collection stations would be a valuable thing.
Brian: You know, I really didn't even realize quite honestly about the collection stations and I had heard before about the days, like you were talking about earlier.
Dr. Fitzgerald: Drug take back days.
Brian: Right. Where you show up and you drop that off. Tell us a little more about how that works, I mean because I'm unfamiliar with that and quite honestly you hear people at home that have drugs and most of the time they'll end up flushing them down the toilet or throwing them in the garbage or something like that.
Dr. Fitzgerald: And that's another huge issue. We need to be certain that we are disposing of controlled substances in a way that does not risk harm to the environment so flushing them down the toilet, things of that nature is not well advised, because of harm to the environment.
The collection stations simply are like boxes. I guess if you think of a box you may have seen in an office environment where everybody can put paper in that they want to be shredded. It's a context of that. And so you just dispose of the unwanted controlled substances in that box. Once that box becomes full or if it's on a schedule of being emptied, the pharmacy, let's use a retail pharmacy as an example of a collection station, they remove the medications from that box and then what is called a reverse distributor, that's somebody that's registered with the US Drug Enforcement Administration to take back, to manufacture or to distribute it or to dispose of through incineration or other ways. So that's the entity that takes unwanted substances from pharmacies, hospitals and other locations. So they come and pick it up and then they take it and dispose of it.
Brian: So, it's obviously highly regulated how this is done and there is information out there if people need it to help set up what that should look like and what those regulations out there, they can obtain that.
Dr. Fitzgerald: Oh, yeah, it's very easy. In fact if you'll just Google “DEA collection stations” or “DEA law on disposal of controlled substances”, any of those words will take you to the DEA's rules about those stations.
Brian: It's very important that you do it correctly.
Dr. Fitzgerald: Yes, in fact, you have to get a registration with a DEA in order to have a separate registration that's unique for the collection station and if you're not following the rules then they'll take that registration away from you.
Brian: I guess the biggest thing is trying to get the excess or the number of controlled substances out of the population. I have heard about going from controlled substances being prescribed in huge amounts or huge doses, to these smaller partial filling of prescriptions. Can you inform me a little bit more about that and our listeners?
Dr. Fitzgerald: Well, in fact that's another one of the laws that was enacted by congress in 2016. It was an amendment to an existing provision in the US Controlled Substances Act. Historically, in our nation, partial filling of controlled substances differs a little bit depending upon whether it's a schedule 2 controlled substance or a schedule 3, 4 or 5 controlled substance so let's talk about schedule twos first 'cause that's where hydrocodone and most of the opioids are scheduled is within schedule 2.
So, historically, if a pharmacy was unable to supply the full quantity for a prescription because the pharmacy's available inventory was low, the pharmacy could partial fill that prescription. So, let's use and example for understanding. Prescription for a sustained release oxycodone with a quantity of 60. And the pharmacy might say, "Well, I don't have but 100 left in stock, so I need to save those in case others until my inventory comes in tomorrow, in case others come in for a prescription." And so instead of 60, the pharmacy might give them 10 tablets to get them through for the next five days, 'cause it's probably twice a day dosing. In that situation the patient had to come back within 72 hours to get the balance or they could not get the balance of the 60 that they were entitled to get with the original prescription.
A few years after that, the government enacted another provision that allows for partial filling for patients that are in long-term care facilities and who are hospice, or terminally ill patients. And there the physician or other prescribers can issue a prescription for a 60 day supply of a controlled substance in schedule 2 and the pharmacy can partial fill it over that 60 day period. So they might set it up on a filling schedule or dispensing schedule of every five days or every seven days. Something of that nature. Well, what happened in 2016 is congress now allows partial filling of schedule 2 controlled substances for anybody for up to a 30 day period.
Brian: So it doesn't have to be for one of those previous reasons.
Dr. Fitzgerald: Doesn't have to be for one of those previous reasons. This is a whole new reason to allow partial filling and so what would happen is, let's go back to that example prescription, the 60 tablets for a 30 day supply. Under the new federal law, if state law does not prohibit partial filling of schedule twos then the prescription would be written for the 60 so you don't change the quantity the doctor is prescribing. What happens is the pharmacy dispenses only a partial amount of what's prescribed. So you'd still prescribe for 60 tablets for a 30 day supply.
Brian: So, it doesn't change how the prescription is written on the end of the physician.
Dr. Fitzgerald: That's correct, it does not change the elements of the prescription, except to put a note on the prescription that you want it partial filled.
Dr. Fitzgerald: So, the physician would do that. Now the other reality about this that's really good is the patient can also request the partial filling. So, the patient may for example have a relative who is an abuser of opioids and so the patient could say, "I don't want a full 30 day supply, I only want a five day supply, because I'm afraid that I may lose it because of a relative who might take this medication when I'm not looking."
Brian: That's a great point. I mean because they're going to be on the frontline of knowing in their family who is a potential abuser as well. Now, you said the doctor can, the patient can, can the pharmacist?
Dr. Fitzgerald: No, only the physician or other prescriber of the controlled substance can put a note on the prescription to partial fill it and it can even specify the day supply, usually most prescribers leave that up to the pharmacy and the patient to decide, do you want a three day supply or a five day supply or a seven day or a 10 day supply. So again, it's a way to keep a lot of controlled substance from being out there in the community where people might have access to it for inappropriate purposes. So, it's a very good law that the government has created to allow us to partial fill these.
Now, one thing to note is that if you begin partial filling that schedule 2 prescription, you have to complete the partial filling within the 30 days. So, for example, if at day 30 after the date on which the prescription was written, Miss Jones still has 10 tablets that she's not picked up, after day 30 you can't give her those 10 tablets. So, that partial filling has to be completed within that 30 day period.
Brian: I gotcha. I picked up on something you said a little bit earlier. You said, if the state allows partial filling. So does that obviously mean all states are not doing that. Is that correct?
Dr. Fitzgerald: Well, the states have different state laws so there are things that states regulate a little bit differently. For example in some states certain drugs are controlled substances even though the Drug Enforcement Administration has not scheduled those drugs as controlled substances. So, yeah, states do have laws that govern controlled substances and so any prescriber needs to know what those laws are in that state in which they're prescribing.
Brian: Since there's probably not a lot of data being 2016, has there been any initial evaluation though, if this is making a benefit or is this just speculation at this point?
Dr. Fitzgerald: Well, it's kind of like those disposal boxes that we talked about earlier. I'm pretty convinced that not a lot of individuals that are prescribers are aware of this new law. I had the opportunity and privilege to speak to a state chapter of the Academy of Physicians, internal medicine physicians, and when I talked about this as a new law under the part of the program that was talking about updates in laws, one of the physicians said, "Why would we do that?" And as we went through the program, other reasons to do this besides just the protection against misuse and abuse of these substances started to come out.
For example, one is a therapeutic trial. So, if you've got a patient that's never been taking an opioid, an “opiate naïve patient” as we call them, why have them but a full 30 day supply of hydrocodone or oxycodone. Why not let them buy a three day supply or a five day supply as a therapeutic trial to see if that medication is one, tolerated by the patient, and two, therapeutically effective. So, this new 30 day partial filling gives prescribers a great opportunity to tailor the use of controlled substances in their patients.
Brian: That's a great point because what works for Mr. Jones may not work for Miss Jones and vice versa.
Dr. Fitzgerald: Correct.
Brian: So, you can really get a better handle of treating that patient's needs appropriately.
Dr. Fitzgerald: Exactly. I think it's a great opportunity.
Brian: So, what do you think is the best way to get this information out there? You said, like we were talking about, the disposal boxes and this new partial filling law and people being unaware of that. Is the DEA doing something to help promote that? To get that message out there?
Dr. Fitzgerald: The DEA does send out information, they also have a website called the DEA Diversion website. And frankly that's a good website for any practitioner that's registered with the DEA, be it a prescriber or a pharmacy, should go to that website and just look at the updates that are there. As far as sending out news releases or things like that to pharmacies and the physicians, the DEA does not do that. State medical associations sometimes will communicate that information.
Dr. Fitzgerald: Probably the source, I think at least in my state, where I observed things that are being publicized is probably through live seminars or online programs that are about controlled substances. In a number of states now, including my state, in order to renew your license if you are a prescriber you must complete a two hour continuing medical education program every two years during a licenser cycle. And that's a great source for these updates, 'cause I know those are included there but again I think it's incumbent upon prescribers to go and look at that DEA website, the Diversion website because it does have a lot of information.
Brian: In our show notes we can put more information about the DEA diversion website as well to help people get to that and navigate that because I think you're right. I think the ability to be informed of what is out there is gonna make a difference, because quite honestly I hear stories constantly about it's not just the way that people are getting the prescriptions, it's once they're in the community how those people that are abusers or whatever are getting their hands on that. I've heard stories from family members stealing narcotics to people going into open houses on a Sunday afternoon in a real estate property and going through the medicine cabinets and things of that nature so I think the availability of them in the community is going to be a big deal, right?
Dr. Fitzgerald: It is, and that continues to be a big deal and I think that this 30 day partial filling gives every prescriber an opportunity to help minimize that risk. If you write a prescription for 60 hydrocodone tablets, then the patient takes two or three and the nausea, they just cannot tolerate it, now you've got tablets of hydrocodone sitting in that person's house that should not be sitting there. It just creates an opportunity for abuse and misuse.
Brian: Well, Dr. Fitzgerald, I certainly appreciate you being here today and informing us on this. And like I said, we'll try to link some of that information in our show notes here so people can get more information on these disposal sites and this new law that is out there. Thank you so much for being here.
Dr. Fitzgerald: Thank you, it's been a pleasure.
Speaker 1: Thank you for listening to this episode of Your Practice Made Perfect with your host, Brian Fortenberry. Listen to more episodes, subscribe to the podcast and find show notes at SVMIC.com/podcast. The contents of this podcast are intended for informational purposes only and do not constitute legal advice. Policy holders are urged to consult with their personal attorney for legal advice as specific legal requirements may vary from state to state and change over time.
The contents of this Podcast are intended for educational/informational purposes only and do not constitute legal advice. Policyholders are urged to consult with their personal attorney for legal advice, as specific legal requirements may vary from state to state and/or change over time. All names have been changed to protect privacy.
About our Guest
Dr. Walter Fitzgerald
Walter L. Fitzgerald, Jr. holds the BS in pharmacy from Mercer University School of Pharmacy, the MS in pharmacy administration from the University of Tennessee College of Graduate Health Sciences, and the JD from the University of Memphis School of Law. Dr. Fitzgerald is a licensed pharmacist and attorney in Tennessee He has over three decades of educating health professions students in medicine and pharmacy, as well as practitioners through postgraduate education programs. The focus of Dr. Fitzgerald’s teaching, research, and publishing is healthcare law and ethics. With extensive experience in the social and administrative sciences, ethics, and law, he is a nationally recognized expert who is often invited to provide medical and scientific presentations. In addition to several articles, Dr. Fitzgerald is the author of three books. Dr. Fitzgerald has received many prestigious awards, such as the University of Tennessee National Alumni Association Public Service Award and the Tom C. Sharp, Sr. Pharmacist of the Year Award by the Tennessee Pharmacists Association.
About our Host
Brian Fortenberry is Assistant Vice President of Underwriting at SVMIC where he assists in evaluating risk for the company and assisting policyholders with underwriting issues. He has been involved with medical professional liability insurance since 2007. Prior to his work at SVMIC, Brian worked in the clinical side of medicine and in broadcast media.