Hospitals, physicians, and pharmacies are on the front lines of the opioid crisis. AHLA’s Opioid Podcast Series explores the critical legal and operational issues related to the opioid epidemic from each of these perspectives and offers expert insight for addressing them. This podcast features the perspective of pharmacies.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
Hospitals, physicians, and pharmacies are on the front lines of the opioid crisis. AHLA’s Opioid Podcast Series explores the critical legal and operational issues related to the opioid epidemic from each of these perspectives and offers expert insight for addressing them. This podcast features the perspective of pharmacies.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
Hello, my name is Ellie Bain. I'm Vice President publications of the A H L A Public Health Systems Affinity Group. We are recording this podcast as part of a series on legal issues related to the opioid crisis. This podcast focuses on legal issues, same facing pharmacies. I'm joined today by Ashley Thomas and Darshaun Colney. Ashley is an associate with Baker Donaldson in Washington, DC and focuses her practice in healthcare with a concentration on hospital and health system matters, regulatory, antitrust and compliance issues, corporate transactions and hospital physician alignment. She the services to an array of healthcare providers, including hospitals, health systems, and physician practices. Ashley is also the Vice President for social media for the HLA Public Health Systems Affinity Group. Dar Colney is the principal attorney of the Colney Law Firm and helps FDA regulated companies bring their products on the market and stay on the market. He is also the Vice President of regulatory strategy and policy. He's responsible to help guide policy development and engagement strategies using various methodologies, including but not limited to, artificial intelligence, blockchain, and big data. Dr. Carney is routinely called on because of 15 years of experience working on the LE legal and regulatory requirements associated with the FDA state and federal VER versions of the Anti-Kickback Law, civil Mental, civil Monetary Penalties Act, false Claims Act, the Sunshine Act, hipaa, and the 21st Century Jurors Act. Dr. Colney is a registered pharmacist with over 20 years of experience. Ashley and Darshaun co-authored the article RX Gatekeeper, looking at the opioid crisis from the pharmacy perspective in the May edition of the Connections Magazine. Ashley and Darshaun, thank you for joining me today. With respect to the article, are there any additional pharmacy cases that you've seen come up similar to the Rite Aid case that was mentioned?
Speaker 2:Yeah, so, um, in January of last year, in 2017, um, Costco, um, paid out a steep settlement at 11, little over 11 million to, um, settle allegations that its pharmacy violated the Controlled Substances Act. And, um, it was cited in the complaint that the DOJ and their press release that Costco had failed. So, um, the filled prescriptions were incomplete. They didn't check, um, valid DEA numbers for prescriptions, and they were also filling prescriptions outside the scope of a practitioner's DEA registration. And then similar to the Rite Aid settlement, Costco also failed to keep and maintain accurate records for controlled substances at its pharmacies and kind of maintain a central database. And so in that press release announcement, the DOJ kind of mentioned that the pharmacies are the gatekeepers responsible for ensuring the lawful use of powerful drugs that have a legitimate medical purpose, hence the title of our article. Um, and so basically, you know, pharmacies are like the last stop in between, you know, medical practitioner and dispensing the controlled substances. So it's really on them to start, you know, obviously monitoring and providing oversight into these kind of shady prescription practices. And in addition to the Costco settlement, there was also a Safeway, um, grocery store settlement that has pharmacy chains as well. And they paid a settlement of 3 million as well for failing to notify the DEA when they, um, encountered a loss of tens of thousands of HydroOne tablets. And the DEA requires that a pharmacy supplier, um, and pharmacist notify the DEA within one business day when there's a suspected loss or theft or controlled substances. And Safeway failed to notify the DEA over several months, and therefore, um, settled with them in regards to, um, this infraction. And we just saw last week, actually from the d DOJ announced coming out of Georgia that, um, they just had the largest hospital drug diversion settle civil penalty settlement. And this was lar in large part due to their pharmacy system, and they, um, the Effingham Health system in Georgia agreed to pay a 4.1 million settlement, um, similar to the previous settlements that I said that they failed to have effective controls and procedures guarding against theft and loss of controlled substances. And as a result of that, they're overhauling their entire pharmacy operations. So it's definitely something that, you know, there's these settlements coming out on a regular basis, and we will definitely probably see them coming out in the future as well.
Speaker 3:And, and I think that's interesting, Ashley, that just the, the fact that there is such prosecution around, um, the opioid crisis, because I, I know we're gonna discuss this a little bit further, but, um, but I think we can talk about it a little bit right now. The fact is that, uh, from a clinical perspective, it's also important to recognize that there are also appropriate times the product should be used. Uh, and, and there has been such qualification around the opioid crisis. Uh, Walmart announced on, uh, on May 7th for example, of 2018, that they aren't going to allow for more than seven days of, uh, opioids for some prescriptions. And that obviously is gonna have ramifications throughout, but pharmacies, as you said, are the front lines and the pharmacists, uh, are going to have to balance the needs of patients who do appropriately need the medication against the needs of patients who are dependent on it and addicted to it, and it's not serving a clinical benefit at any point. Um, so we're gonna have to, we're gonna be cl uh, paying a closer, uh, eye and closer watch, and the DEA obviously is doing the same thing.
Speaker 1:And it seems to me, Ashley and Darshaun that in addition to those types of pharmacy cases and the, the risks, like you said, with balancing the need and, and those who are becoming addicted or abusing them, there are also federal and state actions regarding, um, what we commonly refer to as pill mill. Uh, um, are there any, um, actions of note or things that you would like to comment on regarding the, um, pill mill type of cases, like the Georgia case that you included in your, um, article?
Speaker 3:I mean, today is May 24th. I'm literally looking on the York Daily record and the, the news. Today's police shut down alleged pill mill that operated in York and 16 other Pennsylvania counties. Um, it's something that is active, it's something that people are looking, um, actively into The DEA is, uh, constantly looking. Ashley, I know you can talk to this a lot further. Um, but my, my experience talking to clients, uh, I do a lot of representing representation of, uh, drug manufacturers and, uh, most FDA regulated companies. Um, it's, it's not something that's slowing down. I'll have two positions and caregivers reach out to me every so often as well. It's not something that's slowing down there. Um, Ashley, what have you seen?
Speaker 2:Yeah, no, I definitely, I, I agree with you Darshaun. I feel like every time I get a new OIG kind of news alert, I feel like it's always, you know, encompassing, you know, a physician or a pharmacist or some type of practitioner who's involved in some type of pill mill scam. And I feel like it's something that's kind of on a daily basis, like you said. And the Georgia case that we mentioned in our article kind of had this novelty aspect to it. And in terms of that, it was a husband and wife who owned a pharmacy and they had this kind of business arrangement with a pain clinic across the street that the pain clinic was essentially a pill mill. And they had this arrangement where they would kind of funnel patients to the pharmacy and distribute, um, you know, op uh, controlled substances in opioids on an illegal basis. And what the kind of DOJ did with that was they ordered this husband and wife to pay a settlement of 2.5 million, but they, um, kind of constituted as a community restitution. And basically the funds from this, this settlement are to be paid to the Georgia State agencies responsible for substance abuse treatment and victims assistance. And I feel like that's something that in the DOJ settlement announcement mentioned, that is kind of a novel approach. First of its kind that we've seen the kind of recognizing, um, the public harm that can happen in these situations. And so I haven't seen this type of settlement since then, but I'm curious to see too that, you know, whether this is something we'll be seeing in the future. But this is definitely something like, as Darshaun and I mentioned, we're seeing on a daily basis enforcement actions coming out, which highlights the importance that pharmacies and providers really need to be taking a hard look at their current practices and ensuring that they are following DEA regulations, federal regulations, um, to ensure that, you know, when they're, you know, kind of being investigated that they have sound policies in place that they can go to the government. Um, so yeah, it's something that we're obviously seeing and I don't think it's gonna be slowing down anytime soon.
Speaker 1:Speaking of sort of the daily basis occurrence, and it sounds like it's getting more and more frequent, um, can you share any best practices for training pharmacy staff on how to deal with opioid abuse and fraudulent prescriptions
Speaker 2:Under the Controlled Substances Act? Pharmacies and pharmacists, um, have certain various obligations such as fulfilling their corresponding responsibility. And what that essentially means that individual pharmacists have an obligation to ensure that the controlled substance that they're dispensing is for a legitimate, legitimate medical reason and written by a medical profession in their usual course of professional practice. And then in addition to that, pharmacy pharmacies and pharmacists should be verifying DEA registration or licensure. That was something that came up in the Costco settlement and Safeway settlement, that they weren't verifying DEA licenses from their medical providers that they were receiving the prescriptions from. And then also, pharmacists need to be attempted, uh, attentive to red flags. And these red flags consist of basically looking to see if a patient has multiple controlled substance prescriptions from multiple physicians, um, if they are seeking early refill refills, if they're traveling long distances to see the physician or the pharmacist to get a refill, um, and if they're paying in cash. And then also if a pharmacist learns that, you know, this patient is going to other pharmacists and trying to get the same, you know, opioids. So these types of things, you know, in combination with each other, there's no perfect formula to the red flags in terms of how many you need to have before you should start investigating. Um, basically, you know, you should follow up obviously if you have, you know, prescription drug monitoring program requirements, check those, you should probably be checking those anyways if you have one. And then also, you know, following up with your, um, pharmacist provider that's receiving, receiving the prescription from following up with them to ensure that it's a valid prescription, verifying the DEA license, kind of taking those actions to ensure that you're fulfilling your obligations under the Controlled Substances Act. And then also, you know, I would say, you know, darshaun with these red flags that we've kind of talked about previously in our discussions in drafting the article, is there any Right, you know, I know there's no specific formula to what pharmacist should be clue them in to investigating further, but in your experience, what have you seen in your, um, background?
Speaker 3:So Ashley, you raised some excellent red flags. When I did a rotation at a, um, at a third party pair, it was a pbm. Uh, I remember having to go back and look at inappropriate, um, use of products and to see if, uh, the same patient was getting, uh, meds from different locations at the same time. So I know pairs like for example, are looking over people's shoulders as well to, to, to make sure it's being prescribed appropriately. Um, but still one of the big problems you, you land up facing is this concept of identity management. How do I know that John Smith is the same John Smith over and over and over again, um, to make sure that one John Smith's getting it appropriately and the other one's not inappropriately getting the medication. Um, hopefully in the future when, when we have better technologies, we'll have more secure ways of identifying the person, but, uh, at this point, pharmacists are just making judgment calls. And, um, and while it's a good idea to have these red flags today, um, it, it may make sense to, to think about, um, at a realistic, at a ground floor level without playing Monday morning quarterback. How do you make that decision in a live scenario?
Speaker 2:Well, I know Han you've mentioned in your, uh, experience as a pharmacist that you've been in a hospital setting and in a retail setting. And do you think, cause I feel like that's maybe one of the issues is these large chain retail pharmacies are popping up and acquiring the mom and pop shops, you know, do you, do you feel a sense that the kind of relationship is kind of becoming at a distance between the pharmacist and prescribers where that's part of the pharmacist's job, I guess, in the sense of evaluating and making sure it's a valid, you know, prescription and check, verifying the DEA number and making sure it's a, you know, a handwritten signature on the prescription and everything. And do you, do you get a sense that, you know, with these large retail pharmacies there's a growing distance between providers and pharmacists and that it's harder to manage those relationships as they once were?
Speaker 3:I think that's absolutely true. Having said that, I, I have worked in large retail settings as well and I have worked mm-hmm<affirmative> in everything from ICU setting to the, like, so I, I think it's, in a hospital, it's easy to know that a provider provide a prescription, obviously, cuz you're, you're, you can talk to the provider, they're usually sitting four or five floors upstairs. Um, but, but the difference is in a larger retail setting, um, when you're turning through a hundred, 150, 200 scripts a day, um, it's difficult to know if that one patient is, uh, inappropriately being prescribed. Sometimes they're using a, uh, a script from a physician who you have filled medication for several times. Sometimes it's a new, a new physician. Um, and in a larger setting it gets more complicated, um, in a, in a people will say, uh, that smaller pharmacies, uh, have better, um, controls over their patients, but that's not always true either.
Speaker 1:And are there any specific duties that would apply to a pharmacist versus pharmacy staff? And does that vary if it is a retail pharmacy location versus, um, an in-house pharmacy location? Um, just in general dealing with opioids, repeat users, red flags and, and things like that.
Speaker 3:So when we work as pharmacists, we, we assume that's always on our license and we always assume that even if a technician's acting, they're acting on our behest. Um, having said that, our, is there a, um, is there a plaintiff's counsel who will be able to make the argument that duty is not necessarily delegate? Probably, uh, I, and I'm sure Ashley can talk a little bit further about that piece of it, but I think that as a professional, uh, as a, as a licensed professional, as a, as a registered professional, it's my duty to make sure that, um, that I take as much care as possible to make sure that the medications are being appropriately, appropriately prescribed. Ashley.
Speaker 2:Yeah, no, I, I agree with your assessment cuz at the end of the day, the pharmacist can have their license revoked and that they've lost their, their business, you know, their, you know, everything. So that's kind of on them. So yeah, kind of the things that we've mentioned, you know, individual pharmacists obviously should be paying attention to their, you know, air quote corresponding responsibility and checking these red flags. And then I think in general, compared to larger pharmacies, things that we're seeing with the settlements that have come out, pharmacies really need to kind of keep and maintain accurate records and have very solid internal databases that are tracking your controlled substances and opioid supplies. I mean, as, as I've mentioned previously, the DEA requires that you notify them within one business day when there's a suspected loss or theft. So really pharmacies really need to have, um, you know, a very appropriate tracking measure. Like you need to know what's going in and out of your pharmacy on a daily basis and when something happens you need to immediately be able to report this. So you need to have, you know, competent systems. And something that we saw with the Costco settlement as a re remediation effort, they invested in a 127 million new pharmacy management system. So that's something that pharmacies really need to be attuned to in making sure they have appropriate tracking measures and internal databases. And then I would also say for larger pharmacies too, to have an audit system to kind of make sure, keep on tracking yourself to ensure that, you know, before the government comes knocking on your door that you are following protocols and appropriately monitoring prescriptions. Um, it's something that we also saw out of the Costco settlement. They started Costco start implementing a three-tiered audit system. And how they broke that down was in the tier one of auditing, it was done by pharmacy managers and regional pharmacy supervisors. And then in tier two of that audit system they have an internal audit group consisting of three auditors and an audit supervisor. And then in the final third tier of that, they have an external audit of about 40 annual audits to make sure going forward that they are tracking and, you know, monitoring prescriptions. So I would say that's something that, you know, pharmacies should consider adopting an audit system or kind of a compliance review to ensure that they're effectively managing their obligations under the controlled substance act before the government comes knocking on their door.
Speaker 1:That's great. Um, I appreciate you talking about some of the, you know, best practices and, and types of training that pharmacies can implement and incorporate now that may save them some time anguish or court cases in the future. Uh, Darshaun, is there anything that you can think of from a pharmacist per perspective that you would consider, uh, best practice or a procedure or a type of training that you think pharmacies and pharmacists could incorporate now to both help them deal with the opioid crisis and the immediate see as well as prepare for the future?
Speaker 3:I think the key piece, um, is having those relationships and understanding where your patients are coming from. That's where that small town pharmacist came from. That's where the pharmacist who understood, um, that that, that your child needs certain help, uh, and, and is taking care of, uh, the parents and is giving the medication for those parents is coming from build those relationships. Understand, um, is this, is this person just coming out from a surgery or is this person, uh, coming every week always slightly sooner than they should be expected? And then, then having those relationships where you can go, you know what I think we need to talk about, uh, the medication you're using. Is this being used appropriately for your, for you right now? Uh, having that relationship not just with, uh, with other, uh, with, with patients, but also with caregivers and with other healthcare professionals? One of the most surprising things people will find out is that pharmacists don't like calling physicians. It's scary. Uh, cuz physicians are busy. Uh, it, it often requires, uh, you to reach first, uh, to their office manager and then reach back out and wait to hear from the physician. And that can take several hours. You've got a patient waiting, uh, in a retail setting and, um, you've gotta make a judgment call. Um, and you're, you're often taking this, the situation where you're going, you know what, um, this is on their letterhead. Maybe I should give them the benefit of the doubt. But if physicians and pharmacists work together and there is a faster way of checking these medications, that will also be useful. Pharmacists shouldn't also be scared of saying, you know what? I need, need to check some things. This is gonna take a little bit longer than expected. I may need you to come back. Um, maybe that 15 minute turnaround isn't reasonable in this case. Um, but it's difficult when, when the person is standing there with, uh, with immediate release oxycodone that needs to be given cuz they're, they could very much legitimately be in pain right now. And you saying it's gonna take several hours is not particularly being helpful. So, um, while, while it's important to, uh, to meet the needs of patients, recognize that needs come in many different forms and shapes and sizes, um, and then going back and looking at patient charts, uh, one of the key things that that can happen in long-term care facilities is you get a chance to go back and look at patient charts, evaluate that patient and go, okay, is the, is the medication being used appropriately and prescribed appropriately? Um, it's, it's not something that's done as frequently in a retail setting. Um, it's not done, uh, as frequently in most other settings actually that I can think of. Maybe those need to be considered as you continue is, is this patient getting the right medication? And essentially what's called a D U R drug utilization review at the patient level may be beneficial as well.
Speaker 1:It sounds like as with hospitals and physicians, that there are specific and growing legal concerns that will or are being faced by pharmacies and pharmacists right now as they deal with the opioid crisis. What is the one thing, or if there's not one thing, the several most important things that you think are critical when, um, when advising pharmacy clients on different ways to deal with this opioid crisis? I would say
Speaker 2:A pharmacy, pharmacy and pharmacist should really be doing their due diligence and evaluating the prescriptions that they're receiving. And as Darshaun mentioned, um, an earlier question, following up with the providers and seeing if these are valid checking da registration numbers, is the dosage right? Is this the right prescription for this patient checking the patient charts? I think, you know, pharmacy pharmacists should be going a little bit a step further now in the current state that we're in and really taking a hard look at the prescriptions that they're receiving and in a situation where they feel uncomfortable, they get the sense that a provider may actually not be, you know, prescribing a controlled substance for legitimate medical purpose. The DEA mentions that, you know, you should follow up with your state pharmacy board and then also reach out to your local DEA office if you actually feel that your provider may be running a pill mill clinic. That's a tough judgment call as Darshaun mentioned previously. But I feel like, you know, pharmacists should feel comfortable in doing that in a sense that if they're getting a feel that there's kind of a shady operation going on, that they should be asking questions and investigating further instead of perpetuating the current situation that we're in and, you know, they should be noticing these red flags and I would just say investigating and going a little bit further to make sure that they're actually dispensing the prescriptions for legitimate medical purpose.
Speaker 1:Is there anything else that you feel, um, would be helpful to the folks that are listening to this? Um, anything darshaun, especially in your experience that, um, you know, is unique or, um, would be useful in dec deciding how to advise pharmacy and pharmacist clients?
Speaker 3:I, I, I think it's important to recognize that this is not gonna be a system where you've got, um, the, the problem lies just with the pharmacist that I know that there have been alas on a great job with talking about some of the other stakeholders. Uh, there is another whole piece around, uh, and I can talk about this a little bit further, but, uh, around the other stakeholders, the, uh, people like pharmaceutical companies, people like distributors, uh, people like PBMs all working together, uh, to best control the interests of, uh, the patient in the in, in the end, we're all in this to help patients and, and help comes in different forms and it's important that all these caregivers come together and, and so does, um, so so do gov uh, so does the government, uh, come together to help, uh, their constituents help uh, patients, uh, meet their needs, uh, be as legitimately controlled in their pain as possible. But sometimes one of the key things I heard recently was, um, was this initial perspective we had and, and I used to see this when I walked through different hospitals where they said that, that the goal is zero pain and, and that's great, but is zero pain the best way to achieve, uh, the interest of the patient? Um, and, and sometimes maybe it makes sense to go, is this a pain that you can tolerate or is appropriate? Uh, because in the short term it, it, it's something that you'll be able to get by without worrying about, um, the long term detrimental effects this could have. Well,
Speaker 1:Thank you both Ashley and Darshaun for joining us today and for your very informative article and perspectives on dealing with the opioid crisis from a pharmacist and pharmacy perspective. Uh, I found it educational and I hope everyone who's listening does too. Thank you so much.
Speaker 3:Thank you.
Speaker 1:Thank you.