Narrator - Dr. Abel 00:00 Welcome to HelixTalk, an educational podcast for healthcare students and providers, covering real life clinical pearls, professional pharmacy topics and drug therapy discussions. Narrator - ? 00:11 This podcast is provided by pharmacists and faculty members at Rosalind Franklin University, College of Pharmacy. Narrator - Dr. Abel 00:17 This podcast contains general information for educational purposes only. This is not professional advice and should not be used in lieu of obtaining advice from a qualified health care provider. Narrator - ? 00:27 And now on to the show. Dr. Sean Kane 00:31 Welcome to HelixTalk. Episode 178, I'm your co host, Dr. Kane, and I'm Dr. Patel, and the title of today's episode is law and order pharmacy edition, a concise review of high yield pharmacy law topics for the MPJE. Dr. Khyati Patel 00:45 Surprise today we have a returning contributor, guest faculty. Our professor, Janine winickie, she's an Associate Dean for Student Affairs at our university, Rosalind Franklin, and she's a co course director where she teaches pharmacy law. That's why we have her here to share the expert tips on how to be successful in taking the MPJE, thanks, Dr. Patel, thank you for being here. Dr. Sean Kane 01:08 And of course, for any legal podcast, we must have a legal disclaimer. So a couple things we have to talk about is, you know, we will focus a little bit on federal law, but most law that actually impacts pharmacists is at the state level. So we will be covering a little bit state law specific to Illinois, but please recognize that your state is probably different. With that in mind, the questions that we're going to be asking about our individual state law could be applicable to your state. So can a pharmacist immunize in your state? Can a technician immunize in your state? Speaker 1 01:37 Such a great comment, Dr. Kane, because that's what I tell students all the time. Right within our law course, we're going to focus on the state where which we're located, which is Illinois. But I let students know right up front. Think about these questions, think about these topics, and make sure you're learning those for the state you're going to get licensed in. And they can almost create their own study guide right throughout their law course. Dr. Sean Kane 01:58 And then, you know, today we're not being comprehensive, almost on purpose, you're trying to hit the high points, the high yield topics, and we're recording this in February of 2024, so things may change, because laws change all the time. So just be aware that if you listen to this a year from now, that it may be different. Dr. Khyati Patel 02:14 And talking about laws changing. You know, there might be some buzz out there that the MPJE is going to become a thing of the past, but right now, most states have it. So here we are talking about it. So take it away well. And I think Speaker 1 02:27 one of the things Dr. Patel that has changed within the MPJE, and as of October of 2023 is they've moved to four competencies to help students prepare. It had been three competencies. And so when you think about the MPJE, the content is divided into four competencies, which I'll cover with you. But most students are like, Well, how long is it and how many questions Is it? So to get that out right away, it is 120 questions, of which only 100 are scored. The other 20 are really kind of in testing phase. I think that's the easiest way to think of it. The test is also two and a half hours long. So for students, they're always thinking about how to plan that time, which is amount, amounts to really like, 1.25 minutes, something like that per question, which also means you really need to be prepared, because you don't have a lot a lot of time to ponder each question. I'd mentioned the four competencies, Dr. Kane and Dr. Patel, and they're also weighted differently. You can look this information up on the nabp website, which is a great resource for any licensure exam. But to highlight them briefly today, one is around licensure and personnel that you see in the pharmacy. So you know, what can a pharmacist do? What can a technician do? What can't they do, and so forth. That's like 22% of the exam, which makes sense. That's a really important component pharmacist practice is even higher at 33% of the exam. So when you think about that, what can a prescriber dispense? What can a pharmacy dispense? Who can administer medications, things like that, which leads us into the third competency, which is dispensing. 24% of the exam is on that. And when you think about these competencies, including dispensing. It happens in almost every practice site. So how are prescriptions validated? How are prescriptions transferred? How are they labeled? How are they packaged? So again, community, long term care, hospital, right? All practice settings. And then finally, pharmacy operations. Rounds out the exam with that topic about 21% so when you think about pharmacy operations, right? You think about record keeping. You think about the legal compliance for inventory hazardous drugs, security and access, or lack thereof, of access to the drugs. And that really rounds us out for the four competencies. Dr. Khyati Patel 04:35 And Dean, you know, you're here and talking about this, this is great, because Dr. Kane and I have practice sites that are not contemporary practice site. A lot of these laws apply to contemporary community practice in itself. So it's good to hear and also review what were the laws have been lately. One thing that I always tell students if they're working in a community pharmacy is that your company requirements. Is not necessarily the law. Usually those tends to be a little bit more stringent and stricter. So make sure that they know the distinction that you know because I do this thing at Walgreens, CVS, Jude, Osco, doesn't always mean that this is the law. Speaker 1 05:15 I think that's a great clarification, especially in a community pharmacy. More than anything you might see a limitation on the quantity prescribed to the quantity written on the prescription, and so we're limited by that based on the insurance coverage. Typically not the law, and that's one of the biggest ones I try to clarify with students. Dr. Sean Kane 05:33 One thing when I think about pharmacy law is, how did we get to where we're at right now? Right? Almost like a little history lesson, and that the story actually starts way back in 1906 which is a long time ago, when you think about Speaker 1 05:45 it, it sure is. And when you gave me the opportunity to speak on this, I like it because I do a little lecturing to P ones on history of pharmacy as part of our curriculum as well. And Dr. Kane, as you said, it really does start in the early 1900s with the Pure Food and Drug Act. And you know, the two main concepts there that come out of there is adulteration and misbranding. And so when you think about misbranding, it's easy to think branding and label, right? So anything that says the label is not accurate, the label is not comprehensive. The label doesn't include what is required would make a product be misbranded. An easy example is to think about a bottle saying that it contains St John's Wort or fluoxetine, or whatever you want to say, and it actually does not, it would be misbranded. The other one is adulterated. And some of you, if you are history buffs, this one really came about in conjunction with the Sinclair novel called The Jungle right, which talked about these really inhumane situations in factories, but adulteration is really when a medication or a drug does not satisfy purity standards that are set up by the FDA. So the drug is unsanitary, it's been contaminated, maybe good manufacturing processes or GMP haven't been followed. It might even contain something that's unsafe, right or not the correct strength, adulterated. Dr. Sean Kane 07:05 And I'd also add to that, if the product was not stored appropriately, and it's now been exposed to too much heat or too much sunlight, now it's an adulterated product as well. Speaker 1 07:14 Great clarification, you know. And then you move in, when you think about medications, we all think about the Food and Drug Administration, and really the the act that came before the FDA that formed the FDA, was the Food, Drug and Cosmetic Act in 1938 and so the FDA really is critical for us as pharmacists, because it defined what a drug is. It also required manufacturers to prove that the medication was safe. Does not require, at that point that the medication be effective, but it did require safety, and I don't know, Dr. Patel, Dr. Kane, if you're a history buff, there was some history in the formation of this act as well. I gave you the hint with the jungle for adulteration. Any ideas for the Food, Drug and Cosmetic Act? Yeah. Dr. Sean Kane 07:56 So this one was prompted, unfortunately, by 100 and something, mostly kids that died as a result of consuming an elixir that contained sulfanilamide, which is an antibiotic, but it also had diethylene glycol, which is almost like an antifreeze type solvent in it that is lethal. And that experience is one of the things that led to the food, direct Drug and Cosmetic Act, proving that products that are on the market have to be safe and not harm the consumer, right? Dr. Khyati Patel 08:22 And based on what you said, it sounds like this is more applicable to manufacture of the drugs, like making sure that they're being produced in a proper manner, appropriate manner, following the rules and regulations. So not so much for the pharmacist. Speaker 1 08:34 Yeah, good point by we went by the time we get the medication in in the pharmacy, it's been approved by the FDA, right Dr. Sean Kane 08:40 then, if we keep going on our history lesson here 1951 we have the Durham Humphrey amendment. And this one was interesting, because, again, not being around in 1951 you almost take it for granted in terms of what laws did or didn't exist at certain times. So what happened with this one? Speaker 1 08:56 Yeah, the really big difference here is prescription and OTC medications were defined, right? And so to be a prescription item, it really can only be taken safely under the direction of a prescriber and by pharmacy, whereas over the counter can be safely taken by a patient without intervention by the pharmacist or provider. And because that differentiated with prescriptions, that means now we have refills, right? And so again, the things we take for granted, but refills also became part of that Durham Humphrey amendment. You know, about 10 years later, the Kefauver-Harris amendment came out as well. And there's a little bit of history here, if you're a history buff, and this is really when thalidomide was given to pregnant women in Europe, which caused the birth defects. And so, again, this amendment was an outcome of that tragedy, and so it really established the things that we think about now for clinical trials, new drug applications, and this is where we see that efficacy or effectiveness added to the safety that occurred earlier. So now we have medicationsations that have to be safe, but because of the Kefauver-Harris, we also have to be effective. And. This really also started a review of medications that were, quote, old, right? And they've been in place prior to 19, 1960s one last thing that I would add another law really would be obra obra that came into effect in the 1990s and 1991 actually be exact, and it's a super comprehensive law that involves things that are outside of scope of the scope of today's podcast, but one of them for day to day practice of pharmacy is counseling. And the requirement for counseling, how that's implemented, does vary state by state, but that's really a big change in our practice, right? When we think back to that law and the early 90s. Dr. Khyati Patel 10:36 Yeah, so talking about the bread and butter of pharmacists practice and community is, you know, counseling about medication. So that's great to hear. But you mentioned earlier that the Pure Food and Drug Act is what define what a drug is. So what is by, you know, FDA, how do they define what a drug is? Speaker 1 10:55 Well, the drug would have to be approved in one of the national formularies. So you think about USP, for example. But really then it has to be used to diagnose, to cure, to mitigate, treat or prevent disease, and it's really a non food product. And I think that's really the biggest difference we see between a drug and a dietary Dr. Khyati Patel 11:17 supplement, for example. So food and OTC products are different than drug we established that. How are these drugs approved by FDA? We talked about the act that required safety proving and then proving efficacy thereafter, and so the manufacturers are imposed with some of these requirements on submitting the data for safety and efficacy, which FDA reviews it. So can you walk down the pathway of how the drug Speaker 1 11:42 studies work? Absolutely. You know, if you're a student, you're going to go back to your curriculum and think, Oh, I do remember those clinical trials and what was involved in that. And if you haven't been involved in that for a while, this is a nice refresher, but you're right. Drugs do get approved by the FDA. They start in animal studies, so we can kind of see where that goes, and if those are producing the results that the company is looking for, the drug company and submits to the FDA an investigational new drug application, or ind, another use of acronyms here in our profession. And this allows the drug company, with permission from the FDA, to start really in human trials. And there are human studies that really begin before the drug is approved. Dr. Khyati Patel 12:22 So there are three different types of human studies. I remember phase one, two and three, Speaker 1 12:26 that's right. So when we started, when we think about phase one, this is when the product is tested, or the drug is tested in a small group of people that are healthy, right? They don't necessarily, and they do not have the medical condition that the drug is being investigated for, but they're healthy. If the product moves on right from phase one, phase two is in a larger group of people, and it is people who have that disease or that medical condition that the medication is being going through the trial to be approved for. And then finally, if it makes it through phase two, because typically these are done consecutively, we would get to phase three, which is the largest study, more people are involved, and we really are looking for that strong safety and efficacy that we've talked about in the historical context of law. And then they submit that information along with their application to the FDA, along with the information from the clinical trials. And then the FDA reviews it and then would either move forward and approve the med or not. Dr. Sean Kane 13:25 Of course, we also have phase four studies, which is basically after the drug is on the market. The FDA mandates that the drug companies collect efficacy and safety data, and they actually have to submit a yearly report to the FDA about these phase four trials, which are basically, you know, typically, observational studies where they're looking at rare but serious side effects, or, you know, special populations, things like that. Dr. Khyati Patel 13:48 And this is where we talked about rems episode, you know, safety data in Phase four is collected, and FDA can decide what to do with that data, right, put additional regulations or not, and if any of these companies want to do new studies, or maybe a different indication, or they want to add or change something such as, you know, maybe different route of administration, or maybe a different dose than what was initially labeled, or maybe they want to do it a special population use, right? All of this will need a new application for FDA to review it all over again. Great. Dr. Sean Kane 14:21 Then, for generic manufacturers, if the products in the market, they have a different process where they go through an A NDA, an abbreviated new drug application process, so they don't need to do the IND, the investigational new drug or the NDA, they have an abbreviated version. And this focus is basically on proving that they have some similar kinetic profile to the original branded drug, and that a NDA essentially focuses on the kinetic similarities, and that potentially would allow for a generic drug to make it to Speaker 1 14:50 market, right? And I think Dr. Patel, you mentioned a little bit if a medic if a medication is already on the market, but they want to add a new indication to it, for example. Example, they do have to submit, like it's a supplemental, new drug application. I think it's smda, again, another one of those acronyms. But if they want to change the labeling, they want to change the indications, or even if they wanted to change, you know, where the man or how the drug is manufactured, etc, that all goes through that smda process we Dr. Sean Kane 15:19 kind of talked about earlier, that the Food, Drug and Cosmetic Act of 1938, really focuses primarily on manufacturers. So for a pharmacy, you know, sometimes the lines blur a little bit in terms of compounding versus manufacturing. You know, if you batch compound something, but then dispense it to 10 individual patients, does that count as manufacturing? So where is the line drawn in terms of where a pharmacist may be regulated by the FDA versus state law, right? Speaker 1 15:48 Great question. I mean, really, when you think about the term compounding, it really has a clear kind of triad of relationship, right? You've got the prescriber who has the relationship with the patient they write the compounded prescription for that patient. That patient takes that specific prescription for themselves to a specific pharmacy to have that compounded or made and dispensed to that specific patient. And so that's really what that compounding is compared to manufacturing, and that's a key difference. And then, as you said, Dr. Kane, it kind of becomes a little more gray with these places that have outsourced right, where they're making more of a batch process for those items. You know, I think one of the things when we think about compounding and manufacturing, and a little back to our historical perspective, a lot of this came to light in 2012 when there was a New England compounding Center disaster, right, where we had some meningitis outbreaks due to fungal infiltration, right? Of the products that were being compounded, quote, unquote, and distributed across the country. So if that rings a bell, you'll kind of think about that, if not, might be of interest to just Google and look it up. Dr. Khyati Patel 16:55 Yeah, that was a terrible event for the world of pharmacy, for sure. Yeah. Dr. Sean Kane 16:59 And just to kind of add a little bit of grayness to the picture, so we have these manufacturers that are manufacturing products for the general population. We have compounding pharmacies that have the triad between the patient, the provider, and the pharmacy. But then we have this gray area of these outsourcing facilities that might batch create, let's say, vancomycin or Ancef or something like that, and then send it to pharmacies. From the FDA standpoint, because it's not a patient specific prescription that they're preparing this. This is not technically compounding, but it's also not manufacturing, and the way that the FDA regulates these facilities is based on they have to follow Current Good Manufacturing Practices. They are inspected by the FDA, but they don't have the same labeling requirements, so the product that they prepare and send to a hospital is not going to have the same labeling requirements as a product from AbbVie or Pfizer or something like that. Unknown Speaker 17:53 Great, a great additional comment there, Dr. Kane, and Dr. Khyati Patel 17:56 I think moving on from you know, drug studies and the FDA requirements for manufacturing and compounding, I think the big section of Pharmacy Practice Act is controlled substance and so that's where we bring out another acronym, the Drug Enforcement Agency, and that play a big role. And we understand that, you know, this controlled substance Act is a little bit different on the federal level. Obviously, states tend to be a little bit more stringent with that. What are some of the federal level key points to know about controlled substance act? Speaker 1 18:27 You bet, I think a couple things. One thing that I would point out is the DEA pharmacist manual, I think it's linked in the notes as a great resource for federal DEA manual. Now remember, our Practice Act defines specifically what we need to do within controlled substances, and I think we're going to talk about that later today. But the DEA pharmacist manual in general, I would be remiss if we didn't mention it as a great resource. The other thing to think about for DEA and pharmacy practice is similar to compounding. There's this, there's relationship, right? It's a closed system, so we have this registration process for really, everyone except the patient involved in controlled substances has to be registered. So if I'm going to manufacture a controlled substance, I have to be registered with the DEA. If I'm going to distribute or ship it to a pharmacy, I have to be registered with the DEA. And if I'm a pharmacy and I'm going to dispense medications that are controlled I have to be registered with the DEA, so it performs this closed system to help regulate and prevent fraud, theft and misuse. You all remember that there are, you know, five schedules federally, and the states use those schedules as well for thinking about controlled substance with schedule one being the most strict and schedule five being the least strict. And I think the other thing that we always think about federally with the DEA is, how do I order controlled substances? How do I report theft or loss? Dr. Khyati Patel 19:52 So that's a great overview. Dean vinicky about different schedules. And you know that is a closed system. How does DEA keep track? Where things are moving. So I'm sure there's like forms required for people to document, you know, where things are coming, how many things are going? What are those requirements? Speaker 1 20:08 You bet I think a couple things would be especially for Schedule One and two. And obviously, schedule one, we don't see a lot in practice, unless you're in research, but schedule one and twos have to be ordered through a DEA 222, form. Or now that we've moved a lot into computers, many companies are using a CSOS or a controlled substance ordering system that's been approved by the DEA so that very carefully, will track ordering of C ones or c2 of the DEA 222 for threes, fours and fives. You don't have to order it on a special dea 222 form, but you are required to keep those invoices or ordering records right for a finite period of time to help track and make sure there's no theft or loss. That leads me to theft or loss right? Because, in addition to ordering and tracking what we're getting in and out to help us identify if you do identify potential theft loss or just unforeseen you can't account for the med that's a controlled substance. The DEA has a form called form 106 it's filled out electronically. And then there may be other requirements if there is suspected theft or loss that at your state that you have to fill out. But at a federal level, at minimum, it's the DEA 106 which, again, is an electronic form, Dr. Sean Kane 21:22 and then for any pharmacy student or pharmacist is going to be sitting for the MPJ, it's a really good idea to understand, at least at that state level, but certainly at the federal level as well, what is the schedule for a variety of different medications, right? Speaker 1 21:35 That's exactly right. Dr. Kane, I always tell students, you know you need to know that alprazolam is a schedule for if you need to know where it needs to be stored, for example, right? Because and you need to know that coding by itself is a schedule two so you know how to order that product. Absolutely need to be familiar with that off the top of your head. Dr. Sean Kane 21:56 And states can be more stringent, but not less stringent. So federally, for example, alprazolam and other benzodiazepines are schedule four. A state could say it's a schedule three or schedule two, but they can't make it a schedule five, for example, Speaker 1 22:08 absolutely make it more strict, not less strict. And we've seen over the years, a variety of products go that way, right? Tramadol, hydrocodone comes to mind, and I'm sure there are others as well. Yeah, like, Dr. Khyati Patel 22:18 Gabapentin is a good example for the state of Wisconsin. It's not a controlled substance, but it's something that is monitored by the state. Speaker 1 22:25 Great example. The other one I always make sure students are thinking about is the amount of coding in a combination product will determine what schedule it is, right? So you might have a combination product with coding, that's a schedule three. You might have another product that includes coding, but at a lower strength that would be a schedule five, and that kind of information is important for students to know and memorize again, so that they are comfortable with what are the storage and ordering requirements. Dr. Sean Kane 22:53 So at this point, we've really focused on federal law, and as we mentioned, the Food, Drug and Cosmetic Act of 1938, and therefore the FDA, they're primarily focused on manufacturers getting drugs to market, things like that. So most of Pharmacy Practice is regulated at the state level. So we are going to transition to Illinois specific laws. But even if you're not practicing in Illinois, or if you're preparing for an MPJE outside of Illinois, I think you should be able to answer all of these questions for whatever your state law is, and we're going to format this in a kind of Q and A format, so that the question would be applicable to any state. And the answer, obviously, is going to be Illinois specific. Dr. Khyati Patel 23:29 And I think the first question that comes to mind, you know, Dr. Kane and Dean winickie is, where do you find this information about the law that pertains to the MPJE, and in preparation of it so specific to Illinois Dean winickie, where should the students go to? Speaker 1 23:46 I mean, really, most of the MPJE content is going to come from your Illinois pharmacy practice act, as well as the related Administrative Code or rules. And I believe the links for these are in the show notes, but they really are useful now I will say sometimes folks say that Practice Act is a little bit hard to read, but once you get used to kind of the rhythm and the read and even using the control find can really help you find the content and topics that you're looking for. So I really recommend that students use those, or even pharmacists right who need a quick refresh the Administrative Code. One thing that I always point out, Dr. Kane, Dr. Patel, to students, is it's set up like an outline, so you can actually look at it, almost like a chapter, contents, table of contents. Look at what item or subject you're looking for. Click on it, and it brings it to now I'd mentioned those are the two main resources, but realize there are others as well, such as methamphetamine precursor act you know, which deals with pseudo ephedrine, acts like the hypodermic needle, information, poison prevention, etc. But I really tell students, you know, to focus on those, those two acts primarily, and then complement it with the others. Dr. Sean Kane 24:54 And for me, I would also just highlight that most things are going to have two documents. Associated with them. So the Pharmacy Practice Act, the Act is passed by the legislature for the state, but then there's an Administrative Code for pharmacy practice, and this is basically the in the case of Illinois, the Illinois Department of Financial and Professional Regulation, they are authorized to create a document called the administrative code that focuses on, in this example, the Pharmacy Practice Act, but the administrative code for that so the ACT generally is going to be more general, and then the administrative code is going to have more specific or detailed information on how that particular organization regulates a variety of things related, in this case, to Pharmacy Practice Act, or the Controlled Substances Act in Illinois, Speaker 1 25:41 I know, and I think a great example of that Dr. Kane is, you know, when we think about CE requirement for pharmacists, for example, the specific information, or at least most of the specific information, in terms of hours required, et cetera, are going to be found in that Administrative Code that Dr. Kane was just explaining. Dr. Sean Kane 26:00 Well, why don't we talk about that for a second? So in your state, or in the state of Illinois, how many hours of CE are required for pharmacists, and are there any special requirements on those hours? It's 30 hours. Speaker 1 26:12 30 hours in the state of Illinois are required for pharmacist CE, and that is a two year renewal that happens every other year. Specifically, it's on even numbered years. So that's an easy way to remember. It one exception to that, especially if we have new grads or preceptors who are working with new grads, that CE requirement is exempt, right? It waives that CE requirement for your first renewal. So for example, if we have students graduating next May, May of 2025 they have to renew in the even year, right? So that would be 2026 but because that's their first renewal, they are waived and don't have to complete that CE of 30 hours as a requirement in 2026 but they would be required to complete that 30 hour CE requirement when they renew in 2028 I think Dr. Kane, you'd also asked about, are there specific content, right, or topics? And that's something that really does vary a lot by state, and we've actually seen a lot of updates and changes to that, even in the state of Illinois, a couple of them that have impacted all healthcare providers. But we're really talking about pharmacy today would be for pharmacist implicit bias training, one hour every renewal period, one hour on sexual harassment training every period. And then effective coming up next year is one hour of cultural competency training every year. And another one that I would point out would be that if you are a pharmacist involved in administering and ordering covid or influenza vaccination, then there is a requirement of two hours of vaccination CE with every renewal period. Dr. Sean Kane 27:55 And Dean Mikey, you know, obviously any pharmacist needs to know what are the requirements in terms of CE to kind of stay licensed. But would it be reasonable that the MPGe might ask a question like, how many hours do you need to maintain your license? Absolutely? Speaker 1 28:11 That is a valid and real question when we think about the MPJE, because that absolutely falls within those MPJE competencies when we think of competency number one licensure. Dr. Sean Kane 28:23 And for that reason, I feel like, if you were to get this on the MPJE, this is almost like a layup shot, like this is something that should be so easy to answer. It's just that you need to know that. You need to know it agreed, Dr. Khyati Patel 28:33 and kind of taking a different direction. Now, as we talked about four different sections and scope of practice, one scope of practice or the hat that you know pharmacists, where is pharmacist in charge? And so they are responsible for many different function, but as they say, in charge, a supervisor or manager position, questions come up, like, can they be the pick, which we call pharmacists in charge, for short, pick at different, multiple, different pharmacies, like, what are the our requirement? What happens when they go on leave? What is the state of Illinois say about that? You bet Speaker 1 29:07 that is a great topic, because there is a lot of information on pharmacist in charge, or, as Dr. Patel said, Pick, which is a state defined term, right pharmacist in charge or pick? So usually the questions that I that come up, or things that are specifically outlined in the law, we can review briefly, every pharmacy in the state of Illinois must have a pick pharmacist in charge. The same pharmacist in charge can occur at multiple pharmacies, but there are some requirements within that. So if the pharmacist in charge or pick is going to be that at multiple pharmacies, they do have to work an average of at least eight hours per week at each of those pharmacies, because it is a law to have a pick at each site. If the pic leaves the pharmacy department, they have to notify the state the IDFPR within 30 days of that change and also. So if a pharmacist in charge or pic has to go on leave, sometimes we might see this for health reasons, right? They might need to go on a medical leave. If that leave of any sort is greater than 90 days nine zero, then the pharmacy has to notify again the department, IDFPR for that notification of change a new selection. Dr. Sean Kane 30:21 So then moving on to kind of prescriptions and filling them. And what's valid with a prescription, what is the scenario in the state of Illinois, or in your state where you receive an out of state prescription? So for example, you know, we're very close to the Wisconsin border, if I saw a physician in Wisconsin who wrote me a prescription, can I have that Wisconsin prescription filled at an Illinois pharmacy? Speaker 1 30:44 You know, that's a great question. And Dr. Kane, you said it better than I could. Right? Some places in the country, we see this very common. If you are close to a border, you do see prescriptions coming in and out across the border which is allowed, and this is where you use your professional judgment, right? I grew up in Iowa, more in the middle of Iowa. So if I saw an out of state prescription from Montana, for example, it might be valid, but I might, you know, do a little bit of my due diligence to make sure it is compliant with the regulations, just because it's, you know, not geographically close, but yes, as long as the prescriber has prescriptive authority in Illinois, that prescription is valid in a state other than where the prescriber is licensed, and that includes c2 that's a common question I get, even if it is for a c2 prescription or a schedule two, you can fill that from an out of state prescriber. Now that's assuming the prescriber you know has their DEA number, but absolutely so. Dr. Sean Kane 31:36 Dean winnicie, you said that it's valid as long as the person who's prescribing has prescriptive authority in Illinois, and that naturally begs the next question of who is authorized to prescribe in our state of Illinois. And then, are there examples where a person may have prescriptive authority in a different state, but not in the state of Illinois Speaker 1 31:58 exactly so the person out of state can absolutely have you can absolutely fill the prescription from a provider outside of the state, as long as they have prescriptive authority in Illinois. But because of that scope of practice, or that authority does vary by state, it's important to note that so for example, whether we're talking controlled substances or not, pharmacists in some states have some prescriptive authority. I think California comes to mind. But in the state of Illinois, pharmacists really do not have prescriptive authority right except to order and administer like covid and influenza vaccines. So I would not be able to fill in the state of Illinois a prescription written by a California pharmacist, even though in California that pharmacists might have prescriptive authority. Pharmacists in the state of Illinois do not have prescriptive authority for general prescription items. Other examples, right? You know, when you think about naturopaths, typically chiropractors, those are healthcare providers, but they don't have prescriptive authority in the state of Illinois, physical therapists come to mind as well. Dr. Sean Kane 33:01 So then, who is authorized to prescribe in the state of Illinois? Speaker 1 33:05 Physicians, MD or ODS, dentists, your advanced practice, registered nurses. We see that a lot physician assistants, veterinary we see a lot of veterinary podiatric optometrists. Those are what we really see as having prescriptive authority in the state of Illinois, and it has to be within their scope of of practice. Dr. Khyati Patel 33:24 And then when you have seen some interesting instances where physicians are prescribing for themselves, so is there a law against self prescribing in Speaker 1 33:34 Illinois, you really have to almost break it down into controlled substances versus non controlled substances. And just with that intro, I bet a lot of you can figure out without even necessarily knowing the law, where those differences are. But in the state of Illinois, for controlled substances, self prescribing is prohibited. They cannot self prescribe. Now, a physician or an authorized prescriber can prescribe for an immediate family member as long as there is a true practitioner patient relationship, with records, etc, for non controlled substances, if we shift gears that is allowed in the state of Illinois, you can absolutely self prescribe or prescribe for your yourself. But the prescription does need to be right in the course of the prescribers legitimate professional practice. So, for example, a dentist cannot provide gout prescriptions, or a podiatrist could not prescribe acne medications. Now you'll both laugh, but when I was back in practice, a veterinarian tried to call in their own birth control pills, and I was like, No, that's not allowed. I know your name. I know you're a DVM, that that we can't do. So you know, you've really got to think about regular scope of practice, and you absolutely, as a pharmacist, have the right to not fill the prescription if it doesn't seem right, which I just gave you the example in my practice years ago. And Dean Dr. Sean Kane 34:52 Monica, I want to highlight that just for a second, because I think that's a very common question that comes up with new graduates, in particular when. You receive a prescription where it just doesn't feel right, your spidey sense is up. You don't agree with a dose. You don't agree with, you know, a regimen, whatever it is, what is the role or the ability of a pharmacist to choose to not fill a given prescription, even if it is technically a legal prescription, by way of the definitions in the Pharmacy Practice Act. Speaker 1 35:25 So really, that is within your purview, right? Because it is your license. If you are not comfortable filling the prescription, maybe it's because you can't get a hold of the prescriber to verify the dose, right? Maybe it's after hours or the weekend you can give that prescription back to the patient and say, I'm unable to fill it because I need to verify some information. Maybe you don't have the medication in stock. Maybe you've checked the PMP and you're a little concerned about the validity of the prescription. You absolutely have that within your autonomy to give the prescription back. Say I'm not able to fill that I need to verify some information prior. Dr. Khyati Patel 35:59 So that's a great discussion to kind of you know, trust your senses, and if it doesn't look right, you use your judgment. But what about for the prescriptions that look right? But maybe that goes against the pharmacists belief, like, what happens in those instances? Speaker 1 36:17 We actually saw some of that, even with the pandemic, right when you think about vaccinations, or we might see that right now around women's health issues, but really it's the role of the pharmacist to help the patient meet their needs. So if you're not comfortable filling a prescription that is actually valid and written within the scope of the prescribers purview, then it's your role to help that patient find a pharmacy that will and is able to fill the medication or work with the patient to have someone else at your pharmacy fill that prescription. Perhaps you are a staff pharmacist or partner, right? But it's not our role to impose our beliefs and prevent a patient from getting their prescription filled. Dr. Khyati Patel 36:53 So we talked about the legitimate prescriber. Let's talk about legitimate prescription. So how long the prescriptions are good for, and how many refills should be on different type of prescriptions, and how long are they good for? Speaker 1 37:07 You bet. And so again, similar to my other comment, this is where you really can divide it into non controlled and versus controlled medications. So when we think about a non controlled prescription in the state of Illinois, based on the date that it was the date that it was written, the first fill has to be within 12 months of the date the prescription was written, and refills can actually occur for up to 15 months from that original date. So that's something to keep in mind that changed several years ago, right? You've got 15 months to fill that prescription from its original date for C, threes, fours and fives, those laws are the same at the federal level as they are in the state of Illinois, it's refillable up to five times within six months after that, the prescription is expired, so it's refillable up to five times with, of course, prescriber approval, and expires After six months within our c2 prescriptions, right? We've talked a little bit about how much more stringent that is in terms of record keeping, invoicing, etc, C twos are not refillable. But what we do see in the state of Illinois and across most other states is that a prescriber can write three one month prescriptions to help a patient have an ability to get those prescriptions for more than one month at a time by indicating on each prescription do not fill before such and such a date. And the other thing I always like to remind students with a c2 is a c2 prescription is only good for 90 days. Right after it's been a 90 days written, the prescriptions expired. So that's another reason why you can't, you know, really predate those prescriptions. That's illegal, and it's only good for 90 days. Dr. Sean Kane 38:48 And Dominici, I know, you know, when I was in school, this was a hotter topic in the state of Indiana, where you might have a child that has ADHD and they need a prescription for Ritalin, which is a c2 as an example, and it was difficult for a parent to have monthly visits to the child's prescriber to get those prescriptions. And that's kind of in part, where some of this dating process came from. Is now in the state of Illinois, a prescriber could write today's date, but have it an earliest fill date on the second two prescriptions give three prescriptions, potentially could be worth a 90 day fill between the three, but it's important that the date that they're writing is not a date in the future. It's today's date, which is when it's being written with that cannot fill before date on the prescription. So really, there's two dates on the prescription. Speaker 1 39:38 That's exactly right. Thank you for clarifying that right, the prescriber has to write the date on the prescription that it's being written, given to the patient, right or given to the pharmacy. And within the directions on a c2 prescription, it will include the do not fill before directions. Dr. Khyati Patel 39:55 And another thing comes to mind is people do go to you know what different Pharma. Disease, just like they go and, you know, choose their prescribers. Are these prescription transferable? Speaker 1 40:06 Dr. Patel, you'll laugh, because I think we were in Wisconsin one day for a meeting, and I realized I'd left prescriptions at home, so I needed to get my prescriptions transferred from the state of Illinois up to Wisconsin. So again, all we really have to do is break our answers down for non controlled Absolutely, those medications can be transferred back and forth, unlimited right, as long as there is refills and quantity left on the prescription. When we think of threes, fours, fives, for controlled threes, fours, fives, those can be transferred one time and one time only, with an exception being if the computer systems are connected in real time. So for example, Walgreens to Walgreens. Those can go back and forth as often as they need to, because those computers are connected and talking in real time. But if you were trying to transfer a c3 four or five again, using an example of Walgreens, to an independent pharmacy, that can only happen one time, because those computers are not connected. And then, if we think about C twos, right, they don't have refills, so therefore they're not transferable. I do like to point out there is a new law in the Illinois that allows for transfer of C, twos, threes, fours, fives, for the purpose of the original fill. However, on the back end, really, community pharmacies and health systems, etcetera, are trying to figure out logistically how to do that behind the scenes, but as we move more and more towards electronic prescribing of controlled substances, that law was put in place to really ensure there is access. So Dr. Kane, right? If, if I brought you in a hard copy for my methylphenidate, you had said and you didn't have it at Dr. Kane's pharmacy, he could hand me the prescription back and I could take it to a different pharmacy. But as we see more and more prescriptions coming in electronically, there has to be a way which the law now allows for that prescription to move, for the purposes of original fill, from the Dr. Kane pharmacy to another pharmacy. Again, we're just working that out on the back end with pharmacy systems. Dr. Sean Kane 42:05 So then kind of highlighting, again, more regulation around C twos. Dean winickie, let me give you a scenario, and that really focuses on what can be changed on a c2 prescription. I have three prescriptions with me for my Ritalin, my methylphenidate, and the prescriber did not write must fill before, but they updated the dates. So the dates on the prescriptions, they're today, a month from now, and then two months from now. That's not a legal prescription, because the dates haven't happened yet. You call up the prescriber, are you allowed to change, let's say, the date on those prescriptions, or are those prescriptions not valid? And if you can or can't change it, what else can you change or not change on a c2 prescription in the state of Illinois? Speaker 1 42:50 So actually, Dr. Kane, using the example you gave, those would not be valid prescriptions that are dated in the future. You cannot do that. They have to be dated by the prescriber on the date the patient was seen, and you cannot change that date. You cannot change the patient's name, you cannot change the prescriber name. You cannot add or edit a prescriber signature. Nor can you change the name of the drug if in the example Dr. Kane gave, they had not clearly stated must fill before a date, right? That would be an update to the directions, and you could absolutely call and get confirmation with the prescriber to clarify what is the not filled before date. So you could change that if the dose or quantity was not clearly written, you in the state of Illinois can contact the prescriber, clarify the dose or the quantity, and still have that c2 be valid. But to confirm you cannot change the date, you cannot change the patient name, prescriber, name, prescriber, signature or the name of the drug in the state of Illinois for a c2 prescription, Dr. Khyati Patel 44:00 kind of taking a different scenario. Dean vanickie, let's say I show up to a pharmacy with my opioid pain prescription. My doctor wrote 30, and I don't think I need 30. I just need 15. Is, is these type of partial fields allowed? Speaker 1 44:16 So I think you're probably talking about a c2 product. Dr. Patel, based on your your information for a c2 in the state of Illinois, you can dispense a partial fill. And oftentimes this is because we don't have enough in the pharmacy. It could be that the patient you know only wants a small quantity. However, in the state of Illinois, the remaining quantity has to be filled within 72 hours of the original fill. So let me say that again, right in the state of Illinois, for a c2 prescription, you can do a partial fill at the pharmacy as long as the remaining quantity is filled within 72 hours. That doesn't mean that Dr. Patel, if she's the patient. To pick it up within 72 hours, but it has to be filled within 72 hours. And if, for some reason, that's not feasible, then, you know, as the pharmacist, I have to contact the prescriber, and the patient is not allowed to pick up the remainder. So we oftentimes may see that with drug shortages for C twos, right? I might have a little bit on hand. The rest of my orders coming in in two days. Perfect example of why I might do a partial fill or in. Dr. Patel's example, maybe she had some surgery. It's on a Friday. She definitely wants to make sure she has three or four days on hand, but doesn't feel like she wants to have, you know, the full seven days on hand. Just from a safety standpoint, she might only pick up three, and say, if I need more, I'll come Dr. Sean Kane 45:40 in on Monday. Then what about non controlled substances? Speaker 1 45:44 Yeah, you bet non controlled or even Dr. Kane threes, fours and fives are completely permittable with partial fills, as long as you know your computer system is documented what quantity is given, and that way that ensures that the total quantity given within that prescription doesn't exceed the quantity total that was prescribed. Dr. Sean Kane 46:02 So then switching a little bit, we've already focused a lot on this, but you know, e prescribing, or electronic prescriptions, these are coming more and more common. What does the state law say about electronically prescribing these controlled substances? Speaker 1 46:17 We just saw an update on that here in early 2024 and I was just on a meeting where that was being discussed. So in the state of Illinois, effective this year, all controlled substances should be electronically prescribed. Did you like how I emphasized should? But there are a variety of exceptions for that should, and some of those which I would highlight because it is coming up in the practice of pharmacy in Illinois, the prescriber can actually certify with the Illinois Department financial professional regulations. They're not going to issue more than 150 controlled substances within a 12 month period, right? So that helps us transition, and that amount, 150 does actually drop to 50 later in a few years, 2029 and there's also some other exceptions that are probably beyond the scope of this podcast, you know, like being in a nursing home if there's an emergency situation, etc. But what's really important to clarify, and I saw this coming out in some communications from the state, pharmacists are not required to validate that prescribers are authorized to still use written prescriptions. It is not the pharmacist requirement or responsibility to confirm that they have met those exceptions. It's our responsibility to fill the prescription, even if it's a paper prescription, if we believe it is valid and written in good faith, I want to make sure that medication gets to the patient, and I'm going to believe that the prescription that I received via hard copy is written in good faith, Dr. Khyati Patel 47:42 and that makes sense. You know how you explained it, however, kind of jumping to a different tidbits, again, around the controlled substances. I remember, you know, getting into the gears after all, the patients picked up their prescriptions to do inventories. What does the state of Illinois say about controlled substance inventories, as to how often should it occur, and who should be doing Speaker 1 48:04 it absolutely, you know. And we talked just a little bit ago around the pit pharmacist in charge and the pic also has an important role when it comes to controlled substance inventories in the state of Illinois, annual every year an inventory of controlled substances has to occur, or it needs to occur more often, if there has been a change in that pick or pharmacist in charge, and I point that out, especially depending on the audience that's listening, is that is a law that varies by state, right? Because federally, it's every two years. State of Illinois, it's every year. And when we think about taking a controlled substance inventory, there are actually guidelines for c2 again, most stringent. You actually do have to do an on hand specific count, but you can approximate counts for threes, fours, fives, as long as the bottle has less than like 1000 tablets. But if you're really using those huge stock bottles of controlled substances that are larger, over 1000 you also have to do that actual hand count, or accurate count on Dr. Sean Kane 49:01 those products. Well, transitioning to a different topic, vaccination. So in the state of Illinois, who can vaccinate and who can receive those vaccinations, and what are some regulations around who can give it, what they can give and who can receive it? Speaker 1 49:16 You bet you know, we've seen some increase in responsibility over this through the pandemic. Of course, this involves training. But in the state of Illinois, pharmacists, of course, we know, can vaccinate student pharmacists can vaccinate and also pharmacy technicians can vaccinate once they've completed the required vaccination training by an entity that's been approved by the state, usually by ACP. And then, in addition to completing that training course, it requires BLS Basic Life Support certification, so we would be ready for any emergency that might or hopefully doesn't happen with vaccination. We're ready. Another change that has occurred in the state of Illinois is the age for vaccination, and pharmacies can vaccinate patients. That are seven years of age and older. We typically see in the state of Illinois that vaccinations are given through a standing order through the state. But you know what? You can still receive a vaccination prescription, right for a specific patient from a provider. Keep that in mind. We don't see it very commonly. And then we know, I think we've mentioned it even earlier today in the podcast, that pharmacists can actually order and administer both covid and influenza vaccinations in Illinois without a prescription or without a standing order, we have the ability to order and administer those and again, this ties back into the vaccination CE requirements for pharmacists who do order and administer those types of vaccinations. Dr. Khyati Patel 50:40 Yeah, and just a side caveat for this covid and flu vaccine, the age limit is little bit lower, so as young as three years versus for all the other is seven years and older. That allowance is due the prep act and as it is there right now, but it may change based on the further amendments made. Well, you know, Dean Renegade, lately, there's been a lot of buzz about safe conditions of work and protecting pharmacy personnel from overworking, maintaining wellness and stuff. So what are some of the laws in the state of Illinois regarding pharmacists working hours, such as no Max hours break time, etc, right? Speaker 1 51:22 And we have had in the state of Illinois some workplace conditions and expectations in our practice. Act. A few that I would highlight is the law states that there's a max number of 12 hours per day that can be worked, and that would include some break time. And what does that break time look like? Right? If you're working more than five hours a day, or five hours or more a day, you're required to have a break. And then if the shifts are actually six hours or longer, as a pharmacist, you get a 30 minute lunch break, as well as 15 minute breaks during that six hour period. And then there's additional break requirements if you are, in fact working that full 12 hour shift, one of the questions that came up is, well, what about a pharmacy resident? And the law does state that pharmacy residents are exempt from these requirements. I think both. Dr. Kane, Dr. Patel, you've been a resident, but I would point that out. Dr. Sean Kane 52:14 Well, Dean winickie, you know, we've just barely scratched the surface of common questions that come up both with pharmacy practice within the state, controlled substances within the state, and then kind of federal laws, again, usually don't impact Pharmacy Practice as much, but are definitely still going to be on the MPJE, and pharmacists need to be aware of Dean when I keep you teach. You know pharmacy law in our curriculum, what do you tell students whether they're going to take the MPJE in Illinois, which is what our content would be focused on, or maybe, and this is not uncommon at all, that students go outside of Illinois. They've never taken a class for Wisconsin law or Ohio law, or any other state. How do you recommend that they approach that exam where they feel less prepared and they need to kind of brush up on the material? Absolutely? Speaker 1 53:00 For students who are in our fourth year are getting ready to graduate, I give a variety of resources, and I'll just kind of hit the highlights here. You know, I really do think reading the Practice Act and the rules is a huge benefit to understanding them. So I tell students, print them out and highlight if you know you're going to stay in Illinois, there is a great book you can find it on Amazon that includes all healthcare provider laws, and it is called Illinois pharmacy laws and regulations. And you can, you know, consider that if you're going to consider using it for a long term investment. The other thing for new grads, especially is NABP puts out the MPJE Bulletin each year. It's typically updated about end of January, February, and it gives just some pearls, tools and hints for the examination process and registering for that exam, in specifically thinking about how to prepare for content within the MPJE another resource from NABP is the pre-MPJE exam. And even if you're going to transfer right? So I'm licensed in Illinois now, and I'm going to move to Wisconsin to retire or work part time. You know you can also take the pre-MPJE for a different state, Wisconsin and Ohio, wherever, and you're allowed to take it in each jurisdiction currently, once for new grads. Listening, I think another resource that navp makes available that's useful is their survey of pharmacy law. It's updated once a year, and it is sent to new grads electronically as part of the exam registration process. And it's set up like a big table with various topics, and each topic has an answer provided by nabp that is specific to each state. A lot of new grads tell me they like RxPrep for MPJE preparation. I'm not here to say yes or no, but that's another resource that has a state MPJE module. And there are actually a lot of various online or electronic tools, a lot of apps that are useful for MPJ, E I just tell students, take a peek at them. Look. At their reviews, try it for a trial period to make sure that it works for your learning style, and to make sure the information is up to date and accurate, because with law there are ongoing and regular changes. I always tell folks to also, don't forget about your state associations I shared earlier. I think the importance of contributing to and joining a state organization, but many times, your state associations will offer law resources or guides, and sometimes colleges of Pharmacy also provide study packets or review opportunities for individuals, last but not least, especially for our new grads. Listening. Sometimes employers will offer preparatory resources as a benefit, and that's something to definitely ask about and take advantage of if offered. Dr. Sean Kane 55:47 Well, Dean winnicie, I really appreciate your time and kind of helping us guide through some of the curls associated with, you know, pharmacy law in Illinois specifically. I think that wraps up today's episode quite nicely. Dean winnicie, we really appreciate your expertise and your time in today's episode for the listener, we have a variety of references and show notes, so please check us out at HelixTalk.com again. This is episode 178 with that, I'm Dr. Kane. Dr. Khyati Patel 56:11 I'm Dr. Patel, and thank you again, Dean winickie, for being with us today. My pleasure. Thanks. And as always, study hard. Narrator - Dr. Abel 56:20 If you enjoyed the show, please help us climb the iTunes rankings for medical podcasts by giving us a five star review in the iTunes Store. Search for HelixTalk and place your review there Narrator - ? 56:31 to suggest an episode or contact us. We're online at HelixTalk.com thank you for listening to this episode of HelixTalk. This is an educational production, copyright Rosalind Franklin University of Medicine and Science.