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Todd:
Pharmacy Podcast Nation. This is Todd Eury, founder the Pharmacy Podcast. Thank you so much for an incredible summer. Summer 2019, how many listens and new listeners we've received. It's exciting to see us all coming together and the cross-referencing from one podcast to another. One of the champions of the Pharmacy Podcast Network from their support and dedication to the information that they put out consistently is the team at RJ Hedges and Associates, your compliance experts for today and tomorrow. Longterm Care Pharmacy, Community Pharmacy, Jeff Hedges and team. We did a podcast on USP 800 that has been tremendously popular and today's episode dovetails with that. This is really about preparing the hazardous drugs assessment of risk. But before we get into that, Jeff, you have something to mention from the previous episode on USP 800 and welcome back to the Pharmacy Podcast.
Jeff:
Well, thanks Todd, and it's exciting to continue this series. And we did get a lot of feedback on the last podcast we talked about cleaning, you're cleaning tools with a product called CaviCide or Clorox wipes, which kill TB, HIV and Hep B. And we got a lot of questions about that concerning USP, talking about using alcohol, the 10% alcohol for cleaning tools. And I should've clarified a little bit better, but we covered a lot of information that time. So when we looked at UPS 800 on the cleaning processes, when we go deeper into it, the 10% alcohol and the Clorox bleach and other products for cleaning, those are directly related to clean within USP 795 and USP 797 for non-sterile and sterile compounding.
Jeff:
So when we're working in the retail and longterm care setting, we should still follow the FDA guidelines for using products to clean that will kill Hep B, TB and HIV products. And the two best products on the market is a product called a CaviCide or Clorox wipes, and look at the label and it'll say it'll kill those three diseases. And those should still be the items you clean your cleaning tools as well as your counters and everything from there.
Todd:
So in the previous episode, USP 800, if you haven't listened to that yet, I'm going to put that link into the show notes so that you can listen to that part first. And in that last discussion, we address what each of the pharmacies must do to prepare for implementation of the guidelines. And we covered a multitude of topics. Let's take the listeners through those topics, and then I have some questions about today's episode.
Jeff:
So yes. On the last podcast we covered how to identify hazardous drugs through the NIOSH list, segregating hazardous drugs from the regular stock and the reasons for that. Proper handling of hazardous drugs, when pill scanners and pill counters and robots are permitted to be used within the pharmacies and most cases when not, special handling of hazardous drugs that are required alterations, the determinations of personal protective equipment by using the safety data sheets, and which agencies will be enforcing these guidelines.
Jeff:
You may be wondering why I keep referring to USP 800 as guidelines. USP or United States Pharmacopeia, created the international guidelines or standards for government industry and accreditation organizations to follow. When written, they are not regulatory by nature. However, when the Food and Drug Administration, or FDA, adopted these guidelines as a rule, they become a regulation. USP 800 guidelines are not just intended for implementation here in the United States, but they are also being implemented worldwide. So our friends up north in Canada and across the pond in the United Kingdom are also working on USP 800. The same is true around the globe, in Europe, Asia, Africa, Central and South America, Australia, around the every part of the planet. Each country is implementing and forcing USP differently. But everyone is working through the same processes that we are working. Today we're going to talk about the single most important document for hazardous drugs in a retail or longterm care setting. And it is called the assessment of risk.
Todd:
So are there any designations for hazardous drugs specifically, Jeff?
Jeff:
Yes. Pharmacy management must appoint a hazardous drug designee who is qualified and trained to be responsible for developing and implementing procedures and overseeing compliance. This will normally be the pharmacist in charge, but it can be any pharmacist, or in rare cases, a highly qualified certified pharmacy technician.
Todd:
So let me back up a second. So what is an Assessment of Risk?
Jeff:
An Assessment of Risk is a document designed for any hazardous drug that meets the requirements of a final dose form. And that's the T-dotted term, final dose form. These are the drugs the manufacturer created that required little or no handling of the dispensing process. USP 800 uses a term of manipulation. We've talked about the inventory and segregation of these drugs on the last podcast. A hazardous drug inventory is a starting point for completing the assessment.
Todd:
So what comprises an Assessment of Risk, Jeff? What do I need to know as a pharmacy owner?
Jeff:
The most important thing to remember is the Assessment of Risk does not have to be complicated. This is a functional document developed to provide information to your employees and the inspectors. It is designed to indicate that you have implemented appropriate protective measures. I like the assessment to be broken into four sections.
Jeff:
The first section is Drug Name. List the drug name with the table number or the table name from the NIOSH list. An important thing to note is that each table one has this drug must have its own Assessment of Risk. However, table two and table three hazardous drugs that are the same, for example, drug form, tablet, capsule or liquid, within the brand or generic. A hazardous drug only need one Assessment of Risk for the entire group. For example, that would be like your testosterone injections.
Jeff:
The next section is Risk of Exposure. Determining a hazardous drug is in manufacturer's packaging. Now, a lot of folks get confused on that. Manufacturer packaging is not the tablets or capsules or even the liquid in the container that the manufacturer sent to you. Manufacturer packaging is like birth control tablets. They come in a box and inside that box when you open it up, there is a package that you dispense to the patient. That is manufacturer's packaging. So the form of that hazardous drug is a tablet. So as we look at all the hazardous drugs, we're also looking to see if there's any dust present. We're also looking at the type, whether it's a tablet, a capsule or a liquid. And then we go back what I talked about a moment ago. Is there any manipulation required? Mixing creams is considered a manipulation, but emulsification is not.
Jeff:
Any other relevant information concerning a hazardous drug should be entered in this information line. And again, I want to go back to manipulation. Any time that you change or alter the product, the drug, you're mixing it, you're crushing it, that's manipulation. If you're simply pouring it into another bottle, you're counting it and put it into a vial, that is not manipulation. It's when you're mixing things or you're crushing the drug, that's when the manipulation comes into effect.
Jeff:
The third item is Containment Strategies, which is your work practices. Hazardous drugs should be kept segregated. And again, that is my term and it's from an operational point of view. Their standard doesn't state that. But when you think about it, and I explained it on the last podcast, you got to keep separate, counting tools and if you're bouncing all through the pharmacy like you normally do, you don't want to be thinking, "Oh, I've got my hazardous drugs over here and over there, and you've got to go get your counting tools every time, that's why you want to keep them segregated.
Jeff:
Now mark the area of the pharmacy that has hazardous drugs so it's marked. So that's part of your containment strategy. And then counting of and designating your counting tools. Again, your counting tray and your counting spatula must be marked hazardous drugs. It could be a different color, it could be whatever you decide, but it specifically has to be marked hazardous drugs. And list any other specific requirements that you need for containment of the hazardous drugs. So you make that determination based off of your own internal requirements. And normally that's going to be don't use a robot, don't use a pill counter, use separate counting tools. Those are the three biggest items.
Jeff:
And the final item is Assessment, Signature and Date. The assessment must be signed by the hazardous drug designee and maintained for a period of time, which we recommend that these assessments are kept for a period of six years.
Todd:
All right, so now that the assessments are completed, so where do you put them?
Jeff:
The Assessment of Risk is a very important document and should be placed in document protectors and kept in a binder. The binder should be marked Hazardous Drugs Assessment of Risk, and stored with your other compliance binders or documents. The entire staff must know where the binder is kept so they can retrieve it quickly when they're asked.
Todd:
You know, I'm listening to you and I wonder, as I'm not in pharmacy owner, I'm not a pharmacist, but I would think that even our listeners would say, "So why is this so important?"
Jeff:
When an inspector walks into the pharmacy, and remember, there are five different agencies that will be inspecting the pharmacy. The first document they will ask for is the Assessment of Risk. The Assessment Risk is a mandated document that the pharmacy must have completed available and is annually reviewed in order to dispense a hazardous drug. Remember, without the Assessment of Risk a retail or longterm care pharmacy is forbidden to dispense any hazardous drug or even the have it in stock. So, in layman's terms, it you don't have an Assessment of Risk, you can't dispense birth control tablets, you can't dispense Warfarin or any other hazardous drugs. So it's that important of a document.
Todd:
It's just seems crazy to me because the pharmacies have been dispensing these drugs since their creation.
Jeff:
This is the sad truth of today's reality and the proof of the ever changing regulations we live in.
Todd:
All right, so while the inspectors are in the pharmacy, are they going to ask for any other information?
Jeff:
Yes, the normal inspection will start off, especially when it's your Environmental Protection Agency. The questions will go through, "Where do you keep your hazardous drugs? What do you do with your expired hazardous drugs? Do you have a quarantine area?" Then your Environmental Protection Agencies within your state will then ask, "Do you have an EPA Hazardous Generator permit?" Well, when you get that question, they're trying to trip you up, and the answer should always be, "No". And the reason is, you only need this permit if you're generating 220 pounds or more of hazardous waste per month and your hazardous communications plan and training should cover this requirement, and also, if you have it, it needs to be updated with the new requirements from 800. And if you don't have it, you should have always had one, but it needs to be updated now or created now, and this was a perfect time to do it because we got all these five agencies who are going to be asking for it.
Todd:
The twists and turns of compliance. The ever-changing documentation that's needed. It might seem complex, but if you have the right team in your corner, I think it's going to be a relief to any pharmacy operator or owner. Jeff, that's when you guys come in as the compliance experts. You always have a solution. It's always easy to follow and a very reasonable price. So how can you help our listeners today?
Jeff:
Okay. We have two distinct hazardous drug programs for the pharmacies. Our Hazardous Drug Program is a complete customized ready-to-implement program. The one is for retail and longterm care pharmacies, which we'll talk about as we go through here now. It has all the training requirements that are contained within the program. We provide all updates and personal assistance for each client. And you might think, "okay, why do you need updates?" Well, we launched this in March and we've already updated it twice, and there'll be a third update because the EPA came out with some new changes in August, and a couple of those changes are that you're empty pill bottles and your wipes and everything don't have to be declared hazardous waste, they can be put into your regular trash. So that's great news. And then also with our Non-Sterile Compounding Program, we have that program as well and it contains USB 795 and 800 guidelines.
Jeff:
Plus we have a ton of different things that are hidden within the USP guidelines from other regulatory agencies, like I mentioned with OSHA and EPA, relate into this. So there's a lot of different players to this, a lot of different interpretations constantly change, and we're always updating our programs, whether it's this program or anything else.
Jeff:
So for retail and longterm care pharmacy, our program can be ordered online by going to RJhedges.com and on the homepage hazardous drugs is right there. So you can click on it and it'll take you right into our program and you can order it from there. There's a simple questionnaire, you fill it out and it brings up a payment process and you type in your credit card information. And right now we're on a 36 to 48-hour turn-time depending on traffic coming into the website.
Jeff: And then for our Non-Sterile Compounding folks out there, we do have a full Non-Sterile Compounding Program. It has been updated to USP 795, so we have that available. It's more in depth, so at that point you would need to call into the office and talk to one of my sales team. And our number here is at (724) 357-8380, or you can go into our website and you can fill out a questionnaire there and it'll be directed into my team.
Jeff:
We can answer individual questions or schedule a one-on-one consultation. So on our website we have also posted a lot of information, webinars, this podcast will be out there, as well as the previous one, and so look us up and under the USP 800 Hazardous Drug tab., So we'd love to help you. We've been doing this for years. As far as research, I started this in January and it has been basically a seven-month research and development process. Even once we released it in March, we still have been changing and adapting to it, as OSHA and EPA have been adapting to it, so we continue to update it. So we'd love to have you come on board with us. We have hundreds and hundreds of clients that are very happy. So check us out and we'd love to have you come on board.
Todd:
Jeff, I want to thank you and your team at RJ Hedges and Associates. For the listeners, if you're driving, if you're exercising, running, taking care of your kids and you don't have your hands free, don't worry about it, this will be in the show notes. RJhedges.com/hazardous drugs, is the section specific to the topic of what we talked to today. (724) 357-8380, that's (724) 357-8380. The Pharmacy Compliance Guide, you can find the entire library at Pharmacycomplianceguide.com. Jeff and team have been accumulating incredible episodes since 2016. We are so thankful that they've been a consistent source of great information for the pharmacy owner and operator, and we thank you for listening to the Pharmacy Podcast Network.
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Thanks for listening to another episode of the Pharmacy Compliance Guide. Sponsored by RJ Hedges and Associates. Be sure to search the entire library of podcasts, helping you informed on the latest pharmacy compliance issues by visiting Pharmacycomplianceguide.com.
