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Entries by Koreen Leavitt
<USP 800> is a new safety standard with the intent to minimize the exposure to hazardous drugs from healthcare personnel, patients, and anyone else coming into contact with these drugs written by the United States Pharmacopeia (USP) and the Food and Drug Administration (FDA)
The standard regulates the practice and quality standards of handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection. Handling HDs includes but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal of sterile and non sterile products and preparations.
Since all pharmacy operations handle hazardous drugs, you must make sure your pharmacy complies with these guidelines by December 1, 2019 or risk your pharmacy license and your pharmacist-in-charge-license.
What Are the Steps to Comply With USP <800>?
With the December 1 deadline looming, we’ve broken down the steps needed right now for getting in compliance for USP <800>.
- Identify Hazardous Drugs (HDs) for their final dosage form
- Designate a hazardous drugs point person in your store
- Complete an Assessment of Risk annually
- Ensure hazardous drugs are dispensed or returned a minimum of nine months prior to expiration
- Training – Hazardous Communication, Spill control, competency
Let’s unpack the steps below so you can get a clear understanding of the actions you must take to ensure your pharmacy isn’t at risk.
1. Identify Hazardous Drugs for Final Dosage Form
Final dosage form is when a HD is packed by the manufacturer in a pill or capsule and the pharmacy only counts and repackages them. The existing practices you use to manage this workflow is most likely in compliance, however, there are steps you need to be aware of to comply with <USP> 800. You must segregate your HDs from your regular stock. The way you segregate these drugs, whether it’s on a shelf or a rack, is up to your discretion, as long as it is segregated and labeled as a “Hazardous Drugs Storage Area.” This applies to all pharmacy operations, whether you’re retail, long-term-care or compounding pharmacy.
How do you segregate?
- You can start by referencing the National Institute for Occupational Safety and Health (NIOSH) list to know which drugs to segregate.
- Ensure that your wholesaler is segregating your drugs when they come to you.
- Inventory all your drugs. Document the hazardous drug name, whether they are a tablet, capsule, liquid, and if there is dust in the container.
Some of the HD’s that require more manipulation (if you’re mixing, splitting/crushing or pouring) may require a containment primary engineering control (C-PEC), which is a ventilated device designed and operated to minimize worker and environmental exposures to HDs. We get into more details on this device and how to segregate in our on-demand webinar, USP <800> and Your Pharmacy – What You Need to Know.
2. Designate a USP <800> HD Designee in Your Pharmacy
Assigning a point person in your store is critical to ensure proper processes and procedures are in place. This person should be your pharmacist-in-charge, a pharmacist, or your compliance officer.
3. Perform an Assessment of Risk
This is the most important step you must take as a retail pharmacy operation. An assessment of risk must be performed annually for every hazardous drug dispensed from the pharmacy and must, at a minimum, consider the following:
- Drug Name
- Type of hazardous drug
- Contained in manufacturer’s packaging
- What form is the hazardous drug in?
- Is there any type of manipulation needed?
- Assessment completed annually
Whether you write your own assessment of risk or find other resources online, the bottom line is that this document is not intended to be complicated. As long as you conduct your assessment of risk annually and you include the above information, you’re on your way to compliance. This document must be created between now and December 1, 2019 and must be renewed annually. In our on-demand webinar, USP <800 and Your Pharmacy – What You Need to Know, we detail the second part of the assessment of risk involving an alternate containment strategy plus more options for your pharmacy. Watch it here.
4. Ensure Hazardous Drugs are Dispensed or Returned a Minimum of Nine Months Prior to Expiration
Trace hazardous drug waste includes empty vials with dust or other HD residue in the containers. This type of waste must be disposed of in a licensed hazardous waste landfill. Expired HDs are also considered hazardous waste. Expired HDs are a black hole for money. Even if only one tablet is leftover in a bottle, the cost you pay to dispose of them properly is significant.
How do you solve this? In order to comply with USP <800> standards, you should pull hazardous drugs a minimum of nine months prior to their expiration date unless you are guaranteed to dispense within 45 days. If you cannot guarantee dispensing, you must return back to your returns company. You’ll also want to keep a lookout for the drugs you receive from your wholesaler. If they send you products that will expire within one year and it is a large amount you know you will not use, do not accept it from your wholesaler, otherwise you will get stuck with the waste and have to take steps to dispose of them. Watch our on-demand webinar, USP <800 and Your Pharmacy – What You Need to Know, for more information on hazardous waste and proper disposal practices.
Insider Tip: EPA and State Environmental Agencies are checking pharmacies now for ‘warfarin’ to see whether you are in compliance with the expired drug and whether it is listed as a hazardous waste. They will then ask if you have a hazardous waste generator permit, which you don’t need unless you generate >220 lbs per month. If you’re not educated, they will hit you with a fine. Be warned!
5. Training for Hazardous Communication, Spill Control, and Competency
In order to avoid fines or risking your pharmacy license, you must know the intricacies of USP <800> and what it will impact. If you have a hazardous communication program and training (which is required by OSHA), it must be changed and updated to cover hazardous drugs and hazardous waste, per USP <800>.
Who Regulates What for USP <800>? A Quick Cheat Sheet
It’s easy to get lost with all this talk of hazardous drugs and related jargon. Here is a quick list of who regulates and enforces what.
- Hazardous Drugs are regulated by the U.S. Health and Human Services
- Hazardous Materials are regulated by the U.S. Department of Transportation
- Hazardous Waste is regulated by the Environmental Protection Agency
Start Your USP <800> Compliance Process Now
This is not a hard problem to resolve if you start now. You don’t want to be in a panic in October when you have the fear of the USP <800> deadline around the corner. Luckily, PDS has your back! Below, you’ll find resources on how to properly manage your hazardous drugs before December 1st.
Hazardous Drugs and USP <800> Resources
- Our on-demand webinar hosted by Jeffrey Hedges with R.J. Hedges & Associates, USP <800> and Your Pharmacy – What You Need to Know goes into more detail on the steps above and provides even more insight on what you need to do and why you need to pay attention. Watch it here.
- Don’t do it alone! If you would like more information on how you can get help preparing your pharmacy for USP <800>, contact R.J. Hedges & Associates at
- For more information on USP <800>, visit the United States Pharmacopeia website.
- Chat with your fellow pharmacy owners about how they’re making strides towards the deadline.
- PDS members, use your member portal, PDSadvantage. Click here to login.
- Not a PDS member? There’s an industry message board for you in PDSadvantage — and it’s free to join!
Click here to join and get that conversation started.
Get the Clarity You Need to Run a Better Pharmacy
Pharmacy owners are constantly hit with new rules, regulations and other seemingly endless circumstances that affect your business. Partner with a team who has your back and their ears to the ground! PDS can inform you when industry-related news, such as USP <800> will impact your business and show you your biggest growth opportunities.
Click below to take the first steps to a better pharmacy.
If we were to ask independent pharmacy owners what makes their pharmacy run, many might say their inventory, their customer service or their rock-solid team who keep the ship afloat. While all of those are true, the undercurrent at the heart of these statements is money. Make no bones about it, your cash balance dictates your ability to pay your team (and by extension, their families) and whether or not you shudder at the thought of paying your wholesaler bill.
A large part of understanding the science behind profitability is knowing how your money moves through your business. Once you understand how it works and what financial statements you need to review then you will know what to do to improve your cash balance. Money in the bank means that you have a safety net to see you through those industry forces that impact your pharmacy today, such as lower reimbursements, DIR fees and GER contracts.
As a pharmacy owner, you should be confident in your ability to:
- Pay your wholesaler on time, every time.
- Sleep at night knowing that your cash balance is on solid ground.
- Keep the fear of making payroll a thing of the past.
- Know how your money moves through your business.
If any of these statements hit home, read on for a few tips to get you on the track to financial freedom.
Better Outcomes, Better Profits
If you’re to increase your cash balance, you must understand that profitability follows great patient care. This is not something we tout as a feel-good story. We mean that if you look at your dispensing data to find where there are more effective therapeutic options for your patients which also offer higher reimbursements, this is a win-win for you and your patients.
Real-Life Application: One PDS member pharmacy consulted with their patients and prescribers to help their patients get the most effective drug available with their insurance. Without any changes to the total Rx volume, this pharmacy was able to increase their gross profit by $25,000 – all from one drug!
As you continue to analyze your data, you’ll start to
- Discover more profitable opportunities
- Increase your average margin dollars per prescription
- Earn more profits without filling more prescriptions
- Mitigate low-yield prescriptions
- Build trust as a thoughtful, dedicated healthcare advocate
PDS offers our members access to our proprietary platform, RxAnalytics, a tool that can help you revolutionize how you see patient care and profitability. Fill out the form to learn how you can get a pharmacy performance analysis to know whether RxAnalytics is the right place for you to start.
Synchronize Your Way to Money in the Bank
The foundation for a profitable, high-performing pharmacy is a solid medication synchronization program. Many pharmacies don’t implement this program correctly; therefore, don’t see the benefits of improved workflow, reduced expenses, scheduled staffing, improved adherence, and opportunities for healthy patient interventions.
There’s no magic involved. You don’t have to be a “special kind of owner” to achieve results that impact your profitability so you can rest easy knowing your cash balance is on solid ground. Besides the patient, workflow, prescriber, performance, and marketing impact you gain from implementing a successful synchronization program, the direct financial impact is undeniable.
Your synchronization program should be able to:
- Deliver more prescriptions per patient
- Lower expenses per prescription
- Improve inventory management
- Allow for more effective staffing
You’ll see all of these benefits in your financial statements, and the numbers don’t lie. PDS offers a comprehensive training to equip owners with the tools and knowledge they need to properly implement this program and synchronize their way to better financials.
Get the clarity you need to be sure that medication synchronization, and the PDS exclusive member program SyncRx, is the right place for you to start. Fill out the form to learn how to get started with a pharmacy performance analysis.
Understanding Your Money
In order to move from the unknown to the known, you have to understand the health of your finances. Stop worrying over how much money you have in the bank and start by creating a plan of attack. PDS is offering a pharmacy performance analysis from an experienced independent pharmacy owner. In this analysis, we’ll show you:
- A snapshot of your pharmacy’s performance in four key areas
- The eight KPIs you should measure
- The tools you need to move the needle
Take the next step to secure your financial freedom and leave the stress of making ends meet in the past.
Ready to Experience Your Best Year Yet?
For over 21 years, PDS has helped Independent Pharmacy Owners thrive. We're a team of experts dedicated to your success and who focus on your entire pharmacy. Click below to discover your pharmacy's biggest growth opportunities.
If you’ve ever rolled out a new program that involved a systems strategy or even a new process in your pharmacy, getting your team’s buy-in and commitment is crucial if the system will succeed.
Your team will be the ones who will put your ideas into practice, taking the policies and procedures that you have created for your business and turning them into a force for growth. Give them the tools they need to succeed by giving them an implementation strategy to get them on-board and aligned.
Give Your Team an Implementation Strategy
If you want to get your pharmacy team on-board with your decision, you should give them a business strategy of their own — a process that they can use to implement those changes without constant oversight. Here are three steps that you can take to motivate your employees:
Step 1: Give Them Instructions
Like many independent pharmacy owners, you work with your pharmacy team to complete the day-to-day tasks that come with running a business. Your employees rely on you for direction, guidance, and support as they fulfill their responsibilities — and that becomes even more apparent when you make a series of comprehensive changes to your pharmacy.
Those changes will have a significant impact on their attitude, performance, and career trajectory, so you must make sure that they have the information that they need to adapt. When you create a policy and procedures manual for your new system, they can follow the instructions that are laid out in your workbook without worrying about the implementation process.
Step 2: Give Them an Incentive
Change doesn’t come easily, and some of your employees will push back when you introduce your new systems strategy. At that point, it will be more important than ever for you to have a series of incentives that will motivate them to change their behavior. We recommend a combination of paid and unpaid rewards — including verbal praise, competitions with prizes, commission and bonus plans, and strategies like the uRock Rewards Program — to get your team to buy into your new vision for your pharmacy.
Step 3 – Give Them Your Time
When you roll out your new systems strategy, you need to make sure that you continue to talk to your employees about your goals for your business, their responsibilities, and the benefits that they will receive when the implementation process is complete. You can use team meetings to discuss their progress as a group, and one-on-one performance review sessions to go over their achievements and opportunities for improvement as they put your systems strategy into practice.
Are You Ready To Create A New Systems Strategy For Your Pharmacy?
Download our free, eBook Surefire Systems for Sustainable Growth, and you’ll have what you need to know why, when, where and how to implement a systems strategy for your pharmacy.
Click here or below to download today!
As an independent pharmacy owner, you’ve worn many different hats over the course of your career. You’ve filled prescriptions, counseled new patients and balanced the till in your cash register – you’ve done it all. After years of hard work, you can handle anything that comes your way.
But as your business continues to grow, you rack up more responsibilities than you can handle. If you want to build a successful pharmacy, finding an effective way to delegate those responsibilities to your team members so you can concentrate on the big picture is vital for growth. A systems strategy can help you create, test, and implement new procedures for your employees, saving you the time, money, and energy that it would take to do everything on your own.
Let Go of Stress
Stress comes free and aplenty with pharmacy ownership. Yet there are ways to diminish and mitigate the stress by focusing on what is within your control.
Here are three signs that you need a new systems strategy for your pharmacy:
1. You Are Doing Everything Yourself
Like many business owners, the last thing you should have to worry about are routine tasks that you can delegate to your employees. You may be able to “do it all,” but you shouldn’t have to!
Systems are best practices that have been captured, documented, and repeated. When you create an effective systems strategy for your pharmacy, your team members will have the information they need to complete those tasks on their own. That leaves you – as the owner – with more time that you can spend on the people, places, and activities you love.
2. Your Business Has Stopped Growing
When you started your business, you played a critical role in the day-to-day operation. As you gained more patients, you hired employees to help you manage your workload…but your systems – the procedures that you have developed to consistently and effectively complete those tasks – may not have been updated.
If you use your personal involvement as a substitute for an effective systems strategy, you will bottleneck your pharmacy’s growth before it is truly able to thrive.
3. You Want To Become More Profitable
Your systems strategy will have a huge impact on your bottom line! Marketing, client fulfillment, and cash management systems can transform the way that you run your business, and by extension, the way that your patients view your pharmacy. When you create, develop, and implement an effective systems strategy, your services will improve, your patients will respond, and your pharmacy will become more profitable over time.
Are You Ready To Create A New Systems Strategy For Your Pharmacy?
Pharmacy Development Services is the leading provider of business, leadership, and financial advice for independent pharmacy owners. Click here or below to download our free guide to creating surefire systems for sustainable growth!
Every February for the last 15 years, pharmacy owners around the nation get their travel plans in order and prepare to make the pilgrimage to Orlando, Florida for the most relevant pharmacy conference of the year.
Attendees travel to the PDS Super-Conference for varying reasons:
- They want to see their business grow faster.
- They’re sick and tired of DIR fees and lower reimbursements.
- They simply don’t know what to do or where to go next.
Whatever their reasons, our attendees come looking for solutions, and over the course of three days in Orlando, they get them, from exhibitors, speakers, and the PDS Team. This is why the PDS Super-Conference has garnered the reputation for providing pharmacy owners with solid, valuable, and often unimaginably successful growth for their pharmacy business.
Pharmacy Owners With Purpose
Don't just take our word for it. Watch the short videos below to see two pharmacy owners speak to the value they receive from attending and the message they give to all thinking of joining us this year.
[WATCH] Cliff Holt, Hurricane Family Pharmacy
[WATCH] Josh Rimany, Dilworth Drug
Join Us at the 2020 PDS Super-Conference!
Grab your seats and join us for our next event on February 27-29, 2020. Join us in Orlando, Florida for an immersive 3-days where you’ll get to interact with 1,600+ of the smartest pharmacies in the nation and the best experts in business. This is the event that will change your pharmacy. It is exactly the right content at exactly the right time your pharmacy needs it the most.
Click here to register and save on early pricing.
PBM Audits are painful. If you’re an independent pharmacy owner, it can be one of the most expensive & stressful hurdles for your business. You risk losing money and jeopardizing your contract if you are not familiar with PBM manuals and how to apply them to your pharmacy. In short: with a PBM audit, you’re […]
Dr. Lisa Faast is the VP of Marketing and Pharmacy Expert. She brings tremendous knowledge and insight from starting, owning and operating her own pharmacy in California. Dr. Faast now leads the marketing department and is our resident Profit Guru for our members. Below, is her urgent message to all pharmacy owners. After years of […]
If you’re a pharmacy owner and you missed the 2018 PDS Super-Conference, you left vast opportunities to grow your pharmacy on the table. That is the truth, plain and simple. There were over 2,000 in attendance including the most progressive owners and professionals in the independent pharmacy industry. All of them piqued and ready to […]
We’ll be the first to admit that the cards are stacked against pharmacy owners. Pharmacies are faced with fees, clawbacks and dwindling reimbursements at every turn. It’s no wonder many are trying creative methods to squeeze extra profit from any source they can find in order to avoid shrinking margins. Your PBM could make matters […]