IACPRx.org/Publications | Spring 2015
The Events Issue
PLANNING A SUCCESSFUL EVENT MAKING THE MOST OF EXHIBITING AT A TRADE SHOW TOP TRAVEL TIPS FROM A ROAD WARRIOR
FLIP OVER TO READ
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Contents 4
A NOTE FROM THE PUBLISHER
6
GOOGLE LAUNCHES SMALL-BUSINESS INITIATIVE
8
PLANNING A SUCCESSFUL EVENT
by Scot Maitland
by Macy Pruitt
Macy Pruitt Teresa Roberts
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5 IDEAS TO PROMOTE YOUR IN-STORE EVENT
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GETTING AN EXTRA DOLLAR OUT OF EVERY CUSTOMER!
by Carl Britton Jr.
COMMUNICATION COMMITTEE Richard B. Moon, Pharm.D., R.Ph., FIACP, Chair
by Scot Maitland
Lisa Ashworth, BS, Pharm.D., R.Ph. Kim Hansen, R.Ph. Robert Harshbarger, III, Pharm.D.
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by Jennifer Petska, CPhT
James Matthias, CPhT Linda McElhiney, Pharm.D., R.Ph., FIACP, FASHP
MAKING THE MOST OF EXHIBITING AT A TRADE SHOW
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DOUBLE TROUBLE
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TWITTERVIEW WITH ADAM SILVERTOWN, RPH
by Scot Maitland
Lauren Onsa, BA Andy Ruiz, Pharm.D., MSc, FACA Scott Wepfer, R.Ph., FIACP PHOTOGRAPHY Carol Freedman Scot Maitland DESIGN Dianne Stone
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MEET ME IN DENVER
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HILL DAY: THE WHAT NOT TO WEAR EDITION
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TOP TRAVEL TIPS FROM A ROAD WARRIOR
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MARKET WITH THESE UPCOMING OBSERVANCES
by Scot Maitland
by Lauren Onsa
by David Miller, RPh
IACPRx.org Pharmacy Marketing Quarterly is published four times per year as Spring, Summer, Fall, and Winter. Online subscriptions and print editions are available for purchase at IACPRx. org/Publications/magazine Pharmacy Marketing Quarterly makes all attempts to publish accurate information; however, this publication may contain technical inaccuracies or typographical errors. The reader assumes all risk concerning the suitability and accuracy of the information within this publication. Pharmacy Marketing Quarterly assumes no responsibility for and disclaims all liability for any such inaccuracies, errors or omissions in this publication and in other documents referred to within or affiliated with this publication.
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A NOTE FROM THE PUBLISHER Welcome to your Events Issue! You may be wondering about the pictures that are accompanying this letter. Earlier this year I attended the APhA Annual Meeting & Exposition in San Diego with my co-workers David Miller, Macy Pruitt and Jennifer Petska. During the Opening Session, APhA President Matthew C. Osterhaus, BSPharm, FASCP, FAPhA pulled out a selfie stick to take a group shot. For those of you who know me, I don’t like to miss a good photo opportunity, so I snapped a picture and ended up photo bombing President Osterhaus’ photo.
Here I am!
And that got me thinking about this issue, the Events Issue. The key to a successful event is being right smack dab in the middle of it. And that’s from all angles, planning one or attending one. In these pages, you’ll get the scoop on Planning a Successful Event, page 8, and then turn the page for 5 Ideas to Promote Your In-Store Event on page 10. For those of you who exhibit at trade shows, you’ll want to read and re-read Making the Most of Exhibiting at a Trade Show on page 13. Heck, you might want to laminate it and keep it with your exhibit supplies! And rounding out this issue is a great article on Compounders on Capitol Hill titled Hill Day: The What Not to Wear Edition on page 23. It is easier to be smack dab in the middle when you’re dressed professional and comfortably. Who knows you may find yourself in a photo opportunity with Anderson Cooper! I also want to invite you to our newest IACP Publication, the IACPodcast! We launched in April, and it’s a weekly show with topics that are important to your business. There are two ways to access the IACPodcast. You can visit iTunes at Tiny.cc/IACPodcast and download them to your smart device or computer or can visit our new page IACPRx.org/Publications to stream them from the web. And lastly, we’ve created a new voicemail for all of our publications, 713-730-9043. You can call us and leave a message about what you thought of the issue, give us some suggestions for future topics or ask us a question. It’s just one of the ways we’re working to improve the experience you have with IACP. Now dive into the magazine and put yourself smack dab in the middle! Here’s to the health of your pharmacy!
Scot Maitland Director of Communications & Publications
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Spring 2015 | IACPRx.org/Publications
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GOOGLE LAUNCHES SMALLBUSINESS INITIATIVE by Scot Maitland
Once upon a time, twenty years ago, people used the phone book to find your pharmacy. The web has been around since 1989 and until the advent of Google and Facebook, you didn’t have to worry very much about how your business showed up in search engines or social media. Given the rise of people who own smart devices, if a customer searches for a pharmacy and doesn’t see you, you may never be discovered. That’s the bad news, the good news is, Google just launched a new program to help your pharmacy get found! It’s called “Let’s Put Our Cities on the Map.” By generating a customized web sites for virtually every town and city in the U.S., Google is giving local businesses the access to improve the information that shows up on Google search, Google maps, and Google+. “Small businesses have said that getting online is hard,” said Soo Young Kim, head of marketing for Google’s Get Your Business Online program. “We’re using sophisticated technology on the back end to make it simple for small businesses to get online and create their listing. Google has created over 30,000 websites to provide every business in every city a fast, free and easy opportunity to get them found.” A blog post by Google offered “We’re also forming partnerships with local organizations – like chambers and small business development centers – and equipping them with free trainings and customized city materials to run workshops . . . These local partners know the challenges for local businesses more than anyone – and they recognize the value of getting businesses online.”
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By visiting GYBO.com, your pharmacy can access the Let’s Put Our Cities on the Map website and: • Learn how to put more information about your business into Google • Get your pharmacy verified for Google searches • Add information including your location and hours of operation • Add photos to enhance your listing • Get a diagnostic tool to see how you can improve you listing and visibility • Learn about local training workshops and other resources • If you’re not online, you can get a one-year free website and domain name from Google partner StartLogic To learn more about Google’s program, visit the website at www.gybo.com, enter your local ZIP code, and get involved. Then let us know how it worked for you on our Facebook page: FB.com/IACPRxPubs
Scot Maitland is Director of Communications and Publications and the publisher of IACP’s Compounding Matters Quarterly and Pharmacy Marketing Quarterly and host of our new IACPodcast. He coordinates with other IACP Communications staff to promote the visibility of IACP and the IACP Foundation.
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Fagron has sourcing offices in South America, North America, Europe and Asia, enabling Fagron to source its pharmaceutical raw materials globally while operating close to the production sites of pharmaceutical raw materials. Onsite producer audits, (re)qualifications and regular performance assessments guarantee continuous control of Fagron’s product portfolio. Our innovative bases and vehicles are being developed in our own R&D center in St. Paul, MN, according to the latest scientific insights. We believe R&D never ends. We therefore
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PLANNING A SUCCESSFUL EVENT by Macy Pruitt
Between The Educational Conference, Compounders on Capitol Hill and our Regional Education Meetings I spend quite a bit of time planning successful events. So what does it take to host a successful event? With so many moving parts involved, it requires a lot of planning, but the more pre-planning you put into it, the more likely you will have a smooth, successful event. So let’s start at the beginning with a list.
PLANNING THE EVENT 1. Set Some Goals:
• Why are you doing this event? To increase awareness of a health issue? To sell product? To bring people into your pharmacy?
• What are the metrics you’ll use to measure the success of this event? The number of attendees, number of appointments booked? The dollar amount of products sold?
4. Create Your Budget: If you are doing an event in your pharmacy, it may seem like there’s not very much cost to hosting an event. Every small aspect of the event adds up pretty quickly. Check out our Event Budget Template on page 9 for help.) 5. Decide on your Event Speaker(s):
• Will you be speaking, or will you be working with an outside speaker?
• Will you be utilizing a one speaker format or panel discussion?
• Will it consist of a formal presentation or is it more of a conversation between speaker and audience?
6. If you’re not hosting the event at your pharmacy, choose and finalize your event location. 7. Determine your Event Allies:
2. Determine the Topic of the Event:
• What is your focus?
• Who is your audience? Put yourself in their shoes, why would they attend? What are they expecting to get out of the experience?
3. Choose Your Event Date: This will allow you to work backward to make sure you’ve included all the things you need to do.
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• Keep your target audience’s typical schedules in mind. If they work 8-5, you’ll want to consider holding an event after work or on the weekend.
• Sundays and major holidays should be avoided, as both are typically filled with pre-planned activities.
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• Is there someone you can reach out to help you promote your event? A gym? A local health food store? A prescriber? Look for businesses/people that have a similar but not identical reach.
8. Promote, Promote, Promote! Get people talking about your event.
• Use social media. Create a hashtag for the event. You may think it’s not necessary because your event is small, but you’d be surprised to see how far a hashtag can travel. It’s free and takes only a minute or two to create. Just keep in mind that you want your hashtag to be R.U.S.S. Relevant, Unique, Short & Sweet!
• Create bag stuffers to promote your event.
• Consider hosting your event on a platform like Eventbrite.
• Send invitations to your email subscriber list. Make sure you’ve got a clear subject line, so they open your email. Keep the call-to-action at the beginning of the email. If they have to scroll, you’ll lose their attention. And don’t spam people! • Send a press release to your local newspaper. Send two weeks before the event if it’s an open invitation event. Or directly after the event to promote general awareness. Local press can be golden. And, it’s free!
9. Decide on Food and Beverage. 10. Staff your Sign in Table.
TRACKING LINKS Do you use tracking links? If you’re not, you’re missing out on valuable data. They are the easiest way to see which of your marketing efforts are working out. And they’re simple to create. Use a site like tiny.cc and enter the address of your event website. Then add your custom URL. This is where you’ll want to get creative and remember R.U.S.S. Relevant, Unique, Short & Sweet. Create a unique link for each of the different ways you plan on marketing your event. Copy these links and share them.
• Will you have a print out of those who RSVP’d?
They might include:
• Will you need name badges and markers?
• Are you doing a drawing or giveaway?
• What promotional items will you have on the tables for attendees to grab? (Pens, Flyers, etc.)
Facebook Twitter LinkedIn Bag Stuffers Print Advertising E-Newsletter Event Allies
DAY OF THE EVENT 1. Send a reminder email to all of your guests and if there’s still room, include a call to action to invite a friend or colleague to join them. 2. Get there at least an hour and a half early for small events. Do a walk through and review that you have everything that you need.
• People will arrive early. Make sure everything is completely set-up no later than one hour before the event.
• If everything was planned successfully, you will have downtime before the event, enjoy it! Once the event begins, you’ll be surrounded by attendees, most of whom will have questions about the venue, food, program, etc.
3. Post updates of your event using social media, but keep HIPAA in mind. When in doubt, don’t photograph the participants, just the speakers. And don’t forget to use the hashtag you created! Consider downloading an app like Typic that allows you edit your pictures on the fly and immediately upload to Twitter & Instagram. 4. Consider videotaping your speakers to share on your website or blog. A smartphone and a tripod can do the trick well enough. Looking for something a little more professional? Consider purchasing a batteryless lavalier microphone to get better audio quality.
POST-EVENT 1. Thank your speakers! You never know when you’re going to need them again. 2. Send out a follow-up email to your guests. For those that attended, consider sending them a survey using SurveyMonkey.com or Wufoo.com. For guests who weren’t able to attend, let them know that they were missed and invite them to watch the presentation that you recorded.
Then log back into tiny.cc and see how your different links are working. Event Budget: Venue Room/hall rental Furniture rentals Equipment rentals (speakers, microphones, etc.) Decorations Signage Refreshments Food Drinks Other Promotion Paid advertising Special offers/giveaways Promotional Items/Swag Miscellaneous Name tags/badges Printed programs Other
3. Write about your event in your pharmacy’s blog or share it in your next newsletter. Post pictures or video to Facebook. Just remember HIPAA! 4. Go back to the goals you created and measure the success you had. Make course corrections for your next event.
Macy is the Events & Education Coordinator
at IACP, where she oversees IACP’s CE-related events and activities.
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5 IDEAS TO PROMOTE YOUR IN-STORE EVENT by Carl Britton Jr.
Congratulations, you’ve decided to do an in-store event! Pharmacies have been doing different types of events to showcase their products and services for years. In-store events can be amazing or they can be torture. If you have never experienced an unsuccessful event please allow me to paint you a picture. Imagine it’s your turn to host Thanksgiving for your entire family. You’ve spent hours shopping at the grocery store, hours cooking the perfect meal, hours cleaning, and you have your home decorated with an autumn touch that would make Martha Stewart jealous. Thanksgiving dinner is planned for 6 PM. It’s 5:45 PM and no one has shown up. The panic voice in your mind starts beating you up with questions like, “did I tell everyone 6pm, is it really my year to host, do they hate my cooking, is today the right day, do I have my ringer on?” The clock strikes 6pm and still no one has arrived. The panic voice in your mind is now screaming at you and there are only two things that could help, everyone showing up or you getting started on that dinner wine. Translate that scenario to an in-store event and you are now the proud owner of a Grade A flop. Communication has changed so much in the last 10 years that you can no longer just tell chatty Cathy at church on Sunday about your event and expect a full house. Now we have to reach out to our patients and the community in multiple ways to get results. Continue doing the “normal” things like create flyers and having your frontline employees tell everyone. However, if you
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want to fill your store like an Elvis concert in the 50’s you have to take a few more steps. Here are 5 ideas to help you promote your in-store event: 1. Create an Event on Facebook: Facebook has a feature that allows you to create an event and invite people. Invite everyone that you know and ask your staff to do the same. Encourage the people you invite to invite their friends. Make sure that you give a great description of your event and reasons why it would be silly to miss this wonderful opportunity. Please Note: If you have multiple events each week, do not continually blast your friends with invites. They will get annoyed and unfriend you. Even your own family members will unfriend you! If you need more help visit facebook.com/help. 2. Email Invites and Reminders: Did I just hear you correctly? Did you just say that you do not collect emails from your patients? If you are not currently collecting emails from your patients please start today. If you do not know how there are plenty of resources to help you get started. If you do have an email list, send out an invite and a few reminder emails. Do not get too aggressive with the number of emails and do not waste your time writing a novel. Make your email fun, engaging, and informational. Here are a few resources that may help you get started: MailChimp.com, iContact.com, or ConstantContact.com.
3. Giveaways: Have something cool to giveaway. Honestly, it’s not all about the “what” you are giving away but more about “how” you get people to enter to win. Make a post on Facebook about your event and your really awesome giveaway. Then tell them that to enter to win they must share that post or tag a friend in the comments section. This will give you great exposure on Facebook. Don’t forget, the winner must be present at the event! 4. Facebook Ads: This is an inexpensive way to target a specific area, demographic, or behavior. Facebook ads got a bad name a few years ago but they have revamped their system and it works. During the revamp they also made the ad system user-friendly. Facebook ads are significantly more cost effective than most online ad providers. The magic is in the targeting capabilities. If you are having a weight loss education seminar for men, you can easily set up an ad on Facebook to target males from the age of 20 55 within 10 miles who wants to lose weight. Your ad will only show to those who fit that criteria. Again, if you need more help you can visit facebook.com/help.
your event (i.e. you can enter your name into the drawing an additional time for each friend you bring). Use EventBrite.com, punchbowl.com, or evite.com to create an e-invitation. Create a ticket and have limited seats available for exclusivity. Use these tools and ideas on your next function and hopefully you’ll sell out faster than a Justin Timberlake concert! If you are having trouble coming up with an idea for an event here are a few ideas: After Hours Flu Clinic, Diabetes Education, Weight Loss Education, Patient Appreciation, Vaccination Education, Skin Care Consultations, Comprehensive Medication Review, and Blood Pressure Education. There are obviously many other types of in-store events. Having an event can be amazing or it can be torture. Above all, your event will always be helpful for your patients and make your pharmacy more valuable to the community. Good luck!
Carl Britton Jr., is the President of In Their Face Marketing a boutique marketing agency that works specifically with independent pharmacy. He is also the author of Facebook for Independent Pharmacy available on amazon.com.
5. Other Ideas/Tools: Create a #hashtag on Twitter and Facebook. If you are not sure what this means just give it a Google. Have attendees check-in on Facebook. Have an incentivized refer-a-friend for
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IACPRx.org/Publications | Spring 2015
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GETTING AN EXTRA DOLLAR OUT OF EVERY CUSTOMER! by Scot Maitland
Have you ever walked in a store and wondered why things are where they are? Maybe it’s even your pharmacy! Merchandising is the key to increasing your customer’s basket size. And we can agree that it’s more profitable to enhance the experience of our current customers than try and reach out for new ones. Here are some handy tips for making the most your store, and its merchandise to increase your dollars. Start with looking at your pharmacy through your customer’s eyes. Often we get so focused on individual departments that we miss the big picture. Your pharmacy needs to be inviting. Displays should be full (meaning at least three of each item on the shelf), clean, and signage should be clear. Next, start off with listing each department in your pharmacy and what the key marketing opportunities are in each department. Next you’ll want to look at focusing on tie-ins between purchases. For example, during cold and flu season, it’s recommended to purchase a new toothbrush once you’re feeling better. The solution, consider creating a space for toothbrushes and signage next to tissues and cough and cold items. Your goal here is to increase impulse sales. Cross merchandising needs to make sense though. Need some inspiration? Take a page from amazon.com. I did a search on Kleenex Ultra Soft Tissues and towards the bottom of the page it showed me the “Frequently Bought Together” items which included Quilted Northern Ultra Plush Bath Tissue and Sparkle Paper Towels. Consider doing an end cap with these items bundled together as a marketing promotion. Don’t sell household items like this? No worries, I also did a search on Metagenics - Ultra Flora Plus DF-60 Capsules and Amazon suggested I also pick up a bottle of NOW Foods L- Carnitine Tartrate 1000mg. This is the perfect time to get creative! Next up, consider looking at health observances (see page 26) and create theme events in your pharmacy. Invite customers and look at lining up speakers. Need some ideas? What about a vitamin swap? Have customers bring in their big box vitamins for the quality line you sell. Consider having demos and don’t be afraid to let customers try new items. Sampling sells! And doing during in-store events will allow you to track the success of your sampling. In fact, sampling can be more beneficial than discounting products. Reach out to your
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vendors and partner with them to get more exposure for the products you’re selling in your pharmacy. Finally, take a look at your signage within the pharmacy. By getting creative with your signage, you can share information about upcoming events, as well as new items and their value, which can make a huge difference in your sales. Signage doesn’t just belong on top of counters either. Utilize your restrooms and hallways. Consider purchasing an A-Frame outside of your store to take advantage of foot traffic. Consider the esthetic of your signage. Just because you can use a computer to design your marketing materials doesn’t mean you should. You wouldn’t have a graphic designer dispensing medications would you? Of course not, you’d use a professional trained in that arena. If budget is an issue, look for inspiration in other businesses or use a service like canva.com, choose a template and stick with it. We want to hear about your successes with merchandising. Send us an email at scot@IACPRx.org or post your suggestions on FB.com/IACPRxPubs. Sampling to Get the Most Return on Your Investment. 1. Samples should complement clients’ needs. Giving a 20-year-old customer, a sample of Geritol is not going to generate a sale. 2. Samples should contain enough product to be useful. If samples are small, offer two or three. 3. Make sure the client receiving the sample knows how to use it properly. 4. Inform clients about the benefits of using the product. 5. Include instructions on how to purchase it from your pharmacy.
Scot Maitland is Director of Communications and Publications and the publisher of IACP’s Compounding Matters Quarterly and Pharmacy Marketing Quarterly and host of our new IACPodcast. He coordinates with other IACP Communications staff to promote the visibility of IACP and the IACP Foundation.
MAKING THE MOST OF EXHIBITING AT A TRADE SHOW by Jennifer Petska, CPhT
EXHIBITORS Tradeshows, love them or loathe them, are an excellent way to connect with your target market if you do some planning and execute that plan. We have all been to a tradeshow and watched some exhibitors do things really right and some do things really wrong. There are exhibitors who hide behind their table, some who won’t make eye contact or talk to anyone walking by, others don’t even try to engage with the attendees and worse, some never show up at all leaving their booth a blank space. On the other side of the coin, some booths seem to be the “hot spot” in a sea of booths. They are always busy and engaged, getting a lot of leads. The real question is how many of those leads are qualified and what are they going to do with them?
PRE-SHOW MARKETING Once you decide to go to a show and have booked it, you need to do some pre-show planning and that includes marketing. The main purpose of a pre-show marketing plan is to get as much of your target audience to your both as possible. According to The Trade Group, 70% of attendees go to a tradeshow with an agenda, meaning they know what they are looking for and who they want to see. With some planning ahead you can maximize those experiences and drive people to your booth. Begin with defining your goals. Is it a certain number of new leads? Perhaps you’re looking to secure a percentage of new customers. Or maybe it’s a particular number of appointments to follow up with at the end of the tradeshow. Whatever your goal is, you need to have it in place so you can measure it in the end. Just like our attendees are prepared for the show, you need to be too. You need to know who you want to talk to and what you want to promote. In fact, we recommend that you reach out to your sales team to get their feedback and to have them engage with customers before they leave for the show. You are planting seeds and trying to set up appointments.
Let’s use Compounders on Capital Hill (CCH) as an example. If they aren’t registered to attend the show invite them. Ask them to join their colleagues at CCH and set up appointments with them on-site. Use that opportunity to let customers know about any show specials or giveaways you’re doing. Give them a reason to come to the exhibit hall and see you. Take advantage of the IACP CCH Graphic toolkit and include the “I’m Attending” E-Mail Signature. We’re all for print, this is a magazine after all, but make sure you’re digital too! Create a micro-site or landing page on your existing site to collect emails, find out who’s attending, and share your show specials. Don’t forget use social channels like Facebook, Twitter, and LinkedIn to engage your customers ahead of time.
AT-SHOW MARKETING All right, you’ve made it. You are at the tradeshow, but what’s next? The first thing you have to do is make sure you are attracting the right traffic to your exhibit. A busy booth is only effective if the right people are in it! So if you sell to consumers where everyone in the exhibit hall is a potential client, then everything I list today can be effective for you. But if you’re like most of us, where the target market is much more narrow, you’re going to have to prepare differently. Start by creating booth graphics that clearly state who you are and what you do. This helps weed out people who are not part of your target market, because if they’re not part of your target market, you don’t want them to take up your time. Make sure you’re collecting leads at the trade show. It’s important, and we’ll mention more about this when we talk about measurement. Most show management companies can provide you the technology to capture this information. It doesn’t have to be complicated; a simple business card exchange works just as well. Either way, be sure to include some blank note cards so you can capture the contacts of people who either ran out of
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MAKING THE MOST OF ATTENDING A TRADESHOW! Face to face time is invaluable, so come prepared. Start by making a list of the companies with whom you want to visit. You might want to order those visits in terms of the layout of the tradeshow or perhaps in order of importance. Next you’ll want to formulate questions that you need answered. Is it pricing? Shipping? Customer service inquiries? Then take a look at the times that the exhibit hall is open and create your schedule so you can fit in everyone. Be sure to have some flexible free time for vendors you weren’t expecting to meet with or for meetings that last longer than anticipated. Last, but not least, don’t forget your business cards. The following are list of potential questions to ask: 1. Are you a sponsor of IACP? ACA? Or any other pharmacy association? 2. Tell me about your quality program. 3. What type of testing do you do on your chemicals/products? 4. Tell me about your shipping policy. 5. Tell me about any specials you have. 6. Do you work with any buying groups? 7. Can I order online? 8. Do I have a dedicated sales representative? 9. D o you have training (classes or product specific)? 10. Do you have technical support (product specific/formulas)? 11. Can I order directly through you? If not, who do you distribute through? 12. Does your product integrate with my current computer program or other products? (ex. Does this balance work with your software?) 13. What type of return policy do you have? 14. What type of warranty/guarantee do you have? 15. Are you a membership-based organization? 16. How long have you been in business with compounding pharmacies? 17. Do you have an NDC & AWP on your chemicals? 18. Do you have a catalog? 19. Do you offer financing? Or payment plans? 20. Do you offer a discount for paying my bills at the time of service or within net 10 or net 15? 21. What’s the best way to interact with you? |(Phone, email, Facebook, Twitter) 22. Do you have social media channels? (Facebook, Twitter, Instagram, LinkedIn, etc.) 23. What makes you stand out from your competition?
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business cards or didn’t bring them. You can also take notes about the contact and what their specific needs are. Try giveaways. They are a great tool for capturing leads. Make sure they’re useful and memorable. Customize with your logo, web URL, and/or toll free number depending on print space. Have the attendee do something for you before they get the giveaway. For examples, scan their badge to get their information, have them fill out a short survey, or have them listen to your presentation. Don’t just hand them out or worse, leave them out in a big pile on one of your tables. By doing that, you have lost the opportunity to interact with the attendees. Consider doing live presentations. If you have the right person, the right space and the right product to promote, they can really have a lot of impact. Rather than try and speak to each and every person at length, make the connection and invite him or her back to your booth on the quarter hour to hear a presentation on what your company is about. As with all your marketing, you want to have a call to action. Use social media to your advantage at the show. It’s free and extremely useful. Here’s why, you want to create buzz and engage your audience. Snap pictures to share on Facebook and publish them to Instagram. Tweet a picture or a short video. Make sure you use the show’s hashtag, ex. #CCH2015. Using the show’s hashtag will extend your reach because the conference will then share your posts, comment on them, and like them. Their followers will then see your posts as well thus expanding your reach. Consider doing a live video stream. The metrics on social media change and video is definitely gaining in popularity. How great would it be to not only reach your target audience at the show, but with potential customers who were unable to be there? Make sure you tie it in with your pre-marketing messaging. Let people know where they can find you. Make sure you post the links to your live video, blog and social media pages. Reach out to bloggers and the press. Ask them to come to your booth and take the time to walk them through your exhibit. Share what advantages your products and services might have. If you have a press release, let them know.
POST-SHOW MARKETING Now that you’re home, it’s no time to rest. This is the most important time. It’s time for post-show follow-up: calling, appointment setting, literature fulfillment and continued social engagement. Generating leads at the show is fantastic, but they have to be taken care of once the show is over. It’s estimated that up to 70% of tradeshow leads go uncalled! Why would you waste the time, effort and money you spent on the qualified leads you got? This is gold to a salesperson. It begins on the tradeshow floor with ranking, filtering and qualifying your prospects. Once you’ve done this, assign your leads immediately to your sales team. You’ll want them to report back you on the progress they’re making and the final outcome. This will help provide you data on the show and how to be more effective at future shows. We’ve heard of success stories where up to 54%
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of qualified leads have been converted with a single phone call! But that’s not always the case. Sometimes it’ll take three, four even six calls before the sale. The key takeaway is that you need to call! Prepare a workable timeline for your sales reps to follow. Be sure and hold them accountable. Calls should be begin within 48 hours once the event is over or the first business day after that time frame if it falls on a weekend. Have your staff attempt to make contact at least five times before giving up on the lead.
E D U C A T I N G
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In addition to making calls, be sure and have someone to handle literature fulfillment. You want the mail going out to your prospects as close to that 48 hours mark afterwards, so that they have the information they need to make a decision/purchase. If it’s a VIP, consider a hand written note in addition to a phone call. Remember, email is always free and essentially so are phone calls at this point.
MEASUREMENT Someone once told me, “What gets measured, gets done.” Measurement can seem daunting, but it only is if you don’t know what you’re measuring. The best way to look at your ROI is to start off with what your objectives were in the first place. Every one will have different ways of measuring, but here are a few to consider: • What were you selling? • Who was your target customer?
R E N A I SSA N C E WAS H I N GT O N , D C To register for CCH, visit
iacprx.org/cch
©2014 International Academy of Compounding Pharmacists (IACP). All rights reserved.
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• How did your target customer learn about your product or service? • Did you encourage referrals? If so, how? • What is the measurement of success? Was it the number of people who came to your booth? Was it the number of sales at the booth? Was it the number of qualified leads you got? Or was it the number of sales you closed after the show? • What criteria did you use for sorting your leads? Once you’ve looked at your criteria and sorted through your data, you will have a good idea of what worked, what didn’t work, and if the show itself was a success. Don’t forget to debrief with the tradeshow staff shortly after the show closes. They will have valuable input to make the experience better. Tradeshows can be a blessing or curse, depending on your outlook and experience. Even if you can’t do everything we mentioned, at least do some planning – have at least one goal in mind, execute your plan, and follow up in a timely manner. It’s okay to start small; the important part is to just start somewhere. Your plan can change and grow; that’s normal. Before you know it, you will be a seasoned professional at tradeshows.
Pharmacists. Having issues fitting all of the marketing pieces into your daily routine? Have the pharmacy marketing experts do it for you! Visit GRXMarketing.com or contact them at 515.280.2913.
Jennifer Petska, CPhT is the IACP Director of Development & Membership IACP Foundation Administration & Development. Jennifer is responsible for IACP membership and she coordinates with other staff to promote the visibility of IACP and the IACP Foundation.
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DOUBLE TROUBLE by Scot Maitland photos by Scot Maitland and Carol Freedman
Scot Maitland: So Ashlyn and Macy, tell our readers a little bit about yourselves. How did you learn about IACP in the first place? Ashlyn Grant: In December 2013, I was getting ready to graduate and on a Sunday I found the job posting for Events and Education Assistant. My freshman year, at UTSA, I worked for the President’s office on his events team. So I applied that Sunday, IACP called me the following Tuesday and by that Friday I began working at IACP. It was exciting to start this job two weeks before graduating from the University of Houston. Macy Pruitt: Well I have always wanted to do events. I think I was in high school when I decided I was super organized and maybe a little OCD about things. I graduated from Texas Tech University, and I earned an Adverting Major and dabbled in marketing and PR. Each year I had a different event planning internship. SM: Ashlyn you’ve had three events under your belt now, two Educational Conferences and one Compounders on Capitol Hill, how has your position grown over the last 16 months? AG: When I first joined, I was more of an assistant. |Now I’m more hands-on. MP: We’re both a lot more in charge than we were originally. It’s been great to work together to make sure that everything is taken care of. SM: That’s great that you’ve been able to grow into your positions at IACP. MP: Ashlyn does a lot of the sponsorships and working with corporate partners. Whereas for CCH, I handle the hotel logistics and the speaker tracks. SM: So when you’re not in conference preparation mode, what other tasks are you working on at IACP? AG: Anything corporate partner related falls under me. I handle the exhibitor relationships. MP: If a member wants to host a Regional Education Meeting they can reach out to me. If there’s an issue with getting their CE for CCH, webinars or the Regional Education Meetings, I’m here to help. SM: Well great! Thanks for sharing with us. Macy and Ashlyn can be reached at our Corporate Office in Texas and be on the lookout for them at Compounders on Capitol Hill!
On the following page, you’ll see some great photos from the ACA, IACP, ACVP Educational Conference. And on page 19 there’s a Twitterview I did with Adam Silvertown, RPh of Pace Pharmacy on his experience as a first timer. Two of the people who helped make this conference a success are my co-workers, Macy Pruitt, our Events & Education Coordinator, and Ashlyn Grant, our Events & Education Assistant. As they’re both relatively new to IACP, we thought it would be a good idea to catch up and talk about how they’ve made an impact in coordinating IACP’s Events.
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Scot Maitland is Director of Communications and Publications and the publisher of IACP’s Compounding Matters Quarterly and Pharmacy Marketing Quarterly and host of our new IACPodcast. He coordinates with other IACP Communications staff to promote the visibility of IACP and the IACP Foundation.
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‘‘
MAKING YOUR BUSINESS SUCCESS, OUR BUSINESS.”
www.bbpharm.net | P: (800) 499-3100 | F: (303) 755-5242 B&B Pharmaceuticals, Inc. 8591 Prairie Trail Drive, Ste#C600, Englewood, CO 80112
TWITTERVIEW WITH ADAM SILVERTOWN, RPH
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S AV E
T H E
D AT E !
August 15, 2015 Hilton Columbus at Easton – Columbus, Ohio The Compound Conference is the only conference annually partnering with a state pharmacy association, bringing together the leaders in the pharmacy compounding profession.
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MEET ME IN DENVER
Denver is where the action is this year for pharmacy. With two conferences this late summer and fall, it’s all about the Rocky Mountain state. Denver is also home to IACP Corporate Partner B&B Pharmaceuticals. Check our sidebar for their top five recommendations while you’re in Denver.
by Scot Maitland
EVENT: Total Show Expo DATE: August 22 – 25, 2015 LOCATION: Colorado Convention Center in Denver, Colorado GIST: I had the pleasure of attending this conference last year, and I have to tell you, it’s intense! But it’s manageable intensity. Here’s what I mean, the show is large, but they’ve structured it so that you make appointments with the vendors you want to meet. Last year’s event was at the Boston Convention and Exhibition Center. During the conference, I learned about a slew of new products and learned from great speakers at this collaborative, cross-functional meeting. If you’re not familiar with the Total Show Expo, it’s the flagship event of the National Association of Chain Drug Stores (NACDS). The mission of NACDS is “to advance the interests and objectives of the chain community pharmacy industry, by fostering its growth and promoting its role as a provider of healthcare services and consumer products.” Membership in this trade organization is open to companies operating four or more retail pharmacies open to the public. But I jumped ahead of myself because I forgot to tell you that this show is free for retail attendees. No, that’s not a typo, the conference is free for members of NACDS or if you’re a non-member and have four or more stores. If you meet this criterion and you’re a district, regional or store manager you should be attending. Now if those two factors weren’t enough and the idea of spending time in Denver hasn’t had you log on to TSE.NACDS.org then consider this: • Preview the latest innovations in consumer packaged goods, store/pharmacy technology, pharmaceutical products and more entering the market • Meet with a majority of your suppliers and their senior sales staff at one event, in one place • Obtain that special niche product for your stores • Enhanced collaboration with key trading partners • Learn about new merchandising programs, promotional offers, “market specials” • Review and enhance current programs and make midcourse product and merchandising adjustments • Stay abreast of the emerging market: new people, new products, technology, and services, new thought processes, new styles, colors, trends, and packaging • Education programs covering the latest on state-ofthe-art pharmacy operations, practice and clinical issues, distribution and marketing I’ll be covering the conference in the fall edition of Pharmacy Marketing Quarterly. Different aspects of the conference interest me for different reasons. As a business man, I’m excited to hear Gail Borgatti Croall,
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MD, FAAP speak on Telehealth: Enabling Access to Healthcare Services. As a marketer, I can’t wait to hear Todd Huseby speak about Winning with Digital Marketing. And as an early adopter of technology it’s Deb Weinswig’s presentation on The Collision of Digital Health, The Consumer, and Wearables that has me most excited. Well, that and seeing the Goo Goo Dolls perform that Monday evening in the Centennial Ballroom of the Hyatt Regency Denver! But don’t wait for my follow up report in our Fall issue. Register today for the conference at TSE.NACDS.org and make plans to experience manageable intensity with the Total Show Expo! EVENT: Freedom’s 4th Annual Seminar DATE: September 18 – 19, 2015 LOCATION: Grand Hyatt in Denver, Colorado GIST: This is another conference that I’ve been fortunate enough to attend. Last year, Freedom Pharmaceuticals was up the road from in Dallas. This year they’re headed to a different Big D, Denver. If you’re looking for a show that motivates and educates, consider adding this one to your calendar. On the clinical docket for this year are IACP memebers Dr. Nayan Patel, of Central Drugs Compounding, and Dr. Hamid Bakhteyar, of Carolina Compounding Pharmacy & Health Center. While on the business and law side Dan Benamoz, RPh of Pharmacy Development Services and Jonathan Levitt of Frier Levitt will be speaking. That’s a pretty impressive list of speakers but hold on, they’re not done. They’ve got Mr. Daymond John as their keynote speaker. Mr. John started the clothing line FUBU, which has amassed more than six billion dollars in global sales. But many of you probably know him as a cast member of ABC’s reality television series Shark Tank. Like the Total Show Expo, I’ll be covering the conference in the fall edition of Pharmacy Marketing Quarterly. But don’t wait to read about, register today at FreedomRxInc.com. And if you register by June 1, you’ll save $100 on the registration fee.
WHAT TO DO IN DENVER by Matthew Johnson, Operations Manger of B&B Pharmaceuticals, Inc. 1. V isit a dispensary – Colorado is one of the only states where marijuana is legal. As a pharmacist, this is something unique to experience. Especially if your state is etching towards legalization. 2. Visit Red Rocks Amphitheatre – One of the most premier music venues with beautiful scenic views from the foothills of Denver. Come tour the Performers Hall of Fame and see the history that this site holds. http://redrocksonline.com/ 3. Take a brewery tour or sample local microbrews – Colorado is one of the hottest spots for brewmasters. There are so many great flavors to choose from. http://denverbreweryguide.com/ maps.aspx 4. Denver Botanic Garden – One of the nations topped ranked botanic gardens featuring beautiful displays and chart-topping musicians in the concert area. http://www.botanicgardens.org 5. Say hello to B&B Pharmaceuticals – Our new facility is open, and we’d love to give you a tour. A bit outside of Downtown but just on the outskirts of the Denver Tech Center.
Scot Maitland is Director of Communications and Publications and the publisher of IACP’s Compounding Matters Quarterly and Pharmacy Marketing Quarterly and host of our new IACPodcast. He coordinates with other IACP Communications staff to promote the visibility of IACP and the IACP Foundation.
HOW TO PACK LIKE A PRO ROLL, DON’T FOLD:
BRING A NOTEBOOK:
CARRY ON CLUE:
You’ll save space, and your clothes will arrive wrinkle-free.
To record your bright ideas when your phone is in airplane mode.
Pack light and wear your bulkiest items like your boots and jacket on the plane.
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August 22 - 25, 2015 Colorado Convention Center Denver, CO tse.nacds.org
HILL DAY: THE WHAT NOT TO WEAR EDITION by Lauren Onsa White coats fill the hotel lobby as proud pharmacists head off to our Nation’s Capitol. I’ve never felt so unified and inspired; the vibe was contagious. Compounders on Capitol Hill is one of the most impactful conferences we as compounders attend each year. It is our time to join forces and stand up for our industry at whole. Last year was my second time attending the conference, but it was my first time attending “Hill Day.” Typical woman, I spent the week before laying out my outfit options for the perfect Hill Day look. I decided on a navy Banana Republic dress, white Ann Taylor suit jacket, nude heels and a pulled the whole look together with a J.Crew statement necklace. What was I thinking? Yes, fashion is my passion so if I lost you I apologize. Fortunately, you won’t need Vogue to prepare for Hill Day, just this handy article in Pharmacy Marketing Quarterly! As a first timer, I did collect a few tips along the way that I think will help out any newbie or seasoned pro. Footwear: Make sure it’s comfortable. I’m not talking about your gym sneakers, but something you won’t mind walking in. Those heels I mentioned; it was a bad idea. I ended up having a friend bring my flats to the Hill. It helps to have good connections with people, but that’s another article! I under estimated the amount of walking I would do. You have to be able to navigate through subways, escalators, stairs and cobblestone streets. There’s so much to see in Washington D.C. so you’ll want to enjoy it in comfort. Ladies I would recommend a flat shoe or a very small heel. Men make sure your shoes are broken in. I know it’s a day to rub elbows with some big players, and you might want to bring out those shiny new loafers, but don’t let a blister get in your way. Although we can make some pretty awesome compounds for them, that’s another article. And since we’re speaking of shine, give them a nice buff before heading out that morning. Dress: You’re in the Nation’s Capital so dress to impress! For the ladies a nice dress, blouse, slacks or pantsuit is perfect. The majority of the men wore suits or dress pants, a dress shirt, and tie. If you are a pharmacist or technician, don’t forget to bring your white lab coat! It
is a powerful statement! Consider ironing it with a little spray starch so it keeps all day. Take note the weather can get warm. Our Capitol was built on a swamp after all. So wear layers and consider fabrics that are breathable. With the hustle and bustle and moving between the outside and air conditioned offices, you want to be comfortable. Jewelry and accessories: I mentioned my necklace; I love a beautiful statement necklace, but that necklace had to come off every time I entered into a new building. The buildings have security checks and metal detectors. If you plan to wear jewelry, know you may have to take it on and off. The same goes for belts. It’s very similar to the airport. Pack light. That change in your pockets is going to be a bit of a hassle. Ladies a tote bag is great and gentlemen consider a messenger bag to carry your papers and personal items. Smile: You may have heard this before, but the best accessory of all is to bring your smile! I will admit I was a bit nervous heading down to the State Breakfast and briefing that morning. I met with my group, and they were so helpful. The day was well organized and by the end I felt confident and more aware of what pharmacies of all different specialties and sizes were facing. Walking the halls of the government buildings as a proud compounder and shaking hands with officials was thrilling! I even had a run in with Anderson Cooper! Also, keep in mind that the staff of IACP has hired photographers to capture the day. So be ready for that close-up!
Lauren Onsa is the Vice President of Compounding Operations at Clinical Compound Pharmacy in Naples, Fla. Lauren received a Bachelor of Arts degree in Public Relations from the University of Dayton. She was born and raised in the Philadelphia area. Lauren is a speaker for educational programs within pharmacy marketing and innovations within the field of Compounding. She is a member of IACP and serves on the communications and educational committees. She is also a Charter Marketing Member of the ACA. IACPRx.org/Publications | Spring 2015
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TOP TRAVEL TIPS FROM A ROAD WARRIOR by David G. Miller, RPh
1. C hecking luggage? Don’t. Have no choice? ALWAYS use curbside, pay the $2 fee and tip. You beat the lines inside, and that ramp next to them is sending your bag straight out for sorting and loading. 2. Grab and go. Have three ready-to-go toiletry bags with the basics that you restock every time you return: disposable razor, shaving cream, hair gel, toothpaste, nail clippers, comb, foldable brush, travel size deodorant, contact lens case, lens solution, pair of dollar store reading glasses). Stock up on travel size, 3-ounce versions at Target or WalMart. Every hotel has soap, shampoo, conditioner and if you forget something, ask the front desk. In a pinch, conditioner works as shaving cream. 3. F light canceled? Never get in line for rebooking at “special services.” Run, do not walk, to someplace quiet and call the reservations number of the airline. The booking agent on the phone is using the same reservation system that the agent at the airport is. A 20-minute wait on the phone beats standing in line with 100 people each taking 5 minutes or more. 4. A lways take the soap. Squirrel away all the shampoo, conditioner, soap and other amenities every day and take them home. Do you need them? Heck, no. Put one of those innumerable tote bags that you get at conventions in your linen closet. Then drop all the stuff in it and twice a year, take the bag to your local homeless shelter or a women’s shelter. They need that stuff. 5. Be prepared. Before you even walk into the airport, clean out your pockets of change, the belt, the wallet and put it into your carry-on bag. Don’t wait until you’re in the security line. Assume there is no TSA Pre-Check line, and you will have to take your shoes off. Flying in wintertime and going someplace warm? Leave the topcoat in the car. You don’t need to drag it 2,000 miles. 6. B est days to book a flight? Tuesday. Rates are adjusted by airlines on Mondays. 7. Going to a convention? Check the hotels around the convention center that AREN’T “the host hotel.” Many organizations have a deal with the hotel that they receive a rebate for every booked room that makes the room rate usually higher. IACP doesn’t do that (cheaper rooms = more attendees). So what if you have a few minutes walk in the morning? It’s a good way to get outside. 24
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8. Worst hotel to stay in? Any property with a sealed “bio-dome” environment. No fresh air. Make a point to get outside and breathe at least twice a day. 9. W ash your hands. A lot. You’ll be touching all kinds of places and as your Mom know doubt said to you many times “you don’t know where that’s been.” For the men, watch how many guys use the urinal and then walk right out the bathroom door in an airport without washing their hands? 10. Leave early and relax. My rule of thumb is 30 minutes before departure is boarding, assume 30 minutes to get through security. Add 15 minutes for getting coffee or snacks, and then add the commute time from home to the airport. You don’t want to be the guy running through the concourse at the last minute (been there, done that). 11. The best seat on a plane? Next to a 5 or 6-yearold. They always have toys or cards and find you fascinating when you’re working on a computer. Sometimes it’s fun to stop doing work and play Old Maid (and lose because you forgot how to play which is embarrassing). 12. The worse seat on a plane? Next to anybody that forgot to pack and use deodorant. Second worst? Next to anybody that considers a bottle of cologne equivalent to deodorant. 13. Dress for the flight under the assumption that your checked luggage will be lost. Whatever your first event or meeting is when you land is how you should appear. Pretty much, anything else can be bought or replaced. 14. And yes, you can use the hotel shampoo to wash your socks and underwear if you have to.
David G. Miller, R.Ph., IACP’s Executive Vice President and CEO, works with our volunteer Board and leadership to set and execute the IACP agenda. Whether working on legislation on Capitol Hill, acting as compounding pharmacy’s liaison to other pharmacy and medical organizations, or defending against overzealous government regulation, his primary responsibility is always keeping the professional and proprietary business interests of IACP members first and foremost.
The International Academy of Compounding Pharmacists (IACP) is an association that represents more than 4,000 pharmacists, technicians and students.
Š 2015. IACP. All Rights Reserved.
MARKET WITH THESE UPCOMING OBSERVANCES JUNE
JULY
AUGUST
• Gay Pride Month
•J uvenile Arthritis Awareness Month
•N ational Immunization Awareness Month
• Adopt a Shelter Cat Month • Men’s Health Month JUNE 1 - 7 Sun Safety Week JUNE 7 National Cancer Survivors Day JUNE 15 - 21 Men’s Health Week JUNE 21 Father’s Day JUNE 26 Take Your Dog to Work Day JUNE 30 Social Media Day
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• National Back-to-School Month JULY 1 Canada Day JULY 4 Independence Day JULY 19 - 25 National Zookeeper Week JULY 20 National Lollipop Day
• National Breastfeeding Month AUGUST 2-8 International Assistance Dog Week AUGUST 6 National Fresh Breath Day AUGUST 15 National Relaxation Day AUGUST 26 National Dog Day
SAVE THE DATE FOR THESE UPCOMING PROGRAMS Learn More at http://tiny.cc/IACPRxCalendarSpring
Now, IACP is your one-stop shop for all things compounding! Compounder Calendar provides a comprehensive listing of compounding events and continuing education programs offered by IACP, state pharmacy associations, national pharmacy associations, IACP corporate partners and IACP affiliates.
JUNE 1 Pharmacy Compounding: Past, Present, and Future Webinar
MAY 1–3 Contemporary Compounding– Intensive CE - A Certificate Course
JUNE
MAY
Location: Ponoma, California
MAY 8–9 Freedom Pharmaceuticals Inc. CPCSI Training Course Location: New Orleans, Louisiana
MAY 13–15 Letco Medical: Fundamental Compounding & Calculations Location: Bartlett, Tennessee
MAY 13 Webinar: 2015 OSHA Training– Bloodborne Pathogens
JUNE 6–9 Compounders on Capitol Hill– Register today at IACPRx.org/CCH Location: Washington D.C.
JUNE 20 Sterile Compounding–New Laws and Regulations 2015 Update Location: Pomona, California
JUNE 22–24 Letco Medical: Comprehensive Sterile Compounding Location: Bartlett, Tennessee
JUNE 23 Webinar: 2015 OSHA Training– Bloodborne Pathogens JUNE 26–27 Letco Medical: Compounding for Natural Hormone Replacement Location: Bartlett, Tennessee
JUNE 29–30 Letco Medical: Compounding Options for Pain, Wound, & Scar
JULY JULY 17–18 Letco Medical: Veterinary Compounding Essentials Location: Bartlett, Tennessee
JULY 17–18 Freedom Pharmaceuticals Inc.: CPCSI Training Course Location: Tulsa, Oklahoma
JULY 23 Chicago, IL Regional Education Meeting Location: Chicago, Illinois
JULY 25 MEDISCA NETWORK: Preparing for a State Board of Pharmacy Compounding Practice Inspection Pro Location: Los Angeles, California
We are currently developing the 2015-2016 calendar. If you would like your compounding related events included, send an email to Macy Pruitt at macy@iacprx.org.
Location: Bartlett, Tennessee
Over the last 12 years, the endowment has been used in ways to educate the public and healthcare professionals in an effort to maintain the profession’s viability. Did you know that just about every pharmacy compounds? Most retail pharmacists compound something at some point, hospitals and homecare pharmacists may do both sterile and nonsterile, even prisons and jails may have a pharmacy owned by the government that employs pharmacists that compound necessary medications. Hospital ships, military installation hospitals or floating hospitals, the veterans affairs, even the mail order PBMs, nuclear and Positron Emission Tomography (PET) pharmacies, research facilities (including BIG Pharma research facilities), the National Institutes of Health, AND let’s not forget our animal companions who need sterile and nonsterile medications compounded that are supplied by veterinary schools, veterinarian, veterinarian offices, and retail pharmacies all compound. Education about how to compound, quality of all compounds, testing, stability, etc. is of the utmost importance to the IACP Foundation. In June 2004 the Foundation started an annual fundraiser aptly titled the “RxMixer” and dubbed, “A Party with A Purpose.” Since that time more than $1.6 million dollars have been raised to sustain the endowment and fund research and educational grants. Through lawsuits such as the Western States vs Tommy Thompson with the Supreme Court Ruling, Midland States vs FDA, split on estriol and the current demands from payers to provide evidence for use of compounded preparations the Foundation continues to educate patients, patient caregivers, prescribers, and pharmacists to the benefit of compounded medications. Personalized medications are becoming more personalized in both the human and animal world, and most have to be compounded. Compounding is not going away.
Keeping track of this ever evolving landscape is a challenge. The IACP Foundation and its committees are focused on providing education and research support to patients, prescribers, pharmacists, and students who are studying to become prescribers and pharmacists through scholarships to attend meetings and grants for research. “Rewind: Back to the 80’s” and join us at this year’s RxMixer – “A Party With A Purpose” to raise funds for a good cause and have fun at the same time on Sunday, June 7, 2015 in Washington D.C. during Compounders on Capitol Hill (CCH). In the next issues read more about the IACP Foundation: Part II – History of the RxMixer and the celebration of 15 years in 2019 Part III – History of Research and Education funded
Lisa D. Ashworth, BS Pharm, RPh is the Compounding Specialist and Clinical Pharmacist at Children’s Health System of Texas. She is President of the IACP Foundation and has worked in the pharmacy industry for over 35 years. References: IACP Foundation. Bricks Mortar & Pestle: Building A Foundation For The Future Campaign Brochure. 2003. 2003 Annual Meeting & Compounders on Capitol Hill, An Official Publication of the International Academy of Compounding Pharmacists. 2003 2015_RxMixer_.25pgAD_3.5x4.625_ad_rx_Layout 1 9/30/14 12:55 PM Page 1
B E N E F I T I N G
T H E
I A C P
F O U N D A T I O N
1 1 TH A N N U A L R X M I X E R P R E S E N T S :
Many people have played many roles in the formation and growth of the IACP Foundation. The original committee in 2003 consisted of: John Preckshot and Kathy Jackson as Co-Chairs John was the Lead for Campaign Development with two committees: • Facilities Committee—Lead by Eric Vidrine with members of Dean King, Chuck Leiter, and Phil Pylant. • Public Relations, Marketing & Advertising Committee— Lead by Peter Ford with members of Patricia Paget, Shelley Capps, and Patti Storey Kathy was the Lead for Solicitation with three committees: • Membership—Lead by Matt Kopacki with members of Mike Stein, Jim Paoletti, Ray Moreno and Eldon Armstrong • Stakeholders—Lead by Mike Leake with members of Mike Jones, Ron Petrin and Tom Marks
SUNDAY, JUNE 7, 2015 6:30PM – MIDNIGHT RENAISSANCE WASHINGTON, D.C.
• Foundations – Lead by Bill Letendre with member Leo Blais ©2014 International Academy of Compounding Pharmacists Foundation. All rights reserved.
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IACP FOUNDATION HISTORY by Lisa D. Ashworth, BS Pharm, RPh
Will Rogers said, “If you want to be successful, it’s just this simple. Know what you are doing. Love what you are doing. And believe in what you are doing. “ This is why, in 1991, a group of passionate compounding pharmacists formed Professionals and Patients for Customized Care (P2C2). Originally consisting of less than 300 members, its mission was to protect the birthright of pharmacy, the practice of compounding. In 1996, P2C2 changed its name to the International Academy of Compounding Pharmacists (IACP), expanded its mission and scope, and had grown to almost 4,000 pharmacist, technician and student pharmacist members. In hitting the stride of those teenage years, IACP was seeing constant change in the highly complex and everevolving world of the art and science of compounding medications for humans and animals, not unlike today, this shifting landscape presented challenges. In the Spring of 2003, the IACP Board established the non-profit IACP Foundation to acquire its own physical space for IACP and the IACP Foundation offices (that was housed at Professional Compounding Centers of America (PCCA) since its inception) and pursue growth along with endeavors to provide scientific data supporting compounding. The “Bricks, Mortar and Pestle: Building a Foundation for the Future” Capital Campaign was launched to raise $1.5 million for the new facility as well as establish an endowment to support research and education for the profession of pharmacy, specifically compounding. One million dollars would go to secure or acquire a building for IACP to establish a permanent home and prepare for growth as well as honor achievement within our profession and $500,000 to establish an endowment. Protection and
advancement of the compounding profession were of the utmost importance. As the first-ever permanent endowment in the field of compounding pharmacy, the Foundation pledged to fund research studies and develop programs to: • Raise awareness with consumers and healthcare professionals of the critical role compounding pharmacists play in promoting patient health • Develop and validate best practices for pharmacy compounding • Promote studies to ensure employee safety and quality of medications (e.g. effectiveness, stability) • Advocate for basic scholastic education and training necessary for compounding in pharmacy school / college curriculums • Promote programs that facilitate interested students to pursue a career in this profession (e.g. scholarships) • Enhance the credibility and reputation of pharmacy compounding The support from the compounding community was phenomenal, the goal of $1.5 million was met…and exceeded. In a suite at the Washington Court Hotel, Washington, DC in the summer of 2003, a group of around 40 pharmacists who were passionate advocates for compounded medications convened to establish the Research arm for the Foundation. Our goals were to develop a grant application process, determine what kinds of studies we wanted to fund and when we were going to start distributing funding.
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SM: So, one final question for you, what would you say to fellow student pharmacists out there who might be struggling with their course load and trying to be active and having a personal life?
So my solution to that was to try something new. So I had a break here, for spring break, and I the coach of the North Carolina Polo Team. And asked him if I could have a few lessons. And he offered a spot, and I went out and I took my first two polo lessons. Polo is, in my mind, attractive for two reasons. It’s something new; I hadn’t tried it before. And two it adds the element, a completely different element, that you’re hitting a ball from atop a horse, which is unique to any other horse discipline. There’re not many other ways of riding that involves hitting a ball into a goal from the top of a horse.
actives as well as empowering them to get involved within the profession.
doing instead of what I was doing right then and there on the back of a horse.
SM: I think it’s brilliant that you took something that you love, but was becoming stale for you and mixed it up. You found a new way revitalize it. I know our readers can take a lot from that because pharmacy can get that way. It can become monotonous, compounding in the lab or behind the counter. Even doing patient consults can become tedious, and you can lose your passion for it. I think one of the great things about pharmacy today is the variety it offers. As I mentioned at the beginning of the interview, I met you when you were interning for PCAB and Compounders on Capitol Hill. What other things have you been up to as part of your student career? LMK: Since my time at the Pharmacy Compounding Accreditation Board, I’ve begun to focus on the broader aspects of pharmacy. I’ve worked primarily with the American Pharmacist Association’s Academy of Student Pharmacists. At this point, I am three weeks away from finishing my year-long term as the APhA-ASP Speaker of the House*. In that role, I am one of the five student pharmacists that represent over 34,000 student pharmacists across the country. It’s an honor and a privilege and quite a heavy responsibility to be able to represent those individuals and be a facilitator of all the policy and advocacy actives that APhA offers to student pharmacists. I kind of got started within the policy and advocacy realm when my chapter at East Tennessee University in Johnson City Tennessee began to approach collaborative practice within Tennessee. And how the state’s pharmacy practice act did not include provisions for pharmacists to be able to collaborate with other health care providers. So my school began to take that on as a larger issue. And I got involved with that, and it rolled on from there to where I became very interested and enjoyed the policy and advocacy side of pharmacy. And from then on I pursued a regional position with APhA-ASP and then finally was elected last year to the APhA-ASP Speaker of the House position. SM: So what’s the next step? LMK: Well that is a very good question Scot. At this point, my next step is to graduate. It has always been the constant pursuit, but I have a lot of unique experiences, that I’m very excited about planned for my fourth and final year as a student pharmacist, in that rotation year, so I’m quite, excited to hone in on those experiences and make sure I get the most out of those over the next year. But that doesn’t mean I won’t be involved extracurricular with both riding as well as APhA-ASP. I’ll likely seek a few more positions and see where I can be helpful to student pharmacists in facilitating their policy and advocacy
LMK: I would have to say that the one piece of advice is to learn to prioritize. There are times when an example is the priority. There are times when finishing a compounding lecture or finishing reviewing a lecture for a quiz, and that’s the priority. There are times when working with a group member, in order to complete an assignment for class, is the priority. There are also times when you are the priority. When you’ve been studying all night, and ultimately you are the priority at the end of the night whenever you need to get rest and go into the exam fresh. So learning those priorities is going to be able to allow you to strike a balance within life and by no means have I found the balance. And by no means have I not struggled with finding that balance. But the designation of priorities is what has allowed me to find some degree of success as I’ve worked through finding that balance within life. * Publisher’s note: at the time of the interview, Loren was still serving as the Speaker of the House for APhA-ASP.
Scot Maitland is the publisher of IACP’s two publications Compounding Matters Quarterly and Pharmacy Marketing Quarterly and host of our new IACPodcast. He coordinates with other IACP Communications staff to promote the visibility of IACP and the IACP Foundation.
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PERSONALITY OF PERSONALIZED CARE: LOREN MADDEN KIRK by Scot Maitland
Photo by Melea Kirk Welcome back to another edition of The Personality of Personalized Care. This issue we reached out to one of our student members of IACP, Loren Madden Kirk. Loren is a pharmacy student at East Tennessee State University, and I met him several years ago at IACP’s Compounders on Capitol Hill when he was interning for PCAB. I caught up with Loren right before the APhA trade show in San Diego. Scot Maitland: Loren, I have the benefit of not just being a colleague of yours, but your friend too. So I know that you’re more than just a pharmacy student. You posted a photo on Facebook, which started this conversation, can you tell our readers about the photograph?
Loren Madden Kirk: So, I’ve ridden horses competitively in multiple different disciplines since I was seven. When I would try and escape pharmacy school or try and get pharmacy school off my mind, I would go out to the barn, and I wouldn’t be able to necessary escape that. I wouldn’t be able to forget about my to-do list. Or all of the things that I needed to study before an exam. Even on horseback, when I used to be able to be able to experience was the escape. Where I didn’t have to think about anything except me and the horse and what was going on underneath me. And what was going on with the horse, how fast they were going, how slow they were going, what they were looking at. But like I said, it has now become autopilot. I’m no longer focused on the horse. I was focused on what I was supposed to be
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reside outside their state? Where will patients find pharmacies willing and able to serve them, case by case? Will they be accredited? Will they have the expertise and capability to prepare the treatments? But more importantly, uniformed ‘experts’ and lobbyists for Big Pharma have recently weighed in on this issue: ‘The landscape is shifting,” says Gabrielle Cosel, the manager of drug safety at Pew Trusts. “Access is very important, but you don’t want to preserve access at the expense of quality and safety.” This is a telling statement in America, proactively limit and restrict compounding in case something happens in the future. Exactly how does an MOU increase quality and safety? The FDA prides itself on being evidence based, but there is no scientific evidence on where these restrictive percentages originated. One final thought about drug safety and quality: while the FDA has set its’ eyes on compounding pharmacies, Hospira has had 52 recalls since January 2014, including IV bags of saline. It seems their primary mandate from Congress needs to be addressed. Your voices are needed by the patients you serve, by the physicians you assist, by the health professionals you work with and by your colleagues and IACP. IACP is collaborating with other pharmacy groups and the medical associations,
which recognize there are numerous problems and unanswered questions which will jeopardize and affect patients and their access to needed medications. Speak up, write and send comments to IACP and your representatives and attend Compounders on Capital Hill this June. If not now, when? David Miller, EVP of IACP, recently wrote in article that appeared in the winter 2015 Compounding Matters Quarterly that the MOU’s potential for disrupting patient access isn’t limited to pharmacies. Section 503A applies to all practitioners engaged in compounding in all settings – doctors, nurses, physician assistants, dentists, hospitals, surgery centers – the MOU will apply to then as well. Since the MOU is being created by the FDA in conjunction with the National Association of Boards of Pharmacy, IACP is asking “how will each state board of pharmacy will oversee compliance with that agreement when they have no authority over doctors, nurses, dentists, etc?” Scott Karolchyk, MS, RPh, FIACP is VP of Formulations at QmedRx Compounding Pharmacy in Maitland, Florida. He is a past President of IACP and has worked in and taught compounding for the past 30 years.
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THE MOU: A PHARMACIST’S PERSPECTIVE by Scott Karolchyk, MS, RPh, FIACP
On Friday, February 13, 2015, the Food and Drug Administration released four guidance documents that further explain the regulatory framework the agency intends to use in enforcing the Drug Quality and Security Act (DQSA). One of them is the Memorandum of Understanding (MOU). After reviewing FDA’s most recent MOU regarding a 30% interstate shipping cap restriction for pharmacies, it begs the question: what are we trying to accomplish with this new rule? DQSA is supposed to increase patient safety and quality of sterile compounding, yet the MOU does nothing to address these issues. It reduces patient access, restricts interstate commerce and punishes successful law abiding pharmacies. Compounding pharmacies were already regulated heavily before DQSA by our state boards of pharmacy, the FDA, out of state boards of pharmacy, NABP, and our accreditation associations. The intent of the original MOU was to limit compounders from becoming manufacturers, by limiting office use. The newly issued MOU includes patient specific, dispensed scripts. The rules have changed with no scientific or evidence basis. There should be no limit to shipping scripts across state lines as long as the pharmacy follows the laws of both their state and that of the state where the patient resides. The cap is a more restrictive 5% if a state fails to sign an agreement – a memorandum of understanding – with the FDA. This MOU has emboldened certain compounders’ arguments that other compounders should only work within their state. I disagree for reasons outlined in this article and because of principle and what’s a right of pharmacy. That attitude has been prevalent in all areas of the business when one person is more successful than another, and it’s shortsighted, ignorant and wrong. If you are good at what you do, follow the regulations and laws of your state and the state you are shipping into, there is no difference where your patient lives.
Patient access to medically necessary treatments will be compromised and limited. Compounding pharmacies are not interchangeable. Many medication formulas are proprietary and require highly trained formulators, pharmacists and technicians to prepare these doses in a safe and effective manner. Expensive capital equipment and adhering to accreditation standards are additional factors that set apart these pharmacies. The advent of modern technology and logistics has created the opportunity to service any patient’s custom medication needs from a centralized pharmacy location. With next day FedEx (and in emergencies same day delivery) and E-prescribing, the patient experience has been elevated to having the convenience of home health care services within 24-72 hours. The triad relationship is the same whether the patient lives in your state or across the country. The implementation of this MOU is an unfunded mandate, implemented by an agency of the Federal Government with no authority to tax or set fees. The State Boards of Pharmacy would incur additional costs to monitor and enforce these provisions, depending on whether a pharmacy is using the 5% or 30% standard and whether the home state signs the MOU. Limited resources are already near bandwidth and in some states already maxed so one can only imagine the extra taxpayer dollars this added requirement would cost. The main argument is that the proposed MOU does not increase patient safety or quality. In fact, these new proposals seem to benefit Big Pharma, especially where Avastin compounding is concerned and how Big Pharma is influencing the proposed changes. When recently asked by a New York Times reporter if I had proof of this statement, I answered that there was no proof I was wrong. The implementation of any MOU would force pharmacies to turn away the patients they serve. How do they explain this to their loyal and trusted prescribers that
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specific action against the compounder. That isn’t what the law says. Nothing in the law says that a state agency has to take any action—including reporting their findings to the FDA within a seven-day period. Most importantly, in this draft FDA has defined “distribution” to include individual patient-specific prescriptions. That’s dispensing and something that the law clearly cites as being different. WHAT’S MISSING? Section 503A applies to all traditional compounders and specifically defines those as pharmacists and physicians. Nothing in the proposed MOU addresses physician compounding activities nor does it address the jurisdictional conflict between a state Board of Pharmacy and a state Board of Medicine. Who will be responsible for monitoring physicians? Who will be responsible for collecting adverse event reports? Will this be shared between multiple state agencies? If so, what additional cost burden will a state incur in trying to implement the proposed MOU? The definition of a traditional compounder is also important to keep in mind because the MOU provides for actions against a pharmacist, a physician, and a pharmacy. Nothing within 503A includes the physical practice location as subject to the oversight of the FDA. Of particular concern is the noted absence of possible actions against a medical practice, an ambulatory surgery center, a hospital or any other practice location for physicians. Only pharmacies.
WHAT HAPPENS NEXT The timeline for the MOU and its eventual implementation is still unclear. What we do know at this point is that all comments on the draft must be submitted to the FDA no later than June 18, 2015. After that, the FDA will publish the final MOU and begin circulation to the states for review and adoption. The unknown: when will that happen and how long will that take? Once the states have received the MOU, each state will need to follow its internal process for review, negotiation of terms, and whether or not to agree to the MOU. That process varies significantly from state to state and will no doubt involve Boards of Pharmacy and Medicine, Attorneys General offices, and potentially legislatures. That may involve state-level hearings that are subject to public notification and publication requirements. Those hearings may need to occur at multiple occasions and could result in requests for changes to the MOU as the impact on both in-state businesses and consumers are addressed. The unknown: when will that happen and how long will that take? Given that the ability to execute the MOU is dependent upon a state’s agreement to take on the additional reporting burdens, and the costs associated with those, state budget changes may be required. That involves submission by the Governors’ offices to the legislature, hearing and review and eventual voting by the
CompoundConf_.25pgAD_3.625x4.75_ad_r3x_Layout 1 11/18/14 5:52 PM legislators, Page and then the allocation of those resources.
The budget process in most states lasts for a good year.
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The unknown: when will that happen and how long will that take? There are already sufficient discrepancies between the intent of Congress, the law as written within 503A, and how the draft MOU has been presented for public comment. Although the MOU does not yet formally exist, there is no real cause for petitioning a court for redress. However, once it is final and, states begin to take it up for consideration the clock begins to count down for when a pharmacist or physician may be harmed professionally or economically by the language and can take the judicial remedy. FDAMA was enacted in 1997. It took five years for court challenges to be resolved. Might the new MOU trigger another five-year court challenge by pharmacists, physicians, and even states themselves? That’s also an unknown–and one that will be uppermost on the minds of all those impacted by these four lines of law in the DQSA. David G. Miller, R.Ph., IACP’s Executive Vice President and CEO, works with our volunteer Board and leadership to set and execute the IACP agenda. Whether working on legislation on Capitol Hill, acting as compounding pharmacy’s liaison to other pharmacy and medical organizations, or defending against overzealous government regulation, his primary responsibility is always keeping the professional and proprietary business interests of IACP members first and foremost.
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to determine the root of the problem and correct the issue, must notify FDA within 72 hours of receiving any complaint, and keep records of their actions for at least three years. Is that what the law, as written by Congress, says? While it places the responsibility for investigation of complaints squarely within the jurisdiction of the state agency, most likely the state Board of Pharmacy, it does not mandate or provide for a required reporting to the FDA within a specific time frame, nor does it define what constitutes a complaint, nor does it mandate recordkeeping. Is that what Congress truly intended? That question may have to be answered in the courts. Of particular concern to many Boards of Pharmacy is this: there will be a substantial financial burden to hire new investigators, new staff, and new technical infrastructure to comply with these requirements. This new “unfunded mandate” may have the untoward effect of preventing a state from even considering the MOU solely upon the basis of an economic impact on budgets that are already struggling with increased expenses. DEFINING INORDINATE QUANTITIES AND THE STATES’ RESPONSIBILITY In addition to the reporting requirements for adverse drug reactions or quality issues, the draft MOU requires that a State review compounding records during inspections. They need to determine whether the pharmacy, pharmacist or physician is distributing
inordinate amounts of the compounded medications interstate. This is where the definition of “inordinate amounts” appears for the first time: • “Inordinate Amount”–If the number of units of compounded human drug products distributed interstate in a calendar month is equal to or greater than 30% of the number of units of compounded and non-compounded drug products distributed or dispensed both interstate and interstate.
– The only exception to this rule – prescriptions that have been dispensed to an out-of-state patient at the facility in which the drug was compounded, and the patient or the patient’s agent carries that across state lines, are not counted in the calculation.
If the State determines that the pharmacy, pharmacist, or physician has in fact distributed inordinate amounts of compounded drugs interstate, the State must notify FDA within seven days. The State must also take action against the pharmacy, pharmacist, or physician that may include a warning letter, enforcement action, suspension or revocation of a license, or other action consistent with State law. The FDA may also take action against the pharmacy, pharmacist, or physician. There’s another important issue here that may require judicial interpretation. The language of 503A specifies that the issue or distributing “inordinate amounts” be “addressed”; as proposed in the draft MOU, it requires
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There is no scientific basis for the determination of what that means, especially given the varied nature of pharmacy practice and the geographies of states which are contiguous to multiple states where it’s not uncommon for patients to use an out-of-state pharmacy to meet their medical needs (e.g., New England, the Mid-Atlantic regions). Without specific definition by Congress, this is up to substantial interpretation or guesswork by a regulatory agency, , the FDA, or by the state agency that is entering into the MOU. It is entirely possible that “inordinate” may have two distinctly different meanings to each of those entities. • The law uses the terms “dispense” and “distribute.” These terms are not synonymous and are specifically used in different ways by Congress, further indicating that they are not interchangeable. Dispensing is a formal act by a pharmacist or other practitioner authorized to fulfill a valid prescription for a patient or, in some states, an office-use medication as defined both at the state level and within other sections of the FDCA. Distribution, meaning a sales transaction, is also similarly defined within the FDCA. As written in 503A, the MOU is intended to address the latter. No mention is made of the former proper and legal dispensing of medications. It does not appear that Congress intended to in any manner limit legal and appropriate interstate dispensing of valid patientspecific compounded preparations, at a minimum,
and possibly through this language acknowledged that office-use sales or distribution is what is actually to be addressed. These three points of law will no doubt form the basis of any legal challenge to the MOU and where the line is between federal authority over mail-order prescription services. THE 2015 DRAFT MEMORANDUM OF UNDERSTANDING The FDA distributed a draft MOU on February 13, 2015 and then subsequently filed that document with the Federal Register on February 18, 2015. The public – including all health care stakeholders, regulatory agencies, consumers – are invited to review and submit comments on the draft no later than June 18, 2015 through the regulations.gov website. As proposed, the MOU goes far further than the language enacted by Congress, imposing substantial actions by state regulatory agencies that agree to sign the MOU. It’s important to understand that until those comments are reviewed and considered by the FDA, the MOU still does not officially exist. A revised draft may be offered for additional comment. A revised draft may go directly to the states for signing. The original draft, without any changes to content regardless of the comments submitted, may be presented to the states for signing. What’s contained in the draft? REQUIRING STATE OVERSIGHT In the draft of the MOU, if a State enters into an MOU with FDA, the State where the pharmacist, pharmacy, or physician is located must investigate complaints received regarding compounded medications distributed outside the State. Complaints that the State must investigate include adverse drug experiences or product quality issues that could lead to public health risks: • An adverse drug experience can include an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action. • A product quality issue can include any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article; any bacteriological contaminations; any significant chemical, physical, or other change or deterioration in the distributed drug product; or any failure of one of more distributed batches of the drug product to meet the applicable specifications. Contamination including mold, fungal, bacterial or particulate contamination is a product quality issue. The State investigation must include a determination of whether there is a potential public health risk or safety concern associated with the compounded medication and confirmation that any risk or safety concern is adequately contained. If a complaint is found to be valid, the State must take action to require the pharmacy
Spring 2015 | IACPRx.org/Publications
Congress removed the unconstitutional clause that had resulted in the original court challenge and reaffirmed the remaining language of 503A. For the first time since 2002, section 503A was the law throughout the country and work started again to develop the template for the MOU. Released formally for initial public comment on February 18, 2015, the MOU is still “a work in progress.” WHAT DOES THE LAW SAY Before examining the draft language of the proposed “new” MOU, it’s important to look closely at what the language of 503A says. • There’s no prohibition on interstate distribution. The first part of the 503A language requires that an MOU be put in place that addresses the interstate distribution of compounded preparations. It does not say prohibits or prevents or any other language that would disallow such an act by a traditional compounder. Just that this issue must be “addressed” in the MOU. Nothing in the language mandates that the FDA be involved, or reported to by a state agency, or anything other than the MOU has to in some manner deal with interstate shipments. • It specifically cites the term “inordinate amounts”. The MOU is intended to address (not prevent or prohibit) an undefined and nebulous quantity of compounded medication deemed “inordinate.”
THE MOU PROVISIONS IN §503A OF THE FOOD, DRUG, AND COSMETICS ACT (B) such drug product is compounded in a State– (i) that has entered into a memorandum of understanding with the Secretary which addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or (ii) that has not entered into the memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician. The Secretary shall, in consultation with the National Association of Boards of Pharmacy, develop a standard memorandum of understanding for use by the States in complying with subparagraph (B)(i).
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THE MEMORANDUM OF UNDERSTANDING
What It is, What It Says, And What Happens Next by David G. Miller, R.Ph., Executive Vice President & CEO
In 1997, the Food and Drug Administration Modernization Act (FDAMA) was enacted by Congress. In addition to addressing ways to streamline the drug approval process for branded medications, it also included the first language providing for federal oversight over compounding pharmacy practice. We short-hand reference that language as 503A to designate its section appearance within the Food, Drug, and Cosmetics Act (FDCA). In order to be exempted from specific requirements for the marketing of “new drugs” – which compounds are considered to be by the FDA – pharmacists and physicians must comply with several sections. This includes the use of bulk ingredients, the preparation of “copies” of commercially available medications, and the monitoring of interstate distribution through a memorandum of understanding (MOU). The MOU language of FDAMA’s 503A provided for three things. First, a template would be developed by the FDA and the National Associations of Boards of Pharmacy (NABP) for the states to use. Second, that the MOU would address “inordinate amounts” of compounded drug products. Third, that a state agency would be responsible for investigating complaints about compounds sent in interstate commerce. Fourth, that in the absence of an executed MOU, a traditional compounder – defined as both a physician
and a pharmacist – would be automatically limited to distributing no more than five (5) percent of their compounds out-of-state. Shortly after FDAMA was enacted and before many of the provisions of 503A could be put into place, it was challenged in court, because of language that prevented advertising, marketing or even discussions about compounded medications between physicians and pharmacists.” In a landmark Supreme Court ruling that section of 503A was deemed an unconstitutional restriction of free speech in 2002 (Thompson, et.al. v. Western States Medical Center et. al.). The Court decided the case based upon an appeal by the Department of Health and Human Services that originated within the Ninth Circuit where 503A was essentially nullified in its entirety throughout the states of California, Washington, Oregon, Alaska, Hawaii, Arizona, Idaho, Montana, and Nevada. Even though, a draft MOU had been circulated to States in the late 1990’s, the existence of the Western States challenge essentially put all further work on hold. The case was decided, and so many states were no longer required to engage in a discussion of an MOU with the FDA. As a result, all work on developing, negotiating, and instituting the FDAMA MOU stopped. That remained the case until the enactment of the Drug Quality and Security Act of 2013. In passing DQSA,
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“NECC came as a complete shock to us,” said David Ball, President of the firm. “In our many years of working with the pharmacy profession, we saw the healing, helpful work of compounding pharmacists. Now here was a situation that didn’t just contain one element of a crisis, it had virtually all of them: alleged violations of federal and state law; cover-ups and obstructed investigations; patient injuries and deaths; and investigators, prosecutors, and former employees ready to talk about the wanton disregard for professional standards and horrific safety violations that occurred there.” “We could not let the actions of NECC define this profession,” Ball said. “We put in place a strategy that maintained open lines of communications, provided journalists with essential information, and we made clear with our messaging that NECC in no way represented what this industry is about; that NECC, according to the government, was an illegal manufacturer disguised as a compounding pharmacy to evade public oversight.” “We also needed to remember at every turn,” Ball said, “that this was a national tragedy that took the lives of 64 good people – mothers, fathers, sisters, brothers – and that sickened almost 700. While the profession at large and its association were not to blame, we had to be very sensitive in everything that we said and did. The level of
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human suffering, not only by the victims but among the families that depended on them, was immense.” The strategy enabled IACP to get a handle on the situation and ultimately prevented that feared backlash. While Congress did ultimately enact the Drug Quality and Security Act, the law identified a continued vital role for compounding pharmacy – a vast improvement over earlier dialogue around eliminating the practice of sterile compounding pharmacy altogether. With the crisis under control, a second phase of the strategy involved a media tour that enabled IACP to educate the media and the public about the continued need for compounding and that emphasized the high quality work and rigorous standards currently in place. One-on-one meetings were conducted with journalists from Boston, New York, Washington, D.C., and Los Angeles, and everywhere in between. IACP and its members have emerged from the cloud created by one rogue enterprise. The organization has taken a position at the forefront of Congressional dialogue over the implementation of the Drug Quality and Security Act, and the profession continues to enjoy significant growth.
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E D U C A T I N G
A D V O C A T I N G
N E T W O R K I N G
J U N E 6 - 9 , 2 0 15 ~ WAS H I N GT O N , D C
R E N A I SSA N C E WAS H I N GT O N , D C To register for CCH, visit
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Š2014 International Academy of Compounding Pharmacists (IACP). All rights reserved.
pharmacy because it will enable your business to grow. Its value in a crisis multiplies. The right database can have a huge impact if you need to contact all customers or implement a recall. Making sure that data is backed up in a safe, accessible, off-site location is key. 4. Evaluate Your Insurance—How much is enough insurance for a compounding pharmacy? Whatever your answer is, it likely needs to be doubled or tripled. An independent insurance expert should review your business and its needs and make recommendations about the right level of coverage. Before filing an insurance claim, a public insurance adjuster can provide the expertise you need to ensure fairness in the claims process. 5. Have Your Experts on Hand—Now is the time to build professional relationships that can be a lifeline in a crisis. If you are a compounding pharmacy and your only attorney is the real estate lawyer who reviews your lease or the labor attorney who writes your offer letters, establish a relationship with an attorney that has the regulatory experience needed to successfully interact with the federal and state agencies that would be involved in a crisis. Identify a public relations practitioner who has crisis management capabilities – if you engage them to develop a crisis plan there will be no ramp-up time in a crisis.
6. Keep the Lines of Communication Open with Patients and Providers—Many organizations in crisis forget how important it is to keep customers informed during a crisis. Your website and social media sites are excellent vehicles for keeping the public apprised of your challenges and how you are dealing with them. In our experience, loyalty will be retained as long as the pharmacy keeps in contact with its key constituents. This is a new age for compounding pharmacies. The public demands the highest level of quality and compounders are providing it. Still, things can go wrong. Often, they will be things over which you have no control. So give yourself some control. It is essential to be prepared for whatever may come your way. If you are ready, you will likely weather the storm.
David A. Ball is President of Ball Consulting Group, LLC, a public relations and crisis management firm that serves the compounding pharmacy profession.
How PR Can Have an Impact In much the same way that a slow drip from the hot water heater can quickly evolve into a ruptured tank and a basement with six feet of water, the New England Compounding Center (NECC) crisis began in Fall of 2012 with one or two isolated calls to IACP from reporters wanting to learn more about compounding pharmacies. It seemed that there was a meningitis outbreak relating to a large compounding facility west of Boston and that there were now patient deaths being reported. Those early media calls led to a tidal wave of international media interest, as hundreds of patients took ill, and deaths began to be reported by the CDC seemingly every day. As details emerged about unsafe practices at NECC and a lack of government oversight, journalists were demanding answers, soon to be followed by members of Congress. IACP’s objective was clear: to educate the public about the compounding pharmacy profession and to demonstrate that the practices of NECC were in no way representative of the profession. A backlash that could have prevented patients from getting their medications and potentially put compounding pharmacists across the country out of business had to be stopped. The volume of media calls for an association with a lean staff was overwhelming. CNN, Reuters, CBS, NBC, ABC, Associated Press, The New York Times, The Washington Post, The Wall Street Journal and hundreds of other
outlets all wanted access and answers. They were waiting for the profession to say something. The risk of being unresponsive in a crisis like that is a loss of credibility among media and the members. Journalists remember not getting their calls returned and to do so would limit IACP’s future access to the media. Moreover, if the message could not be perfected and provided, the entire profession would be under an assault that would have deep and farlasting consequences. A black mark would forever be associated with the practice of compounding pharmacy. “For those who lead associations, you often have an intuitive feel about when an event is so extraordinary that outside help is urgently needed,” said IACP EVP & CEO David G. Miller, RPh. “We needed help, our members needed help, and we activated a plan to bring in the resources that we needed to gain control over the situation.” IACP engaged Ball Consulting Group, LLC, a public relations and crisis communications firm in the Boston area that had experience in, and familiarity with, compounding pharmacy issues. The firm came up with a strategy for dealing with the crisis. It developed messages, issued statements, prepared IACP leaders for media interviews, and ensured that every media call would get a response. Continued on page 9
IACPRx.org/Publications | Spring 2015
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SIX THINGS I HAVE LEARNED FROM COMPOUNDING PHARMACY CRISES by David A. Ball
Our firm has worked with compounding pharmacies across the country in dealing with a multitude of crises, including patient deaths, product contamination, recalls, FDA warning letters, state board of pharmacy ceaseand-desist orders, indictments, and civil actions. We believe strongly in the mission of compounding pharmacies because their work is vital, and they sustain and save lives. Since the New England Compounding Center tragedy in 2012, this profession has been under attack in a way experienced by few others. Compounding pharmacies today operate in one of the most highly regulated environments, and they are subject to review, inspection, and scrutiny like few other organizations. At the first hint of an issue with the quality of a product, a cascade of events begins that could result in a pharmacy’s temporary or permanent closure. Sometimes the outcome is worse, and a pharmacist can be charged with a crime or personally sued. All businesses have inherent risks, such as larceny, fire, and flood, and pharmacies must manage against those risks. The risks that are specific to compounding pharmacies add an entirely separate and new layer of complexity. In thinking back to all of the pharmacies that we have been honored to help deal with a crisis, there are six clear lessons.
1. Putting Potential Crises Out of Mind is Not A Strategy—Nobody ever wants to think the unthinkable will happen to them. The odds are, however, that a compounding pharmacy will be confronted with a crisis because there are simply so many things that can go wrong. It is imperative for compounding pharmacy owners to think through the scenarios and how they would deal with them, and to have a crisis plan that is regularly updated on which staff are briefed and frequently drilled. 2. Budget for a Crisis—The one thing you will need above all else in a crisis is money. The experts to guide you, including clinical consultants, lawyers, recall specialists, and public relations practitioners, will be costly. If you need to lease satellite space, put a modular lab in place, or make emergency repairs, the costs will be even greater. Lastly, in most cases, once a crisis begins, the revenue stops. Either because a regulatory agency has shut the pharmacy down or because of a loss of customer confidence. Either way, you will need funds to get by and to take care of loyal staff. Every pharmacy should have a significant financial reserve and have access to a credit line. Don’t wait for a crisis to apply for a credit line, because you likely won’t get one. Have a credit facility in place. 3. IT is the Backbone of Your Business—Data is king, and having access to it in a crisis is essential. IT investment should be a priority for your compounding
Spring 2015 | IACPRx.org/Publications
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Join PPP at www.PrescriptionPartnership.com, today!
Š2014 Partnership for Personalized Prescriptions. All rights reserved
A NOTE FROM THE PRESIDENT Compounders on Capitol Hill is just around the corner. If you have not yet made plans to attend, I would like to offer my top ten reasons you should sign up NOW: 10. D iscounted Travel – get discounted travel by visiting IACPRx.org/CCH and click on meeting discounts. 9. We’re Back in DC – IACP has moved Compounders on Capitol Hill back to Washington D.C.! 8. Get Away from the store to get re-energized and spend some time in our nation’s Capitol, and possibly consider bringing the family for some sight-seeing. 7. The Rx Mixer – a fun-filled night of casino games, music, dancing and live auctions to raise funds for the IACP Foundation. One highlight each year is the excitement created by Bob Brensel at the craps table. 6. Networking – an opportunity to network with some of the brightest minds in the compounding industry. Don’t forget those business cards! 5. Exhibit Hall – Did you know that IACP as more than 70 Corporate Partners? These are vendors offering every service imaginable for compounding pharmacy. This is your opportunity to stay abreast of the new services and innovations in compounding. 4. Continuing Education Credits – The opportunity to catch up on live C.E. 3. Legislative and Regulatory Updates – Learn the latest in Federal and State proposed and adopted legislation that affects our ability to provide compounding services to our patients. 2. Litigation Updates – No getting around the fact that there is always ongoing or pending litigation in our industry. 1. Visit With Your Elected Officials – This is always the number one reason IACP conducts this annual event. I can’t overestimate the importance of developing relationships with your elected representatives and their staff persons. I have found that developing a relationship with a key staff member is just as important as the relationship with the Representative or Senator. The health policy advisor for one of my Senators was in constant contact with me when legislation was being drafted, and later became the Drug Quality and Security Act. This person was so interested in knowing more about the compounding industry that he scheduled a visit at my pharmacy. Did we eventually get what we wanted? NO. But we were part of the process, and we developed relationships that will help in any future legislation. Please, if you do plan on attending CCH this year, stay for Hill Day on Tuesday, because, in the final analysis, that is THE reason we go to Washington each year.
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Spring 2015 | IACPRx.org/Publications
IACP STAFF David G. Miller, R.Ph. Cynthia E. Blankenship, Esq. Dagmar Anderson Scot Maitland Jennifer L. Petska, CPhT
Contents 4 6
A NOTE FROM THE PRESIDENT SIX THINGS I HAVE LEARNED FROM COMPOUNDING PHARMACY CRISES by David A. Ball
Ashlyn Grant Michelle McMahan Macy Pruitt
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Teresa Roberts
THE MEMORANDUM OF UNDERSTANDING What It is, What It Says, And What Happens Next by David G. Miller, R.Ph., Executive Vice President & CEO
COMMUNICATION COMMITTEE Richard B. Moon, Pharm.D., R.Ph., FIACP, Chair Lisa Ashworth, BS, Pharm.D., R.Ph.
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Kim Hansen, R.Ph. Robert Harshbarger, III, Pharm.D. James Matthias, CPhT Linda McElhiney, Pharm.D., R.Ph., FIACP, FASHP Lauren Onsa, BA Andy Ruiz, Pharm.D., MSc, FACA Scott Wepfer, R.Ph., FIACP
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THE MOU – A PHARMACIST’S PERSPECTIVE by Scott Karolchyk, MS, RPh, FIACP
PERSONALITY OF PERSONALIZED CARE: LOREN MADDEN KIRK by Scot Maitland
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IACP FOUNDATION HISTORY PART 1 2015 by Lisa D. Ashworth, BS Pharm, RPh
SAVE THE DATE FOR THESE UPCOMING PROGRAMS
PHOTOGRAPHY Melea Kirk Scot Maitland DESIGN Dianne Stone
IACPRx.org/Publications Compounding Matters Quarterly is published four times per year as Spring, Summer, Fall, and Winter. Compounding Matters Quarterly makes all attempts to publish accurate information; however, this publication may contain technical inaccuracies or typographical errors. The reader assumes all risk concerning the suitability and accuracy of the information within this publication. Compounding Matters Quarterly assumes no responsibility for and disclaims all liability for any such inaccuracies, errors or omissions in this publication and in other documents referred to within or affiliated with this publication.
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