Pharmacy Edge

Pharmacy Edge Magazin

Issue

Seventeen

e

December/2017 - January 2018

Darshan Kulkarni Pharm.D, MS, Esq.

Dr. Zubin Damania MD

The Dynamics of Independent Pharmacy Ownership Price Hikes Insulate Celgene From a Failure

Pharmacy Edge 2017

Contents - December 2017

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A message from Founder

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A message from our President

08

Zubin Damania MD

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Darshan Kulkarni

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Put Data to Work! Addressing the Opioid Epidemic

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The Dynamics of Independent Pharmacy Ownership

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Pharmacy Benefits Manager

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Engaging Patients in Research: PCORI Triggering a Culture Shift

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Price Hikes Insulate Celgene From a Failure

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Specialty

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US P <800>: The Why, What, Who and How to Compliance

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Opioid Crisis

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Pharmacy Edge 2017

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Pharmacy Edge 2017

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Pharmacy Edge 2017

Brandon Welch

A message from our President As the new President of APPA, I am humbled and honored to have the opportunity to build on a phenomenal foundation we have here at the American Pharmacy Purchasing Alliance.

We have built up a strong alliance over the years and my vision is to continue to push it forward. Not only has our membership grown exponentially since our initiation in 2014, but we have also expanded our relationships with key stakeholders in the pharmaceutical industry. This has all resulted into a stronger presence in our industry and more value to our members.

First off, we want to truly thank AmerisourceBergen and their welcoming staff for inviting us to attend “ThoughtSpot 2017”. ThoughtSpot, is an annual conference and trade show by Good Neighbor Pharmacy that offers independent community pharmacies practical and clinical education to help you diversify your revenue streams and optimize your core business.

ThoughtSpot turned out to be another opening success with great pharmacy advocacy meetings and clinical education forums. I was delighted to be able to take this information and share this with you all. I hold myself accountable for keeping this organization abreast of the new changes and challenges we face in our industry, so we know how to successfully position ourselves and become adaptable. We must keep up the great fight and continue to show our value in the market place of healthcare. Let’s continue to emerge in the healthcare ecosystem.

I believe we are at a critical juncture to advance our services by recruiting more diverse audiences. Our world’s changing demographics, demand for greater flexibility, and advancing technology are factors that play a key role

in today’s Industry. Our members need us now more than ever. Our values are built on advocacy, education, networking, purchasing solutions, and being able to adapt to the ever changing needs of our members.

2016 year was an exciting time for APPA as we continued to build on work that began in the previous year. We finally completed the development of our strategic plan. This will help guide the alliance over the next five years.

The plan includes specific action items that will support the achievement of our strategic priorities. Our three strategic plans include the following: »» Operational Practices for the Alliance: APPA is committed to the principles and practices of sustainability in its management and operational strategies. The Alliance listens to and consults with its members to be sure that actions are in line with the needs of its members. This way, we could simultaneously work on advancing the organization toward a shared vision in changing times. »» Professional development: APPA offers timely professional development opportunities for continuing education and learning through webinars, meetings, seminars and industry partners. It also fosters the development of leadership within the student pharmacist community. »» Partnerships: APPA engages with educational partners who provide learning opportunities for APPA. In the 2017 - 2018 year, our work as an association will focus on the following five priorities that support strategic directions: »» Advocacy – finding ways to inform and educate policy and de-

»»

»» »»

»»

cision makers on the importance of provider status to better serve the pharmacy community Communities of Practice – supporting and expanding our communities of practice to serve the many constituents working in the field of continuing education Benchmarking – collecting and disseminating meaningful data to our members Conference Model – re-imagining the conference model to leverage expertise and build capacity through our strategic partnerships.

Relationship building – Expand our network to provide more services and discounts for our members

These accomplishments could not have been possible without the continued service of our valued members, leadership team, advisory board, and sponsors. I would like to give them all a heartfelt thank you for all of their hard-working efforts in striving to make this organization the best it can be.

I also want to give a special thanks to our Gold Sponsor, Republic Pharmaceuticals for the immense amount of support you have given APPA. We have received nothing but great compliments on the services you offer.

Republic Pharmaceuticals is a wholesale distributer of generic pharmaceuticals and medical supplies to pharmacies, hospitals, and physician’s offices throughout the United States.

Our collective work is an important part of the social fabric of our great nation. This is an exciting time to be part of the field of pharmacy, and I look forward to another prosperous year for APPA!

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Pharmacy Edge 2017

Zubin Damania MD 8

Zubin Damania MD is an internist and founder of Turntable Health, an innovative healthcare startup that was part of an ambitious urban revitalization movement in Las Vegas spearheaded by Zappos.com CEO Tony Hsieh. During a decade-long hospitalist career at Stanford, Dr. Damania won clinical teaching awards while simultaneously maintaining a shadow career performing stand-up comedy for medical audiences worldwide. His videos and live shows, created under the pseudonym ZDoggMD, have gone epidemically viral with over a quarter billion views on Facebook and YouTube, educating patients and providers while mercilessly satirizing our dysfunctional healthcare system.

Pharmacy Edge 2017

Darshan Kulkarni,

Pharm.D, MS, Esq.

THE KULKARNI LAW FIRM

Dr. Kulkarni is the Principal Attorney at the Kulkarni Law Firm. He provides regulatory and legal advice to pharmacies and other FDA regulated entities and their service providers and focuses on the intersection of pharmacy and FDA related issues.

He has worked as a pharmacist for more than 14 years in multiple capacities, including hospitals, retail pharmacies, managed care, and has even participated as a clinician in clinical trials.

Dr. Kulkarni is regularly quoted in numerous national and international magazines on life sciences related matters and serves in the American Bar Association in various Interest Groups including the Healthcare Fraud and Compliance section and the Life Sciences Interest Group.

Dr. Kulkarni has taught at and for a variety of schools including Johns Hopkins University, Thomas Jefferson University Medical School, Drexel University School of Chemical Engineering, Temple Law School etc.

He is currently the Visiting Professor and teaches in both the Biomedical Writing Program and the MBA program at the University of the Sciences where he won the 2014 Outstanding Adjunct Professor award.

Dr. Kulkarni has written numerous articles and textbooks including chapters on pharmacy compounding, for the 2nd edition and the upcoming 3rd edition of the American Bar Association’s Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing Dr. Kulkarni is featured on the Gavel and Pestle on the pharmacypodcast and has even been a been a blogger for pharmacy times. He currently serves on various Editorial Advisory Boards and was voted in the Top 50 of the #Pharma100 for 2012 and 2013.

He can be contacted at Darshan@conformlaw.com.

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Pharmacy Edge 2017

Put Data to Work!

Addressing the Opioid Epidemic

It is safe to say that I am a numbers person. I enjoy utilizing and crunching numbers, visualizing trends, and trying to predict what would happen based on an available subset of information. Depending on the type of data collected and analyzed, I am able to build and translate stories that can be described as a complete novel, or just chapters within the book.

One such story currently broken out into pieces is the opioid epidemic in the U.S. Recently, it has been declared a public health emergency by the current presidential administration. While it remains to be debated how much of our time and resources are needed to effectively tackle the issue, it is important to realize the role prescription opioids have on the epidemic, and how analytics can help tackle the problem.

From 1999 to 2010, the number of overdose deaths due to opioids has quadrupled. Even more concerning is that half of all deaths involve a prescription opioid. These medications

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accounted for 15,000 overdose deaths in 2015 alone. Of the available medications, the one’s most commonly involved in overdose deaths include methadone, oxycodone, and hydrocodone. Addressing this problem will require solutions from multiple fronts.

Analytics is a hot topic in healthcare, with buzz words like, “big data” and “artificial intelligence” making their rounds through several organizations.

These tools can be used to generate insight towards understanding what makes a patient at risk of abusing an opioid medication. However, they are only as valuable as the data being fed into their system. For example, the prescription drug monitoring program (PDMP) has been successfully used to alter physician prescribing habits, as well as help law enforcement shut down pill-mill pharmacies and candy doctors. In other words, it has been effective on a large-scale level. However, it falls short of giving insight that is valuable at the patient-provider level.

What we are aiming for is analytics on a scale that will have an impact on the way we “see” patients.

Previous medication, disease, and social history can be used to help gain insight into the story of each particular patient. Having access to the prescribing patterns of providers in various domains of the healthcare sector can help determine what the best possible outcome would be for a patient with a particular type of pain, and furthermore, asking what was done to achieve that outcome.

Another use of analytics in combatting the opioid epidemic is that it can help us plan where we want our resources to go into addressing this problem. We can put resources into curbing access to illegal street drugs, improving emergency room work flow, and providing education to providers, patients, and communities, but each of these solutions have “side effects” associated with them. For example, while reducing the number of prescribed opioids has without a doubt played a role in helping address the root problem, there has been an increase in individuals turning to street drugs. Analytics can help us see the effects of our policies, and define our desired goals.

Several challenges exist that should temper expectations. The most glaring is the trove of silos that the needed data sit in. Our data is currently located in the PDMPs of states with varying levels of reporting requirements, inside the several different electronic health records in both in-

Pharmacy Edge 2017

patient and outpatient settings, as well as pharmacy claims data. More importantly, these silos of information need to be interoperable so that it can get to where it needs to go in a reasonable period of time, as patients may move faster than our healthcare systems can keep up.

chain technology. This technology has made its headlines because it solved the main problem with cryptocurrency, but its potential as a way of maintaining a comprehensive record of patients’ health history is promising.

Once data is able to flow across the healthcare ecosystem, reports and analytics will need to be automated so they can be easily incorporated into provider workflow, allowing them spend their time applying these insights into their practices instead of working on the data itself.

Addressing the issue of data interoperability has been around the moment electronic health records were created. Several iterations of solutions have popped up over the years, but one of the more intriguing options to keep an eye on is block-

At the end of the day, the most important thing regarding the opioid epidemic is that we approach it from many different angles and perspectives to develop a comprehensive plan to tackle it. These plans must help our providers improve their practices and patient outcomes, but also help make sure that we do not turn away patients that do need opioids for their pain. Data-driven approaches can help shed light on the story behind the individual, and it is the painting of this story that we can use to address a growing problem in the country.

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Pharmacy Edge 2017

The Dynamics of Independent Pharmacy Ownership The concept of independent pharmacies uniting to form one larger entity is one that has drawn quite some interest over recent years.

The landscape of retail pharmacy has evolved over the years with the incorporation of larger retail magnets such as CVS and Walgreens.

The benefit of having a larger presence in the market are tremendous.

The benefits include that of having greater purchasing power, assisting with advertising costs, and condensing of owner responsibilities to a more feasible amount.

Benzer pharmacy opened the doors to their first pharmacy in 2009 in Flint Michigan with now having grown to greater than 65 locations.

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The purchasing of product is one of the most vital components of getting a pharmacy up and running.

The lack of ability to buy in bulk comes at a cost for owners of pharmacies. This basically allows for less ability to negotiate costs with manufacturers and other entities within the supply chain. As of 2010, their is an estimate of 24,000 independent pharmacies compared to a combined total of 18,000 CVS and Walgreens pharmacies. If 10% of these

independent pharmacies changed their name to unite under single entity, then they would have purchasing power of 2,400 pharmacies.

A few of the independent pharmacy franchises available on the market today are the Medicine Shoppe, Health Mart, and Benzer pharmacy.

The Medicine Shoppe Pharmacy’s selling point is that it is the largest pharmacy franchise system that has been built over 35 years in the industry. It has a liquid capital requirement of $100,000 and a total investment ranging from $115,800$954,900. Health Mart has over 3,000 franchises throughout the country with the details of the startup costs associated with a Health Mart franchise is available through McKesson via their website. Benzer pharmacy opened the doors to their first pharmacy in 2009 in Flint Michigan with now having grown to greater than 65 locations. Great insight can be found on Benzer pharmacy’s website with respect to it’s startup process.

Pharmacy Edge 2017

Advertising is another major component of operating a viable pharmacy. The amount of money that it takes to advertise on entire billboards or sponsoring an athletic team will not be a true option for the majority of independent pharmacy owners. However, if combining the resources with that of 2,400

pharmacies would make it much easier to get the necessary capital together to advertise by the aforementioned means. The number of hats that an independent pharmacy owner is more than one could imagine a single person can handle. The responsi-

bilities include that of marketer, accountant, HR, and trainer just name some of the matters that an independent pharmacy owner would have to manage. Using the leverage of a larger company would provide owners an opportunity that may be too good to pass up.

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Pharmacy Edge 2017

Pharmacy Benefits Manager Looking 5 years forward, the Pharmacy Benefits Manager (PBMS) industry is expected to grow. Why is this? The number of new generic medications entering into the market is expected to slow down, due to these blockbuster drugs loosening their patent exclusivity; diminishing industry revenue. Pharmacy Benefits Managers are known for negotiating lower prices for generic drugs, which helps increase profitability. Moreover, viewing this industry from an economical standpoint, we will see more growth in public and private healthcare insurances, decrease in unemployment rates, and more consumers covered under a prescription drug plan. The Patient Protection and Affordable Care Act (PPACA) is expected to keep expanding over the next five years. Penalties for uninsured consumers will force new consumers into the marketplace.

In 2015, the penalty for being uninsured increased by 1% and nearly doubled in 2016 and will be adjusted for inflation thereafter.

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New regulations will require PBMs to disclose more information on discounts and rebates from pharmaceutical manufacturers, forcing PBMs to become more transparent.

While the industry is consolidating, it enables Pharmacy Benefits Managers to have the leverage required to secure low-cost drugs from Pharmaceutical Manufacturing companies.

Major players have aggressively started acquiring smaller companies in an attempt to increase their retail pharmacy network, bargaining power with drug manufacturers and customer base.

Pharmacy Benefits Managers that offer mail-ordering services will begin to see the strongest growth.

This is because of their lower cost on prescription medications they can offer, from selling direct to consumers at a lower operating cost. This is something we’re starting to see more often in the retail setting. More patients are being automatically switched over to mail order pharmacy.

Industry profitability is predicted to continue its upward trend over the next couple of years. We will begin to see more specialty medications and biologic therapy. The PPACA will expand consumer access to lowercost generic drugs by preventing brand-name manufacturers from making label changes to the brand name or listed drugs; delaying generic products.

Patents for a remarkable number of blockbuster drugs started to expire in 2011 and continued this “patent-cliff” into 2016. The majority of these therapies are considered small molecule drugs and used to treat common conditions that affect a great size of the population. This “patent cliff” has started forcing more pharmaceutical companies to pivot their focus on developing large molecule biologic drugs, which are used to treat rare conditions (also called “orphan” medications) that affect a smaller

Pharmacy Edge 2017

size of the population. Biologics benefit from a 12-year patent period to justify its investment into innovative treatment. This becomes more advantageous, as you compare this to smaller molecule therapies like your blockbuster drugs, that have only a 5-year patent period. Thus, the PPACA will assist to accelerate generic approval for these generic alternatives, or biosimilars, to biologics--which are very costly drugs on the market.

Typically, Pharmacy Benefits Managers benefit from lower cost of

generics because of their ability to negotiate stronger discounts. The steady drop in the number of new generics into the marketplace will impel growth in industry profitability. We will see Pharmacy Benefits Managers likely to witness stronger pressure to pass on cost savings to more consumers. Greater regulatory scrutiny is expected to expand compliance costs for PBMâ&#x20AC;&#x2122;s. New regulations will require PBMs to disclose more information on discounts and rebates from pharmaceutical manufacturers, forcing PBMs to become more transparent.

Major companies with most Marketshare 1. CVS Health Corporation 2. Express Scripts Holding Company 3. United Health Group, Inc. 4. Aetna Inc. 5. CIGNA Corporation

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Pharmacy Edge 2017

Engaging Patients in Research: PCORI Triggering a Culture Shift.

PCORI is a nonprofit organization established by the U.S. Congress in 2010.

PCORI is leading a research culture shift from the patients being involved only as subjects, to a collaborative approach, known as Patient-Centered Outcomes Research, or PCOR. Studies that receive funding from PCORI follows the following principles: »» The research topics, questions and outcomes most important to patients and those who care for them. »» A variety of healthcare stakeholders are involved– including patients, caregivers, clinicians, scientists, health systems and insurers. »» Requires patients to be engaged as partners, involved in determining what to study and how.

Meet “Research Done Differently”, introducing PCORI.

By Matthew Szasz, PharmD.

Author Bio: Matthew is a Pharmacist and PCORI Ambassador with a passion for healthcare analytics and patient-centered care.

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The Patient-Centered Outcomes Research Institute, or PCORI for short, has changed the landscape of what it means to be patient-centered. Healthcare providers today often understand that when patients are actively engaged in their healthcare, optimal individual outcomes are likely. This engagement, through open communication between provider, and patient is essential for optimal care in many scopes of practice.

In the last seven years since PCORI was founded, the U.S. Food and Drug Administration established an engagement advisory committee, and Geisinger Health System has adjusted their research process to involve more patient engagement. PCORI’s leadership with defining what it means for research to be patient-centered is progressively improving the information available for future healthcare practice guidelines and patient communities.

Pharmacy Edge 2017

CSI Specialty Group Named One of Consulting Magazine’s Fastest Growing Firms for 2017 SANFORD, Fla. (November 3, 2017) – CSI Specialty Group has once again been awarded the coveted distinction of being named one of Consulting Magazine’s Fastest Growing Firms, ranking no. 8 out of 50 award recipients.

The Fastest Growing Firms list recognizes the consulting industry’s elite movers and shakers of all organizational sizes, through all sectors in the United States. To qualify for the award, consulting firms must be privately or publicly-held and have achieved a minimum of $2 million in revenue in 2016.

“Winning this award a second time in just three years is a testament to the synergy our team develops with

each and every client we’re honored to serve. Every day I’m privileged to watch the magic unfold, whether it’s building a health system’s specialty pharmacy to expand patient services or helping a pharmaceutical manufacturer launch a rare, orphan drug, we’re excited to be at the pinnacle of the tremendous innovations taking place across the healthcare landscape today,” says Suzette DiMascio, CHE, CMCE, CPC, President and CEO of CSI Specialty Group. “Every day our team collaborates to align our services to impact and improve the patient journey for the clients we serve.

If the patient is always at the forefront of the solutions we help clients implement, the growth and accolades will take care of themselves.”

Based on client requests, CSI Specialty Group expanded their offerings last year to include more solutions for the pharmaceutical industry to complement their existing specialty pharmacy focused practice.

About CSI Specialty Group CSI Specialty Group is a globally recognized; WBE Certified Leadership Consulting Firm helping clients drive sustainable, accelerated growth. CSI is on the forefront of pioneering inventive consulting, workforce planning & talent acquisition solutions that are uniquely tailored to meet the needs of specialty pharmacy, home infusion, mail order/PBM, health systems and pharma/biotech clients across the USA and throughout Europe.

For more information about CSI Specialty Group, visit our website at www.CSIgroup.net

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Pharmacy Edge 2017

Price Hikes Insulate Celgene From a Failure A gap caused by a late-stage trial failure may be bridged by rising prices on the company’s top-selling medicine.

By: Todd Campbell, The Motley Fool

After independent monitors concluded a phase 3 trial of GED-301 in Crohn’s disease was a failure, Celgene (NASDAQ: CELG) shelved its plans to develop this drug for use in that billion-dollar indication. The setback is bruising for the company because management spent $710 million upfront to license it just three years ago. The failure forces Celgene to write down hundreds of millions of dollars and it eliminates a drug that could’ve added a billion dollars or more in annual sales.

Overcoming the headwinds associated with GED-301’s failure pressures Celgene to succeed in its efforts to boost demand for its existing drugs and develop new drugs, but drug development isn’t the only way Celgene will close the gap created by GED-301. Drug price increases will also help make up the difference.

Riding coattails Celgene’s track record for discovering and commercializing blockbuster medicine is envy-inspiring, but Revlimid is by and far its biggest success.

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Initially approved in 2006 for use in multiple myeloma patients who have failed at least one prior therapy, Revlimid’s label has since expanded to include its use in the first-line multiple myeloma setting and as a maintenance therapy for multiple myeloma patients.

Revlimid’s efficacy has made it the most commonly prescribed first- and second-line drug in the indication, and a growing addressable market because of label expansions has helped turn it into one of the world’s best-selling medicines. However, it’s not just solid efficacy and a bigger patient pool that’s sent Revlimid revenue soaring.

Price increases have had a lot to do with Revlimid’s revenue growth, too.

According to SunTrust analyst Yatin Suneja, Revlimid’s wholesale acquisition cost (WAC) has almost doubled to $18,546 from $9,853 in 2010. Revlimid’s price has increased steadily over the period, but prices are increasing by an abnormally large amount this year.

After a 9% increase earlier this month, Revlimid’s WAC is 19.8% higher than it was at the start of 2017. For perspective, Revlimid’s average annual price increase was 7.85% between 2010 and 2016. The 9% increase in October follows a 1.8% increase in July and an 8%

increase in January, according to SunTrust’s research.

The following table shows how Revlimid’s price has changed over time.

Year Price Change 2010 $9,853 -2011 $10,445 6.01% 2012 $11,071 5.99% 2013 $11,745 6.09% 2014 $13,140 11.88% 2015 $14,075 7.12% 2016 $15,483 10.00% 2017 $18,546 19.78% Data sources: SunTrust and Wolters Kluwer PriceRx. Prices close the gap Given Revlimid’s selling at an annualized quarterly pace of $8.1 billion exiting the second quarter, the impact of price increases this year on future sales will be substantial because any future increase will be calculated off of a higher base price.

To illustrate just how big of an impact the price increase this year could have on Revlimid’s revenue, let’s consider a couple hypothetical scenarios.

Image source: Getty Images.

Pharmacy Edge 2017

First, let’s imagine that Revlimid’s price increased by the historical average of 7.85% in 2017, 2018, 2019, and 2020. In that scenario, its WAC would grow to $20,948 in 2020, which is 32.7% higher than its WAC exiting 2016. If Revlimid’s 2016 revenue of $6.97 billion grew 32.7%, then Revlimid’s sales would be $9.25 billion following the increases.

its 2016 price. In this scenario, Revlimid’s sales would grow to $10.5 billion, which is $1.25 billion more per year than under the first scenario.

Now, let’s see how price increases impact revenue based on the 19.8% increase this year. If Celgene follows up this year with increases to Revlimid’s price by 7.85% in 2018, 2019, and 2020, respectively, then Revlimid’s WAC will grow to $23,265 in 2020, which is 50.3% higher than

The takeaway Payers negotiate prices based on discounts to the WAC price, so Revlimid’s price increases will translate into revenue tailwinds. The size of these tailwinds depends on the size of future price increases. However, it’s possible that the positive impact on sales will be bigger

In short, leveraging this year’s increase into the future will add billions of dollars to Celgene’s top line over time, arguably closing the gap created by lost sales and write-offs associated with the shuttering of GED-301.

than in my hypothetical scenarios. I held prescription volume constant in my examples, but in reality, prescription volume should climb following Revlimid’s approval as a maintenance treatment earlier this year.

Celgene’s set a goal for itself of $21 billion in sales and $13 per share in earnings in 2020, and reaching or exceeding that goal will depend on a variety of strategies, including label expansions, price increases, and new drug approvals. The optics of price increases are poor, but from an investor’s standpoint, pricing power remains an important tailwind to future growth that helps insulate the company from inevitable setbacks like GED-301.

This The Motley Fool article originally appeared at https://www.fool.com/investing/2017/10/25/price-hikes-insulate-celgene-from-a-failure.aspx.

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Pharmacy Edge 2017

specialty A common theme among these manufacturers is some sort of specialty accreditation. This is often the first step to becoming a Specialty Pharmacy.

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How many times has a patient presented to you a prescription for a “specialty” medication that you are unable to fill? It could be that you are not able to order the medication from your wholesaler. Or worse, the patient’s insurance is mandating a specific pharmacy different than yours. It can be frustrating when a current or prospective customer is coming to you, the pharmacist for a solution to their chronic and sometimes rare, condition.

There is no finite definition for what qualifies as a “specialty” medication.

In general, specialty medications are used to treat chronic or complex conditions and usually require special

handling or administration and close monitoring of the patient. Sometimes, these prescription medications are indicated for rare diseases, which means that the disease affects less than 10,000 people. And they are therefore given “orphan drug status” under the Orphan Drug Act of 1983.

This Act allows for fast-track FDA approval for drugs intended to treat these rare diseases due to limited drugs available on the market.

Some specialty drug manufacturers may limit the number of pharmacies who have access to order their medication. These are deemed “Limited Distribution Drugs,” or LDDs for short.

When attempting to order one of these medications from your wholesaler, you may notice that the drug’s name is not listed in the system. Or it may take you straight to a screen that reads, “due to manufacturer limitations, this product is only available through a limited distribution network” and to contact the manufacturer directly.

Pharmacy Edge 2017

Upon calling the manufacturer, you may find out that in order to gain access to this drug, there are many rigorous requirements to meet first.

It is also worth mentioning that all manufacturers are different and have different specifications that must be met. A common theme among these manufacturers is some sort of specialty accreditation. This is often the first step to becoming a Specialty Pharmacy.

reputable in the field. Both sets of standards set the stage for core activities such as: »» Patient Care »» Coordination of Care and/or Delegation »» Information Management »» Compliance Program »» Quality Management and Continuous Quality Improvement »» Etc.

Achieving accreditation proves a commitment to quality and standards that are becoming the norm in the specialty space. Accrediting bodies such as the Accreditation Commission for Health Care (ACHC) and the Utilization Review Accreditation Commission (URAC) are arguably the most

Accreditation is strongly recommended but could become mandatory by payers in the near future in order to ascertain preferred contracts for reimbursement purposes. The entire process can take up to six months to a year for full accreditation and can be very arduous and labor intensive.

The key is to connect with a professional who has been through the process. Ideally, they should have been able to achieve and has maintained accreditation for some time.

Embarking on a project like this size could be overwhelming and a competent expert can guide you through the process.

There are many resources available though, if you choose to take on a project independently. However, there is a lot of competition out there in specialty pharmacy but accreditation can set you apart from others. Visit www.

ACHC.org or www.URAC.org to learn more about the various programs in accreditation and visit www.HVRSSolutions.com to learn more about guidance through the process.

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Pharmacy Edge 2017

USP <800>

The Why, What, Who and How to Compliance The Delay Last month compounders that handle hazardous drugs (HDs) received a reprieve from the United States Pharmacopeia (USP) (https://www. cdc.gov/niosh/topics/antineoplastic/ pdf/hazardous-drugs-list_2016-161. pdf); an extension of the implementation date for USP chapter <800> to December 1, 2019. The reasoning behind the delay according to USP’s website is, “to align the official date of General Chapter <800> with the official date of the next revision of General Chapter <797>.”

Despite the seemingly good news, if you haven’t already started the process for implementing compliance with the newest chapter I wouldn’t procrastinate any further because the planning, budgeting, construction, and implementation process is time

24

consuming. In this article I’ll be outlining the reasoning behind the chapter’s intent as well as a strategy for implementation. While many articles focus on specifics for compliance, this article will give you our real world experience to quickly get up to speed with USP <800>.

The Why First, let’s get one misconception out of the way. If you’re a retail/community pharmacy and you’re worried about having to purchase engineering controls (hoods and HVAC equipment) and build a cleanroom you have an “out” for complying with USP <800>; it’s written into the chapter on page 2 in Section 2. Simply stated, for dosage forms like tablets and capsules that are intact and will not be further manipulated there is no need to comply with the engineering standards. How-

ever, you do have to perform a risk assessment documenting there is no personnel or environmental exposure while handling the solid dose forms, and of course repeat the risk assessment process every 12 months per the chapter’s requirements.

The risk assessment process may seem intimidating or overwhelming but fear not, we have multiple sources for how to perform one.

I’ve written (https://pharmacyinspection.com/save-500k-hacking-usp/) about this actually and how to easily get this done. Additionally, here’s an article that walks you through the process step by step and only introduces one form for accomplishing the risk assessment: https://learn. nuaire.com/white-papers/hazardous-drug-risk-assessment Why is this USP <800> chapter so important and what makes it more difficult than others to accomplish? The handling of HDs was addressed to some degree in USP <797> but without much direction. The new chapter gives medical personnel a codified way for handling these drugs properly so as not to contaminate ourselves, our work environments, our patients and other products. While many state boards of pharmacy are deciding

Pharmacy Edge 2017

to what extent they will be adopting this newest standard (https://naspa. us/2017/08/usp-800-adoptionsstate/), we would like to suggest the implementation in spite of what your state may decide. While the data for contamination from various HDs is sparse, I contend that exposure to POWDERS specifically, whether they’re “hazardous” or not isn’t healthy because every chemical that we handle has some occupational exposure risk. This point alone specifies the need for Primary Engineering Controls (PECs - commonly referred to as “hoods” - powder containment and/or biological safety cabinets). The takeaway here is that whether your state will enforce or not is irrelevant, it’s my opinion that pharmacies have a duty to protect their personnel to some degree and depending on what dosage form your compounding with (i.e. powders) you should really be using the proper containment protocols.

The What To accomplish what USP <800> is asking us to do, for those of us doing high risk sterile HD compounding especially, it requires us to potentially do some major renovations. We need to turn our rooms themselves (in addition to our PECs) that we compound in from positive pressure to negative pressure. There are numerous ways to accomplish this going by directions from the chapter but essentially what you need to know is that rather than pushing air OUT of our rooms, we’re actually pulling air into them. This is done via the hoods or low air exhausts in an attempt to keep any hazardous material away from the operators handling them and adjacent rooms. The one thing I will caution everyone is that along with air being pulled into these spaces that also means that particles that carry bacteria, fungi and humidity could be pulled into what should be

an extremely clean environment. The one thing I learned from this project is that you should ensure that you have clean air in the adjacent space(s).

Again, this can be accomplished in a number of ways. The really long explanation of how we accomplished this is on my site https://pharmacyinspection.com/dangers-usp-800-cautionary-tale-2/ but to summarize we made sure: 1. We weren’t exhausting TOO much air (pulling too much air into our space) and 2. The air that was being pulled in from adjacent spaces was HEPA filtered. We actually made the area directly outside of our ante room a HEPA filtered environment as well to help clean the air.

Of course there’s more than one way to accomplish this and the next section explains probably the biggest factor in assessing your needs and the best solution for compliance.

The Who When my pharmacy decided to undertake this project back in 2015, I don’t feel like there were many resources for us to turn to. Looking back, we made a whole lot more errors than necessary. Had we done a little more planning in selecting our contractors and consultants we would’ve saved a lot of money and caused us so much less frustration and sleepless nights. The good news for those reading this is two-fold: you can learn from our mistakes and you have more time.

How should you go about determining who to use? Interview. Ask for references, call those references. Ask other pharmacies around you and if the cleanroom builder operates nationwide call somewhere far. I really

like the International Journal of Pharmaceutical Compounding’s (IJPC) listserv for asking questions like this.

Social media sites like LinkedIn may be of benefit too, but let me give additional caution because there is a lot of bad information out there as well.

As pharmacists we need to start sharing more of this information because the meaningful collaboration can and will save us money and time.

The How If you haven’t already read in detail what it may take to get compliant I would make yourself familiar. While you don’t need to know how to build and install a cleanroom I highly suggest you know at least what’s going on. It may save you some headaches and make you educated enough to ask intelligent and coherent questions as to why your contractors are doing what they’re doing. This will serve you well in the planning stages especially as some may try to sell you unnecessary extras and drive up the cost of the build or even the long term maintenance and operating costs of your new cleanroom. A good example of this is trying to build rooms above the necessary ISO class that’s required or a biologic safety cabinet that exhausts 100% of the air as opposed to recirculating some of its own air back into the room. If someone is suggesting you build an ISO 5 room, tell them to take a walk; it’s not necessary and will drive up the costs tremendously. There are only a few situations where that is absolutely 25

Pharmacy Edge 2017

necessary and most likely you’re not doing those tasks (lyophilization to name one).

There is so much to be said and discussed on the topic of USP <800> that Bryan and I started a podcast together to dig deeper into the issue of compliance and compounding quality. We encourage you to listen to our Pharmacy Inspection Podcast (http://pharmacyinspection. libsyn.com/); the first few episodes

have been dedicated strictly to USP <800>. Our goal with the podcast is to share industry knowledge through our own experiences and those who we interview within compounding pharmacy.

About the Author: Seth DePasquale is a compounding pharmacist and Co-owner of BET Pharm, LLC. In 2017 he started writing on compounding pharmacy compliance through his website pharmacyin-

spection.com and subsequently also started producing a podcast with his co-host Bryan Prince.

Contributing Author to this article: Bryan Prince is the owner of Lab Red Pharmacy Consultants LLC and specializes in compounding safety, workflow, and USP <800> design.

Bryan has published numerous articles and been the invited speaker at compounding conferences throughout the U.S.

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Pharmacy Edge 2017

Opioid Crisis

Introduction The number of drug-induced deaths in the U.S. rose to 16.3 per 100,000 in 2015, according to the National Center of Health Statistics. It has resulted in such a dramatic impact on large populations that cities have even taken to suing pharmaceutical companies and accused them of colluding with dealers and addicts. On October 26, 2017 President Trump declared the Opioid Epidemic a Nationwide Public Health Emergency and took steps to address this problem including providing a billion dollars in funding.

Opioid addicts have taken to new and innovative ways to chase the next â&#x20AC;&#x153;highâ&#x20AC;? including, destroying controlled

release products to release all the drug at the same time and taking oral medication intended to be swallowed intravenously. These addicts often eventually graduate from regulated opioids to non regulated drugs like heroin.

Background There has been repeated and consistent effort to address the opioid crisis from a number of sources - both federal and state, private payors and providers have all tried to help these patients.

Federal FDA: The FDA has tried to proactively help companies bring products onto the market that assist with the ongoing opioid crisis. To help with

this process, it has provided its current thinking associated with opioids and addiction by providing the FDA guidance on addiction and on Abuse -Deterrent Opioids â&#x20AC;&#x201D; Evaluation and Labeling. To limit the fall-out of patients who will inevitably overdose on narcotics, the FDA even helped make Naloxone, the product used to address Opioid overdose, an over the counter product and hence improve access to the product. Nevertheless, there have been challenges. While the FDA supports products that can help the addiction crisis, it still looks to balance safety and efficacy. To that end, the FDA rejected the new drug application from Pain Therapeutics at least 3 times despite it helping solve the addiction problem.

27

Pharmacy Edge 2017

The Joint Commission is now taking active steps to address these misunderstandings and hopefully combat the Opioid Epidemic.

Drug Enforcement Administration (DEA) and Department of Justice (DOJ): While the FDA has busied itself with helping prevent the opioid crisis, the DEA and DOJ have taken to more stringent and diligent enforcement of rules. The DEA uses a series of “red flags” to evaluate whether a pharmacy is not maintaining effective control over its opioids. Most recently, the DOJ settled with a variety of pharmacies and distributors including Rite Aid, Costco and McKesson due to violations of the Controlled Substances Act. States: Prescription Drug Monitoring Programs: Like the FDA, the states have also worked to help their citizens avoid and address addiction to prescription medications. To that end, they have helped setup monitoring and registration programs that use “state-run electronic databases used

28

to track the prescribing and dispensing of controlled prescription drugs to patients” (CDC). These programs are an important tool in monitoring potential drug abuse since they help detect problems like pharmacy and prescriber hopping, and early refills.

Marijuana: The use of marijuana in some states has coincided with a 6.5 percent reduction in opioid overdose deaths. Some states have therefore begun taking non traditional steps to combat the opioid crisis, including by introducing medical marijuana to treat a variety of conditions including certain types of intractable pain.

Physician: Like the government, providers have also been making efforts to protect their patients. To enable and educate prescribers many states, like Kentucky, now require that these prescribers take a certain number of

continuing medical education credits, or take an exam in order to enable them to continue to practice.

These credits help a physician gain greater understanding of opioid risks and benefits and hence enable them to make smarter prescribing decisions.

Joint Commission (JCAHO): The Joint Commission is an independent, not-for-profit organization which accredits and certifies nearly 21,000 health care organizations and programs in the United States.

Accordingly, it has significant impact on the prescribing of opioids.

However, misunderstandings about the expectations of the Joint Commission may have inadvertently exacerbated the Opioid epidemic. The Joint Commission is now taking active steps to address these misunderstandings and hopefully combat the Opioid Epidemic.

Pharmacy Edge 2017

Issue Can we do more to prevent opioid-induced deaths?

Rule We can do more to prevent opioid induced deaths if: A. Drug companies make efforts to reformulation and redevelopment, REMS reporting and otherwise addressing patient needs B. Use lessons from other countries C. Empower other professionals Analysis Drug Companies Reformulations and Redevelopment Reformulation: Companies like Purdue Pharmaceuticals tend to focus on the pain market. The FDA’s attention to the opioid crisis would affect

the bottom line for Purdue Pharmaceuticals. Accordingly, they reformulated their product, Oxycontin, into an“abuse-deterrent formula”. ‘Reformulation’ is the development of different formulations for the same pharmaceutical drug. Accordingly, Oxycontin was made in a different way to reduce the ability of Oxycontin addicts to abuse the product.

Hysingla ER an ER hydrocodone tablet formulation by Purdue Pharmaceuticals, and Zohydro ER, an ER hydrocodone capsule formulation

by Zogenix both used reformulation strategies to obtain FDA approval.

This reformulation was advantageous in that it resulted in a decrease in the drug’s illicit use. However, there was an unexpected shift from opioids like Oxycontin which was now difficult to crush or otherwise abuse, to heroin which was often cheaper and easily accessible.

There is additional help for patients since IntellipharmaCeutics International Inc.’s (IPCI) hopes to release Rexista, its own abuse resistant, extended release oxycodone formulation.

Redevelopment: While reformulation typically involves taking a product and revising it for the same indication, redevelopment may often include adding or removing ingredients for the same or different indications. Seeing the success of Purdue’s reformulation strategy, the FDA’s interest in approving abuse resistant drugs, and the profit potential associated with such products, drug companies have already started investing into such products. To that end, Pfizer (PFE) redeveloped its product Embeda ER to include an extended morphine with naltrexone. This is similar to the strategy used by Purdue with its product Targiniq ER, an opioid agonist/antagonist combination con-

29

Pharmacy Edge 2017

taining ER oxycodone and naloxone as well.

Smaller companies, have however had problems producing these products and get them through the FDA pipeline. Remoxy ERâ&#x20AC;&#x2122;s New Drug Application by Pain Therapeutics was rejected 3 times by the US FDA and Arymo ER (a modified morphine formulation) from the Egalet Corporation (EGLT), despite being approved in January of 2017, is not available on the market. On March 21, 2017, the FDA provided positive regulatory guidance to Pain Therapeutics which resulted in the stock spiking by around 61% to hit $1.10 per share during after hours trading.

REMS Reporting Abuse resistant opioids, as part of their Risk Evaluation and Mitigation Strategy

30

(REMS) typically require a training program for the appropriate use of their product. These programs will hopefully help physicians and other prescribers to appropriate prescribe the product and eventually lead to lower dependence on these opioids.

Addiction Engagement Casinos as part of their marketing plan routinely provide access to addiction counsellors to help individuals with addiction problems. Purdue Pharmaceuticals already offers support in its effort to combat drug abuse and addiction. It is hence important to expect more from drug companies and insist that they support opioid addiction programs via funding and other means.

Learn from Other Countries There may be lessons to learn from

other countries since different countries have found their own ways to address the opioid epidemic.

India: Recent studies suggest that non opioid drugs can treat pain as effectively as opioids. Unlikely many developed countries, narcotics are rarely prescribed in India. Opioids are the last line of treatment with some cancer patients barely receiving the drug. While this does serve the needs of addicts, it is difficult to argue that it helps patients with real chronic pain including those with debilitating illnesses like sickle cell disease or cancer.

Canada: Unlikely India, Canada is looking to limit the prescribing of opioids by limiting a maximum dose of opioids. While this may be useful for a large majority of patients, pa-

Pharmacy Edge 2017

tients with legitimate yet outlying medication needs like patients with cancer or sickle cell disease may be left in tremendous pain since they can often require hundreds of times the normal dose required for other patients.

Norway: Unlikely many other countries that choose to let opioid addiction languish in back alleys and broken homes, Norway instituted the use of drug consumption rooms (â&#x20AC;&#x153;Roomsâ&#x20AC;?). These Rooms allow for the use of certain drugs under medical supervision.

Started around 2004, the scheme permits the injection of heroin in rooms manned by healthcare and social service personnel for individuals who are heavy drug users.

These individuals are required to

register themselves and must meet a variety of requirements including bringing no more than a single dose of heroin to be brought and injected on the premises and being over the age of 18.

Some may argue that this effectively legitimizes drug use and opioid addiction, while others see this as proactively addressing a problem that already exists.

Empower Other Professionals Lastly, while guiding prescribers via CME and REMS programs is useful, it is important to harness other tools that may be available. Professionals like pharmacists and social works with specific strengths and access to these patients may also be able to guide and control patient addi-

tion problems, especially if they are reimbursed for such services and if they are provided with specific training. Health insurers, like CeltiCare, have begun assigning social workers to a number of its insurees). This will, however require political clout to engage other professionals in additional roles.

Conclusion We can do more to prevent opioid induced deaths because drug companies are making efforts to reformulate and redevelop opioid products, increase REMS reporting and otherwise helping address patient needs, since there are additional lessons to learn from other countries and because we have the opportunity to empower other professionals to help treat this addiction.

31

The latest and the most significant industry-related news and trending stories.

This magazine is produced by APPA - American Pharmacy Purchasing Alliance If you wish to submit an article-to Pharmacy Edge, or would like to request a media kit for sponsorship The latest and thesend most industry-related news opportunities, ansignificant email to info@joinappa.com. and trending stories.

This magazine is produced by APPA - American Pharmacy Purchasing Alliance If you wish to submit an article-to Pharmacy Edge, or would like to request a media kit for sponsorship opportunities, send an email to info@joinappa.com.

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