Pharmacy Edge

PHARMACY EDGE

MAGAZINE ISSUE

THREE

PHARMACY EDGE APRIL BIOSIMILARS VERSUS GENERICS PHARMACEUTICAL INDUSTRY AWARD WINNERS and more...

APR/2016

Table of Contents Issue 3 / April, 2016

Presidents Message Biosimilars versus Generics: Understanding the Difference

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Can Talcum Powder Really Cause Cancer?

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Pharmaceutical Industry Awards

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What Is the Purpose of a Drug Utilization Review?

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Pharmacists, Here Are 10 Ways To Maximize Your Expired Return Credits‌

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DSCSA Compliance Tips

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HIPAA 2016 Audits Phase 2: Pharmacies and Business Associates Take Notice

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Spring into Action

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Sometimes people say the craziest things

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PRESIDENT’S MESSAGE “Great things in business are never done by one person. They’re done by a team of people.” - Steve Jobs.

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ear Friends, The first quarter of 2016 has been eventful for APPA. We launched our online magazine, Pharmacy Edge, and introduced APPA’s first Industry Awards. For the second quarter of 2016, we look forward to the continued advancement of our alliance, which begins with a new website.

The creation of our new website, along with the assistance of one our members, GRX Marketing, was launched and is much more user friendly. It consists of bios for the individuals who make up the board of our Alliance, as well as additional significant and useful information relevant to the pharmaceutical purchasing industry.

Other changes include: • The “Marketplace” section contains a resource directory for easy access to businesses, to assist you in your everyday needs • “Events” section for future APPA events such as our first industry convention expected in early 2017 • “News” section for a one stop connection to relevant industry news • “Forum” section for the public to be able to post inquiries or topics for group discussion and for peer advice • “Sponsorship” section where companies/individuals can sponsor an event or pharmacy program • “Industry Awards” section to remind us all that excellence doesn’t stop once you’ve received an award, but to always strive for the greatness not simply for ourselves, but for the industry and for the consumers. After all, as Steve Jobs said, great things done in business is not just the work of one person, but by a team of people.

Please take the time to navigate our new website and as always, comments are welcomed.

Thank you again to all who participated in APPA’s first Industry Awards. The public participation was overwhelming and is evidence that what we do for the public is an integral part of the pharmaceutical industry.

We make a difference and our commitment to the consumers as well as to the industry is important and should be acknowledged and recognized. Though we had one winner for each category, as a whole, we are all winners. If you haven’t already viewed the winners, please take a look on the new website under the Marketplace Industry Awards.

The Industry Awards were open to the public, but next year’s awards will be limited to APPA Members. As a member, a multitude of opportunities will be available to assist you with the growth of your business as well as offer opportunities for professional advancement. As a member, you will become an integral part of making sure the pharmaceutical purchasing industry is no longer a voice in the background, but a voice to be heard, recognized, and acknowledged. We currently have 3500 subscribers, but as there are strength in numbers, it is our members who will help us make us stronger and an institution in the pharmaceutical purchasing realm. For additional information on becoming a member and the benefits, please visit the Membership section on the website.

Joshua Pirestani President pharmacy edge

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BIOSIMILARS VERSUS GENERICS: UNDERSTANDING THE DIFFERENCE

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edicines these days come from a variety of sources. Some are developed using natural substances, such as plant extracts, while others are produced in a laboratory using a mixture of different chemicals. Some of the most important medications, however, are biological. That is, they are made from living organisms. These biological products are categorized in two new types – interchangeable and biosimilar.

The various types of medications on the market give consumers a range of options to choose from. It also gave rise to a number of questions.

»»What are biosimilars? »»How is it different from generic medicines? »»Which is better: biosimilars versus generics? »»What differentiates one from the other?

This article aims to address the difference between biosimilars and generics, and to eliminate confusion.

Biosimilars versus Generics: Structure Between biosimilars and generics, the former is more complex with possible variations in structure. This is mainly due to the fact that it is sourced from living organisms, which genetic structure varies, even when it is of the same species, because of several factors. The look and taste of tomatoes, for example, would vary depending on where and how it is grown. Factors, such as the quality of soil, use of fertilizers, and other environmental elements can cause complexity in the structure of biosimilars.

Generics, on the other hand, have a simple and well-defined structure, because the chemicals used in its production are measured accordingly. It is also manufactured in a controlled environment.

Complexity The complexity of generics is easy to fully characterize, while it is the complete opposite with biosimilars due to heterogeneity. No two living organisms are completely alike, after all.

Size Biosimilars are larger than generic medicines, 200 to 1,000 times the size of a small molecule drug to be exact.

In terms of size, Biosimilars take the prize.

Molecular weight Weight, in this case, is relative to size. This makes biosimilars heavier than generic drugs. It’s a marked difference between <500-900 Daltons and 4000 to >140,000 Daltons.

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Stability All medications are tested for stability, considering that they will be exposed to aggregation and degradation when they are out on the market. A productâ&#x20AC;&#x2122;s sensitivity to temperature, absorption onto surface, and other factors can have a significant impact on the stability or the lack thereof of medicines. Testing showed that generics are relatively stable, as opposed to biosimilars that are sensitive to handling conditions and storage.

Adverse immune reaction This refers to a drugâ&#x20AC;&#x2122;s potential to cause or illicit immune response and reaction. Between the two, biosimilars have a higher potential to lead to adverse immune reaction than generics. High-risk individuals should think twice before using biosimilars.

Approval requirements Before any drug is approved by FDA, it must meet approval requirements, such as clinical testing. Biosimilars must conduct large clinical trials in patients, as it is not expected to be exactly the same as the product used as a biological reference. To demonstrate similarity, they must go through lab testing and non-clinical testing as well.

These fundamental differences explain why biosimilars are not the same or equal to generics. In fact, their similarity stops in the sense that these products are medicines.

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CAN TALCUM POWDER REALLY CAUSE CANCER? Johnson & Johnson has been accused by more than 1,000 women for covering up a cancer risk.

And earlier this year, the company was ordered by the St. Louis jury to pay $72 million in total damages – $62 million in punitive damages and $10 million in compensatory damages, to the family of a now-deceased Alabama woman who claimed that the talcum powder, and other products of Johnson & Johnson was the cause of her ovarian cancer.

Particles of talcum powder were found in the plaintiff’s cancerous tissues. She regularly used J&J’s talcum powder for over 30 years.

The jury’s decision strengthened suspicions that the company’s products can really cause cancer. Although Johnson & Johnson maintains that all their products are safe, a newly published study in the journal Epidemiology showed evidence against the company’s claim.

Evidence points that there may be a link between talcum powder and cancer.

»»Powder made from talc contains magnesium, silicon and oxygen. »»Some talc contains asbestos, which has been linked to respiratory cancers when inhaled, according to the American Cancer Society. »»In an analysis conducted by British researchers 45 years ago, 10 out of 13 ovarian tumors had talc particles deeply embedded in them. The 1971 published study was the first to raise the alarm. »»A study in the journal Cancer by epidemiologist Daniel Cramer was the first to show a statistical link between ovarian cancer and genital talc use.

Johnson & Johnson reportedly used asbestos-free talc. But when Daniel Cramer’s study was known in 1982, J&J’s executive Bruce Semple reached out to Cramer and spent his time trying to convince him that talc use was completely harmless.

Findings from most studies, however, are based on limited evidence from human studies. And research from the Brigham and Women’s Hospital in Boston only showed an increased risk of developing ovarian cancer due to application of talcum powder on genitals, not that it is directly linked with talc. Other factors also come into play, such as smoking habits, use of menopausal hormone and the weight of the study participants.

The International Agency for Research on Cancer (IARC), which identify causes of cancer, also classified talc as: “Not classifiable as to carcinogenicity in humans” when inhaled, based on the lack of data from human studies and on limited data in studying lab animals.

“Possibly carcinogenic to humans” when used on genital as talc-based baby powder, based on limited evidence of human studies.

The jury ruled in favor of the plaintiff on the basis that J&J failed to warn her of the risks of developing cancer in the ovaries after using baby powder. The only warning that the company placed on their product is against inhalation and external use only.

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While the science isn’t conclusive about the link of talc with ovarian cancer, the lawsuit was based on evidence that showed a connection. J&J’s failure to tell their customers also weighed in heavily with the jury’s decision.

Can talcum powder really cause cancer? The answer is not definite. Even Cramer admits that more studies are necessary.

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PHARMACEUTICAL INDUSTRY AWARDS

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hen American Pharmacy Purchasing Alliance, “APPA”, was first established, our goal was to educate and inform our members of the ever-changing pharmaceutical purchasing industry. By keeping our readers abreast of ongoing changes and enhancements, our members become equipped with beneficial and relevant information to assist their personal and professional growth in this complex industry. APPA also offers a forum for members and non-members alike to share their experiences and build lasting relationships that will hopefully assist in their expansion as well as in ours.

APPA is proud to have a considerable representation of experts and professionals in the field of Pharmacy Purchasing in its membership roster. These individuals along with APPA believe pharmacy purchasing deserves recognition in the industry. To acknowledge the commitment, dedication, and excellence for distributors, wholesalers, manufacturers, vendors, pharmacy technicians, pharmacists and pharmacy buyers, APPA has introduced the Industry Awards.

APPA’s Industry Awards, not only serves to acknowledge the commitment of excellence from these professionals, but also to relay to the rest of the pharmaceutical world the significance of their field to the overall pharmaceutical community. These individuals are a small representation of the hard work and dedication that is necessary and essential for the success of this industry and the importance of the services offered to the public in their daily lives. What may take a few hours in their day, will translate to make life altering differences in the customer who receives their care and services.

The polls were opened on January 1, 2016 and closed on March 31st, 2016 to an overwhelming response of industries’ peers and customers. These individuals voted on nominees listed in 18 categories.

Though there is only one winner, all nominated individuals are already winners for making the list.

Without further ado, the winners are:

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PHARMACY BUYER OF THE YEAR Lisa Saminathen – Santa Clara Valley Medical Center – San Francisco, CA PHARMACY TECHNICIAN OF THE YEAR Steffani Sweetman – Asher College – Sacramento, CA PHARMACIST OF THE YEAR Travis Hale – Remington Drug – Remington, VA PHARMACEUTICAL SALES REP OF THE YEAR Marc Weiss – AmerisourceBergen – Fort Lauderdale, FL INSIDE SALES REP OF THE YEAR Kelby Keeling – AmerisourceBergen – Dallas, TX CEO OF THE YEAR Steven H. Collis – AmerisourceBergen Corporation HALL OF FAME AWARD (20+ YEARS OF INDUSTRY EXPERIENCE) Suzette DiMascio – CSI Specialty Group HOSPITAL PHARMACY OF THE YEAR Florida Hospital Orlando – Orlando, FL INDEPENDENT PHARMACY OF THE YEAR Good Neighbor Pharmacy SPECIALTY PHARMACY OF THE YEAR OptumRX COMMUNITY ADVOCATE OF THE YEAR AmerisourceBergen INDUSTRY NEWS PROVIDER OF THE YEAR Pharmacy Times PHARMACEUTICAL TECHNOLOGY COMPANY OF THE YEAR Accudose PHARMACEUTICAL COMPANY OF THE YEAR MannKind Corporation PHARMACEUTICAL DISTRIBUTOR OF THE YEAR AmerisourceBergen PHARMACEUTICAL WHOLESALER OF THE YEAR ParagonMeds PHARMACY SPECIALTY SUPPLIER OF THE YEAR Humco TELE MEDICINE COMPANY OF THE YEAR LifeMD

Congratulations to all the winners and thank you for your ongoing commitment to excellence!

Also, APPA would like to thank all of our members and participants for their loyalty and support.

We are only as successful as the company we keep. pharmacy edge

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The Pharmacy Choice online network is collectively the most popular destination on the internet for pharmacy professionals.

The Pharmacy Choice online network consists of three primary web portals PharmacyChoice.com, RxSchool.com and RxCareerCenter.com. Each of these portals serves a specific purpose while leveraging the marketing power of the others.

Combined, these portals are the most visited websites in the pharmacy industry.

Pharmacy Choice ®

RxSchool AMN Healthcare Education Services

RxSchool offers the best Live Internet education available through the popular RxSchool Live seminar room. Our leading internet delivery solution provides pharmacy professionals with a convenient way to get quality live education that qualifies for live CE credit.

The Pharmacy Choice web portal provides pharmacists, pharmacy technicians, students and others in the pharmacy industry with the most comprehensive suite of web-based tools and information available, including drug information, industry news, career opportunities and educational programs.

Rx Career Center is home to the largest job board for pharmacy professionals. Job candidates can search career opportunities using a secure and confidential system. Employers have the ability to upload their open jobs and search résumés.

www.rxschool.com

www.pharmacychoice.com

www.rxcareercenter.com

For more information please contact Trevor Oxley ¨ (877) 223- 6121 â trevor.oxley@pharmacychoice.com

Phases of DURs DURs involve a two-phase process. The first phase is the prospective DUR, which evaluates the patient’s pharmacological therapy before it starts. During this phase, prescription drug claims are electronically screened to spot signs of incorrect dosage, clinical misuse or abuse, drug-disease contraindications, and other problems.

The second phase is retrospective DUR, which is done after the patient has received the medication. It examines the drug therapy that was prescribed for the patient and evaluates if it achieved positive results and helped the patient get better. It also looks out for drug-drug interactions, drug-disease contraindications, clinical abuse and misuse, and other problems and helps physicians and other healthcare providers in improving their interventions.

WHAT IS THE PURPOSE OF A DRUG UTILIZATION REVIEW? If you work in the healthcare industry, you’ve probably heard of a “drug utilization review” or DUR. But what exactly is this review? And how can it help pharmacists, physicians, patients, and the healthcare system as a whole?

Drug Utilization Reviews, which are also called Drug Utilization Evaluations or Medication Utilization Evaluations, are structured reviews that monitor physicians, pharmacists, and patients. They ensure that medications are properly prescribed, dispensed, and taken, promote good medical decisions among healthcare providers, and help patients achieve positive outcomes and enjoy better health.

It’s important to note that the two-phase process is adopted by the State Medicaid program. In institutional settings like hospitals and nursing homes, DURs are a three-phase process. In between the prospective and retrospective DURs is a second phase called concurrent DUR, which takes place while the patient’s drug therapy is ongoing.

During this phase, pharmacists monitor the therapy to see if the drug is under- or over-utilized, has too little or too much dosage, or is interacting with the other drugs that the patient is taking. If these problems arise, the pharmacists can work with the physician to alter the therapy and make it better.

Importance of DURs in Pharmacies Drug utilization reviews might seem like a good idea, but do pharmacies really have to implement these reviews in their dayto-day operations? The answer is “Yes”.

For one thing, having a DUR program in place allows pharmacies to comply with government rules and regulations. It

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also gives them the opportunity to identify trends in prescribing medication according to drug groups (such as antibiotics, anticholinergics, etc.) and/ or according to patient groups (like those with hypertension, those with asthma, etc.). Pharmacies can then share the information they collect with physicians and other healthcare providers and use it to make improvements to drug therapies.

If a pharmacyâ&#x20AC;&#x2122;s DUR program spots any problem in a prescription, it will reject the prescription and send electronic alerts or messages to the pharmacists to inform them about the rejection.

Pharmacists should then review these alerts and, using their professional judgment, decide whether they should accept them or override the rejection.

If they opt for the latter, they need to input NCPDP standardized codes, which are made of three parts: the conflict code, the professional service code, and the outcome code.

If the DUR gives an alert for excessive medication dose, for example, the pharmacist can use the reject code 88 (also known as the DUR Reject Error).

This code covers a wide range of issues including high medication doses as well as late refills, early refills, low insufficient doses, and drug-disease contraindications. __________

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PHARMACISTS, HERE ARE 10 WAYS T YOUR EXPIRED RETURN CREDITS…

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very day at United Rx Solutions, we see many Non-Returnable items that could have been Returnable for credit with just a little due diligence. Here are some simple ways you can save your facility thousands of dollars per year.

1. Don’t condense bottles of the same medication.

It’s tempting to save space on your shelves by condensing bottles. The problem is, manufacturers will not credit a product if it’s overfilled. The extra tabs/caps could have been returnable for credit if they were in their original bottle. Manufacturers will not credit products that are out of their original bottle.

2. Don’t break the seal on a bottle until it’s about to be dispensed. Some manufacturers (especially generics) will only accept full and sealed bottles for credit. We have seen many instances when a seal has been broken, and all of the tabs/caps are still inside. Even though the bottle is full, it may not be returnable for credit because the seal has been broken.

3. Send in your expired returns at least every 6 months. Some manufacturers have tightened their return policies and will no longer accept returns once they are expired more than 6 months.

4. Call us for information about which generic companies have the most liberal return policies.

Some companies have stricter return policies than others. We’ll be happy to consult with you about the different return policies.

5. Rotate your stock. Too often, a product becomes Non-Returnable for credit because it was buried under or behind newer, similar products.

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TO MAXIMIZE 6. Don’t deface the labels on bottles. If a sticker is placed over the lot number and expiration date, it may deface the label when the sticker is peeled off.

Manufacturers will not credit a product if the lot number and expiration date are illegible.

7. Don’t forget the creams or the refrigerator. The cost of creams and refrigerated items has skyrocketed in recent years. On many of these products, the lot numbers and expiration dates are difficult to read.

Use a highlighter marker to make them more legible.

8. Don’t overfill your robot or blister pack machine. If possible, pour only half of a bottle of brand name medication into the machine. Keep the rest in the original bottle. Many times, products become NonReturnable for credit because they were not dispensed from the machine quickly enough, and the original bottle was discarded.

9. Open one box of ampoules/vials at a time. Many hospitals will open multiple boxes at once. Some manufacturers will not credit loose ampoules/vials.

10. Don’t prepare more IV bags and syringes than are necessary. Too often, we see incredible waste because hospitals are preparing far too many.

Here at United Rx Solutions, we’re always looking for ways to save you money. If you have any questions about your returns or the return industry, give us a call at 844.741.9718. __________

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The New Normal DSCSA Compliance Tips: Policy

Matters

Compliance Tips brought to you by,

What is my new normal? The newly enforced Food and Drug Administrationâ&#x20AC;&#x2122;s (FDA) Drug Supply Chain and Security Act (DSCSA) requires electronic tracking and tracing of all dispensed prescription drugs and requires a process for product verification in the event of a suspect product and mandatory reporting requirements.

These latest regulations bring a new way of life and create a new normal when approaching compliance as a part of your day to day business practices. The best way to document standard operating procedures related to DSCSA is to adopt and document policies.

Developing your Policy and Procedure Manual for DSCSA compliance may seem like a daunting task, especially when considering all of the elements of the new law and what is required of you as a dispenser. A store policy clearly communicates to staff the standard operating procedures for any process, ensuring that all employees handle situations consistently. Adopting a policy is also an important risk management move because, if done properly, it verifies your standard business practices.

Even if an employee makes mistakes, evidence of a clear policy and guidelines (which the employee may not have followed) will be helpful to lessen any potential fines or penalties. A clear policy combined with annual staff training is excellent protocol to show compliance with regulatory process requirements.

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Keeping a policy up to date and easily accessible to staff will bring you real protection and peace of mind!

InfiniTrak, has been following the development of these DSCSA regulations since they began in 2012.

When designing their software solution, they looked at the situation from the point of view of the dispenser - and independent pharmacies like yours.

The result is a cost-effective, easy to use software that will save you time and money, increase productivity, ensure full compliance, and provide the peace of mind that comes from knowing that all of your data is at your fingertips, when you need it.

InfiniTrak provides to its customers a sample track and trace policy. Contact us today to learn more about how you can electronically create and transmit FDA and other government reports as required, all in a cloud solution.

Questions regarding your store policy and your compliance plan? Contact info@infinitrak.us.

www.infinitrak.us

Your Easy, Cost-Effective Solution to New FDA Regulations InfiniTrak is a cloud-based software solution designed from the point of view of the dispenser - and independent pharmacies in particular. The result is a cost-effective, easy to use software designed to save time and money, increase productivity, ensure full compliance, and provide the peace of mind that comes from knowing that all of your data is at your fingertips, when you need it.

APPA DSCSA Compliance Preferred Solution: InfiniTrak As of March 1, 2016, the Food and Drug Administrationâ&#x20AC;&#x2122;s (FDA) Drug Supply Chain and Security Act (DSCSA) requires electronic tracking and tracing of all dispensed prescription drugs. This means pharmacists are fully accountable to new standards of receiving and maintaining drug purchasing data.

Verification Trading Partners

must be verified. Do you have a business process in place to verify that your trading partners are properly licensed under federal or state law? Before you purchase a product from a wholesaler, you need to verify that the wholesaler is licensed to do business in your state.

You also have to be sure your pharmacy is properly licensed â&#x20AC;&#x201C; trading partners will be verifying you, as well.

Quality Inspecting & Reporting Trading Partners must

Are you ready? APPA presents

InfiniTrak as its preferred DSCSA compliance solution, a quality, costeffective track and trace software designed for independent pharmacists.

InfiniTrak helps you become compliant with the three key requirements of DSCSA, and ensures that you remain compliant as the regulations continue to roll out.

To Register for InfiniTrak: To register and subscribe for Infinitrak visit app.infinitrak.us Questions? customercare@infinitrak.us

www.infinitrak.us

InfiniTrak manages the verification process for you and reminds you when your own license is coming up for renewal.

InfiniTrak includes a series of built-in work flows to help you analyze and investigate any possible tainted product.

establish a process to inspect, investigate and quarantine any suspect or potentially adulterated or counterfeit product and quickly communicate this information up and down the supply chain. Do you have a process in place to handle any suspect or potentially counterfeit products? Are there training materials in place for employees about how to be on the lookout for such products, hot to investigate them, and how to quarantine them?

Transaction Data Management Trading Partners

must be able to receive track and trace transactional data and store the information with ready access for 6 years. Do you have a system in place that holds transaction data for a minimum of 6 years, AND gives you the ability to retrieve the information (within 48 hours) in response to a federal or state inquiry? Further, if you are asked to research a product in response an FDA request regarding a potential suspect product, do you have a system to keep that data for an additional 6 years?

InfiniTrak holds your info and allows you to produce reports at the touch of the keyboard. Quickly, easily, accurately.

HIPAA 2016 AUDITS PHASE 2: PHARMACIES AND BUSINESS ASSOCIATES TAKE NOTICE PRACTICE AREA / INDUSTRY: HEALTHCARE ; WHITE COLLAR LITIGATION & GOVERNEMENT INVESTIGATIONS

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s part of its continued effort to assess compliance with the HIPAA Privacy, Security and Breach Notification Rules, the U.S. Department of Health & Human Services (“HHS”) Office for Civil Rights (“OCR”) announced on March 21 that it has begun its next phase of audits of covered entities and their business associates.

In the 2016 Phase 2 HIPAA Audit Program, OCR will review covered entities and business associates’ implemented policies and procedures through desk audits however, some on-site audits will be conducted.

This second phase of audits follows OCR’s 20112012 pilot program of 115 entities. From the data collected and results achieved, OCR developed enhanced protocols to be used in the 2016 Phase 2 HIPAA Audit Program, including a new strategy to test the efficacy of desk audits in evaluating compliance with privacy, security and breach notification rules. OCR is identifying pools of covered entities and business associates that represent a wide range of health care providers that include pharmacies, physicians, hospitals, health plans, health care clearinghouses and business associates. OCR will not audit entities with an open complaint investigation or that are currently undergoing a compliance review.

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The first desk audits will be for covered entities, followed by a second round of desk audits of business associates. All desk audits in this phase will be completed by the end of December 2016. A third set of audits will be onsite and will cover a broader scope of requirements from the HIPAA Rules than desk audits. It is anticipated that results from desk audits may trigger a subsequent onsite audit and potential investigations if deficiencies are uncovered.

The audits are underway and begin with an email notification requesting contact information. Click here to view a sample email. The emails will originate from OSOCRAudit@hhs.gov and if your pharmacy’s spam filtering and virus protection are automatically enabled, OCR expects you to check your junk or spam folders for their email. Failure to respond to the notification email may result in OCR using publicly available information to create its audit pool thus a desk or onsite audit notification may not reach the appropriate company representative in a timely fashion. From the responses to the initial email, OCR will create a pool of targets for desk and onsite audits.

If your pharmacy is chosen for a desk audit, requested information must be submitted electronically within 10 business days of the request. OCR will provide draft findings and auditees will have 10 days to review and return written comments. Similarly, pharmacies chosen for onsite audits will also receive an email notification. OCR will schedule an entrance conference to provide more information about the process and onsite audits will be conducted over a 3-5 day period, depending upon the size of the operations. You will have 10 business days to review draft findings and provide written comments to the auditor. OCR will complete and provide a final audit report within 30 business days.

As we have advised in previous articles regarding HIPAA enforcement trends, we believe the 2016 Phase 2 HIPAA Audit Program will have a keen focus on business associates and covered entities’ Business Associate Agreements (“BAAs”). Business associates have been covered by HIPAA only since 2013, therefore compliance with the HIPAA Privacy, Security and Breach Notification Rules may not be as robust or as fully vetted as required by OCR. Business associates that conduct third-party billing, data analysis, storage and management and the covered entities who have BAAs with these vendors are particularly vulnerable to being a target of OCR audits. Other business associates such as cleaning services, marketing companies, and pharmacy delivery services also require a BAA. Covered entities and business associates must exercise due diligence in reviewing their HIPAA compliance programs and conducting system wide audits of their PHI safeguards to identify and update areas that may have vulnerability that could put personal health information at risk.

For further information on the subject matter of this alert, please contact the following FisherBroyles attorneys: Brian E. Dickerson brian.dickerson@fisherbroyles.com 202.570.0248 Nicole Hughes Waid nicole.waid@fisherbroyles.com 202.906.9572 Anthony J. Calamunci anthony.calamunci@fisherbroyles.com 419.376.1776

__________

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SPRING INTO ACTION By: Nicolle McClure, GRX Marketing

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hen was the last time your pharmacy had a good Spring cleaning? And I don’t just mean tiding up this and that, I mean a FULL cleaning. If a new customer were to walk into your store today, what would they see? What would they smell? How easy would it be for them to find what they are looking for?

With work, as well as your home, we get so used to where things are and how things look that we rarely think about it from an outside perspective.

Some things to consider when looking at your pharmacy:

»»Do the products or shelves need dusting? »»Are there any shelf tags that need updating? »»Do you need to remove or expand any OTC or specialty product lines?

»»Are your in-store marketing materials up to date or do you still have items up from last spring?

»»How does the exterior of the store look? Do you

need to have the windows washed, hedges trimmed, plant some flowers?

»»When you walk through the front door of the pharmacy, is it inviting?

Additionally, consider doing a spring cleaning of your customer database as well. Do you have all of the necessary information on each customer? When was the last time anyone’s email address got updated?

First impressions go a long way with new customers and current customers will also appreciate you taking the time and effort to make your store a place where they are proud to conduct their business. __________

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SOMETIMES PEOPLE SAY THE CRAZIEST THINGS Here’s a collection of ACTUAL things said to me at the pharmacy: My friend’s dentist said this is exactly what I need. [an OTC item that has nothing to do with dental work] You WILL fill that with generic. [Pointing at me] I have an upset stomach. I need Imodium or Milk of Magnesia now.

I’m calling to have you fill my prescription that’s on automatic refill...

I’m allergic to prednisone and all steroids.

I refuse to take a Medrol pack because I don’t want big muscles.

Don’t run it on my insurance. I want to save them some money.

Did you fill my Silverstatin?

Did you fill my Atorka-statin?

Please fill my Lipitor. It’s for my cholesterol. [Thanks, we didn’t know that] You don’t really think I need to go to the ER, do you?

[Patient’s arm is covered in blood-soaked rags] This medication expired in 2004. Do you think it’s ok?

How come you’re never here anymore? [I work 40 hours a week, sometimes more...]

Where’s the Viagra? I can’t find it out here anywhere.

[Phone rings several times... caller gets put on hold... finally I get to the phone] Wow, are you guys busy?

Why doesn’t my insurance cover it?

[Phone rings... I answer] Is this a secure line?

Where’s the Liver Pills?

[Waits in line 15 minutes to drop off a new script] Why will it take 45 minutes to fill it?

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What’s Prozac for? [Patient asks same question EVERY time he comes in] YOU gave me Endocet. MY prescription was for Oxycodone!

But the OTHER pharmacist said it would be here...

I need BRAND. Generic didn’t do ANYTHING for me.

I’m allergic to anything man-made.

I’m looking for the Tylenol with the Motrin in it.

Where’s the bathroom?

Where’s the dairy section?

I want the REAL stuff.

Can you fill this right now? My dog/husband/wife is waiting in the car.

I read it on the Internet.

Dr. Oz says to get it. It’s homeopathic you know!

My stomach can’t tolerate anything but brand.

I’m allergic to all genetics. [Yes, he said GENETIC] It’s cheaper across the street.

Wow, that’s the FIRST time I’ve ever seen you sitting down.

Are you eating lunch? [Clearly I’m eating lunch] I have a question.

[On a medication NOT on Auto Refill] Why did you fill this medication? I don’t need it yet.

I need the NON-DROWSY psuedofed.

I need the NON-DROWSY Benedryl.

I need a NON-DROWSY sleep aid. [Yes, someone actually said that to me] [Monday Morning] Oh? You can’t fill them right now? Are you busy?

Why do I need a prior authorization? My doctor prescribed it!

Provided by Crazy RxMan – Your Friendly Druggist

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pharmacy edge 23

PHARMACY EDGE

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