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A Closer Look at COVID-19 Testing at Pharmacies

As of April 8, 2020, pharmacists have been given authorization to order and administer COVID-19 tests under the guidance of the Public Readiness and Emergency Preparedness (PREP) Act. This includes nasal and serology tests. On May 19, 2020, the Office of General Counsel (OGC) released a document answering whether PREP Act preempts state licensing laws that restrict pharmacists to order and administer these tests. The conclusion is that the PREP Act preempts any state or local laws that would restrict “a qualified person”, a licensed pharmacist under PREP Act, from ordering or administering FDA-authorized COVID-19 tests. A practicing pharmacy must apply for a Clinical Laboratory Improvement Amendment (CLIA) certificate of waiver before they can accept human samples for diagnostic testing. In some states, such as Pennsylvania, pharmacies must obtain a state-specific CLIA waived lab license in addition to the federal CLIA waiver. In the Emergency Use Authorization (EUA), the FDA specifies which patient care settings are authorized for the tests. If the FDA authorizes a test as a point-of-care test, the test is CLIA waived for the duration of the emergency declaration and can be used in pharmacies. The Department of Health and Human Services Centers for Medicare & Medicaid Services manages the process to obtain CLIA waivers.

Pharmacists may administer tests which are authorized for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance. Tests allowed include the ID NOW COVID-19, Accula SARS-COV-2 Test, Xpert Xpress SARS-CoC-2 test, and serology tests. A complete list of COVID-19 tests given Emergency Use Authorizations (EUA) and their authorized settings can be found here. The FDA is allowing development and distribution of serological tests without going through the EUA process. However, these tests to identify to SARS-CoV-2 must be validated, and the FDA must be notified of the validation.

Tests using patient saliva are currently available by prescription only and intended for at-home collection and mail in for results.

APhA is also offering COVID-19 Specimen Collection Training, COVID-19 educational videos (link 1 link 2), and COVID-19 fraudulent medical device and scam guidance to train pharmacists and keep them up to date and aware of the latest science and data pertaining to COVID-19. Many pharmacies are already offering testing at no cost to eligible individuals who meet criteria set by the CDC. Most pharmacies require patients to preregister in advance to be directed to the nearest testing location. Testing can deliver results in as little as 15 minutes.

With 90% of Americans living within 5 miles of a community pharmacy, testing can become much more accessible, which can lead to earlier identification and improved outcomes relating to COVID-19.  Hopes are that many more patients will be tested and can take appropriate measures to reduce the spread of COVID-19. Is your pharmacy prepared to participate and offer COVID-19 point-of-care testing?

 

 

Posted May 2020

A New Way to Control Pain

The Food and Drug Administration (FDA) recently gave approval to GlaxoSmithKline (GSK) for their new OTC pain product, Advil Dual Action with Acetaminophen. This pain medication contains 250mg of ibuprofen and 500 mg of acetaminophen. It is the first OTC combination of ibuprofen and acetaminophen for pain control. This combination fights pain in two different ways. The first way is with ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), that targets pain at the source by blocking the production of prostaglandins which cause swelling and pain signaling in the body. The second way is with acetaminophen, which blocks pain signals from being sent to the brain. This medication gained approval based on several studies to demonstrate efficacy and safety for pain relief. The data from these studies support that the fixed dose combination of ibuprofen and acetaminophen had better outcomes for pain relief than using ibuprofen or acetaminophen individually.  Advil Dual Action will be available later in 2020.

 

Posted April 2020

Non-Alcoholic Steatohepatitis (NASH) Updates

Non-Alcoholic Steatohepatitis (NASH) is characterized by fat accumulation in the liver that causes inflammation and cell damage without regard to alcohol use. If you would like to know more about NASH, please click here to read our previous blog post.

The FDA has not approved any medications to treat NASH. This condition is important to identify early on and treat by means of lifestyle modifications. Due to the prevalence of NASH and the possibility that an afflicted patient could progress to cirrhosis or even liver cancer, drug manufacturers have been studying products that could be of potential use. There are a few pharmacological treatments close to entering the market – maybe as early as this year.

For patients unable to lose enough weight or maintain weight loss, pharmacological treatment is necessary. This is particularly true if a patient has progressed to the later stages of NASH, as they are at a higher risk for serious complications (i.e. cirrhosis, liver failure, and, in some cases, liver cancer). Some patients have used pioglitazone or vitamin E off label, but there is not enough data to support recommending these products. Benefits and risks must be weighed for individual patients.

Genfit and Intercept have manufactured the two most promising treatment options. Genfit is in Phase 3 studies for its drug elafibranor, a peroxisome proliferator-activated receptor (PPAR) alpha/delta dual agonist. PPARs are nuclear receptors that play major roles in the development of NASH and its comorbidities. Pioglitazone is a PPAR-gamma agonist. Activation of the gamma receptor is associated with weight gain, edema, and fluid retention, making it a less viable option.

Intercept is in Phase 3 studies for its drug obeticholic acid (OCA). The company filed an NDA for FDA approval in September of 2019. OCA is a farnesoid X-receptor (FXR) agonist. OCA is available as brand name product, Ocaliva, indicated for use in the treatment of biliary cholangitis. A month of treatment is estimated to cost $7,000.00, making it an expensive option. Although this drug has displayed the ability to stabilize and sometimes reverse the features of NASH, its high cost will be a clear limitation to its widespread use.

Due to the lack of successful treatment options, drug manufacturers are anxious to launch approved products to serve the NASH market of over 300 million potential patients worldwide. The question is, when a drug does hit the market, will payers cover it, and will patients be able to afford it? The first step to accessing treatment will likely be a diagnosis of NASH and fibrosis staging through a liver biopsy. Payers will need to weigh the cost of these new medications against the cost of alternatives, such as bariatric surgery or a liver transplant. There are few existing alternatives, and if a patient has damage that is too severe, they will likely require medication.

At this time, healthcare professionals should recommend lifestyle modifications and emphasize the need to control comorbid conditions, such as diabetes, hypertension and dyslipidemia. FDA-approved drugs will likely be available in the near future – stay up to date and knowledgeable!

 

Posted April 2020

Medication Clean Out and Disposal

A great way to keep yourself busy and tidy up your medicine cabinet is to participate in National Clean Out Your Medicine Cabinet Day on Friday, April 17, 2020.  There are still ways you can dispose of your medications, even with the postponement of the DEA Prescription Drug Take Back Day scheduled for April 25th.

For medications that have a greater potential for misuse, one simple way to dispose of medications may be by flushing them. You can check the patient information leaflet that comes with the medication or the FDA flush list to see if your prescription medication is one of the 15 active pharmaceutical ingredients that can be flushed down the sink or toilet.  The flush list has details on safe disposal. You may wonder if this will have an impact on the environment. The FDA and Environmental Protection Agency published a paper stating they have not found any negative environmental effects from flushing the ingredients specified on the flush list. The FDA also suggests that the benefits outweigh the risks when other disposal options are not available.

If you are concerned with flushing medications, you can still dispose of the medications in your household trash. Follow the steps listed below for prescription and over-the-counter (OTC) pills (tablets and capsules), liquids, drops, patches, and topical products (creams, ointments, lotions, gels, etc.).

  1. Remove the drugs from their original containers and mix them with something undesirable, such as used coffee grounds, dirt, or cat litter. This makes the medicine less appealing to children and pets and unrecognizable to someone who might intentionally go through the trash looking for drugs.
  2. Put the mixture in something you can close (a re-sealable zipper storage bag, empty can, or other container) to prevent the drug from leaking or spilling out.
  3. Throw the container in the garbage.
  4. Scratch out all your personal information (including the Rx number) on the empty medicine packaging to protect your identity and privacy. Throw the packaging away.

Disposing of unwanted or expired medications decreases the risk of someone taking or misusing your medications and prevents confusing an older medication with a newer one.  These steps will help ensure that a child or pet cannot access or ingest the medications after they are in the trash.

If you do not feel comfortable disposing of medications at home, you can contact your local pharmacy or health care provider, as they may have other options to dispose of your medications. Local police or fire departments may have drug disposal bins, and there are also options to mail back medications to a disposal company. With the current pandemic and social distancing orders, the options may be more limited for disposing of medications at a pharmacy or police station. Finally, there are pouches that can be purchased to effectively get rid of unwanted medications.  Products such as DisposeRx® (www.disposerx.com) and Deterra Drug disposal pouches  (www.deterrasystem.com) can be purchased for environmentally safe drug disposal.  No matter the route, discarding expired and unwanted medications will help protect you and your family from accidental medication exposure.

 

Posted April 2020

America’s Pharmacies – Ready and Open

Pharmacy Healthcare Solutions, LLC shares this message from the National Association of Chain Drug Stores (NACDS) supporting pharmacies across the nation.

 

Rise from NACDS

Posted April 2020

 

Poison Prevention Week 2020

Poison Prevention Week started in 1961 and is the third full week of March each year. The American Association of Poison Control Centers (AAPCC) 2018 report stated that over two million cases were managed by poison control, a call to poison control was made every 12 seconds, and that nearly two billion dollars of medical costs were saved because of poison control centers.

What is poison?Tips for med safety

Anything that can cause harm if used in the wrong way, if used by the wrong person, or if used in the wrong amount.

When is Poison Prevention Week?

March 15, 2020 to March 21, 2020

Why is there a Poison Prevention Week?

The United States dedicates a full week to poison prevention to raise and promote awareness about the risk of poisoning.

How can pharmacists help?

Pharmacists are the most available and easily accessible healthcare professionals. They can provide the public with information on poison and where to go for help, educate patients about the importance of proper medication storage, provide over the counter medication safety, promote awareness about common medications that can be toxic, and information on resources for local medication take back locations.

Where to gPoison Helpo for help?

Poison Control phone number 1-800-222-1222

Text POISON to 797979 to save the contact information for poison control in your phone

Online help at PoisonHelp.org

 

Local poison control center.

Pittsburgh Poison Center

University of Pittsburgh Medical Center

200 Lothrop Street

Pittsburgh, Pa 15213

 

Additional Resources on poison prevention:

https://aapcc.org/

https://www.poison.org/

 

Published March 2020

New Look: PHSI is now PHSL

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Pharmacy Healthcare Solutions, Inc. (PHSI) is now Pharmacy Healthcare Solutions, LLC (PHSL).  PHSL is pleased to announce the promotion of Ann Johnson, PharmD to President and Melissa Krause, PharmD to Vice President.

Former President Tim Kosty, R.Ph., MBA, and former Vice President Don Dietz, R.Ph., MS, remain committed to the company they founded in 1996. Kosty and Dietz will assume the titles of co-founders, remain active in the company, and will be close advisors to Johnson and Krause.

“Ann and Melissa both possess a rare mix of healthcare informatics expertise and business prowess. We are excited to see where their leadership takes this company in the next decade and beyond,” said Kosty. “Their commitment to this company and the clients we serve is seen in their high standard of excellence in their work every day.”

Dietz stated, “Both Melissa and Ann have been dedicated to the growth and success of Pharmacy Healthcare Solutions since joining the company as student pharmacists at the beginning of their careers.  Their desire to go ‘above and beyond’ to meet our clients’ needs positions us for future growth.”

Johnson has been with the company since 2010 and Krause since 2004.

“This is an exciting time for the pharmacy industry and Pharmacy Healthcare Solutions,” said Johnson.  “I am excited to expand our service offerings and continue to provide our clients with the high level of service they have come to expect from our consultants.”

Krause added, “I am eager to help lead Pharmacy Healthcare Solutions into the future.  We have an excellent team of professionals committed to our mission to serve our clients as invaluable advisors.”

Under Johnson and Krause’s leadership, PHSL will continue to serve clients in the pharmacy, payer, pharmaceutical manufacturer, and health informatics industries.

The Argument for Establishing USP and Compendia Guidelines for CBD Products

The market for over-the-counter cannabidiol (CBD) products continues to grow rapidly as seen at the 2019 NACDS TSE conference. PHSL identified roughly 50 different CBD companies with booths at this conference to promote different oils, tinctures, creams and lotions, capsules and tablets, and edibles. The FDA has not evaluated CBD products but has stated that they may not be sold as dietary supplements.  A 2017 JAMA article on label accuracy of CBD products reported that only 30% of CBD products were labeled accurately.  The mislabeled products either contained less product than labeled (26% of products tested) or more product than labeled (43% of products tested).1 This year the FTC, FDA and legal cases have all been in the news regarding CBD promotional statements, claims, label accuracy, and the existence of Tetrahydrocannabinol (THC) above the legal limit. For example, this past November the FDA acted by issuing warning letters to 15 companies for promoting their CBD products in ways which violate the Federal Food, Drug and Cosmetic Act (FD&C Act).2 Many of these letters were related to CBD companies marketing their products as preventative, diagnostic, therapeutic, and/or curative for certain diseases.

As more consumers use CBD products in the hope of alleviating various health conditions, there is a growing need for healthcare professionals to record CBD products in their respective EMR/EHR and pharmacy systems along with other patient medication history. This is a critical step to assure accurate clinical screening including identification and reporting of adverse effects, drug interactions and allergies.  There are multiple steps and processes for CBD products to follow to be listed in the respective EMR/EHR and pharmacy systems. United States Pharmacopeia (USP) has been hampered by prior rules and regulations surrounding cannabis, but with the Hemp Farming Act of 2009 and the 2014 Farm Bill, federal law allows cannabis derived products to contain no more than 0.3% of THC. Moreover, a growing number of CBD products are being promoted with 0% THC.

USP needs to establish standards to measure cannabis derived products for identity, strength, quality, and purity. CBD products would be required to be labeled appropriately. These standards would then enable the respective drug compendia to group and categorize CBD products in their drug databases. Absent USP standards, there are too many CBD products with varying claims of ingredients, purity and standards for the drug compendia to sufficiently group/categorize these products.  The absence of standards results in insufficient information to identify, categorize, and perform clinical screening for physicians, nurses, pharmacists, and other health professionals with ultimate potential of patient harm,

The growth of CBD products is like the days when many once prescription-only drugs became available OTC.  For example, when ibuprofen became available OTC, there was data available to accurately identify its use on patient profiles and allow for screening against other anti-coagulants.  This does exist yet for CBD.  As the order of information becomes more important to prove legitimacy, the market will mature and progressive leaders in this space will recognize that following agreed upon standards that can be tested, measured and reported objectively will help all stakeholders, including patients, physicians and retailers. Recognition of CBD products within USP and new standards will help move us in the right direction.

  1. https://jamanetwork.com/journals/jama/fullarticle/2661569
  2. https://www.theshelbyreport.com/2020/01/06/fda-regulating-cannabis-cbd-products/?MessageRunDetailID=1147119967&PostID=10404678&utm_medium=email&utm_source=rasa_io

 

Posted February 2020

Biologic Products Approved as NDAs Transition to BLA

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) will require biologic products (which include insulin products and human growth hormones) to be regulated under the Public Health Services (PHS) Act as of March 23, 2020. These products are currently regulated under the provisions of the Food Drug & Cosmetics Act (FD&C Act) where new drug applications (NDAs) are used.  Under the PHS Act, a biologics license application (BLA) will be required.

In a 2018 statement, former FDA Commissioner Scott Gottlieb addressed the upcoming change, stating, “There are currently no approved insulin products that can be substituted at the pharmacy level. One reason is that it was hard to bring a substitutable generic insulin to the market under the conventional drug pathway. The biosimilar pathway should make this kind of competition more accessible. Once an interchangeable insulin product is approved and available on the market, it can then be substituted for the reference product at the pharmacy, potentially leading to increased access and significantly lower costs for patients.”

How will FDA transition these responsibilities? The agency developed a document called “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers” to provide answers regarding its interpretation of the transition guidelines. The document also includes FDA’s compliance policy for labeling biological products that are subjected to BLA approval. The FDA proposes its “nonbinding recommendations” to create a set of standards to follow after the transition date. These preset guidelines will be used to deem approval of biological products under the FD&C Act for a license for biological products under the PHS Act. The FDA will be sending letters to holders of approved NDAs on March 23, 2020 to notify them the approved application will be “deemed to be a license” for the biological product on the transition date. Current NDA holders are still responsible for post-approval requirements.

The FDA released the “Preliminary List of Approved NDAs for Biological Products That Will Be Deemed to be BLAs on March 23, 2020” which has gone through multiple updates since its original release. The current version has been updated through December 31, 2019. Most recently, the update added three NDAs that now fall into the “biological product” category following an updated definition made by the Further Consolidated Appropriations Act, 2020. The current list contains approximately 95 NDAs set to transition to BLAs in March.

One consequence of the transition from NDAs to BLAs will be that drugs will lose their unexpired exclusivities when transitioning to biological products (with an exception of the orphan drug exclusivity).  Any 3 or 5 year exclusivity applied to an NDA- approved biological product will end at midnight on March 20, 2020. Of the nearly 100 products on the list, only 10 have an initial NDA approval date after March 2015. Newer products will likely feel the effects to a greater extent, as they lose out on years of exclusivity. Manufacturers with pipeline products approved via NDA but expected to transition to BLAs should have already evaluated the consequences of an NDA approval prior to March 23, 2020.

The goal of this change is to promote biosimilar entry to create competition and encourage lower cost options. Insulin products, which have been in the spotlight regarding patient affordability, make up over 25% of NDAs on the list. The FDA released draft guidance for industry in November 2019 to encourage development of biosimilar insulin products. Time will tell if biosimilar entry of these biological products deemed to be BLAs has the intended effect on pricing and availability.

 

Posted February 2020

Pharmacies to Face Unintended Consequence of Blues Plans Manufacturing Select Generic Medications

A recently published story in Axios highlights how 18 Blues plans are working together through their subsidiary, Civica Rx, to manufacturer select generic medications that are high priced and in short supply. Civica Rx initially focused on 14 high-cost hospital medications but is now hoping to expand to the retail space. While their efforts should be applauded to reduce costs for these plans and their beneficiaries, the mechanics of how this strategy is implemented are likely to bring unintended consequences to pharmacies.

Pharmacies rely on their wholesalers to contract with pharmaceutical manufacturers to secure best prices and a continuous supply of generic medications. It is unlikely that all the major wholesalers will secure the lowest price for these target generics from Civica Rx. If pharmacies purchase directly from Civica Rx, there are volume and dollar thresholds that may not be maintained with wholesalers for the balance of pharmaceuticals purchased. The cost of other generics and brands may increase if these select generics are purchased from Civica Rx, and rebate thresholds cannot be met.

Health plans and PBM’s typically do not place manufacturer specific requirements on FDA A-rated generics, so it is incumbent on the wholesalers to purchase the lowest cost generic product for their pharmacy customers. If the Blues plans require use of Civica Rx products on their formularies, pharmacies have at least two choices. If the Civica Rx products truly have the lowest net cost, pharmacies may switch their entire inventory to the new, lower-cost Civica Rx product.  Otherwise, bifurcating purchases and inventory based on payer preference for otherwise equivalent, A-rated generics would increase inventory carrying cost for pharmacies and increase efforts to order and maintain product in a busy environment with limited shelf space. Finally, competition from Civica Rx may result in the manufacturers of these high cost, short supply medications lowering their acquisition costs to remain competitive in the market removing the incentive for pharmacies to switch.

 

Posted January 2020