Kratom Risks

UPDATE: Since our last blog was written, on 11/15/17, the death toll linked to kratom has risen to 44.  A new analysis at the FDA shows that the compounds in kratom act like opioids. “Claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous.”

The FDA concluded that all of the compounds in kratom are structurally similar to morphine.  These compounds also bind to cells the same way opioids do.

Especially concerning is that at least one reported death was in an individual who had no known prior opioid use. "Cases of mixing kratom, other opioids, and other types of medication are extremely troubling because the activity of kratom at opioid receptors indicates there may be similar risks of combining kratom with certain drugs, just as there are with FDA-approved opioids.”

Kratom should not be used to treat medical conditions, nor as an alternative to opioids. There is no evidence that it is safe or effective.

https://www.medscape.com/viewarticle/892375?nlid=120572_3901&src=wnl_newsalrt_180206_MSCPEDIT&uac=288603AT&impID=1552596&faf=1

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Over the past several years, a botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks resulting in the FDA issuing a “public health advisory” [source]. Evidence shows that kratom has effects similar to opioids, and carries similar risks of abuse, addiction and in some cases, death. Thus, it’s not surprising that kratom is often taken recreationally by users for its euphoric effects.

Kratom is a plant that grows naturally in Southeast Asia. It has gained popularity in the U.S., with some marketers touting it as a “safe” treatment with broad healing properties. Reportedly, some are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider.

Calls to U.S. poison control centers related to kratom exposure increased 10-fold from 2010 to 2015, in which there were 263 calls. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. The FDA issued a public health advisory on November 14, 2017, related to mounting concerns. The next day, the American Kratom Association (AKA) petitioned the FDA to “review and correct” this finding. The AKA, a consumer-based nonprofit organization, said the advisory is based on "discredited, incomplete, and mischaracterized scientific claims" and should be retracted. However, since we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning. In addition, there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder.

For additional information, please visit the link below. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

(CAR) T Chimeric Antigen Receptor T Cell Based Gene Therapy

After the approval of Kymriah in August 2017, with a price tag estimated to be $475,000, followed by Yescarta at $373,000,  and more in the pipeline, it is now time to better understand Chimeric Antigen Receptor T cell therapy (CAR) T cell infusion therapy. This type of cancer therapy will replace the current high cost Specialty Drugs as a new industry of high pharmaceutical costs for payers.

Chimeric Antigen Receptor T cell therapy or (CAR) T is a type of treatment in which patient’s T cells, a type of immune cell, are taken from a patient’s own blood, and then genetically engineered to produce CAR-producing T cells.   In the laboratory a gene for a special receptor, Chimeric Antigen Receptor, is inserted into the patient’s T Cells so that they will bind to a certain protein on the patient’s cancer cells.   After millions of (CAR) T cells are grown in the laboratory, they are then infused into the patient’s body, where they further multiply and attack cancer cells. 

On August 30th, 2017, the FDA approved Kymriah (tisagenlecleucal), the first (CAR) T cell therapy drug manufactured by Novartis.   Kymriah is indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. It will be supplied through two (2) specialty distributors, and then shipped to one of only 32 treatment centers in the US that can administer this drug.

“The price for a single infusion of Kymriah does not include pre-infusion treatment costs, drug administration and hospitalization costs.   When those costs are added, the average total cost….is estimated to be up to $750,000.”

http://www.onclive.com/web-exclusives/novartis-sets-a-price-of-475000-for-car-tcell-therapy

The second cell-based gene therapy, Yescarta (axicabtagene ciloleucel),  was approved  by the FDA on October 18th, 2017 and  is manufactured by Kite Pharma, which was recently bought by Gilead, the makers of the Hepatitis C blockbuster, Harvoni.   Yescarta will be used to treat certain types of Lymphoma, including Diffuse Large B-Cell Lymphoma (DLBCL), that have not responded to at least 2 prior therapies.  

Each dose of Yescarta is a customized treatment created using a patient’s own immune system to help fight the lymphoma.  The complete remission rate after treatment was 51 percent; however, treatment with Yescarta has the potential to cause severe side effects, including 3 reported deaths. The FDA is requiring that hospitals and their associated clinics be specially certified to dispense this drug.   There are currently only 16 treatment certified centers, including Dana Farber and Sloan Kettering. 

Diffuse large B-cell lymphoma (DLBCL) is the most common type of NHL (Non-Hodgkin’s Lymphoma) in adults. NHLs are cancers that begin in certain cells of the immune system and can be either fast-growing (aggressive) or slow-growing. Approximately 72,000 new cases of NHL are diagnosed in the U.S. each year.

There are 20 similar drugs currently in development by various pharmaceutical manufacturers.   Novartis is studying CTL119, for multiple B-Cell malignancies, as well as therapies for leukemia, multiple myeloma, and solid tumors.  Juno Therapeutics is developing several more, for multiple myeloma, and pediatric leukemia.

In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” said FDA Commissioner Scott Gottlieb, M.D.  
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm581216.htm

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Unifine Pentips Recall

PBIRx®
Intelligent Solutions in Pharmacy Benefits
12 Wheelers Farms Road, Milford, CT 06461
(888) 797-2479

On November 7, 2017, Owen Mumford announced a voluntary, user-level recall of one lot of Unifine Pentips 5mm pen needles due to a potential sterility issue.   The lot number is 1705722 and there are two NDC#s associated with the recall:  Unifine Pentips 5mm pen needles, 100 count (NDC 08470-3550-01) and 30 count (NDC 08470-1150-01).  These needles work with major brand injection pens for subcutaneous insuline administration.

Any exposure to water or a device exposed in the end user packing could potentially compromise the sterilityThere may be yellowing or discoloring of the protective seal.

Owen Mumford has issued this recall as a precaution.  There have been no complaints or adverse events reported as of November 3, 2017.   Anyone in possession of these Unifine Pentips should discontinue use and contact Owen Mumford Customer Service Department at 1-800-421-6936 for return information.

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Trump ACA Changes Summarized

PBIRx®
Intelligent Solutions in Pharmacy Benefits
12 Wheelers Farms Road, Milford, CT 06461
(888) 797-2479

The following health care actions have been announced by the Trump administration on October 13th.   Feedback is starting to come in from Congress, managed care plans, etc.   As such, this summary lends itself to change as Trump deals with this feedback.

• Contraception Mandate (amendment to existing August 2012)

• Birth Control Pills, Shots, morning after pill and other devices;
• Broadens entities that may claim religious objections to providing contraceptive coverage, including higher institutions’ student coverage and individuals whose employers are willing to provide health plans consistent with their beliefs;  
• Includes moral objections excluding publicly traded companies; and
• License for discrimination; many contesting new mandate

• Allow Employers  to form Association Health Plans (AHPs) to:

• Facilitate the purchase of insurance across state lines;
• Allow small businesses in the same line of work or the same trade organization to band together and purchase insurance;
• Provides exemption from ACA regulations including essential benefits
• Critics state that AHPs will draw away healthy patients from the individual market and drive up premiums, though the fact that the plans are limited to small businesses and not individuals could change effect.

• Expand availability of short term, limited-duration insurance from current 3 months to 12 months.
• Discontinue payment of cost sharing subsidies to insurance companies, which offset costs for low-income Americans to be effective immediately.   

• Payers will either exit exchanges or increase premiums
• Current and projected taxpayer costs for subsidies are:

• 2017 $7B
• 2018 $9B to $10B
• 2023 $100B

• Expand availability and permitted use of Health Reimbursement Arrangements (“HRAs”) to include premium costs

• HHS, Labor Dept and Treasury Department “proposed rule changes” due:

• 60 days AHPs and Short Term Plan expansion
• 120 days HRA changes

Blue Cross Blue Shield of Massachusetts has weighed in and released the following statement:

"We are deeply concerned that the Administration's recent actions will create further instability in the insurance market and threaten our shared goal of providing affordable and quality coverage and care to everyone, regardless of economic status, age, or condition.

At Blue Cross and Blue Shield of Massachusetts, our highest priority is ensuring that quality health coverage is accessible and affordable for our members, employer customers, and the community. The measures proposed by the Administration would likely create an unfair and unstable market, making coverage out of reach for those who need it most and undermining the meaningful progress that our state and nation have made in extending health insurance coverage to our fellow citizens.

We encourage policy makers to work in a bipartisan spirit to improve the Affordable Care Act to create a health care system that is high quality, affordable, and sustainable."

http://newsroom.bluecrossma.com/2017-10-13-Blue-Cross-Blue-Shield-Of-Massachusetts-Releases-Statement-On-Trump-Administrations-Recent-Actions-Related-To-Health-Care

PBIRx will closely monitor any updates to these Executive Orders by the Trump Administration and will keep you abreast of any changes.  

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

National Prescription Drug Take Back Day

PBIRx®
Intelligent Solutions in Pharmacy Benefits
12 Wheelers Farms Road, Milford, CT 06461
(888) 797-2479

The Drug Enforcement Administrative (DEA) has announced another opportunity for consumers to dispose of unneeded and expired prescription drugs during the 14th DEA National Prescription Drug Take-Back Day, which will be held Saturday, October 28, 2017. On this day, from 10 AM to 2 PM, thousands of temporary collection sites will be available across the country to accept unneeded prescription drugs, including CS, for safe and legal disposal. To date, DEA’s Take-Back Day initiative has collected a combined total of more than 900,000 pounds of unneeded medications, helping to prevent diversion, misuse, and abuse of the drugs. Follow this link to find the site in your area for drug disposal.
https://www.deadiversion.usdoj.gov/drug_disposal/takeback/


The National Association of Boards of Pharmacy (NABP) AWARXE® Prescription Drug Safety Program encourages consumer participation in DEA Take-Back Day events and provides information about the importance of safe drug disposal in helping to curb prescription drug abuse rates. Consumers who are unable to participate in the DEA Take-Back Day can find locations of permanent drug disposal sites using AWARXE’s Drug Disposal Locator Tool. https://nabp.pharmacy/initiatives/awarxe/drug-disposal-locator/


PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Walgreens to Purchase Rite Aid Stores

PBIRx®
Intelligent Solutions in Pharmacy Benefits
12 Wheelers Farms Road, Milford, CT 06461
(888) 797-2479

Walgreens has finally received approval to acquire 1,932 Rite Aid stores, three distribution centers and inventory for $4.375 Billion in cash.  This acquisition will leave Rite Aid with 2,600 stores and thus, be one of the three remaining nationwide chain pharmacies together with CVS and Walgreens.  Walgreens will now be able to negotiate with drug manufacturers for lower drug costs, providing competition for CVS

The Rite Aid store purchases will begin in October and should be completed in the Spring of 2018 followed by rebranding those stores to Walgreens.  Most of the stores to be purchased are located in the Northeast and Southern United States.  As a result, Walgreens will have close to 10,000 locations (CVS has more than 9,600 stores) and expects to save about $300 Million annually through cost cuts over the next four years.   Walgreens also owns Duane Reade pharmacies .

It will be interesting to watch what happens to Rite Aid in the future as their stock plummets.    The deal does include the option for Rite Aid to join the Walgreens group purchasing  agreement for discounts on generics, which should help them to compete with the other chain pharmacies.

For additional reading, please access the following links:

https://www.reuters.com/article/us-rite-aid-m-a-walgreens-boots/walgreens-gets-regulators-nod-to-buy-rite-aid-stores-idUSKCN1BU1KP

http://money.cnn.com/2017/09/19/news/walgreens-rite-aid-deal/index.html

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

New Cancer Drug Approved

PBIRx®
Intelligent Solutions in Pharmacy Benefits
12 Wheelers Farms Road, Milford, CT 06461
(888) 797-2479

The FDA has just approved the Novartis drug Kymriah, a groundbreaking treatment intended to cure a patient’s cancer.  The AWP cost is an estimated $570,000 and the WAC is $475,000.  This is the first gene therapy approved by the FDA; a one-time treatment using the patient’s own T cells to fight cancer.

Kymriah is approved to treat B-Cell Acute Lymphoblastic Leukemia in children and young adults (up to age 25) whose cancer has come back after previous treatment or resisted treatment altogether.   Acute Lymphoblastic Leukemia (ALL) is the most common childhood cancer in the U.S.  There are approximately 3,100 patients aged 20 and younger who are diagnosed with ALL each year and 15-20 percent of the patients do not respond to the current treatment available. This new treatment option has shown promising remission and survival rates in the clinical trials.

Twenty treatment centers have been selected for the administration of the drug with an increase to 32 centers by the end of the year.  Additional expenses are incurred when Novartis collects the patient’s T-cells for re-engineering and when the personalized Kymriah is administered.

The FDA is committed to helping to expedite the development and review of groundbreaking treatments that have the potential to be life-saving. Please read the full FDA release from the link below.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574058.htm

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Hurricane Harvey

Our goal at PBIRx is to provide pharmacy benefit and health care savings to our clients, but sometimes things happen that make us forget about business and turn our attention to the health and safety of our fellow Americans. Hurricane Harvey has wreaked havoc on Texas and Louisiana, and the Houston area is feeling the brunt of the effects. We work with clients throughout the United States, but to our friends and associates in the Houston area know that you are in our thoughts and prayers.

This storm is catastrophic and record breaking in more ways than one and the statistics really leap off the page:

• On average, the Greater Houston Area accumulates about 49.75 inches of rainfall annually - 51.9 inches of rain has fallen thru late Tuesday afternoon
• 130 mph winds near Corpus Christi were reported when Harvey came ashore
• More than 30,000 people have fled to shelters
• An estimated $160 Billion price tag is expected – more than Hurricane Katrina
• First time in 56 years that a major hurricane made landfall in Texas

After careful research, PBIRx has made a donation to Samaritan’s Purse to provide assistance to our fellow Texans.

If you are interested in donating to Hurricane Harvey survivors, please visit Charity Navigator to do some research to ensure that YOUR donation will go to a reputable organization that will use the money as promised.

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Is the PPACA Annual Tax on Branded Drugs Contributing to Higher Drug Costs?

PBIRx®
Intelligent Solutions in Pharmacy Benefits
12 Wheelers Farms Road, Milford, CT 06461
(888) 797-2479

Hidden in the many pages of the original  2010  Patient Protection and Affordable Care Act (ACA), is Section 9008 from the Internal Revenue Service, which requires an annual fee on each covered entity engaged in the business of manufacturing or importing branded prescription drugs to “specific government programs”, to be paid not later than September 30th of each year.    “Specific government programs” refers to Medicare Parts B and D, Medicaid, Department of Veterans Affairs, Department of Defense and the Tricare retail pharmacy program.

On July 28, 2014, the Internal Revenue Service (IRS) issued final regulations (26 CFR Parts 51 and 602) on the fee, which is treated as an excise tax for purposes of subtitle F of the Internal Revenue Code (Code) (sections 6001-7874).  The final regulations describe the rules related to the fee, including how the IRS computes it and how covered entities pay it.  The fee is assessed, collected, enforced, subject to examination and summons and subject to confidentiality rules in the same manner as taxes imposed by the Code.  The fee applies to calendar years beginning after December 31, 2010.  

In general, the fee is imposed on each covered entity with aggregated branded prescription drug sales of over $5 million to specified government programs or pursuant to coverage under such programs.

There were a few articles in June about the rising drug costs by Pfizer – 91 drugs rose by an average of 20% in 2017.   How much of that price increase is due to the IRS’s required brand fee/excise tax?   Obviously the brand manufacturers are going to pass this fee down the chain of payers including pharmacies, wholesalers, plan sponsors and, of course, consumers.    

The Washington Examiner article dated June 2, 2017, commented that pharmaceutical companies price their drugs high to recoup the soaring research and development costs. Consumer and patient advocacy groups complain that there is no way to determine how much of the revenue goes to actual research versus marketing.  However, few mention the required fee/tax, payable to our government by covered entities, i.e. pharmaceutical manufacturers , as being another contributor of the two to four  increases in Average Wholesale Prices on drugs per year.

If you would like to learn more about these fee calculations, please go the IRS website at:

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Voluntary Drug Recall

PBIRx®
Intelligent Solutions in Pharmacy Benefits
12 Wheelers Farms Road, Milford, CT 06461
(888) 797-2479

Lupin Pharmaceuticals, Inc. has announced that they voluntarily recalled Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1mg/0.02 mg chewable and ferrous furnarate 75mg) Tabelts -- Lot L600518 with an expiration date of 5/18.

A packaging error occurred and the weekly tablet orientation has been reversed whereby the first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets.

This product is an oral contraceptive indicated for the prevention of pregnancy.  The products are packaged in blistered packs containing 28 tablets.  

Customers who have these products should contact their physician and return the prescription to the place of purchase.

PBIRx has not only notified its Clients who have members on this drug, but also worked with the client’s various PBMs to be sure that the members are notified.

To view the full announcement, go to https://www.fda.gov/Safety/Recalls/ucm560904.htm

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Auditing PBM Agreements Can Save Money

PBIRx®
Intelligent Solutions in Pharmacy Benefits
12 Wheelers Farms Road, Milford, CT 06461
(888) 797-2479

“Pharmacy” benefit costs in the US are predicted to increase from $323 Billion in 2016 to $580-$610 Billion in 2021 according to a report by QuintilesIMS Holdings, Inc.    

Pharmacy Benefit Managers love when their clients do NOT audit their pharmacy benefit agreement!   This way the creative language in their contracts is not revealed and you pay more and more each month and each year.

Auditing pharmacy claims can generate significant monetary recoveries, while at the same time providing you with the confidence that your current pharmacy benefit financial discounts and guarantees are competitive for 2017.  PBIRx can tell you what parts of your PBM contract are not competitive. PBIRx clients experience a 5%–15% recovery of total drug spend, while at the same time ensuring that the PBM contract financial terms are being adjudicated correctly.

PBIRx®, a pharmacy benefit auditing and consulting corporation with locations in Connecticut and Missouri  since 1993, has the technology, tools, years of experience and experts that can help you recover lost dollars using our AuditRx® technology.   

PBIRx has several references nationwide that will attest to not only the audit recoveries that we facilitate, but also the savings to their pharmacy benefit budget.  Pharmacy Benefit Agreements, whether direct with the PBM, through the health plan carrier (i.e. Anthem, Cigna, Aetna, etc), or through a coalition, state that auditing may be limited to a certain time period (typically the previous 12 months).  Not knowing the period of time that you can audit your pharmacy benefit claims and not reaching out to PBIRx results in a lost recovery opportunity!

Why you should have PBIRx review your Pharmacy Benefit Agreement with no fee:

• To determine if there is a potential pharmacy benefit claims  recovery
• To know if the discounts in the PBM Agreement are actually being adjudicated as stated
• To learn if the financial model (discounts, rebates, guarantees, etc.) is 2017 competitive
• To provide union negotiated pharmacy benefits at a lower cost
• To know if there are other opportunities for savings to reduce costs while maintaining current copays and plan design features in negotiated union contracts
• To be reminded of important dates that could result in lost “time value of money”, i.e. guarantee/rebate remittance, agreement renewal period, non competitive automatic renewals, etc.

PBIRx will provide a courtesy review of your PBM agreement upon request.  Please contact David Sirowich at dsirowich@pbirx.com or call 203-882-1188 to discuss your potential savings in greater detail.  You can also visit our website www.pbirx.com for more information.

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Glucose Meters and Test Strip Tips for Diabetes Patients

PBIRx®
Intelligent Solutions in Pharmacy Benefits
12 Wheelers Farms Road, Milford, CT 06461
(888) 797-2479

Follow instructions carefully. Glucose meters and test strips are sold with instructions for use. You can call the manufacturer of your device or your health care provider if you have questions.

Ask your health care provider to watch you test yourself to be sure you are using your device correctly.

Do quality control checks of your device. Regularly test your meter using a control solution to make sure the test strips and meter are working properly together.

Understand what the meter display means. Be sure you know how high and low glucose values are displayed on your meter. Sometimes they are displayed as “LO” or “HI” when the glucose level is beyond the range than the meter can measure. Talk to your health care provider if you have questions.

Know which test site gives the most accurate results. 

• Readings from alternate sites—such as your forearm or palm—can be less accurate than fingertip readings when your glucose levels change quickly (like after you eat or during exercise).
• Take a reading from a fingertip if you think your blood glucose is low, especially if results from an alternate test site don’t match how you feel.

Know when and how to clean and disinfect your glucose meter.  Always read and follow the directions in your manual.

Do not use pre-owned or second-hand test strips.

• Test strips should be properly stored to give accurate results. If you buy pre-owned strips, it is hard to know whether the strips were stored properly.
• Test strip vials that have been opened by another person may have small amounts of blood on them, which can put you at risk for infection.
• Pre-owned test strip vials may have been tampered with, which means that they may not be safe to use. (i.e., the expiration dates might have been changed or covered up.)
• Pre-owned strips also may not have been cleared by the FDA for sale in the United States.

Know when to report device problems. In an emergency, call 9-1-1. For non-emergencies, the FDA encourages you to report any issues to MedWatch, the FDA’s voluntary reporting program. (i.e., devices that don’t work, suspected incorrect results, or any other problem with your meter or test strips.)

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.