PFOA logo

"To Preserve, Protect and Promote

the Interests of Pharmacy Owners."


October 2018
In This Issue
Welcome New
PFOA Members
   
Potter Drug
Athens, IL
 
Potter Drug
Petersburg, IL
 
Jones Drug 05
Millbrook, AL
 
Zoha's Pharmacy
Bakersfield, CA
 
Metier Pharmacy
Phoenix, AZ
 
Carepharm Pharmacy
Bakersfield, CA
 
Honest Pharmacy
Monterey Park, CA
 
Medicine Shoppe 1718
Orinda, CA
 
Spencerport Family Apothecary
Spencerport, NY
Educate Patients About Safe Acetaminophen Use During Cold and Flu Season
 
During cold and flu season, the Acetaminophen Awareness Coalition encourages health care providers to educate patients about safe acetaminophen use. Almost 50% of acetaminophen overdoses are unintentional and a result of not reading and following the medicine label, according to the Acetaminophen Awareness Coalition's Know Your Dose campaign.
 
The campaign offers several key tips to share with patients when discussing acetaminophen, such as:
  • Read and follow the instructions on the label.
  • Know which medicines contain acetaminophen.
  • Take only one medicine at a time that contains acetaminophen.
  • Ask a pharmacist or health care provider about dosing instructions or medicines that contain acetaminophen.
 
Pharmacists are trained to understand how medications work in the body and to identify medication interactions. Their accessibility and expertise can help educate patients about safe acetaminophen use. To download or order free patient educational materials, including posters, flyers, and talking points, visit the Know Your Dose website. NABP's AWARXE® Prescription Drug Safety Program is a coalition member. The AWARXE Program also offers educational resources for pharmacists about medication safety and drug disposal.
From NABP E-News
Health Care Providers Encouraged to Discuss Medication Use With Patients to Promote Better Outcomes
 
October is recognized as "Talk About Your Medicines" month, an annual opportunity that encourages conversations between patients and their health care providers to promote better medication use and improved health outcomes. Focusing on opioid safety, the 2018 theme, "Taking Action to Prevent Opioid Abuse and Misuse," aims to address how patients, their families, caregivers, and health care professionals can work together to manage opioids and avoid potential misuse or abuse. To learn more, visit NeedyMeds' BeMedWise website.

NABP and the boards of pharmacy are committed to ensuring pharmacies and pharmacists are providing consumers and their families medicines and patient services that are safe. NABP's AWARXE® Prescription Drug Safety Program provides helpful offerings to educate pharmacists, colleagues, and patients about safe medication use. For more information visit the Pharmacist Resources section.
From NABP e-News
PFOA logo
PFOA
Board of Directors
 
President:  
Todd Pendergraft
todd@bafamilydrug.com

Vice President:
 Doug Coyle
 
 
  Treasurer:
    Larry McIntosh 
Larry@PharmaxPharmacy.com

Secretary:
Phil Rigsby
256-536-1910
phillip@huntsvillecompounding.com


  Board Members: 

Gabriel Guijarro
936-634-3006
grgrph@gmail.com

 Eric Pusey
rprp3@aol.com

  Ron Robichaux
bayourx@bellsouth.net

Ty Stout
661-717-1814
tystout@eltejonpharmacy.com
  
John Zuzack
jdzuzack@gmail.com

Non-Voting Board Members:

Dirk Andrepont
337-948-7703

Gaye Moseman
910-617-8549

   
PFOA-MS
Board of Directors
 
President:
Dirk Andrepont
337-948-7703
 
Secretary/Treasurer: 
John Zuzack
 
David Cole
610-539-7282

Phil Rigsby
256-536-1910
 
 
PFOA-MC
Board of Directors

  President:
Eric Pusey
 
Vice President:
Devin Trone
208-571-6434 
 
Secretary/Treasurer: 
Bobbie Barbrey
919-345-8736

PFOA Staff
Contact Information 
 
   
David Mayper
Executive Director
305-773-5822
DMayper@pfoai.org

Wesley Drake III
National Director of Sales
704-488-0270
WDrake3@pfoai.org
 
 
Nancy Coibion
Administrative Assistant
Phone:844-270-0290
Fax:314-843-5579
Nancy@pfoai.org
 
Mailing Address
  10944-B Gravois Industrial Court 
  St. Louis, MO 63128
 
Wesley Behar
West Region Sales
661-904-4939
WBehar@pfoai.org

Wes Drake
Florida Sales
863-944-0747
WDrake@pfoai.org

Karen Godbold
Executive Administrator
407-456-3231
KGodbold@pfoai.org

Ronda Hubbard  
Generics Specialist/Sales
407-492-8845
Fax: 270-632-4206
RHubbard@pfoai.org
   
Al Schuster
Northeast Sales
216-409-6597
ASchuster@pfoai.org
 
Bob Sutton
Vendor Programs/Mid-West Sales
636-577-7107
BSutton@pfoai.org
 
Nancy Tataronis
Vendor Relations/Marketing
786-556-0007
NTataronis@pfoai.org
 
  Jamie Wilbanks
Inside Sales/Service
Toll Free: 888-406-7467
JWilbanks@pfoai.org

Get Linked In!  
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Pharmacy Franchisees and Owners Assn
   
(FPN) Federation of Pharmacy Networks
 
       (NCPDP) National Council for Prescription Drug Programs
   www.ncpdp.org  
 
        (NCPA)  National Community Pharmacists Association
    www.ncpanet.org 

(NABP) National Association of
Boards of Pharmacy

(NASPA) National Alliance of State Pharmacy Associations

  Pharmacist E-Link   
 
 

Dave Mayper
In September, PFOA conducted our first meeting of the reengineering project.  The meeting included a combination of select board members, our professionals, vendor representation, affiliate partner representation, and an independent store owner outside of our organization with experience in multiple organizations affiliated with Healthcare.  We continue working on this important project.
 
We recently held a PFOA staff meeting at the offices in South Florida.  It proved to be an excellent opportunity to cover some strongly needed areas. I want to thank our vendor sponsors who made the meeting financially possible:  Windmill Labs, Rx Systems, Prescribe Wellness and Selzer Insurance. All of them presented material at the meeting which was very helpful. 
 
We have had good news on both the AAP and American Pharmacy fronts.  A significant number of members of American Pharmacies are signed up for dual membership and the process continues.  This will help the members and the PFOA organization.  AAP has reached an updated agreement with Cardinal Health.  The new program will provide the vast majority of members with significant opportunity for savings.  Our members are already signing up to take advantage of this new program.  We have been asked by a number of members to weigh in on the best direction for both these programs. 
  
Two PFOA staff members and I attended the NCPA annual meeting in Boston where we attended meetings with vendors and partners as well as visiting the show floor and attending pertinent CE presentations.
 
Last week I received an urgent call from one of our members.  Their former prime vendor had been holding their reimbursements by their PSAO.  With no real response, the member felt he was less than a week away from having to close the doors in the two locations.  We got our legal team in touch with them and looks like we will have a resolution.  Once again we show our value to a member who never  thought he had that kind of need until the issue emerged.  One of the vendors presenting at the recent staff meeting indicated we were the most successful at saving our members money via their service. A board member earlier in that week verified they were able to save significantly because we put the member in touch with him.  Very often members see daily purchases and rebates and miss the multitude of opportunities to add to their success. We will continue to reach out to our members and to prospects with programs and services that can add to their success.
 
Thank you for continuing to permit me to serve as your executive director
  

Yours Truly,
David Mayper
 
Trump Signs Industry-backed Legislation Ending 'Gag Clauses'

On October 10, 2018, President Trump signed the Patient Right to Know Prices Act (S. 2554) and the Know the Lowest Price Act (S. 2553) at a ceremony at the White House.
 
The bills will help patients save money on prescription drugs by ending so-called "gag clauses" that prevent pharmacists from telling patients about instances in which they could save money by paying cash out-of-pocket instead of using their insurance benefit. S. 2553 pertains to Medicare Part D and Medicare Advantage, and S. 2554 pertains to private plans.
 
In addition, S. 2554 includes a separate NACDS-backed provision that requires the Federal Trade Commission and the Department of Justice to be notified of any biosimilars patent settlements, as a way to prevent such agreements from delaying patients' access to lower-cost drugs.

By Sandra Levy, Published in Drug Store News (edited)
CVS Health-Aetna Merger Gets Conditional DOJ Approval
 
CVS Health has been given the Department of Justice's approval for its proposed acquisition of health insurer Aetna - with one condition. The DOJ's clearance came with the requirement that Aetna divest its standalone Medicare Part D prescription drug plans - a move that already has been announced, with WellCare Health Plans set to take over the plans, which have roughly 2.2 million members. Under the agreement with WellCare, Aetna will administrate and retain financial results from the plans through 2019.
 
CVS Health noted that several state regulatory approvals have already been granted, and that the acquisition is now on track to close in the early part of the fourth quarter of 2018. Once the merger is complete, Aetna will operate as a standalone business within CVS Health's enterprise, led by current members of its management team.
By David Salazar, Published in Drug Store News (edited)

WellCare Agrees to Buy Aetna's Part D PDP Business Ahead of CVS Health Merger
  
WellCare Health Plans will be acquiring the entirety of Aetna's standalone Medicare Part D prescription drug plan business, effective 11:59 p.m. on Dec. 31, according to a Securities and Exchange Commission filing from CVS Health.
 
The company said that the Part D drug plan business had roughly 2.2 million members as of June 30. The filing notes that the divestment doesn't affect Aetna's Medicare Advantage, Medicare Advantage Part D or Medicare Supplement plans for individuals or groups.
By David Salazar, Published in Drug Store News (edited)

New York Poses Potential Hurdle for CVS Health-Aetna Merger

New York regulators on October 19, 2018,  threatened to block CVS Health's $69 billion merger with health insurer Aetna, demanding that the companies not raise insurance premiums in New York and that its pharmacy-benefits manager, or PBM, submit to state regulation, according to a New York Post report.
 
With federal regulators conditionally approving the merger, and Connecticut giving thumbs up this week, New York is one of the last hurdles that CVS Health is facing in getting the go-ahead to buy the nation's third-largest insurer.
 
"I can stop the deal if it is reasonably necessary to protect New Yorkers," said Department of Financial Services superintendent Maria Vullo at a public hearing, according to the report.
 
Vullo's concerns are largely focused on ensuring that insurance premiums don't increase in the aftermath of the merger, as well as with getting CVS Health to support a proposed state law that would require PBMS to register with New York's finance department. Proponents of the bill said that it would give DFS the power to reduce drug prices and limit abusive practices.
 
The report noted that CVS Health lawyer Elizabeth Ferguson said, "We would not oppose it," when asked if the company would support the bill.
By Sandra Levy, Published in Drug Store News (edited)
NABP Report Shows How Social Media Leads Consumers to Dangerous Pharmacy Sites
 
NABP published the September 2018 Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators . The report shows how social media sites can lead consumers to dangerous rogue pharmacy sites through simple keyword searches.

During a four-week study, the Association performed keyword searches on multiple social media platforms and easily found posts leading to rogue pharmacy websites selling commonly counterfeited and/or abused prescription medications. On the social media platform Pinterest, for example, NABP found 66 posts promoting the sale of medications, and 38% of these posts provided links to websites selling prescription medicines illegally. Characteristics of these illegal sites include selling medicine that was not approved by the United States Food and Drug Administration (FDA), not requiring a prescription, and selling controlled substances. Keyword searches performed on Instagram, Facebook, Twitter, Reddit, and eBay garnered similar results.

Keywords and terms used to perform the searches included "Viagra," "Ciprofloxacin" (brand name Cipro®), and "Xanax for sale online." This review of social media sites was a subset of NABP's ongoing study of online drug sellers, which has found that 95% of websites selling prescription drugs online are doing so illegally.

NABP has been working with social media companies and other stakeholders to protect consumers from fake pharmacies. One example is Twitter's and Snapchat's requirement that advertisers of pharmacies and pharmacy products must be verified by NABP. In addition, NABP shared the results of the study with representatives from Pinterest, who said they are aware of the problem and are taking steps to further reduce the number of illicit Pins that slip through their filters. As Americans' reliance on social media platforms for news and information has grown in recent years, it is expected that the prevalence of rogue online pharmacies in these spaces will also increase. The goal is for social media companies to take steps and use available resources to screen and monitor their platforms for harmful content linking to illegally operating websites.

Consumers who buy medicines from NABP-verified websites can be confident they are buying medicine from trustworthy, legitimate pharmacies. An easy way to know that a website has been verified by NABP is to look for the .pharmacy domain at the end of the web address. A list of safe online pharmacies and related resources can be found on the Find a Safe Site page of
www.safe.pharmacy .

Read the full report and learn more about social media sites and rogue online pharmacies by visiting the Program and Committee Reports page in the Publications and Reports section of
www.nabp.pharmacy .
FDA Offers CE Course on Reducing Hypoglycemic Events in Patients with Type 2 Diabetes
 
With National Diabetes Month approaching in November, Food and Drug Administration (FDA) is offering a free, one-hour continuing education (CE) course for health care providers (physicians, pharmacists, nurses, and others) about the reduction of hypoglycemic events in patients with Type 2 diabetes. The course, Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemic Events in Patients with Type 2 Diabetes , will describe the prevalence of hypoglycemic events and identify risk factors leading to an event.

Further, the course will introduce methods of assessing health literacy and numeracy of patients and caregivers; review effective ways to incorporate patient preferences into care plans; and list action steps to reduce the likelihood of a hypoglycemic event for high-risk patients. FDA's CDERLearn in the Center for Drug Evaluation and Research (CDER) offers a variety of learning opportunities. To learn more, visit FDA's website.

The FDA CDER is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education (CPE). This program meets the criteria for one contact hour (0.1 CEU) of CPE credit. The ACPE Universal Activity Number for this knowledge-based activity is 0453-9999-17-449-H01-P.
From NABP e-News
Complete Your 2018 Fraud, Waste and Abuse Attestation by December 31st
 
It's that time of year! Please take a moment to complete your 2018 FWA Attestation-all attestation must be completed before the end of the year to remain in compliance with CMS and contracted PBMs.
 
How to Complete the Attestation
CMS has developed a standardized FWA training education module, available on their 
Medicare Learning Network . You will need to create a CMS account to access the training.

Attestation must be completed on the NCPDP website (
www.ncpdponline.org ), and directly with Caremark.

Why FWA Attestation Matters
CMS provides guidance and specific requirements to participate in Medicare Part D. Provider Network and NCPDP worked together to create the FWA Attestation to satisfy those CMS obligations under agreements that we sign on your behalf with PBMs and Payers. In order to continue to participate in Medicare Part D Plans and service Medicare patients, all Provider personnel must complete training each calendar year. 

While you are logged in to NCPDP don't forget to complete your Expanded Profile!

From Elevate Provider Network e-Newsletter (edited)
Bose Wins FDA Green Light for Direct-To-Consumer Hearing Aid
 
The FDA has cleared a direct-to-consumer hearing aid, developed by speaker manufacturer Bose, potentially opening the door for other consumer-focused electronics companies.
 
The de novo clearance makes it the first hearing aid authorized by the agency that allows users to fit, program and control the device on their own, without help from a healthcare provider. The Bose Hearing Aid is a wireless amplifier placed in the ear canal that can be adjusted by the user through a smartphone app.
 
In its review, the FDA evaluated clinical study data from 125 patients that showed outcomes with self-fitting of the Bose Hearing Aid were mostly comparable to professional fittings of the same device, between the amount of amplification selected, speech-in-noise testing and overall benefits.
 
In addition, when participants self-fit the hearing aid, they reported generally preferring their settings over professionally selected settings.
 
Though users may fit the hearing aid on their own, the Framingham, Massachusetts-based Bose must comply with applicable federal and state laws regarding the sale of hearing aids, including state laws that might require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser, the FDA said.
 
The agency said it is working on proposing regulations that would allow for a new legal category of over-the-counter hearing aids, required by the latest reauthorization of the FDA's user fee agreements passed last year.
 
By Conor Hale Published in fiercebiotech (edited)
FDA Approves New Drug 
to Treat Influenza
 
On October 24, 2018, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
 
"This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. ...This novel drug provides an important, additional treatment option," said FDA Commissioner Scott Gottlieb, M.D. "While there are several FDA-approved antiviral drugs to treat flu, they're not a substitute for yearly vaccination. Yearly vaccination is the primary means of preventing and controlling flu outbreaks."
 
"When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick," said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research. "Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs."
 
The safety and efficacy of Xofluza, an antiviral drug taken as a single oral dose, was demonstrated in two randomized controlled clinical trials of 1,832 patients where participants were assigned to receive either Xofluza, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms. In both trials, patients treated with Xofluza had a shorter time to alleviation of symptoms compared with patients who took the placebo. In the second trial, there was no difference in the time to alleviation of symptoms between subjects who received Xofluza and those who received the other flu treatment.
 
The most common adverse reactions in patients taking Xofluza included diarrhea and bronchitis.

Xofluza was granted Priority Review
under which the FDA's goal is to take action on an application within an expedited time frame where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
 
The FDA granted approval of Xofluza to Shionogi & Co., Ltd.