Samaritan Medical Tower Pharmacy
Los Angeles, CA
Anthony's Family Pharmacy
Seneca Pharmacy of W New York
Nickel City Pharmacy
Nine Generic Firms Get FDA Approval for Generic Lyrica
The Food and Drug Administration has approved multiple applications for first generics of Pfizer's Lyrica (pregabalin).
Following on the heels of news that the FDA gave its approval to Amneal, the FDA announced that the following companies also received clearance for generic Lyrica: Alembic, Alkem, Dr. Reddy's, InvaGen, MSN Laboratories, Rising Pharmaceuticals, Sciegen, and Teva.
By Sandra Levy Published in Drug Store News (edited)
Drug Prices in Ads?
Not so Fast: Court Strikes Down HHS Rule at 11th Hour
Change of plans: Just one day before the Trump administration rule requiring pharma to put drug list prices in TV ads was to go into effect, a federal judge struck it down.
U.S. District Court Judge Amit Mehta vacated the rule on July 9, 2019 on the grounds that the Department of Health and Human Services (HHS) does not have the statutory authority to adopt the rule. The ruling backs the lawsuit filed three weeks ago by Merck, Eli Lilly and Amgen, along with the Association of National Advertisers (ANA), to stop the implementation.
Changes on the Way for Track-and-Trace
Requirements for wholesalers that may impact your pharmacy under the Drug Supply Chain Security Act (also known as the "track-and-trace law") are coming in November. After Nov. 27, wholesalers can only accept pharmaceutical products from any trading partner, including pharmacies, that have a DSCSA-compliant product identifier, unless it is subject to a waiver, exception, or exemption under the law or it meets FDA guidance regarding grandfathered product. It is critical for community pharmacists to understand these changes impacting returns to wholesalers and plan accordingly. We'll have programming on this at the 2019 NCPA Annual Convention, in the meantime, here are the requirements and more information from the FDA.
PFOA Board of Directors Election Results
Our Board elections are complete and results have been tabulated.
Todd Pendergraft and Doug Coyle have been reelected to the PFOA Board. In addition, David Spence will be joining the Board.
Doug Coyle will be serving double duty as he was also elected to the PFOA-MS Board. Dave Cole was also reelected.
Bobbie Barbrey was reelected to the PFOA-MC Board and Gene Windom will be serving on the MC Board as well.
The Board members will be meeting soon to elect Officers.
Meet Our New
David Spence has owned Spence's Medical Center Pharmacy in Lake Jackson, TX and Long Term Care Rx in Angleton, TX since 1999. He has been a member of PFOA since its inception.
David earned his pharmacy degree from the University of Texas. His vision for working with PFOA is to try to level the playing field where store owners compete and succeed on their own merits as well as to practice progressive pharmacy.
In his leisure time, David enjoys playing golf.
PFOA - MC Board
Gene Windom has owned Medicap Pharmacy in Clermont, Florida since 2006. He graduated with his PharmD from Mercer University Southern School of Pharmacy. His store specializes in compounding for animals, hormone replacement and ED drugs.
Gene has been a member of PFOA since 2010 and he is also a member of the Florida Pharmacy Association. Gene is a dedicated compounding pharmacist and wants to work toward keeping compounding in credentialed pharmacies.
In his leisure time, Gene enjoys fishing.
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(NCPA) National Community Pharmacists Association
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(NASPA) National Alliance of State Pharmacy Associations
July included participating in the Cardinal RBC and the ABC ThoughtSpot. We opened PFOA's annual meeting in Nashville at the RBC and closed it in Las Vegas at the ABC ThoughtSpot. Board elections were conducted and the results will be announced shortly. We will then conduct a Board Meeting to elect officers.
is up and running. Please look for an email from PFOA with instructions on registering your password. The Members Only section includes rebate information, videos and vendor information. We will continue to build and share information through the website. We also urge you to join our members only Facebook page:
With Nancy Coibion officially retired, our staff continues to perform day to day administrative operations. Nancy was officially honored for her years of service at the annual meeting in Nashville.
We have begun member surveys, working on getting to know our members better. Please take time to complete and return these questionnaires.
Day to day operations will shift to the Coral Springs office and those arrangements will continue throughout the month of August. We will work to get our members participating in data mining programs that will help them expand abilities to increase profitability.
In July, one of our long-time board members, Ron Robichaux and his wife sold their store. I spoke with Ron as have a number of board members. For Ron it's a time of mixed emotions. He has a pharmacy family and a long-time association in his community. We wish them well. Ron would like to stay involved with PFOA and I feel sure he can contribute to the success of the organization and its members.
As always, I thank you for the opportunity to serve as PFOA's executive director.
NACDS Launches Campaign Urging DIR Fee Reform in Drug Pricing Bill
The National Association of Chain Drug Stores is using cable, broadcast and digital advertising to spread the message about the dire nature of direct and indirect remuneration, or DIR fees.
Pharmacy DIR fees have exploded by 45,000% from 2010 to 2017 and are inflating seniors' out-of-pocket costs for prescription drugs and forcing pharmacies out of business, and must be addressed in drug-pricing legislation, the ads state.
"About one-quarter of the U.S. Congress signed letters in June urging DIR fee relief. Patient and consumer groups including the National Consumers League, The AIDS Institute, the National Multiple Sclerosis Society, the Lupus and Allied Diseases Association, and many more have called for DIR fee relief. These ads will turn up the volume even more on this crucial message: now, as part of drug-pricing legislation or through regulatory action, Congress and the administration need to address these phantom fees that secretly inflate seniors' out-of-pocket drug costs and that shutter pharmacies by forcing them to sell prescription drugs often below-cost," NACDS president and CEO Steve Anderson, said.
The ads coincide with the anticipated legislative markup by the Senate Finance Committee. Other Senate and House panels are writing drug-pricing packages as well.
In a January 2019 survey conducted by Morning Consult and commissioned by NACDS, about 7-in-10 voters said they find pharmacists credible for drug-savings solutions, and said they want to see changes in rules by which payers reimburse pharmacies below-cost and unpredictably.
By Sandra Levy, Published in Drug Store News (edited)
DOJ Indicts 2nd Opioid Distributor for Role in Illegally Pushing Pills Despite Warning Signs
With federal scrutiny mounting on claims it profiteered from the nation's opioid epidemic, Ohio-based Miami-Luken shuttered its doors for good last year. But if the former company's leaders thought that was the end of their problems, they were sorely mistaken.
On July 18, 2019, Department of Justice (DOJ) prosecutors charged Miami-Luken's former president, Anthony Rattini-along with a former compliance officer and two pharmacists-with illegally distributing opioids at the height of the nation's addiction crisis. The charges come with a maximum penalty of 20 years in prison.
Miami-Luken is now the second wholesale opioid distributor that has faced criminal charges for its role in the opioid epidemic after two former executives from Rochester Drug Co-Operative (RDC) were indicted by the DOJ in April. According to the Dayton Daily News, Miami-Luken shut down in October amid congressional inquiries, multiple lawsuits and a $2.5 million settlement with the state of West Virginia.
The newest charges against Miami-Luken come as federal scrutiny focuses on drugmakers, distributors and manufacturers for their role in fueling a nationwide opioid epidemic that claimed nearly 100,000 lives between 2006 and 2012.
In April, RDC and two former execs were charged with illegal distribution, a move Drug Enforcement Administration Special Agent in Charge Ray Donovan said "should send shock waves throughout the pharmaceutical industry." RDC agreed to pay a $20 million penalty and admit guilt in exchange for five years of deferred prosecution.
The two former RDC execs, former CEO Laurence Doud III and former Chief Compliance Officer William Pietruszewski, both face 15 years in prison.
Although Miami-Luken and RDC are the only distributors that have faced criminal charges for their role in the nation's opioid epidemic, McKesson agreed to pay a record $150 civil penalty in early 2017 for not reporting suspicious sales of controlled drugs from its distribution centers in Colorado, Ohio, Michigan and Florida. The distributor had previously paid a $13.25 million penalty on similar charges.
The DOJ also knocked distributor Cardinal Health for $44 million on similar violations of the Controlled Substances Act, and both Cardinal and AmeriSourceBergen reached settlements with the state of West Virginia for a combined $36 million.
By Kyle Blankenship, Published in Fierce Pharma (edited)
Trump Administration Tosses
Drug Rebate Rule
The Trump administration has killed its plan to eliminate safe harbors for drug rebates, dealing a blow to the pharmaceutical industry.
A White House spokesman confirmed to Fierce Healthcare that the controversial rebate rule is dead after "careful analysis and thorough consideration," declining to elaborate. The change was first reported by Axios.
Under the rule, the Department of Health and Human Services would lift safe harbor protections from drug rebates negotiated by PBMs and instead offer them for pass-through discounts.
This follows significant pushback from payers, pharmacy benefit managers and providers, who warned that nixing the safe harbors in Part D could lead to higher premiums for patients.
PBM and insurer industry groups also warned that ending rebates doesn't target the true source of the problem: pharmaceutical companies..
Eliminating the rebate rule is a blow to the pharma industry, which backed the plan and took great lengths to shift blame for rising drug prices to PBMs and insurers.
A report from the Congressional Budget Office suggested that eliminating the rebates would increase Part D premiums and federal spending.
President Trump also said that he will unveil in the next two weeks an executive order to install a "favored nations" clause to ensure the U.S. doesn't pay more than other countries on drug prices. The White House has not elaborated on what the clause will apply to or when the order will drop.
Published Changes to USP General Chapters Will Become Official on December 1, 2019
The published revisions to United States Pharmacopeia (USP) General Chapters 795, 797, and 800, will become official on December 1, 2019. To provide guidance and answers to frequently asked questions for these changes, USP has developed several resources:
Because of the many questions related to the enforceability of General Chapter 800, USP also developed a short video that discusses the compendial applicability of the Chapter, including what types of activities require it to be enforced. This video can be accessed under the Resources section on the General Chapter web page.
For more information about USP 800, visit our website www.pfoai.org
, log into the Members Only section and watch the webinar recently conducted by Spectrum Pharmacy Products.
Pharmacists Flex their Clinical Muscles, Build Revenue
According to the National Community Pharmacists Association's 2018 Digest, 73% of independent pharmacies are immunizing. As of December 2018, more than 340,000 pharmacists have been trained to administer vaccines across the patient lifespan. This is a substantial increase from the 40,000 who had been trained in 2007, according to Janet Engle, department of pharmacy practice professor and senior associate dean for professional and international affairs at the University of Illinois at Chicago College of Pharmacy. Engle said that all accredited schools of pharmacy are required to include immunization training as part of their core curriculum.
Although state laws vary for the need for a protocol and/or prescription to give a vaccine, minimum age limit, and the vaccines pharmacists are authorized to administer, pharmacists have the authority to prescribe vaccines in all 50 states, as well as Puerto Rico and the District of Columbia.
Indeed, pharmacists have made substantial headway as immunizers, even overcoming pushback from many physicians who viewed pharmacists as a threat to their revenue stream to become a trusted resource and accessible source for patients' vaccination needs.
Education is Key
Like many healthcare providers who vaccinate, pharmacists face challenges, including the growth of the anti-vaccination movement, which has been spreading misinformation that vaccines cause illnesses and such conditions as autism. The movement has been tied to the current measles outbreak, as the majority of cases are occurring among unvaccinated children, the CDC said.
Pharmacists can be instrumental in providing accurate information to parents since they more usually are accessible than other healthcare providers, experts said.
"Part of the guidelines for pharmacy-based immunizations is for pharmacists to keep up to date with current recommendations so that they can address the myths and facts," Mitchel Rothholz, APhA's chief strategy officer said. "Pharmacists are able to take the information that emanates from the CDC and other reputable organizations and share those consistent messages with the public, and answer some of those questions that arise when there is misinformation."
A crucial part of administering vaccinations for pharmacists is keeping abreast of the range of immunizations available to them.
For instance, Merck's Zostavax has been in use since 2006, but since the introduction of GSK's Shingrix in 2017, Shingrix has become the CDC's preferred vaccine for prevention of herpes zoster and related complications in healthy adults age 50 years old and older, GSK said. Other changes include expanded age indications for certain immunizations and new immunizations for dengue or protecting children against diphtheria, tetanus, pertussis, polio and hepatitis B all at once.
It also is imperative that pharmacists are aware of their state's regulations. For example, New York State has a sunset on the legislation that gives pharmacists the authority to vaccinate, and it has to be renewed every two years.
APhA, which 25 years ago created a certificate training program in immunizations across the lifespan, had immunizing pharmacists who saw a need in their community for travel health services. APhA now has an advanced practice training program for travel health services, and pharmacists also can obtain an international certification.
"Pharmacists doing travel health provide more than vaccinations; they also address other healthcare needs if people are traveling to areas where there is a water or food issue," APhA's Rothholz said. "Pharmacists can educate patients on how to protect themselves." As more pharmacists become involved with immunizations and travel clinics, they have an opportunity to expand their health-and-wellness services.
It appears likely that pharmacists will play a key role in the growth of vaccination rates, especially if vaccination registries, which are voluntary in some states, become mandatory.
By Sandra Levy, Published in Drug Store News (edited)
Senate Privacy Bill Aims to Set
New Federal Standard for
Consumer Health Apps
Sens. Amy Klobuchar (D-Minn.) and Lisa Murkowski (R-Alaska) have introduced a bill that would create new privacy regulations protecting consumer health data collected through health tracking apps, fitness wearables and direct-to-consumer DNA testing kits. The bill would set a new federal standard for biometric consent, the Senators said.
"New technologies have made it easier for people to monitor their own health, but health tracking apps and home DNA testing kits have also given companies access to personal, private data with limited oversight," Klobuchar said in a statement. "This legislation will protect consumers' personal health data by requiring that regulations be issued by the federal agencies that have the expertise to keep up with advances in technology."
The topic of consumer data privacy is heating up, both on and off the Hill. Facebook recently came under fire for its privacy policies after a complaint filed with the FederalTrade Commission accused the social media company of exposing users' sensitive health data. Facebook has since made privacy changes to its platform when it comes to users discussing health conditions or sharing health information in closed groups.
An investigation by The Wall Street Journal also revealed that apps tracking sensitive information are sending that data back to Facebook, unbeknownst to the people using those apps, and the Washington Post reported that a pregnancy tracking app has been selling user data to employers.
Current laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA) do not adequately address the emerging privacy concerns presented by these technologies, Klobuchar and Murkowski said.
The legislation requires the Secretary of Health and Human Services (HHS) to promulgate regulations for genetic, biometric and personal health data that are not regulated by existing laws and ensure that the new regulations take into account appropriate standards for consent.
The measure also would create a national task force to evaluate cybersecurity risks and privacy concerns associated with consumer products that use personal health data. It also would give consumers the ability to navigate their health data privacy options, including deleting personal health data that companies collect or use.
"This legislation takes important steps to ensure guidelines are created for security and privacy protections of modern health information. Our policies must evolve to keep up with advancements in recent technology," Murkowski said in a statement.
by Heather Landi , Published in Fierce Heathcare (edited)|