GPhA outlines 2014 priorities
WASHINGTON — The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization.
“Generic pharmaceuticals play a critical role in any strategy to hold down health costs,” stated Ralph Neas, president and CEO of GPhA. “As we approach the 30th anniversary of Hatch-Waxman, it is especially important that we preserve and strengthen its legacy by ensuring unimpeded patient access to affordable generic medicines," he said. "We will continue to work with policymakers to ensure any proposed laws and regulations do not undo the framework responsible for decades of more affordable generics and trillions of dollars in savings.”
Through 2013, generic utilization hit an all-time high as 84% of prescriptions dispensed were generic, Neas added. "Efforts to promote generic competition are continuing to bear fruit. Congress passed the Drug Quality and Security Act to establish a nationwide, reliable system for tracking prescription medicine that further safeguards our nation’s prescription drug supply and protects patients," he said. "The law also enhances the ability of regulators to limit risks posed by counterfeit or adulterated products and reassures patients that the generic medicines they receive are secure from the manufacturer all the way to the pharmacy.”
In the states, legislation that would hinder access to biosimilars and interchangeable biosimilars was introduced in 19 states in 2013, blocked in 11, enacted with significant amendments in three states, and enacted with Amgen and Genentech-backed provisions intact in only one state (North Dakota).
Also in 2013, the Supreme Court reaffirmed the constitutionality of patent settlements with consideration and preserved the unprecedented success of the current path for getting generics quickly to patients and consumers.
Looking ahead to 2014, GPhA’s top priority is to protect patient safety and access to affordable medicines by working with stakeholders to ensure that the FDA’s proposed rule on prescription drug labeling reflects sound policy, rather than politics, the association stated. GPhA opposes the FDA proposed rule that would alter the requirements for labels on generic medicines, which the association states would undermine the essential “sameness” of the label between generic and brand drugs mandated by law. It is difficult to overstate the confusion that would be created among health care professionals and consumers when multiple versions of critical safety labeling information makes its way to the marketplace under this rule.
Further, the rule as drafted would lead to billions of dollars in cost increases for government and private payors, and could result in fewer generic drugs coming to market, manufacturers withdrawing from certain markets, drug shortages, the undermining of consumer confidence in affordable generic medicines, and increased drug spending, GPhA noted.
GPhA restated its opposition to any efforts that could hinder timely access to biosimilars and interchangeable biosimilars at the state, federal and international levels. "We will fight against any provisions creating roadblocks to patient access such as limits on substitution, added paperwork for prescribers and pharmacists, or unnecessary mandates for notifying physicians that extend beyond current practice," the association stated. "While there is no ‘one-size-fits-all’ model for states, one can look to the bill enacted in Florida, which sought to create the same substitution model for biosimilars and interchangeable biosimilars as operates so successfully for generic drugs."
And GPhA will continue to promote the value of generics. "Our population is aging and prescription spending continues to weigh on seniors and others, particularly those enrolled in Medicare and/or Medicaid. Generics are one of the few bright spots in the health cost story," the association stated. "Indeed, generics saved the U.S. health system $217 billion in 2012 and $1.2 trillion in the most recent decade, according to the fifth annual 2013 Generic Drug Savings in the U.S. report. Prompt approvals for first generics and prompt resolution of scientific issues are essential to continuation of the benefits reaped by patients and payors alike."
Quality assurance is also a key focus for the generic industry association. "The association stands firmly in support of regulatory goals outlined in the Generic Drug User Fee Act, an effort 100% funded by industry dollars, and is seeking a permanent fix in order to avoid the sequestration of user fees," GPhA stated. GPhA is in constant communication with regulatory partners to ensure that products contain the same active ingredient and are manufactured to identical strength and dosage form as the branded counterpart. Generic drugs also have the same indications of use, dosing and labeling, and provide the same quality, potency, efficacy and safety profile to patients as the brand medicines. These criteria ensure that the generic and the brand have “no clinically meaningful difference and can be safely substituted for each other.”
GPhA also plans to build on last year’s work with Congress, the U.S. Trade Representative and others involved with international trade negotiations such as the Trans Pacific Partnership. These agreements are integral in efforts to open access to global markets and preserve the balance between promoting innovation and competition, GPhA noted. "The association will continue to ensure that barriers to entry for generic products in TPP countries are limited, including mandates of patent term extensions, patent linkage and exclusivity."
And GPhA will be continuing its efforts this year to push for the release and the finalization of the proposed rule to allow for the electronic distribution of prescription information, known as electronic labeling. Under an e-labeling system, prescribers would have immediate access to the most current prescribing information, prescribing errors could be reduced and significant waste would be reduced when millions of pounds of unused outdated paper labels would no longer be disposed each year.
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Report: Hospitals show renewed interest in on-campus retail pharmacies
NEW YORK — A desire to provide an integrated continuum of care that leads to improved outcomes and patient satisfaction has placed a renewed focus on U.S. hospitals offering on-campus retail pharmacies, according to a report by HealthLeaders Media.
While hospitals need to be mindful of economics of scale and the potential for a low rate of prescription refill orders, the opportunities can be significant. Those hospitals that have on-campus retail pharmacies can offer patients integrated care, greater convenience and enhanced customer service, the article states.
According to the article, the American Society of Health-System Pharmacists states that the percentage of hospitals that have on-campus retail pharmacies has held steady over the past decade at about 25%, and ASHP is now asking hospitals about how many pharmacies they have at their facilities.
According to ASHP hospital survey data cited by HealthLeaders Media, about 70% of hospitals with 600 or more beds have at least one on-campus retail pharmacy. But very few hospitals with 200 or fewer beds have retail pharmacies.
Regional chains, suppliers gather for NACDS Regional Chain Conference
NAPLES, Fla. — Leaders from the National Association of Chain Drug Stores set the stage Monday morning at the Regional Chain Conference for regional chain attendees to tackle issues ranging from the Affordable Care Act implementation to digital’s impact on shoppers and stores, to how to engage in interactive discussions and business meetings.
“A forum such as this, which includes both retail operators and the vendor community, provides us with a unique opportunity to listen, learn, share and collaborate for the common goal of mutually growing our businesses while serving the wants and needs of our customers and our communities,” Jim Spencer, president of Kinney Drugs and conference chairman, told attendees during the morning’s Opening General Session.
During his remarks, Spencer celebrated regional operators’ talent for “leveraging our nimbleness and knowledge of local markets in building custom strategies that appeal to our customers, local healthcare providers and payers,” and the importance of executing those strategies “quickly and with precision.”
“Pharmacy is changing, and we have the opportunity to be part of that change, as long as we work together to improve our customers’ health and reduce the overall healthcare spend for our patients,” Bob Narveson, NACDS chairman and president and CEO of regional chain Thrifty White Pharmacies, told attendees, contrasting today’s emphasis on new pharmacy services with the nearly exclusive focus on dispensing medications, which characterized the past.
Narveson emphasized that government advocacy remains vital to pharmacy’s cause, and he cited aspects of the Centers for Medicare and Medicaid Services’ recently proposed rule related to Medicare Part D as an example of “our voice being heard.”
Narveson also advised attendees to begin planning immediately for the 2014 NACDS Total Store Expo, saying, “This meeting is all about preparation. It pays to plan ahead, and put together the right meetings that can make a difference for you. Now is the time to ensure your trip to Boston — Aug. 23 to 26 — proves successful.”
He noted, “After the show last year, 92% of the attendees who completed a survey said that they would return to the show in 2014. That’s amazing, and if you take a look at just the regional chain company representatives who responded, more than 90% said the same thing. So, whether you are a regional chain or one of our partners, this event can work for you.”
Narveson delivered special thanks to supplier companies for their involvement in all NACDS conferences and for “their commitment to the regional chains.”
Meanwhile, NACDS president and CEO Steve Anderson showcased the work of the NACDS Foundation, a separate charitable organization affiliated with NACDS that works to improve patient health through partnerships in the areas of research, education and medication management.
“When it comes to setting big goals — like improving public health — and attacking those goals, there are not many examples better than the NACDS Foundation,” he said.
Anderson showed a video, titled “Inspired,” that showcases initiatives supported by NACDS Foundation grants in the areas of emerging healthcare models, rapid flu and strep tests, primary medication nonadherence, and evaluating medication management and hospital readmissions.
He demonstrated that the NACDS Foundation’s work is focused on timely and relevant issues, noting that television’s "Dr. Oz" said on his show that he hopes to see rapid strep tests in pharmacies soon, and that preliminary findings from research related to medication management in accountable care organizations and medical homes was published in the Journal of Managed Care Pharmacy.
Following his remarks about the NACDS Foundation, Anderson introduced a panel discussion on the status of a host of public policy issues, and on NACDS’ member-focused approach to advocacy. In addition to participation from attendees, panelists shaping the discussion included: Dennis Wiesner, H-E-B’s senior director of privacy, pharmacy and government affairs; Tim Weippert, Thrifty White Pharmacy’s EVP pharmacy; and Carol Kelly, NACDS’ SVP ogovernment affairs and public policy. The discussion included the implementation of the Affordable Care Act and of the new prescription drug supply chain law, CMS’ proposed rule on Medicare Part D issues, Medicaid pharmacy reimbursement and the pursuit of “provider status” for pharmacists.
The day-by-day schedule for the conference details the diverse topics that attendees will address through the conclusion of the event on Tuesday. Additional general session topics include proven retail strategies; digital technology’s role in store operations and consumer behavior; employment policy trends; controlled substances and the Drug Enforcement Administration; telepharmacy; and pharmaceutical trends. Interactive Idea Exchange sessions will address a range of additional issues, and one-to-one business conferences will empower chains and suppliers to meet in a productive format.
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