chief executive officer

Patient nonadherence to medication is a well-known problem plaguing health care. For this reason, many quality measures now focus on improving adherence. As medication experts, pharmacists are the obvious go-to health care team member to take the lead in finding and implementing solutions. Unfortunately, finding the right solution is no simple matter. That is why 

 has dedicated its May issue to this important topic.

The reasons for nonadherence are as complex as the patients themselves. Co-editor-in-chief Troy Trygstad, PharmD, PhD, MBA, in his article on page 8, says that it is important to find the right intervention for a given situation. He asks, “Are all increases in medication adherence created equal?” In the push toward more patient-centered care, it is becoming increasingly clear that the answer to this question is a resounding “no.” According to Elizabeth Whalley Buono, BSN, RN, MBA, JD, tackling the nonadherence problem requires a truly individualized approach and collaboration among stakeholders. “The key to success lies with informed patient engagement,” she notes in her article on page 5.

Some pharmacists grappling with the hectic retail environment pace of nonstop prescription dispensing may say they simply do not have the time to focus on patient services, especially when those services are not reimbursed. Remarkably, many pharmacies are finding a way. For example, learn how Bob Lomenick, RPh, improved adherence and grew his business using a proactive, rather than reactive, business model (see page 12). He describes his approach as one that “liberates pharmacists from the knee-jerk process that pharmacies have used for years.”

In this era of collaboration, everyone has a stake in the game. Addressing adherence problems amidst all the other issues pharmacies face is a challenge, but one worth facing. The bottom line is, for patients to benefit from medications, they have to take them. Devoting resources toward improving medication adherence is a worthwhile investment, and the pharmacist is in a position to lead the charge. As Christy Whitlock notes in her article on page 15, “The true focus of pharmacy is not merely filling prescriptions, it is making sure patients understand what their regimen entails and that they are taking their medications as prescribed.” We couldn’t agree more.

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Patient nonadherence to medication is a well-known problem plaguing health care. For this reason, many quality measures now focus on improving adherence.

Nonadherence Is a Nonstarter

The move away from traditional quantity-driven models toward value-based care has helped put pharmacists at the forefront of efforts to improve the quality of care patients receive. The pharmacist’s role continues to evolve into one that is part of a team of health care providers collaborating to innovate, share information, and improve outcomes.

For years, the health care industry has been coaxing pharmacists out from behind the counter so they can offer more services. Although the pressure was on for them to get in the quality business, reimbursement for their efforts has lagged. Times are changing.

Health plans are beginning to offer pharmacists financial incentives to help them achieve better star ratings, according to Sam Stolpe, PharmD, of the Pharmacy Quality Alliance. In his article on page 8, Dr. Stolpe discusses the changing landscape as well as ways that pharmacies can ensure they stay ahead of the movement. “To be successful, pharmacists will need to make a cultural shift to focus more on quality,” he says.

But sweeping changes of this nature can bring reimbursement anxieties to community pharmacies, notes Tripp Logan, PharmD, in his article on page 22. Dr. Logan discusses ways to allay those fears and “build the revenue bridges needed to shift from the current fee-forservice model to a scenario in which pharmacies are reimbursed for quality.” The Department of Health and Human Services’ aim to tie 85% of fee-for-service Medicare payments to quality or value by the end of 2016 and 90% of these payments by the end of 2018 illustrates just how rapidly stakeholders, including pharmacies, will need to converge on quality in order to be successful.

Although there are many ways to go about improving quality at the pharmacy level, including appointment- based modeling (see the article on page 12), wellness initiatives, and patient education, we know from past experience that financial incentives will ultimately drive the innovation and the change in pharmacy culture.

 Co-Editor in Chief Troy Trygstad, PharmD, makes a case to “Let Quality Be Our North Star.” He notes, “Pharmacists can expect to see changes both in the scope of services they provide and the ways they are incentivized and reimbursed by health plans over the next few years.” He further argues that focusing on high-quality care will have the added benefits of improving efficiencies and reducing overall health care costs.

 lower costs? That would be the ultimate win.

The move away from traditional quantity-driven models toward value-based care has helped put pharmacists at the forefront of efforts to improve the quality of care patients receive.

Accelerating Toward Quality

Health care reform has both good and bad news for patients. Americans will receive health care coverage and seniors no longer have to worry about falling into the Medicare "doughnut hole," but affordable biogenerics will not be available for decades. 

A tough Washington, DC, winter has given way to spring just as the often acrimonious debate over health care reform has yielded to reflections on what was and was not accomplished. Now that health reform has been signed into law, we can look back at how Congress extended access to generic medicines on one hand, and on the other erected a significant road block with respect to biogenerics. 

Responding to long-standing criticism that the Medicare Part D prescription drug benefit must be improved, Congress moved to close the coverage gap or “doughnut hole” in which many seniors found themselves before catastrophic coverage kicked in. Medicare beneficiaries who use Part D coverage will now enjoy a $250 rebate to cover part of the cost of the doughnut hole, plus a federal government subsidy to cover most of the cost of both generic and brand name drugs. By subsidizing generic medicines, Congress put into place a cost-containment measure that hopefully may offset the discounts on brand drugs that is likely to drive up brand drug spending. This is good news for many seniors who are struggling every day to pay their bills and refill their prescriptions. 

Congress also rejected language that would have changed the current generic patent resolution mechanism that now can quicken access to affordable medicines. During this year’s debate on health reform, independent entities put forward several convincing studies and analyses that showed banning patent settlements would deny patient access and reduce the number of patent challenges brought by generic companies, working contrary to the goal of creating incentives to bring lower-cost generic drugs to market sooner. Recent research has shown that settlements that successfully conclude patent litigation typically result in the early and predictable introduction of generics competition—resulting in savings for the consumer. 

Congress endorsed a science-based approval pathway sought by the GPhA. Unfortunately, the provision provides excessive and unprecedented 12 years of market exclusivity to new biologic products and through an “evergreening” provision, and provides almost every next-generation product another 12 years of market exclusivity. 

Congress’ failure to set a reasonable market exclusivity period is extremely problematic for patients and undermines the sustainability of the health care system. Why? Because the 12—12 market exclusivity paradigm skews investment away from the biogeneric sector toward brand biologics by assuring the brand industry’s continued monopoly on biologics for several decades. This adverse outcome occurred as a result of undue political influence from the brand drug industry. The chief stumbling block to ensuring consumers access to more affordable biogenerics is that the current federal law—the Hatch-Waxman Act, which allows for affordable generic versions of popular medicines&mdash;does not apply to biopharmaceuticals. 

The need for a workable biogeneric approval pathway is urgent. Currently, 160 biologics are approved and used in the treatment of life-threatening illnesses. Biologics are becoming increasingly popular and will account for half of the new drugs approved in 2012 by the FDA. Also in 2012, 12 of the current top 20 biologic products driving US sales of $18 billion in 2009 will be off-patent. 

We are pleased that Congress agreed with GPhA that the science exists for the FDA to create a science-based approval process that allows the agency to approve biogenerics on a case-bycase basis. The need to create a market for biogenerics, however, demands that GPhA continues to urge Congress for a more reasonable market exclusivity period and limit brand companies from “evergreening” their products. 

All in all, health care reform has both good and bad news for patients. While it is certainly welcome news that more Americans will be receiving health care coverage and seniors no longer have to worry about falling into the Medicare doughnut hole, it is deeply disappointing to the countless Americans struggling with the high price of brand biopharmaceuticals that more affordable biogenerics will not be available for decades. â–  

Good and Bad News in Health Care Reform for Patients

Although not for the first time, and, sadly, probably not for the last, a concerted effort is under way to cast doubts about the safety and efficacy of FDA-approved generic medicines as compared with their brand counterparts. This effort is particularly prevalent at the state level, where carveout legislation is spreading like wildfire, and there has been an uptick in media stories questioning generics. 

Unfortunately, these scare campaigns sometimes frighten and confuse patients. They also lead to many questions. As pharmacists, you see this firsthand when your customers come in the door with concerns about medicines you have filled. For this reason, the FDA has updated its Web site to help provide patients with sciencebased, consumer-friendly information about bioequivalence. 

According to the Web site, the “FDA recently evaluated 2070 human studies conducted between 1996 and 2007. These studies compared the absorption of brand name and generic drugs into a person’s body. These studies were submitted to FDA to support approval of generics. The average difference in absorption into the body between the generic and the brand name was only 2.3%. Some generics were absorbed slightly more, some slightly less. This amount of difference would be expected and acceptable, whether for one batch of brand name drug tested against another batch of the same brand, or for a generic tested against a brand name. In fact, there have been studies in which branded drugs were compared with themselves, as well as with a generic. As a rule, the difference for the generic-to-brand comparison was about the same as the brandto- brand comparison” (www.fda.gov/ Drugs/ResourcesForYou/Consumers/ BuyingUsingMedicineSafely/Under standingGenericDrugs/ucm167991. htm). 

We applaud the FDA for its strong stance demonstrating that sound science drives the drug approval process. The FDA is a valued partner in our collective efforts to ensure that patients have the most accurate information they need to make wise decisions about their health care. 

The generic industry’s top priority is to ensure the safety and effectiveness of its medicines. We make sure that the products we bring to market produce the equivalent therapeutic effect of their brand counterparts. 

Over the years, the FDA has confirmed that bioequivalence requirements for generics and brands are rigorous and sufficient to ensure that approved generics are therapeutically equivalent to their brand counterparts. Based on FDA analysis of hundreds of bioequivalence studies, the FDA has determined that small differences in blood levels—less than 4%&mdash;may exist in some cases between a brand and its generic equivalent. The FDA has repeatedly pointed out, however, that this minor difference is no greater than the difference that may exist between 2 separate manufactured batches of the brand drug.

A misstatement is frequently made regarding the bioequivalence of generic drugs, which asserts that blood levels of the active ingredient in generic drugs may vary from —20% to +25%, compared with the brand. This simply is not true, and any generic with a difference that dramatic would never be approved by the FDA. The 20% to 25% margin is one part of a complex statistical calculation used to help measure the bioequivalence. In no way does it represent the actual difference in the amount of active ingredient in a patient’s bloodstream, which the FDA has determined is typically <4% between generic and brand or between 2 different batches of a brand drug. 

The FDA’s approval process for generic drugs is equally as stringent as the process followed to approve brand drugs. The rigorous chemistry, manufacturing, and controls phase is applicable to both new brand drugs and generic drugs. Labeling and testing requirements are also the same for both brand and generics. The same FDA field inspectors evaluate the manufacturing facilities for generics and brand products, using the same standards, to ensure compliance with good manufacturing practices. 

Although no scientific evidence exists to show that problems with inequivalence exist, the agency is under increasing pressure to examine alternative approaches for demonstrating bioequivalence for certain products. Needless to say, GPhA will continue to speak out on the issue of bioequivalence and will work with the FDA to ensure that any changes to current bioequivalence standards are well-grounded in science. Our shared goal must be to ensure that patients have access to safe and effective generic medicines. â–  

Although questions have been raised regarding the safety and efficacy of generic drugs, compared with their brand drug counterparts, the FDA supports the bioequivalence of generic drugs and is helping to deliver important information to patients. 

Rigorous Standards for Bioequivalence

In marking the 25th anniversary of the Hatch-Waxman Act this past year, the generic industry issued a reminder to the public about how far the industry has come in the past quarter century. We constantly remind ourselves about how much this growth has contributed to our responsibility to enhance public health. 

When President Reagan signed the Hatch-Waxman Act 25 years ago, it was estimated that generics would save $1 billion over 10 years. As it turns out, that was a hugely conservative estimate. The fact is that generic medicines have saved an astonishing $734 billion over the last decade—$ 121 billion in savings last year alone.That equates to about $1 billion every 3 days! 

Saving the American health care system this amount of money is an extraordinary accomplishment, but savings are not the generic industry’s sole strength. Our member companies are constantly working to ensure that their products meet the highest standards for safety and efficacy because we take our responsibility to produce safe, effective, and affordable medicines very seriously. We know that pharmacists, doctors, patients, and the FDA will accept nothing less than highquality, effective medicines. And that is what we strive to deliver every day. 

We endeavor to fulfill this mission despite facing numerous obstacles every day at every level in getting safe and effective generics to patients in a timely way. For instance, we are continually outspent by special interests that have the resources to fight us in Congress and in state legislatures across the country on issues such as authorized generics and therapeutic carve-outs. But we keep up our efforts resolutely in meeting our responsibility to increase access to quality care while also reducing health care costs. 

Consumer research suggests that the current economic crisis has caused dramatic shifts in health behavior over the past 2 years. One significant fact is that in 2008, according to IMS Health, nearly 40 million Americans decided not to fill a prescription. Research also shows that 1 American in 7 is not receiving needed prescriptions and nearly a quarter of all Americans have reduced the number of times they see their doctor. 

Fortunately for patients, affordable generics are available for an increasing number of branded drugs. Since 2004, $59 billion worth of branded drug sales have lost patent protection, with another $90 billion opening for generic competition by the end of 2013. This has helped drive the use of generics to record highs. 

New IMS data show that nationwide, the generic utilization rate was 71.8% for the first 6 months of 2009, accounting for just 17.4% of the total dollars spent for prescription drugs. Generic prescription volume growth is now at 5.6%, with sales growth at 11.9%. Generic sales have more than tripled over the past 10 years, climbing from $15 billion in 1999 to more than $51 billion in 2008. 

The growth in the generic industry has truly been remarkable. This past year, we marked the celebration of our industry’s 25th anniversary with the theme of “Celebrating the Past, Forging the Future.” There is no doubt that we are poised to head into our next 25 years stronger than ever with a continued commitment to improving lives for less. â–  

With nearly 40 million Americans not filling a prescription in 2008, according to IMS Health, affordable generics are even more important in this economic climate.  

Improving Lives for Less

From town halls to 24-hour cable news to congressional hearings and speeches by President Barack Obama, we have been saturated with wall-to-wall information about health care reform. As this issue continues to be debated, the one fact that hasn’t been discussed much, but is indisputable, is that for 25 years generic pharmaceuticals have been contributing billions of dollars in prescription drug savings. As Congress grapples with increasing access to quality care while also cutting costs, clearly one solution is expanding access to generics.

On September 24, 1984, the Drug Price Competition and Patent Term Restoration Act was signed into law by President Ronald Reagan. Commonly called the Hatch-Waxman Act, this landmark legislation created the modern generic pharmaceutical industry.

Twenty-five years ago, I am not sure that President Reagan, Senator Orrin Hatch, or Representative Henry Waxman could have envisioned the lasting magnitude of the Hatch- Waxman Act. Today, generic medicines represent 72% of the total prescriptions dispensed in the United States, but only 17% of all dollars spent on prescription drugs.

 Even more amazing is the savings that generic medicines are bringing to the American health care system. One billion dollars is saved every 3 days by using generics. That’s extraordinary savings—far more than anyone predicted or could have even imagined 25 years ago, when experts estimated that generic competition would create $1 billion in savings in the first decade.

It is a testament to our industry’s strong record of producing safe and effective medicines at affordable prices. And it is also a testament to the confidence that consumers have placed in our products. They know that when they take generic medicines, they are getting the same drugs, delivering the same benefits as brand name drugs, but at much lower costs.

 At the recent GPhA Annual Policy Conference held in mid-September, leaders of the Obama administration and the architects of the Hatch- Waxman Act reflected on the success of this legislation, and the contribution of the generic industry.

Health and Human Services Secretary Kathleen Sebelius told the attendees, “I have been actively working on the promotion and expansion of access to generic drugs for sometime, both in my role in Kansas and continuing on at the Department of Health and Human Services. I think that it’s appropriate this year that as we look at what’s pending in Congress on health reform that we are also celebrating the quarter-century anniversary of the Hatch- Waxman Act, which really began to transform the pharmaceutical industry and made generic drugs much more widely available to Americans.

“We still have a huge problem with access to affordable medicines for way too many Americans. The current battle which is under way is with follow-on biologics. I just want to tell you at the outset that you have allies in the President of the United States and in our department because we very strongly believe that this initiative needs to move forward and give everyone access to these critical new drugs.”

Senator Hatch, the chief Senate architect of Hatch-Waxman, told the audience that Hatch-Waxman was the outcome of bipartisan compromise, and called for such compromise as health care reform progresses.

“In the end, we passed a bill that has not only worked well, but has saved consumers and state and federal governments billions of dollars. So, perhaps it’s not too late for Congress to benefit from that important lesson as we reconsider health care reform. Maybe Henry [Waxman] and I can pull off another miracle. This time, I’d even be willing to call it the Waxman-Hatch Act.”

Congressman Waxman summed up the role of the generic industry and its ongoing and growing contribution. “When Senator Hatch and I developed the legislation 25 years ago to produce generic drugs… we thought that the result of this law would save perhaps a billion dollars…. But the reality has been that in the last decade alone, generic drugs have saved consumers and businesses and state and federal governments $734 billion. Making sure that Americans have access to, and can afford, life-saving medicines has been one of my chief goals as a member of Congress. And I’m proud of the success of generic competition and of the generic industry in helping to achieve that goal. But there’s still much to do to increase savings for generic drugs….”

Yes, there is much to do in shaping health care reform in a way that will increase access, while simultaneously reducing costs for patients. The generic pharmaceutical industry is fully prepared to continue our contribution to savings and improved health for all Americans.