Pharmacy Blog

Addressing attendees at the opening business program of the National Association of Chain Drug Stores (NACDS) Pharmacy & Technology Conference yesterday, H-E-B chief administrative officer and NACDS chairman of the board Robert D. Loeffler called for even stronger grassroots engagement on public policy priorities that are vital to pharmacy patient care.

Specifically, Loeffler urged attendees to participate in the grassroots advocacy program NACDS RxIMPACT - by attending the Day on Capitol Hill in Washington, D.C. and by weighing in with their federal and state legislators on key legislation throughout the year.

"NACDS has never been stronger, and NACDS needs to confront any threat to the viability of pharmacy patient care services. That said, I need to emphasize an undeniable, unavoidable, and perhaps under-appreciated fact: we need your engagement," Loeffler said.

Loeffler noted that the complexity of pharmacy issues requires true dedication in demonstrating to policymakers the importance of pro-patient policy "that reduces the nation's overall healthcare expenses and maintains patient care at high levels, while keeping the pharmacy industry viable."

"It's not that grassroots engagement is a missing ingredient within pharmacy," he said. "It just needs a lot more muscle. We need your engagement."

Loeffler cited NACDS' success in rallying the involvement of pharmacy in public policy advocacy, "from those just beginning pharmacy school, to those who could write their textbooks." He said that in 2011 NACDS RxIMPACT already has nearly tripled the number of letters written in 2010 by pharmacy advocates to their legislators - from 5,000 to 14,000; that the program has generated 26 pharmacy tours in 2012; and that NACDS RxIMPACT Day on Capitol Hill has grown in participation from 150 advocates in 2009 to 350 this year.

He called on attendees to visit the NACDS RxIMPACT website (www.rximpact.org) and contact lawmakers in support of the Pharmacy Competition and Consumer Choice Act (H.R. 1971 in the House of Representatives and S. 1058 in the Senate).

"This bill includes provisions about transparency, the frequency of updating MAC pricing, networks, audits, use of data, and many of the topics that threaten many in this room, and the patients we serve," Loeffler said.

Loeffler urged participation in the 2012 NACDS RxIMPACT Day on Capitol Hill, scheduled for March 14-15, 2012.

"It is a top priority of NACDS to ensure that the health of patients, and the wellness of the nation's healthcare delivery system, can benefit from pharmacy services that are accessible by every patient and give every patient choices. And we will take that stand with vigor and with resolve," said Loeffler.

Increases in vaccination rates for human papillomavirus (HPV) are trailing increases in rates for two other vaccines recommended for teens and preteens, according to data from the Centers for Disease Control and Prevention.

Coverage rates for the other two vaccines --Tdap, which protects against tetanus, diphtheria and pertussis, and MenACWY, which protects against meningococcal meningitis--are continuing to increase, but vaccination rates for HPV vaccine remain low, the study found. HPV infection can lead to cervical cancer, but vaccination dramatically reduces this risk.

The study in CDC's Morbidity and Mortality Weekly Report drew on data from the 2010 National Immunization Survey-Teen.

"More U.S. teens are being protected against these serious, and sometimes deadly, diseases," said Anne Schuchat, M.D., director of the CDC's National Center for Immunization and Respiratory Diseases.

"However, the HPV results are very concerning. Our progress is stagnating, and if we don't make major changes, far too many girls in this generation will remain vulnerable to cervical cancer later in life. Now that we have the tools to prevent most cervical cancers, it is critical that we use them."

About 6 million people become infected with HPV each year, and the CDC reports that every year, about 12,000 women will be diagnosed with cervical cancer.

CDC recommends HPV vaccine for 11- or 12-year-old girls to protect against the types of HPV that cause cervical cancer and also recommends teenage girls who have not yet been vaccinated with HPV vaccine complete the vaccination series. HPV vaccines are given in three doses (as shots) over six months. To ensure the highest level of protection, girls must complete all three shots.

The CDC NIS-Teen survey found:

• Coverage for the three routine teen vaccines was 49 percent for one dose of HPV vaccine; 63 percent for MenACWY; and 69 percent for Tdap vaccine.

• For girls who received the recommended three doses of HPV vaccine, coverage increased 5.3 points to 32 percent over the previous year.

• Hispanics had higher coverage for one dose of MenACWY and HPV, but third-dose HPV coverage lagged for blacks and Hispanics compared with whites. Girls living in poverty were also less likely to complete the HPV series.

• Coverage increases for HPV were less than half of the increases seen for Tdap (13.3 points) and meningitis (9.1 points) vaccines.

Continued improvements in MenACWY and Tdap are important. With 27,550 cases of pertussis reported in 2010 - 4,858 in 11- to 18-year-olds - it is critical that preteens get their Tdap vaccine. "This one-time dose of Tdap can prevent pertussis infection," said Dr. Schuchat.

"Also, preteens and teens who get vaccinated with MenACWY are protecting themselves from an infection that can lead to lifelong disability - or, in some cases, death in 48 hours or less. Let's make sure all teens are protected."

Dr. Schuchat stressed that any visit to the doctor--such as annual health checkup or physicals for sports, camp, or college--can be a good time for preteens and teens to get the recommended vaccinations. By making sure all recommended vaccines are given at every opportunity, coverage for all the teen vaccines could increase substantially.

Families who may need help paying for vaccines should ask their health care provider about the Vaccines for Children program, which provides vaccines at no cost to uninsured children younger than 19 years. For help in finding a local health care provider who participates in the program, parents can call 800-CDC-INFO or go to www.cdc.gov/vaccines.

The CDC has conducted the National Immunization Survey-Teen since 2006. This survey of more than 19,000 teens aged 13-17, is similar to the standard NIS which began collecting immunization information in 1994 among children 19 through 35 months old. The NIS-Teen is a random telephone survey of parents or caregivers, followed by verification of records with health care providers. The survey estimates the proportion of teens aged 13 through 17 years who have received the three recommended adolescent vaccines, as well as three of the recommended childhood vaccines, by the time they are surveyed.

Amgen today announced that the U.S. Food and Drug Administration (FDA) will target a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2012 for the supplemental Biologics License Application (sBLA) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases.

Bone is one of the most common places for cancer to spread. If approved in this expanded indication, XGEVA would become the first therapy licensed to prevent or delay the spread of cancer to bone.

XGEVA is the first and only RANK Ligand inhibitor approved by the FDA indicated for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors.

XGEVA was initially approved following a six-month priority review by the FDA. It is not indicated for the prevention of SREs in patients with multiple myeloma. XGEVA is the first novel bone metastases treatment for advanced cancer patients in nearly a decade.

Delivered as an every four week 120 mg subcutaneous injection, XGEVA provides a unique option for urologists and oncologists to prevent SREs in patients with advanced cancer.

XGEVA is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts (the cells that break down bone). XGEVA prevents RANK Ligand from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction.

XGEVA has been studied in over 7,000 patients with cancer. In clinical trials, XGEVA demonstrated a clinically meaningful improvement compared to the previous standard of care in preventing bone complications. XGEVA is also being investigated for the potential use to delay the onset of bone metastasis in adjuvant breast cancer.

Seattle Genetics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Adcetris (brentuximab vedotin) for two indications:

(1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.

(2) the treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen.

The indications for Adcetris are based on response rate. There is no data available demonstrating improvement in patient-reported outcomes or survival with Adcetris. Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years, and provides a new therapeutic alternative for Hodgkin lymphoma and systemic ALCL in these settings.

Seattle Genetics expects to make Adcetris available to patients next week. Adcetris is an antibody-drug conjugate (ADC) directed to CD30.

"Bringing a new product to the market is a significant milestone for Seattle Genetics in fulfilling its mission to improve the lives of people with cancer," said Clay B. Siegall, PhD, president and CEO of Seattle Genetics.

"The approval of Adcetris is a result of more than a decade of research and development by talented scientists and physicians. The company has deep appreciation for the hundreds of patients who participated in Adcetris trials, and the passion and determination of the clinicians at sites around the world in investigating this first in a new class of targeted anticancer agents.

"We are committed to continued clinical investigation of Adcetris through a broad development program for CD30-positive malignancies, including confirmatory trials in front-line Hodgkin and T-cell lymphomas that we have planned in consultation with the FDA."

"The marked single agent activity seen with Adcetris, including a high durable complete remission rate, offers an opportunity to improve the treatment paradigm of patients for whom the treatment is indicated," said Owen A. O'Connor, MD, PhD, professor and director, Division of Hematology and Medical Oncology at NYU Cancer Institute. "This approval represents a major advancement in the care of these patients."

Pfizer Inc. announced today that it has prevailed in its patent infringement action against Teva Pharmaceuticals USA, Inc. in the United States District Court for the Eastern District of Virginia.

"We are pleased that the court recognized the validity and enforceability of our Viagra patent for the treatment of erectile dysfunction," said Amy Schulman, executive vice president and general counsel for Pfizer.

"Protecting the intellectual property rights of our innovative core is critical, and Friday's court decision acknowledges Teva's clear violation of our patent rights."

The court's decision, which is subject to appeal by Teva, prevents Teva from receiving approval for a generic form of Viagra until October 2019. Litigation on the same patent remains pending against other generic companies, but no trials are scheduled in those other cases.

Preliminary data from a study of private insurance and Medicare claims commissioned by the American Association of Diabetes Educators reveals that ongoing diabetes education continues to deliver results in terms of better health and reduced private insurance and Medicare claims.

The new study data show that people who receive continuing diabetes education after the initial one-year period demonstrated fewer inpatient hospital admissions, and higher compliance with diabetes medications.

"The study confirms the argument that diabetes education is not a one-shot deal," said Karen Fitzner, PhD, AADE chief science and practice officer. "There are clear benefits to ongoing, long-term diabetes education that not only bend the cost curve, but improve the health of patients with diabetes."

The study was conducted by Solucia Consulting, an actuarial consulting firm in Farmington, CT.

The authors studied three years of claims data (2005-2007) from commercial insurance and Medicare plans that reflect care of nearly 635,000 individuals with diabetes. The researchers compared claims from those who received diabetes education with those who did not. The preliminary results of this latest study, which adds a further year of experience, show that the benefits of diabetes education continue to be observed in the study population.

One year ago, AADE first presented the results of the study, which was among the first to state with statistical certainty that diabetes education reduces health care costs and improves public health.

The update to the study, presented today, demonstrates that ongoing diabetes education beyond the first year continues to yield benefits, and it bolsters the argument for additional reimbursement by Medicare and private insurers for diabetes education. Currently, Medicare pays for one hour of individual education and nine hours of group education in the first year; and two hours of group education in subsequent years.

In practical terms, professionally qualified diabetes educators teach individuals with diabetes and pre-diabetes the essential tools needed to control their diabetes: accurately monitoring blood glucose levels, adopting healthy eating habits, engaging in appropriate exercise, and coping with specific diabetes-related emotional and physical challenges.

Professionally qualified diabetes educators are state licensed or registered health care professionals, most commonly nurses or advanced practitioners, dietitians, pharmacists, or podiatrists.

The study presented today also includes an additional year of data that reinforces the initial claim that diabetes education in general reduces claims and increases compliance with medications.

Despite gas prices that are more than 30 percent higher than last year, cross-channel shopping is alive and well in the CPG industry, according to a report, "Channel Migration: A Quest for Affordability," from SymphonyIRI Group Inc.

In fact, three-quarters of today's consumers shop across five or more channels to meet their ongoing CPG needs.

Consumers' cross-channel quest for affordability clearly underscores the mindset of today's shoppers, where learning to live with less and making purchases deliberately and cautiously has become the norm.

During the beginning of the economic downturn, shoppers flocked to value retailers, particularly supercenters and mass merchandisers, demonstrating a willingness to drive the extra distance in a desperate effort to save money. Today, grocery, drug, dollar and club stores are enjoying increased shopper visits, at the expense of supercenter and mass stores. Share trends reflect these shifts in shopper behavior.

"Channel shifting will continue, and channels will continue to blur," said John McIndoe, senior vice president, Marketing, SymphonyIRI. "The blurring is the result of consumer changes, and also of changing CPG manufacturer and retailer strategies. New products, new marketing programs and new store formats are what keep CPG interesting and also what makes the job of CPG marketers so difficult."

Across CPG channels, purchase frequency increased 2 percent during the past year, with grocery, dollar and club channel trends closely mirroring industry average. Across other channels, though, trends vary significantly. For example, frequency within the drug channel accelerated sharply within the last year, increasing by 6.7 percent. This growth is being driven by a number of factors, including shifting trip mission trends.

Quick trips, small "need-it-now" excursions with an average basket size of less than $40, have become more common as consumers look to minimize large one-time outlays of cash. With a broad assortment of health and wellness solutions and a growing assortment of food and beverage offerings, close-to-home drug stores are a logical destination for shoppers looking to quickly pick up needed items with only minimal gas and time investment. Dollar stores also are benefitting from this trend due to generally convenient locations and broader, expanded assortments. These efforts are clearly paying off, with dollar channel frequency increasing by 2.6 percent during the past year.

"When thinking about channel migration trends, CPG and retail leaders must consider changes in the channels themselves and how those changes will impact shoppers," said Susan Viamari, editor, Times & Trends, SymphonyIRI. "For instance, as 'big box' retailers open smaller format stores, such as Target opening CityTarget, closer to downtowns, will shoppers continue driving to traditional value formats that tend to be located in more out-of-the-way locations?"

CPG manufacturers and retailers seeking to capture new growth opportunities and minimize risks associated with channel and consumption migration trends should consider the following action items:

o Identify new growth opportunities and risks through ongoing category and brand channel migration tracking: Manufacturers should closely monitor the evolving competitive set at the channel and retailer level to understand channel share shifts across key categories and brands, including competitor brands, as well as existing and emerging product distribution strategies. Retailers should invest to understand core consumer segments while closely monitoring high-potential targets and their evolving channel, banner and brand selection processes.

o Align distribution, marketing and merchandising strategies with channel migration patterns: Manufacturers should isolate their most important shoppers and ensure distribution strategies cater to their preferred trip types, channel preferences and store locations. Retailers should cross reference their key shoppers against key consumer segments across key manufacturer partners to find common ground for co-marketing programs.

o Protect and grow share among top shoppers: Manufacturers should drive satisfaction, trip and basket size with specially-targeted promotional programs that entice and reward top shopper segments. Retailers need to maintain a deep understanding of emerging shopper patterns and competitive threats among key shopper and target segments.

Stiefel, a GlaxoSmithKline company, announced yesterday that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for tazarotene foam for the topical treatment of facial acne vulgaris in patients 12 years of age or older.

Tazarotene foam will be subject to evaluation and approval by the regulatory authorities before it can be made available to physicians for prescribing to their appropriate patients.

Stiefel, a GlaxoSmithKline company, is committed to advancing dermatology and skin science around the world in order to help people better achieve healthier skin.

Stiefel's dedication to innovation, along with its focus on pharmaceutical, over-the-counter and aesthetic dermatology products, has established Stiefel as a world leader in the skin health industry.

The National Association of Boards of Pharmacy (NABP) last week issued a public health alert to warn Americans about the serious dangers associated with medicines purchased through fake online pharmacies.

A report from NABP on Internet drug outlets found that 96% of 8,000 rogue web sites analyzed continue to operate out of compliance with United States pharmacy laws, fuel prescription drug abuse and misuse, and provide an outlet for counterfeit medicines to enter the U.S. drug supply - all of which significantly endanger the health and safety of Americans.

"The fake online pharmacy crisis has reached an epidemic level - they prey on prescription drug abusers and the most vulnerable members of society who rely on medicine every day for their health," said NABP president Malcolm J. Broussard, RPh.

"They offer easy access to potent medicines without a prescription and indiscriminately push dangerous counterfeit drugs. This problem poses a clear danger to Americans' health and safety and weakens the essential relationships between pharmacists and patients. By issuing a public health alert, we are calling on pharmacists, physicians, and other health professionals to educate their patients about the growing public health threat posed by these illegal online enterprises."

In the Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: July 2011, the Association found that although the Internet marketplace has evolved somewhat in response to new laws, it remains a pervasive contributor to the rampant misuse and abuse of prescription drugs.

To help consumers find safe sources for purchasing medicine online safely, NABP developed the VIPPS (Verified Internet Pharmacy Practice Sites) accreditation program. Consumers should look for the VIPPS Seal on an accredited site, or check NABP's database at http://vippspharmacies.net/.

Rogue sites are also known to sell dangerous counterfeit drugs, not only to those seeking lifestyle drugs like Viagra, but also to people who depend on medication for their health or even their lives for chronic conditions such as asthma, diabetes, and cancer.

As part of its continued efforts to combat these rogue sites, NABP and the state boards of pharmacy are stepping up their efforts to educate the public through the AWARxE consumer protection program.

The AWARxE Web site, www.AWARErx.org, provides information on safely obtaining medications and includes updated news, tips, information, and links to relevant NABP resources.

In its report, NABP reviewed more than 8,000 web sites and found that 96% of these sites can be traced to rogue affiliate networks obtaining prescription drugs from questionable sources, and dispensing them indiscriminately to patients without a valid prescription or medical oversight. The report also found that of the Web sites:

• 6,812 (more than 85%) do not require a valid prescription

• 3,687 offer foreign or non-Food and Drug Administration-approved drugs

• 2,100 have a physical address located outside of the U.S.

• 2,878 have server locations in foreign countries

While some recent studies and the media have down-played the role of the Internet in prescription drug abuse, health care experts and medication safety advocates continue to underscore the connection between increased use of the Internet and the rise in drug misuse and abuse. NABP's report highlights how the increased availability of the Internet and new technology has enabled the continued success of rogue Internet drug outlets:

• A study published in the 2011 Journal of Health and Affairs found that for every 10% increase in high-speed Internet use at the state level, there is a corresponding 1% increase in admissions to treatment centers for addiction to prescription drugs. Based on these findings the authors surmise that the rise in prescription drug abuse can be explained by increased access to rogue Internet drug outlets.

• Illegal online drug sellers are now using social media to make illicit prescription drug sales, according to the article "Protecting Our Drug Supply: Internet Pharmacies, Fake Drugs and the Debate Over Imported Medicine," by Bryan Liang, M.D., Ph.D., JD, vice president of the Partnership for Safe Medicines.

• LegitScript reports that 1,000 Internet drugs outlets (a number consistent with NABP's findings) overtly promote the illicit sale of controlled substances without a valid prescription, a violation of the Ryan Haight Online Pharmacy Consumer Protection Act. The report further states that while many of these sites have foreign ties, more than half and as many as three-fourths of these illicit drug sites are using U.S.-based servers or domain name registrars.

Patients receiving their prescription medications through a mail-service pharmacy achieved better cholesterol control compared to those who obtained their statin prescriptions from their local pharmacy, according to a new study published in the Journal of General Internal Medicine.

The study found that 85 percent of patients who used mail-order pharmacies achieved target cholesterol levels, compared to 74.2 percent of patients who only used local pharmacies.

The new study adds to the growing body of evidence that mail-service pharmacies improve patient outcomes, bringing a new dimension to existing peer-reviewed and government research showing that mail-service pharmacies cost consumers less than "brick-and-mortar" pharmacies, according to the Pharmaceutical Care Management Association (PCMA).

What this reveals is a growing opportunity for traditional pharmacies to ramp up their offerings to customers and make themselves a more valuable resource. Offering one-on-one counseling makes a pharmacy and pharmacist a partner in healthcare.

What traditional brick-and-mortar stores can't do--or at least don't yet--is deliver to customers' doors, so they need to find ways to emphasize what they can do--offer a range of over-the-counter merchandise, for example, or even some basic groceries and maybe they offer a DVD rental service like Red Box.

"While everyone knows that mail-service pharmacies make prescriptions more affordable, this new study shows how they can also improve outcomes for patients with chronic conditions," said PCMA president and CEO Mark Merritt.

Home delivery is popular with patients because it offers 90-day prescriptions that are less expensive and is more convenient than driving to the drugstore every 30 days. With mail-service pharmacies, patients can get private counseling over the phone from trained pharmacists seven days a week, 24 hours a day. Home delivery also solves one of the biggest problems in health care: 25 percent of patients don't pick up the drugs prescribed by their doctors.

Numerous government and peer-reviewed studies have confirmed that mail-service pharmacies lower costs for consumers and payers, improve accuracy, and increase medication adherence for those suffering from chronic conditions.

• The Federal Trade Commission (FTC): The FTC concluded in a 2005 report that PBM-owned mail-order pharmacies offer lower prices on prescription drugs than retail pharmacies and are very effective at capitalizing on opportunities to dispense generic medications.

• U.S. Government Accountability Office (GAO): In January 2003, the GAO examined the value provided by PBMs participating in the federal employees' health plan. For prescription drugs dispensed through mail-order pharmacies, the average mail-order price was about 27 percent below the average cash-price paid by consumers for a brand name at a retail pharmacy and 53 percent below the average cash-price paid for generic drugs.

• Pharmacotherapy: Official Journal of the American College of Clinical Pharmacy: Peer-reviewed data found that highly automated mail-service pharmacies dispensed prescriptions with 23 times greater accuracy than retail pharmacies. The mail-service error rate was zero in several of the most critical areas, including dispensing the correct drug, dosage, and dosage form.

• American Journal of Managed Care: Consumers receiving their prescription medications for chronic conditions through a mail-service pharmacy "were more likely to take them as prescribed by their doctors than did patients who obtained them from a local pharmacy." Key findings from the study include:

- Mail-order pharmacy users were more likely than local pharmacy users to have a financial incentive to fill their prescriptions by mail (49.6 percent vs. 23.0 percent), and to live a greater distance away from a local pharmacy (8.0 miles vs. 6.7 miles).

- 84.7 percent of patients who received their medications by mail at least two-thirds of the time stuck to their physician-prescribed regimen, versus 76.9 percent who picked up their medications at "brick and mortar" Kaiser Permanente pharmacies.