Bill to improve compounding pharmacy falls short of protecting public health

By Ayanna Johnson, Health Policy Associate

Legislation proposed to clarify the practice of compounding pharmacy falls short of protecting the public’s health. In early October, a deadly meningitis outbreak killed 55 individuals and caused 741 cases of fungal meningitis, as a result of shoddy practices and absent safeguards at a large compounding facility in Massachusetts. The proposed bi-partisan legislation from the Senate Health, Education, labor and Pension (HELP) Committee was drafted in response to this outbreak, but does not do enough to address public health threats. After a unanimous vote in the HELP committee this Wednesday, the bill, S.959 the Pharmaceutical Compounding Quality and Accountability Act, is now headed to the full Senate for deliberation.

Compounding pharmacies provide a unique service to consumers by reformulating medicines for patients with special medical needs that cannot be met by FDA-approved drugs. However, compounding processes can introduce new risk into the health care system, as evidenced by the tragedy this past fall. This proposed legislation attempts to clearly define compounding pharmacies. The legislation clarifies that traditional compounding pharmacies will continue to be regulated by the states and then creates a new category for large-scale drug compounders and calls these businesses “compounding manufacturers.” These businesses make sterile compounded drugs in advance of a prescription and sell them across state lines.

Though the FDA is given the authority to regulate the new class of compounding manufacturers, there are concerns that FDA’s authority is not complete and that the definition of compounding manufacturers is too narrowly defined. In order to qualify in this category a business must meet all three of the following criteria: 1. Compounds at least one sterile drug. 2. Compounds before receiving a prescription. 3. Ships (sells) those drugs interstate.   However, this definition leaves open several questions. What happens if a compounder operates only within one state, and does not ship across state lines?  Also this definition does not allow for monitoring of large compounding pharmacies that sell non-sterile oral drugs, such as those used in cancer treatment. There have been reports of contaminated, counterfeit, and inactive drugs in this class of non-sterile drugs as well.

FDA launches new campaign to keep consumers safe from illegal online pharmacies

By Rebecca Burkholder, NCL Vice President for Health Policy

The sales of counterfeit drugs through bogus online pharmacies continue to rise. According to a recent survey by the U.S. Food and Drug Administration, nearly one in four adult Internet consumers has purchased prescription medicine online. Some of these Internet users may be at risk of harm because they have purchased medicine from questionable online sources.  To protect consumers from the growing threat of fake online pharmacies, FDA is launching a national educational campaign, “BeSafeRx – Know Your Online Pharmacy.” The campaign seeks to increase public awareness about the dangers of buying from illegal online pharmacies and provides resources to help consumers buy prescriptions safely online.

The National Association of Boards of Pharmacy (NABP) estimates that more than 97 percent of websites that present themselves as online pharmacies do not meet pharmacy laws and NABP’s practice standards. These websites are often selling unapproved versions of medicines used in the United States—or worse, the drugs may be made with harmful ingredients.  A 2011 Wall Street Journal report, estimated that the counterfeit drug industry netted $24 billion worldwide every year. These drugs are not FDA approved, have not been tested, and their contents are unknown. Consumers should not be tempted by the appeal of cheap drugs at the risk of their health.

The BeSafeRx website contains an interactive map that lets consumers search for licensed online pharmacies in their state. A few signs that an online pharmacy might be illegitimate include:

• The Web site does not ask you for a prescription before purchasing the drug.
• There is no doctor or pharmacist you can easily talk to if you have questions or concerns regarding a drug.
• The Web site asks you to pay for the prescription using a third party payment system such as Western Union or PayPal.

Every year, the FDA issues numerous warnings about counterfeit versions of drugs intended to treat cancer patients. The stakes are high, and with the counterfeit market continuing to expand, many in Washington want to take action to curb this problem. One bill proposes a track-and-trace system that mandates a bar code be placed on prescriptions and then be scanned by everyone who comes in contact with the drug so the medication can be better tracked through the supply chain.

Buying counterfeit drugs can not only hurt your health, but also hurt your wallet. If you think you have purchased counterfeit drugs please report the incident to the FDA. For more information, check out our information on counterfeit drugs at Fraud.org. Before purchasing any drugs online make sure you are using a reputable online pharmacy.

Partnering for a healthy America — How to improve medication adherence

By Ayanna Johnson, Health Policy Associate

NCL was proud to be a part of a new initiative Prescriptions for a Healthy America: A Partnership to Advance Medication Adherence that launched on May 2. This initiative is a partnership of patients, health care providers, pharmacy organizations, consumers, and health care industry leaders that are working together to advance policy solutions to improve patient health and reduce health care costs through improving rates of adherence.

NCL has been a leader in the medication adherence arena with its public education campaign Script Your Future. Launched in 2011, Script Your Future works to raise awareness among consumers, their family caregiver and health care professionals about the importance of taking medications as directed. Non-adherence costs the health care industry an estimated $290 billion a year and 125,000 people lose their lives annually from complications related to non-adherence. The stakes are high when it comes to encouraging patients to take their medication as directed.

A panel discussion, , announcing the launch of this new initiative included various players, including the National Consumers League, interested in improving rates of adherence.  Often patients have rational reasons for not adhering to their medicines; barriers such as cost, side effects and confusion about the purpose of medication all contribute to non-adherence. Sally Greenberg, Executive Director of National Consumers League, stressed that improving the communication between patients and their health care providers—communicating the consequences of poor adherence and impact of medication—increases the likelihood of better adherence.

Anita Allemand, Vice President of Product Innovation and Management for CVS Caremark noted that patients could save $8,000 a year with improved adherence. She added that the most critical element of improving adherence is face-to-face interactions between healthcare professionals and patients.

Dr. Rebecca Jaffe a board member of the American Academy of Family Physicians and family doctor said that health care professionals must engage their patients. “It is important that heath care professionals talk with them, not at them,” she said. Patients are often hesitant or unwilling to ask their doctors or pharmacists the essential questions that would enable increased adherence. Opening up this new line of communication and ensuring that patients feel comfortable asking questions and expressing worries about potential side effects, or how different drugs might affect each other, or what a patient can expect from a particular prescription will help people understand the need to adhere.

This new initiative is an exciting opportunity to bring together different voices from all parties concerned with the issue of non-adherence to work towards practical policy solutions. For more information about the initiative please visit the newly launched Web site.

For more information on the Script Your Future campaign visit www.scriptyourfuture.org.

FDA issues advisory on foreign counterfeit Botox

The FDA has issued an advisory, warning consumers and healthcare professionals about counterfeit Botox that has entered the marketplace.  The outer carton of these counterfeit products appears to be the FDA approved version of Botox, but inside there is a foreign version of Botox, not approved by the FDA. These counterfeits are being sold through “blast faxes” in which a foreign company solicits sales from medical practices at very low prices.

There is no indication that the FDA approved version of Botox is unsafe, but these foreign counterfeit versions are unfamiliar and untested. Medical practices should not purchase products that are unsolicited. Signs that the Botox is counterfeit include the incorrect active ingredient listed on the outer carton, or expiration dates on the outer carton that do not match the accompanying vial enclosed within.

Consumers must be aware that fraudulent Botox is being widely distributed, and should take extra precaution before beginning Botox treatment. If you see any suspicious looking products please report these cases of fraud immediately to Fraud.org, the FDA, or call the FDA’s Office of Criminal Investigations at 1-800-551-3989 to prevent other consumers from falling victim to the same traps.

TEDMED’s take on the future of health

By Rebecca Burkholder, NCL Vice President for Health Policy

I attended TEDMED last week, a one-of-a-kind event that explores the future of health and medicine through the lens of innovators and artists. During the three-day event at the John F. Kennedy Center for the Performing Arts, in Washington, DC, we heard from an array of speakers on a variety of topics from the power of small data to monitor our health to treating gun violence as a health epidemic. Attendees even got a workout session with fitness guru Richard Simmons. The TEDMED format uses short talks that focus on the story behind the science. TED stands for technology, entertainment, and design—elements that are interwoven throughout the event.

NCL’s Rebecca Burkholder with the legendary Richard Simmons

NCL was invited to attend TEDMED because of our role in The 20 Great Challenges of Health and Medicines. Since last fall, we have been part of a team discussing one of the challenges: The Role of the Patient. Through an online format, we have been discussing how patients engage (or are prevented from engaging) in their health care. The last day of TEDMED was focused specifically on the Great Challenges and coming up with solutions to the meet those Challenges. More on that below.

The overall theme of TEDMED 2013 was the power of connections. As TEDMED curator, Jay Walker stated “TEDMED brings together doctor, nurses, scientists, researchers, technologists, business leaders, policymakers, rescue workers, educators, armed service personnel, artists, media, and athletes all eager to share, learn listen and grow. The result? A series of creative collisions that spark imaginative new thinking.”

Each session contained a variety of talks, united by a theme. For instance, one session I found particularly riveting, was “Thinking Outside the (Check) Box.” The session included, among other things, Sue Austin showing off her work as an artist performing underwater in her scuba wheelchair. She claimed to be the most mobile person at TEDMED despite being paralyzed from the waist down. Jessica Richman asked if a citizen scientist (a person with no formal science training) could ever win the Nobel Prize in science. Ryan Panchadsaram shared his ideas for the uses of data in public policy, and Salvatore Iaconesi described how his community, both in person and online, helped him deal with his brain cancer diagnosis and say “Hey Cancer! You’re not all there is to me!”

Finally, Andrew Solomon, who was one of the more compelling speakers of the three-day conference, offered his ideas on the merging of illness, identity, and relationships, and his opinion that relationships of all types help us deal with illness.

The last day of the conference focused on The 20 Great Challenges of Health and Medicine. The Great Challenges Day, hosted by George Washington University and made possible by the Robert Wood Johnson Foundation, kicked off with a plea to recognize the inherent value of stories that lie behind the data. As part of The Role of the Patient Challenge, we were charged with using storytelling to understand the issue and plot out potential solutions. Our team of about 25 participants gathered and with the help of a doodle artist, came up with a host of solutions. For more on what the Challenge teams came up with, follow the TEDMED Great Challenges in the coming weeks and months. Join in on the conversion about the Role of the Patient and how we can change our culture from one that provides care to patients to creating heath with patients!

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Looking for ROI? Try investing in public health

By Ayanna Johnson, Health Policy Associate

This week, April 1-7, is National Public Health Week. This year’s theme is Public Health is ROI: Save Lives, Save Money. The public health model relies extensively on prevention—preventing deaths, preventing illness, and preventing high healthcare costs. Since 1995, communities nationwide have celebrated NPHW each April to draw attention to the need to help protect and improve the nation’s health. Investing in public health systems and interventions saves money and certainly saves lives.

Every year in the United States, seven out of 10 deaths are due to preventable chronic diseases such as diabetes and heart disease. Chronic conditions, like asthma, COPD and diabetes, cost our health care system millions. In fact, chronic diseases account for a whopping 75 percent of national health care spending, yet only 3 percent of our health care dollars go toward prevention. Nearly 45 percent of individuals with a chronic disease require at least one medication. However, one-third of people never fill their prescriptions, which is costly and can lead to unintended health consequences. With the implementation of the Affordable Care Act, it is now more important than ever to invest in preventative health care, like medication adherence, to manage our growing epidemic of preventable chronic diseases.

Poor medication adherence is a national problem that contributes to our growing health care costs, especially among those with chronic conditions. It is estimated that nearly 3 out of 4 Americans don’t take their medications as directed, costing Americans nearly $300 billion per year in avoidable hospitalizations, doctor’s visits, ER visits, and nursing home admission.

Improved medication adherence leads to cost savings. Patients with chronic conditions who are adherent to their medications have fewer emergency department visits and hospitalizations than patients who are not adherent, saving as much as $7,800 per patient annually in overall health care costs. And, every additional dollar spent on improving adherence saves $7 in medical costs for people with diabetes; $5 in medical costs for people with high cholesterol, and $4 in medical costs for people with high blood pressure.

At the National Consumers League, our campaign to raise awareness of the importance of medication adherence is an example of how improving public health can save money on health care costs in the long run.  The Script Your Future campaign provides patients, their family caregivers, and health care professionals with the tools needed to take control of their health. This includes knowing the right questions to ask a doctor, pharmacist, or other health care professionals about medications. For patients to manage their medications, it is important that they understand their chronic condition, the role of medication, and the importance of adherence.

For more information about Script Your Future, visit. http://www.ScriptYourFuture.org.

For more information about National Public Health Week, visit http://www.nphw.org.

Consumers have many choices to save money on prescription drugs

From 2011 to 2012 prices for brand name drugs increased in price by an average of 13 percent. As healthcare costs continue to rise, all indications are prescription drugs will rise in cost as well. The good news is consumers have more resources than ever to help them save money on their prescriptions. The easiest way consumers can save money is by finding out whether a generic or non-brand name drug is available.  Generic drugs contain the same active ingredients in the same dosages as brand name drugs, but they cost far less.

Another resource available to consumers is co-pay cards. The co-pay on any prescription is a fixed amount of money that insurance companies ask consumers to pay for a specific drug. By using a co-pay card that sum of money can be greatly reduced or eliminated. There are a variety of co-pay cards available. Consumers can also save money using drug discount cards which are often available online. These cards are offered by state governments, pharmacies, non-profit groups, pharmaceutical companies or large retail chain stores. To compare prices and see which medications are covered by which cards you can visit freecopay.com, needymeds.org, or familywize.org.

To find out more about discount and co-pay cards visit the National Consumers League Web site at nclnet.org. Be wary of any discount card that requires a fee up front because those fees may cost more than the prescription itself.

Public health thwarted

By Teresa Green, Linda Golodner Food Safety & Nutrition Fellow

In our staff meeting this morning I announced that I was planning to write a blog to celebrate tomorrow’s implementation of New York City’s limits on the sale of sugary beverages over 16 ounces. Since Mayor Bloomberg announced the measure, NCL has been behind it, and our Executive Director Sally Greenberg, actually traveled to New York City to testify in support of the measure. I planned to write about the impact that sodas have on our health, and the way that sugary beverages have contributed to obesity. I planned to applaud the Major for his forward thinking when it comes to public health matters; we feel strongly that any measure which helps us consumer fewer sweetened beverages is a good one.

However, as I was working on my blog post, news began to filter in that a New York judge had issued an injunction barring the Mayor’s proposal from going into effect. My blog post of the morning was no longer the right one to post. While all of the positive things I had written about the soda ban were still true, the bigger issue now was that this common-sense ban has been delayed if not completely derailed. Judge Milton Tingling argues that the rules are “fraught with arbitrary and capricious consequences,” and I feel the same way about childhood obesity. How arbitrary for our children that they grow up in an era where the very fabric of society predisposes them towards poor health; in fact more than two-thirds of adults are overweight or obese, meaning most kids will likely end up that way as well unless we change something. Placing reasonable limits on the sale of sugary beverages by certain establishments certainly seemed like a great place to start. Mayor Bloomberg has said he will challenge the judge’s ruling, and we can only hope he will be successful.

Remembering C. Everett Koop

By Sally Greenberg, NCL Executive Director

C. Everett Koop’s recent passing reminds us what it means for a public official to put America’s health over ideology. Koop served as Surgeon General of the United States from 1981-1989, appointed by President Reagan. He was a practicing physician who conducting groundbreaking surgeries on babies with birth defects, when he was appointed by Reagan to the post.

Koop’s evangelical upbringing and strong opposition to abortion evoked fear among women’s groups that he would use his post to preach against abortion. He determined early on in his tenure that since abortion wasn’t threatening the health of women, he wouldn’t spend the Surgeon General’s resources on the issue.

Instead Koop, who the New York Times calls “the most influential surgeon general in American history,” devoted his energies to fighting smoking in the United States and raising awareness about AIDS and HIV prevention.  He warned about the consequences of smoking, noting that 300,000 people every year at the time were dying from smoking.

Several senators from tobacco states wanted him ousted from the job. He was unfazed, and his campaign was effective: When he came to the SG job, 33 percent of Americans smoked. Nine years later, the percentage had dropped to 26. By 1987, 40 states were restricting smoking in public places and 17 banned it inside workplaces and offices.

Koop also prepared the first extensive report on AIDS and HIV infection during the early years of the disease’s emergence. He resisted demands from conservatives to remove the recommendations that people use condoms if they weren’t practicing abstinence or monogamy. “Too many people place conservative ideology far above saving human lives.”

He lived a long life and happy life, marrying for the second time at age 93. We owe C. Everett Koop a debt of gratitude for his brave crusades against smoking and AIDS. Americans should remember him as one of the great public health pioneers and a truly outstanding Surgeon General.

Federal medical privacy rules strengthened; Medication adherence must be protected

By Sally Greenberg, NCL Executive Director

Last week, the U.S. Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) published its long-awaited final rule revising the nation’s federal medical privacy requirements under the HITECH Act of 2009 – a.k.a. the “HIPAA Privacy Rule.” NCL, a founding member of the Best Privacy Practices Coalition, congratulates HHS for strengthening consumer privacy and data security protections, and enhancing enforcement for HIPAA violations by covered entities and their business associates.

The final rule attempts to strike a balance between patients’ privacy concerns and the meaningful benefits of sponsored and non-sponsored communications that can improve adherence to prescribed therapies and greatly improve patient health. Notwithstanding HHS’s efforts, there remains some tension between certain of the privacy protections and the goals of bolstering public health.

The problem of poor medication adherence is a major, and significantly under-appreciated health problem. Studies suggest that nearly three-out-of-four Americans do not take their medication as directed and that the cost to the health care system of non-adherence annually is a $290 billion. To address the problem, NCL is leading a medication adherence public awareness campaign, Script Your Future (www.scriptyourfuture.org). NCL’s campaign is designed to help patients take their prescribed medication as directed and better manage health problems such as diabetes, COPD, asthma, high blood pressure, and high cholesterol.

To help combat this problem of poor adherence, most pharmacies, health plans, and doctors provide a broad range of patient-directed communications regarding prescription drug therapies, including communications that encourage patients to stay on prescribed therapy. NCL’s views these communications, particularly “refill reminders,” as tools that help patients follow their medication regimen.

While we are pleased that the rule does allow use of “refill reminders” we are concerned that HHS’s final rule is more restrictive than the prior HIPAA Privacy Rule in requiring patient authorization (opt in) for health care providers’ (and health plans’) capability to use patient information to execute certain sponsored patient communications programs (refill reminders are excepted). To its credit, in addition to codifying the statutory exception for “refill reminder” messages, HHS also maintained the exception for sponsored communications that are delivered in face-to-face settings (e.g., in the pharmacy or doctor’s office).

In particular, we are concerned that the statutory exception for “refill reminders” is available only if compensation received by the covered entity provider or plan is “reasonably related” to the entity’s costs of making the communication. Although Congress included this “reasonable in amount” limitation in the HITECH Act, NCL believes that HHS has gone too far in its preamble interpretation by limiting such compensation to only certain direct costs. Specifically, under the final rule, HHS considers permissible costs to be restricted to those of labor, supplies, and postage to make the communication and that they include “only the pharmacy’s cost of drafting, printing, and mailing the refill reminders.” It sounds like a minor point, perhaps, but we are concerned that this could have a negative impact on patient adherence. We think that a broader definition of costs is called for, including such things as computer hardware, software, and other overhead – because we don’t want to inhibit in any way communications that can help improve the likelihood of patient adherence to medication.

We also are concerned that, from a policy standpoint, the “reasonable compensation” requirement may inhibit HHS efforts to promote medication adherence, and in the end does little to advance patient privacy. For instance, HHS’s Centers for Medicare and Medicaid (CMS) requires and rewards patient adherence programs in several respects, including through physicians’ “meaningful use” of electronic health records (EHRs). Furthermore, in order for vendors implementing Medicare part D to qualify for reimbursement, they must make use of CMS’s Medication Management Therapy Programs (MTMP), which are, by their very nature, adherence -focused incentives. In addition, HHS’s Agency for Healthcare Research and Quality (AHRQ) has studied the comparative effectiveness of medication adherence interventions and funds adherence educational programs.

We’re concerned that HHS’s interpretation of “reasonable compensation” may not be grounded in good public policy and could actually hamper sponsored adherence efforts, which are widely regarded as beneficial to public health. In the final rule, HHS signaled its intention to issue informal guidance on the “refill reminder” exception. NCL hopes that, in so doing, HHS will make clear that the exception serves an important public health function and that “reasonable compensation” ought to be interpreted in the broadest possible fashion in order to ensure that we are doing all we can to promote improved medication adherence.