Lots to talk about during Talk about Prescriptions Month

burkholder1By Rebecca Burkholder, NCL Vice President for Health Policy

October is Talk about Prescriptions Month, and with 50 percent of Americans taking at least one or more prescription drugs, there are a lot of conversations that need to happen. If you are taking a prescription medication, always ask your doctor or pharmacist why you are taking the medication, its name, how to take it properly, and if there are any side effects. Taking medication as directed is important to obtain the full benefits of the medication; this is especially true if you are taking a medication for a chronic condition. How you access your medications is also important. This month FDA reminds us that if you buy your medications on line, do so safely.

Earlier this month a report released from the National Council on Patient Information and Education (NCPIE) emphasized that with the increased number of Americans with chronic conditions, proper use of mediation is more important than ever.  Today, 27 percent of Americans are living with multiple chronic conditions, and 68 percent (21.4 million people) of Medicare beneficiaries are being treated for at least two concurrent chronic illnesses. Treating multiple chronic conditions accounts for 66 percent of the nation’s health expenditures.  Of the $300 billion Medicare spent in 2010 on health care, the price tag for treating the 14 percent of beneficiaries with six or more conditions was over $140 billion.  For these patients, poor medication adherence is commonplace and they are at higher risk for medication-related problems and the costly emergency room visits and hospitalizations that can result.

The new report, Accelerating Progress in Prescription Medicine Adherence: The Adherence Action Agenda, which was based on input from 23 organizations, including NCL – underscores that as morbidity, mortality and health care costs rise action needs to be taken quickly to improve adherence among Americans living with multiple diseases.  The report outlines a 10-point action agenda that advocates for an increased focus on multiple chronic conditions and policy and programmatic solutions for improving adherence.  For practical tips on taking medications as directed, especially if you have a chronic condition, see NCL’s Script Your Future website.

 

In addition to being careful about taking our medications, Americans also need to continue to be mindful about where they purchase medications, especially if buying online. Buying medicines from fraudulent Web sites – which often look legitimate – puts your health at risk because the products may contain the wrong ingredients, too little or too much of the active ingredient, or they might be made with other harmful substances. As a result, consumers may not receive the therapy they need, or they may experience unexpected side effects and possibly get worse.

The FDA campaign, BeSafeRx: Know Your Online Pharmacy Web site has a new video featuring FDA’s Health Fraud Coordinator Gary Coody, who explains how to avoid fake online pharmacies.

In addition to the “how to” video, the BeSafeRx Web site provides an interactive map for checking a pharmacy’s license through states’ boards of pharmacy, fact sheets, and other materials. For more information about counterfeit drugs, check out our information at Fraud.org.

Bill to improve compounding pharmacy falls short of protecting public health

92_ayannaBy 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.

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FDA energized to reexamine caffeine added to products

By Teresa Green, Linda Golodner Food Safety & Nutrition Fellow

The biggest buzz in the food community in the last few weeks has been around FDA’s announcement to take a closer look at caffeine added in food products.  This recent trend has led to caffeine showing up in products ranging from gum, to marshmallows, to maple syrup, to cracker jacks.

Given the increasing popularity of energy drinks, it should come as no surprise that companies are trying to tap into that market.  However, because there have been some deaths linked to energy drink consumption, and because many of the foods that have added caffeine are particularly attractive to children and teens, FDA has decided to look into these products.

After the announcement by FDA, Wrigley’s, which had been developing a caffeinated gum, has decided to withdraw the product “out of respect” for FDA.  This demonstrates the power of targeted action by the agency.  In a time of constrained resources, it is understandable that FDA has to prioritize.  This announcement by FDA clearly illustrates that one “warning shot” can send a message to the industry to change their behavior.  We hope the agency will continue taking similar action on food fraud and labeling issues, problems we consider important parts of FDA’s mission.

Fishy labeling harming consumers’ health and pocketbooks

By Teresa Green, Linda Golodner Food Safety & Nutrition Fellow

A new study was recently released, reaffirming something those of us who work on food fraud have known for a while: adulteration and food fraud is rampant, especially in the most vulnerable products. This most recent study addresses fish products sold in the D.C. metropolitan area, NCL’s backyard. The study found that one-third of seafood sold in both restaurants and grocery stores is mislabeled as a different type of fish. For some types of fish, like snapper, as much as 87 percent of the fish sold nationwide may be mislabeled.

The motivation for mislabeling fish is the same as the motive for any food fraud: economic profit. Whenever a cheaper product can be sold in place of a more expensive one, this increases the potential profit margin for the producer. Unfortunately, economically motivated adulteration can hurt consumers. First and most obviously, customers are not getting what they paid for. Secondly, when products are adulterated, consumers are unaware of what they are consuming and thus cannot avoid ingredients that they do not want to consume. This is particularly harmful when these ingredients are allergens. Finally, one major concern revolves around food safety. If a producer is breaking the law by substituting products, it is certainly possible that they are cutting corners in other areas. In particular, they may not be following the most up-to-date food safety practices.

Unfortunately for consumers, identifying when a product has been adulterated is very difficult. Prices that seem too good to be true can be one indicator that a product isn’t what it claims to be. Beyond that, consumers who are concerned about this issue should let the FDA know that enforcement and testing should be a high priority.

House and Senate hearings begin to shed light on compounding pharmacies and meningitis outbreak

By Sally Greenberg, NCL Executive Director, and Ayanna Johnson, NCL Health Policy Associate

This past week, the House and Senate held hearings on the fungal meningitis outbreak and the state of compounding pharmacies in the US. Both the current FDA Commissioner, Dr. Margaret A. Hamburg, and the Massachusetts Department of Health Interim Commissioner, Dr. Lauren Smith, testified at the hearings, offering accounts of the roles their respective agencies played in the issue. The hearings highlighted the slipshod practices of drug compounding by the New England Compounding Center (NECC) in Massachusetts, which at times reached a scale of production resembling drug manufacturing. The co-owner of NECC, Barry Cadden, was subpoenaed and present at the House committee hearing, but invoked his 5th amendment right. The hearings are a part of the ongoing investigation into the outbreak and what can be done to prevent future threats to public health, like this, from happening again.

To date, the outbreak has left 34 patients dead, over 400 sickened and more than 14,000 patients who received injections wondering what is next. At the House hearing, the wife of a deceased victim gave a compelling account of her husband’s unexpected and rapid demise due to receiving a contaminated injection to relieve pain, stemming from a car accident. One thing was clear from her account: she and her family “have lived a nightmare” and had no idea what was happening to her husband. Unexplained headaches and periodic numbness were the only symptoms that signaled something was going terribly wrong. Stories like these put a name and face to the tally of victims. Our thoughts and condolences go out to all those who have lost loved ones or had loved ones sickened by this outbreak. Patients and consumers should be able to rest assured that their medicines are safe; the House committee members pledged to provide bipartisan support to finding a solution.

Since its opening in 1998, NECC has come under fire for numerous violations at both the state and federal levels. The hearings often focused on a timeline of events where NECC was inspected, was cited for violations and unlawful interstate commerce, or even risked closure for copying a manufactured prescription drug. NECC’s consistent interaction with government begs the question why was something not done earlier, but—as pointed out by numerous testimonies—the authority with which FDA can act in these situations is unclear. In fact, Dr. Hamburg brought a map of FDA jurisdiction over compounding pharmacies across the US, describing it as a patchwork of laws lacking clear lines of regulatory oversight.

Neither Dr. Hamburg nor Dr. Smith were heading their respective agencies when the state board of pharmacy or FDA interacted with NECC, each described her role, potential next steps, and why FDA’s jurisdiction over compounding pharmacies needs to be clarified through legislation. As we sat in the hearing room, we were startled at the questions directed at Dr. Hamburg by certain Committee members. They struck us as disrespectful and offensive. Committee members demanded a yes or no answer for complicated issues. There is a difference between compounding and drug manufacturing, which lawmakers must recognize in order to make substantive headway in creating an effective law. Additionally, the compounding industry has evolved substantially and new laws are required to reflect that. We appreciate the close regulatory attention that Dr. Hamburg and Dr. Smith are advocating for, to ensure that tainted drugs never get into the marketplace.

One congressman asked the FDA what it would need to prevent this from happening again, which we thought this was constructive. While it is important to determine what went wrong, pointing fingers and playing the blame game will not protect consumers and patients in the end. Finding out how to increase our public health agencies’ power to protect is important.

Dr. Hamburg agreed that FDA was in need of increased funding if all compounding pharmacies are to fall under FDA jurisdiction. The 7,500+ compounding pharmacies need to be registered with the FDA, and currently they are not. Dr. Hamburg also proposed a tiered system of management for compounding pharmacies that leaves traditional compounding under the jurisdiction of the state, and non-traditional compounding becomes FDA regulated. The Senate committee commended the work of the Centers for Disease Control (CDC) in investigating and reporting on the outbreak. It was encouraging to see Congress recognize the importance of public health, and the need for continued funding to support its efforts in the broader health care arena.

As the events surrounding the meningitis outbreak continue to unfold and more holes in regulation are exposed, it is important that efforts are directed to closing these gaps in the law. FDA’s commitment to bring those compounding pharmacies that are actually making drugs under its regulatory umbrella is laudable and the appropriate next step. The president of the International Association of Compounding Pharmacies also testified at the Senate hearing that legislators would have his organization’s support and commitment to collaborate on a bill to protect the public’s health. We hope he makes good on that promise.

Finally, the National Consumers League also calls on all members of Congress to support legislation introduced by Congressman Ed Markey (D-MA) —whose district includes NECC headquarters—to clarify FDA’s regulatory role and that of the state health departments and require registration of these pharmacies and labeling of all products they make.

Meningitis outbreak: how could it have happened?

By Sally Greenberg, NCL Executive Director

It’s hard to accept that 29 patients have now died and 338 are sick across 18 states from meningitis because the injectable steroid medications they were administered for pain were contaminated with fungus. The drugs were prepared by the New England Compounding Center (NECC) and shipped across the United States. After the outbreak, an FDA investigation showed in the first nine months of the year, NECC’s so-called “internal monitoring program” showed mold or bacterial contamination at more than 80 locations, including numerous places in its “clean rooms” where sterile drugs are made. In more than half the cases, the company’s own testing showed bacteria and mold above its “action” limits, but NECC took no action.

It gets worse. After the steroid was recalled, the FDA also found that 83 vials from one lot of the tainted steroid contained “greenish black foreign matter.’’ Another 17 vials had white material floating in them. Further testing found that another 50 out of 50 vials from the same lot had “viable microbial growth.”

A lot of people are asking how this could have happened. Indeed, the outbreak raises many difficult questions – how could the system of regulation and oversight patients have come to rely on have broken down so completely?  How could patients have been injected with obviously contaminated drugs? What happened to the internal oversight at NECC? Why didn’t someone on staff at NECC blow the whistle before these drugs were shipped?  Why wasn’t the Board of Pharmacy in Massachusetts conducting the oversight needed to make sure a compounding pharmacy like NECC was maintaining safe practices? Why didn’t the FDA have jurisdiction to oversee what was clearly drug manufacturing, not simply drug compounding?

NCL’s concern is with the 14,000 patients who received the injectable drugs, those who are sick from meningitis and the families of those who have died from the outbreak. We issued a fact sheet and press release in the last week asking these questions, providing information for patients, and calling for legislation to ensure proper regulation of compounding pharmacies.

We’ve learned a lot about the compounding pharmacy industry. NECC is part of the International Academy of Compounding Pharmacists (IACP), the industry’s Texas-based trade association, which until this disastrous NECC outbreak, has argued that existing regulations are more than adequate to protect patients.

The FDA in 2001 testified before at a US Senate hearing that the agency surveyed drugs from 12 compounding pharmacies, including hormones, antibiotics, steroids and drugs to treat glaucoma, asthma and erectile dysfunction and ten of the 29 drugs failed one or more quality tests, including nine that failed potency testing, some with less than 70 percent of their declared potency. By contrast, in its analyses of more than 3,000 samples from drug manufacturers, who are subject to FDA oversight, only four had quality problems.

Even after the FDA testified about its findings, Congress killed legislation to give the agency oversight on pharmacy compounding. It was the first in a series of failures to regulate a clearly problematic industry, one that had managed to fight its way out of effective regulation through lobbying and political donations.

In a recent article, one patient group provided this quote about IACP: “They mobilize their members, they scare patients and parents, and they flood Capitol Hill,” said Sandra Fusco Walker, director of patient advocacy at Allergy & Asthma Network Mothers of Asthmatics. “They are dedicated to making sure they never have FDA oversight.”

In the coming months, NCL will be on the front lines on behalf of patients to see that what happened in the shipping and administration of contaminated drugs is never allowed to take place again. We are working with Congressman Edward Markey (D-MA), a member of the House Energy and Commerce Committee, which has jurisdiction over the FDA and health issues generally. The Congressman, a longstanding champion of consumers and patients, has introduced a bill to close the gaping hole in regulation of compounding pharmacies.

Weighing in on the overuse of antibiotics in livestock

Antibiotic resistance is a growing public health problem. While there are many causes of resistance, one major reservoir for resistant bacteria is livestock. With more than 80 percent of the antibiotics used in this country administered to livestock, resistance arising from food-producing animals is of no small concern. Antibiotics are used in livestock for three main purposes. First, they are used to treat a sick animal. Secondly, they are used to prevent illnesses, diseases which are largely the result of the crowded agricultural conditions that are so common these days. Finally, antibiotics are used to promote faster growth so that animals may be taken to slaughter at younger ages, a practice which yields higher rates of profit for farmers.

Because antibiotic resistance develops when bacteria are exposed to antimicrobials intended to kill them, all three uses of these drugs can lead to problems. Some bacteria are stronger, often due to a genetic mutation. Antibiotics may kill the weaker bugs but these stronger bacteria will survive and flourish.

The consequences of increasing antimicrobial resistance are very real. Patients who become ill with a resistant infection will have to make choices about alternative drugs, which may be less effective or have more serious side effects.

In response to the problem of increasing drug resistance caused by livestock, the FDA recently issued a draft Guidance for Industry which set outs a new paradigm for reducing antibiotic use in livestock. Unfortunately, this new framework is entirely voluntary, meaning that manufacturers of these drugs get to decide whether or not they abide by FDA’s recommendations.

In formal comments filed with the FDA, NCL made the following recommendations for strengthening the program:

  1. Because disease prevention uses of antibiotics create the same selective pressures as growth promotion, FDA should move forward with withdrawing approvals for the use of antimicrobials for prevention of diseases. This is necessary as drug companies are unlikely to make this move on their own.
  2. The new system that FDA has proposed relies on a voluntary scheme for eliminating the use of antimicrobials for growth promotion. Because some companies may choose not to participate, a voluntary system is not sufficient for reducing the use of antibiotics. We encourage FDA to use its regulatory authority to create a mandatory reduction plan that will ensure compliance and increased public health.
  3. The FDA should choose a measure of success that is meaningful to public health. Because of our concerns that drug sponsors may add indications to their drugs for prevention uses, merely looking at whether sponsors do away with growth promotion uses of antimicrobials is an insufficient measure of whether the program is succeeding. A more appropriate measure of success would be to look at whether or not the amount of antibiotics used has decreased.
  4. Transparency in the implementation of this new process is essential. FDA has proposed a three year implementation period. FDA should publish detailed quarterly reports on proposed and finalized voluntary changes. These reports should facilitate the independent verification of progress made towards implementation as well as an assessment of the public health implications of these changes.

NCL urges FDA to implement mandatory reductions in antibiotic use in livestock. Without these changes, we face the very real possibility of losing our arsenal of drugs we use to treat human disease.