NCL applauds USP for new and revised compounding standards

Every day, thousands of consumers in the United States—including those with rare diseases or allergies to commercially available drugs—rely on specially and individually made medicines known as compounded drugs. Compounding is critically important for patients but, if done improperly, this process can pose significant risks to patients and healthcare workers alike. Patients could—and have—received contaminated drugs or preparations that are subpotent, contaminated, or super-potent. Healthcare workers, in turn, can face risks of exposure to hazardous drugs.

A stark example is the 2012 series of medical errors that resulted in the contamination of compounded medicines, which in turn caused a deadly fungal meningitis outbreak in the United States—killing more than 70 people and causing more than 750 cases of infection in 20 states.

To reduce these public health risks, Congress and other policymakers have swung into action. Today, compounding requires universal standards that advance public health and patient safety priorities. A key player in this is the United States Pharmacopeia (USP), a scientific non-governmental standards-setting organization, which recently published new and revised compounding standards to help produce consistent quality compounded medicines and ensure that patients receive medicines that are the right strength, quality, and free of contaminants.

These updated standards reflect the latest advancements in science and clinical practice, and incorporate input from thousands of stakeholders in the medical and public health community—patients, healthcare practitioners, policymakers, academicians, and industry. The standards complement robust implementation of existing laws intended to ensure quality compounded products with the goal of protecting the safety of patients.

Consumers have an important role to play as we roll out the new guidelines for quality compounding and implementation of the new USP standards:

  • If you receive compounded medicines through your pharmacist or healthcare provider, report any resulting adverse events to your healthcare provider.
  • Sign up for FDA email alerts on safe compounding.
  • Remember to always contact your healthcare provider if you have questions or concerns about your health.

NCL is encouraged to see that the revised USP standards are consistent with FDA guidances. We applaud the efforts of FDA and USP to collaborate with the public health community to help protect patient safety.

Knowledge is power: What consumers need to know about safe use of pain treatments – National Consumers League

Sally GreenbergThe National Consumers League has long worked to inform consumers about the safe use of medication. Sadly, today many American communities are struggling with an epidemic: the misuse of prescription opioids, which seems to know no socioeconomic or demographic bounds. In 2016, more than 11 million people misused prescription opioids in the United States, and the latest data show that 115 Americans die each day from an opioid overdose.

The explosion of opioid abuse has complicated roots, but among them is the mistake of keeping unused prescriptions in the medicine cabinet long after they are prescribed. In that vein, NCL recommends specific steps consumers, families, and the public can take to mitigate the chances of opioid abuse.

Since as many as one in four people prescribed opioids long term struggle with addiction, the conversation about treatment and safe use must start before a medicine is prescribed.

Consumers should engage their healthcare provider and/or pharmacist before they take home a prescription opioid.

Be prepared ahead of medical appointments or surgery.

We have all walked out of a doctor’s office failing to ask important questions. Before your next doctor’s appointment, write down all your questions ahead of time and include an updated list of the medications you are taking. If you are prescribed a painkiller, ask about safe use and ask whether it’s habit forming. Some drugs are, while some are not.

Understand the risks and benefits of any new medicine.

If opioids are truly needed to manage pain, understand the potential benefits, risks, and side effects associated with them.

Here are a few questions to ask your healthcare provider when prescribed a new medicine:

  • What side effects should I expect and what should I do about them?
  • Will this medicine interact with any other medicines I am taking?
  • How should I safely store this medicine?

We recommend checking out the National Council on Patient Information and Education’s Talk Before You Take website.

Ask about partial-fill options.

When prescribed a prescription painkiller, consider asking to only partially fill your prescription, an option available in some states. If you need to fill the rest of the prescription, you can pick up the remaining dose at the pharmacy.

Use opioids only as prescribed — do not share your prescription.  

About 40 percent of those who misused prescription opioids in the past year said they obtained the medicine from a family member or friend for free, according to a national survey.  That’s a problem; opioids should only be taken as prescribed by your healthcare provider and stored in a secure place.  

Immediately dispose of unused pills.

As noted in my December blog post, disposal of unused prescription medications is critical.  Allied Against Opioid Abuse has compiled a list of national and state resources to assist you.

Consumers using the strategies outlined here have gone a long way toward reducing the chance of opioid abuse and misuse, which is one of the country’s biggest public health challenges.

Knowing your rights, risks, and responsibilities with prescription opioids can help all of us prevent abuse and misuse before it occurs.

From patient To consumer: Reimagining health care from a consumer perspective – National Consumers League

family-on-bikes.jpgThe following Huffington Post op-ed was published August 18, co-authored by NCL’s Sally Greenberg and Marilyn Tavenner, the President and CEO of America’s Health Insurance Plans.

Navigating our health care system is no easy task. For decades, consumers have been forced to contend with a fragmented health system that makes decision making an all-consuming challenge. Whether it’s choosing a provider, knowing where to get information about cost or quality of doctors, or understanding a dictionary of complex health care terms, many consumers often feel left to fend for themselves in a system that is working against them.

For many individuals, it’s hard to know where to start. A recent state analysis by Rice University in Texas found that 42 percent of consumers who bought their own insurance felt like they lacked a clear understanding of their health insurance plans. Nearly a quarter of those surveyed who had employer-sponsored coverage still struggled with understanding their benefits.

We need to find a way to change this. While we all recognize the seismic shift underway as the age of consumerism in health care finally takes hold, we have to ask ourselves if we are truly practicing what we preach. We all have a responsibility to provide consumers with the transparent, actionable information they need to make smart choices about their care.

The good news is that online and mobile apps are making it increasingly easy for consumers to access information on their own time and with relative simplicity. Health plans have rolled out provider cost and quality calculators, and websites like FAIR Health make it possible for patients to see what a typical doctor’s visit or MRI will cost before they even walk into a provider’s office.

But even with this push towards more available data, we know that individuals and families still struggle when it comes to understanding and using their insurance benefits. Commonly searched online terms around insurance include, “what are deductibles?”, “finding a doctor,” and “how much will I pay in premiums?” Consumers are clearly telegraphing the need for simple, easy-to-understand information about their coverage.

Recently, our two organizations came together to compare notes on how we could collaborate to improve consumers’ health care experience. As a first step, we agreed that while there is a wealth of information in the market available for consumers, it is often poorly organized, out-of-date, or like the health care system itself, requires consumers to search multiple places for the information they need. Our first joint project will bring critical information together and present it in ways that are useful for consumers. We will rely on AHIP’s considerable knowledge of health insurance and NCL’s more than 100 years of consumer education to make information accessible, understandable, and actionable.

Our work builds upon what we have learned over the past several years on the frontlines of this health care transformation. A recent report from McKinsey found that although consumers are beginning to research their health plan choices, many of them are not yet aware of key factors they should consider before selecting coverage, such as the type of health plan and provider network, level of coverage, premiums, cost-sharing, covered services, drug formularies and tiers, and health status and anticipated utilization. Even once they have their insurance plan, many consumers may not be aware of all the benefits that are included, including free preventive services, disease management programs, fitness plans – and equally important, the tools they have available to get the best value for their health care dollars.

As consumers prepare for the upcoming open enrollment periods for Medicare and the Exchanges, AHIP and NCL will share new consumer resources and information answering some of the important questions about insurance coverage and health care ranging from how to choose a health plan to how to choose a doctor, as well as consumers’ rights if they feel they’ve been inappropriately denied a product or service that should be covered by their plan.

We know that health care isn’t always simple, but if we are to be successful in moving towards a patient-centered health system, we have to start by making health care information more accessible and usable for consumers. While this partnership is a first step, our hope is that our combined efforts will encourage and support the important work underway to improve consumers’ experience with the health system and the wellbeing of the country as a whole.

This article originally appeared in the Huffington Post.

So Simple, So Hard tackles adherence challenges in CA – National Consumers League

“So Simple, So Hard” was the theme of the medication adherence conference the National Consumers League (NCL) held on September 15 in Sacramento, California. Sponsored by the Agency for Healthcare Research and Quality (AHRQ), the speakers and attendees explored the challenges and barriers to medication adherence – why it is so hard – and highlighted the tools and strategies to make it simpler and to improve adherence and health outcomes, especially among underserved populations.

NCL gathered more than 80 stakeholders in Sacramento, including health care professionals, community health workers, advocates, industry representatives, policymakers, and researchers. Throughout the day, conference participants heard from researchers and experts on adherence, and engaged with each other about possible collaborations and solutions.

The meeting kicked off with presentations on adherence research and health disparities, and continued with a variety of strategies and tools to improve adherence that could be utilized in health care practices or organizations. Takeaways from the presentations included the following:

  • One size does not fit all – adherence intervention work best when tailored for the patient
  • Quality of communication and a sense of collaboration between patients and health care professionals impact adherence, especially among people of color   
  • Adherence rates are unique to each medication a patient takes 
  • Cultural considerations are vital to understanding barriers to adherence
  • Always consider the health literacy of the patient
  • Determining the reasons for poor adherence is essential to developing effective interventions   

Specific strategies and solutions:

  • Medication synchronization
  • Comprehensive medication review
  • Tools for translating medication labels into the patient’s native language
  • Best practices and tools for more culturally competent clinical care

The conference provided a forum for participants to interact, connect, and lay the groundwork to develop partnerships for collaborative initiatives. We will be following up with all conference participants to determine the benefits of the conference and learn of any connections and /or collaborations developed.  

At NCL, we view poor adherence, with its devastating effect on health outcomes, as a public health problem. Since 2011, we have been leading Script Your Future – a public education campaign to increase awareness among patients, their family caregivers, and health care professionals of the importance of taking medication as directed.

As leaders of Script Your Future, NCL convened an AHRQ research dissemination conference to further explore possible solutions to this public health problem. The adherence issue is complex and taking medications is NOT so simple, especially for ethnic and racial minorities who often face health disparities. Collaboration among stakeholders who are dedicated to keeping the patient at the center of the discussion, is a critical first step toward developing and implementing effective medication adherence strategies to help people better self-manage their care.  

Conference participants and others are encouraged to distribute information from the conference to interested colleagues and through their networks. We look forward to hearing how others are sharing the information, tools, and resources from the conference, and the possible collaborations that will grow out of the meeting.   

* Funding for this conference was made possible in part by grant number 1R13HS023948-01A1 from the Agency for Healthcare Research and Quality (AHRQ). The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government

A Big Win For California Patients And Consumers – “Refill Reminders” A “Go” – National Consumers League

sg.jpgCalifornia’s Office of Health Information Integrity (CalOHII) just delivered a big victory for patients and consumers by expressly recognizing that sponsored medication adherence programs for a currently prescribed drug (commonly called “refill reminders”) do not require patient authorization in California. In publishing its long-awaited State Health Information Policy Manual, CalOHII takes a step to harmonize the state’s Confidentiality of Medical Information Act (CMIA) with the federal medical privacy laws and regulations (a.k.a., the HIPAA Privacy Rule).

For years now, due in part to privacy concerns, confusion has persisted within the healthcare community about the types of refill reminder programs that can legally run in California. In fact, California is the only state in the U.S. where pharmacies do not, to any meaningful degree, operate sponsored refill reminder programs. California consumers deserve the benefit of refill reminders that provide helpful information to patients about their prescription drugs. Patient access to this information is now guaranteed.

CalOHII’s publication of its Manual makes clear that California adopts the same approach that the U.S. Department of Health and Human Services (HHS) took in its 2013 final rulemaking and “Refill Reminder Guidance.” Under that HHS Guidance, pharmacies are able to provide their patients with sponsored refill reminders. NCL applauds CalOHII for clarifying that the CMIA should be interpreted consistently with the HIPAA Privacy Rule. With that clarification, NCL is hopeful that California pharmacies and their sponsors will jumpstart sponsored refill reminder programs. 

NCL is a longstanding supporter of refill reminder programs. NCL leads  “Script Your Future,” a public education campaign designed to raise awareness of the importance of taking medication as prescribed. Poor medication adherence is a major, and significantly under-appreciated, health problem. Studies establish that nearly three-out-of-four Americans do not take their medications as directed, which costs the healthcare system nearly $300 billion per year and results in almost 125,000 unnecessary deaths per year. To help combat this problem, 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. The sponsored refill reminder programs endorsed by CalOHII in its Manual are a key part of these efforts in California.  

 As a founding member of the Best Privacy Practices Coalition, NCL is also a strong believer in the protection of medical privacy. However, medical privacy does not exist in a vacuum. NCL is pleased that CalOHII has arrived at a great middle ground that balances the need for information with privacy concerns of patients. This balance is a win for Californians.