On June 28, 2022, the U.S. Food and Drug Administration (FDA) reported Bryant Ranch Prepack Inc.’s voluntarily recall of one lot of morphine sulfate 30 mg extended-release tablets and one lot of morphine sulfate 60 mg extended-release tablets because the products are incorrectly labeled. Bottles labeled as 60 mg tablets may contain 30 mg tablets and bottles labeled as 30 mg may have 60 mg tablets.

On June 24, 2022, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (Breyanzi®) for adult patients with large B-cell lymphoma (LBCL) whose disease is refractory to first-line chemoimmunotherapy, have relapsed within a year of first-line chemoimmunotherapy, or are not eligible for hematopoietic stem cell transplantation (HSCT) after relapse. It is not for patients with primary central nervous system lymphoma.

Patients with cancer and other healthcare consumers would receive reinforcements in the fight against financial toxicity with new legislation that would “empower the Federal Trade Commission (FTC) to increase drug pricing transparency and hold pharmacy benefit managers (PBMs) accountable for unfair and deceptive practices that drive up the costs of prescription drugs.” U.S. Senators Maria Cantwell (D-WA) and Chuck Grassley (R-IA) introduced the proposed bill in May.

Out-of-pocket prescription drug costs for beneficiaries with Medicare Part D could start to lower with improved price transparency and market competition thanks to a January 2022 proposed rule from the Centers for Medicare and Medicaid Services (CMS). The rule, which would take effect on January 1, 2023, would improve beneficiaries’ experiences with Medicare Advantage and Medicare Part D and work to improve health equity in the programs, according to CMS.

Preventing overdoses—from any substance, but particularly opioids—is an urgent need during the U.S. opioid epidemic that involves a four-step process: prevention, harm reduction, treatment, and recovery, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra announced. HHS released a new overdose prevention strategy in October 2021 to increase access to services for patients and their families who use substances that can put them at risk for overdose.

Few political and policy issues resonate with all Americans as much as the costs of prescription medications, particularly those for acute and chronic diseases that affect the body and spirit, like cancer. Seizing the opportunity for real change, in August 2021 President Joe Biden made a major announcement about his administration’s intent to change the dynamic on the financial impact of drugs and government oversight.

On September 9, 2021, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra released the Drug Pricing Plan to combat excessive pricing or prescription drugs and reduce the prices paid by the federal government for such drugs, and to address price gouging in the industry. The plan is a part of an initiative from President Biden’s executive order on Promoting Competition in the American Economy to advance the federal government’s ability to address overconcentration, monopolization, and unfair competition in the economy.

Drug pricing is a bipartisan issue that ranks very high on public opinion polling, and patients with cancer in particular feel the effects of an unregulated market. 

Common classes of non-cancer medications that affect a patient’s microbiome are associated with increased or decreased survival with immune checkpoint inhibitor drugs, researchers reported in study findings published in BMC Cancer.

As one of the only not-entirely-pandemic-related health policy topics currently in policymakers’ discussions, lawmakers are again revisiting the high cost of prescription drugs. Voters have voiced concerns in the current economic climate, and, eager to appease in the months before the November presidential election, the Trump administration responded.

Capecitabine (Xeloda^®) was approved by the U.S. Food and Drug Administration (FDA) in 1998 as a nucleoside metabolic inhibitor with antineoplastic activity indicated for adjuvant colon cancer, metastatic colorectal cancer, and metastatic breast cancer.

Approved in 2006 as monotherapy for the treatment of patients with EGFR-expressing metastatic colorectal cancer (mCRC) after disease progression following treatment, panitumumab has been a mainstay metastatic disease for more than a decade. In 2014, it received additional indication as first-line therapy for the treatment of patients with EGFR-expressing mCRC in combination with FOLFOX, but in 2017, use was narrowed to wild-type RAS (not mutated RAS). 

Drug pricing is a top legislative issue for Congress, and amid rising COVID-19 concerns, health policy topics are more pressing than ever. On March 5, Senator Martha McSally (R-AZ) introduced the Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020, which would allow Medicare to negotiate prices after a drug’s patent expires as well as cap out-of-pocket prescription spending for seniors at $3,100 per year.

Despite restrictive legislation raising the age of purchase for tobacco products to 21, vaping remains a top legislative concern, and some believe that vaping restrictions are already out of date. For nearly two decades, youth smoking rates were on the decline. After e-cigarette companies like Juul brought their products to market, those rates have seen a sharp uptick and led the U.S. surgeon general to declare a youth smoking epidemic. Although some progress has been made, the issue remains a top priority for organizations like ONS and its members.

Oral oncolytics have introduced a different level of complexity to care. Many patients won’t ever receive their treatments in the infusion room, which is where nurses have traditionally offered in-depth patient education. Instead, nurses are using new tools—like the Oral Chemo Education Sheets—to ensure patients have the information they need to understand their treatment and its side effects.

The Elijah E. Cummings Lower Drug Costs Now Act of 2019, otherwise known as H.R. 3, is a top priority for House Speaker Nancy Pelosi (D-CA). But she’s facing challenges from progressive Democrats on her left more so than the conservative Senate on her right. Watering down provisions in H.R. 3 too much will lose her the votes she needs to pass the bill in the House, but passing a bill that’s too overarching or progressive will allow Senate Majority Leader Mitch McConnell (R-KY) to refuse to take up the legislation at all.

Addressing the rising costs of prescription medications is a key priority for the Trump administration. As patients struggle with the financial burden of high drug prices, the U.S. Food and Drug Administration is reviewing options to import medications from Canada at a lower cost to consumers. However, the plan has major hurdles that FDA must address before it can become a reality.

The vaping conversation has drawn the attention of everyone on Capitol Hill, and it’s been a contentious debate so far. Tensions were high at the White House during a meeting with smoking cessation advocates after the Trump administration decided to step back from promises to ban flavored vaping products.

Blinatumomab received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of B-cell precursor acute lymphoblastic leukemia. The drug’s unique administration procedures have prompted nurses to evaluate their practice for safety.

After news of the vincristine shortage affecting the cancer community made headlines in several news outlets, the country’s prescription medication issues took center stage again. It’s a sign of larger problem: supply, demand, and drug pricing are all enveloped in the same issue that’s directly affecting patients and their families.

With the 2020 presidential election cycle in full swing, some Democratic candidates are pushing an aggressive proposal to combat the rising costs of prescription drugs by potentially ending patents for high-cost medications. Breaking the patent of an existing drug to allow competitors to make a cheaper version is a bold step to combat the drug pricing issue, but the potential proposal doesn't seem to be getting much negative push back from either side of the aisle. Many see it as a way to keep the industry in check, and the provision makes for great political fodder on the campaign trail.

As ONS advocates participate in the 2019 ONS Capitol Hill Days training and advocacy event in Washington, DC, from September 22–24, 2019, a recent Journal of Nursing Administration post about nursing influence in health policy is timely. It serves as a reminder that a nurse’s work in patient-centered care goes beyond the bedside or chairside. Nurses are educators, influencers, innovators, and sage guides for patients, policymakers, and the greater healthcare industry.

With more deaths reported from vaping and a forceful U.S. Senate declaration to the U.S. Food and Drug Administration (FDA) acting commissioner to either enact stronger federal provisions restricting e-cigarettes, flavored tobacco, and inhalants or resign, the Trump administration moved quickly to demonstrate a recognition that cessation is a national, bipartisan concern. FDA sent a warning letter to Juul about its marketing and labeling, and the president, Health and Human Services secretary, and FDA commissioner issued very public statements on the matter, making it clear that federal oversight will be enforced on youth tobacco issues.

Chicago ONS Chapter member Janice Phillips, RN, CENP, PhD, FAAN, said it all in her op-ed published on Morning Consult. The entire Democratic field of presidential candidates has declared some form of healthcare overhaul, albeit to varying degrees of change. With expanded access and reduced costs for patients and families as a priority, the centerpiece to most presidential hopefuls’ domestic policy program is redesigning a struggling system.

On September 3, 2019, AmEx Pharmacy issued a voluntary recall of two dosages of injectable bevacizumab. Although injectable bevacizumab is used in cancer treatment, the formulations affected by the recall are for much smaller dosages that are used to treat eye diseases (i.e., macular degeneration and diabetic retinopathy).

Health care is a top domestic issue for U.S. voters, and the president is speaking more and more about his administration’s plans to find accessible, affordable healthcare options for millions of Americans. Speaking this summer at the Better Medicare Alliance in Washington, DC, Department of Health and Human Services Secretary Alex Azar outlined three key points where the Trump administration plans to improve health care.

From New Hampshire to Arizona, millions of American families are confronted by the impact of opioid addiction. It’s one of the few remaining bipartisan issues on which the U.S. Congress continues to agree. Its reach is pervasive, it’s an international and domestic issue, and it has led politicians to cross the aisle and work together. Finding initiatives and funding programs to enact real solutions has become a national priority, and the Department of Health and Human Services (HHS) is earmarking nearly $400 million to fight the ongoing opioid epidemic.

With our heads held high, Michelle Santizo, RN, PHN, MSN, and I walked right into Capitol Hill, ready to tackle meetings with important members of the U.S. Congress. On that day in July 2019, we spoke with staff members working for the offices of both Kamala Harris (D-CA) and Diane Feinstein (D-CA).

The high cost of prescription medications—often lifesaving drugs—has become an unsustainable burden for many American patients. It’s a central topic in the healthcare conversation and a complex issue with countless moving parts. National opinion polling finds that a majority of people want to see changes in drug pricing.

The decision to allow Medicare to cover the cost of CAR T-cell therapy—a new and expensive form of immunotherapy—is an important one for patients seeking the treatment, especially after rounds of failed tradition therapies. Educating federal agencies and government representatives about the importance of new treatments like CAR T cells have helped drive coverage decisions, and the patient advocacy community—like ONS’s very own advocates—are to thank.

Few know the power that prescription medications have on the quality of life for patients more than nurses. In more than just physical ways, access to affordable drugs is essential to patient-centered care and emotional, psychological, familial, and even financial stability. For too long, the cost and availability of medicines have been barriers to health care, rather than opportunities for survivorship. 
 

From soaring prescription medication costs to surprise medical bills, the issue of high healthcare costs has dominated headlines for months. Both sides of the aisle have been outspoken about the issue in a rare showing of bipartisanship. But despite the attention paid to the issue, little has been done legislatively to corral rising healthcare costs for patients and consumers. The recent announcement that the Senate wouldn’t vote on its healthcare cost bill prior to the August recess has left many wondering if the issue would be addressed at all.

Surprise medical bills—a long-time problem for patients and consumers—was not on the legislative radar until recently. In short order, the issue has quickly moved through the House Energy and Commerce Committee, one of the most powerful on Capitol Hill, to offer some hope for consumers. Part of the committee’s mark up added an amendment allowing for arbitration to address specific medical charges if hospitals disagreed with the agreed-upon rate. Some committee members felt that without it, providers would have limited recourse in special circumstances.

An ONS priority bill, the Palliative Care and Hospice Education and Training Act (PCHETA) emphasizes how providers are educated and trained in palliative care, enabling them to provide a higher level of care to their patients. PCHETA legislation—and its reception on Capitol Hill—has evolved from being misinterpreted as training providers to hasten death to a true understanding that palliative care is patient-centered care, and it provides patients and their family members with further treatment options, symptom management resources, and quality of life. In a display of bipartisanship, Senators Tammy Baldwin (D-WI) and Shelley Moore Capito (R-WV) reintroduced PCHETA legislation to the Senate floor for consideration.

On March 26, 2019, more than 40 nurses came together at the Maryland General Assembly’s Senate President’s Conference Center for the Oncology Nurses Night in Annapolis. This was the Greater Baltimore Chapter of ONS’s (GBCONS’s) third advocacy trip to the statehouse, but it was the first statewide ONS event. All four Maryland chapters were active in planning the night, and many new advocates were inspired to speak out.

As challenges mount to find new and innovative ways to provide quality health care at affordable prices for patients, a battle is brewing over what patients can and cannot know about their healthcare costs. On June 24, President Trump released an executive order directing his administration to take steps to improve healthcare prices and transparency to address the pricing woes patients face.

Healthcare advocates assembled in the U.S. Congress to hear from panelists about the national epidemic of youth smoking. From those conversations, a common theme emerged: many believe that the rise in youth vaping and smoking is directly related to marketing and sales tactics by large tobacco manufacturers.

In March and April 2019, the Centers for Medicare and Medicaid Services (CMS) issued several proposed and final rules that affect patient coverage for cancer-related benefits, payment models, and the paperwork nurses often complete to ensure those benefits are billed correctly.

In the aftermath of the 2018 midterm election, one domestic policy issue shone through as a common ground for most Americans: healthcare costs. In particular, the dramatic rise in prices for prescription medication seems to be a pervasive worry among voters. To address the issue, elected officials in Washington, DC—in a bipartisan fashion not often seen—have consulted and impaneled congressional hearings to understand the economic impact medication costs.

Medicare Part D will continue to give patients access to certain cancer drugs, according Centers for Medicare and Medicaid Services’ (CMS’s) final ruling issued May 16, 2019. The final rule does not allow for utilization controls like step therapy and prior authorizations for patients who are already in an established treatment regimen; does not restrict drugs that have had certain price increases over a specified time period; and does not restrict new formulations of an existing protected class drug.

Washington is the first state in the country to offer a public insurance option to its residents after Governor Jay Inslee signed the bill into law on May 13, 2019. Is it any coincidence that Inslee is also running for president? Coming from a traditionally “blue” state with a strong progressive legislature allowed this Democratic candidate to deliver on a particularly interesting policy.

Trying to find a path forward is a common theme among elected officials in Washington, DC, and drug pricing appears to be a bipartisan initiative. In that vein, Senator Chuck Grassley (R-IA)— working with representatives from both sides of the aisle—announced his plan to release a drug pricing proposal by the beginning of summer 2019.

As Washington attempts to address the soaring costs of prescription medications, some experts are attempting to shed light on the many complicated aspects of the drug pricing issue. The free-market system has countless moving parts, and perhaps so-called big government ownership isn’t the answer to inflating drug costs. As the author aptly states, “From a public-relations standpoint, drug companies are often their own worst enemies. Occasionally, a breathtakingly awful company taints the image of the whole industry.”

Reducing the high cost of prescription drugs continues to be a priority focus for both the U.S. Congress and Trump administration, and ONS is closely monitoring and providing input on how key proposals could affect patient access to oncology care.   

On April 8, 2018, nearly a dozen Democratic senators announced they would investigate the marketing practices of e-cigarette giant Juul along with a new deal to sell a minority stake of the company to Altria, maker of Marlboro cigarettes. Not long ago, the U.S. Food and Drug Administration (FDA) and Juul—along with others in the smoking cessation community—supported efforts to use electronic tobacco mechanisms to help 60 million Americans quit smoking. However, along the way, the U.S. surgeon general and FDA discovered that youth smoking and vaping have seen a dramatic increase from the advertising, marketing, and distribution of e-cigarettes.

The 116th congressional session is well underway. Committee meetings are being held and policy discussions are taking shape all over Capitol Hill. In January 2019, the U.S. House and Senate held separate public hearings on the biggest healthcare issue from the 2018 midterm election: drug pricing.

It’s been almost a decade since the Institute of Medicine—now the National Academies of Medicine (NAM)—released The Future of Nursing: Leading Change, Advancing Health report. Although many aspects of the nursing profession have been enhanced, still others are woefully lacking in change. Healthcare workplace safety incidents are still too high—up to 12 times higher than in the overall workforce—educational opportunities are still too expensive, and scope-of-practice authority is still too limiting in many states—all of which are ONS policy priorities.

Although nurses are the number one trusted profession in the United States for the past 18 years in a row, they’re not necessarily the most protected sector. Hostile workforce environments and exposure to hazardous chemicals are still a part of too many nurses’ daily lives. Recently, the U.S. House Education and Labor Committee held hearings on workforce safety to better understand the what nurses and other healthcare workers endure.

For the past year, President Trump has championed efforts to lower drug prices for Americans to more accessible and affordable medications. Lowering soaring prescription costs is an issue with wide bipartisan support in Congress. To date, several Congressional committees have held hearings in early 2019 with pharmaceutical executives.

Democrats control the majority of the House of Representatives, and it’s their responsibility to provide and pass a U.S. budget. As with any Congress, it’s always easier said than done. With a larger, more progressive freshman class interested in pushing more environmental, health, and welfare policy issues forward, costs will be a concern.