COVID-19 Pandemic and the Supply Chain Among Reasons for the 2022 Drug Shortages, FDA Says
In its annual report to the U.S. Congress on drug shortages, the U.S. Food and Drug Administration cited the COVID-19 pandemic, supply chain problems, and approval processes as reasons for the shortages during the 2022 calendar year.
Prescription Medication Legislation Helps Americans Access Affordable Care
In 2019, the mood was hopeful. As we looked ahead to the next decade, Republicans and Democrats in both the U.S. House of Representatives and Senate appeared to be at a consensus point on a major policy issue: access to affordable prescription medications for the American public.
Legislators Reintroduce Bill to Cut Prescription Drug Costs for Older Adults
In bipartisan, bicameral effort to help older adults save money when choosing a Medicare healthcare plan, Senators Bill Cassidy, MD (R-LA), and Tom Carper (D-DE) and Representatives Earl Blumenauer (D-OR) and Brad Wenstrup, DPM (R-OH), reintroduced the Program of All-Inclusive Care for the Elderly (PACE) Part D Choice Act in the U.S. House of Representatives and U.S. Senate in May 2023. The legislation allows Medicare-only PACE participants to choose between the PACE Part D plan or a standalone Medicare Part D plan without incurring high Part D premiums.
Medicare Part D Restructure Gives CMS the Ability to Negotiate Drug Prices
Health care consumes an inordinate amount of the U.S. gross domestic product at 18.3%. In 2021, healthcare spending increased by 2.7% to $4.3 trillion, equating to $12,914 per person annually. Under that average, prescription medications are the highest expenditure. According to the Centers for Medicare and Medicaid Services, “Retail prescription drug spending increased 7.8% to $378.0 billion in 2021, a faster rate than in 2020 when spending increased by 3.7%. The acceleration in growth was due to an increase in the use of prescription drugs in 2021.” On top of that staggering national economic impact are the personal, emotional, and familial burdens that take a toll on patients and caregivers.
The Oncology Nurse’s Role in Oral Anticancer Therapies
The expansion of oral chemotherapy agents since 2000 has transformed the treatment landscape. More than 150 novel oral anticancer medications are currently U.S. Food and Drug Administration approved, with new agents continuously in the pipeline. When caring for patients who are taking oral therapies, oncology nurses and pharmacists can work together to handle drug refills, deliver patient education, and manage the entire treatment cycle—including adverse events.
Latest CDC Clinical Practice Guideline Facilitates Safe Use of Opioids for Pain
Giving providers the latest evidence to inform the safe use and management of opioid prescriptions for cancer-related and other types of short- and long-term pain, the Centers for Disease Control and Prevention updated and expanded its recommendations in November 2022. The updated information was published in the CDC Clinical Practice Guideline for Prescribing Opioids for Pain, which replaces the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain.
New Cancer Drugs Launch at Record-High Prices
Inflating more than 50% since 2017, the annual price of newly launched cancer drugs averages $283,000 in 2022, according to a new report from the office of U.S. Representative Katie Porter (D-CA). Although new drugs for any condition are also seeing record-breaking high prices, the cost of new anticancer therapeutics is 3.7 times higher than that of non-oncology drugs.
Strategies to Promote Safe Medication Administration Practices
Medication administration is a high-risk process that requires critical thinking, efficient decision-making, attention to detail, and a foundational knowledge of basic pharmacology. The process is not a single task but a cascade of events that include handling, ordering, preparing, dispensing, administering, and monitoring. Although nurses’ involvement varies at each phase, the risk for errors always exists, and consequences can have a lifelong impact on patients, families, and healthcare workers. Nurses can use the following strategies in their responsibility as the last line of defense for safe medication administration.
U.S. Senator Speaks About Prescription Medication Prices, Joined by ONS Chapter President
Pending legislation would help residents save on prescription drug costs by empowering Medicare to negotiate lower drug prices, capping out-of-pocket costs, and limiting pharmaceutical price increases to the rate of inflation, U.S. Senator Jack Reed (D-RI) said during a discussion with a plethora of healthcare professionals, including ONS member Heather Murphy, MSN, FNP, OCN®, president of the ONS Rhode Island and Southeastern Massachusetts Chapter, about rising prescription drug prices at a Rhode Island conference in July 2022.
FDA Approves Pemigatinib for Relapsed or Refractory Myeloid or Lymphoid Neoplasms With FGFR1 Rearrangement
On August 26, 2022, the U.S. Food and Drug Administration approved pemigatinib (Pemazyre®) for adults with relapsed or refractory myeloid or lymphoid neoplasms with fibroblast growth factor receptor 1 rearrangement.
Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Because of Faster-Than-Expected Flow Rates
On August 29, 2022, the U.S. Food and Drug Administration reported Intera Oncology’s recall of the Intera 3000 hepatic artery infusion pump because of reports that the devices were delivering medications faster than expected. FDA identified it as a class I recall, the most serious type of recall, where use of the device may cause serious injuries or death.
Baxter Healthcare Corporation Recalls Abacus Software for Risk of Medication Label Errors
On July 25, 2022, the U.S. Food and Drug Administration (FDA) reported Baxter Healthcare Corporation’s recall of the Abacus order entry and calculation software because of a printing error that could cause final bag labels for compounded mixtures to be incorrect. FDA identified it as a class I recall, the most serious type of recall, where use of the software may cause serious injuries or death.
Oncology Drug Reference Sheet: Lutetium Lu 177 Vipivotide Tetraxetan
After clinical trial results demonstrated a four-month improvement in overall survival compared to best standard care, in March 2022 the U.S. Food and Drug Administration approved lutetium lu 177 vipivotide tetraxetan (PluvictoTM) to treat prostate-specific membrane antigen–expressing metastatic castration-resistant prostate cancer.
FDA Approves Crizotinib for Anaplastic Lymphoma Kinase-Positive Inflammatory Myofibroblastic Tumor
On July 14, 2022, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori®) for adult and pediatric patients aged 1 and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT).
Legislation Funds FDA Programs to Support Safety, Lower Costs, and Spur Innovation
To improve safety and regulation for drugs and devices, U.S. Senators Patty Murray (D-WA) and Richard Burr (R-NC) introduced the Safety and Landmark Advancements (FDASLA) Act in May 2022. The act reauthorizes and builds on the U.S. Food and Drug Administration’s (FDA’s) prescription drug, generic drug, biosimilar, and medical device user fee agreements.
FDA Reports Recall of Morphine Sulfate Extended-Release Tablets Because of Label Mix-Up
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.
FDA Approves Lisocabtagene Maraleucel for Second-Line Treatment of Large B-Cell Lymphoma
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.
Senators Cantwell, Grassley Introduce Bipartisan Bill to Battle Unfair Drug Pricing
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.
CMS Takes Action to Lower Out-of-Pocket Medicare Part D Prescription Drug Costs
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.
HHS Secretary Becerra Announces New Overdose Prevention Strategy
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 announcedHHS 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.
Legislators Want Medicare to Negotiate Drug Prices to Improve Access and Affordability
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.
HHS Secretary Releases Proposal to Lower Prescription Drug Costs
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.
Medications That Affect Microbiome May Influence Checkpoint Inhibitory Response
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.
Trump Uses Executive Orders to Lower Drug Pricing
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.
Oncology Drug Reference Sheet: Capecitabine
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.
Oncology Drug Reference Sheet: Panitumumab
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).
Prescription Drug Proposal; COVID-19 Safety Legislation; Drug Costs Outpace Inflation
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.
Vaping Ban; Bipartisan Drug Plan; Tobacco Regulation Agency
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 Chemo Education Sheets Provide Key Information to Patients
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.
Bill to Lower Drug Costs; Surprise Medical Billing; The Fight Against Vaping
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.
Drug Importation Resistance; Flavored Vaping Ban; 2020 Candidates' Health Policy
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.
Trump Vaping Meeting; Drug Pricing Stalemate; DC Sues Juul
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.
Oncology Drug Reference Sheet: Blinatumomab
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.
Vincristine Shortage; Democrat Healthcare Vote; Cummings Drug Bill
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.
Bold Drug Pricing Plan; Limiting Nicotine Levels; Representative Lowey Retires
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.
Nurses Impact Health Policy; State Vaping Legislation; Pelosi's Drug Plan
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.
FDA Calls Out Juul; Opioid Crackdown; States Tackle Drug Pricing
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.
Health Care in Campaigns; Respiratory Illness From Vaping; Drug Importation Politics
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.
Oncology Formulations Not Affected by Bevacizumab Recall
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).
Azar Remarks on Trump Administration’s Healthcare Vision
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.
HHS Awards Nearly $400 Million to Combat Opioid Crisis
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.
Nurses Advocate for Palliative Care, Drug Parity by Sharing Patient Experiences
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).
HHS Announces Safe Importation Action Plan for High Medication Costs
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.
Medicare Covers CAR T; HPV Vaccine Confusion; Officials Target Drug Makers
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.
The Battle Against Drug Pricing Wages On
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.
No Health Cost Vote; FDA Youth Tobacco Campaign; Senate Committee Drug Bill
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 Billing Legislation; Drug Pricing Reform Stalls; GOP's ACA Repeal
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.
PCHETA in the Senate; Armed Forces Tobacco Use; Drug Pricing Executive Order
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.
Chapters Advocate for Patients and Nurses at Statewide Event in Annapolis
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.