Bulletin Today
APhA Staff
A new statement from APhA, the American Medical Association (AMA), American Society of Health-System Pharmacists (ASHP), and National Community Pharmacists Association (NCPA) cautions that, following the Supreme Court’s Dobbs v Jackson Women’s Health Organization decision, “health care professionals face a confusing legal landscape due to state laws’ lack of clarity, confusing language, and unknown implementation by regulatory and enforcement bodies.”
According to the groups, “Physicians and pharmacists need clear guidance from state boards of medicine and pharmacy, agencies, and policymakers to support the prescribing and dispensing of medically necessary medications that may be affected by this new legal and regulatory paradigm. Without such guidance, we are deeply concerned that our patients will lose access to care and suffer irreparable harm.” The organizations said many questions remain about how broadly state laws on abortion will be interpreted and how these actions will affect providers’ abilities to serve their patients.
Following the Supreme Court’s decision, more than 50% of states have severely limited or are expected to soon limit access to abortion services.
Many of these state laws bar providers from prescribing and dispensing an “abortion-inducing drug” and other similar terms; however, the groups note “this language is vague, and it is unclear whether it prohibits certain medications only when prescribed to induce abortion or whether a medication is prohibited entirely if it has the potential to induce abortion regardless of the condition for which it was prescribed.” This uncertainty is affecting care.
“Without access to medications proven to be safe and effective, our patients’ health is at risk. As physicians and pharmacists, we view patient well-being as paramount and are deeply troubled that continuity of care is being disrupted,” the groups assert. They call on state medical and pharmacy boards, agencies, and policymakers to ensure patients retain continuity of care and that their members understand their legal and licensing obligations. ■
Researchers say heart disease will surge in next decade
A new study in the Journal of the American College of Cardiology predicts that millions more Americans will develop CVD over the next few decades.
Researchers from Massachusetts General Hospital estimated that from 2025 to 2060, cases of ischemic heart disease may increase from 21.9 million to 28.7 million, 9.7 million to 12.9 million for heart failure, 12.3 million to 16.0 million for myocardial infarction, and 10.8 million to 14.5 million for stroke.
They also forecast that by 2060, there would be 54.6 million Americans with diabetes, 162.5 million with hypertension, 125.7 million with dyslipidemia, and 125.7 million with obesity.
Differences between men and women are expected to stay fairly stable, but CVD will likely disproportionately affect Black and Hispanic people, the authors said.
The researchers wrote that “emphasis on education regarding CV risk factors, improving access to quality health care, and facilitating lower cost access to effective therapies for treatment of CV risk factors may stem the rising tide of CV disease in at-risk individuals; such advances need to be applied in a more equitable way throughout the United States, however.” ■
Analysis finds record prices for novel drugs in 2022
Drug companies are asking for lofty prices for new medications coming to market, a Reuters analysis finds, often while disclosing little pricing information about the treatments.
Investigators put the median price at $257,000 a year for 13 novel drugs receiving FDA clearance to treat chronic diseases so far in 2022. That far exceeds the 2021 number reported in a JAMA article in which researchers calculated a median annual price of $180,000 based on the first 30 drugs marketed through mid-July of last year.
While Reuters included drugs that are used intermittently and did not adjust for rare drugs that are exceptionally expensive, its finding nonetheless underscores the continued upward trajectory of prices for new drugs.
Industry insiders maintain that the pricing is a reflection of drugs’ value and also note that it is health plans, not drugmakers, that determine how much U.S. consumers pay for their prescriptions.
Still, when pressed by Reuters for pricing data, 6 of the 15 manufacturers with new drugs out this year ignored the request or provided only “per vial” cost estimates. Experts suspect drugmakers may be providing only partial or incomplete disclosures in an effort to take the focus off of steep annual costs. ■
USPSTF updates statin recommendations for CVD prevention in adults
The U.S. Preventive Services Task Force (USPSTF) has issued new recommendations governing the use of statins for primary prevention of CVD in patients age 40 to 75 years with no history of CVD and no signs or symptoms of it.
Based on a review of the evidence, USPSTF advises clinicians to prescribe a low- or moderate-dose statin to patients who have at least one risk factor for CVD—such as diabetes, high blood pressure, or smoking—coupled with an estimated 10-year CVD risk reaching or exceeding 10%.
For patients who have one or more CVD risk factors but whose 10-year CVD risk is 7.5% to 10%, the data suggest at least a small net benefit is derived from statin use. The guideline authors suggest that providers use their discretion to decide whether statin prescribing will benefit individual patients who match this profile. Meanwhile, the evidence was insufficient to gauge the benefits of harms for adults aged 76 years and older.
The recommendations update USPSTF’s 2016 guidance with few changes. ■
New study gives insight into statins and muscle pain
While many patients who stop taking statins say that adverse effects, including muscle pain, are to blame, a new study in The Lancet says the drugs are not the cause of the pain for most statin patients reporting it.
Researchers from Oxford Population Health and the Medical Research Council Population Health Research Unit at the University of Oxford conducted a meta-analysis of 19 randomized double-blind trials of statin regimens as well as 4 double-blind trials of more and less intense statin regimens.
The analysis found that “even during the first year of a moderate-intensity statin regimen, [statin therapy] is likely to be the cause in only approximately 1 in 15 patients who report muscle symptoms, rising to approximately 1 in 10 in those who are taking a more intensive regimen. In other words, the statin is not the cause of muscle symptoms in more than 90% of individuals who report such symptoms.”
According to the results, there were reports of at least one episode of muscle pain or weakness from 27.1% of patients assigned a statin compared with 26.6% of those who had a placebo over a median 4.3-year follow-up period.
The researchers found that statin therapy, during the first year of use, caused about 11 additional muscle pain reports per 1,000 patients. ■
ACIP issues recommendations on seasonal influenza vaccines
According to CDC’s 2022–2023 Advisory Committee on Immunization Practices (ACIP) recommendations, all vaccines for the approaching influenza season will be quadrivalent. Trivalent influenza vaccines have been taken out of circulation.
Absent any contraindications, the panel recommends vaccination for all U.S. residents aged 6 months and older, ideally during the months of September and October.
Generally, ACIP does not prefer any one available vaccine over another as long as it is age appropriate. The exception is the population of people age 65 years and older, who are recommended to receive higher-dose or adjuvanted influenza vaccines—specifically, quadrivalent high-dose inactivated vaccine (HD-IIV4), quadrivalent recombinant influenza vaccine (RIV4), or quadrivalent adjuvanted inactivated influenza vaccine (allV4)—if possible. In cases in which these vaccines are not available, older adults can receive another age-appropriate option instead.
The ACIP guidance also offers vaccination recommendations for special populations who have an elevated risk for medical complications if they develop severe influenza, including pregnant people, immunocompromised people, individuals with extremely obesity, and Native populations, among others. ■
Study highlights urgency of facilitating access to OUD meds
Researchers at NYU Grossman School of Medicine say 86.6% of people living with opioid use disorder (OUD) in the United States are not receiving medications proven to reduce opioid overdoses, including methadone, buprenorphine, and extended-release naltrexone. Their study, published in International Journal of Drug Policy, looked at differences between new estimates of OUD prevalence and the use of medications for OUD (MOUD) at the national and state levels from 2010 to 2019.
The use of MOUD increased by more than 100% over the last decade, but this rise in treatment failed to keep pace with OUD and surging overdose mortality rates that have been primarily attributed to fentanyl.
“We need to rethink how treatment for OUD is delivered, eliminate stigma, [and] make it easier for people to enter and remain in treatment as well as ensure that all treatment programs provide and encourage use of evidence-based medications that we know save lives,” the researchers wrote in a news release.
Noa Krawczyk, PhD, lead study author and assistant professor in NYU’s Department of Population Health and a member of the Center for Opioid Epidemiology and Policy at NYU Langone, noted that more than 70% of residential treatment programs nationwide do not offer MOUD.
Facilitating access to MOUD may include removing special waiver requirements to allow more physicians to prescribe buprenorphine and increasing the use of MOUD among mobile health clinics, community-based organizations, and the criminal justice system. Making methadone less controlled and more accessible through avenues other than highly regulated opioid treatment programs is essential, Krawczyk added. ■
Study finds lower prescription rates associated with race and ethnicity
In a new study published in JAMA in September 2022, researchers sought to examine differences in the prescribing of SGLT-2 inhibitors and glucagon-like peptide-1 (GLP-1) agonists among adults with type 2 diabetes along ethnic and racial groups. The American Diabetes Association recommends these as first-line treatments with or without metformin for people with type 2 diabetes who have or who are at high risk for atherosclerotic cardiovascular disease, heart failure, and chronic kidney disease.
Among patients with type 2 diabetes in the Veterans Health Administration system during 2019 and 2020, prescription rates of SGLT-2 inhibitors and GLP-1 agonist medications were low, and individuals of several different racial groups and those of Hispanic ethnicity had statistically significant lower odds of receiving prescriptions for these medications compared with individuals of white race and non-Hispanic ethnicity, according to the researchers.
The cross-sectional analysis was based on data from the U.S. Veterans Health Administration’s Corporate Data Warehouse. The sample comprised adult patients with type 2 diabetes and at least 2 primary care clinic visits in 2019 through 2020. The primary outcomes were prevalent SGLT-2 inhibitors or GLP-1 agonist prescriptions, defined as any active prescription during the study period. Among nearly 1.2 million patients, 10.7% and 7.7% were prescribed an SGLT-2 inhibitors or a GLP-1 agonist, respectively. ■