News from the Industry
One in ten older adults in the U.S. has dementia, study suggests
November 3, 2022
A study published in JAMA Neurology estimated that in the United States, 1 in 10 adults over the age of 65 has dementia and 1 in 5 has cognitive difficulties.
The study was based on information from the Health and Retirement Study, specifically test results from 2016–17 comprising almost 3,500 study participants age 65 years and older. They underwent tests to gauge their memory, attention, and comprehension as well as their ability to live independently and how their faculties changed over the previous decade.
According to the findings, about 10% of U.S. adults aged 65 and older have dementia and 22% have mild cognitive impairment, indicating their memory and other functions are affected.
About 3% of people in their 60s had dementia, rising to 35% among people in their 90s. The dementia rate was higher for older adults identified as non-Hispanic Black compared with their counterparts.
The study found that 15% of older Black adults have dementia, compared with 11% of older White adults and 10% of older Hispanic adults. In addition, 13% of people with no high school diploma had dementia, compared with 9% among those who finished high school or attended college, according to the study.
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New interactive map promotes access to pharmacy services
November 3, 2022
Dima M. Qato, PharmD, MPH, PhD, regards pharmacy access as a human rights issue. Qato, an associate professor at the School of Pharmacy at the University of Southern California (USC) and a senior fellow at the USC Leonard D. Schaeffer Center for Health Policy & Economics, developed an interactive, nationwide mapping tool that reveals the presence of “pharmacy deserts” around the country.
The map identifies nearly 1 in 4 neighborhoods as being areas with pharmacy shortages.
“By collaborating, we have been able to attack the problem on a national scale using faster spatial computation and spatial analysis to better understand geographic contexts, like urban versus rural areas,” said Robert Vos, PhD, in a news release. Vos is an associate professor of spatial sciences with the USC Spatial Sciences Institute who helped build the tool.
The map defines a pharmacy shortage area as one where the distance to a pharmacy is greater than 10 miles in a rural area, 2 miles in a suburban area, 1 mile in an urban area, and 0.5 miles in neighborhoods where its residents have low income and low vehicle ownership.
Qato hopes the mapping tool will inform federal and state policy changes that enhance health equity.
“In terms of the equitable implementation of federal and state policies, it’s important to ensure that local pharmacies are actually stocking essential medicines and offering essential services they are authorized to provide,” Qato said in the news statement.
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FDA releases draft guidance to spur development of CDI drugs
November 3, 2022
New guidance released by FDA provides advice for sponsors on developing drugs for treating Clostridioides difficile infection (CDI). The draft guidance discusses how to design trials and trial populations, efficacy and safety endpoints, nonclinical studies, and pharmacokinetic studies.
CDC described C. difficile as “threat-level urgent” in its 2019 Antimicrobial Threats Report and estimates that C. difficile causes the hospitalizations of 223,900 individuals per year and 12,800 annual deaths.
The guidance examines the development of CDI treatments consisting of small molecule drugs and biological products and how to reduce the recurrence of CDI, especially in at-risk patients.
Clinical trials should be randomized, double-blinded, and use an active control for both CDI treatment and curbing CDI recurrence, FDA’s guidance document said.
To demonstrate efficacy, sponsors should supply evidence from 2 competent and well-controlled trials, with one trial demonstrating efficacy only for treatment and another trial for preventing CDI. Sponsors are advised to submit safety data from at least 300 individuals exposed to the proposed investigational drug treatment. Clinical programs for drugs developed only for preventing CDI may require a larger safety database.
Sponsors should discuss a suitable size of the premarket safety database with FDA during clinical development. For nonclinical studies, applicants should test the investigational drug in vitro and in animal models prior to submitting an investigational new drug application.
FDA also recommends an I.V. toxicology study in at least one mammalian species to identify possible risks, noting that CDI may increase oral drug absorption because of the disruption of the intestinal barrier.
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Survey: Nearly All Community Pharmacies Experiencing Drug Shortages
November 3, 2022
ALEXANDRIA, Va. (Nov. 3, 2022) – A new survey of community pharmacists reveals that 98 percent are experiencing drug shortages, the National Community Pharmacists Association says. Periodically since the start of the COVID-19 pandemic, NCPA has surveyed pharmacy owners and managers about staffing concerns, supply chain issues, inflation or other economic pressures. The latest survey, conducted between Oct. 19-31, 2022, focuses on drug shortages.
Eighty-nine percent of survey respondents say they are currently experiencing a shortage of Adderall, which is commonly used to treat attention deficit hyperactivity. This is a higher percentage than in a survey released in August, when 64 percent of respondents said they’d had trouble getting the medicine.
Nearly 66 percent of respondents also report experiencing difficulty in getting the antibiotic amoxicillin. “The scary part is, we’re coming into the time of the year where you have the greatest need,” NCPA President Hugh Chancy, owner of Chancy Drugs in southern Georgia, recently told NBC News. The Food and Drug Administration has acknowledged some “some intermittent supply interruptions” and has warned it is in short supply.
NCPA CEO B. Douglas Hoey, who sounded the alarm on supply chain problems at the height of the COVID-19 pandemic, said those problems haven’t gone away.
“We’re heavily reliant on foreign countries, some of which can be adversarial, for many of our pharmaceuticals. And the supply chain issues that resulted from the pandemic have not been fully resolved,” said Hoey. “Community pharmacies are the last link in the supply chain, and the only one that deals with patients directly. If there’s a disruption anywhere between the manufacturer and the patient, it affects the entire health care system and community pharmacists are the ones helping patients figure out their options.”
Note: This NCPA survey was conducted from Oct. 19-31. It was sent to approximately 8,000 independent pharmacy owners and managers, with approximately 330 responding.
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Founded in 1898, the National Community Pharmacists Association is the voice for the community pharmacist, representing over 19,400 pharmacies that employ nearly 240,000 individuals nationwide. Community pharmacies are rooted in the communities where they are located and are among America’s most accessible health care providers. To learn more, visit www.ncpa.org.
NCPA
Pharmacy DIR Proposal Supported by Nearly 3,500 Pharmacists, 150+ Pharmacy Stakeholder Organizations
January 29, 2019
by NCPA | Jan 29, 2019
ALEXANDRIA, Va. (Jan. 29, 2019) — A years-long effort led by the National Community Pharmacists Association to build support for a proposal to move pharmacy price concessions to point-of-sale reached a critical milestone on Jan. 25, 2019. Nearly 3,500 pharmacists and 170 patients formally voiced their support for parts of a proposed Centers for Medicare and Medicaid Services drug pricing rule that would eliminate the retroactive nature of pharmacy direct and indirect remuneration fees, or pharmacy DIR.
The proposed changes also received support from more than 150 pharmacy stakeholder organizations representing diverse interests, which unified their voices and submitted a joint letter of support to CMS. Additionally, more than two dozen patient advocacy organizations supported the proposed rule on the premise that, if finalized, the pharmacy DIR fixes will save the average patient nearly $200 per year or more in some cases on their out-of-pocket prescription drug costs.
NCPA submitted its own comments in response to the proposed rule, which is titled "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses." NCPA joined forces with the National Association of Chain Drugstores and the National Association of Specialty Pharmacy on a joint comment letter asking for a pharmacy DIR fee fix and standardized pharmacy metrics, and also also sent a joint comment letter with the American Society of Consultant Pharmacists and the Senior Care Pharmacy Coalition focusing on harm to seniors with proposed protected class changes, as well as on the need for a new definition of negotiated price and standardized pharmacy measures.
Several letters supporting the proposed DIR fixes are also being sent by members of Congress. Review letters of support for the pharmacy DIR provisions in the proposed drug pricing rule.
"NCPA had asked CMS to include all pharmacy price concessions at the point of sale – or, ideally, eliminate pharmacy DIR altogether – in response to the administration's request for information about its ‘Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs,'" said NCPA CEO B. Douglas Hoey, Pharmacist, MBA. "This proposed rule is evidence that we are being heard, and we applaud the administration for putting out this proposal to include pharmacy price concessions at the point of sale. Eliminating the retroactive application of these fees would provide much-needed predictability and stabilization to pharmacy operations, and would save Part D beneficiaries billions of dollars.
"Less uncertainty for pharmacies, lower costs for seniors – that's a no-brainer in our book. And as witnessed in comments to CMS, an overwhelming number agree.
"Now is the time to bring more transparency into our health care system and a reprieve to small business community pharmacies and seniors. We are grateful to the administration for recognizing this, and strongly encourage them to finalize this proposal. Community pharmacists are ready partners in this and other ongoing efforts to lower drugs costs and eliminate pharmacy DIR once and for all."
NCPA's July 2018 response to the administration's RFI to lower drug costs.
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Founded in 1898, the National Community Pharmacists Association is the voice for the community pharmacist, representing 22,000 pharmacies that employ 250,000 individuals nationwide. Community pharmacies are rooted in the communities where they are located and are among America's most accessible health care providers. To learn more, visit www.ncpanet.org.
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Legislation re-introduced in Ohio to end PBM co-pay clawbacks & gag orders.
March 1, 2019
The fight to lower drug costs for Ohioans isn't over yet. In Ohio, State Representative Scott Lipps (R-Franklin)and Representative Thomas West (D-Canton) are again aiming to end a secretive practice that is causing patients to pay more than they should at the pharmacy counter. Specifically, they announced this week that they have introduced HB 63, legislation that would prohibit co-pay clawbacks and pharmacist "gag orders" that stand in the way of lower prices for patients at the pharmacy counter. Additionally, newly-elected Senator Tina Maharath (D-Columbus) companion legislation, SB 14, over in the Senate this week as well.
In the previous General Assembly, Reps. Lipps & West's HB 479, dubbed the "Prescription Drug Co-Pay Integrity Act," sought to prohibit the practice of pharmacy benefit managers (PBMs) requiring pharmacists to charge patients an amount greater than the pharmacy's cash price for a particular prescription drug. Second, the legislation would have prohibited "gag clauses" that some PBMs place in pharmacy contracts that penalize pharmacists for disclosing a complete picture of the financials of a patient's prescription drug transaction. Reps. Lipps & West have reintroduced the language in HB 63. Sen. Maharath's bill has been designated as SB 14.
This issue has received significant attention in the media in recent years, and it all started with a 2016 investigative report from a news station in New Orleans. Similar legislation has already been passed in more than a dozen states. The practice has resulted in more than 16 lawsuits across the country, as well as federal prohibitions on gag clauses signed into law by President Trump in October 2018.
As prescription drug prices continue to grow, 6 in 10 Americans say lowering the cost of prescription drugs should be a “top priority” for lawmakers. In Ohio, despite the failure of the unworkable "Drug Price Relief Act" (Issue 2), a message was sent that something must be done to get drug pricing under control. The Ohio Pharmacist Association (OPA) has worked extensively with lawmakers to address out-of-pocket expenses for patients and to shed light on a problem that OPA members have said must be stopped.
Last year, OPA stood alongside Reps. Lipps & West, and Holly Pendell, director of advocacy and activist engagement for the National Multiple Sclerosis (MS) Society, to announce the bill's introduction. To view that press conference in its entirety, see the Ohio Channel's video HERE. To view the discussion of the bill on the House floor, see the Ohio Channel's video HERE.
It's no secret that OPA has been very outspoken about the problems with prescription drug pricing (see here, here, here, and here). The Columbus Dispatch has spent a full year pulling back the drug pricing curtain in a special Side Effects investigative series that is exposing millions of dollars in drug pricing waste. We've spent a great deal of time working to reform a broken system that rewards big supply chain middlemen and results in higher drug costs for employers, taxpayers, and patients. The "Prescription Drug Co-Pay Integrity Act" is just one attempt at ensuring that patients aren't paying any more than they have to for their needed medications.
"We remain determined to expose and stop the malicious and greedy practices utilized by PBM’s to hurt our citizens and Ohio’s budget. We are excited to reintroduce House Bill 479, from the 132nd General Assembly, which eliminates gag rules and clawbacks. Governor DeWine and his administration are keenly aware of the millions of dollars PBMs have siphoned out of Ohio. It is time for all of us, including the Legislature, Managed Care Organizations (MCO’s) and Medicaid to work together and FIX this," said Rep. Lipps.
"Consumers shouldn’t be priced out of their health care, especially when cheaper options are available," said Senator Maharath.
"The clawback is just the one example of PBM tactics that deceive patients, inflate the cost of prescription drugs, and line the pockets of administrative middlemen," said OPA Executive Director Ernie Boyd. "Pharmacists should not be prohibited from empowering patients to save money, and PBMs should not profit off of the over-inflated co-pays that they set for patients at the pharmacy counter. It's wrong.".
Here's hoping that other states take note and follow suit!