pharmacy

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US drug shortages reach record high with 323 meds now in short supply

Terrible —

The shortages affect everything from generic cancer drugs to ADHD medication.

Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023.

Enlarge / Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023.

Drug shortages in the US have reached an all-time high, with 323 active and ongoing shortages already tallied this year, according to data collected by the American Society of Health-System Pharmacists (ASHP).

The current drug shortage total surpasses the previous record of 320, set in 2014, and is the highest recorded since ASHP began tracking shortages in 2001.

“All drug classes are vulnerable to shortages,” ASHP CEO Paul Abramowitz said in a statement Thursday. “Some of the most worrying shortages involve generic sterile injectable medications, including cancer chemotherapy drugs and emergency medications stored in hospital crash carts and procedural areas. Ongoing national shortages of therapies for attention-deficit/hyperactivity disorder [ADHD] also remain a serious challenge for clinicians and patients.”

Erin Fox, associate chief pharmacy officer of University of Utah Health, told CBS MoneyWatch, that most of the drugs in short supply are generic, older products, and around half are injectable drugs that require more stringent manufacturing processes.

There are myriad reasons for the hundreds of drug shortages now facing doctors and patients, many of which remain unclear. But, as Ars has reported before, the root cause of shortages of low-cost, off-patent generic drugs is well established. These drugs have razor-thin to non-existent profit margins, driven by middle managers who have, in recent years, pushed down wholesale prices to rock-bottom levels. In some cases, generic manufacturers lose money on the drugs, disincentivizing other players in the pharmaceutical industry from stepping in to bolster fragile supply chains. Several generic manufacturers have filed for bankruptcy recently.

For other drugs, the situation is more complicated. The ADHD drug Adderall, for instance, has been in critical shortage since October 2022, causing millions of patients around the country to struggle to fill their prescriptions. It began when a manufacturing delay for one manufacturer kicked off a shortfall. Although that problem has since been resolved, it came amid a significant increase in Adderall prescriptions, which spiked further during the pandemic when telehealth prescribing became more common. Additionally, because Adderall—made of amphetamine-mixed salts—is a controlled substance, the Drug Enforcement Administration sets limits or “quotas” on how much of it manufacturers can make. Such quotas can exacerbate shortages, ASHP said.

But, in a joint letter with the Food and Drug Administration last August, the DEA said that, by its data, manufacturers of amphetamine products (including Adderall) only sold approximately 70 percent of their allotted quotas in 2022. That meant that there were approximately 1 billion more doses that they could have produced but did not make or ship. At the time, the agencies said its 2023 data was trending in the same direction.

In 60 percent of cases, manufacturers do not know or do not provide reasons why their drugs fall into short supply, ASHP found.

The organization has put forth policy recommendations to prevent shortages and improve supply chains, advocating for federal and regulatory changes. “Much work remains to be done at the federal level to fix the root causes of drug shortages,” Abramowitz said. “ASHP will continue to engage with policymakers regularly as we guide efforts to draft and pass new legislation to address drug shortages and continue to strongly advocate on behalf of our members for solutions that work.”

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The White House has its own pharmacy—and, boy, was it shady under Trump

yikes —

It wasted $750K during the Trump years and freely handed out Ambien and Provigil.

The White House seen in the early evening.

The White House has its own pharmacy that, until recently, could perhaps best be described as a hot mess, according to a recent investigation report from the Department of Defense’s Office of the Inspector General.

For years, the White House Medical Unit, run by the White House Military Office, provided the full scope of pharmaceutical services to senior officials and staff—it stored, inventoried, prescribed, dispensed, and disposed of prescription medications, including opioids and sleep medications. However, it was not staffed by a licensed pharmacist or pharmacy support staff, nor was it credentialed by any outside agency.

The operations of this pseudo-pharmacy went as well as one might expect, according to the DoD OIG’s alarming investigation report. The investigation was prompted by complaints in May 2018 alleging that an unnamed “senior military medical officer” was engaged in “improper medical practices.” This resulted in the OIG’s investigation, which included 70 interviews of military office officials who worked in the White House between 2009 and 2018 and covers the office’s activity until early 2020. However, the investigation heavily focused on prescription drug records and care between 2017 and 2019 during the Trump administration.

During that time, staff at the White House pharmacy kept handwritten records of prescriptions, the OIG found. The records frequently contained errors in medication counts, illegible text, crossed-out text, and lacked medical provider and mandatory patient information. The pharmacy let White House staff pick up over-the-counter drugs from open bins, in violation of Navy medical regulations. It didn’t dispose of controlled substances properly, increasing the risk of diversion. Staff provided prescriptions without verifying patients’ identities, and provided prescriptions to people who were ineligible for care. And it dispensed pricey brand name products freely, rather than generic equivalents that are considerably cheaper—also a violation of regulations.

In one interview, a White House pharmacy staff member said an unnamed doctor asked “if I could hook up this person with some Provigil as a parting gift for leaving the White House.”

Provigil is a drug that treats excessive tiredness and is typically used for patients with narcolepsy, sleep apnea, and other sleep disorders. Brand-name Provigil is 55 times more expensive than the generic equivalent. Between 2017 and 2019, the White House pharmacy spent an estimated $98,000 for Provigil. In that same time frame, it also spent an estimated $46,500 for Ambien, a prescription sedative, which is 174 times more expensive than the generic equivalent. Even further, the White House Medical Unit spent an additional $100,000 above generic drug cost by having Walter Reed National Military Medical Center fill brand-name prescriptions.

White House baggies

Another White House pharmacy staff member gave clues as to what the staff was doing with those brand name prescriptions. The staffer told OIG investigators that ahead of overseas trips, the staff would prepare packets of controlled medications to be handed out to White House staff. “And those would typically be Ambien or Provigil and typically both, right. So we would normally make these packets of Ambien and Provigil, and a lot of times they’d be in like five tablets in a zip‑lock bag. And so traditionally, too, we would hand these out. . . . But a lot of times the senior staff would come by or their staff representatives . . . would come by the residence clinic to pick it up. And it was very much a, ‘hey, I’m here to pick this up for Ms. X.’ And the expectation was we just go ahead and pass it out.”

In addition to the excessive costs of Ambien and Provigil, the White House Medical Office may have spent hundreds of thousands of dollars on health care for ineligible staff members. White House Medical Unit senior officials estimated that its Executive Medicine clinic has 60 enrolled patients, but it provided care for 6,000 employees, potentially billing the DoD. Between 2017 and 2019, officials also offered senior government officials a patient category code for care at Walter Reed, such that the facility was unable to properly bill them. In the three years, Walter Reed waived over $496,000 in outpatient fees because of these patient categories.

Overall, the OIG concluded that “all phases of the White House Medical Unit’s pharmacy operations had severe and systemic problems due to the unit’s reliance on ineffective internal controls to ensure compliance with pharmacy safety standards.”

The report does not mention Rear Admiral Ronny Jackson, who served as the physician to the president from 2013 to 2018 under both Barack Obama and Donald Trump. Stat, which first reported on the OIG’s new report, noted that Jackson had been accused of fostering a toxic work environment, engaging in alcohol-fueled misconduct, and misusing Ambien, specifically. OIG received those allegations during the first part of 2018, around the same time when the pharmacy complaints came in. And some of the allegations against Jackson were confirmed by a separate OIG investigation released in 2021.

Though a draft of the new report on the White House pharmacy was completed in 2020, it sat under review in the White House Military Office until July 2023.

The OIG laid out a series of recommendations for establishing oversight of the White House pharmacy, create policy to determine staff eligibility, and pharmaceutical oversight. DoD officials have agreed to the recommendations and are working to implement them, the OIG report noted.

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CVS, Rite Aid, Walgreens hand out medical records to cops without warrants

prescription for privacy —

Lawmakers want HHS to revise health privacy law to require warrants.

CVS, Rite Aid, Walgreens hand out medical records to cops without warrants

All of the big pharmacy chains in the US hand over sensitive medical records to law enforcement without a warrant—and some will do so without even running the requests by a legal professional, according to a congressional investigation.

The revelation raises grave medical privacy concerns, particularly in a post-Dobbs era in which many states are working to criminalize reproductive health care. Even if people in states with restrictive laws cross state lines for care, pharmacists in massive chains, such as CVS, can access records across borders.

Lawmakers noted the pharmacies’ policies for releasing medical records in a letter dated Tuesday to the Department of Health and Human Services (HHS) Secretary Xavier Becerra. The letter—signed by Sen. Ron Wyden (D-Ore.), Rep. Pramila Jayapal (D-Wash.), and Rep. Sara Jacobs (D-Calif.)—said their investigation pulled information from briefings with eight big prescription drug suppliers.

They include the seven largest pharmacy chains in the country: CVS Health, Walgreens Boots Alliance, Cigna, Optum Rx, Walmart Stores, Inc., The Kroger Company, and Rite Aid Corporation. The lawmakers also spoke with Amazon Pharmacy.

All eight of the pharmacies said they do not require law enforcement to have a warrant prior to sharing private and sensitive medical records, which can include the prescription drugs a person used or uses and their medical conditions. Instead, all the pharmacies hand over such information with nothing more than a subpoena, which can be issued by government agencies and does not require review or approval by a judge.

Three pharmacies—CVS Health, The Kroger Company, and Rite Aid Corporation—told lawmakers they didn’t even require their pharmacy staff to consult legal professionals before responding to law enforcement requests at pharmacy counters. According to the lawmakers, CVS, Kroger, and Rite Aid said that “their pharmacy staff face extreme pressure to immediately respond to law enforcement demands and, as such, the companies instruct their staff to process those requests in store.”

The rest of the pharmacies—Amazon, Cigna, Optum Rx, Walmart, and Walgreens Boots Alliance—at least require that law enforcement requests be reviewed by legal professionals before pharmacists respond. But, only Amazon said it had a policy of notifying customers of law enforcement demands for pharmacy records unless there were legal prohibitions to doing so, such as a gag order.

HIPAA and transparency

The lawmakers note that the pharmacies aren’t violating regulations under the Health Insurance Portability and Accountability Act (HIPAA). The pharmacies pointed to language in HIPAA regulations that allow health care providers, including pharmacists, to provide medical records if required by law, with subpoenas being a sufficient legal process for such a request. However, the lawmakers note that the HHS has discretion in determining the legal standard here—that is, it has the power to strengthen the regulation to require a warrant, which the lawmakers say it should do.

“We urge HHS to consider further strengthening its HIPAA regulations to more closely align them with Americans’ reasonable expectations of privacy and Constitutional principles,” the three lawmakers wrote.

They also pushed for pharmacies to do better, encouraging them to follow the lead of tech companies. “Pharmacies can and should insist on a warrant, and invite law enforcement agencies that insist on demanding patient medical records with solely a subpoena to go to court to enforce that demand. The requirement for a warrant is exactly the approach taken by tech companies to protect customer privacy.” The trio noted that Google, Microsoft, and Yahoo have since 2010 required law enforcement to have a warrant to obtain customers’ emails.

Also noting tech companies’ lead, the lawmakers encouraged pharmacies to publish annual transparency reports. In the course of the investigation, only CVS Health said it planned to do so.

“Americans deserve to have their private medical information protected at the pharmacy counter and a full picture of pharmacies’ privacy practices, so they can make informed choices about where to get their prescriptions filled,” the lawmakers wrote.

For now, HIPAA regulations grant patients the right to know who is accessing their health records. But, to do so, patients have to specifically request that information—and almost no one does that. “Last year, CVS Health, the largest pharmacy in the nation by total prescription revenue, only received a single-digit number of such consumer requests,” the lawmakers noted.

“The average American is likely unaware that this is even a problem,” the lawmakers said.

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