adderall

Huge telehealth fraud indictment may wreak havoc for Adderall users, CDC warns

adderall, ADHD, CDC, department of justice, Done Global, fentanyl, fraud, health, illicit drugs, overdose, prescription drug, Science, stimulants, telehealth / Mike M. / June 14, 2024

Tragic —

The consequences are dangerous, possibly even deadly, for patients across the US.

Beth Mole – Jun 14, 2024 4: 59 pm UTC

Enlarge / Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc, is shown in a Cambridge, Massachusetts pharmacy Thursday, January 19, 2006.

The Centers for Disease Control and Prevention on Thursday warned that a federal indictment of an allegedly fraudulent telehealth company may lead to a massive, nationwide disruption in access to ADHD medications—namely Adderall, but also other stimulants—and could possibly increase the risk of injuries and overdoses.

“A disruption involving this large telehealth company could impact as many as 30,000 to 50,000 patients ages 18 years and older across all 50 US states,” the CDC wrote in its health alert.

The CDC warning came on the heels of an announcement from the Justice Department Thursday that federal agents had arrested two people in connection with an alleged scheme to illegally distribute Adderall and other stimulants through a subscription-based online telehealth company called Done Global. The company’s CEO and founder, Ruthia He, was arrested in Los Angeles, and its clinical president, David Brody, was arrested in San Rafael, California.

“As alleged, these defendants exploited the COVID-19 pandemic to develop and carry out a $100 million scheme to defraud taxpayers and provide easy access to Adderall and other stimulants for no legitimate medical purpose,” Attorney General Merrick Garland said in a statement. “Those seeking to profit from addiction by illegally distributing controlled substances over the Internet should know that they cannot hide their crimes and that the Justice Department will hold them accountable.”

Deadly consequences

According to the Justice Department, Done Global generated $100 million in revenue by arranging for the prescription of over 40 million pills of Adderall and other stimulants, which are addictive medications used to treat ADHD (attention-deficit/hyperactivity disorder). Done Global allegedly eased access to the drugs by limiting the information available to prescribers, instructing prescribers to prescribe Adderall and other stimulants even if the patient didn’t qualify, and mandating that the prescribing appointments last no longer than 30 minutes. The company also discouraged prescriber follow-up appointments and added an “auto-refill” feature.

Prosecutors further allege that He and Brody continued with their scheme after becoming aware that patients had overdosed and died.

The CDC cautioned that the disruption from lost access to Done Global prescriptions comes amid a long-standing, nationwide shortage of Adderall and other stimulant medications. For patients with ADHD, the disruption could be harmful. “Untreated ADHD is associated with adverse outcomes, including social and emotional impairment, increased risk of drug or alcohol use disorder, unintentional injuries, such as motor vehicle crashes, and suicide,” the CDC warns. Further, a loss of access could drive some to seek illicit sources of the drugs, which could turn deadly.

“Patients whose care or access to prescription stimulant medications is disrupted, and who seek medication outside of the regulated healthcare system, might significantly increase their risk of overdose due to the prevalence of counterfeit pills in the illegal drug market that could contain unexpected substances, including fentanyl,” the CDC said. Fentanyl is a synthetic opioid that is up to 50 times stronger than heroin and 100 times stronger than morphine.

The Drug Enforcement Administration recently reported that seven out of every 10 pills seized from the illegal drug market contain a potentially lethal dose of illegally made fentanyl, the CDC noted.

This post was updated to clarify that the DEA’s data indicated that 70 percent of illicit pills seized contained “potentially” lethal doses, which was not included in the CDC’s warning.

Huge telehealth fraud indictment may wreak havoc for Adderall users, CDC warns Read More »

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.

Beth Mole – Apr 12, 2024 10: 20 pm UTC

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.”