ReportWire

Tag: Adderall

  • Hundreds of drugs are in short supply around the U.S., pharmacists warn

    Hundreds of drugs are in short supply around the U.S., pharmacists warn

    U.S. agencies open generic drug shortage inquiry


    U.S. agencies open generic drug shortage inquiry

    00:31

    A growing number of drugs are in short supply around the U.S., according to pharmacists. 

    In the first three months of the year, there were 323 active medication shortages, surpassing the previous high of 320 shortages in 2014, according to a survey by the American Society of Health-System Pharmacists (ASHP) and Utah Drug Information Service. It also amounts to the most shortages since the trade group started keeping track in 2001.

    “All drug classes are vulnerable to shortages. 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,” ASHP said in a statement

    “Most of the drugs in short supply are generic, older products, and about half are injectable drugs that are hard to make,” Erin Fox, associate chief pharmacy officer, University of Utah Health, told CBS MoneyWatch. “Because the FDA says all generics are equal, the only way to compete is on price,” creating a race to the bottom that results in companies either halting production of the drugs or taking cost-saving shortcuts in quality, Fox said.

    “The Biden-Harris Administration remains focused on strengthening the resilience of critical supply chains, including for medical products like pharmaceuticals,” the White House told CBS MoneyWatch on Friday. The effort to “ensure Americans can access the medicine they need when they need it,” with steps including investing $35 million in domestic production of materials needed to produce sterile injectable medicines.

    Drug shortages have plagued the nation’s health care system for several decades, largely due to market failures and “misaligned incentives,” the Department of Health and Human Services stated in a paper published earlier this month. 


    FDA warns about Adderall, albuterol shortages

    02:16

    Adderall, which is used to treat attention deficit hyperactivity disorder, is among the medications that are hardest to track down. The Drug Enforcement Administration said last fall that more than a dozen manufacturers planned to hike production of the drug, which has been in short supply since October 2022, but the problem persists, the pharmacist group found. 

    “Ongoing national shortages of therapies for Attention-Deficit/Hyperactivity Disorder (ADHD) also remains an issue for clinicians and patients,” it said. 

    Federal agencies have been tackling the shortages by offering pharmaceutical companies their version of carrots and sticks. The DEA, for example, recently announced quota increases of roughly 25% for methylphenidate, another type of ADHD medication, to help manufacturers to increase supply. 

    After noting that manufacturers had for years not been using their full quota allotments for amphetamine salts — which include Adderall — the FDA and DEA in August notified manufacturers that they need to produce to quota or return the ingredient so it could be used by another company.  

    2024-q1-chart3-1.png
    Active shortages by quarter — 10-year trend.

    American Society of Health-system Pharmacists


    Contributing to the Adderall shortage include a spike in prescriptions during the pandemic, while a key manufacturer experienced production delays and other companies fell short on production targets. 

    The FDA recently approved several generic forms of a third type of ADHD medication, Vyvanse, or lisdexamfetamine, which could have a meaningful impact on supply, the White House said.

    Most drug manufacturers did not disclose the factors behind the shortages, the pharmacy group noted in its quarterly findings. But experts have pointed to demand outstripping supplies, manufacturing constraints and disruptions in supply lines for raw materials. 

    As things currently stand, medicine labels are only required to name the company selling the product, not the product’s manufacturer — a lack of transparency Fox said the White House has joined the ASHP in advocating against. 

    Because manufacturers make so little on low-cost generic drugs, when there is a shortage, it’s only a problem for patients. The “companies are not facing any sort of hardship,” Fox added.

    Meanwhile, insurance companies, as a matter of course, oftentimes only cover generic medications, putting a financial burden on patients unable to find a pharmacy that can fill the less-expensive version of a drug. “One recommendation is to call your insurance company, and ask for coverage for brand names,” Fox advised.

    Source link

  • Drug Makers Struggle to Replace Stimulants with Non-Addictive Alternatives | High Times

    Drug Makers Struggle to Replace Stimulants with Non-Addictive Alternatives | High Times

    Unfortunately, the same drugs with high potential for abuse are also the ones that work best for certain individuals with neurobehavioral conditions. According to GlobalData, penetrating the stimulant-dominated pharmaceutical market remains challenging without comparable efficacy from non-stimulants. 

    The attention deficit hyperactivity disorder (ADHD) market is a lucrative business: Stimulants, amphetamines, and methylphenidates continue to dominate the ADHD drug market across the seven major markets, Express Pharma reports. (The seven major markets are in France, Germany, Italy, Spain, the UK, the US, and Japan.)

    Non-addictive drugs demonstrate a “crippling lower” efficacy in treating ADHD.

    Drug makers are in a race to develop safer alternatives. Three out of the four late-stage pipeline drug candidates in Phase III development within those markets have non-stimulant properties: Axsome Therapeutics Inc’s solriamfetol, Otsuka Pharmaceutical Co Ltd’s centanafadine and Neurocentria Inc’s L-Threonate Magnesium Salt. 

    The lower abuse potential of solriamfetol and centanafadine is a major selling point created by developers, but without displaying efficacy comparable to stimulants, they will struggle to penetrate the market—even if they are approved.

    The use of stimulants for ADHD treatment is increasing.

    The key opinion leaders (KOLs) in the treatment of ADHD say that patients and parents have been hesitant to use stimulants for the treatment of ADHD in children and adolescents, but this is changing with time, and the use of stimulants for ADHD treatment is increasing.

    “Marketing emphasis on abuse potential is common in non-stimulates both marketed and pipeline; this is despite KOLs viewing the abuse potential of ADHD stimulants as overstated,” said Lorraine Palmer, Pharma Analyst at GlobalData. “The KOLs interviewed by GlobalData were not concerned about whether a treatment is a stimulant or a non-stimulant, rather they are focused on the pharmaceuticals efficacy and side-effect profile.”

    Four non-stimulants are commonly marketed: guanfacine, clonidine, atomoxetine and viloxazine. Sleep disturbances and a decreased appetite have been reported from both clonidine and atomoxetine. 

    “All four display cripplingly lower efficacy in the treatment of ADHD than stimulants,” Express Pharma reports.

    “Rather than an emphasis on abuse potential, a better alternative strategy to penetrate the saturated ADHD market would be to target key unmet needs in ADHD treatment such as improving compliance or providing coverage into the evening without affecting sleep.”

    Part of this challenge likely includes the impact of addiction itself.  Regarding the popular ADHD drug Adderall, adults and children 6 years of age and older are eligible to take Adderall, beginning at 5 milligrams, while children 3 to 5 years of age are able to start at 2.5 mg per day. Only children under the age of 3 are prohibited from being prescribed the drug in all cases.

    Adderall’s active ingredients are dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. Columbia University psychiatry professor Carl Hart famously wrote for Vice in 2016 that meth is “almost identical to Adderall” in terms of chemistry and its effects on the brain.

    A 2016 study published in the Journal of Clinical Psychiatry indicates that an increasing number of young adults have been checking into emergency rooms over the past few years due to accidental overdoses on Adderall and similar drugs.

    Other Reasons for Stimulant Alternatives

    High Times reported last September that leading drug makers and pharmaceutical companies are having little luck addressing nationwide shortages of stimulant-based ADHD medications like Adderall, Vyvanse, and Ritalin.

    The Adderall shortage began in Fall of 2022, marked by an FDA notice acknowledging the shortages with an estimate that things would be resolved in a month or two. That is not the case, however, as issued a joint notice on August 1 acknowledging that the shortage had been “understandably frustrating” for patients and providers.

    “The current shortage of stimulant medications is the result of many factors. It began last fall due to a manufacturing delay experienced by one drug maker,” the joint notice said. “While this delay has since resolved, we are continuing to experience its effects in combination with record-high prescription rates of stimulant medications. Data show that, from 2012 to 2021, overall dispensing of stimulants (including amphetamine products and other stimulants) increased by 45.5 percent in the United States.” 

    Teva Pharmaceuticals, Adderall’s biggest manufacturer, reported shortfalls. Teva CEO Richard Francis told Bloomberg that the company is operating at “full capacity” at the moment and blamed their decreased output in previous years to COVID-induced work shortages which they have only just barely recovered from. Should they wish to increase the amount of Adderall they produce, they would have to buy or build more factories as their current infrastructure cannot handle bigger output. The company has declined to comment on whether or not they plan to invest in such infrastructure.

    This adds to the multiple reasons less addictive non-stimulant drugs are needed to treat ADHD.

    Benjamin M. Adams

    Source link

  • Feds seek to limit telehealth prescriptions for some drugs

    Feds seek to limit telehealth prescriptions for some drugs

    The Biden administration moved Friday to require patients see a doctor in person before getting attention deficit disorder medication or addictive painkillers, toughening access to the drugs against the backdrop of a deepening opioid crisis.

    The proposal could overhaul the way millions of Americans get some prescriptions after three years of relying on telehealth for doctor’s appointments by computer or phone during the pandemic.

    The Drug Enforcement Administration said late Friday it plans to reinstate once longstanding federal requirements for powerful drugs that were waived once COVID-19 hit, enabling doctors to write millions of prescriptions for drugs such as OxyContin or Adderall without ever meeting patients in person.

    Patients will need to see a doctor in person at least once to get an initial prescription for drugs that the federal government says have the the most potential to be abused — Vicodin, OxyContin, Adderall and Ritalin, for example. Refills could be prescribed over telehealth appointments.

    The agency will also clamp down on how doctors can prescribe other, less addictive drugs to patients they’ve never physically met. Substances like codeine, taken to alleviate pain or coughing, Xanax, used to treat anxiety, Ambien, a sleep aid, and buprenorphine, a narcotic used to treat opioid addiction, can be prescribed over telehealth for an initial 30-day dose. Patients would need to see a doctor at least once in person to get a refill.

    1670371617286.png
    Patients will need to see a doctor in person at least once to get an initial prescription for drugs that the federal government says have the the most potential to be abused. 

    CBS News


    Patients will still be able to get common prescriptions like antibiotics, skin creams, birth control and insulin prescribed through telehealth visits.

    The new rule seeks to keep expanded access to telehealth that’s important for patients like those in rural areas while also balancing safety, an approach DEA Administrator Anne Milgram referred to as “expansion of telemedicine with guardrails.”

    The ease with each Americans have accessed certain medications during the pandemic has helped many get needed treatment, but concerns have also mounted that some companies may take advantage of the lax rules and be overprescribing medications to people who don’t need them, said David Herzberg, a historian of drugs at the University of Buffalo.

    “Both sides of this tension have really good points,” said Herzberg. “You don’t want barriers in the way of getting people prescriptions they need. But anytime you remove those barriers it’s also an opportunity for profit seekers to exploit the lax rules and sell the medicines to people who may not need them.”

    U.S. overdose deaths hit a record in 2021, about three-quarters of those from opioids during a crisis that was first spun into the making by drug makers, pharmacies and doctors that pushed the drugs to patients decades ago. But the grim toll from synthetic opioids like fentanyl far outstripped deaths related to prescription drugs that year, according to Centers for Disease Control Data. Fentanyl is increasingly appearing on the illicit market, pressed into fake prescription pills or mixed into other drugs.

    The proposed rules deliver a major blow to a booming telehealth industry, with tech startups launching in recent years to treat and prescribe medications for mental health or attention deficit disorders. The industry has largely benefitted from the reprieve on in-person visits for drugs brought on by the pandemic, although some national retailers stopped filling drug orders generated by some telehealth apps over the last year.


    Justice Department investigating online mental health provider Cerebral

    08:17

    The DEA has grown increasingly concerned over the last two years that some of those startup telehealth companies are improperly prescribing addictive substances like opioids or attention deficit disorder medication, putting patients in danger, a DEA official told The Associated Press on Friday.

    The official said the agency plans to have the new rule in place before the COVID-19 public health emergency expires on May 11, which will effectively end the loosened rules. That could mean people who may seeking treatment from a doctor who is hundreds of miles away need to start developing plans for in-person visits with their doctors now, pointed out Boston-based attorney Jeremy Sherer, who represents telehealth companies. Patients will have six months to visit their doctor in person when the regulation is enacted.

    “Providers and their patients need to know what that treatment is going to look like moving forward and whether, once the public health emergency ends in May, if they’re going to need to figure out a way to have a visit in person before continuing treatment, and that can be a real challenge,” he said.

    Many states have already moved to restore limitations for telehealth care across state lines. By October, nearly 40 states and Washington, D.C., had ended emergency declarations that made it easier for doctors to see patients in other states.

    Source link

  • Questions emerge about an Adderall prescription obtained online

    Questions emerge about an Adderall prescription obtained online

    Questions emerge about an Adderall prescription obtained online – CBS News


    Watch CBS News



    During the pandemic, online mental health companies began to offer treatment for ADHD, often prescribing Adderall, a controlled substance. One mother says her son obtained an Adderall prescription that he shouldn’t have been able to. Anna Werner investigates.

    Be the first to know

    Get browser notifications for breaking news, live events, and exclusive reporting.


    Source link

  • Young man’s death leads to questions about an Adderall prescription obtained online

    Young man’s death leads to questions about an Adderall prescription obtained online

    Elijah Hanson struggled with his mental health for years. The 21-year-old from Tacoma, Washington, had been diagnosed with antisocial personality disorder and was receiving treatment from a local behavioral health clinic. According to years of therapy notes, he was desperate to better understand himself and his emotions. 

    “It was him and I in this huge battle, constantly looking for therapists, psychiatrists, anybody to take him on to help him with his issues,” his mother, Kelli Rasmussen, told CBS News.

    Earlier this year, Hanson followed an increasingly familiar path at a time when online mental health care providers were flourishing: He signed up with an online provider called Cerebral. As demand for such services soars, CBS News has been looking into the growing segment of the mental health marketplace that operates online — and one of the most prominent players in that space is Cerebral.

    Hanson told Cerebral he needed help for ADHD — Attention Deficit Hyperactivity Disorder — despite never having been previously diagnosed. He was able to secure a prescription for the stimulant Adderall without any in-person consultations, even though, as his brother, Ethan Hanson, would later allege, he only wanted the drug to abuse it. 

    “He lied and said he had ADHD,” Ethan Hanson said. 

    According to his brother, Elijah Hanson lied to Cerebral because he wanted Adderall, a prescription stimulant that is sometimes misused to get high. Ethan Hanson said that he and his brother had both abused the medication before. 

    Soon, his family said, Elijah Hanson dropped weight and started isolating in his room. 

    “You can definitely tell he was taking way too much. And he wasn’t in his right mind at all,” his brother said.

    His mother believes Elijah Hanson’s misuse of Adderall exacerbated his mental health issues. On June 25, she returned home to an inconceivable sight: Elijah Hanson lying dead on the kitchen floor. He’d found a gun kept in the house and recorded himself playing Russian roulette.  

    Before the pandemic, medical providers were not permitted to prescribe medications like Adderall to patients without first seeing the patient in person. Adderall is a controlled substance and in a class of drugs tightly regulated by the Drug Enforcement Administration because it carries a “high potential for abuse.” 

    “These are dangerous drugs that are controlled for a good reason,” Dr. Andrew Kolodny, an expert on prescribing, told CBS News. 

    Distribution was restricted under the Ryan Haight Act, a 2008 law named for an 18-year-old who died of an overdose from drugs he obtained online. It requires medical professionals to see patients in person before prescribing any controlled substance. But due to the pandemic, the law was temporarily lifted, meaning those drugs can now be prescribed through online, virtual appointments – something Kolodny sees as risky.  

    “Without the requirement for a face-to-face visit, you can see businesses take advantage of the ease in which these drugs can be prescribed,” Kolodny said.

    Data shows the U.S. saw a 15% increase in Adderall prescriptions for adults ages 22 to 44 from 2020 to 2021. Currently, there is a nationwide shortage of drugs like Adderall, raising questions about whether the explosion of digital mental health companies that diagnose and prescribe medications online may be in part to blame.

    Cerebral is one of a number of online mental health companies that surged in popularity during the pandemic and helped meet a growing demand for virtual care. But some experts fear online providers make it too easy for people looking to abuse drugs like Adderall. 

    Cerebral’s records show the first prescriber Elijah Hanson met on the platform in February declined to give him a stimulant, deeming him a “risk to prescribe [a] controlled substance.” So Elijah Hanson created a new account in April and tried again. This time, a different Cerebral prescriber gave him the Adderall. Records show a family doctor later refilled Elijah Hanson’s prescription, relying on the ADHD diagnosis made by Cerebral. 

    “I’m angry that this online platform just thinks that handing out these medications to people … is OK. Because it’s not,” Rasmussen said. 

    While Cerebral and others have urged the government to drop the in-person visit requirement permanently, the company has stopped prescribing controlled substances to new patients, telling CBS News in a statement that the decision was a way for the company to get ahead of the termination of the pandemic waiver that has yet to take place. 

    “Patients who were prescribed a controlled substance before May have, as clinically appropriate, been tapered off controlled substances or were transitioned to providers who can provide in-person care,” a spokesperson told CBS News. “To date, no regulator has accused the company or any clinician of any wrongdoing or violation of any law.”

    The company declined to comment on Elijah Hanson’s case. “While we cannot comment on specific client cases, we can say that Cerebral has robust systems in place across the board to detect and intervene when we suspect drug-seeking behavior,” a spokesperson told CBS News.

    In an exclusive interview with CBS News earlier this year, Cerebral CEO Dr. David Mou defended the company’s prescribing practices after Cerebral confirmed it was the subject of a Justice Department investigation. 

    “We have really, really good clinical outcomes when it comes to depression and anxiety and P.T.S.D. and ADHD, and even serious mental illnesses, such as bipolar disorder,” Mou said. 

    But in a letter written last month and obtained by CBS News, Cerebral founder Kyle Robertson — who was removed by Cerebral’s board earlier this year — claims some of the company’s leading investors “push[ed] for increased prescriptions of controlled substances” like Adderall. Robertson alleges one board member told him, “the easier you make it for people to get stimulants, the better for the business and its customers.” 

    The company told us Robertson’s allegations are “categorically untrue.”


    If you or someone you know is struggling, help is available 24-7 at the National Suicide Prevention Lifeline. Just call 988 or 1-800-273-8255. For more resources, please click here

    If you want to share your experience using online mental health services, email us at mentalhealth@paramount.com.

    Source link

  • FDA Announces Adderall Shortage

    FDA Announces Adderall Shortage

    The FDA has confirmed a nationwide shortage of the attention-deficit/hyperactivity disorder medication Adderall due to manufacturing issues, with the shortage expected to last through the end of the year. What do you think?

    “Pretty sure meth’s still in stock.”

    Miles Seelbach, Crypto Banker

    “Between this and the formula shortage, what am I supposed to feed my baby?”

    Anita Santana, Cannoneer

    “I guess I have to go back to bribing teachers.”

    Hank Schilsky, Content Aggregator

    Source link