Amphetamine

HELENA, Mont., Oct. 24, 2024 /PRNewswire/ -- When the Substance Abuse and Mental Health Services Administration (SAMHSA) updated their recommendations governing Opioid Treatment Programs (OTPs) in April 2024, Montana was among the first to implement significant changes for OTPs in the state. Community Medical Services (CMS) currently provides care to Montana residents at 4 clinics, (Billings, Bozeman, Kalispell and Missoula), and has been working to adjust their clinical guidance to institute these changes aimed at improving patient safety and retention in treatment programs. This is a crucial step forward in addressing the opioid epidemic, providing more effective care for individuals struggling with opioid use disorder. Extended Take-Home Doses Under the new rules, patients are no longer required to come to a clinic at the same frequency as they have historically needed to. Medical providers can determine the appropriate number of take-home doses based on individual patient needs and criteria, including: Absence of active substance use disorders or other health conditions that increase the risk of patient harm Regular attendance for supervised medication administration Absence of serious behavioral problems Absence of known recent diversion activity Safe transportation and storage of take-home medication Higher Initial Dosing The initial dose of methadone, which was historically capped on the first day, can now be titrated more quickly at the medical provider's discretion, allowing patients with higher opioid tolerance to get to a therapeutic dose more quickly. This change acknowledges the varying levels of opioid tolerance among patients, exacerbated by the increased presence of fentanyl in the illicit drug supply, and enables medical providers to tailor treatment to individual needs. Drug Screens The presence of unprescribed amphetamine or cocaine on drug screen results will no longer be the sole limiting factor to requiring patients to not have to come into clinics daily, unless it increases the risk of overdose. This change recognizes that patients with opioid use disorder may also struggle with other substance use disorders and requires medical providers to assess each patient's unique situation. Conclusion The SAMHSA Final Rule changes mark a crucial step forward in enhancing Opioid Treatment Programs in Montana. By providing more flexible and individualized treatment options, these changes aim to improve patient safety and retention, decrease daily patient volumes at clinics, and ultimately support individuals in their journey towards recovery. How CMS is Implementing SAMHSA's Changes At its 4 clinics in Montana, CMS has proactively implemented the SAMHSA Final Rule changes. Our approach focuses on balancing patient safety with reducing barriers to treatment, ensuring that any changes benefit our patients and their recovery outcomes. Triweekly dosing—allowing patients to come to the clinic only three times per week—has become the new standard. This means that most patients, even those who might test positive for stimulants or miss some clinic days, are not required to visit the clinic more than three times a week. For patients who meet certain stability criteria, the option to advance to weekly clinic visits is available after just two weeks of triweekly dosing. This provides immense relief to patients who previously struggled to balance daily trips to the clinic with their other responsibilities, such as work or family. Visit the CMS blog on our website for a complete review by our Chief Science Officer, Dr. Robert Sherrick, of how we are taking an active step toward implementing these changes and seeing early positive results Media Contact: John Koch- Director Public Relations [email protected] 2827 Fort Missoula Rd, Missoula, MT 59804 8707 Jackrabbit Ln Suite D, Belgrade, MT 59714 2415 S Catlin St, Missoula, MT 59801 795 Sunset Blvd F, Kalispell, MT 59901 2040 Rosebud Dr, Billings, MT 59102 2827 Fort Missoula Rd, Missoula, MT 59804 SOURCE Community Medical Services WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

To address an ongoing shortage of ADHD drugs, the Drug Enforcement Administration has increased the production quota on Takeda's Vyvanse and its generic versions by 24%. Less than four months after Teva’s Adderall was erased from the FDA shortage list, supply problems with another attention-deficit/hyperactivity disorder (ADHD) treatment, Takeda’s Vyvanse and its generic versions, are such that the U.S. Drug Enforcement Administration (DEA) has increased (PDF) production quotas on the drug by 24%.The move comes eight weeks after an FDA request to the DEA to bump up production limits. As Schedule 2 controlled substances, Vyvanse (lisdexamfetamine) and Adderall (amphetamine/dextroamphetamine) are subject to DEA limitations that help prevent them from being abused.The DEA has raised the aggregate production quota on lisdexamfetamine by 6,236 kilograms, according to a final order set to be published Thursday in the Federal Register. Of that figure, 1,558 kg has been allocated to domestic demand for medications, while the remaining 4,678 kg addresses foreign demand for the products.“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” the DEA wrote in its notice. Because the drugs are so tightly controlled, there is a ripple effect when one has a supply issue. Shortages of ADHD drugs have persisted since the summer of 2022 when a labor problem on Teva’s packaging line reduced the supply of Adderall. That issue then triggered increased demand and supply issues with most of the 11 companies making generic versions of Adderall, including Sandoz, Amneal and Sun Pharma. Then, in June of last year, Takeda reported in a statement on its website that it was experiencing “low inventory” for Vyvanse brought on by increased demand and a manufacturing delay. In addition, the timing of Vyvanse's shortage raises a question around the economics of producing the medicine in the aftermath of generic launches. Takeda reported its Vyvanse supply shortfall last June, and the first U.S. generics ⁠launched two months later. Lawmakers and industry watchers have repeatedly flagged that ⁠economic factors can drive drug shortages when companies don't see a potential profit motive in dedicating their manufacturing equipment to low-margin—or even loss-making—products. Meanwhile, on the DEA's manufacturing allocation, the agency last summer committed to “reviewing and improving” the quota process. In 2022, that limit was not met, and drugmakers sold only 70% of their allotted quota for the year, making for some 1 billion extra doses that could have been produced, the FDA and the DEA revealed in a joint letter (PDF).At the time, the agencies said they had called on manufacturers to confirm production increases and asked that those that opt to no longer produce the meds “relinquish” their remaining quota so the DEA can redistribute it.