Articles related to PUBLIC HEALTH

Understanding Xylazine: The Rising Challenge in Opioid Crisis Management As physicians, it’s crucial to stay informed about emerging drug threats. Xylazine, a powerful livestock tranquilizer mixed into fentanyl, is one such threat that’s gaining momentum.

Join us as we explore the dynamic world of compounding pharmacies tackling the challenging semaglutide shortages head-on. Compounding pharmacies have stepped up to address the shortage of two semaglutide products, Ozempic and Wegovy. Consequently, they’re facing increased scrutiny from federal and state regulators, as well as Novo Nordisk, the manufacturer of these products. Novo Nordisk is actively monitoring and taking action against entities unlawfully selling compounded semaglutide. The company has sent cease-and-desist letters to some 503A pharmacy compounders. This move is seen as the first step towards potential legal actions. The Alliance for Pharmacy Compounding has defended the rights of 503A pharmacies to compound active pharmaceutical ingredients (APIs) in brand-name medications for specific patients, as long as the brands are on the FDA’s “currently in shortage” list. However, the distinction between legitimate 503A pharmacy compounders and shady operators has been blurred. These operators have rushed to fill the semaglutide gap without proper oversight of their compounding safety processes, source of APIs, or marketing techniques. This negligence could potentially cause serious patient harm. Kristina Bryowsky, PharmD, MBA, Vice President of Pharmacy Services for SSM Health Care, Missouri Region, believes that 503A compounding pharmacies should be allowed to make a product for […]

Oncologists and cancer drug shortages are creating a crisis, with patient care at risk and legal liabilities looming. In the face of critical cancer drug shortages, oncologists grapple with suboptimal patient care and possible legal liabilities. The issue worsens due to insufficient guidelines for alternative treatment options. A contributing factor is the weak financial incentive for drug manufacturers to produce unprofitable generic drugs, compared to branded ones. Consequently, there’s greater dependence on foreign factories, leading to supply chain hitches and quality control issues. Barbara McAneny, MD, CEO of New Mexico Cancer Center, foresees drug shortages persisting, particularly affecting low-cost treatments. The American Society of Health-System Pharmacists (ASHP) reports shortages of vital oncology drugs like methotrexate, cisplatin, carboplatin, and fluorouracil, crucial for treating various common cancers. Furthermore, the lack of guidelines on alternative treatments exacerbates oncologists’ concerns about patient outcomes and legal liabilities. This absence of direction leaves physicians making crucial decisions single-handedly. In response, the American Society of Clinical Oncology (ASCO) has formed an advisory group to develop clinical guidance during these drug shortages. Immediate recommendations include reprioritizing nonessential use of scarce antineoplastic drugs, increasing interval cycles, reducing doses when clinically acceptable, and selecting evidence-based alternatives. Dr. Jeff Patton, CEO […]

Let’s delve into the complexity of mask effectiveness against SARS-CoV-2 in diverse settings. Debate rages on about optimal mask use for COVID-19 prevention. This trial takes a fresh look at the issue. It evaluates N95, surgical, and cloth masks in preventing SARS-CoV-2 infections. The team sourced data from MEDLINE, EMBASE, and medRxiv. They also scanned relevant reference lists. They selected randomized trials and observational studies. These studies increased mask use and controlled for confounding factors in assessing SARS-CoV-2 infection risk. Two investigators carried out the data extraction process. They carefully abstracted data from each study and evaluated its quality. Their efforts resulted in the inclusion of three randomized trials and 21 observational studies. Evidence from two trials and seven studies points to a possible reduction in SARS-CoV-2 infection risk through mask use in community settings. Despite this, observational studies failed to provide sufficient evidence for other mask comparisons due to methodological inconsistencies. In routine patient care settings, one new trial and four studies indicated comparable infection risk between surgical masks and N95 respirators. However, the study couldn’t disregard the potential beneficial effects of N95 respirators. Yet, several limitations cloud these findings. These include a limited number of randomized trials, methodological […]

The FDA’s controversial approval of Recarbrio in 2019 marked a deviation from the expected standards of drug effectiveness. Before 1962, US drug approvals didn’t require pre-market proof of effectiveness. Following Senate hearings and the Thalidomide disaster, however, the law changed. Nowadays, FDA approval for new drugs requires substantial evidence of effectiveness from well-controlled investigations. Strikingly, a National Academy of Sciences review found over 30% of pre-1962 drugs to be ineffective, highlighting the importance of these regulations. FDA’s regulations provide a detailed explanation of what constitutes substantial evidence. Though not perfect, these regulations reassure prescribers, patients, and payers of the scientific basis of drug efficacy claims. It’s important to note that an FDA review found 59% of rejected NDAs had deficiencies in efficacy evidence. Nevertheless, the FDA’s controversial approval of Recarbrio in 2019 raised eyebrows. This drug, a combination of imipenem, cilastatin, and relebactam, was approved despite lacking substantial evidence of effectiveness and proper clinical investigations. Disturbingly, FDA officials cited animal and laboratory studies as substantial evidence, a move contrary to legal and regulatory norms. Moreover, the Recarbrio approval showcased other troubling departures from regulatory principles. The FDA failed to require proof of each active component’s contribution to the claimed effect. […]

The United States is currently experiencing a shortage of Adderall, a medication used to treat attention deficit disorder (ADD)/attention deficit hyperactivity disorder (ADHD) and narcolepsy. The FDA, in frequent communication with manufacturers, has not provided a clear timeline for when the shortage will be resolved. The shortage is attributed to various factors. The demand for Adderall has increased significantly, with a 10% rise in prescriptions filled in 2021 compared to the previous year. The US Drug Enforcement Agency’s efforts to combat prescription drug misuse have also played a role in limiting production. Furthermore, the pandemic led to the emergence of telemedicine startups, making it easier for individuals to obtain Adderall prescriptions, sometimes inaccurately. While waiting for the supply to be restored, healthcare professionals can consider alternative therapies such as dexmethylphenidate, methylphenidate, and dextroamphetamine.