Sagent Pharmaceuticals, announced the voluntary nationwide recall of Lot Number M813513 of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL). This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP to the to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
The American Society of Clinical Oncology, the American Society of Hematology, and the National Comprehensive Cancer Network® received a letter from the Centers for Disease Control and Prevention (CDC) clarifying the CDC Guideline for Prescribing Opioids for Chronic Pain on prescribing opioids to manage pain from certain conditions.
The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.
This funding will expand access to treatment that works, especially to medication-assisted treatment (MAT) with appropriate social supports.
Comments from the American Academy of Pain Medicine (Docket HHS-OS-2018-0027-0001)
The American Academy of Pain Medicine (AAPM) wishes thank the HHS Pain Management Best Practices Inter-Agency Task Force for their dedication and efforts to improve pain care nationally. The document has been thoroughly reviewed by two major committees within AAPM: the Scientific Review and Guidelines Committee and the Behavioral Medicine Committee.
The emphasis on patient-centered and individualized care is appropriate, and special attention to particularly disadvantaged populations and often neglected populations such as children, adolescents, and older adults is appreciated.
A common theme throughout the HHS document is the inclusion of nearly all available options of treatments within a particular category with relative equal emphasis. While this approach provides a comprehensive review of the subjects, it is important to consistently acknowledge the level of evidence supporting any included therapies, as is the standard practice for the publishing of Practice Guidelines.
We provide below several key concerns and recommendations to improve the document and to better align its content with the biospsychosocial model of pain care and current evidence. We urge these recommendations be considered to improve the content of national policy and training needs for providers as well as information available for those who suffer chronic pain.