Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication
Today, the U.S. Food and Drug Administration issued a Safety Communication titled “Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication.” The FDA is sharing important information with health care providers, pharmacists, compounders, patients, and caregivers about the risks of using medications delivered into the spinal fluid to treat or manage pain that are not approved for use with the implanted pumps.
Summary of Problem and Scope:
The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump. While individual patients may experience some relief from using pain medicines not approved for intrathecal administration in their implanted pumps, such use may create additional risks including dosing errors, pump failures, and other safety concerns. The FDA wants to ensure that patients, caregivers, compounders, pharmacists, and health care providers are aware of these risks to make informed treatment decisions.
The FDA-approved implanted pump labeling identifies which pain medicines are approved for use with each pump. Pain medicines approved by FDA for delivery into the spinal fluid must meet additional safety standards because the spinal cord and brain tissue are highly sensitive to preservatives or infectious organisms such as bacteria or viruses. The implanted pump’s current labeling should be reviewed to determine which pain medicines are approved for use in each pump.
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Abstract Submission Open!
Abstract submissions are now being accepted for the 2019 ASIPP Annual Meeting Abstract and Poster Contest. The top 10 abstracts selected by our panel will be presented at the annual meeting. The top 25 abstracts will be presented as electronic posters in view for all our attendees.
Click
HERE to submit. Deadline is Feb. 18
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SAVE THE DATES!
February 22-24, 2019
Orlando, FL
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CMS releases final 2019 fee schedules for physicians, HOPDs, and ASCs:
Mixed news for interventional pain management physicians
The Centers for Medicare and Medicaid Services (CMS) released the final 2019 Medicare physician fee schedule (PFS), ASC & HOPD rules, addressing Medicare payment rates and policy provisions for 2019.
ASC & HOPD Payment Rates:
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CMS FINALIZES OUTPATIENT ‘SITE NEUTRALITY’ RULES
The Centers for Medicare and Medicaid Services (CMS) issued a new, massive set of final regulations November 2 which, it says, “removes unnecessary and inefficient payment differences between certain provider and supplier types so patients can have more affordable choices and options” starting January 1, 2019.
Behind the lofty language: hospital off-campus surgery centers will see a payment cut, sending an estimated $300 million per year in patient business to independent ambulatory surgery centers (ASCs).
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Methamphetamine Use on the Rise in Patients With Opioid Use Disorder
The rate of past-month
methamphetamine
use was found to have risen significantly in individuals with opioid use disorder from 2011 to 2017, according to a study published in
Drug and Alcohol Dependence
.
The study included patients entering drug treatment programs in the United States (n=13,521) who were asked to complete an anonymous survey of drug use patterns from 2011 to 2017. The researchers also interviewed a subset of participants (n=300) to expand upon the survey results.
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Two Screening Tools May Accurately Predict Transition From Acute to Chronic Low Back Pain
Two screening tools, the STarT Back Screening Tool and the Örebro Musculoskeletal Pain Questionnaire, may be useful in predicting the transition from subacute and acute to
chronic low back pain
, according to a systematic literature review published in
Pain Medicine
.
Predicting a transition to chronic low back pain with the use of reliable screening instruments is essential for optimal therapeutic targeting and management. Investigators conducted an integrative metareview of studies examining screening tools for chronic low back pain, searching MEDLINE/PubMed, PsychINFO, CINAHL, and
Cochrane Database of Systematic Reviews
for relevant articles. Only studies published after 2000 were included. From an initial total of 2274 candidate reports, 42 were selected for inclusion in the review and were categorized into 3 classes, depending on whether they involved screening instruments that assessed psychological, clinical, or functional metrics.
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Interventional Pain Management Reports
is an Open Access online journal, a peer-reviews journal dedicated to the publication of case reports, brief commentaries and reviews and letters to the editor. It is a peer-reviewed journal written by and directed to an audience of interventional pain physicians, clinicians and basic scientists with an interest in interventional pain management and pain medicine.
Interventional Pain Management Reports
is an official publication of the American Society of Interventional Pain Physicians (ASIPP) and is a sister publication of
Pain Physician
.
Interventional Pain Management Reports Interventional Pain Management Reports
is an open access journal, available online with free full manuscripts.
The benefits of publishing in an open access journal that has a corresponding
print edition journal are:
- Your article will have the potential to obtain more citations.
- Your article will be peer-reviewed and published faster than other journals.
- Your article can be read by a potentially much larger audience compared with traditional subscription-only journals.
- Open Access journals are FREE to view, download and to print.
So submit today your:
- Case Reports
- Technical Reports
- Editorials
- Short Perspectives
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New Abuse-Deterrent IR Oxycodone Drug to Be Reviewed
MNK-812 employs multiple technologies to make snorting painful and injection difficult
WASHINGTON -- Two FDA advisory committees will have their say Wednesday about yet another opioid manufacturer's attempt to design an immediate-release oxycodone product that significantly discourages abuse.
The product is MNK-812, from Mallinckrodt Pharmaceuticals' SpecGx unit, which aims to be "more difficult to crush and is designed to form a viscous hydrogel not suitable for injection," according to
an FDA staff summary
. "Additionally, two aversive agents were included in the formulation to cause potentially irritating effervescence when the tablet comes into contact with water."
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November Podcast Now Available
Miles Day of Texas Tech Discusses Multiple Pain Management Techniques
Miles Day, MD, DABA, FIPP, DABIPP, Treweek/ Racz Endowed Professor in Pain Research, Pain Management Fellowship Program Director, Department of Anesthesiology, Texas Tech University Health Sciences Center discusses pain management with Hans Hansen, Interventional Pain physician and the ASIPP Podcast producer. Dr. Day is internationally known throughout the pain community by face and name. He is the Program Director of the Pain Management Fellowship Program at one of the leading institutes for training and developing pain management as we know it. Dr. Day takes us through an interesting discussion about what it takes to be competent to sit for the Board Exam. Only 300 passed the test last year and can enter the world of pain management and be able to help those that suffer the most with painful conditions. It's an evolving field and keeping residents abreast of safe and effective techniques is daunting. Dr. Day also discusses where the pain management field is headed. Join us on this journey with Dr. Day and his perspective from one of the premiere pain management institutes in the world.
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Pain Physician
September/October 2018 Issue Features
Health Policy Review
Systematic Reviews
Randomized Trials
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DOJ NEWS
Co-Owners of Miami Pain Management Clinic and Patient Recruiter Sentenced to Prison for Scheme to Distribute Medically Unnecessary Opioid Prescriptions
The husband and wife co-owners of a Miami, Florida pain management clinic and a patient recruiter who doubled as a drug diverter were sentenced to prison today for their participation in a scheme to unlawfully distribute thousands of pills of oxycodone.
Assistant Attorney General Brian A. Benczkowski of the Justice Department’s Criminal Division, U.S. Attorney Ariana Fajardo Orshan of the Southern District of Florida, Special Agent in Charge George L. Piro of the FBI’s Miami Field Office, Special Agent in Charge Shimon R. Richmond of the U.S. Department of Health and Human Services Office of Inspector General’s (HHS-OIG) Miami Regional Office, Special Agent in Charge Brian Swain of the U.S. Secret Service’s (USSS) Miami Field Office and Special Agent in Charge Adolphus P. Wright of the U.S. Drug Enforcement Administration’s (DEA) Miami Field Division made the announcement.
David Bosch, 46, and Tania Sanchez, 47, both of Hialeah, Florida, and Odalys Abreu, 45, of Miami, were sentenced by Chief U.S. District Judge K. Michael Moore of the Southern District of Florida. Bosch, Sanchez and Abreu were sentenced to serve 108, 97 and 57 months in prison followed by three years of supervised release, respectively. In addition to the prison term, U.S. District Court Judge Moore ordered Abreu to pay a forfeiture money judgment of $75,000 and ordered Bosch and Sanchez to pay a forfeiture money judgment in the amount of $131,250, jointly and severally. Each of the defendants pleaded guilty in August 2018 to one count of conspiracy to distribute controlled substances.
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July 12-14, 2019
GSIPP 2019 - 15th Annual Meeting & Pain Summit
The Cloister Hotel at Sea Island
Sea Island, GA
July 26-28, 2019
PAIN 2019
West Virginia Society of Pain Physicians
Loews Miami Beach, FL
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