Breaking News
December 15, 2018 - Eczema Can Drive People to Thoughts of Suicide: Study
December 15, 2018 - Link between neonatal vitamin D deficiency and schizophrenia confirmed
December 15, 2018 - Nurse denied life insurance because she carries naloxone
December 15, 2018 - Ritalin drug affects organization of pathways that build brain networks used in attention, learning
December 15, 2018 - Research pinpoints two proteins involved in creation of stem cells
December 15, 2018 - Gut bacteria may modify effectiveness of anti-diabetes drugs
December 15, 2018 - How imaginary friends could boost children’s development
December 15, 2018 - Folate deficiency creates more damaging chromosomal abnormalities than previously known
December 15, 2018 - Study provides new insights into molecular mechanisms underlying role of amyloid in Alzheimer’s disease
December 15, 2018 - For the asking, a check is in the mail to help pay for costly drugs
December 15, 2018 - UA scientists uncover biological processes leading to rare brain disorder in babies
December 15, 2018 - The largest database on industrial poisons
December 15, 2018 - ESMO Immuno-Oncology Congress showcases novel technologies set to benefit many cancer patients
December 15, 2018 - Ovid Therapeutics Announces Plans to Move into a Phase 3 Trial in Pediatric Patients Based on End-of-Phase 2 Meeting for OV101 in Angelman Syndrome
December 15, 2018 - Left ventricular noncompaction – Genetics Home Reference
December 15, 2018 - Children’s sleep not significantly affected by screen time, new study finds
December 15, 2018 - When should dementia patients stop driving? A new guidance for clinicians
December 15, 2018 - Researchers use INTEGRA’s VIAFLO 96/384 to streamline the experimental workflow
December 15, 2018 - Researchers discover protein involved in nematode stress response
December 15, 2018 - Cancer patients have greater risk of developing shingles, study shows
December 14, 2018 - UAlberta scientists identify biomarkers for detecting Alzheimer’s disease in saliva samples
December 14, 2018 - Study uncovers link between tube travel and spread of flu-like illnesses
December 14, 2018 - Caffeine plus another compound in coffee may fight Parkinson’s disease
December 14, 2018 - GW researchers review studies on treatments for prurigo nodularis
December 14, 2018 - Lack of peds preventive care ups unplanned hospital admissions
December 14, 2018 - Miscarriage: When Language Deepens Pain
December 14, 2018 - New method helps better understand pathological development of ALS
December 14, 2018 - Intellectually active lifestyle confers protection against neurodegeneration in Huntington’s patients
December 14, 2018 - Mammalian collagen nanofibrils become stronger and tougher with exercise
December 14, 2018 - Considerable Morbidity, Mortality Due to Animal Encounters
December 14, 2018 - Researchers find inhibiting one protein destroys toxic clumps seen in Parkinson’s disease
December 14, 2018 - How early physical therapy can lessen the long-term need for opioids
December 14, 2018 - Depression, suicide rates highest in Mountain West states
December 14, 2018 - New model could cure the potential to underestimate how quickly diseases spread
December 14, 2018 - Exercise-induced hormone activates cells critical for bone remodeling in mice
December 14, 2018 - Researchers discover new mechanism behind spread of malignant pleural mesothelioma
December 14, 2018 - Health Tip: Celebrate a Healthier Holiday
December 14, 2018 - Scalpel-free surgery enhances quality of life for Parkinson’s patients, study finds
December 14, 2018 - Early physical therapy can reduce risk, amount of long-term opioid use | News Center
December 14, 2018 - Genetic marker, predictor of early relapse in common childhood cancer discovered
December 14, 2018 - Study could lead to a potential new way of treating sepsis
December 14, 2018 - New protein complex helps embryonic stem cells to maintain their indefinite potential
December 14, 2018 - Salk professor receives $1.8 million from NOMIS Foundation for research on mechanisms to promote health
December 14, 2018 - New discovery will improve the safety and predictability of CRISPR
December 14, 2018 - Geneticists discover how sex-linked disorders arise
December 14, 2018 - New method to visualize small-molecule interactions inside cells
December 14, 2018 - Study describes mechanism that makes people more vulnerable to hunger-causing stimuli
December 14, 2018 - Chronic opioid therapy associated with increased healthcare spending and hospital stays
December 14, 2018 - Blood Types
December 14, 2018 - Obesity linked to increased risk of early-onset colorectal cancer
December 14, 2018 - Blood test helps identify distinct molecular signatures in children with cystic fibrosis
December 14, 2018 - In California, doctors accused of sexual misconduct often get second chances
December 14, 2018 - Scientists use water to track electrical activity of nerve cells
December 14, 2018 - Recurrence of urinary tract infection may depend on bacterial strain, study shows
December 14, 2018 - GBT Announces U.S. FDA Agrees with its Proposal Relating to Accelerated Approval Pathway for Voxelotor for the Treatment of Sickle Cell Disease and GBT Plans to Submit New Drug Application (NDA)
December 14, 2018 - Partial Thromboplastin Time (PTT) Test: MedlinePlus Lab Test Information
December 14, 2018 - Common tactics for health promotion at work may be detrimental to employees with obesity
December 14, 2018 - Myths about migration and health not supported by available evidence
December 14, 2018 - Recent findings on rare genetic disorder may help develop new treatment options
December 14, 2018 - New drug shows promise in treating sarcomas
December 14, 2018 - Scientists perform lung lavage as new approach for tuberculosis diagnosis in rhinoceros
December 14, 2018 - Answering the Biggest Neurological Research Questions of Today
December 14, 2018 - Recent winners of the Nobel Medicine Prize
December 14, 2018 - KHN’s ‘What the Health?’ Insurance enrollment is lagging — and there are lots of reasons why
December 14, 2018 - Study assesses safety and efficacy of new treatment for pancreatic cancer
December 14, 2018 - Weakened metabolism of immune T cells may account for serious complications in elderly
December 14, 2018 - Study finds drug targets for Ebola, Dengue, and Zika viruses
December 14, 2018 - Face masks may offer protection against staph bacteria for hog farm workers and their household members
December 14, 2018 - Shining new light on neuron firing
December 14, 2018 - Study highlights need for personalized approach to treat ICU acquired delirium
December 14, 2018 - Soot particles from road traffic significantly contribute to air pollution
December 14, 2018 - Massage helps relieve pain, improve mobility in patients with knee osteoarthritis
December 14, 2018 - Researchers explore home healthcare nurses’ knowledge attitudes toward infection control
December 14, 2018 - Average outpatient visit in the U.S. costs nearly $500, shows new study
December 14, 2018 - Reference Infliximab, Biosimilar Equivalent for Crohn’s Disease
December 14, 2018 - New contact lens to treat eye injuries
December 14, 2018 - Acne could have a genetic basis find researchers promising new cure
December 14, 2018 - Higher physical activity associated with improved mood
December 14, 2018 - New UGA study points to optimal hypertension treatment for stroke patients
December 14, 2018 - Study highlights factors that can reduce food cravings
FDA takes new steps to address opioid crisis by approving Opioid Analgesic Risk Evaluation and Mitigation Strategy

FDA takes new steps to address opioid crisis by approving Opioid Analgesic Risk Evaluation and Mitigation Strategy

image_pdfDownload PDFimage_print

Today, the U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS now, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to a REMS since 2012.

The REMS program requires, for the first time, that training be made available to health care providers who are involved in the management of patients with pain, and not only to prescribers. For example, the training provided through the REMS must be made available to nurses and pharmacists. The new REMS also requires that the education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain. The agency is also approving new product labeling containing information about the health care provider education available through the new REMS.

“Opioid addiction is an immense public health crisis. Addressing it is one of the FDA’s highest priorities. As part of our comprehensive work in this area, we’re taking new steps to rationalize prescribing and reduce overall exposure to these drugs as a way to cut the rate of new addiction. Many people who become addicted to opioids will have their first exposure in the medical setting. Providers have a critical role to play in making sure these products are appropriately prescribed to patients. Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain. This includes ensuring that prescriptions are written for only appropriate purposes and durations of use. Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements. The action also adds new labeling for all opioids to raise awareness about available educational materials on prescribing these powerful medications,” said FDA Commissioner Scott Gottlieb, M.D. “Appropriate prescribing practices and education are important steps that we’re prioritizing to help address the human and financial toll of this crisis. Our aim is to make sure the medical community can take advantage of the available education on pain management and safe use of opioid analgesic products. At the same time, we’re also taking new steps to advance the development of evidence-based, indication-specific guidelines to help further guide appropriate prescribing of opioids. The goal is that these guidelines will provide evidence-based information on the proper number of opioid doses that should be dispensed for different medical conditions for which these drugs may be indicated. The aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines.”

Since 2012, manufacturers of ER/LA opioid analgesics have been subject to a REMS that requires as its primary component, that training be made available to prescribers of those products. To meet this requirement, drug companies with approved ER/LA opioid analgesics have been providing unrestricted grants to accredited continuing education providers for the development of education courses for prescribers based on content outlined by the FDA. As part of the final action being taken today, these REMS requirements now also apply to IR opioid analgesic products intended for outpatient use. The IR drugs account for about 90 percent of all opioid pain medications prescribed for outpatient use. Additionally, the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines have been subject to a REMS since December 2011.

In addition to expanding the REMS to include IR opioid analgesic products intended for outpatient use, the agency has approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint). This includes updated educational content. The agency believes that all health care providers involved in the management of patients with pain should be educated about the safe use of opioids so that when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving these medications, they can help ensure the proper product is selected for the patient and used with appropriate clinical oversight. It is expected that continuing education training under the modified REMS will be available to health care providers by March 2019.

Today’s action greatly expands the number of products covered by the REMS. Prior to today, the ER/LA Opioid Analgesic REMS included 62 products. But the modified Opioid Analgesic REMS now requires that 347 opioid analgesics intended for outpatient use be subject to these REMS requirements. The REMS program continues to include Medication Guides for patients and caregivers to read, new Patient Counseling Guides to assist health care providers with important discussions with patients, and plans for assessing the program’s effectiveness.

The FDA is also approving new safety labeling changes for all opioid analgesic products intended for use in an outpatient setting. For the first time, the FDA is requiring the labeling for those products to include information about the availability of education through the REMS for prescribers and other health care providers who are involved in the treatment and monitoring of patients with pain. The new labeling includes information about REMS-compliant education in the Boxed Warning and Warnings and Precautions sections of labeling and strongly encourages providers to complete a REMS-compliant education program; counsel patients and caregivers on the safe use, risks, and appropriate storage and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist; and to consider other tools to improve patient, household and community safety.

There is no mandatory federal requirement that prescribers or other health care providers take the training provided through the REMS and completion of the training is not a precondition to prescribing opioid analgesics to patients. However, the FDA’s Opioid Policy Steering Committee continues to consider whether there are circumstances when the FDA should require some form of mandatory education for health care providers and how the agency would pursue such a goal. The FDA also recently awarded a contract to the National Academies of Sciences, Engineering, and Medicine to help develop a framework to assist medical professional societies in creating evidence-based guidelines on appropriate opioid analgesic prescribing to treat acute pain resulting from specific medical conditions and common surgical procedures for which these drugs are prescribed. The agency’s aim is to reduce unnecessary and/or inappropriate exposure to opioids by making certain that prescribers are properly informed about appropriate prescribing recommendations, that providers understand how to identify abuse by individual patients, and know how to get patients with opioid use disorder into treatment. The crisis of opioid addiction is a public health tragedy of enormous proportions. The FDA’s goal is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse and abuse of opioid analgesics, while maintaining patient access to pain medications.

As part of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis, the FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing unnecessary and/or inappropriate exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioid products. The FDA will also continue to evaluate how drugs currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.

Source:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620935.htm

Tagged with:

About author

Related Articles