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Editorial: Reducing Risk with Abuse-Deterrent Formulations
Increasing prevalence of drug misuse and abuse is driving a heightened and more stringent approach to abuse-deterrent formulations. Possibly the most...
2 min read
Battling the opioid and overall prescription drug abuse epidemic has been a critical focus for many agencies within the U.S. government and industry. The following are a collection of important documents and resources that are important to this initiative.
White House - "Epidemic: Responding to America's Prescription Drug Abuse Crisis"
This Prescription Drug Abuse Prevention Plan expands upon the Administration’s National Drug Control Strategy and includes action in four major areas to reduce prescription drug abuse: education, monitoring, proper disposal, and enforcement. Read White House plan
Abuse-Deterrent Opioids — Evaluation and Labeling Guidance for Industry
This guidance explains FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. The guidance makes recommendations about how those studies should be performed and evaluated and discusses how to describe those studies and their implications in product labeling. Access Guidance
This guidance is intended to assist a potential applicant who plans to develop, and submit an abbreviated new drug application (ANDA) to seek approval of a generic version of a solid oral opioid drug product that has the potential for abuse and which references an opioid drug product with abuse-deterrent properties described in its labeling. The guidance recommends studies, including comparative in-vitro studies that should be conducted by the potential ANDA applicant and submitted to FDA in an ANDA to demonstrate that a generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug (RLD) with respect to all potential routes of abuse. Access Guidance
CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016
This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care. The guideline addresses 1) when to initiate or continue opioids for chronic pain; 2) opioid selection, dosage, duration, follow-up, and discontinuation; and 3) assessing risk and addressing harms of opioid use. CDC developed the guideline using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework, and recommendations are made on the basis of a systematic review of the scientific evidence while considering benefits and harms, values and preferences, and resource allocation. Access Guideline
FDA Facts: Abuse-Deterrent Opioid Medications
Overview of definitions, concepts and general plans of action for FDA’s role in combating the opioid abuse and addiction crisis. Read Abuse-Deterrent Opioid Medications Facts
Fact Sheet – FDA Opioids Action Plan
In response to opioid abuse crisis, the agency has developed a comprehensive action plan to take concrete steps toward reducing the impact of opioid abuse on American families and communities. Read Action Plan
Presentation: A U.S. Regulator’s View on Abuse-Deterrent Formulations of Opioids
Insights from Douglas C. Throckmorton, MD, Deputy Director for Regulatory Programs, CDER, FDA. View presentation
The Opioid Epidemic: By the Numbers
An infographic update from the department of Health & Human Services. Outlines the epidemic and progress to date tackling the epidemic. View infographic
White Paper: Abuse-Deterrent Studies for Controlled Drugs – A Changing Landscape
Engineering abuse-deterrent properties into prescription forms of drugs with abuse potential has become a primary strategy for abuse prevention.
This paper addresses:
- The cost of prescription drug abuse
- Overview of government action
- Abuse-deterrent strategies
- Abuse-deterrence study approaches
The initiative to reduce abuse of prescription drugs has gained significant momentum impacting compliance issues, medical community education and market opportunities for opioid drug manufacturers. This executive brief addresses:
- Overview of the prescription drug crisis
- Government Action Directed at the Opioid Drug Abuse Epidemic
- Medical Community Response—Where Do Doctors Stand?
- FDA Position on Abuse-Deterrent Opioid Drug Products
- Three Benefits of Abuse-Deterrent Determination for Opioid Manufacturers
- Factors Contributing to Opioid Abuse-Deterrence
- Abuse-Deterrence Determination
- In Vitro Manipulation and Extraction Studies Approaches
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