FDA’s Regulatory Measures on Opioid Pain Management

The use of chronic opioid therapy for chronic non malignant pain has increased significantly and is associated with significant morbidity in the United States. The chronic pain affect the normal activities of daily living, absenteeism from work, disrupts the family life which eventually leads to depression, social isolation and low self esteem. The American Pain Society and the American Academy of Pain Medicine commissioned a systematic review of the evidence on chronic opioid therapy for chronic non malignant pain and summoned a multidisciplinary expert panel to review the evidence and formulate recommendations. The evidence suggested that chronic opioid therapy can be an effective therapy for carefully selected and monitored patients with chronic non-malignant pain.

Misuse of Opioid

The use of non prescription pain relievers for nonmedical purposes is now the second most common form of drug abuse, which only comes second to marijuana use. Statistics suggest in 2007, an estimated 5.2 million individuals older than 12 years reported nonmedical use of prescription pain relievers during the preceding month. Although opioid products are an important component of pain management, the abuse of this product has created a serious public health problem.

 What FDA is doing?

 To reduce the misuse of opioids, the White House has unveiled a multi-agency plan called “Epidemic: Responding to America’s Prescription Drug Abuse Crisis” aimed at reducing the “epidemic” of prescription drug abuse in the U.S.—including an FDA-backed education program. The key elements of the plan include:

  • expansion of state-based prescription drug monitoring programs
  • recommending convenient and environmentally responsible ways to remove unused medications from homes
  • supporting education for patients and health care providers
  • reducing the number of “pill mills” and doctor-shopping through law enforcement

Along with the White House plan, the FDA is announcing a new risk reduction program—called a Risk Evaluation and Mitigation Strategy—for all extended-release and long-acting opioid medications. FDA’s new REMS plan focuses mainly on educating doctors about proper pain management, and improving patient awareness about how to use these drugs safely. In addition, FDA wants companies to give patients education materials, including a medication guide that uses consumer friendly language to explain safe use and disposal.

The pharmaceutical industry needs to accurately comprehend the FDA roles and regulation governing controlled substances so that compliance can be adequately achieved. Expert

speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA is taking an informative audio session to help the pharmaceutical industry get a better insight into FDA’s expectations concerning opioid pain management. The session will help you understand and adequately implement the regulatory requirements concerning opioid pain management.

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