Docket Management
Docket: 01N-0256 - Use of Opiate Analgesics in Various Patient Populations, Including Pediatric Patients
Comment Number: EC -221

Accepted - Volume 4

Comment Record
Commentor Mr. Ronald Vignone Date/Time 2002-01-16 12:45:56
Organization Enhanced Marketing, Ltd
Category Company

Comments for FDA General
1. General Comments Our organization, which is involved in the development of informational and educational programs for health care professionals who manage pain, supports the Consensus Statement of 21 health organizations and the DEA which was published last year. We wish to encourage the FDA Advisory Committee to consider the following facts in their discussions of use of opioid analgesics in various patient populations: Undertreatment of pain is a serious problem in the United States, including pain among patients with chronic conditions and those who are critically ill or near death. Effective pain management is an integral and important aspect of quality medical care, and pain should be treated aggressively. For many patients, opioid analgesics, when used as recommended by established pain management guidelines, are the most effective way to treat their pain, and often the only treatment option that provides significant relief. Helping doctors, nurses, pharmacists, other healthcare professionals, law enforcement personnel and the general public become more aware of both the use and abuse of pain medications will facilitate proper and wise decisions regarding the treatment of pain. Drug abuse is a serious problem. Those who legally manufacture, distribute, prescribe and dispense controlled substances must be mindful of and have respect for their inherent abuse potential. Focusing only on the abuse potential of a drug, however, could erroneously lead to the conclusion that these medications should be avoided when medically indicated, generating a sense of fear rather than respect for their legitimate properties. We urge the Committee not to take any action or make any recommendation that would restrict access to pain medication for patients in need.

EC -221