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OPTIMIZING THE RISK MANAGEMENT PROCESS: TWO SUGGESTIONS

OPTIMIZING THE RISK MANAGEMENT PROCESS: TWO SUGGESTIONS. FDA/CDER ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE 9 September 2003 Daniel Carr, MD Tufts -New England Medical Center. IN AN IDEAL WORLD.

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OPTIMIZING THE RISK MANAGEMENT PROCESS: TWO SUGGESTIONS

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  1. OPTIMIZING THE RISK MANAGEMENT PROCESS: TWO SUGGESTIONS FDA/CDER ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE 9 September 2003 Daniel Carr, MD Tufts -New England Medical Center

  2. IN AN IDEAL WORLD... • Prospective identification, plans for patients at risk of undertreatment of pain and adverse effects of Rx • Prompt (?pre-emptive) individualized antinociceptive, and palliative interventions -- including adjuvants • Effective treatments, based upon rigorous evidence • Standardized data capture (effects, adverse effects) • Supportive climate: policies, payment, attitudes • Recognition at the system level that • disease burden of undertreated pain outweighs that of abuse, addiction, diversion • people have always, and will always, treat their pain • adverse effects often preclude adequate pain control

  3. EBM:24,000 Citations Screened for 2001+2002 AHRQ Cancer Symptom Reports

  4. Problems with “the Evidence” • RCTs a tiny fraction of the literature • 675 of 13,000 (acute pain, 1992) • 180 of 20,000 (cancer pain, 2001) • 218 of 24,000 (cancer pain NCI/NIH SOTSC, 2002) • vast majority are observational or describe a technique • underpowering a pervasive problem • Pooled efficacy estimates precluded by heterogeneity of diagnosis, patient, outcomes • 125 instruments in 218 pain trials for 2002 SOTSC • even worse picture for non-pain symptoms • 2003 Sysrev on opioid side effects (McNicol et al) hampered by lack of focus to date

  5. Towards an Answer (1) • To date, assessment of effects and side effects of drugs have proceeded in different dimensions [Mannheimer, Cochrane Collab] • effects: prospective, deliberately sought via instruments more likely to reflect consensus • side effects: captured if volunteered, ad hoc • Given side effects’ clinical importance, consensus instruments/methods should be encouraged, possibly required • Standardization of instruments will allow pooling of data not currently possible

  6. Towards an Answer (2) • Discouraging clinicians from prescribing controlled substances worsens underRx • Thus, adding to risk management burdens may INCREASE societal risks from undertreated pain or unregulated analgesics (street drugs, alcohol, OTC NSAIDs…) • True “risk” is aggregated and system-wide • Shutting one spigot in a multi-spigot system: • increases the aggregate impedance, slightly • shifts flow through other spigots

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