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OPTIMIZING THE RISK MANAGEMENT PROCESS: TWO SUGGESTIONS

This document discusses two critical suggestions for enhancing risk management processes in the context of anesthetic and life support drugs, as presented at the FDA/CDER Advisory Committee. It highlights the importance of proactive identification of patients at risk of inadequate pain management and adverse drug effects, along with the need for effective individual interventions. The text emphasizes evidence-based treatment approaches, standardized data collection on drug effects, and a supportive healthcare climate to address the burden of untreated pain while minimizing societal risks.

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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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