Treatment of breakthrough pain with fentanyl buccal tablet in opioid-tolerant patients with chronic pain: appropriate patient selection and management.

BACKGROUND Opioids can be a safe and effective option for carefully selected patients with a structured treatment program that includes consistent monitoring. However, the benefits and risks of opioid therapy for patients with chronic pain, and society as a whole, have been sharply debated. A key component of this debate has involved the administration of rapid-onset opioids for the management of breakthrough pain. OBJECTIVE Review key aspects of breakthrough pain management with fentanyl buccal tablet, with a focus on minimizing risk to optimize therapeutic outcomes. Recommendations that apply broadly to all rapid-onset opioids are also discussed. DESIGN Available fentanyl buccal tablet clinical and post-marketing data were reviewed. RESULTS Like other schedule II controlled substances, and because fentanyl buccal tablet is a highly potent opioid, its use is associated with risk of overdose, misuse, and diversion. As with all rapid-onset opioids, particular attention to patient selection and risk assessment is warranted. The inclusion and exclusion criteria in fentanyl buccal tablet clinical studies represent patient selection standards that should be translated to clinical practice, most importantly, that patients are opioid-tolerant before fentanyl buccal tablet initiation. Titration of fentanyl buccal tablet from a low starting dose to a successful dose allows the safe identification of a dose that provides the greatest pain relief without unacceptable adverse events. After initiating fentanyl buccal tablet therapy, all patients should continue to be regularly monitored for response, including analgesia, functioning, tolerability, and aberrant behavior. CONCLUSIONS Fentanyl buccal tablet can be an effective and generally safe treatment for breakthrough pain when appropriate patient selection, administration, dosing, and monitoring are applied.