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Monday, January 19, 2009


Patient Impact Assessments: A late entry in the category of Most Intriguing Ideas of 2008: require that the DEA conduct a “Patient Impact Assessment” (PIA), analogous to the Environmental Impact Assessment required prior to major building projects, before issuing new controlled-substance regulations. David Brushwood, a pharmacist and lawyer, has suggested this idea as a way for the DEA to make more informed and balanced decisions. The PIA would do the following:

  • Describe purpose of proposed regulation, including the problem it is intended to address
  • Alternatives that have been considered and found to be inferior to the proposed regulation
  • Describe the patient population affected
  • Describe adverse effects on access, if any, to necessary therapies, and health outcomes that could result from new restrictions
  • Describe strategies to minimize adverse effects, including monitoring of effects
  • Explain challenges of unknown aspects of the situation

    Brushwood DB. Should the DEA conduct a "Patient Impact Assessment" when promulgating new restrictions on controlled substance distribution? J Pain Palliat Care Pharmacother. 2008;22(4):322-326.

WHO Analgesic Ladder Reconsidered: In the ever-interesting guideline vs rule debate, two short essays from a European perspective question the ladder, especially Step 2, the so-called weak opioid step. Both authors credit the ladder with helping to improve cancer pain management over the past 20 years. They point out that the Ladder assumes a gradual progression of pain, starting with mild pain amenable to non-opioid analgesics. The second step has been criticized on a couple of points. Some researchers and clinicians see no advantage to using codeine, tramadol, or propoxyphene rather than low doses of “strong” opioids such as morphine and oxycodone. Codeine & propoxyphene, in particular, may have more problematic side effect profiles than the strong opioids. Neither author addresses the combination products oxycodone or hydrocodone plus acetaminophen, which appear as Step 2 drugs. They also complain that if a patient has rapidly escalating pain, strict adherence to the ladder forces a delay in getting to the strong opioids, because of the belief that the 2nd step must be exhausted before the 3rd step can be entered.

Also pointed out is that there is no provision for either psychological approaches nor invasive approaches at any step.

Personally, I think the ladder is a useful construct that, after all these years, seems so logical and straightforward that is needs little defending, nor should a lot of ink be spent on attacking its perceived inadequacies. It’s a guideline--not a rule. It was promulgated at a time when using opioids was controversial in most places. It remains a useful teaching tool for new clinicians or those new to cancer pain management. As with any other guideline, individual patient needs trump the guideline (because it is not a rule) and adequate measures need to be taken, including skipping steps one or two and using invasive interventions earlier rather than later, if necessary.
That said, I would not object to a major multinational, multidisciplinary study group being tasked with bringing the ladder up to date with the complexities of pain management as we now know it.

See the International Perspectives on Pain & Palliative Care section of J Pain Palliat Care Pharmacother. 2008;22(4):327-330.

Number needed to treat, Number needed to harm: "Number needed to treat" is an interesting construct intended to translate (primarily) pharmaceutical research findings into information that clinicians can use in decision-making about whether to recommend a particular treatment. The lower the NNT, the more likely it is to have the intended effect in patients in the target population. An excellent review of history, interpretation, and appropriate and inappropriate use of this measure is found in the Sept 2008 Canadian Medical Association Journal.

A logical extrapolation is the notion of the "number needed to harm" which followed close on the heels of NNT. An article describing the use of both numbers in clinical decision-making is Sierra (below).A recent appeal to apply NNH to palliative care appears in a short letter to the editor by a hospice medical director (Herbst, below) who wonders if it's application would result in better utilization of resources in large medical systems.

McAlister FA. The "number needed to treat" turns 20--and continues to be used and misused.
CMAJ. 2008 Sep 9;179(6):549-53. (Free full text)

Sierra F. Evidence-Based Medicine (EBM) in practice: applying number needed to treat and number needed to harm. Am J Gastroenterol. 2005 Aug;100(8):1661-3.

Herbst L. Number needed to harm. J Palliat Med. 2008 Dec;11(10):1291.

New agents: Two new unrelated agents for pain--tapentadol and milnacipran--use inhibition of reuptake of norepinepherine as the primary mechanism of action. Tapentadol is a cousin of tramadol, and like tramadol is also a weak mu receptor agonist. Milnacipran (trade name Savella) is a serotonin-norepinephrine re-uptake inhibitor (SNRI). As with the two previous SNRI's on the market, duloxetine and venlafaxine, it is approved for fibromyalgia. Unlike the other two (as far as I can tell) it has not been approved for major depression.

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