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in canada, the initial formulary for buprenorphine for oud included only sublingual tablets that were indicated for use alone. the initial formulary also included a limited number of tablets for use in conjunction with naloxone (1 mg buprenorphine in combination with 4 mg naloxone) for the reversal of opioid overdose. the use of a naloxone/buprenorphine combination in canada would be considered to be a case of combined administration (see section 11.8.1, special treatment of combinations of agents). the fda’s product development guidance notes that the primary intended use of a product is a significant consideration when evaluating the drug-drug interactions that a product may present. the fda expects that prescribers and dispensers are likely to be familiar with the indications for use of the product they select, so consideration of the risks and benefits of potential interactions should be balanced against the intended use of the product (cottler et al., 2013 ).
recently, buprenorphine and naloxone products have been reformulated and repackaged, with the intent that these products will be less prone to tampering or diversion. the reformulation of naloxone tablets has resulted in a product with a dose strength in naloxone that is lower than that found in the original product, which is subject to abuse. the different dose strengths mean that additional data are needed to determine whether an adf would be effective in preventing naloxone abuse, as is the case with oxycodone. with respect to the reformulation of buprenorphine products, the dose strength in buprenorphine tablets is increased from 4 mg to 8 mg. this change makes it easier to detect tampering, and it may contribute to better security of these products, but it makes it more difficult to reverse an overdose if it is used along with naloxone, as is the case with oxycodone. the higher dose strength in buprenorphine tablets has the potential to increase the risks of opioid overdose in people who use the medication illicitly.
the fatal opioid overdose problem highlights the need for improved pharmacotherapy to reduce opioid misuse, and perhaps the opioid epidemic in general. the problem of opioid misuse is complex and multifaceted. numerous strategies may be appropriate to address it. to date, however, there is little evidence to support the effectiveness of these strategies. the chapter reviews the evidence on interventions that have been implemented, or could be implemented, in the united states to address the problems of opioid misuse, oud, and related deaths.
drug overdose is a major cause of injury death in the united states. the office of national drug control policy has listed overdose prevention and medication treatment as priority interventions for the years 2011 through 2014 (2014). in a review of drug overdose prevention programs, the national institute on drug abuse identified 15 programs with evidence of their effectiveness. one program involving pharmacists’ communication with patients about using naloxone to treat opioid overdoses was shown to be effective in the reduction of subsequent opioid overdose deaths among people who participated in the program ( jones et al., 2015 ). however, the effectiveness of other naloxone programs has not been evaluated ( jones et al. in a review of interventions to prevent opioid-related overdose, a randomized controlled trial of overdose prevention education and naloxone provision to high-risk patients found that the intervention reduced fatal opioid overdose by 58 percent (49 percent among patients with a history of opioid abuse) ( orosz et al., 2014 ). however, the study was not powered to determine if the effect was sustained over time. in a review of the effects of opioid overdose education and naloxone access, the authors found that opioid overdose education alone appears to be effective in reducing opioid overdose deaths, particularly among high-risk groups ( kohn et al., 2013 ). the authors also noted that access to naloxone reduces opioid-related overdose deaths among patients who use naloxone, particularly among those who misuse prescription opioids and heroin ( kohn et al. this review also found that policies that restrict the use of high-dose opioid medications may be effective in reducing opioid overdose deaths, particularly among patients with a history of opioid abuse. the authors noted that a significant limitation of the studies included in this review was that none examined the effects of the interventions in a real-world setting (kohn et al., 2013).
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