Correspondence
Kate Costeloe and colleagues1 report outcomes that are different to those initially registered (ISRCTN05511098). Three primary outcomes were prespecified in the protocol, all of which are reported in the Article. 19 secondary outcomes were prespecified, of which 18 were correctly reported in the Article and one was not reported anywhere in the publication. In addition, the authors report eight secondary outcomes that were not prespecified, five of which are described as prespecified in the Article. We declare no competing interests.
For more on the COMPare project see www.COMPare-Trials.org
*Eirion Slade, Aaron Dale, Kamal Mahtani, on behalf of the COMPare project team
[email protected] Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK 1
Costeloe K, Hardy P, Juszczak E, Wilks M, Millar MR. Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial. Lancet 2016; 387: 649–60.
Opioid analgesics Stefano Berterame and colleagues1 report the results of their comprehensive worldwide longitudinal survey of opioid analgesic medicine use, (April 16, p 1644) and offer an analysis of the impediments to availability of these drugs in 214 countries. From a list of ten impediments, fear of addiction ranked second worldwide and fear of diversion to illicit channels ranked sixth, neither of which were reported in North America. Risk of overdose was not proposed in the list of impediments. Berterame and colleagues1 advocate for addressing of the impediments in order to increase opioid analgesic coverage worldwide. We stress that, although adequate access to opioid analgesics for pain relief is a public health priority, the harms related to large-scale opioid analgesic prescription should not be denied. 2 Prescribing of opioid pain relievers has quadrupled since 1999 in the USA, where abuse of 656
prescription opioid analgesics is now deemed an epidemic. 3 An overall trend of increasing deaths from prescription opioid use has been reported worldwide,4 and this trend is particularly dramatic in the USA, where these deaths have tripled since 2000.3 The increased rate of opioid overdose is greatly driven by prescription opioid pain relievers in the USA.3 In 2009–10, more than 80% of opioids obtained illicitly in the USA were fuelled by legitimately written prescriptions.2 Finally, increased use of opioid analgesics seems to be related to an escalation of heroin abuse in the USA.5 Faced with these changes, we call for a balanced argumentation when public health professionals advocate for addressing impediments for opioid analgesics in order to increase worldwide access to effective pain relievers. We declare no competing interests.
*Henri-Jean Aubin, Jill M Williams, Amandine Luquiens
[email protected] Université Paris-Saclay, Unive Paris-Sud, Université de Versailles Saint-Quentin-en-Yvelines, Center for Research in Epidemiology and Population Health, Institut national de la santé et de la recherche médicale, Villejuif, France (H-JA, AL); APHP, Hôpitaux Universitaires Paris-Sud, Villejuif, 94800, France (H-JA, AL); and Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA (JMW) 1
2
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4
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Berterame S, Erthal J, Thomas J, et al. Use of and barriers to access to opioid analgesics: a worldwide, regional, and national study. Lancet 2016; 387: 1644–56. Manchikanti L, Abdi S, Atluri S, et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: part I—evidence assessment. Pain Physician 2012; 15: S1–65. Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in drug and opioid overdose deaths—United States, 2000–2014. MMWR Morb Mortal Wkly Rep 2016; 64: 1378–82. Martins SS, Sampson L, Cerda M, Galea S. Worldwide prevalence and trends in unintentional drug overdose: a systematic review of the literature. Am J Public Health 2015; 105: 302843. Muhuri PK, Gfroerer JC, Davies MC. Associations of nonmedical pain reliever use and initiation of heroin use in the US. Center for Behavioral Health Statistics and Quality Data Review SAMHSA 2013. http://www. samhsa.gov/data/2k13/DataReview/DR006/ nonmedical-pain-reliever-use-2013.htm (accessed April 4, 2016).
Stefano Berterame and colleagues’ findings1 highlight a crisis of public health and public conscience. 55 years after the acknowledgment that narcotic drugs are “indispensable for the relief of pain and suffering”,2 pain management in the developing world continues to be inadequate.3 In 2011–13, the defined daily dose for statistical purposes of opioid analgesics was 110 per million inhabitants per day in Mexico as compared to 43879 per million inhabitants per day in the USA.3 As a result of the potential for diversion and misuse, Mexican regulation has classified all strong opioids (including prescription opioids) as Schedule 1 drugs, severely limiting their prescription. The introduction of abuse-deterrent formulations (ADFs), with an associated review of the drug classification convention, could remove this barrier and make prescription opioids more accessible. Most ADFs impose mechanical or chemical barriers that reduce potential misuse. Results of a study4 show that ADF formulations successfully reduce misuse of the active drug, particularly in those who relied on tampering for injected or inhaled misuse. The US Food and Drug Administration has subsequently released guidelines on the evaluation and labelling of abuse-deterrent opioids and considers their use a “high public health priority”.5 We hope that developing countries will follow suit. The introduction of ADFs presents an available, cost-effective, and proven strategy to increase legitimate access to pain control, without increasing the risks of diversion and misuse. We declare no competing interests.
*Silvia Allende-Pérez, Alfredo Covarrubias-Gomez
[email protected] Instituto Nacional de Cancerología, Colonia Sector XVI, Delegación Tlalpan, CP 14080, México DF, México (SA-P); and Department of Pain Medicine, National Institute of Medical Sciences and Nutrition Salvador Zubirán, Tlalpan, Ciudad de México, DF, Mexico (AC-G)
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