Access to opioids: a balance of harms

Abstract

Opioid overdose killed 64 070 Americans between 2016–17 to become the leading cause of mortality in the USA for people younger than 50 years. On March 29, 2017, US President Trump gave an executive order to investigate the crisis. The interim report called upon the US Administration to immediately increase capacity for addiction treatment through the removal of the Institutes for Mental Diseases exclusion from Medicaid funding. This recommendation is in stark contrast to this Administration's aim of cutting the government health budget, and Trump has refused to declare the current situation a national emergency, an action that would increase national impetus to act. What is causing this devastating increase in opioid abuse in the USA, and what implications will failure to act have on provision of legitimate opioid access? Opioid analgesics are essential for the relief of moderate-to-severe pain in patients with cancer. In recognition of this fact, morphine, a naturally-occurring opiate, was added to the WHO Model List of Essential Medicines in 2015. Nonetheless, because of the long and chequered history of the recreational use of opiates, access is still limited worldwide, with approximately 80% of the world's population estimated to have insufficient access to analgesics for pain relief. A 2016 paper by the International Narcotics Control Board found that the use of opioid analgesics remained low in Africa, Asia, Central and South America, the Caribbean, and eastern and southeastern Europe. When compared with cancer incidence in these areas, there is a clear disparity between the level of need (especially in regions where cancers are more likely to be diagnosed at advanced stages) and analgesic provision, with barriers including inadequate medical training medical training, fear of addiction, inadequate financial resources, cultural attitudes towards treatment of pain, fear of criminal prosecution, and onerous regulatory frameworks for prescription of medical narcotics. Consequently, harm is now being done in these countries through overly cautious prescribing and regulation constraints. In high-income countries, the pendulum has arguably swung the other way, with prescriptions for opioid analgesics tripling between 1991 and 2013 in the USA, and doubling between 2000 and 2015 in the UK. Beginning with recently deceased Ted Stanley's discovery that fentanyl (a synthetic opioid analgesic between 50–100 times more potent than heroin) could be combined with sugar to make a palatable, quick-acting analgesic lollipop, synthetic opioids are now readily available in easily ingestible formulations, including delayed-release and oral spray formulations. Part of the unprecedented increase in prescriptions has been driven through unscrupulous pharmaceutical marketing strategies of these easy-to-ingest formulations to physicians; in 2007, Purdue Pharma executives pleaded guilty to criminal charges of misbranding OxyContin (a timed-release formulation of the opioid oxycodone) as less addictive and less prone to substance abuse than other formulations. Although Purdue Pharma was fined US$634 million, such aggressive product marketing continues, with Insys Therapeutics currently under investigation for insurance fraud for approval of their oral fentanyl spray SUBSYS. Such overprescription might be the driving force behind the current increase in opioid abuse in the USA. In the absence of a care network to address and help with addiction rehabilitation, patients who are addicted are driven to find new sources of opioids, including cheaper, and more readily-available, black market sources of opioids of unknown quality and strength, thus leading to frequent accidental overdose. This situation is untenable, but so is reduced access to opioids for those in genuine need. The WHO Access to Controlled Medications Programme defines balance as the dual obligation of a government to enable adequate availability of controlled substances for medical need while simultaneously preventing abuse. It is clearly a difficult remit, with many of the world's governments failing to fulfil the former requirement and others the latter. In the USA at least, multiple steps to address the situation must be taken, including provision of adequate rehabilitation facilities and a legislative end to overprescription and unethical marketing of opioids. What must be avoided at all costs is the demonisation of opioids and inadvertent addicts. Patients in genuine need must retain access to pain relief, and analgesic provision worldwide must increase to end unjustifiable suffering. Patients must not be forced to endure ameliorable pain, or become victims of addiction, through governmental inaction.