SAN DIEGO COUNTY, CA / ACCESSWIRE / January 8, 2019 / In this post, Dr. Najib Babul, an entrepreneur, experienced pharmaceutical scientist, drug developer, inventor and consultant discusses Opioid Use Disorder (OUD) and the opioid overdose crisis. OUD is a chronic relapsing illness characterized by repeated, compulsive opioid seeking or use despite harm. Opioid addiction generally refers to moderate to severe OUD, which the American Society of Addiction Medicine defines as "a primary, chronic disease of brain reward, motivation, memory, and related circuitry."
A diagnosis of OUD confers a high risk for adverse medical consequences, including poor physical and mental health, increased health care utilization, a higher incidence of HIV and Hepatitis C, opioid overdose deaths and a 14-fold higher all-cause mortality than the general population. OUD is also associated with many adverse non-medical consequences, including higher rates of criminal behavior and incarceration, impaired social functioning, reduced labor force participation and lost productivity. The Council of Economic Advisers (CEA) estimated the economic cost of the opioid crisis at $504 billion in 2015. The CEA noted that previous economic cost estimates greatly undervalued the most important component of the loss - fatalities resulting from overdoses. The CEA estimate was derived from 2015 data, when opioid overdose mortality was 30% lower than the most recently available estimate (2017).
More than 2.1 million Americans have an opioid use disorder (OUD), including 626,000 with heroin related OUD. Overall life expectancy in the U.S. began to decline in 2015 due to the opioid overdose crisis, the first such decrease since the 1960s. According to a recent report from the Centers for Disease Control and Prevention (CDC) for the year 2017, 47,600 Americans died of opioid overdoses, a 12% increase over 2016. This means that on average, 130 Americans died each day from opioid overdoses in 2017, up from 116 daily opioid overdose fatalities in 2016. Synthetic opioids which include illicitly manufactured fentanyl and fentanyl analogs were involved in almost 60% of opioid overdose deaths, an increase of about 45% from the previous year. Overdose deaths from prescription opioids and heroin remained stable during 2016-2017.
According to Babul, stabilization of prescription opioid overdose deaths may be due to improved diversion control, a decline in opioid prescribing rates since 2012, and high-dose opioid prescribing rates since 2009, and the introduction of abuse deterrent (or tamper resistant) dosage forms. There is now compelling evidence that oral prescription opioid abuse by non-oral routes more than doubles the risk of death or life-threatening events. Furthermore, a changeover to abuse deterrent formulations can reduce the extent of tampering and diversion into the illicit market. For example, following the introduction of abuse deterrent OxyContin®, the desirability of OxyContin among persons with OUD decreased dramatically. The rate of intentional abuse, diversion, oral and non-oral abuse variously declined by approximately 60 to 90%, and the street price decreased by about 40%.
Similarly, the levelling of heroin overdose deaths may reflect its displacement by synthetic opioids, including fentanyl and fentanyl analogs clandestinely manufactured at labs in far-flung places including China, Mexico, Bulgaria, Greece, Slovakia, Belarus, the Ukraine and Russia, and trafficked through both traditional illicit drug distribution channels, and increasingly, over the internet. Starting in 2016, the number of overdose deaths involving synthetic opioids surpassed heroin and prescription opioids. In some cases, manufacturers of illicit opioids and/or drug dealers are responding to periodic declines in the purity of heroin by using synthetic opioids as heroin adulterants to maintain stable retail pricing. In other cases, synthetic opioids entirely substitute for heroin. Some of the synthetic opioids are characterized by new features, including ease of availability on the web, low price and high purity. Many of the new synthetic opioids are derived or resurrected from patent filings or published scientific literature of pharmaceutical companies.
Babul notes that fentanyl precursors are also being shipped from China to individuals and drug cartels for processing and distribution across the U.S. for manufacture of fentanyl-laced pills sold as counterfeit oxycodone or hydrocodone, underscoring the need for a robust harm reduction strategy. This can include: (i) not using alone so that others can call for help; (ii) education on the overdose potential of synthetic opioids and how to recognize an overdose; (iii) naloxone rescue use training for people who use drugs, their family and peers; (iv) use of small test doses to assess the potency; and (v) activating emergency medical services by calling 911. More recently, some organizations have expressed interest in the use of fentanyl test strips (FTS) to identify illicitly manufactured synthetic fentanyl in street purchased drugs. Studies suggest that use of FTS may have the potential to effect changes in drug use behavior and/or reduce opioid overdose fatalities, particularly if used as part of a broad harm reduction strategy.
The increase in opioid overdose and deaths is not for lack of significant efforts on the part of operating divisions of the HHS, including the National Institute on Drug Abuse (NIDA), the Food and Drug Administration (FDA), and the Substance Abuse and Mental Health Services Administration (SAMHSA). These efforts have included the NIH HEAL Initiative, a public-private partnership in conjunction with the FDA to address the opioid crisis via more effective and safe ways to prevent and treat OUD and overdose; increased availability of the opioid overdose reversal agent naloxone; expanded access to medication-assisted treatments; and linking individuals with OUD to treatment and harm-reduction services. Without significant Congressional appropriations for the opioid overdose crisis, and intervention by various HHS operating divisions and other stakeholders at the Federal, State and local level, the devastation from the opioid overdose crisis would be far greater.
Unfortunately, things may get worse before they get better. Synthetic opioids are an increasingly major public health hazard which present unique interdiction challenges. The worldwide recreational drug market is being flooded at a rapid pace with a diversity of synthetic compounds. Recent interdiction data show that while illicitly manufactured fentanyl is the predominant synthetic opioid, increasingly, many fentanyl analogs and structurally-diverse non-fentanyl synthetic opioids are being encountered as adulterants in illicit heroin or as constituents of counterfeit prescription opioids.
Dr. Najib Babul, PharmD, MBA, is a graduate of the University of British Columbia, the State University of New York, and the California Institute of Advanced Management. He has over two decades of experience in bringing new and repurposed drugs to market. Dr. Babul is the author of over 170 abstracts and manuscripts published by leading medical journals and scientific proceedings, including the Lancet, the Journal of Clinical Pharmacology, the Journal of Clinical Oncology, Cancer, Anesthesiology, Clinical Pharmacology & Therapeutics, and Anesthesia & Analgesia.
SOURCE: Cinergen
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