CLARK COUNTY, NV / ACCESSWIRE / January 7, 2021 / The overwhelming nature of the COVID-19 pandemic and associated mitigation efforts have disrupted nearly every other aspect of health care delivery, including the management of opioid use disorder, when compared to pre-pandemic care. Dr. Najib Babul, an experienced drug development and regulatory affairs consultant discusses the controversial use of fentanyl test strips as part of harm reduction to prevent opioid overdose complications and death.
More than 2.1 million Americans have an opioid use disorder, including 626,000 with heroin use disorder. According to data on the opioid overdose crisis from the January 4, 2019 issue MMWR, 47,600 Americans died of opioid overdoses in 2017, a 12% increase over 2016. This means that on average, 130 Americans died each day from opioid overdoses in 2017. Synthetic opioids, primarily 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.
The levelling of heroin overdose deaths may reflect its displacement by 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. Dr. 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.
Fentanyl and its analogs are sold as adulterated heroin, heroin substitutes and fentanyl-laced counterfeit opioid pills. The involvement of synthetic opioids in a majority of opioid overdose deaths underscores the need for a robust harm reduction strategy, particularly for non-treatment seeking individuals (opioid users). Dr. Babul notes that there is reasonable agreement about many components of an overall harm reduction strategy, including: (i) using drugs only in the presence of others who can call for help; (ii) naloxone rescue training and dispensing; and (iii) activating emergency medical services upon overdose. However, there continues to be an urgent need to develop more effective harm reduction interventions in response to the harm producing eﬀects of heroin adulterated with fentanyl.
Recently, some organizations have advocated the use of fentanyl test strips to identify illicitly manufactured fentanyl in street purchased drugs (“drug checking services”) as part of a harm reduction strategy. A small number of published studies suggest that fentanyl test strips have the potential to effect changes in drug use behavior and reduce opioid overdose fatalities. In one study of young adults in Rhode Island in whom 37% had previously overdosed, 92% wanted to know if there was fentanyl in their drug supply prior to use. In another study of 32 stakeholders in Baltimore, Boston and Providence, there was significant support for the concept of fentanyl test strip use with the goal of providing risk reduction resources and a point for greater engagement for users. Unfortunately, fentanyl test strips provide only qualitative results, i.e., whether fentanyl is present, absent or the test is invalid, and not quantitative results, i.e., how much fentanyl is present. Since approximately 90% of heroin is adulterated or substituted with fentanyl or its analogs, fentanyl test strips can only allow for limited decision making regarding the opioid supply, in other words: do not use it; use it in a small, test amount; use it in the presence of a non-user; or use as before, at greater risk of opioid overdose and death.
The use of fentanyl test strips is not without controversy, particularly for self-administration by drug users, notes Babul. Dr. Elinore McCance-Katz MD, PhD, First Assistant Secretary for Mental Health and Substance Use who leads SAMHSA published a blog entitled “For Beating The Opioid Crisis, America Has Better Weapons Than Fentanyl Test Strips” which states that “The entire approach [to fentanyl test strip use] is based on the premise that a drug user poised to use a drug is making rational choices, is weighing pros and cons, and is thinking completely logically about his or her drug use. Based on my clinical experience, I know this could not be further from the truth. People who are addicted to opioids are not making a rational choice to continue their drug use. Addicted individuals whose bodies demand that they find their next opioid to stave off withdrawal symptoms are not in positions to weigh all options and to choose to not use the only opioid at their disposal.”
Concerns have been expressed that fentanyl test strips are being distributed for self-testing in the absence adequate ethical, scientific and operational deliberation or a full understanding of potential unintended consequences that might increase harm. In response, others have argued that the proliferation and widespread use as fentanyl which now accounts for a majority of opioid overdose deaths means that the access to fentanyl test strips cannot wait any longer. This is a “movement for social justice built on a belief in, and respect for, the rights of people who use drugs”. Some proponents of fentanyl test strips would also argue that “syringe exchange” and “naloxone peer distribution” initiatives came out of the harm reduction movement and went mainstream grudgingly and only after considerable loss of life.
Dr. Najib Babul, PharmD, MBA, a drug development and regulatory affairs consultant 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 180 abstracts and manuscripts published in 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.
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