#1 Serious birth defect associated with Rx opioid use
A CDC report on January 18, 2019 notes the increased number of babies being born with gastroschisis in recent years, a serious birth defect of the abdominal wall that results in some of the abdominal contents like the intestines extending outside the body at birth. Gastroschisis requires surgery and unfortunately babies could die or have life-long complications and issues. An association of the birth defect with high and medium opioid prescription rates was found in the data from 20 states.
Possible causes for the increase in gastroschisis cases reported not just in the US but worldwide are not well understood. However, this analysis looking at data between 2006-2015 supports the findings from a large case-control study suggesting that self-reported prescription opioid use in the first trimester was associated with gastroschisis that was published in 2011 (Broussard CS, Rasmussen SA, Reefhuis J, et al. Maternal treatment with opioid analgesics and risk for birth defects. Am J Obstet Gynecol 2011;204:314 e1–11).
It is important to note that the current report does not attribute causation of the birth defect to medium and high opioid prescriptions. By showing the correlation, it is hoped that further studies will be done to understand the contributing factors.
For more information review the published study: Short TD, Stallings EB, Isenburg J, et al. Gastroschisis Trends and Ecologic Link to Opioid Prescription Rates — United States, 2006–2015. MMWR Morb Mortal Wkly Rep 2019;68:31–36.
#2 FDA in unprecedented move, creates consumer drug labels for Naloxone to encourage new OTC products
On January 17, 2019, FDA Commissioner Scott Gottlieb, M.D. issued a press statement notifying that the agency had taken the unprecedented step of developing a model DFL (drug facts label) for Naloxone. The DFL is required for OTC products and the FDA has been encouraging manufacturers to come up with cheaper, generic versions. Currently, there are two consumer Naloxone products, a nasal spray Narcan from Emergent Bio and an auto-injector Evzio from Kaleo. The current FDA-approved naloxone formulations have instructions for use in the product labeling, but they do not have the consumer-friendly Drug Facts label (DFL) which is required for over-the-counter drug products.
Companies interested in developing an OTC drug product must have a DFL that has undergone market research with consumers to make sure that they understand the instructions without needing a health care professional to supervise. This data has to be submitted with a new drug application or supplemental application for an OTC product. Apparently, some stakeholders had flagged this requirement to the FDA as being a barrier to the development of OTC naloxone products.
To encourage drug companies to enter the OTC market and increase access to naloxone, the FDA therefore took it upon themselves to develop a model DFL with easy-to-understand pictograms with instructions that are simple to follow. The FDA also conducted the necessary label comprehension testing to verify that consumers understood the instructions without needing aid from a healthcare professional.
As Dr. Gottlieb states: “This is the first time the FDA has proactively developed and tested a DFL for a drug to support development of an OTC product. We proactively designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone and make it available to patients. One of the key components for OTC availability is now in place. In short, we’ve crafted model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access.”
For more information review the press release: Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths — https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629571.htm.
#3 For first time, study correlates opioid overdose deaths to pharmaceutical spending
A January 18, 2019 JAMA Network study breaks down the $39.7 million in opioid marketing targeted to 67,507 physicians across 2,208 US counties between August 1, 2013 & December 31, 2015 and shows a link with increased mortality. In total there were 434,754 payments of varying sizes, from paying for a meal tab to thousands of dollars in consulting fees.
The study shows a link at the county by county level. It is important to note that while a correlation or link has been shown, direct causation was not attributed.
“The counties that had the most opioid product marketing from pharmaceutical companies were the counties that subsequently one year later had more opioid prescribing and had more opioid overdose deaths,” noted Dr. Scott Hadland, the lead author of the study who is a pediatrician and addiction researcher at Boston Medical Center’s Grayken Center for Addiction.
For more information review the published study: Hadland SE, Rivera-Aguirre A, Marshall BDL, Cerdá M. Association of Pharmaceutical Industry Marketing of Opioid Products With Mortality From Opioid-Related Overdoses. JAMA Netw Open. 2019;2(1):e186007. doi:10.1001/jamanetworkopen.2018.6007 — https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2720914?resultClick=1.
#4 Americans now more likely to die from an opioid overdose than a motor vehicle crash
For the first time, the lifetime odds of dying from a motor vehicle crash was eclipsed by that from an opioid overdose. In a January 14, 2019 press release, the National Safety Council noted that in 2017 the odds of dying from an opioid overdose had risen to 1 in 96 compared to 1 in 103 for motor vehicle crashes.
Their website carries statistics for the lifetime odds of dying from selected other causes in 2017. Of concern is seeing the odds of dying from suicide to be 1 in 88. Odds of dying from gun violence was 1 in 286 and from a fall 1 in 114.
NSC notes that preventable injuries which include opioid overdose deaths, motor vehicle crashes, falls, and other causes, are the third leading cause of death, resulting in 169,936 fatalities in 2017, behind heart disease and cancer. However, of the three leading causes of death, preventable injuries were the only category to experience an increase in 2017, according to their analysis of CDC data from December.
For more information review the press release from the National Safety Council: For the First Time, We’re More Likely to Die From Accidental Opioid Overdose Than Motor Vehicle Crash – https://www.nsc.org/in-the-newsroom/for-the-first-time-were-more-likely-to-die-from-accidental-opioid-overdose-than-motor-vehicle-crash
#5 Medical marijuana use in Ohio, Illinois and other states starting to accelerate
The week of January 14, 2019 saw medical marijuana sales begin in Ohio. Medical marijuana dispensaries are regulated in the state by the Ohio Board of Pharmacy. However, when asked if the state views legal pot as a potential weapon in the battle against the deadly opioid epidemic, a spokesman for the Board of Pharmacy said, “The state has no official policy on this.”
That hasn’t stopped patients from visiting the currently open dispensaries and paying hundreds of dollars for the product. According to the state’s official medical marijuana website, up to 60 dispensaries will be approved to operate across the state.
Illinois announced that its Alternative to Opioids Act would go into effect later in January. Already, the state’s 55 medical marijuana dispensaries are averaging $50,000 in weekly sales. The formalization of the opioid program will only increase the number of new patients and of course sales.
New Mexico’s Governor, Michelle Lujan Grisham, stated last week that she will ask state health officials to begin making opioid addiction a qualifying condition for patients seeking to use medical marijuana.
And, New Hampshire lawmakers heard testimony last week related to a bill to add opioid addiction as a qualifying condition for access to the state’s medical marijuana program.
IANA Health seeks to be that easy, one-stop online resource for opioid and other substance abuse and addiction information, clinicians, and support groups. https://ianahealth.com.