Supply Chain Problem May Bottleneck CA Retail Marijuana Industry
(Winter 2017) As of January 1, 2018, California will allow retail sales of recreational marijuana. In preparation, this past fall the City of San Diego began accepting applications from business people interested in starting marijuana production sites; it will choose up to 40 of these candidates. As with legislation already set up for retail marijuana shops, mandates are in place for production centers. They must be in industrial areas and are barred from being closer than 1,000 feet from daycares, schools and parks. The new companies must also obtain a conditional use permit — which could take up to a year to receive — and then later a license from the Bureau of Cannabis Control.
Here is where things hit a snag: California law does not permit retailers to obtain products from unlicensed suppliers. This complicates legal product sourcing because, even though medical marijuana statutes have been in place for 20 years, not many of the state’s cities and counties have implemented laws for the retail marijuana supply chain, and they do not face a deadline for doing so. Although wheels are in motion, San Diego’s local marijuana supply chain would not be set to provide licensed dispensaries with goods in 2018. Other areas, such as Los Angeles, San Francisco and San Jose, are in similar (if not worse) situations as they continue to wrestle with legislation and logistics. To further complicate issues, some areas in the state have outlawed the recreational use of the drug. Coupled with high demand, these factors could become a black-market breeding ground that would detract from legal retailers once the supply chain is in place.
Voters in California originally approved Proposition 64 to legalize recreational marijuana in 2016, which also immediately allowed individuals age 21 or older to possess and grow small amounts of the drug legally.
Excessive Cost of Entry for Medical Marijuana?
(Winter 2017) Phoenix lawyer Sean Berberian has requested that the state’s Court of Appeals require health officials to lower the $150 permit fee required for Arizona residents to access medical marijuana. Berberian argues that the charge is much higher than needed to underwrite the administrative costs of Arizona’s medicinal marijuana statutes. He also says that former governor Jan Brewer and current Governor Doug Ducey have instructed Arizona’s Department of Health Services to maintain high registration costs as a means of dissuading residents from registering for the program.
Waiting for Medical Marijuana in Florida
(Winter 2017) Lawsuits are slowing down the roll-out of Florida’s medical marijuana program, says Christian Bax, who heads the state’s initiative. At least 52,000 residents of the Sunshine State suffering from ongoing ailments have registered for access to the drug and are waiting for Amendment 2 — passed overwhelmingly by 71% of Florida’s voters in 2016 — to be fully enacted.
John Morgan, a high-profile Orlando lawyer who assisted in writing the medical marijuana amendment, is currently contemplating a run for the Florida governor’s office in 2018. He is accusing Bax of deliberately dragging his feet on getting Florida’s medical marijuana system ready to launch and calling for Bax to be removed from office. Morgan has also said he believes the slow-down with this program could harm Republican Florida Governor Rick Scott’s chances in the upcoming Senate campaign he’s anticipated to announce.
Bax, continues to stress his commitment to getting the state’s medical marijuana program up and running, and he recently announced that his department gave the nod to two new marijuana grow sites.
New York State Tries to Bolster Medical Marijuana Sales
(Winter 2017) A combination of issues has merged to create a lackluster start for New York’s medical marijuana program. It was conservatively structured, with only five for-profit manufacturers and a total of 20 dispensary locations. Additionally, physicians have been reluctant to get involved; only about 1% of the state’s physicians have signed up as licensed practitioners. And another potentially restrictive drawback, like Ohio, New York does not permit the drug to be smoked.
However, since the beginning of New York’s program in 2016, its largest obstacle has been sluggish sales due to low demand. Of the 200,000 patients able to sign up, only about 9% have done so. With low patient participation, New York State’s five approved medical marijuana firms only grossed a combined total of $16 million between April 2016 and August 2017. Even as these companies worry about their profitability, New York announced it would add another five medical marijuana manufacturers to the mix. The state’s decision resulted in a lawsuit from the existing manufacturers, charging that their operations are still unprofitable and would be further diluted by more competition.
The low sales, which New York taxes at 7%, have brought in considerably less revenue for government coffers than the state had originally predicted. Of the four million dollars in taxes it had expected to collect from marijuana proceeds during 2016-2017, the state garnered just $585,000.
New York’s tax revenue received from the industry pales in comparison to that of other states with more lenient medical marijuana laws. For example, Colorado currently allows approximately 500 dispensaries and levies just under a 3% tax on medical marijuana resulting in the collection of over $12 million in 2016 from medical marijuana taxes — indicating that medical marijuana sales totaled $419 million. California is even more liberal in its medical marijuana laws, having approved approximately 1,000 dispensaries that logged combined taxable receipts of about $575 million in the first half of 2016.
New York has made some adjustments, though, and is noticing an uptick in medical marijuana sales and licensed users. The Empire State’s Health Department expanded its program’s list of approved prescribing medical professionals as well as covered conditions to include chronic pain in March of 2017. This addition doubled the ranks of the state’s certified medical marijuana users. New York is now also permitting nurse practitioners to certify marijuana patients. Five months into the new fiscal year, New York saw $574,000 in medical marijuana taxes, which almost rivaled the entirety of the previous fiscal year’s sales tax generated by the program.
Now the state has added post-traumatic stress disorder (PTSD) as another condition treatable with medical marijuana. PTSD can manifest after an individual experiences an extremely distressing event. It is often linked to veterans, but PTSD affects first responders and survivors of accidents, domestic violence and rape. Those with the disorder may suffer from flashbacks, insomnia, nightmares and bouts of aggression. It’s thought that approximately 19,000 New York State residents who suffer from PTSD could benefit from medical marijuana.
Cities Sue Drug Makers, Distributors
(Winter 2017) The City of Indianapolis is taking 10 pharmaceutical makers to federal court, charging them with contributing to the spread of opioids and falling short in their attempts to pinpoint and halt questionable drug orders. Indianapolis also accused these companies of using misleading advertising about the applications, safety and hazards of opioid use. In addition, three opioid distributors were named in the suit: Cardinal Health, Inc., AmerisourceBergen Drug Corporation and McKesson Corporation.
The lawsuit seeks financial reparation for the high costs the opioid epidemic has levied on both Indianapolis and Marion County, where the city is located. In 2014, Indiana was listed 15th in the country for overdose fatalities, with Marion County accounting for the highest number of deadly overdoses and non-life-threatening emergency room visits in the Hoosier state.
Following in Indy’s footsteps, Phoenix is taking action against both drug makers and distributors for restitution of funds the city has poured into battling opioids. Leaders there charge that the nationwide spike in deaths due to the dangerously-addictive substances traces back to drug distributors and manufacturers that downplayed the dangers of opioids.
City officials instructed Phoenix’s attorney to send a letter to drug firms outlining costs for which the municipality wishes to be reimbursed. This includes escalating justice system costs and the high price of naloxone, the opioid overdose-reversal drug, which is now standard equipment on all of the city’s fire department vehicles. If the letter is not effective in collecting reparations, Phoenix plans on securing outside legal counsel to take the matter to court.
A representative for Pharmaceutical Research and Manufacturers of America (PhRMA), a group that backs drug research firms, declined to discuss the possibility of Phoenix’s lawsuit. However, PhRMA’s president stated in September that the organization is in favor of guidelines curbing opioid prescriptions to a maximum of one week for the management of short-term pain.
Prescribing-Reduction Efforts Not Universal
(Winter 2017) In 2016 the Centers for Disease Control and Prevention (CDC) advised physicians to back away from managing their patients’ chronic pain with opioids. The CDC also recommended that doctors issue the lowest dosage of an opioid for the shortest time necessary when writing prescriptions for acute pain. Additionally, the organization advocated for a maximum of three days’ prescription of high-powered drugs in most acute-pain situations.
Reinforcing the CDC’s guidelines, 17 states have enacted legislation limiting the prescription of opioids. While some have capped the strength of dosages, other states have restricted the amount of these painkillers to seven days or less.
To further combat misuse, as of January 1, 2018, the health insurance company Cigna will pull OxyContin® from its list of covered drugs. The organization will instead replace it with a comparable product called Xtampza ER, which, unlike OxyContin®, is less prone to abuse because it cannot be crushed or cut to accelerate its effect.
Counter to all these efforts, some insurance companies are making it more costly and difficult to get pain medications that reduce the chance of addiction. For example, an analysis of Medicare prescription drug plans covering over 35 million individuals revealed that nearly all of these plans cover common opioids, with only a small percentage requiring pre-approval. However, when it comes to non-addictive alternatives, these medications are more expensive than generic opioids and require prior approval.
VA Borrows Tactic from Drug Reps
(Winter 2017) The Veterans Affairs (VA) department is trying a new method to fight the opioid epidemic by employing an additional 285 pharmacists. Their mission is to visit VA doctors’ offices and point out situations in which alternatives to opioids could be used. The VA is borrowing this effective one-to-one approach, known as “academic detailing,” from the pharmaceutical industry. Drug makers for decades have used this tactic to promote doctors’ prescription of their drugs — which is suggested to have fueled the opioid problem.
The VA emphasized that its new approach isn’t solely about the removal of opioids from a patient’s regimen but also about prescribing a different remedy from the very beginning of treatment. Over the past three years, its new program assisted in lowering the number of opioid prescriptions written at VA sites in Kentucky and Tennessee by over 30%; the VA has placed the specialized pharmacists in every site it runs in these two states.
Tennessee officials believe this type of anti-opioid academic detailing could play an important role in reducing the prevalence of opioids throughout the state.
Physician Training Funded by Drug Makers
(Winter 2017) Over 70 manufacturers of immediate-release opioids will now be required by the U.S. Food and Drug Administration (FDA) to pay the cost of optional training for physicians, nurses and pharmacists. The instruction will cover best practices for prescribing opioids and include information on non-opioid alternatives. This requirement for the immediate-release drug makers follows an earlier, similar requirement for manufacturers producing extended-release and long-acting opioid versions to foot the cost of similar professional education.
The FDA stated that nine of every ten opioid painkiller prescriptions written in America are for a quick-release version, amounting to about 160 million prescriptions annually. The federal agency said it may also require opioid training in the future.
Opioid Crisis Declared Public Health Emergency
(Winter 2017) This past October, President Trump officially named the opioid epidemic a public health emergency. The declaration allows states to reallocate federal grant money originally earmarked for other health initiatives to fund opioid treatment. Public health emergencies end after three months, but they are eligible for renewal.
The president’s Commission on Combating Drug Addiction and the Opioid Crisis, headed by New Jersey Governor Chris Christie, recently issued a report outlining over 50 suggestions for turning the tide on opioid abuse. One of these is an anti-drug multimedia advertising program directed at America’s youth. To have the intended effect, however, those in favor of the project say it will require millions of dollars in backing. At this time, no funding source has been specified, although Christie suggested sharing the cost between the federal government and private business sponsors.
Those in favor of the advertising initiative point out this should be one facet of a multi-pronged strategy that also offers more treatment resources and alters physicians’ opioid-prescribing rates. Advocates advise that an ad campaign will only be successful if it takes into account what has worked previously and regularly evaluates the current message’s efficacy.
The Commission also endorsed adding more drug courts, which are designed to handle criminal cases; juvenile offenders; and parents with pending child welfare cases involving those suffering from substance use disorders.
Other recommendations of the Commission include:
- providing more widespread alternatives for pain relief
- mandating that physicians provide proof of training on best opioid prescribing practices as a condition of license renewal
- requiring health care providers to use prescription drug monitoring systems to curb doctor shopping
- stemming the flow of illicit fentanyl
- allocating money for the development of new pain and addiction treatments
- requiring insurance companies cover the cost of addiction treatment
- instituting block grants that states could use as needed for addiction treatment and prevention
FDA, DEA Struggle over Kratom’s Fate
(Winter 2017) The U.S. Food and Drug Administration (FDA) recently issued a warning to the public regarding kratom. This herbal supplement, sold in a variety of forms including powder and capsules, is made from a Southeast Asian evergreen tree. It is used to reduce pain, depression and anxiety, as well as to dampen the symptoms of opioid withdrawal. Kratom is said to act somewhat like an opioid.
The FDA’s statement highlighted the substance’s potential for misuse and addiction. Additionally, the organization emphasized a large spike in calls to poison control centers between 2010 and 2015 due to kratom use. Some batches of the substance have also been found mixed with opioids such as hydrocodone. Side effects of kratom may include liver damage, seizures and withdrawal symptoms.
The FDA’s announcement came one month after the U.S. Drug Enforcement Administration’s (DEA) halted plans to temporarily outlaw kratom by making it a Schedule I drug. The DEA had abandoned their plan because of public outcry, including a letter with the signatures of 62 Congress members and a demonstration staged by the American Kratom Association at the White House, protesting that making Kratom an illegal drug would limit research into its therapeutic benefits.
Although still legal under federal law, some states, such as Alabama, Arkansas, Indiana, Tennessee and Wisconsin, have outlawed kratom.
IV Opioid Addiction Hikes Incidence of Related Diseases
(Winter 2017) Side-effects of intravenous opioid abuse are filling hospitals with patients presenting a variety of conditions. Among these are Hepatitis C, MRSA and endocarditis and all can be expensive to treat.
Hepatitis C is the most widely-occurring communicable disease that afflicts individuals with an opioid addiction. The number of reported cases of Hepatitis C increased almost three-fold between 2010 and 2015.
MRSA, an infection that is difficult to treat, is another ailment often found among people with an opioid use disorder. The price tag for fighting MRSA is approximately $60,000 per patient. The last condition, endocarditis, is an inflammation of the heart’s inner lining caused by opioid addiction. Between 2002 and 2012 hospital stays for endocarditis increased by nearly 50%, with a ballpark cost of $50,000 for each case presented.
The Opioid Impact on Ohio’s Workforce
(Winter 2017) The Akron Beacon Journal/Ohio.com recently analyzed over 12,000 death records of Ohioans who overdosed between 2010 and 2016. In each of these fatalities, coroners identified that an opioid was present in the decedent’s system, either in the form of prescription pain relievers, synthetic opioids or heroin.
The information, furnished by the Ohio Department of Health, detailed the victims’ occupations, giving some insight into opioids’ impact on the workforce. Statewide, the number of deaths due to opioids has more than tripled in less than a decade — from 970 in 2010 to 3,393 in 2016. The construction and extraction sector has been hardest hit, with construction workers dying from an opioid overdose seven times more often than the average Ohio employee. Unfortunately, a prescription painkiller written for an on-the-job injury can be the first step to opioid addiction — and possibly a fatal overdose.
In 2010, construction workers’ chances of filing for workers’ compensation were triple that of employees in other industries. At that time eight in ten construction claimants were prescribed opioids such as OxyContin®, Vicodin®, or Percocet. However, with the extreme risks associated with prescription opioids becoming more apparent, by 2016 the Bureau of Workers’ Compensation (BWC) had reduced the number of injury claims from “overprescribed” opioids by half. It is surprising to note, though, that over 70% of construction workers hurt on the job were still written a narcotic prescription in 2016.
Another segment of the population showing a higher-than-average risk for deadly opioid overdoses in 2016 is the unemployed, which factors into what some health professionals have deemed “deaths by despair.”
Young workers or those just eligible to enter the workforce are sadly not immune to the wave of deadly overdoses, either. The Centers for Disease Control and Prevention (CDC) report that U.S. teenage overdose mortalities jumped 19% from 2014 to 2015, with drugs taking the young lives of 772 Americans between the ages of 15 and 19 in 2015. Opioids, mainly heroin, were most often to blame for overdose deaths in this age range. Although a majority of teen overdose fatalities were accidental, female suicides in this category outpaced males by more than two to one.
Overall, the latest National Survey on Drug Use and Health (NSDUH) estimates that approximately 14% of Americans are currently battling a substance abuse disorder.
Drugs Infiltrate Navy Special Ops Force
(Winter 2017) Mirroring civilian life, drug use is rising even among the elite Navy SEALs. Just over a year ago, the growing problem led to a “safety standdown,” which temporarily stopped SEAL training, and within a three-month period, five SEAL members were removed due to drug use.
It was identified that SEALs, who are trusted with national security duties and intelligence reports, have a higher rate of drug use than the remainder of the Navy. Several active SEALs disclosed to a CBS reporter that it had been years since they were subject to a drug screening.
The spike in use may be caused, in part, by lax drug testing practices among the SEALs. Even though guidelines state that they should be tested at the same frequency as other sailors, Navy SEALs have not been screened when deployed. This accounts for a majority of the time, as their expertise is always in demand.
Recently all 900 SEALs based on the East Coast were mandated to either attend or watch via the web a meeting regarding the issue, and they were then screened for drugs. It was made clear the SEALs should now expect to be tested when traveling and when in the field.
U.S. Cracks Down on Lethal Fentanyl-Like Substances
(Winter 2017) As we have reported previously, when used inappropriately, the powerful prescription opioid drug fentanyl can be deadly. Now the Drug Enforcement Administration (DEA) is taking steps to fight back by categorizing illicit fentanyl analogues as Schedule I drugs on an emergency basis for at least two years, with the possible addition of a third. The new DEA order allows individuals who possess or in any way deal with these derivatives to be prosecuted in a manner comparable to fentanyl offenders. All Schedule I drugs are viewed as addictive and without any medical application.
Legally-prescribed fentanyl, which is 100 times more potent than morphine, is used to manage severe pain. It is a Schedule II drug, defined as extremely addictive but with a valid medical purpose.
In addition to the new fentanyl analogue action, the federal government is turning its eyes to the supply side of the issue, largely contributed to by laboratories in China. The U.S. Department of Justice (DOJ) recently issued charges against two Chinese nationals who peddled fentanyl to Americans via the Internet. These are the first fentanyl manufacturers and distributors housed in China to be named Consolidated Priority Organization Targets, ranked by the DOJ as among the top global drug trafficking threats.
One of the men ran websites from which Americans could buy fentanyl and operated two or more chemical manufacturing sites in China with the capacity to make vast quantities of the drug and its analogues. The second man oversaw at least four Chinese fentanyl manufacturing plants and sold the drug via the web.
It is uncertain whether the pair will ever actually face charges in a United States court.
With the widespread concern over fentanyl, employers may wonder about screening for the drug. At this time, doing so is difficult on a couple of levels. Labs don’t currently have a standard urinalysis panel which includes fentanyl, so including it would be more expensive. Additionally, fentanyl does not remain in the body long, and it can be removed from the system even faster by over-hydrating. Most likely, a drug test administered more than 24 hours after fentanyl use would not detect it.
DOT Implements Screening for Common Rx Opiates
(Winter 2017) On January 1, 2018, the Department of Transportation (DOT) expanded its drug and alcohol testing requirements to encompass hydrocodone, oxycodone, hydromorphone and oxymorphone. Including these four potentially performance-impacting substances in testing panels will permit the DOT to identify instances in which these drugs are not being used legally and help fight the rampant opioid crisis sweeping across the country. The new rule also removes MDEA from the confirmatory testing process and nullifies the specification that employers and consortium/third-party administrators submit blind specimens.
Requiring the addition of these four drug categories reflects best-practice drug testing now recommended for all employers (including non-DOT mandated employers).
Changes to the DOT’s drug screening brings its requirements into line with updated Mandatory Guidelines written by the U.S. Department of Health and Human Services (HHS) for federal urine testing.