Approximately 112 million adults (abt 50% of adult pop) have tried cannabis at least once

A Record Number of Americans Have Tried Marijuana, New Survey Shows

https://www.fool.com/investing/2017/08/20/a-record-number-of-americans-have-tried-marijuana.aspx

Marijuana: it was once a taboo topic, but is no longer.

According to a newly released study from national pollster Gallup, more Americans than ever have tried marijuana.

Gallup has been sporadically asking Americans if they had tried cannabis over the past 48 years. Back in 1969, just 4% of respondents claimed to have tried the drug. By 1999, just a few years after California became the first state to legalize medical cannabis for compassionate use, about a third (34%) of respondents had claimed to have tried marijuana before. However, between the mid-1980s and 2010, this figure was essentially static, give or take a few percent. According to Gallup’s July 2017 survey, 45% of Americans have now tried marijuana, an all-time high. If Gallup’s profile is consistent with that of America, then, utilizing data from the U.S. Census Bureau in 2016, more than 112 million adults have tried marijuana at least once in their lives.

A person rolling a cannabis joint.

Image source: Getty Images.

Along those same lines, Gallup also asked its respondents if they were current marijuana users. In 2013, just 7% affirmed that they used marijuana on a somewhat regular basis. However, in the 2017 poll, 12%, or roughly one out of eight Americans, admitted to regularly smoking cannabis. Interestingly, this was down 1% from 2016, albeit still well within the standard margins for error in polling.

Five likely reasons why more Americans than ever are trying marijuana

So, this begets the question: Why are more people experimenting with marijuana than ever before? The answer probably lies with a confluence of factors.

For starters, we’ve witnessed a notable shift in the way the American public views marijuana over the past two decades. Gallup, which has also polled Americans on their views regarding legalization for the past 48 years, has shown that favorability toward legalization has soared recently. After just 25% of the public favored its nationwide legalization in 1995, 60% were in support of such a move in its 2016 survey, an all-time high. 

The expansion of medical cannabis and recreational weed in select U.S. states, along with the end of the war on drugs, has also likely encouraged experimentation with the drug. Since 1996, 29 states have legalized medical cannabis, including Ohio and Pennsylvania last year, which did so entirely through the legislative process (i.e., without putting the measure on a ballot for residents to vote on). Eight states have legalized recreational weed since November 2012. Expansion gives Americans a legal means to try pot or, in rarer instances, become a regular legal consumer.

A hemp farmer pruning a plant.

Image source: Getty Images.

Select state governments could also be behind higher experimentation rates. It’s no secret that certain states struggle to balance their budgets, thusly legal cannabis acts as a new stream of tax revenue and fees that can help close or ebb budget deficits. States like Nevada, which only recently opened their doors to recreational marijuana, are counting on tax revenue from the sale of legal weed in order to make ends meet.

We can probably also point to politicians for increasing the experimentation rate. Even though marijuana is entirely illegal at the federal level, this past November was the first presidential election cycle where marijuana was a mainstream topic for the candidates. It cemented the idea that pot was no longer a taboo topic that could be avoided by our nation’s lawmakers.

Lastly, the advancement of medical cannabis and cannabinoid-based drugs in clinical trials has probably cast a more favorable view on marijuana. GW Pharmaceuticals (NASDAQ:GWPH) is attempting to bring the very first cannabis-derived drug to market next year. The cannabidiol-based oral drug, known as Epidiolex, breezed through multiple pivotal-stage studies in two rare types of childhood-onset epilepsy, Dravet syndrome and Lennox-Gastaut syndrome. Clinical studies from GW Pharmaceuticals, along with more informal research studies from universities, have painted a picture that suggests marijuana could be helpful, not harmful, in treating certain diseases.

Despite weed’s growing popularity, the federal government has dug in its heels

However, it’s also worth pointing out that in spite of more Americans than ever having tried marijuana, any chance for change in the federal government’s scheduling of the drug still seems to be a ways off.

Cannabis buds on a table sitting next to a judge's gavel.

Image source: Getty Images.

One issue is Attorney General Jeff Sessions, who is among the most ardent opponents of marijuana. It was uncovered in June that Sessions had sent congressional leaders a letter in May requesting that they repeal the Rohrabacher-Farr Amendment, which protects legally operating cannabis businesses in legal states. In other words, Sessions requested permission from Congress to trample states’ rights and go after medical marijuana businesses.

Another issue is that Congress has far too much on its plate to concern itself with marijuana legislation. Republicans have been working on healthcare reform for more than five months, while tax reform talks have been progressing at a snail’s pace. Of the multitude of things that President Trump wants to accomplish as president, legalizing marijuana isn’t remotely on the list as of now.

The U.S. Drug Enforcement Agency (DEA) is probably of little help, too. Last year, the DEA had an opportunity to review two petitions that requested the scheduling for marijuana be changed. The DEA declined to do so, citing a lack of clinical evidence on the benefits and risks of the drug, as well as a lack of proper usage oversight. 

There’s a Catch-22 as well. Most lawmakers, along with the DEA, want more clinical data to pore over in order to make an educated decision about weed’s scheduling. Unfortunately, its restrictive scheduling also makes running the studies that are needed very difficult. You could almost say that red tape is ensuring that marijuana remains an illegal substance.

A street sign that reads "Risk ahead."

Image source: Getty Images.

 

Investing in marijuana is a highly risky venture

Even with a record number of people experimenting with pot, and legal sales expected to grow by a double-digit percentage for the next five to 10 years, investing in marijuana stocks will remain a risky venture at best.

There are a number of concerns with marijuana companies that simply aren’t going away anytime soon. For example, weed companies have little or no access to basic banking services, such as a line of credit or even a checking account. This forces marijuana companies to deal solely with cash, which is a big security risk and an inhibitor of growth.

Also, the Internal Revenue Service doesn’t look too kindly on profitable pot companies. U.S. tax code 280E disallows businesses that sell an illegal substance, like marijuana, from taking normal corporate income tax deductions. Thus, if a weed business does turn a profit, it’s likely handing over far more in taxes than a “normal” business.

The result for most marijuana stocks is steady losses with no chance of really thriving until the federal government changes its stance on pot. Unfortunately, it’s unclear when, if ever, that’s going to happen.

 

Financial Investigator Supporting the DEA at Forfeiture Support Associates Portland, OR 97204 – WTF ?

Financial Investigator Supporting the DEA at Forfeiture Support Associates

Portland, OR 97204

http://job-openings.monster.com/Financial-Investigator-Supporting-the-DEA-Portland-OR-US-Forfeiture-Support-Associates/11/187550335

About the Job

FSA, a rapidly growing professional support services company delivering high-quality service in support of the Department of Justice (DOJ), has an immediate vacancy for a Financial Investigator to support DEA’s Office of Diversion Control (ODC), and the Diversion Control Program.


 


In this role, a Financial Investigator will:


    • Support a Federal law enforcement agency in the analysis of complex financial and business records to support federal diversion related investigations, prosecutions, and the seizure and forfeiture of illegally derived property.
    • Organize and conduct detailed examinations of information generated during complex financial criminal/civil investigations and information available through alternative sources for the purpose of conducting financial analyses of personal/business assets of targeted organizations/individuals.
    • Utilize information obtained as a result of the financial analysis and prepares documentation for use by law enforcement personnel pursuing civil and criminal matters.

A Financial Investigator must meet the following qualifications:


    • Bachelor’s Degree in any field
    • 5 years of criminal investigative experience, with minimum of 2 years of experience in financial investigations
    • Working knowledge of current financial investigation techniques
    • Skilled and capable in oral and written communications
    • Minimum of INTERIM SECRET Clearance


This position requires U.S. Citizenship and a 7 (or 10) year minimum background investigation. 

Forfeiture Support Associates (FSA), LLC is proud to be an Affirmative Action/Equal Opportunity Employer. We recruit, employ, train, compensate, and promote qualified persons in all job titles without regard to age, ancestry, color, gender, HIV status, marital status, medical condition, national origin, physical or mental disability, race, religion, sex, sexual orientation (including gender expression and identity), veteran status, family leave status or any protected group status as defined by applicable law.

Pharmacist quotes CDC guidelines as reason to deny pt’s pain meds

In her own words: a woman with constant pain is denied her meds

http://www.ktuu.com/content/news/In-her-own-words-a-woman-with-cronic-pain-is-denied-her-meds-441051633.html

ANCHORAGE (KTUU) Cathy Therrien is a breast cancer survivor who’s undergone four surgeries and lives with constant pain.

She says her bones rub against each other and she relies on opioid based prescriptions to control her pain.

But, recently Therrien’s prescription was denied by several pharmacies.

Watch her story above about how the state’s opioid epidemic is impacting people’s ability to get the pills their doctors prescribe.

FDA’s Standards for Device Approvals Under Scrutiny

FDA’s Standards for Device Approvals Under Scrutiny

Studies often low quality — or missing entirely when it comes to post-market surveillance

https://www.medpagetoday.com/publichealthpolicy/fdageneral/67300?xid=nl_mpt_WeeklyVideos_2017-08-19&eun=g578717d0r

A study appearing in the Journal of the American Medical Association documents the occasionally poor quality of clinical studies used to expand FDA approvals for high-risk medical devices. But as F. Perry Wilson, MD, discusses in this 150-second analysis, adequate post-marketing surveillance may help to balance regulation with access to improved devices.

This week, we take a walk along the rocky path of medical device regulation with this study, appearing in the Journal of the American Medical Association.

image

Devices are regulated in a different way than drugs. Once approved, a drug doesn’t really get changed. Indications may be expanded, but the drug is still the drug. But devices get modified frequently – think different pacemaker leads.

image

The FDA does not require a clinical trial demonstrating proof of safety and efficacy for all those changes – far from it. In fact, in the vast majority of cases the FDA requires no clinical data at all for approval.

One exception to that rule is for high-risk devices, which include things like cardiac stents. Modifications of these devices need to utilize the most rigorous standard, known as the “panel track.”

But, as the JAMA paper suggests, the panel track is not really that rigorous. There have only been 78 panel-track approvals between 2006 and 2016, underscoring how rare it is for a manufacturer to use this pathway. In contrast, from 1979 through 2012 there have been 5,800 non-panel track supplements for cardiac implantable electronic devices alone.

According to the study, the data supporting the changes rarely measure up to the quality we might expect. Of 83 studies supporting these approvals, only 45% were randomized. Only 30% were blinded.

image

Almost a quarter didn’t specify a primary endpoint. And shockingly, only 87% reported the number of patients enrolled. Only 84% reported the mean age of enrollees. These are pretty basic stats, folks.

Obviously, we could spin this data to make it look like the FDA is asleep at the wheel — but before we grab our pitchforks, let me ask this question: Why were some studies randomized, and some not?

 

The reason is that there are civil servants at the FDA whose job it is to interface with manufacturers to decide how these studies should be conducted. They are charged with determining the “least burdensome” standard of data. That’s the law. In other words, sometimes a blinded, randomized trial is the least burdensome thing you can do to make sure the device is still safe and effective. But not always. We’d need to review each of these 78 approvals separately to determine if we, as a medical community, think the data presented was inadequate.

I’m actually OK with this system, with one caveat. Rigorous post-approval research must be conducted to ensure safety, especially as indications are expanded. And here the FDA has not done a great job. The FDA has been lax about enforcing post-marketing surveillance. According to the study authors, only 13% of post-marketing safety studies are completed between 3 and 5 years after FDA approval, and the FDA has never issued a warning letter, penalty, or fine against a manufacturer for noncompliance.

Getting these products to patients quickly may be laudable, but once they are in the wild manufacturers should not be left entirely to their own devices.

Postscript

After making this video, I heard from lead author Rita Redberg concerning some questions I had with the manuscript.

I was curious about the “denominator” for these approvals. The study looks at 78 device supplement approvals, but we are not told how many rejected applications there are. Her response: “FDA does not make available the number of applications they receive and do not approve … Anecdotally, I have heard it is about 80% approved.”

Dr. Redberg also stated that she feels the current standard for approvals is relatively lax, citing a recent cluster of deaths associated with a rapidly-approved gastric balloon. She suggests that high-risk devices should face the same standard as drugs, where two preferably randomized clinical trials with meaningful endpoints are necessary for approval. Finally, she notes that post-marketing surveillance may not be the best solution to this problem (as I had suggested), as while drugs can be quickly pulled from the market, many devices are not easily removed from patients.

F. Perry Wilson, MD, MSCE, is an assistant professor of medicine at the Yale School of Medicine. He is a MedPage Today reviewer, and in addition to his video analyses, he authors a blog, The Methods Man. You can follow @methodsmanmd on Twitter.

A smoker would theoretically have to consume nearly 1,500 pounds of marijuana within about fifteen minutes to induce a lethal response

Did Marijuana Kill This Young Marijuana Advocate? Um, Nope

www.thefreshtoast.com/cannabis/did-marijuana-kill-this-young-marijuana-advocate-um-nope/

The headline from TODAY.com was alarming. It was equally odious. “Did marijuana kill this young man? Doctors may never know for sure” screamed the NBC-owned website known for its clumsy muchie jokes and outdated Cheech and Chong references.

The story details the death of Michael Ziobro, a 22-year-old New Jersey marijuana advocate. The story shares that Michael’s parents found medical-grade marijuana in his room, and the medical examiner found evidence of cannabis in his blood. Kristina and her husband are convinced the highly active marijuana caused Michael’s heart to go into arrhythmia and killed him.

‘He was such an advocate,’ Kristina Ziobro told TODAY.com. ‘He thought it was wonderful. He thought it was safe. He just thought it was natural and organic and it ended up killing him.”

Ending up killing him? There is no doubt that the parents are upset and grieving over the tragic loss of their son and they are grappling to understand how it could happen.

The 1,600-word story is chock full of somber quotes and cherry-picked studies, but nowhere in the story does the reporter provide these helpful informational nuggets:

  • Earlier this year, the DEA published its 2017 resource guide Drugs of Abuse. The report states: “No deaths from overdose of marijuana have been reported.” The guide goes on to warn that cannabis may cause “merriment,” “happiness,” “enhanced sensory perception,” “increased appreciation of music, art and touch,” and “heightened imagination.”
  • In 1988, a DEA judge wrote that a user would have to ingest somewhere between 20,000 to 40,000 times the amount of THC contained in a single joint to approach lethal toxicity. “A smoker would theoretically have to consume nearly 1,500 pounds of marijuana within about fifteen minutes to induce a lethal response,” wrote Judge Francis Young.
  • Every single day, the opioid epidemic kills 146 Americans.
  • Every single day, alcohol poisoning kills 6 people every day. This does not include alcohol deaths due to accident or disease. Just alcohol poisoning.

The click-baiting headline does not match the facts in the story. Nowhere in the story is there any data that would suggest that the young man died from cannabis.

Even the medical examiner says so:

Michael Ziobro’s death certificate does not list cannabis as the cause of death and Union County Medical Examiner Dr. Junaid Shaikh said he cannot say what caused the young man’s heart to start beating so erratically that it stopped.

Victor and Kristina Ziobro are unhappy with the explanation and asked state legislators, as well as the police, to investigate.

“Although there is scarce research that indicates smoking cannabis can evoke cardiovascular complications, one is unable to attribute the ‘Cause of Death’ was due to smoking cannabis,” Shaikh wrote in a letter to New Jersey state senator Thomas Kean after an inquiry.

“In my opinion, it is highly warranted that family members consult a geneticist and possibly consider cardiovascular genetic testing for hereditary causes of cardiac arrhythmia,” Shaikh added in the letter, which the Ziobros provided to NBC News. His office did not immediately respond to NBC’s request for further comment.

In this case, the alarming headline simply does not jibe with the 1,600 words below it. Perhaps a more accurate headline would read: “Did marijuana kill this young man? Grieving parents say yes, but science says no.”

Ohio: BIG BROTHER keeping “an eye” on LEGAL MJ

State seeks bids for real-time access to medical marijuana facility cameras

http://www.cleveland.com/open/index.ssf/2017/08/state_seeks_bids_for_real-time.html

COLUMBUS, Ohio – The state is seeking bids from companies that can provide a surveillance system so regulators can keep tabs on medical marijuana dispensaries, processors, testing laboratories and growers.

The Ohio Board of Pharmacy needs a system to access cameras that will be installed in all facilities being licensed under the state’s nascent medical marijuana  program, said Stephanie Gostomski, a spokeswoman for the Ohio Department of Commerce, which is overseeing the bidding process. Regulators will watch the activities in the facilities to ensure companies and their employees comply with state law.

The Medical Marijuana Control Program is still in its beginnings. Thus far, the state hasn’t yet awarded any licenses and is currently reviewing grower applications, ahead of a scheduled September 2018 deadline for the first crop of cannabis.

“An inspection is done before a location receives a certificate of operation,” Gostomski said. “Functioning cameras must be in place during that inspection.”

People who suffer from 20 medical conditions will be able to qualify for medical marijuana – such as cancer, chronic and severe or intractable pain and Parkinson’s disease.

Ohio legalized medical marijuana: Here’s what you need to know

Gov. John Kasich signed legislation legalizing medical marijuana last year. The law prohibits smoking cannabis or growing it at home. 

FDA acknowledges benefits of CBD in public comment request

FDA acknowledges benefits of CBD in public comment request

https://www.csindy.com/coloradosprings/fda-acknowledges-benefits-of-cbd-in-public-comment-request/Content?oid=6759370

 
SHUTTERSTOCK

  • Shutterstock

The Federal Drug Administration (FDA) wants to hear from you.

In a notice published to the federal register this week, the agency, which regulates pretty much anything that goes into your body, announced that it’s “requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances.”

FDA will then funnel those comments up the chain and out of the country, though they could come to impact domestic drug policy.

Some context: the United States is party to the 1971 Convention on Psychotropic Substances, a United Nations (UN) treaty meant to curb drug trafficking and abuse by restricting imports/exports, limiting use to scientific and medical settings, and compelling member nations to punish infractions of the treaty. It’s like the international version of the Controlled Substances Act (CSA). So, ahead of an upcoming meeting scheduled for Nov. 6-10 in Geneva, Switzerland, World Health Organization (WHO)’s Expert Committee on Drug Dependence (ECDD) is gathering input from member nations’ health departments to prepare recommendations for the U.N. Secretary-General, subject to a vote by the United Nations Commission on Narcotic Drugs (CND). If the UN ends up changing its drug controls, it’s likely that member nations, including the U.S., would follow suit.
OK, so here are all the substances under consideration: Ocfentanil; Furanyl fentanyl (Fu-F); Acryloylfentanyl (Acrylfentanyl); Carfentanil; 4-fluoroisobutyrfentanyl (4-FIBF); Tetrahydrofuranylfentanyl (THF-F); 4-fluoroamphetamine (4-FA); AB-PINACA; AB-CHMINACA; 5F-PB-22; UR-144; 5F-ADB; Etizolam; Pregabalin; Tramadol; Cannabidiol; Ketamine.

Good for you if you know what half those substances are. About that last one, Time Magazine just ran an illuminating cover story on Ketamine, the party drug that’s showing promise as an anti-depressant.

What jumped out to us is the FDA’s description of Cannabidiol (CBD), emphasis ours:

Cannabidiol (CBD) is one of the active cannabinoids identified in cannabis. CBD has been shown to be beneficial in experimental models of several neurological disorders, including those of seizure and epilepsy. In the United States, CBD-containing products are in human clinical testing in three therapeutic areas, but no such products are approved by FDA for marketing for medical purposes in the United States. CBD is a Schedule I controlled substance under the CSA. At the 37th (2015) meeting of the ECDD, the committee requested that the Secretariat prepare relevant documentation to conduct pre-reviews for several substances, including CBD.

That little phrase is a big deal, since it puts the FDA at odds with another executive branch agency, the Drug Enforcement Agency (DEA), which (possibly illegally) considers CBD to have no medical benefit. (Medical benefit is, of course, a defining characteristic of drug scheduling that, consequently, has a major effect on criminality, health applications and scientific research.)

Many people, here in Colorado and nationwide, can attest to the therapeutic properties of CBD. If you’re one of those people, and you want FDA and WHO to hear about it, you can submit a comment up until September 13.

You can do so online through the Federal eRulemaking Portal or by mail addressed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Apparently, all submissions must include the Docket No. FDA-2017-N-4515 for “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil; Furanyl fentanyl (Fu-F); Acryloylfentanyl (Acrylfentanyl); Carfentanil; 4-fluoroisobutyrfentanyl (4-FIBF); Tetrahydrofuranylfentanyl (THF-F); 4-fluoroamphetamine (4-FA); AB-PINACA; AB-CHMINACA; 5F-PB-22; UR-144; 5F-ADB; Etizolam; Pregabalin; Tramadol; Cannabidiol; Ketamine; Request for Comments.”

Got that?

Most People Who Misuse Opioids Don’t Have a Prescription

Most People Who Misuse Opioids Don’t Have a Prescription

http://time.com/4881191/mmost-people-who-misuse-opioids-dont-have-a-prescription/

In the latest National Survey on Drug Use and Health, government researchers documented the extent of the opioid epidemic in the U.S., providing details on which groups are most vulnerable to abuse and addiction, and the factors that drive misuse.

More than 51,000 people completed an hour long survey conducted in person by public health officials. Using those responses as a representative sample, the researchers calculated national rates of opioid use and abuse. Nearly 92 million people, or 40% of the adult U.S. population that isn’t institutionalized, reported using prescription opioids. Among them, nearly 5% said they misused them, which included everything from using opioids without a prescription to relying on the drugs for something other than the reason they were prescribed by the physician, or taking them in larger doses or more often than prescribed. Among people who misused opioids, nearly two million were addicted to the drugs or had some type of abuse disorder.

 The survey revealed how people were obtaining opioids. For those who reported misusing the drugs, 60% were using opioids without a prescription, according to the report published in the Annals of Internal Medicine.

About 40% of these people accessed opioids free from friends or relatives. Among people who developed addiction or other abuse disorders, 14% said they bought them from drug dealers or strangers.

The researchers note that over prescribing of opioids can lead to excess medications that can then be passed on, intentionally or unintentionally, to others who might abuse them. Prescribing the powerful pain killers for less serious conditions can also lead to such diversion and abuse.

People said the main reason they turned to opioids was to relieve pain, which the researchers say suggests that the drugs aren’t effective in addressing pain, or are too addictive to be useful as pain relievers.

People who were uninsured or unemployed were more likely than people with health coverage or jobs to misuse and abuse opioids. Those who said their health was poor were also more likely to both use and abuse opioids than people who were healthy. Having other addictions, to drugs like heroin, cocaine, sedatives or tranquilizers, also put people at higher risk of abusing opioids, as did having behavioral conditions such as depression. Programs to reduce opioid addiction should consider people’s history of mental illness and behavioral disorders and include close monitoring of their response to opioids, say the researchers.

OHIO: New Limits on Prescription Opioids for Acute Pain

Subject: State of Ohio Board of Pharmacy Acute Prescribing Limits Update
Date: Fri, 18 Aug 2017 15:23:49 +0000

From: State of Ohio Board of Pharmacy <contact@pharmacy.ohio.gov>

Reply-To: PRX-noreply@pharmacy.ohio.gov

E-NEWS UPDATE
ACUTE PRESCRIBING LIMITS UPDATE

New Limits on Prescription Opioids for Acute Pain

Effective August 31, 2017, the State of Ohio will have new rules for prescribing opioid analgesics for the treatment of acute pain.

Please be advised, these rules DO NOT apply to the use of opioids for the treatment of chronic pain.

In general, the rules limit the prescribing of opioid analgesics for acute pain, as follows:
1. No more than seven days of opioids can be prescribed for adults.
2. No more than five days of opioids can be prescribed for minors and only after the written consent of the parent or guardian is obtained.
3. Health care providers may prescribe opioids in excess of the day supply limits only if they provide a specific reason in the patient’s medical record.
4. Except as provided for in the rules, the total morphine equivalent dose (MED) of a prescription for acute pain cannot exceed an average of 30 MED per day.
5. The new limits do not apply to opioids prescribed for cancer, palliative care, end-of-life/hospice care or medication-assisted treatment for addiction.
6. The rules apply to the first opioid analgesic prescription for the treatment of an episode of acute pain.
NOTE: These rules do not apply to veterinarians.

A guidance document and links to the rules for prescribers can be accessed here: www.pharmacy.ohio.gov/AcuteLimits.

Rule 4729-5-30 – Manner of Issuance
• Starting December 29, 2017, rule 4729-5-30 will require prescribers to include the first four characters (ex. M16.5) of the diagnosis code (ICD-10) or the full procedure code (Current Dental Terminology – CDT) on all opioid prescriptions, which will then be entered by the pharmacy into OARRS.
• Starting June 1, 2018, this requirement will take effect for all other controlled substance prescriptions.
• Starting December 29, 2017, rule 4729-5-30 will also require prescribers to indicate the days’ supply on all controlled substance and gabapentin prescriptions.
Effective December 29, 2017, rule 4729-37-05 requires the use of the ASAP Version 4.2A Standard for reporting dispensing information to OARRS. Pharmacies should begin contacting software vendors now to be able to implement this change by the effective date of the rule.

For additional questions regarding the proposed rules, please review frequently asked questions by visiting: www.pharmacy.ohio.gov/AcuteFAQ.

If you need additional information, the most expedient way to have your questions answered will be to e-mail the Board office by visiting: http://www.pharmacy.ohio.gov/contact.aspx.

State of Ohio Board of Pharmacy | 77 S. High Street, 17th Floor | Columbus, OH 43215-6126

 

 

 

 

 

 

Heads In The Sand — The Real Cause Of Today’s Opioid Deaths

Heads In The Sand — The Real Cause Of Today’s Opioid Deaths

http://www.acsh.org/news/2017/08/16/heads-sand-%E2%80%94-real-cause-todays-opioid-deaths-11681

“I cut it three times and it’s still too short”

Old carpenter’s joke (1)

Pretty funny, especially for us do-it-yourselfers, who may not think things over carefully enough before we plunge into a home project like a new deck or replacement windows. This kind of stuff happens when amateurs try to do the work of professionals, and it’s often good for a chuckle or two. I mean, who amongst us hasn’t hung a door upside down or measured deck boards incorrectly?

But when so-called professionals who act like amateurs screw up public health policy, things become decidedly less funny. Especially for the many victims of political and bureaucratic incompetence and the opportunists who have managed to elevate themselves to sufficiently lofty positions where they actually have enough power to do damage.

If you’ve been paying attention to the nationwide narcotic catastrophe that is now claiming 142 lives every day (and seems to be getting worse), you may be shaking your head in disbelief. If so, it is not without reason. The idea that slapping three-day caps on Vicodin and Percocet prescriptions will in any way decrease overdose deaths is so supernaturally stupid that no one could really believe this nonsense anymore, right? No, wrong.

Charleston Gazette-Mail, 8/10/17

According to a new article in the Charleston Gazette-Mail, the faulty premise of controlling the overdose dilemma by restricting pain medications is still pervasive throughout the country. So much so that there are now 17 states that have passed laws limiting the number of days of opioid prescriptions, the total number of pills, and the maximum dose, with the goal of putting the breaks on an unprecedented epidemic of overdose deaths. How’s that working out? Exactly as you would predict—terribly.

Before I discuss the foolish actions that are blindly being implemented by regulators and legislators and how badly they are failing, we need to first understand the real causes of today’s opioid catastrophe. Because without a clear understanding of the problem, even a rational plan of attack – let alone a solution – will be impossible. Unfortunately, there is little evidence that public health officials understand what is really going on, which is why we keep hearing the same illogical and hackneyed responses over and over. Here’s the real story.

Today’s opioid overdose crisis began in force in 2010 (Figure 1), in what was a quintessential example of the law of unintended consequences. After years of research, Purdue Pharma finally discovered a new formulation for OxyContin—a significant driver of opioid addiction since its introduction in 1996. The new formulation was difficult to abuse; when users tried to grind up the pills so the drug could be smoked, snorted, or injected it turned into a gum instead of a powder as it had before. 

Grinding up OxyContin before and after reformulation. Prior to 2010, the pill was easy to grind up, which defeated its time-release formulation, to give as much as 80 mg (16 Percocet pills) of pure oxycodone, which could be snorted, smoked or injected. The new formulation changed that. Photo: Popular Science

Figure 1 (below) shows a clear inverse relationship between the availability of abusable OxyContin and the subsequent mad rush to heroin—a fact that the press, the CDC, and many politicians either don’t understand or, choose to ignore. This is beyond obvious. Simply look at the red arrows on both graphs. As OxyContin use dropped (left) heroin overdose deaths soared (right). This relationship is indisputable. Although pre-2010 OxyContin played a significant part in creating a huge population of opioid addicts, it could be argued that the improvement of the pill inadvertently did even more damage. Addicts could no longer get the pure oxycodone they needed and promptly switched to heroin. This switch marked the beginning of the unprecedented surge in heroin (now fentanyl) deaths that now appear on the news almost every day. 

Figure 1: The real cause of today’s skyrocketing overdose opioid deaths.

Left: OxyContin abuse dropped sharply beginning in 2010 when the FDA approved an abuse-resistant formulation. Source: Pain News Network, Radar Systems.

Right: Soaring heroin use immediately followed the reformulation of OxyContin. Note that the number of heroin deaths between 2001-2010 was stable, in the range of 2000-3000 per year.  But between 2010 and 2015, this number shot up to 10,000. It is clear that not only was the onset of today’s overdose epidemic not driven by pills, but it was, in fact, driven by the SCARCITY of pills (2). Source: NIH

Another common fallacy that is now all but “fact” is that opioid pills are now responsible for the surge in overdose deaths in the US, but a bit of digging around on the NIH site tells us otherwise. In 2010, the year that OxyContin became abuse-resistant, 20,000 people died from opioid overdoses. During the ensuing five years, OxyContin abuse dropped and the strict restrictions we now see on opioid pills began to take hold. The result? Between 2010-2015 opioid overdose deaths in the US increased by 65%, roughly 13,000. And even a cursory examination of Figure 2 shows that increase was entirely due to injectable drugs like heroin or fentanyl. 

Source: Adapted from NIH figures

Figure 2. The increase in opioid deaths from 2010-2015. The 65% increase in deaths arose from heroin and fentanyl, not pills. Overdose deaths from pills remained unchanged during that time.

Figure 3 reinforces this conclusion. Pill deaths during that time were unchanged.

 

Figure 3: Deaths from overdoses of prescription opioids were unchanged between 2010 and 2015 (pink box). Source: National Institute on Drug Abuse (NIH)

Yet we still routinely see headlines such as the following:

“Prescription opioids are behind the deadliest drug overdose epidemic in the US”

It is this fallacy that is causing genuine harm, both to people who are addicted to opioids and those who depend on them for pain control. Pain patients suffer while addicts die in greater and greater numbers. Our policies have been an abject failure by any measure. Disgraceful.

Next: Part 2: States Crack Down On Pills To Fight Fentanyl. Crazy. 

Notes:

(1) Thanks to Jamie Ragusa for this one.

(2) Economic factors also play a big role. Heroin is cheaper than pills. The street value of opioid pills ranges from $5 to $80. A bag of heroin is about $5.