Vitamin D Deficiency May Boost COVID-19 Risk

Posted on September 6, 2020 by Pharmaciststeve

Vitamin D Deficiency May Boost COVID-19 Risk

https://www.medscape.com/viewarticle/936928

People who are deficient in vitamin D may be at higher risk of contracting the novel coronavirus than those with sufficient levels, according to the results of a new retrospective study from Illinois.

Individuals with untreated vitamin D deficiency were nearly twice as likely to test positive for COVID-19 relative to their peers with adequate vitamin D levels.

“These findings appear to support a role of vitamin D status in COVID-19 risk,” the authors say in the study, published online September 3 in JAMA Network Open.

“Vitamin D is important to the function of the immune system and vitamin D supplements have previously been shown to lower the risk of viral respiratory tract infections. Our statistical analysis suggests this may be true for the COVID-19 infection,” lead author David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, said in a news release from his institution. 

Important for Immune Function

Meltzer and colleagues studied 489 University of Chicago Medicine patients (mean age 49 years, 75% women) whose vitamin D levels were determined in the 2 months before being tested for COVID-19. 

Vitamin D deficiency was defined as < 20 ng/mL 25-hydroxycholecalciferol or < 18 pg/mL 1,25-dihydroxycholecalciferol.

Vitamin D status was categorized as likely deficient for 124 participants (25%), likely sufficient for 287 (59%), and uncertain for 78 (16%).

A total of 71 participants (15%) tested positive for COVID-19.

In a multivariate analysis, a positive COVID-19 test was significantly more likely in those with likely vitamin D deficiency than in those with likely sufficient vitamin D levels at the time of COVID-19 testing (relative risk [RR], 1.77; 95% CI, 1.12 – 2.81; P = .02). 

The estimated mean rate of COVID-19 in the deficient group was 21.6% compared with 12.2% in the sufficient group.

Testing positive for COVID-19 was also associated with increasing age up to age 50 years (RR, 1.06; P = .02) and race other than White (RR, 2.54; P = .009)

Protective Effect of Treatment?

The findings also raise the possibility that treatment for vitamin D deficiency may lower the risk of COVID-19, the researchers say.  

Patients with deficient vitamin D levels who had their vitamin D treatment increased did not appear to have increased risk for COVID-19.

This suggests a “protective effect of treatment, but the confidence intervals on estimated rates for these groups are too wide to exclude the possibility of no treatment effect,” Meltzer and colleagues note.

“If vitamin D does reduce COVID-19 incidence, it is tempting to consider whether it might reduce COVID-19 transmission,” they hypothesize.

Because vitamin D strengthens innate immunity it could be expected to decrease COVID-19 infection and transmission. Vitamin D also affects zinc metabolism, which decreases replication of coronaviruses.

As previously reported by Medscape Medical News, a recent study from Israel suggested low plasma vitamin D levels are an independent risk factor for COVID-19 infection and hospitalization.

In that study, participants positive for COVID-19 were 50% more likely to have low vs normal vitamin D levels in a multivariate analysis that controlled for other confounders.

Half of Americans are deficient in Vitamin D, with much higher rates seen in African Americans, Hispanics, and individuals living in areas like Chicago where it is difficult to get enough sun exposure in winter.

“Understanding whether treating Vitamin D deficiency changes COVID-19 risk could be of great importance locally, nationally, and globally,” Meltzer said. “Vitamin D is inexpensive, generally very safe to take, and can be widely scaled.”

Meltzer and colleagues say randomized clinical trials are now needed to see whether broad population interventions and interventions among groups at increased risk of vitamin D deficiency and COVID-19 could reduce COVID-19 cases.

The study was supported by the Learning Health Care System Core of the University of Chicago/Rush University Institute for Translational Medicine (ITM) Clinical and Translational Science Award and the African American Cardiovascular Pharmacogenetics Consortium. The authors have declared no relevant conflicts of interest.

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‘Very promising’: UK’s first full heroin-prescribing scheme extended after reductions in crime and homelessness

Posted on September 6, 2020 by Pharmaciststeve

‘Very promising’: UK’s first full heroin-prescribing scheme extended after reductions in crime and homelessness

https://www.independent.co.uk/news/uk/home-news/heroin-prescription-treatment-middlesbrough-hat-results-crime-homelessness-drugs-a9680551.html

‘Prison, increased sentencing, police crackdowns and all other efforts to break that cycle have failed,’ says police and crime commissioner

The UK’s first fully-fledged scheme to provide heroin users with a safe and legal supply of the drug has been extended for a further year, after showing “very promising results”.

Heroin-assisted treatment has been used successfully for decades in Switzerland, based in part on Britain’s long-forgotten model of heroin prescribing, and despite “impressive” UK trials, government funding for post-pilot schemes was removed in 2015.

But in Cleveland and Glasgow, police and local health experts have pushed in recent years for the creation of two of the UK’s first fully-fledged centres, both of which are now up and running, providing access to medical-grade diamorphine twice per day and to wider social support.

Campaigners celebrated the first “dramatic” results from Middlesbrough’s scheme on Wednesday, which found a vast reduction in re-offending rates and use of street drugs, and significant improvements in participants’ health and quality of life, including seeing those homeless at the outset placed in accommodation.

Thirteen of the city’s most at-risk heroin users, who had found other treatments unsuccessful and were of concern to criminal justice agencies and health services, accessed the programme – which will now be largely funded by money seized from criminals. Eight remain, while five dropped out or were suspended.

Researchers studied six of the participants over 29 weeks in the programme, who prior to the scheme had been responsible for at least 541 crimes at an estimated cost to the public purse of £2.1m.

Between them, they committed just three lower-scale offences over 29 weeks of treatment.

After this period, four had not reoffended. One completed their probation period but committed one crime – down from an average of three offences every six months prior to the programme.

The other participant, who had previously not gone longer than two weeks between prison sentences having committed some 239 crimes, committed two offences during treatment.

“I used to shoplift to feed my habit,” one of the participants told researchers. “I needed at least £40 a day for my addiction. Even day, seven days a week. That’s £40 I’d sell it for so it had to be £80’s worth of their stock. Seven days a week at £80 a day.

“I don’t need to do that now. I’ve stopped doing all that.”

The estimated annual cost of each participant’s diamorphine is £12,000, in addition to staffing and administration costs. Tablet and powder forms of diamorphine are considerably cheaper but Home Office regulation restricts their use.

In addition to a 99 per cent reduction in illicit heroin use and 98 per cent for cocaine, researchers noted clients’ on average used less of every other type of drug measured, save for tobacco. Four of the cohort did not test positive for illicit heroin at any point between weeks 19 and 29.

With the need to constantly fund street heroin removed, individuals were able to engage on a one-to-one basis at the clinic with various agencies including health, housing and welfare.

Though this additional engagement was put on hold because of coronavirus, the twice daily supervised diamorphine injections have continued, with a 98 per cent attendance record.

None of the six were homeless after one month, with four in secure accommodation after four months. At the outset, just two of the cohort lived in secure accommodation, with an additional two sleeping rough.

Furthermore, scores for their psychological and physical health – based on self-declarations – all more than doubled after just one month of treatment, rising by 329 per cent and 142 per cent respectively after seven months.

The number of self-declared hospital visits and ambulance requirements were also reduced, with only four ambulance call-outs and no A&E visits in six months, compared with two of each in the month prior to treatment.

“The latest analysis suggests the pilot has delivered very promising results and so it was very important we find the funding to continue,” said Cleveland Police and Crime Commissioner Barry Coppinger, who launched and part-funds the scheme.

“I’m delighted that money seized from criminal gangs who have blighted local communities is now being used to fund this pioneering approach that brings hope to users and their families and improves local life for residents and businesses.”

He added: “We should not forget we are talking about entrenched users who have been on a cycle of committing crime to fund addiction for over 20 years. Prison, increased sentencing, police crackdowns and all other efforts to break that cycle have failed nationally and, indeed, globally.

ITV News takes a look at County Lines drug dealing

“There have been setbacks, as was expected, and Covid has thrown up a whole new challenge that no-one could have expected, but overall the early signs are very promising.”

Martin Powell from Transform Drug Policy Foundation, who has been campaigning for the roll-out of HAT clinics for years, added: “These results are a testament to incredible work, which has led to reduced crime, fewer ambulance call outs and lower costs to the NHS.

“Most importantly, vulnerable lives have been turned round. None of the clients are now sleeping rough, and their treatment has been stabilised.

“But we shouldn’t be surprised. Heroin prescribing clinics have achieved similar benefits from Vancouver to Geneva. This only adds to the evidence for their value.

“The government should ensure all areas have the funds needed to adopt this approach, for the benefit of everyone.”

Starting in the 1920s, Britain’s model of prescribing heroin to those who required it was known globally as the British System, with the number of known users – who could pick up prescriptions in Boots the chemist – rarely surpassing 1,000 until the late 1960s.

This practice was effectively prohibited in the 1970s and, as the black market grew, the number of heroin users grew to more than nearly half a million by the mid-1990s.

“The UK only developed a heroin problem the moment doctors were stopped from prescribing it,” said former undercover drugs detective Neil Woods, co-author of Drug Wars, which charts the history of the British system.

“Gifting such a lucrative market to organised crime was madness. Doing so has taken us on the journey to the point where children are now exploited to sell it through county lines.”

Meanwhile, Swiss researchers developed heroin-assisted treatment, basing their model in large part on the old British System, and setting up the first such clinic in 1994.

The model has since spread to Germany, Holland, Denmark and Belgium, and was also trialled successfully in Darlington, Brighton and London in the years leading up to 2009.

After lead researcher John Strang, of King’s College London, recommended it be made available to select users following “impressive” results, three post-pilot centres were opened in 2012.

But despite a pledge to honour Dr Strang’s recommendations, central government funding was later removed and the schemes were closed in 2015.

Mr Woods, now chair of LEAP UK – an anti-drugs war partnership of former law enforcement officials – welcomed the “dramatic” results from the Cleveland clinic, saying: “What politician or police leader can ignore results like this?”

Despite an effective ban in the 1970s, diamorphine prescriptions have since remained legal under Home Office regulations, and – as revealed by The Independent last August – 280 people still received a prescription for take-home diamorphine in 2017-18.

As such, some have pushed for the heroin-assisted treatment model to go further in allowing a wider proportion of heroin users access, and by eventually allowing for take-home prescriptions to reduce the necessity of daily clinic visits.

“Imagine what could be achieved if this was made easier and cheaper through government action?” Mr Woods said.

“More liberal heroin prescribing could mean that vulnerable people are rescued from the exploitation of organised crime before they are in such a mess, before they’ve been further traumatised by the system.

“Forget vacuous moral judgements. It’s time to save lives and reduce crime. Cleveland have shown the way.”

The results of the first year of Middlesbrough’s programme will be evaluated by Teesside University starting in October 2020.

Following its extension, the next year of the scheme will be largely funded by money seized from criminals under the Proceeds of Crime Act.

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Employee Fatally Stabbed At Wicker Park Walgreens

Posted on September 6, 2020 by Pharmaciststeve

Employee Fatally Stabbed At Wicker Park Walgreens

https://chicago.cbslocal.com/2020/09/06/breaking-employee-fatally-stabbed-at-wicker-park-walgreens/

CHICAGO (CBS) — A worker at a Walgreens in Wicker Park was stabbed and killed during daylight business hours Sunday.

The 32-year-old woman was working at the Walgreens at 1372 N. Milwaukee Ave. around 9:30 a.m., when she was approached by an unknown person with a knife, police said. She was stabbed multiple times, and pronounced dead on the scene.

On Sunday evening, the Walgreens was shuttered, but police tape had come down. More than a dozen investigators were scouring the area for surveillance video from the Walgreens itself and nearby businesses.

The details of the crime were still unfolding late Sunday afternoon, but the initial call over police radio was chilling.

“The caller just found the female coworker on the floor bleeding,” the dispatcher is heard saying.

“Detectives are canvassing the area now,” said Chicago Police News Affairs Officer Jose Jara. “Police are looking for an individual wearing a light-colored top, dark pants, and white gym shoes.”

Inside the Walgreens, outside in the parking lot, and in the bustling and popular neighborhood next door, police were searching for clues into who was responsible for the deadly stabbing.

“The offender walked into the store, observes the victim – who is an employee of the store – fatally stabs her,” Officer Jara said. “Were’ not sure if it was a robbery or if it was just a random act of violence.”

“I go here every other day,” a neighbor said. “I probably did know her.”

“I hope it doesn’t happen to other people out here,” said another neighbor, Jash Shah. “I really feel bad for her and her family, you know, on a Sunday morning, having to wake up to such kind of news. I send my condolences to them.”

Shah saw the police response at Milwaukee and Wolcott avenues unfold beginning around 9:30 a.m.

He is saddened about the violent crime, and he added he is fortunate that he and his family were not there during the attack.

“I basically look at this Walgreens every day, so it’s just mixed emotions,” Shah said.

But over the past several days, police have tracked violent crimes at other Walgreens stores or other drugstores in the area – including two this past Wednesday.

Police said in both incidents, a man, armed with a knife with a red handle, went into a pharmacy and demanded money. In one case he successfully took money from the store. He fled the scene in both incidents.

One of those incidents took place at 7:20 a.m. Wednesday, a short walk away from the Wicker Park scene at a Walgreens at North and Western avenues. The other took place 17 minutes later at the very same Walgreens on Milwaukee Avenue where the murder happened Sunday morning.

Investigators on Sunday said they were looking into whether those crimes were connected to the fatal stabbing.

“I’m sure they’re going to work on that tomorrow, yes,” said Officer Jara.

“It’s scary. It’s scary,” Shah said. “I hope they catch them and I hope the family gets the justice that they deserve.”

No one was in custody Sunday afternoon in the fatal stabbing, and it was not clear whether police had recovered a weapon. But Area Five detectives were working on leads late Sunday.

The victim’s identity has not been learned.

Anyone with information is asked to call detectives at (312) 746-5446. Anonymous tips can be made at cpdtip.com.

 

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History Channel: America’s Book of Secrets: Special Edition

Posted on September 5, 2020 by Pharmaciststeve

America’s Book of Secrets: Special Edition

S 1 E 4  https://play.history.com/shows/americas-book-of-secrets-special-edition

The Power of Money

1h 23m | 2020 | TV-PG | CC

Reveals not only the underground world of America’s wealthiest citizens and the depths at which their power and influence take root, but the power and influence that money and the promise of wealth wields over all of us. Do billionaires think they know better than the majority? Are the American masses just objects to control? How much gold does the United States really have? Is the American government overstating the amount of gold in its reserves to create the mystique of financial superiority? American treasure hunters are convinced that there are missing fortunes just waiting to be discovered all around the country, but why does the government deter some searches, and perhaps even seize land to keep treasure hunters out?

I just stumbled on to this series of 2 hr shows that is very interesting… it goes back to the President Roosevelt ‘s time and up thru the current times. There are parts that deals with the start and going-ons with the war on drugs. At times I wondered if I was watching mystery movie, others I wondered if I was watching some sort of conspiracy theories. Even if half of the stories presented were fabrications… the entire stories presented were extremely interesting as to what goes on without the average American being aware of any of it 

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Straight from the “Pharmacist’s mouth” – I don’t give a shit what the doc writes – if I don’t want to fill a Rx

Posted on September 4, 2020 by Pharmaciststeve

The only thing I agree with this pharmacist is that no one can force a pharmacist to fill a prescription… but we have a very serious surplus of pharmacists and if an employer doesn’t agree with how their employee pharmacist is exercising – or abusing – their “clinical decisions”  all the chains have hard drives full of pharmacist willing to take that pharmacist position.

I often wonder what part of their clinical decision making process makes them “not comfortable”.  So this pharmacist makes clinical decisions without having access to all of the pt’s medical record other than what is on the store’s computer system or the PDMP report that has been pulled. Not comfortable is an emotional opinion… which doesn’t take much if  any clinical experience and typically lacks mostly clinical facts as a real reason to refuse to fill.

I have refused to fill prescriptions before… sometimes because of the pt’s allergy to a new med, sometimes because of a serious level one interaction, a few times that was because what I considered a lethal dose of a opiate and in every incident such as that… the prescriber was very grateful that I refused to fill that particular prescription and they replaced it with an appropriate dose.

I never gave back a prescription that I had concerns about without trying to reach the prescriber and I typically started the conversation- can you help me understand why I should not have a problem with this Rx with the pt’s other meds, medical history, allergies – whatever was appropriate..  If the prescriber was adamant about filling it as written… I would document the conversation on the back of the Rx and fill it as written along with my concerns.  I would typically tell the pt what my concerns were and what side effects that they may encounter and what they needed to do if they experienced them…  I was never sued, so … either the pt was cautious and experienced the side effects and acted appropriately and nothing seriously happened to the pt.

I have had a gun pointed at me… but my own independent pharmacy was NEVER ROBBED IN TWENTY YEARS… maybe because it was common knowledge that I had a conceal permit and could probably be armed.  In fact, in our small town of 35,000 population… I had the city record for having the most people attempting to pass a forgery arrested and the record for filling the least number of forged/altered prescriptions.  One particular occasion a person impersonated a prescriber office and phoned in a Hydrocodone/Acetaminophen Rx… and wanted it delivered .. .so I call my friend who was the head of the county narcs and he offered to deliver the Rx to the pt for me and arrested the woman at her front door after she accepted the delivery. Every time that I had someone arrested, No one tried to pass another forged Rx for 12-18 months.

I remember one young man that handed me a folded Rx … .that was obviously  a forged… I did not feel  like wasting my time and calling the cops and having him taken care of …. so  I wrote on the back of the Rx “THIS IS A FORGERY and handed back the folded Rx … and gave him an excuse that I could not fill it for some reason… 

I find it interesting that this pharmacist besides not giving a shit about what the prescriber wrote for… she quickly proceeded about she is perfectly fine about pharmacists lying to pts about having inventory and/or being robbed. IMO, most of these chains are being robbed because the Rx dept is fairly OPEN with lower counters that bad guys can quickly jump over and many of these 24 hr chain pharmacies are 15,000 – 20,000 sq ft and over night shift is one pharmacist in the pharmacy and one person at the front register.

These chain stores don’t want to the Rx dept to look “too unfriendly” to the pt. Stolen meds are replaceable as are most Rx dept employees.

This pharmacist said that her Mother was a pharmacist and had been robbed… so she should have had some idea of what she was getting into becoming a pharmacist and she went right straight ahead to become a pharmacist…  When  you know the danger and you head straight into the danger… you should not be surprised when  you have to personally deal with the danger.   You should not take it out on the pts that you are committed to serve, but these seems to be the place pts find themselves.  I just wonder what the ratio of refusal to fill Rxs for chronic health issues is controlled substances to all other chronic meds… with controlled substances Rxs are normally abt 15% to 20%… my money is on that the percentage of denied controlled Rxs is much larger than the 15%-20% of the total.

I have copied this video down to my hard drive… so it is not going to “disappear” from the web.

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per Queen Marie Antoinette: let them eat cake

Posted on September 4, 2020 by Pharmaciststeve

Filed under: General Problems | 2 Comments »

Nursing home: 447 residents and staff members tested positive for the disease, and 73 people died

Posted on September 3, 2020 by Pharmaciststeve

FBI raids Pennsylvania nursing home where hundreds caught coronavirus, dozens died

https://www.nbcnews.com/news/us-news/fbi-raids-pennsylvania-nursing-home-where-hundreds-caught-coronavirus-dozens-n1239256

Federal and state investigators raided a Pennsylvania nursing home Thursday where hundreds of residents and staff members tested positive for coronavirus and dozens have died, authorities said.

Investigators from the Federal Bureau of Investigation, the state attorney general’s office and other agencies executed the search warrant at Brighton Rehabilitation and Wellness Center northeast of Pittsburgh, said Scott Brady, U.S. Attorney for Pennsylvania’s Western District.

The Mt. Lebanon Rehabilitation and Wellness Center, another nursing home in the Pittsburgh area operated by the same company that owns Brighton, was also searched by authorities on Thursday, NBC affiliate WPXI reported.

Brady did not offer details about the search warrant but he encouraged anyone with information about suspected fraud, abuse or victimization to contact a regional COVID-19 task force.

Last month, Pennsylvania Attorney General Josh Shapiro said that the facility was under investigation over reports of “deeply troubling” conditions and practices.

“I can confirm that Brighton is one of the subjects of our criminal investigations into neglect at nursing homes during the pandemic,” he tweeted.

State Department of Health data show that 447 residents and staff members tested positive for the disease, and 73 people died. In late July, the facility announced that it had no cases for the first time since March, according to WPXI, but its outbreak remains the worst in a Pennsylvania.

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Characteristics of Drug Overdose Deaths Involving Opioids and Stimulants — 24 States and the District of Columbia, January–June 2019

Posted on September 3, 2020 by Pharmaciststeve

Characteristics of Drug Overdose Deaths Involving Opioids and Stimulants — 24 States and the District of Columbia, January–June 2019

https://www.cdc.gov/mmwr/volumes/69/wr/mm6935a1.htm

Summary

What is already known about this topic?

After decreasing from 2017 to 2018, provisional data indicate that drug overdose deaths increased in 2019, driven by opioid-involved and stimulant-involved overdose deaths.

What is added by this report?

Illicitly manufactured fentanyls (IMFs), heroin, cocaine, or methamphetamine (alone or in combination) were involved in 83.8% of overdose deaths during January–June 2019; at least one potential opportunity for intervention was identified in 62.7% of overdose deaths.

What are the implications for public health practice?

Targeting crucial opportunities for intervention with evidence-based overdose prevention programs can help reverse increases in drug overdose deaths. Interventions to reduce overdose deaths involving illicit opioids and stimulants, particularly IMFs, are needed and should be complemented by efforts to prevent initiation of prescription drug misuse and illicit drug use.

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Abstract

Introduction: Provisional estimates indicate that drug overdose deaths increased in 2019 after a slight decrease in 2018. In 2018, overdose deaths primarily involved opioids, with continued increases in deaths involving illicitly manufactured fentanyls (IMFs). Deaths involving stimulants such as cocaine and methamphetamine are also increasing, mainly in combination with opioids.

Methods: CDC analyzed data on drug overdose deaths during January–June 2019 from 24 states and the District of Columbia (DC) in the State Unintentional Drug Overdose Reporting System to describe characteristics and circumstances of opioid- and stimulant-involved overdose deaths.

Results: Among 16,236 drug overdose deaths in 24 states and DC, 7,936 (48.9%) involved opioids without stimulants, 5,301 (32.6%) involved opioids and stimulants, 2,056 (12.7%) involved stimulants without opioids, and 943 (5.8%) involved neither opioids nor stimulants. Approximately 80% of overdose deaths involved one or more opioid, and IMFs were involved in three of four opioid-involved overdose deaths. IMFs, heroin, cocaine, or methamphetamine (alone or in combination) were involved in 83.8% of overdose deaths. More than three in five (62.7%) overdose deaths had documentation of at least one potential opportunity for overdose prevention intervention.

Conclusions and implications for public health practice: Identifying opportunities to intervene before an overdose death and implementing evidence-based prevention policies, programs, and practices could save lives. Strategies should address characteristics of overdoses involving IMFs, such as rapid overdose progression, as well as opioid and stimulant co-involvement. These efforts should be complemented by efforts to prevent initiation of prescription opioid and stimulant misuse and illicit drug use.

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Introduction

Provisional estimates indicate that drug overdose deaths (overdose deaths) increased in 2019 after a slight decrease from 2017 to 2018 (1,2).* Approximately two thirds of overdose deaths in 2018 involved an opioid, but the opioid types and combinations contributing to deaths are changing (1–3). For example, although overdose deaths involving prescription opioids and heroin decreased from 2017 to 2018, those involving synthetic opioids excluding methadone (primarily illicitly manufactured fentanyl [IMF]) and co-involving stimulants increased (2,3). Deaths co-involving cocaine and IMF, and involving psychostimulants with abuse potential (e.g., methamphetamine) with and without opioids have driven recent increases in stimulant-involved overdose deaths (3,4). The specific drugs and drug combinations involved in overdose deaths have implications for substance use disorder treatment regimens and outcomes, overdose prevention strategies (e.g., avoidance of using drugs when alone) (5), and overdose response (e.g., stimulant use can affect the response to administered naloxone) (6).

Targeting common fatal overdose circumstances with effective and promising public health interventions can prevent deaths (7). Examples include treating underlying substance use disorder (8), targeting important touchpoints to facilitate linkage to treatment (e.g., during treatment for a nonfatal drug overdose or upon release from incarceration) (9,10), providing mental health treatment (11), and expanding community naloxone distribution (12).

This report describes decedent demographic characteristics and circumstances surrounding overdose deaths during January–June 2019 among 25 jurisdictions participating in CDC’s State Unintentional Drug Overdose Reporting System (SUDORS),† and it highlights the involvement of opioids and stimulants, separately and in combination.

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Methods

Twenty-one jurisdictions participating in SUDORS reported all unintentional and undetermined intent overdose deaths that occurred during January–June 2019; four additional states reported overdose deaths in a subset of counties.§, Jurisdictions abstract data from death certificates and medical examiner/coroner reports, including death scene investigation findings and all drugs detected by postmortem toxicology testing. Detected drugs were classified as involved in (i.e., contributing to) overdose deaths if the medical examiner/coroner listed them as causing death on the death certificate or in the medical examiner/coroner report.**

Overdose deaths were grouped by opioid and stimulant involvement into four mutually exclusive categories: 1) opioids without stimulants, 2) opioids and stimulants, 3) stimulants without opioids, and 4) neither opioids nor stimulants. Also, overdose deaths were grouped into the 10 most frequently occurring mutually exclusive combinations of opioid type or types (illicitly manufactured fentanyls†† [referred to as IMFs, which include fentanyl and fentanyl analogs], heroin,§§ prescription opioids,¶¶ other illicit synthetic opioids [e.g., U-47700]), and stimulant type or types (cocaine, methamphetamine, other illicit stimulants [e.g., MDMA], and prescription stimulants***). Overdose death combinations included deaths involving one drug type (e.g., involving IMFs without other opioid or stimulant involvement) and deaths involving two or more types (e.g., co-involved IMFs and cocaine), but did not reflect nonopioid, nonstimulant drug involvement (e.g., benzodiazepines). The following potential intervention opportunities (per evidence††† in the medical examiner/coroner report) were assessed: 1) recent institutional release (<1 month),§§§ 2) previous nonfatal overdose, 3) mental health diagnosis, 4) ever having been treated for substance use disorder, 5) bystander present when fatal overdose occurred, and 6) fatal drug use witnessed.

Frequencies and percentages of decedent demographics, overdose location,¶¶¶ geographic region**** of the jurisdictions, and potential opportunities for intervention were stratified by opioid/stimulant involvement. Pairwise chi-squared testing was used to detect statistically significant differences (p<0.01) among percentages. Because of the potential for incomplete data, the analysis of potential opportunities for intervention only included deaths with overdose-specific circumstances noted in the medical examiner/coroner report (15,295; 94.2% of overdose deaths). Analyses were conducted using SAS statistical software (version 9.4; SAS Institute).

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Results

Twenty-five jurisdictions reported 16,236 overdose deaths during January–June 2019. Among these, 7,936 (48.9%) involved opioids without stimulants, 5,301 (32.6%) involved opioids and stimulants, 2,056 (12.7%) involved stimulants without opioids, and 943 (5.8%) involved neither opioids nor stimulants (Table). In all regions, overdose deaths involving opioids without stimulants were most common (36.9%–54.1%), followed by deaths involving opioids and stimulants (30.6%–33.8%), then deaths involving stimulants without opioids (7.4%–27.1%) (Figure 1). This pattern was most prominent in Northeastern and Midwestern jurisdictions, where deaths involving opioids (with or without stimulants) accounted for 87.6% and 83.0%, respectively, of all overdose deaths.

More than two thirds (68.5%) of decedents were male, and three quarters (75.2%) were non-Hispanic White (Table). Among overdose deaths involving opioids (with and without stimulants), most decedents (53.3%) were aged 25–44 years; among overdose deaths involving stimulants without opioids, most decedents (55.7%) were aged 45–64 years. Evidence of injection drug use†††† was more common among opioid-involved deaths than among deaths that did not involve opioids.

Most overdose deaths (83.8%) involved one or more of four illicit drugs (IMFs [61.5%], cocaine [28.3%], heroin [28.2%], or methamphetamine [17.6%]) (Table); nearly one half (49.8%) of these deaths involved two or more of those drugs. IMFs were involved in 80.4% of opioid overdose deaths with stimulants and in 72.2% without stimulants. Heroin was involved in 34.6% of opioid overdose deaths, and 73.6% of heroin overdose deaths co-involved IMFs (data not shown). Either cocaine or methamphetamine was involved in nearly all stimulant overdose deaths (96.2% with opioids, 97.5% without). Prescription opioids were involved more often in deaths involving opioids without stimulants (30.7%) than in those with stimulants (17.2%).

The 10 most frequently occurring opioid and stimulant combinations accounted for 76.9% of overdose deaths (Figure 2). Six drug combinations, including the three most common, involved IMFs and 1) no other opioid or stimulant (19.8% of deaths), 2) cocaine (10.5%), 3) heroin (10.3%), 4) heroin and cocaine (5.1%), 5) methamphetamine (3.7%), and 6) prescription opioids (3.3%). Deaths without IMFs involved a single opioid without other opioids or stimulants (only prescription opioids [9.2%], only heroin [3.2%]) or a single stimulant without other opioids or stimulants (only methamphetamine [6.3%], only cocaine [5.5%]).

More than three in five overdose deaths (62.7%) had evidence of at least one potential opportunity for intervention (Figure 3). Approximately one in ten opioid overdose deaths had evidence of past-month institutional release (10.7% with stimulants; 10.8% without stimulants) or previous overdose (10.9%; 12.1%). Mental health diagnoses were documented for one quarter (25.8%) of overdose deaths. Evidence of current or past substance use disorder treatment was more common among opioid overdose deaths (18.6% with stimulants; 19.1% without stimulants) than nonopioid overdose deaths (<10%). Among overdose deaths, 37% occurred with a bystander present.

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Discussion

This report provides three critical insights that can inform overdose prevention efforts. First, approximately 80% of overdose deaths involved opioids, and three of four opioid overdose deaths involved IMFs. The supply of IMFs and overdose deaths involving synthetic opioids excluding methadone (primarily IMFs) are projected to have increased for the seventh straight year in 2019 (1).§§§§ Second, IMFs, heroin, cocaine, or methamphetamine (alone or in combination) were involved in nearly 85% of overdose deaths. Complicating intervention and treatment efforts, one half of these deaths involved two or more of these four drugs. Third, potential opportunities for intervention, which could be targeted for overdose prevention, were documented in approximately 60% of overdose deaths.

Interventions should address characteristics of overdoses involving IMFs. First, IMFs can be highly potent (e.g., fentanyl has 50–100 times the potency of morphine; carfentanil has 30–100 times the potency of fentanyl) (13), and use might quickly progress to overdose (5,14), especially when injected. Consequently, improving overdose response time by expanding community naloxone distribution, increasing naloxone prescribing and dispensing from pharmacies, and encouraging persons to not use drugs when alone might reduce IMF overdose deaths (5,12). Second, powdered IMFs are often sold as or mixed with white powdered heroin (primarily east of the Mississippi River) with or without the knowledge of the person buying the products, but deaths involving IMFs and products containing IMFs are less prevalent in western black tar heroin markets.¶¶¶¶ Mixing of IMFs into heroin, and in some places IMFs supplanting the heroin supply, is increasing over time, consistent with findings that more than seven in 10 (73.6%) heroin-involved overdose deaths co-involved IMFs. Pressing IMFs into counterfeit prescription pills resembling both prescription opioids and other drugs (e.g., benzodiazepines) has allowed IMFs to spread into additional drug markets. IMFs are difficult to mix consistently, resulting in possibly varying concentrations of IMFs between and within products, or persons might use IMFs when expecting to use heroin, other opioids, or (rarely) nonopioids; either could increase the risk for overdose.***** Interventions conducted by risk reduction organizations (e.g., syringe services programs) to reduce overdoses among persons exposed to IMFs (e.g., naloxone distribution) and to link populations at high risk (e.g., persons who inject drugs) with prevention and treatment services might mitigate these overdose risks (15).††††† Finally, timely response by public health and public safety officials to growing threats such as mixing of IMFs in nonopioid products, and outbreaks involving fentanyl analogs (e.g., carfentanil) is warranted.§§§§§

In this report, one third (32.6%) of overdose deaths co-involved opioids and stimulants. Co-use of opioids and stimulants elevates fatal overdose risk and is associated with poorer medical, mental health, and substance use disorder treatment outcomes (16). Supporting increased access to medications for opioid use disorder¶¶¶¶¶ and evidence-based treatments for stimulant use disorders (17) can help mitigate risks. Research into more effective treatments for co-occurring opioid and stimulant use disorder is also needed. Methamphetamine was involved in approximately one half of stimulant overdose deaths without opioids. The methamphetamine supply has increased substantially since 2011,****** with accompanying increases in methamphetamine-related treatment admissions (18) and overdose deaths involving psychostimulants with abuse potential (e.g., methamphetamine) (1,4). Tracking of and response to these increases might help prevent further deaths.

Public health interventions targeting overdose risk factors identified in this report have shown effectiveness, especially for opioid overdose prevention (7). Recent release from an institution and previous overdose were both reported for approximately one in 10 opioid overdose deaths. Initiating or continuing medications for opioid use disorder among persons leaving prison (7,10) and expanding linkage to care programs targeting persons treated for a nonfatal overdose (7,9) can mitigate overdose risk. Also, outreach to groups at higher risk for overdose (e.g., persons who inject drugs) shows promise in reducing drug overdose deaths (7,15). For one quarter of deaths, there was evidence of a mental health diagnosis. Integrating substance use disorder and mental health treatment can improve treatment outcomes, which could help reduce drug overdoses (11,19). Finally, presence of a bystander at nearly four in 10 opioid- and stimulant-involved overdose deaths suggests a need to increase bystander naloxone training, access, and use (5,12). CDC, through the Overdose Data to Action program, is supporting expansions of programs linking persons at risk for overdose to treatment and risk reduction programs.

The findings in this report are subject to at least five limitations. First, the 25 jurisdictions are not nationally representative, and four states reported a subset of overdose deaths. Western states are underrepresented, likely resulting in an underestimation of methamphetamine overdose deaths that more frequently occur in the West (20). Second, toxicology testing and drug involvement determination varies over time and across jurisdictions. Third, all drugs detected are listed as involved when the cause of death does not specify drugs (e.g., multitoxicity death), which might overestimate drug involvement. Testing, drug involvement determination, and coding biases are minimized by focusing on commonly tested drugs frequently involved in deaths. Fourth, medical examiner/coroner reports likely underestimate intervention opportunities as investigators might have limited information. Finally, details about potential opportunities for intervention were limited (e.g., no information about whether a decedent was referred to treatment after a prior overdose), and they should therefore not necessarily be interpreted as missed opportunities.

Drug overdose interventions should address the combination and lethality of drugs being used (e.g., IMFs in combination with stimulants) and also work to prevent initiation of prescription drug misuse (e.g., inappropriate prescribing) and illicit drug use. The finding of this report that nearly 85% of overdose deaths involved IMFs, heroin, cocaine, or methamphetamine reflects rapid and continuing increases in the supply of IMFs and methamphetamine, coupled with illicit co-use of opioids and stimulants. This report also highlights important intervention opportunities for persons who use illicit drugs (especially IMFs), including the presence of bystanders, recent release from institutions, and high-risk routes of drug use (e.g., injection) that can be targeted to both prevent overdoses (e.g., by enhancing linkage to evidence-based treatment and risk reduction services) and improve response to overdoses to prevent deaths.

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Acknowledgments

Jurisdictions participating in CDC’s Overdose Data to Action (OD2A) program and providing data in the State Unintentional Drug Overdose Reporting System, including state and jurisdictional health departments, vital registrar offices, and coroner and medical examiner offices; CDC OD2A team, Division of Overdose Prevention, National Center for Injury Prevention and Control, CDC.

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Corresponding author: Julie O’Donnell, irh8@cdc.gov, 404-498-5005.

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1Division of Overdose Prevention, National Center for Injury Prevention and Control, CDC.

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All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

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* https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.

† SUDORS began in 2016 as part of CDC’s Enhanced State Opioid Overdose Surveillance (ESOOS) program, which funded 12 states, with an additional 20 states and the District of Columbia (DC) funded in 2017 to abstract data on opioid overdose deaths. In 2019, SUDORS expanded to collect data on all drug overdose deaths from 47 states and DC (collectively referred to as jurisdictions) as part of CDC’s Overdose Data to Action (OD2A) program. https://www.cdc.gov/drugoverdose/od2a/index.html.

§ Alaska, Connecticut, DC, Delaware, Georgia, Kentucky, Maine, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, North Carolina, Ohio, Oklahoma, Rhode Island, Tennessee, Utah, Vermont, West Virginia, and Wisconsin reported data on all overdose deaths within the jurisdiction. Illinois, Indiana, Pennsylvania, and Washington reported data from a subset of counties that accounted for 86.6%–88.7% of all unintentional and undetermined intent drug overdose deaths in those states in 2017 (SUDORS funding requirement was to report data from counties accounting for ≥75% of the drug overdose deaths in the state in 2017, the most recent year of statewide data available at the time of funding).

Data are reported to SUDORS in half-year increments (January–June and July–December) based on when deaths occurred. Jurisdictions that participated in SUDORS under ESOOS (32 states and DC) were eligible to report data for deaths that occurred during January–June 2019. Twenty-five of the 33 jurisdictions eligible to report data for that period submitted complete data at the time of analysis and were included in this report. Data for this report were downloaded on July 7, 2020, and might differ from other reports because death data might be updated over time, and SUDORS supplements death certificate data with medical examiner/coroner reports.

** When the cause of death indicated multiple drugs were involved but did not indicate specific drugs, all drugs detected by postmortem toxicology testing were classified as involved in the drug overdose death. For example, if the cause of death was “multidrug overdose” and toxicology results were positive for five drugs, all five were classified as involved.

†† Fentanyl was classified as likely illicitly manufactured or likely prescription using toxicology, scene, and witness evidence. In the absence of sufficient evidence to classify fentanyl as illicit or prescription (<7% of deaths involving fentanyl), it was classified as illicit because the vast majority of fentanyl overdose deaths involve illicit fentanyl. With few exceptions, fentanyl analogs are considered illicit because they do not have a legitimate medical use in humans. The three fentanyl analogs with legitimate human medical use are alfentanil, remifentanil, and sufentanil. Fewer than 10 deaths involved any of these three analogs, and they were classified as prescription opioids rather than illicit fentanyl. All other fentanyl analogs were included in the category of illicitly manufactured fentanyls.

§§ If morphine was detected along with 6-acetylmorphine (a metabolite of heroin indicating heroin use), it was classified as heroin. Detection of morphine in the absence of 6-acetylmorphine was classified as likely heroin using toxicology evidence of heroin impurities or other illicit drugs detected or scene or witness evidence that indicated injection drug use, illicit drug use, or a history of heroin use.

¶¶ Drugs coded as prescription opioids were alfentanil, buprenorphine, codeine, dextrorphan, hydrocodone, hydromorphone, levorphanol, loperamide, meperidine, methadone, morphine, noscapine, oxycodone, oxymorphone, pentazocine, prescription fentanyl, propoxyphene, remifentanil, sufentanil, tapentadol, and tramadol. Also included as prescription opioids were brand names (e.g., Opana) and metabolites (e.g., nortramadol) of these drugs and combinations of these drugs and nonopioids (e.g., acetaminophen-oxycodone). Morphine was included as prescription only if scene or witness evidence did not indicate likely heroin use, and if 6-acetylmorphine was not also detected.

*** Drugs coded as prescription stimulants were amphetamine (in the absence of methamphetamine), atomoxetine, ephedrine, and methylphenidate.

††† Reported evidence of decedent and overdose characteristics in SUDORS is likely an underestimation of the true prevalence of those characteristics because SUDORS uses information from medical examiner/coroner reports, which are completed for death investigations, not specifically for SUDORS, and therefore might not reflect all information about the deaths or decedents.

§§§ Release within the month before death from institutional settings, such as prisons/jails, residential treatment facilities, and psychiatric hospitals.

¶¶¶ This is the location where the overdose occurred such as decedent’s home, the home of a person other than the decedent, or a motor vehicle.

**** Jurisdictions were grouped as Midwestern (Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin), Northeastern (Connecticut, Maine, Massachusetts, New Jersey, Pennsylvania, Rhode Island, Vermont), Southern (DC, Delaware, Georgia, Kentucky, North Carolina, Oklahoma, Tennessee, West Virginia), or Western (Alaska, Nevada, Utah, Washington), according to U.S. Census region groupings. This report includes 50% of jurisdictions in the Midwest region, 78% of those in the Northeastern region, 47% of those in the Southern region, and 31% of those in the Western region, so groupings should not be interpreted as fully representative of the corresponding Census regions.

†††† Route of drug use is likely underestimated, because physical evidence varies among routes (e.g., syringes/needles as evidence of injection and pipes as evidence of smoking) and can be subject to scene-cleaning by bystanders before death investigations. High percentages of deaths with no information about route of drug use result from lack of physical or witness evidence, lack of documentation of evidence, or data entry error.

§§§§ https://www.nflis.deadiversion.usdoj.gov/DesktopModules/ReportDownloads/Reports/13408NFLISDrugMidYear2019.pdfpdf iconexternal icon; https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.

¶¶¶¶ https://www.dea.gov/sites/default/files/2020-01/2019-NDTA-final-01-14-2020_Low_Web-DIR-007-20_2019.pdfpdf iconexternal icon.

***** https://www.dea.gov/sites/default/files/2020-01/2019-NDTA-final-01-14-2020_Low_Web-DIR-007-20_2019.pdfpdf iconexternal icon.

††††† https://www.cdc.gov/ssp/syringe-services-programs-summary.html.

§§§§§ https://www.dea.gov/sites/default/files/2020-01/2019-NDTA-final-01-14-2020_Low_Web-DIR-007-20_2019.pdfpdf iconexternal icon; https://emergency.cdc.gov/han/han00413.asp.

¶¶¶¶¶ https://www.hhs.gov/opioids/about-the-epidemic/hhs-response/better-access/index.htmlexternal icon.

****** https://www.nflis.deadiversion.usdoj.gov/DesktopModules/ReportDownloads/Reports/13408NFLISDrugMidYear2019.pdfpdf iconexternal icon.

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DEA Submits Proposed Quotas for 2021

Posted on September 3, 2020 by Pharmaciststeve

Looks like the “powers to be” believe that very very many people suffering from chronic pain – over the this year and next – will be cut off their medically necessary pain medications, die from under/untreated pain compromising their underlying comorbidity issues or just chose a “death of desperation ” (Suicide).  Since our Founding Fathers did not define what the  “pursuit of happiness” encompassed, so our bureaucrats – using their own moral compass – have apparently decided that treatment of chronic pain is not part of our RIGHTS to be engaged into the pursuit of happiness.

To me, the timing of this proposed cuts in quotas is not accidental, starting this weekend all 435 members of the House and 1/3 of the Senate will be in full blown re-election mode.  Not much will get done between now and Jan, 2021 when the new Congress starts.

How many times have members of the community made phone calls, sent emails/letters, signed petitions, responded to proposed changes during public comment period and has anyone seen how any of those actions has impacted a positive change toward those in the community or if all the comments made actually made in changes in the original proposal ?

I remember a bill passed by Congress that would attempt to restrict the availability of opiates to treat pain and ONLY ONE in the Senate and a HANDFUL- or so – in the House VOTED AGAINST IT…  Probably the only time in the last several years that Congress has acted in a nearly unanimously bipartisan manner toward any bill/proposed law.   That would suggest that no matter if your representatives in Congress is a Democrat or a Republican… they could care less about how much you suffering you are dealing with. They obviously DON’T FEEL YOUR PAIN !

Could this be DEA’s reaction to some states trying to pass laws that would try to allow chronic pain pts a better access to pain management meds ?  If there is fewer doses of opiates available at the local pharmacy…  Does it really make any difference how many Rxs for opiates are written ?

Businesses spend 9+million/day on lobbying Congress… because they are successful in getting Congress to change directions in a way that benefits those businesses.  But it would seem that those in the community believe that their votes and their opinions will impact the member of Congress to see things their way..  Since the expiration of the Decade of Pain Law expired in 2009 and was not renewed… nothing has went in the direction that those in the community would like to see it happen.

I refer you to Einstein’s definition of INSANITY 

DEA Submits Proposed Quotas for 2021

https://www.deachronicles.com/2020/09/deas-submits-proposed-quotas-for-2021/

DEA rolled out its proposed aggregate production quotas for 2021 earlier this week, the same day, in fact, that it proposed adjustments to its 2020 quotas. Let’s start off by looking at the Big Five, at least as far as the SUPPORT Act is concerned: fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone.

Here is a snapshot:

Drug Proposed 2021 Quota (g) Vs. Original 2020 Quota Vs. Adjusted 2020 Quota
Fentanyl 666,249 -18% -29%
Oxycodone 57,110,032 -15.5% -13%
Hydrocodone 30,821,224 -12% -9%
Oxymorphone 28,204,371 +15% No Change
Hydromorphone 2,827,940 -7.5% -19.5%

As you can see, with the exception of oxymorphone, the proposed quotas are down significantly for the Big Five, from both the original 2020 quotas and the adjustments we saw both in April and yesterday.

Some of the reduction may be explained by DEA’s April adjustments, which were largely in response to the coronavirus pandemic. DEA increased the quotas for particular substances related to the treatment of the virus, including fentanyl, oxymorphone, and hydromorphone.

Now, under the SUPPORT Act, when arriving at the aggregate production quota, DEA must estimate the amount of diversion of any “covered controlled substance,” (i.e., the Big Five.) So how does DEA arrive at these diversion estimates? Well, under the SUPPORT Act, when analyzing diversion rates, DEA is charged with acting “in consultation” with HHS to determine “rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance…” (DEA may also consult any other source it deems reliable.) DEA did not find most of the consultations particularly helpful apparently, finding both the CDC information on the rates of overdose deaths and the CMS information on rates of overprescribing either incomplete or unreliable for estimating diversion.

DEA fared better with the FDA apparently, but even here there was a wrinkle. FDA is responsible for providing “estimates and predictions of legitimate medical needs” for controlled substances in a calendar year. Quite an estimate it was too. FDA’s predicted level of medical need was “expected to decline on average 36.52 percent for calendar year 2021.” Wow. That said, “FDA’s predicted level of medical need for the United States was calculated by FDA at the beginning of the Coronavirus . . . pandemic and, therefore, did not take into account changes in usage that are necessary to treat patients who require schedule II controlled substances.”

I should note here, however, that DEA did “consider FDA’s concerns” over potential shortages in ADHD medications (amphetamine, methylphenidate, and lisdexamfetamine) when calculating its quotas for these controlled substances. But DEA also indicated that it “has grown increasingly concerned over the misuse of prescription stimulants among young adults and the demand for methamphetamine in the U.S.” This concern is leading DEA to “closely” monitor “trends in licit stimulant use.” The numbers indicate DEA largely held steady on the quotas for these stimulants.

Finally, DEA mentions that nine states’ attorneys general submitted PDMP data in response to a DEA request. “The data that DEA received varied in its form and content,” however, “and was ultimately determined to be inapplicable at the national level.”

So, for the most part and as DEA has historically done, DEA used its own internal reports to arrive at its diversion numbers for the Big Five. And, given the FDA’s whopping prediction about the decrease in medical need, the quota decreases may not be so dramatic as they might have been.  The historic and ongoing conflict between DEA’s assessment of the legitimate medical needs of the United States versus FDA’s assessment does not seem to be abating.  It will be interesting to see what, if anything, Congress will have to say about this.

Filed under: General Problems | 6 Comments »

Ready for Human 2.0?

Posted on September 2, 2020 by Pharmaciststeve

https://youtu.be/ywuCRVJVDqs

I am not sure about this… color me skeptical… I do know that “they” are experiencing with some different ways of creating vaccines than what has been done in the past.  I am just sharing this.

Filed under: General Problems | 1 Comment »

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