DEA Proposes Reduction in US Opioid Manufacturing Quotes

https://www.natlawreview.com/article/dea-proposes-reduction-us-opioid-manufacturing-quotes?

Yesterday, in a joint statement by the US Department of Justice and the US Drug Enforcement Administration (DEA), the government proposed a reduction in the Aggregate Production Quotas (APQ) for certain controlled substances that may be manufactured in the United States next year. The government indicated that its intent was to “cut nationwide opioid prescription fills by one-third within three years.” The proposal decreases manufacturing quotas for six opioids (oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl) by an average of 10 percent, as compared to 2018 quotas.

As the government noted, the action marks the third straight year of proposed reductions. Although the reduction was not formally tied to diversion statistics, the government stated that the reduction was consistent with its announcement earlier this year of a rule amending DEA’s regulations to improve the agency’s ability to consider the likelihood of whether a drug can be diverted for abuse when it sets annual opioid production limits.  

The APQ is designed to control the quantities of basic ingredients needed for the manufacture of controlled substances. The APQ is the first step in determining allocations made available for individual US manufacturers to produce controlled substances. Once the APQ is set, the DEA allocates individual manufacturing and procurement quotas to those manufacturers that apply for them. The DEA noted that these individual manufacturer allocations may be subject to further revision during the course of a year based upon a number of factors, including increased or decreased sales or exports, new manufacturers entering the market, new product development or product recalls.

This is where the DEA “found” their opinion(s) on abuse

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I have the photo.This is from a pt from WA.  ”Last night after a bad bicycle accident with lacerations down to the bone they gave me two Tylenol in the ER as I was screaming through my clenched teeth.
“We can’t give you anything else.” Why? Because doctors are afraid of losing their licenses if they prescribe pain medication”. This is happening all over the country folks. You better get up and do something or you and your children will be next.************

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Prescription Drug Monitoring Program May Not Cut Opioid Use

https://www.clinicaladvisor.com/pain-information-center/prescription-drug-monitoring-program-may-not-cut-opioid-use/article/791479/

HealthDay News — Implementation of a mandatory prescription drug monitoring program (PDMP) does not necessarily reduce the overall rate of opioid prescribing or the mean number of pills prescribed for patients undergoing general surgical procedures, according to a study published online Aug. 22 in JAMA Surgery.

Ryland S. Stucke, MD, from Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and colleagues conducted a prospective observational cohort study at an academic hospital among 1057 patients undergoing representative elective general surgical procedures from July 1, 2016, to June 30, 2017. Beginning Jan. 1, 2017, new state legislation mandated the use of a PDMP and opioid-risk assessment tool for all patients receiving an outpatient opioid prescription.

The researchers found that there was no significant reduction in the percentage of patients prescribed opioids after surgery before versus after the new requirements (80 vs 77%; P = 0.29). In the six months before the mandatory PDMP requirement, the mean number of opioid pills prescribed decreased from 30.8 to 24 (22.1%); in the 6 months after the legislation, the decrease was less, from 22.8 to 21.9 pills (3.9%). No high-risk patients who subsequently were not prescribed opioids were identified by the new requirements.

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https://www.clinicaladvisor.com/pain-information-center/odds-of-death-up-with-exposure-to-pregabalin-opioids/article/789877/

HealthDay News &,dash; Concomitant exposure to pregabalin and opioids is associated with increased odds of opioid-related death, according to a research letter published online Aug. 21 in the Annals of Internal Medicine.

Tara Gomes, Ph.D., from the University of Toronto, and colleagues conducted a population-based nested case-control study and identified a cohort of persons aged 15 to 105 years who received publicly funded opioid prescriptions between Aug. 1, 1997, and Dec. 31, 2016. Case patients (1,417), defined as those who died of an opioid-related cause, were matched with up to four controls based on age, sex, index year, history of chronic kidney disease, and Charlson comorbidity index (5,097 participants).

The researchers found that, compared with opioid exposure alone, concomitant exposure to pregabalin in the preceding 120 days correlated with significantly elevated odds of opioid-related deaths (adjusted odds ratio, 1.68). Results were consistent in sensitivity analyses assessing pregabalin use overlapping the index date and after matching on prior use of central nervous system depressants (odds ratios, 1.81 and 2.00, respectively). A high dose of pregabalin correlated with increased odds of opioid-related death compared to no pregabalin exposure in the dose-response analysis (adjusted odds ratio, 2.51), while the odds of opioid-related death were lower but still significantly elevated with a low or moderate dose of pregabalin (adjusted odds ratio, 1.52).

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These pharmacies topped J.D. Power’s 2018 survey

https://www.drugstorenews.com/pharmacy/these-pharmacies-topped-j-d-powers-2018-survey/

The pharmacy industry continues to provide superior levels of customer satisfaction in the brick-and-mortar and mail-order segments, according to the J.D. Power 2018 U.S. Pharmacy Study, released Tuesday. Health-and-wellness services available in brick-and-mortar pharmacies and the timeliness of delivery for mail order pharmacies are among the key factors driving customer satisfaction.

Good Neighbor Pharmacy ranked highest overall among brick-and-mortar chain drug stores, with a score of 903. Health Mart (890) ranked second and Rite Aid Pharmacy ranked third (846). Sam’s Club ranked highest overall among brick-and-mortar mass merchandiser pharmacies, with a score of 892. Costco (860) ranks second and CVS/pharmacy inside Target (859) ranks third. Among brick-and-mortar supermarket pharmacies, Wegmans ranked highest overall, with a score of 906. H-E-B (897) ranked second and Publix (891) ranked third.

Humana Pharmacy ranked highest overall in mail order with a score of 885. Kaiser Permanente Pharmacy (866) ranks second and Express Scripts (862) ranks third.

The 2018 study is based on responses from 10,749 pharmacy customers who filled a prescription during the three months prior to the survey period of May-June 2018.

“The retail pharmacy business has been in the spotlight ever since Amazon announced in June 2018 that it’s getting into the space,” J.D. Power senior director and healthcare practice leader Greg Truex, said, in a press statement. “Amazon, or any other organization looking to disrupt the $100 billion U.S. mail order pharmacy market, will have their work cut out for them. Legacy pharmacy players have invested heavily in delivering superior service, while brick-and-mortar pharmacies are starting to reap significant customer satisfaction gains from retail-style clinics offering health and wellness services.”

The study also found the following:

•  The average customer satisfaction score for brick-and-mortar pharmacies was 847 on a 1,000-point scale; mail order was 859, which is favorable when compared to h other high-scoring industries evaluated by J.D. Power, such as direct banks (863), property and casualty insurance companies (860) and full-service investment advisors (839). Among the different pharmacy segments, supermarkets have the highest levels of overall satisfaction (863).
• Among brick-and-mortar pharmacies, the key driver of overall customer satisfaction is the availability of health and wellness services. Availability of these services is associated with a 66-point improvement in overall satisfaction. Such services are currently present in 86% of chain drug stores, 83% of supermarket pharmacies and 75% of mass merchandiser pharmacies.
• Among mail-order pharmacies, the key driver of overall customer satisfaction is having a prescription ready/delivered when promised. Delivering prescriptions on time is associated with a 78-point increase in overall customer satisfaction. Customers also evaluate the speed of delivery, adding 42 points to overall satisfaction scores when prescriptions are received within five days of completing an order.
• •Some of the most significant drivers of customer satisfaction in all pharmacy segments include friendly, engaging service. Among brick-and-mortar pharmacies, the second-most effective driver of overall satisfaction is “non-pharmacist staff greeted you in a friendly manner,” which is associated with a 64-point increase in customer satisfaction. Even in the mail-order segment, a “thank you” from non-pharmacist staff is associated with a 17-point increase in satisfaction.

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Sign this #MEAction petition and stop the CDC from making ME treatment guidelines without our input!
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Take urgent action to stop the CDC from repeating a terrible mistake.

Dear GivePain,

We need your help.

The US Centers for Disease Control (CDC) is updating its ME treatment guidelines. As part of this work, it is attempting to quietly hire the same independent contractor that previously recommended graded exercise therapy (GET) and cognitive behavioral therapy (CBT) for the treatment of ME.
We cannot let history repeat itself: Sign the #MEAction petition to stop the CDC from repeating a terrible mistake. Then SHARE on social media and with friends and loved ones. We must act quickly and respond by Friday, Aug. 31st. That’s this Friday!

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The CDC is attempting to quietly hire the Pacific Northwest Evidence-based Practice Center (EPC) for a sole-source contract to help them develop new federal guidelines for ME/CFS treatment. That may not sound that bad, but there is plenty of reason to be alarmed. This same contractor was hired four years ago to do a similar literature review of the evidence base for ME/CFS treatments by a CDC sister-agency, the Agency for Healthcare Research and Quality (AHRQ). It did not go well.
The EPC’s 2014 report included recommendations for graded exercise therapy (GET) and cognitive behavioral therapy (CBT), and concluded that PACE was a good trial with little bias! Only through the dogged work of many ME advocates and an #MEAction petition did EPC finally issue a reanalysis TWO YEARS LATER. However, they still refused to publish this 2016 addendum in a peer-reviewed journal, making their conclusions effectively invisible to any future developers of treatment guidelines for ME. This is not a contractor whose expertise or quality of work the CDC should trust.

We cannot let history repeat itself. We have to stop this right now. The CDC is trying to rush the EPC contract through with minimum time for us to respond. We only have until August 31 – THIS Friday – to respond.

Sign the petition to demand that the CDC not issue this contract, put the project on hold, and meet with #MEAction immediately to discuss implementing a transparent and collaborative process for creating future guidelines that engages advocates and community representatives, and includes experienced ME researchers and expert practitioners.
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