Looks like the FDA has drank the CDC’s Kool-aid and ate their brownies regarding opiate dosing

Posted on April 13, 2023 by Pharmaciststeve

Here is a interesting statement from our Federal government:  When we draw on the wisdom of a workforce that reflects the population we serve, we are better able to understand and meet the needs of our customers-the American people.  Diversity, Equity, Inclusion, and Accessibility 

This Administration is a strong supporter of DEI (Diversity, Equity, Inclusion), but there seems to be less and less EQUITY for  those within the chronic pain community. It seems to totally the support those groups whose mantra is “My body my choice”, ” I am who I say I am ‘, No justice No peace”. Seems like every week there is a new subset of our population and a new agenda and another mantra.

Below, I have put links to two different posts on my blog that explains that Hyperalgesia is just a little less rare than a UNICORN !

FDA Announces New Safety Label Changes For Opioid Pain Medicines

The perceived prevalence of OIH in clinical practice is a relatively rare phenomenon

Opioid Induced Hyperalgesia—Exploring Myth and Reality

The FDA is requiring several updates to the prescribing information for immediate-release (IR) and extended-release/long-acting (ER/LA) opioid analgesics.

The updates also include a new warning about opioid-induced hyperalgesia (OIH) which is a condition where opioids cause an increase in pain (hyperalgesia) or an increased sensitivity to pain (allodynia).

Opioid pain medicines are an important treatment option in appropriate situations when used as prescribed; however, they also have serious risks. Although the number of dispensed prescriptions for opioid pain medicines has substantially decreased, data suggests that patients who use opioids for pain relief after surgery often have leftover tablets, which can pose a risk for nonmedical use, accidental exposure, addiction, and overdose. We also know that for a number of disorders that can cause chronic pain, non-opioid medications and other treatments can provide effective pain relief without the risks associated with opioid medications. These safety labeling changes (SLCs) are intended to provide clarity on appropriate patient populations for opioid treatment, appropriate dosage and administration, and updated information on the risks associated with opioid use.

The required safety labeling changes, listed in the Drug Safety Communication, include stating:

  • the risk of overdose increases as the dosage increases for all opioid pain medicines;
  • IR opioids should not be used for an extended period of time unless a patient’s pain remains severe enough to require them and alternative treatment options continue to be inadequate;
  • many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine; and
  • it is recommended to reserve ER/LA opioid pain medicines for severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine and for which alternative treatment options are inadequate.

The updates also include a warning about OIH for both IR and ER/LA opioid pain medicines, including information on differentiating OIH symptoms from those of opioid tolerance and withdrawal.

This action is just one facet of the FDA’s progress towards implementing the FDA Overdose Prevention Framework, which provides our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths.

We remain focused on responding to all facets of substance use, misuse, overdose, and death through the four priorities of the framework, including: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

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Chronic Pain Affects 21% of Americans, CDC Reports

Posted on April 13, 2023 by Pharmaciststeve

Chronic Pain Affects 21% of Americans, CDC Reports

https://www.medpagetoday.com/neurology/painmanagement/104010

 Nearly 7% have pain severe enough to restrict daily activities

Chronic pain continued to affect more than one in five U.S. adults, new CDC survey data showed.

During 2021, an estimated 51.6 million adults (20.9%) had chronic pain lasting 3 months or longer, and 17.1 million (6.9%) had high-impact chronic pain — pain severe enough to restrict daily activities — reported S. Michaela Rikard, PhD, of the CDC’s National Center for Injury Prevention and Control, and co-authors.

Pain prevalence was higher in adults who were American Indian or Alaska Native, who identified as bisexual, or who were divorced or separated, the researchers said in Morbidity and Mortality Weekly Reportopens in a new tab or window.

“Clinicians, practices, health systems, and payers should vigilantly attend to health inequities and ensure access to appropriate, affordable, diversified, coordinated, and effective pain management care for all persons,” Rikard and colleagues wrote.

The 2022 CDC guideline for prescribing opioidsopens in a new tab or window provides recommendations about multimodal approaches to pain management and strategies to reduce pain care disparities, the researchers stated. “In addition, policies and programsopens in a new tab or window that address primary injury prevention, improved access to affordable, culturally responsive health care, and more effective pain management therapies can mitigate the burden of chronic pain,” they pointed out.

The prevalence of chronic pain in 2021 was similar to the prepandemic estimate of 20.4%opens in a new tab or window in 2016, Rikard and co-authors noted.

The new findings come from the 2019-2021 National Health Interview Surveyopens in a new tab or window (NHIS), a cross-sectional poll conducted annually by the National Center for Health Statistics. Sample sizes and response rates for the NHIS were 31,997 adults in 2019 with a response rate of 61.1%; 31,568 in 2020 with a response rate of 48.9%; and 29,482 in 2021 with a response rate of 50.9%.

Consistent with previous surveys, chronic pain was defined as pain most days or every day in the previous 3 months. High-impact chronic pain was defined as chronic pain that limited daily life or work activities most days or every day in the previous 3 months. Pain prevalence was adjusted for age.

Chronic pain prevalence ranged from 28.0% in American Indian or Alaska Native populations to 7.7% in Asian populations. High-impact pain was 12.8% in American Indian or Alaska Native respondents, but considerably less in white (6.5%) and Asian (2.1%) adults.

Among people identifying as bisexual, chronic pain prevalence was 32.9%, and was lower in people who identified as straight (19.3%) and gay or lesbian (20.7%).

Divorced or separated people had a higher prevalence of both chronic pain and high-impact chronic pain (29.6% and 10.1%, respectively) than married people (18.2% and 5.2%, respectively).

Among all chronic medical conditions reported in the survey, the prevalence of chronic pain and high-impact chronic pain was highest among people with a history of myalgic encephalomyelitis/chronic fatigue syndrome (70.0% and 43.8%, respectively) or dementia (54.9% and 34.2%, respectively).

The findings have several limitations, Rikard and co-authors acknowledged. Military personnel and people in nursing homes and other institutions were excluded from the study, they noted. Survey responses were self-reported and subject to recall bias. In addition, the COVID-19 pandemic affected data collection and changed health care access and utilization, which may have influenced results.

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There is just no words

Posted on April 13, 2023 by Pharmaciststeve

“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – VP/Pharmacist Hubert Humphrey

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Patients and patient advocates, it’s time to tell your story!

Posted on April 10, 2023 by Pharmaciststeve

Patients and patient advocates, it’s time to tell your story!

https://www.daily-remedy.com/survey/patients-and-patient-advocates-its-time-to-tell-your-story/

https://www.daily-remedy.com/survey/patients-and-patient-advocates-its-time-to-tell-your-story/

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Proposed DEA restrictions on telehealth will accelerate America’s opioid crisis

Posted on April 10, 2023 by Pharmaciststeve

Proposed DEA restrictions on telehealth will accelerate America’s opioid crisis

https://rollcall.com/2023/04/04/proposed-dea-restrictions-on-telehealth-will-accelerate-americas-opioid-crisis/

Former Democratic congressman calls for ‘Cabinet-level leadership’ on opioids

On Friday, the Drug Enforcement Administration (DEA) proposed new rules to permit the ongoing use of telemedicine to treat patients with opioid use disorder that fail to accomplish their stated objective and will effectively end access to treatment for the 8 million Americans estimated to have OUD.

If these rules move forward as drafted, tens of thousands will experience overdose or other harms from lack of treatment — and many could die.

Unfortunately, this is not my opinion — it is a fact. Cumulative research collected over the past 20 years shows that long-term treatment of opioid use disorder with buprenorphine reduces opioid relapses, overdoses and deaths.

An FDA-approved medication called buprenorphine has been shown to keep people with opioid use disorder from relapsing into problematic opioid use, which, in turn, reduces opioid-related overdoses and deaths and lowers the cost of care for OUD patients by more than 40 percent. When prescribed correctly, buprenorphine saves lives.

In spite of the mountains of research demonstrating the efficacy of OUD treatment with buprenorphine, by January 2020 — in the midst of an opioid epidemic that would claim more than 75,000 lives that year — less than 10 percent of people with OUD were receiving treatment with buprenorphine. For a country as large and wealthy as ours, that number is a disgrace by any measure.

When the COVID-19 pandemic hit in March of 2020, something unexpected happened: The COVID-19 public health emergency (PHE) temporarily waived limitations on telemedicine, making it possible for treatment programs to prescribe Suboxone (a formulation of buprenorphine that prevents misuse) to patients without an in-person visit. Even as the opioid crisis worsened, within a year of opening up access to treatment via telehealth, the rate of opioid-related overdoses and deaths began to decline.

Between January and August of 2022, researchers at CMS and NIH published studies showing that access to medications for opioid use disorder (MOUD) via telemedicine had reduced opioid-related emergency room visits and overdoses. In the eight months between those two studies, access to MOUD via telemedicine was supported by bipartisan leaders in Congress, a bipartisan coalition of state attorneys general and by the Biden White House.

With the PHE ending in May, DEA was required to update their requirements for writing buprenorphine prescriptions via telemedicine, and on Feb. 24, a summary of their proposed rules were published. The net effect of their proposal will restrict access to buprenorphine to a 30-day prescription via telemedicine.

This increases the risks to this vulnerable patient population, and once again, this isn’t my opinion. In 2003 the medical community learned that a 30-day opioid “detox” using buprenorphine has a 100 percent failure rate, compared with a 75 percent success rate for patients who received MOUD treatment with buprenorphine for at least 12 months. Six years later, in 2009, researchers found that 70 percent of OUD patients who tapered off of buprenorphine over a 28-day period had fallen back into illicit use within a month.

No matter how many new studies are run, the outcomes stay the same. Reducing access to buprenorphine increases overdoses, ER visits and deaths.

I’m an adviser to an in-person OUD treatment center that began prescribing Suboxone via telemedicine in 2021. Since the COVID PHE began, that company, Bicycle Health, has expanded to 32 states and treated more than 20,000 patients with opioid use disorder. They’ve had their care model studied by researchers, and while a number of the studies are currently in peer review, two have been published in peer-reviewed medical journals with phenomenal results.

The pieces support that, with telehealth, patients stay in treatment longer (nearly twice as long when care is covered by insurance) than patients treated in-person. Patients also found OUD treatment via telehealth to be easier to access and safer when compared to in-person treatment.

A fair interpretation of DEA’s proposed rule is that the DEA feels telemedicine-only OUD care should remain illegal, even though it’s well-supported to be safe and effective. Their requirement of in-person physical contact with a DEA-registered health care provider in order to continue tele-OUD care has no rational purpose for patient care or safety. There is no medical necessity of in-person contact to provide an OUD diagnosis or prescription. Either the DEA misunderstands the value of direct physical contact in treating OUD or perhaps the unstated goal is to limit buprenorphine access through yet another unnecessary barrier.

There’s no question that access to MOUD treatment via telehealth needs to be regulated, but the DEA is flat-out wrong with this initial draft. Even if you put the data to the side for a moment, and just think about the human aspect of this problem, restricting access to care is morally reprehensible.

Unlike the COVID public health emergency, where we labored without effective treatment options for more than a year, the opioid public health emergency has increased in intensity for years with a highly effective treatment option available that is massively under-utilized.

I believe these kinds of regulatory missteps could be avoided if the Biden administration had followed the recommendations of the Bipartisan Mental Health and Substance Use Disorder Task Force — and 51 other members of Congress — and reinstated the director of the Office of National Drug Control Policy (ONDCP) to a Cabinet-level position. Since the position was removed from the Cabinet, deaths from overdose in the U.S. have more than doubled.

In the absence of Cabinet-level leadership here, it is my sincere hope that lawmakers in Washington, D.C., and at the state level push back on the DEA in support of commonsense regulations on MOUD treatment via telehealth. Congress can come together, increase access to care and save people’s lives.

Patrick J. Kennedy is a former Democratic congressman and the co-founder of One Mind, a nonprofit focused on mental health. Patrick is an advisor of Bicycle Health, a provider of virtual opioid use disorder treatment and was a member of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. He represented Rhode Island’s 1st Congressional District from January 1995 until January 2011.

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Is the large chain pharmacies getting out of filling controlled med Rxs ?

Posted on April 10, 2023 by Pharmaciststeve

Here is the SMOKING GUN to prove civil rights violations – could support a class action lawsuit – but the community needs to stand up

Above is a post that I made just a couple of days ago and below is a quote I saw on the web, don’t know what city this is happening in, but this would appear to be the actions/reactions of one or more chain pharmacies to the recent HUGE FINES that these chains agreed to because without admitting to any guilt – agreed to pay BILLION OF DOLLARS because of being part of the contribution to the fabricated opioid crisis. It would appear that chronic pain pts are going to be the collateral damage of this “social” war on drugs/pts.  This could be the FIRST SHOE of many shoes that will drop.  Use this phrase in a search engine to find the law firms “law firms and class actions civil right Americans with Disability Act”  If you are waiting for GEORGE TO DO IT –   George is NOT COMING TO HELP YOU !

If you don’t believe that healthcare is nothing more – nothing less than a PROFIT DRIVEN INDUSTRY.  Pay attention to the graph below,  look at the average GROWTH of these major healthcare entities REVENUE. Remember that United Health is endorsed by AARP and what article I have read in AARP publications, they are mostly in lock step with the DEA and others believing that prescription opiates are the genesis of the fabricated opioid crisis.

 

Every preferred pharmacy has let my pain management practice know that they are no longer accepting prescriptions from their practice. I originally thought this was just my pain management practice but after speaking to other pain patients in our area who see other pain management doctors or practices they have run into this same issue. All the work spent in open enrollment to figure out where best to get medications was all for naught since I am no longer receiving discounts for a preferred pharmacy and worse trying to find pharmacies that will accept and fill your prescriptions are few and far between and most requiring that all your medications be filled by them no matter the cost that you as a patient have to pay. Someone said it was due to the suits discussed here and these bigger pharmacies and chain pharmacies just are not accepting or filling prescriptions that can set them up for additional settlements or suits in the future.

From 2021 to 2022, the big 5 payers got even bigger.

In order, here’s their 2022 revenue:
– UnitedHealth Group: $435B
– CVS: $367B
– Cigna: $181B
– Elevance Health: $180B
– Humana: $93B

Whether you like it or not, these plans (along with the large BCBS plans and Kaiser) dominate health insurance.

The fundamental problem with health insurance as a pure business is that it is low margin (due to MLR and ALR requirements), hard to scale, and has high capital costs (i.e., risk-based capital requirements).

Since 80-85% of the cost is guaranteed to go into medical spend (although some reclassification of expenses exists), it only makes business sense for payers to launch provider services.

To some degree, they are able to double dip profits, first from the plan perspective and then from the provider side.

Now the question remains, will doctors use services rendered by payer entities? I know many doctors who prefer not to refer to these subsidiaries, because they often battle with the payer over prior auth and rate negotiations.

Regardless, bigger ideas are coming. Who is next and what will they buy?

Credit: Gist Healthcare

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Here is the SMOKING GUN to prove civil rights violations – could support a class action lawsuit – but the community needs to stand up

Posted on April 8, 2023 by Pharmaciststeve

The link below is to the nearly 600 page agreement between the three major drug wholesalers and 50 state AG’s, Native American Reservations and others. There is supposedly a similar settlement for 13+ billion with Walgreen, CVS, Walmart. SURPRISE !! the settlement money is suppose to be used in a “don’t do drugs” patterned after the Tobacco Lawsuit.  Most of the state annuity that the Tobacco lawsuit created will mostly DRY UP in another couple of years, and many of the state involved in that lawsuit, promised a “do not smoke education campaign” with the money they got from the lawsuit, but many states have just put that money into the STATE’S GENERAL FUND.

What was agreed  upon in this agreement could be the basis for chronic pain pts to approached law firms that deal with civil rights violations under ADA, especially class actions.  This could be the “SMOKING GUN ” for the chronic pain community to seek some level the playing field

The 3 major drug wholesalers agreed to funding educating prescriber to be consistent with the 2016 CDC opioid dosing guidelines, even hospital pts. Which heavily references the MME SYSTEM which has been proven to have no science nor double blind clinical studies to support its conclusions.

This article makes the point that the DEA/DOJ are targeting the limiting of Adderalls and Xanax being sold to pharmacies by these drug wholesalers  Xanax and Adderall Access Is Being Blocked by Secret Drug Limits   

It is claimed that there is 25-35  million intractable chronic pain pts… each requiring pain management 24/7, these are high acuity pts – the sickest of the sick.  What would happen if all these pts were limited to the fabricated 90 MME/day or  have their necessary pain medication reduced and/or totally stopped ?

If you are reading this – SHARE IT… feel free to contact a civil rights law firm… this is not a single state issue, this is happening in most/all states.  Use this to do a web search “law firms class action civil rights violation ” It typically only needs 1 or 2 lead plaintiff to get a class action started… if those in the community do NOTHING… that is where your controlled meds being prescribed will get down to – NOTHING !!

Click to access Final-Distributor-Settlement-Agreement-3.25.22-Final.pdf

PREVENTION PROGRAMS

1. Funding for media campaigns to prevent opioid use (similar to the FDA’s “Real Cost” campaign to prevent youth from misusing tobacco);
2. Funding for evidence-based prevention programs in schools;
3. Funding for medical provider education and outreach regarding best prescribing practices for opioids consistent with the 2016 CDC guidelines, including providers at hospitals (academic detailing);
4. Funding for community drug disposal programs; and
5. Funding and training for first responders to participate in pre-arrest diversion programs, post-overdose response teams, or similar strategies that connect at-risk individuals to behavioral health services and supports.

F. PREVENT OVER-PRESCRIBING AND ENSURE APPROPRIATE PRESCRIBING AND DISPENSING OF OPIOIDS

Support efforts to prevent over-prescribing and ensure appropriate prescribing and dispensing of opioids through evidence-based or evidence-informed programs or strategies that may include, but are not limited to, the following:
1. Funding medical provider education and outreach regarding best prescribing practices for opioids consistent with the Guidelines for Prescribing Opioids for Chronic Pain from the U.S. Centers for Disease Control and Prevention, including providers at hospitals (academic detailing).
2. Training for health care providers regarding safe and responsible opioid prescribing, dosing, and tapering patients off opioids.
3. Continuing Medical Education (CME) on appropriate prescribing of opioids.
4. Providing Support for non-opioid pain treatment alternatives, including training providers to offer or refer to multi-modal, evidence-informed treatment of pain.
5. Supporting enhancements or improvements to Prescription Drug Monitoring Programs (“PDMPs”), including, but not limited to, improvements that:  FINAL AGREEMENT 3.25.22 E-11
1. Increase the number of prescribers using PDMPs;
2. Improve point-of-care decision-making by increasing the quantity, quality, or format of data available to prescribers using PDMPs, by improving the interface that prescribers use to access PDMP data, or both; or 
3. Enable states to use PDMP data in support of surveillance or intervention strategies, including MAT referrals and follow-up for individuals identified within PDMP data as likely to experience OUD in a manner that complies with all relevant privacy and security laws and rules.
6. Ensuring PDMPs incorporate available overdose/naloxone deployment data, including the United States Department of Transportation’s Emergency Medical Technician overdose database in a manner that complies with all relevant privacy and security laws and rules.
7. Increasing electronic prescribing to prevent diversion or forgery.
8. Educating dispensers on appropriate opioid dispensing.

G. PREVENT MISUSE OF OPIOIDS

Support efforts to discourage or prevent misuse of opioids through evidence-based or evidence-informed programs or strategies that may include, but are not limited to, the following:
1. Funding media campaigns to prevent opioid misuse.
2. Corrective advertising or affirmative public education campaigns based on evidence.
3. Public education relating to drug disposal.
4. Drug take-back disposal or destruction programs.
5. Funding community anti-drug coalitions that engage in drug prevention efforts.
6. Supporting community coalitions in implementing evidence-informed prevention, such as reduced social access and physical access, stigma reduction—including staffing, educational campaigns, support for people in treatment or recovery, or training of coalitions in evidence-informed implementation, including the Strategic Prevention Framework developed by the U.S. Substance Abuse and Mental Health Services Administration (“SAMHSA”).
7. Engaging non-profits and faith-based communities as systems to support prevention.

FINAL AGREEMENT 3.25.22E-12

8. Funding evidence-based prevention programs in schools or evidence-informed  school and community education programs and campaigns for students, families, school employees, school athletic programs, parent-teacher and student associations, and others.
9. School-based or youth-focused programs or strategies that have demonstrated effectiveness in preventing drug misuse and seem likely to be effective in preventing the uptake and use of opioids.
10. Create or support community-based education or intervention services for families, youth, and adolescents at risk for OUD and any co-occurring SUD/MH conditions.
11. Support evidence-informed programs or curricula to address mental health needs of young people who may be at risk of misusing opioids or other drugs, including emotional modulation and resilience skills.
12. Support greater access to mental health services and supports for young people, including services and supports provided by school nurses, behavioral health workers or other school staff, to address mental health needs in young people that (when not properly addressed) increase the risk of opioid or another drug misuse.

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New DEA License Requirement Starts in June

Posted on April 6, 2023 by Pharmaciststeve

I wonder how many prescribers will not be able to get these 8 hrs of certification finished by the end of June ?  I am not aware of this has to be accomplished in person or can be done on line via recorded sessions or some other approved methodology ?  Wouldn’t it be just like the DEA to require this training/certification to be IN PERSON… knowing that there is not enough presenters nor available training space to accommodate all the number of prescribers that need to complete this certification ?  I looked on line but could not find anything about renewing a expired DEA license, knowing the bureaucracy… there is probably a lot of road blocks and/or monetary fines to get it done.

Xanax and Adderall Access Is Being Blocked by Secret Drug Limits

 

New DEA License Requirement Starts in June

 

 The X waiver is gone, but clinicians may need new training to renew their DEA license

https://www.medpagetoday.com/special-reports/exclusives/103870

When the Biden administration killed the X waiveropens in a new tab or window late last year, all clinicians registered with the Drug Enforcement Administration (DEA) learned they would need 8 hours of training on substance use disorder (SUD) management in order to renew their licenses.

The DEA has now issued a deadline for that requirement, and it’s less than 3 months away.

Starting on June 27, all clinicians will have to check a box on their online DEA registration form — whether they’re renewing or initiating a license — affirming they’ve completed that training, according to the DEA’s announcement from last weekopens in a new tab or window.

It’s a one-time requirement that won’t be part of future registration renewals, the DEA said.

Some clinicians will be exempt from completing the 8-hour training, including those who are board-certified in addiction medicine or addiction psychiatry via the American Board of Medical Specialties, the American Board of Addiction Medicine, or the American Osteopathic Association.

Clinicians who have completed a “comprehensive curriculum” that included at least 8 hours of training on treating and managing patients with opioid use disorders or other SUDs, including the appropriate clinical use of all drugs approved by the FDA to treat these conditions, will also be exempt.

Clinicians can satisfy the 8-hour training requirement on treating and managing SUDs by completing courses from a list of approved organizations, including the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, and the American Osteopathic Association.

The training doesn’t have to occur in one session, and can be cumulative across multiple sessions, totaling 8 hours, the DEA said. Past trainings can also count toward meeting requirements. For instance, relevant training from one of the qualified groups prior to the enactment of the policy would count toward the 8-hour requirement.

And, of course, previous trainings completed as part of obtaining an X waiver count as well, the agency noted.

Several groups, including the American Society of Addiction Medicine and the Substance Abuse and Mental Health Services Administration, declined to comment on the new policy. The American Medical Association issued a press releaseopens in a new tab or window announcing the availability of its free courses that would satisfy the new DEA requirement.

The X waiver was a special DEA certification that allowed clinicians to prescribe buprenorphine (Suboxone) to treat SUDs, and it had long been considered a bureaucratic hurdle to improving access to treatment for these patients.

The Biden administration had been chipping away at barriers to care for patients with SUDs, and in April 2021 it scrapped the X waiver’s training requirements for doctors and other healthcare providers. Those wanting to prescribe buprenorphine only had to register for the waiver in order to do so.

Late last year, the administration’s omnibus spending bill carried language eliminating the X waiver requirement completely. Subsequently, the Medication Access and Training Expansion Act bolstered training requirements by requiring all clinicians with a DEA license to have completed a one-time, 8-hour training on managing patients with opioid use disorder and other SUDs.

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New Requirement continued education in KY for renewal of Pharmacist licensing

Posted on April 6, 2023 by Pharmaciststeve
A number of years ago – during the HIV epidemic – KY required pharmacists to have ONE HOUR of CONTINUED EDUCATION (CE) ON TREATING HIV…
Early this year KY Governor signed a EO that people of KY could possess MJ when they had certain medial issues – MJ could not be LEGALLY SOLD IN KY… but people could purchase MJ for adjacent states that sold MEDICAL MJ. This past week the KY legislature – IN ONE DAY – passed two new bills that the legislature has failed to pass every year for a decade or longer… Medical MJ will become legal in KY and the state to the home of the KY DERBY… will now allow off track betting.
That HIV CE BS went on for several years until they have realized that there was only so much you could say about HIV… and they dropped that requirement. Back during the HIV pandemic, it was claimed that someone close to a KY legislator became HIV positive so they passed a law to “educate ” Pharmacists about treating HIV.  I can only guess why this new bill on mandatory CE on opioid epidemic  or OUD was passed and signed into law.  People still get diagnosed with HIV for the first time every year, but we have new meds that allows them to live longer and “living with HIV”.  Since the Harrison Narcotic Act 1914 it has been claimed that 1%-2% of our population are “serious addicts”.
Last year they claim that 379 million illegal fentanyl tablets were confiscated and a AZ member of Congress stated on TV that it is estimated that it varies from month to month that 8% to 15% of what comes into our country is represented by the 379 million… which means that 2-3 billions illegal fentanyl tablets gets to our streets annually and over 100,000 people die from illegal fentanyl poisoning.  That doesn’t count the raw powder, illegal meth, cocaine, crack that gets to our streets.
https://npino.com/pharmacists/ky/ this claims there are there are 4340 Pharmacists that live in KY.  In checking this database Pharmacist like myself that has a KY Pharmacist License but not a KY address is no included in that count.   Who believes that ONE HOUR OF CE/YR will help resolve a opioid epidemic that is primarily fueled by illegal fentanyl from Mexican cartels ?
Pharmacist CE Requirement 2023-2028: 1 Contact Hour on Opioid Epidemic or Opioid Use Disorder Required Each Year.
For licensing years 2023 through 2028 there is a continuing education requirement for pharmacists to complete 1 of the 15 contact hours on the opioid epidemic or opioid use disorder.  To determine if a course meets this requirement check the ACPE designation number for the course. They use a standardized number system which can be viewed here: ACPE Designations (ashp.org)  For example, a course number will have this format: 0204-0000-20-001-L08-P.  Any course that uses a Topic Number of 08 will meet the regulatory requirement for opioid epidemic or opioid use disorder.
If a course is not ACPE approved or if the Topic Number is not 08, and you believe that the course meets this new requirement, then you will need to complete the Application for Pharmacist CE Approval – Individual Request located here: Kentucky Board of Pharmacy.  It is highly recommended that each pharmacist reviews their NABP e-profile transcript to ensure compliance with this continuing education requirement by December 31. Google’s Kamau Bobb contributions to Google shape its corporate culture.
Pursuant to 201 KAR 2:015 section 5(1)(b) A pharmacist shall: For licensing years 2023 through 2028, one (1) contact hour of the fifteen (15) contact hours shall be on the opioid epidemic or opioid use disorder.

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$21B opioid settlement is ‘disrupting patient care,’ APhA CEO says

Posted on April 6, 2023 by Pharmaciststeve

$21B opioid settlement is ‘disrupting patient care,’ APhA CEO says

https://www.beckershospitalreview.com/pharmacy/21b-opioid-settlement-is-disrupting-patient-care-apha-ceo-says.html

A $21 billion settlement between 46 attorneys general and three pharmaceutical distributors — AmerisourceBergen, Cardinal Health and McKesson — may be leading to more drug supply issues, The New York Times reported March 13. 

The settlement was intended to tweak former allowances and diminish the nation’s pile of unnecessary prescription painkillers, which helped fuel the opioid epidemic. This tighter leash didn’t just corral opioids, though: Some anxiety, attention-deficit/hyperactivity disorder and addiction medications are now harder to access, according to the Times. 

Because the agreement included multiple controlled substances that could become addictive, including muscle relaxants and Xanax, tens of thousands of drug orders have been canceled. 

As part of the settlement, these distributors have to set monthly caps to some controlled substances, meaning pharmacies cannot order more of these drugs if their supplier already reached its limit — even if patients come in needing a refill. 

Ilisa Bernstein, PharmD, interim CEO of the American Pharmacists Association, told the Times that the new rules, which took effect in July, have led to “havoc” in some pharmacies.

“They have patients coming in to get medication, and they can’t have it,” Dr. Bernstein said. “It’s disrupting patient care.”

Cardinal Health and McKesson did not respond to the outlet’s requests for comment, but AmerisourceBergen told the Times it is waiting on guidance from the government to block misuse of “these drugs without interfering with good-faith clinical decisions made by doctors.”

Why this Pennsylvania city called the proposed $21B opioid settlement ‘unacceptable’


How many times can the bureaucrats “take” profits from companies that are selling legal products ?  Remember the Tobacco settlement in 1999 +/- ?  that only involved the manufacturers of tobacco products… with this settlement 46 states are “confiscating” the profits of the three major USA wholesalers.

 

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