“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.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
FDA investigators discovered more quality issues at an Intas Pharmaceuticals factory in Ahmedabad, India, which halted some production after a November inspection found a truck full of shredded documents, Bloomberg reported June 15.
In May, the FDA inspected the facility and investigators said they could not ensure the “safety, efficacy, purity and overall quality of drug products manufactured” at the site, according to a 30-page report obtained by Bloomberg.
Some drug supply experts have pointed to the site’s shutdown in November as a cause of the shortages of cisplatin and carboplatin, two cancer drugs that have seen low supply for months. Intas produced about 20 percent of the nation’s supply of carboplatin, according to The Wall Street Journal.
The latest report could spur worsened drug shortages, Bloomberg reported, because the May visit found employees altering recorded data that did not meet U.S. standards for particles, such as black specks, fiber and glass, found in injectable drugs. The FDA also recorded evidence of Intas employees disregarding three years’ worth of more than 1,000 “spore-forming organisms.”
On June 1, the FDA instituted an import ban on all but 25 of Intas’ drugs made at its three India-based facilities, according to agency documents. The products excluded from the import ban include multiple cancer drugs in shortage, including cisplatin, carboplatin, fluorouracil and docetaxel.
The drugmaker also has not verified its quality test procedures for more than 100 of its drugs. Intas did not respond to Bloomberg’s requests for comment.
Recently, quality issues have prompted a cascade of drug supply issues, the American Society of Health-System Pharmacists said in May, and providers are growing worried about their ability to adequately care for cancer patients because of multiple shortages of oncology treatments.
Opioids are often prescribed for pain management after surgery — but for the 19 million people in the U.S. with a history of substance abuse, that option may not be safe or desired. That is why some doctors are recommending to better use cbd gummies for pain that could potentially help alleviate pain after surgery due to their anti-inflammatory and analgesic (pain-relieving) properties. Studies have shown that CBD can reduce both acute and chronic pain, making it a potential alternative to traditional pain medications.
Until now, there hasn’t been a cohesive set of guidelines for managing surgical pain in patients with a history of addiction and/or opioid tolerance.
To address this, the American Society of Anesthesiologists (ASA) gathered 15 medical organizations representing over 500,000 physicians to develop seven guiding principles to improve pain management before, during and after surgery for these patients.
The guidelines have been published in the Regional Anesthesia & Pain Medicine journal.
FOR ACUTE LOWER BACK PAIN, THESE ARE THE BEST MEDICATIONS, NEW STUDY FINDS
Dr. David Dickerson, an anesthesiologist and pain specialist at North Shore University Hospital in Chicago, Illinois, is chair of the American Society of Anesthesiologists’ Committee on Pain Medicine. (ASRA is the American Society of Regional Anesthesia and Pain Medicine.)
“Patients with these complex issues may require additional care after surgery,” Dickerson told Fox News Digital.
Woman upset in hospital Opioids are often prescribed for pain management after surgery — but for the 19 million people in the U.S. with a history of substance abuse, that may not be a safe or desired option. Now, a new set of guidelines may help. (iStock)
“When someone undergoes a surgical procedure and they have a substance use disorder, chronic pain or pre-operative opioid tolerance, their nervous system is different,” he told Fox News Digital in an interview.
“Their ability to self-soothe in the face of injury or pain is also going to be a very different experience.”
TAKE THESE 5 SMART STEPS TO RELIEVE MUSCULOSKELETAL PAIN
As the director of four hospitals, Dickerson sees patients with many different types of pain in many different care environments. It’s why he’s calling for adopting a unified approach for patients who may not have a straightforward experience with pain management when it comes to surgery, injury, trauma or disease.
“Their ability to self-soothe in the face of injury or pain is also going to be a very different experience.”
“We want to make sure the patient has a consistent experience in terms of getting pain alleviated and also minimizing the risks of pain treatments,” he said.
Over a span of several years, Dickerson and other pain management specialists and physicians crafted the following seven principles to use as a “north star” for screening, treating and educating these vulnerable patients, while building awareness and education for safe and effective surgical care.
1. Identify patients at risk Physicians should “screen for substance abuse preoperatively, risk stratify and refer for treatment as needed,” the first principle states.
The doctor should speak with the patient prior to surgery to determine whether there is any history of substance abuse, identify any risk factors and provide recommendations for referrals as needed.
“Clinicians should identify patients with a substance use disorder and facilitate evaluation and treatment before surgery.”
“As the majority of patients receive a post-surgery opioid prescription and 100,000 Americans die annually from accidental opioid overdose, clinicians should identify patients with a substance use disorder and facilitate evaluation and treatment before surgery,” Dickerson told Fox News Digital.
“Identifying and treating substance use disorders saves lives — especially when we recognize that 19 million Americans have at least one substance use disorder.”
2. Coordinate care for complex patients “Coordinate care pre-operatively for complex patients and consult with pain medicine, behavioral health or addiction medicine specialists to optimize the treatment plan,” the second principle states.
It’s also important to note that CBD gummies should not be used as a substitute for medical treatment and recovery after surgery. but this is a good option for patients to alleviate pain.
COVID VACCINE MANUFACTURER’S LIABILITY, ILLEGAL MANDATES AND HUMAN RIGHTS VIOLATIONS
On June 22, 2023, in the United States District Court for the Southern District of Florida, the Court in which President Trump stands indicted, Drs. David Basch and Richard Arjun Kaul filed a lawsuit (Kaul/Basch v Federation: 23-CV-22325) (K11-14) against, amongst others, Defendant Federation of State Medical Boards and 2024 US Presidential candidate, Christopher J. Christie, on racketeering charges pertaining to injuries caused by the so called COVID ‘vaccine’:
“The most recent catastrophe is that related to the mass forced/coerced inoculations of the American public with an mRNA toxin, that the public was deceived into believing was a ‘vaccine’ against COVID-19. This gene manipulating toxin has resulted and will continue to result in, amongst other things, premature death, increased rates of cancer, cardiac disease, and early-onset dementia/neuro-cognitive deterioration.”
“Commencing in early 2020, just after the announcement of the purported pandemic, Plaintiff Kaul began writing articles and filing legal documents that highlighted the multiple profit purposed COVID related frauds that mandated knowingly toxic and ineffective mRNA ‘vaccines’, the wearing of masks and ubiquitous, but non-specific PCR testing.”
“In a time period commencing in or around May 2020, Defendant FSMB-FBM/agents in collusion and conspiracy with co-conspirators Pfizer/Moderna/agents and others did order American state medical boards and coerce foreign medical councils to compel, under penalty of license suspension/revocation and or medical registration suspension/erasure, its physicians to deceive patients into being inoculated with an mRNA compound that patients were falsely led to believe was a vaccine against COVID, but that Defendant FSMB-FBM and its corporate/state medical board co-conspirators knew was not only not a vaccine, but a substance with immense/lethal toxicity.”
“Crimes Against Humanity: Defendant FSMB-FBM and its ‘vaccine’ manufacturer co-conspirators CEO Joaquin Duato/Agents (Johnson + Johnson) CEO Albert Bourla/Agents (Pfizer), Pascal Soriot/Agents (Astra Zeneca) and CEO Stephane Bancel/Agents (Moderna), knew that the ‘vaccine’ was toxic and ineffective, and that it would cause death, permanent injury, and generational injury in that ‘vaccine’ caused genetic mutations/injuries would be transmitted in reproduction.”
On June 14, 2023, there was a second attempt on Kaul’s life and liberty, the first being on May 27, 2021.
Episode 2. On this episode of Real Pain, Real Talk, our Host, Kat Hatz, is joined by two fellow APDF patients and advocates, Bob Sheerin & Andrew Hohenthaner, to talk about how pain impacts everything, from functionality to basic quality of life. We discuss our journeys as patients and advocates, both before and after the Centers for Disease Control & Prevention (CDC) issued draconian Guidelines for Prescribing Opioids in 2016, which were revised in 2022 but with no substantive improvements. We also talk about the heartbreak involved when we advocate for a community we belong to, that consists of extremely vulnerable, disabled, and marginalized individuals. We try to raise awareness about how hard it is to know we will continue to lose members of our community until substantive changes are made to the harmful and widely adopted current policies pertaining to pain medicine. In addition, we discuss how those policies have hurt us and countless other patients. We hope this episode is heard by both the pain community and healthy people, as we try to give a voice to people who face intractable chronic pain. Please tune in and help us debunk a flawed media narrative that has been pushed by government agencies, legislators, insurers, and others, and which has resulted in millions of preventable harms and deaths that pain patients have sustained. Follow our podcast, and you will immediately be notified when a new episode is out!
lists a whole array of practitioners licensed in KY to prescribe controlled substances. One thing I find interesting is according to the CSA NO ONE can prescribe a controlled substance without doing a IN PERSON PHYSICAL EXAM. What I also find interesting is that most of the pts prescribed controlled substances are – or could be – a covered entity under the Americans with Disability Act and perhaps any laws, rules, or regulations that would place a limit on the mgs/day or some sort of other limitations of therapy. Besides, the FDA has established all those daily limits already!
Besides, most all controlled meds are prescribed with pts dealing with subjective diseases and there is no lab or other test to determine the impact of the disease on the pt’s QOL.
If these “dosage recommendations” come out without some sort of reference to pharmacogenomic testing on individual pts, and/or using the “junk science” MME system, they will not be using current pharmaceutical knowledge on appropriate prescribing.
Also, notice on the list of who is going to be on this committee – NOT ONE – chronic pain pt. Human Psychology suggests that a person cannot truly understand certain things — unless they have personally experienced certain issues.
Date: June 22, 2023
TO: All Kentucky licensed pharmacists
FROM: Christopher Harlow, Pharm. D., R.Ph.
Executive Director
RE: Controlled Substances Prescribing Council
Senate Bill 94 enacted during the 2023 Regular Session creates the Controlled Substances Prescribing Council under the Office of Inspector General. See Section 2 of the bill, which was codified as KRS 218A.025.
KRS 218A.025(1)(h) provides that the Kentucky Board of Pharmacy will select one licensed pharmacist to serve as a member of the Council. The Council will meet at least quarterly “to discuss matters relating to the safe and appropriate prescribing and dispensing of controlled substances.”
Members will be selected by the Board from applications submitted by interested individuals. If interested, please submit the completed application along with a resume or curriculum vitae [CV] to the Board office by mail, email, or fax.
Please return your completed application to the Board office by close of business July 19, 2023. Please enclose a copy of your resume or curriculum vitae [CV].
A new Florida law will require certain Florida-licensed providers to ensure that patient information is physically maintained only in the continental United States and its territories or in Canada. Florida SB 264, which goes into effect July 1, 2023, amends the Florida Electronic Health Records Exchange Act, adding a ban on offshoring health information that goes beyond the requirements under HIPAA and most other generally applicable health privacy and security laws. Florida licensees to which the new requirements apply will need to attest upon initial licensure and any renewals that they are in compliance with the new requirements. Applicable licensees will also be required to ensure that no individual or entity with a controlling interest in the licensee has an interest in an entity that has a business relationship with certain foreign countries, as discussed below.
The new privacy requirements apply to all “qualified electronic health records that are stored using technology that can allow information to be electronically retrieved, accessed or transmitted” used by the categories of health care providers listed below. “Qualified electronic health records” are electronic health records that can provide clinical decision support, support physician order entry, capture and query relevant quality information, and exchange electronic health information with and from other sources. The new anti-offshoring requirements are separate from the recently passed Florida Digital Bill of Rights, which our Mintz privacy colleagues covered here.
Impacted provider types encompass facilities including, but not limited to, hospitals, clinics, ambulatory surgical centers, home health agencies, hospices, nursing homes, labs, pharmacies, and individual practitioners including physicians, physician assistants, advanced practice registered nurses, registered nurses, pharmacists, dentists, chiropractors, podiatrists, certain behavioral health providers, physical therapists, occupational therapists, speech-language pathologists, audiologists, and respiratory therapists. The law only applies to providers who use “certified electronic health record technology”, or CEHRT, which meets the federal interoperability standards. Because of ambiguity in the statute, it is unclear if the law is meant to apply only to providers who participate in the CMS payment programs that require CEHRT or if the requirements are more broadly applicable to any provider who utilizes CEHRT, regardless of whether they are required to do so.
The new licensure requirements included in the statute require providers applying for and renewing their Florida Agency for Health Care Administration (AHCA) licensure to submit an affidavit attesting under penalty of perjury that the applicant is in compliance with the prohibition on offshoring health care information. Failure to maintain compliance with the requirements could result in disciplinary action by AHCA.
The requirement to store qualified electronic health records within the U.S. and Canada also extends to third-party vendors and subcontractors who store such records on behalf of the affected Florida providers. This could also affect vendors overseas who access electronic health records if the access involves downloading a copy of the records. Because of the potential reach of this law, providers operating in Florida should take steps to confirm that neither they nor their vendors are storing electronic health records outside of the U.S. and Canada.
While HIPAA does not prohibit offshoring health information, covered entities outside of Florida should always take steps to ensure that vendors who store PHI offshore are able to comply with all of the privacy and security requirements under HIPAA and other applicable privacy laws. Third-party payers, including Medicare Advantage plans and state Medicaid programs, also often include provisions restricting or prohibiting the use of offshore vendors, so providers should stay on top of how and where their health records are being stored.
The new law also requires entities licensed by AHCA to confirm that no individual or entity with a controlling interest in the licensed entity holds, directly or indirectly, an interest in an entity that does business with a “foreign country of concern.” “Foreign countries of concern” include “the People’s Republic of China, the Russian Federation, the Islamic Republic of Iran, the Democratic People’s Republic of Korea, the Republic of Cuba, the Venezuelan regime of Nicolás Maduro, or the Syrian Arab Republic, including any agency of or any other entity of significant control of such foreign country of concern.” Under Florida law, a controlling interest is defined to mean a person or entity that serves as an officer or director of or has a 5% or greater ownership interest in the licensee or a management company that manages the licensee. The law as drafted does not include a carve-out for ownership interests held by publicly traded entities, unlike the current ownership limitations related to holding an interest in a facility that has previously had its license revoked. Notably, as drafted the restrictions do not include any carve out for activities that the Office of Foreign Assets Control has permitted to be conducted with sanctions nations. Additionally, the inclusion of the People’s Republic of China in the list of foreign countries of concern will require entities licensed in Florida to review potential business relationships that they or their parent companies have in China that are otherwise permissible under U.S. law.
It has not been well disclosed that Experian owns Narxcare and that Experian HQ is in Ireland and that they are storing all of the health information databases off-shore, because that makes those databases outside of our HIPAA laws. Some have compared the collecting and selling of data to the “California gold rush” in the mid 19th century
Pain physician Hersh Patel MD captured authoring fraudulent EMR note with “cut and paste” medical history. He documented a physical exam that never happened. Also documented advising patient about risks of opioids, risks,alternatives etc. etc that never actually happened. Hersh Patel MD, straight out of his pain fellowship training, telling elderly folks that they can be arrested for taking their physician-prescribed FDA approved opioid
Dr. Naburun Dasgupta informative lecture on the falsehood of the Morphine Milligram Equivalent and calls into question the Prosecution of healthcare providers by the US Attorney General and the Department of Justice and DEA in the use of Narcotic Analgesic Medications (Opioids)
reported by norman j clement rph., dds
THE MYTH OF MORPHINE MILLIGRAM EQUIVALENTDAILY DOSE
In 2016, the CDC issued its Guidelines for Prescribing Opioids for Chronic Pain Patients. In publishing the guidelines, the CDC explicitly stated that they were meant to be voluntary and “not prescriptive,” stating that healthcare practitioners knew their patients’ unique clinical situation and should weigh the potential risks and benefits when prescribing opioids. Many of its recommendations were based on what the CDC characterized as “Type 3” or “Type 4” evidence, which are categories of evidence that are less probative and carry a significant risk of inaccuracy. The guidelines thus came under significant criticism from many pain and addiction specialists for lacking a strong basis in the evidence.
Others criticized the use of morphine milligram equivalents (MMEs) in determining the appropriate dosing of different opioids. As Fudin and others have argued, MME dosing was designed in an attempt to examine opioids with similar analgesic effects and should not be used to determine an exact mathematical dosing conversion.
“MME IS NOT A STANDARDIZE CLINICAL METRIC”
The pharmacology and unique properties of each opioid and patient individuality must be considered when a therapeutic opioid conversion is contemplated. Conversion should not simply rely on a mathematical formula embedded within the CDC calculator software.
Furthermore, the current calculation for methadone employed by the calculator could allow for potentially dangerous conversions. This is especially problematic, considering this calculator is intended to target nonspecialist general practitioners. We expect a higher level of scientific accuracy and integrity from an agency entrusted to protect citizens’ health and welfare.
Recognizing the controversy surrounding MMEs, in August 2021, the FDA held a “public workshop” entitled “Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.” The workshop’s stated purpose was to “provide an understanding of the science and data underlying existing MME calculations for opioid analgesics, discussing the gaps in these data, and discussing future directions to refine and improve the scientific basis of MME applications.”
During the workshop, Nabarun Dasgupta of the University of North Carolina Injury Prevention Research Center presented research stating: “Contrary to conventional wisdom, conversion values are not based on pharmacologic properties. Instead, they arose 60 years ago from small single-dose clinical studies in post-operative or cancer populations with pain score outcomes; toxicologic effects (e.g., respiratory depression) were not evaluated.”
The research concluded: “The overlooked inconsistency among daily MME definitions revealed by our study calls into question the clinical validity of a single numerical risk threshold. . . . Our findings call into question state laws and third-party payer MME threshold mandates. Without harmonization, the scientific basis for these mandates may need to be revisited.”86 Some critics consider the use of MMEs to be “junk science.”
Nevertheless, many states implemented statutory or regulatory limits on the dose (in MMEs) and number of opioids that may be prescribed to patients in acute, chronic, and postoperative situations, respectively, and they encouraged policies promoting the rapid or abrupt tapering of chronic pain patients off the opioid therapies on which they had been maintained long-term.
In 2018, Oregon proposed a mandatory reduction to zero opioids calculation for methadone employed by the calculator could allow for potentially dangerous conversions. This is especially problematic, considering this calculator is intended to target nonspecialist general practitioners. We expect a higher level of scientific accuracy and integrity from an agency entrusted to protect citizens’ health and welfare in Medicaid patients over 12 months. The state reversed itself after receiving fierce criticism from pain management and addiction specialists.
Many of Delfino’s assertions regarding the evolution of drug regulation in the United States are either inaccurate or lacking nuance. For example, the Article states that the Opium Exclusion Act of 1909 “was the first government regulation of opioids.” Delfino, supra note 4, at 354. While this law was the first federal prohibition on opiate use, Congress had previously regulated opiate availability through taxation and tariffs, see Audrey Redford & Benjamin Powell, Dynamics of Intervention in the War on Drugs:
Dr. Randy Lamartiniere, MD, did everything by the book, as we all do. He monitored their care with drug screens and conducted reevaluations every three months for his very reasonable standard medical fee without any added charges for pain management. And got 15 years Fed Prison by one of America’s most Corrupt Federal Judge in America’s Most Corrupt Judicial Circuit. “No Justice, No Peace…Free Dr. Randy Now!!!
