“PAIN MANAGEMENT IS A HUMAN RIGHT EVERY INDIVIDUAL DESERVES ACCESS TO SAFE EFFECTIVE SAFE AND COMPASSIONATE CARE TAYLORED TO THIER SPECIFIC NEEDS“

AMERICAN MEDICAL ASSOCIATION

reposted reported republished in yourarewithinthenorms

NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA,AISHA GARDNER, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

Glossary of Key Terms

• AMA (American Medical Association): A professional organization representing physicians and advocating for the medical profession and public health.
• CDC (Centers for Disease Control and Prevention): A federal agency responsible for protecting public health and safety through the control and prevention of disease, injury, and disability.
• Opioid Analgesics: Medications used to relieve pain, such as morphine, codeine, and oxycodone.
• Opioid Use Disorder: A problematic pattern of opioid use leading to clinically significant impairment or distress.
• PBM (Pharmacy Benefit Manager): A third-party administrator of prescription drug programs for health insurance plans.
• MME (Morphine Milligram Equivalents): A standardized measure used to compare the potency of different opioid medications.
• Prior Authorization: A requirement by health insurance plans for pre-approval before certain medications or procedures are covered.
• HOD (House of Delegates): The principal policy-making body of the American Medical Association.
• NABP (National Association of Boards of Pharmacy): An organization that supports state boards of pharmacy in protecting public health.
• FSMB (Federation of State Medical Boards): A national non-profit organization representing all medical boards within the United States and its territories.

“PAIN IS PART OF THE HUMAN EXPERIENCE“

INTRODUCTION

The document addresses the inappropriate application of the CDC’s opioid prescribing guidelines by pharmacies, insurance companies, and pharmacy benefit managers. It highlights concerns that blanket restrictions based on numerical thresholds are interfering with the patient-physician relationship and patient care. 

The AMA has been actively engaging with stakeholders to advocate against these policies, emphasizing the guidelines were intended for acute pain management, not as rigid limits for all patients. While supporting judicious prescribing and pharmacist collaboration, the AMA opposes policies that create barriers to necessary pain medication.

 The report specifically calls out Walmart for its “blacklist” letters to physicians and advocates for policies that prioritize individualized patient care over hard thresholds. It recommends the AMA support balanced opioid-sparing policies and oppose the use of “high prescriber” lists that lack due process. 

The document further reinforces AMA’s existing policies supporting optimal pain care and opposing arbitrary restrictions on patient access to effective treatment.

PAIN MANAGEMENT IS A HUMAN RIGHT

DISCUSSION

On June 10, the AMA issued Board of Trustees Report 22 which, among other things, condemns the use of “high prescriber” lists by national pharmacy chains to blacklist high-prescribing physicians and prevent their patients from having pain prescriptions filled.

k) AMA House of Delegates Resolution 235 [November 2018] and AMA Board of Governors Study 22 [June 2019] apply directly.

l) American Academy of Family Physicians and five other medical associations declared on behalf of front-line physicians [April 2019]:  that law enforcement must be removed from doctors’ offices. [9]

PROVEN-RELIABLE AND SAFE ALTERNATIVES TO OPIOID THERAPY FOR MODERATE TO SEVERE PAIN DO NOT YET EXIST.

m) Medical evidence for effectiveness of non-pharmacological therapies is very weak; there is no direct comparisons with opioids (a critical absence), and there are no Phase III trials. [10]

n) Some published studies comparing NSAIDs to Opioid therapy are fatally flawed by errors of methodology; [11]. Tylenol and Ibuprofen are likewise associated with thousands of hospital admissions for liver toxicity and gastrointestinal bleeds.

o) Opioid analgesics must remain an indispensable therapy in pain management for the foreseeable future and this must be acknowledged.

p) Incidence of protracted prescribing in opioid-naive post-surgical patients is less than 1%. [12]

q) Incidence of diagnoses of post-surgical substance abuse is less than 0.6% — influenced by hostile regulatory environment as much as by any actual patient drug seeking. [13]

r) Mortality risk from managed exposure to medical opioids is on the order of 0.02% per year — too small to reliably measure or control. [14]. Even for daily dosage greater than 100 MMED, it is only 0.25%/year — comparable to the risk associated with use of anticoagulants to prevent stroke.

NO PUBLISHED TRIALS DEMONSTRATE BENEFIT FROM INVOLUNTARY TAPERING OF LEGACY PATIENTS. COERCED TAPERING INSTEAD RISKS PATIENT MEDICAL COLLAPSE. [15] 

s) There are no proven profiling instruments with predictive accuracy to assess risks of opioid prescribing in individual patients.  [16]

t) “Tapering” as now practiced often amounts to unilateral patient discharge and desertion without support.

u) There is no medical, ethical, or moral justification for coerced tapering of chronic pain patients who are otherwise stable. 

v) Denial of effective pain relief to new patients when it is available and managed by medical professionals may be a fundamental violation of human rights.

IF CDC IS TO REWRITE THE 2016 CDC GUIDELINES, THEN AMA HOUSE OF DELEGATES RESOLUTION 235 MUST BECOME AN EXPLICIT AND CENTRAL GUIDING PRINCIPLE IN RECOMMENDED PRACTICE.

w) Guidelines writers’ group must include multiple patient advocates and comprehensive pain management experts as voting members. 

x) Explicit attention must be given to removing 2016 and newer Guidelines from drug enforcement legislation.

y) Draft treatment guidelines must be publicly circulated with a 90-day comment period, a commitment to full public transparency and incorporation of the comments received.

CONCLUSION UPDATE 2024

“Substance abuse” is a very different beast:  it is characterized by continuing cravings and use of opioids even when the user knows that such use is harmful to their relationships and quality of life. 

The DSM-5 identifies a spectrum of symptoms to characterize the severity of substance abuse. 

However, nowhere in that deeply flawed document is a clinical framework offered within which clinicians may choose a therapeutic course of action that is appropriate to the patient’s needs if they suffer from both chronic pain and substance abuse.  

Likewise, the consequence of patient exposure to prescription opioids is almost always an improvement in quality of life.

We now know definitively that — despite repeated misdirection from the US CDC and DEA — there is no relationship between physician prescribing and either opioid addiction or overdose-related mortality.  

Many so-called “diagnoses” of opioid use disorder by clinicians actually reflect a disorder called “pseudo-addiction,” suffered not by patients but by clinicians intimidated by the risk of possible criminal sanctions.” 

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REFERENCES:

Briefing Document: Inappropriate Use of CDC Guidelines for Prescribing Opioids

Subject: Concerns regarding the misapplication of the CDC’s “Guideline for Prescribing Opioids for Chronic Pain” by pharmacies, PBMs, and insurers, leading to restricted patient access to necessary pain medication.

Source: Report of the Board of Trustees (B of T Report 22-A-19) to the American Medical Association (AMA) House of Delegates.

Date: [Inferred from content: 2019, following up on the 2018 Annual Meeting]

Key Themes and Ideas:

• Opposition to Blanket Restrictions: The AMA actively opposes policies from pharmacy chains, PBMs, and health insurers that impose blanket restrictions on opioid prescriptions based on numerical thresholds (e.g., Morphine Milligram Equivalents – MME) without considering individual patient needs and clinical context. The original resolution prompting this report arose from a concern about communications sent to physicians that included a “blanket proscription against filling prescriptions for opioids that exceed numerical thresholds without taking into account the diagnosis and previous response to treatment for a patient and any clinical nuances that would support such prescribing as falling within standards of good quality patient care.”
• Misinterpretation and Misapplication of CDC Guidelines: A central argument is that the CDC’s 2016 Guideline, intended as voluntary guidance for primary care providers managing acute pain, is being incorrectly applied as a rigid standard, particularly for chronic pain patients. The report emphasizes, “It is important to note that CDC Guideline Recommendations 5 and 6 were intended guidelines for acute pain episodes, not a hard threshold, and not intended for chronic pain patients.”
• Disruptive Interference in the Patient-Physician Relationship: The report highlights instances of pharmacists questioning prescriptions, demanding patient records, recommending alternative medication strategies, and even refusing to fill prescriptions based on perceived CDC guideline violations. The report notes concerns from physicians and patients about “the disruptive nature of health plan, pharmacy chain or PBM interference in the patient-physician relationship.” This interference undermines the therapeutic relationship and can harm patients.
• The Importance of Individualized Patient Care: The AMA emphasizes the need for patient-centered care and opposes “one-size-fits-all” approaches to opioid prescribing. They advocate for policies that consider “patient individuality” rather than “hard thresholds.”
• Physician-Pharmacist Collaboration (Generally Supported, but with Caveats): The AMA generally supports pharmacists as key partners in medication safety, but objects to instances where pharmacists overstep their bounds and interfere with physician’s clinical judgement. The report states, “The AMA also supports pharmacists as key partners in helping ensure medication safety and as part of the patient-physician-pharmacist therapeutic triad.” However, the report also details concerns when pharmacists misinterpret guidelines and create barriers to patient care.
• Walmart’s “Blacklist” Policy: The report specifically calls out Walmart for sending “blacklist” letters to physicians, informing them that their controlled substance prescriptions will no longer be filled at Walmart pharmacies. The AMA has been unable to get a meaningful response from Walmart regarding this policy. “Specifically, Walmart has sent an unknown number of what can be considered “blacklist” letters to physicians… [Walmart] determined that we will not be able to continue filling your controlled substance prescriptions.”
• Payer Restrictions: The AMA is aware of health insurance companies implementing hard-threshold guidelines based on the CDC guideline. The AMA raised concerns about these payer policies directly to the National Association of Insurance Commissioners (NAIC). “AMA is acutely aware of health insurance companies implementing hard-threshold guidelines based on the CDC guideline.”

• Advocacy and Policy: The AMA has a long history of advocating for better pain care and opposing arbitrary restrictions, including engaging with organizations like the National Association of Boards of Pharmacy (NABP) and the Federation of State Medical Boards (FSMB). The AMA has extensive policy in support of ensuring patients receive optimal pain care and removal of arbitrary restrictions on the provision of that care. This includes having AMA “oppose legislative or other policies that arbitrarily restrict a patient’s ability to receive effective, patient-specific, evidence-based, comprehensive pain care.”
• Recommendations: The Board recommends that the AMA support balanced opioid-sparing policies that are not based on hard thresholds, but on patient individuality. The Board also recommends that the AMA oppose the use of “high prescriber” lists used by national pharmacy chains, pharmacy benefit management companies or health insurance companies when those lists do not provide due process and are used to blacklist physicians from writing prescriptions for controlled substances and preventing patients from having the prescription filled at their pharmacy of choice.

Quotes from the CDC Guideline:

The report references the following statements from the CDC Guideline:

• “[T]he recommendations in the guideline are voluntary, rather than prescriptive standards. They are based on emerging evidence, including observational studies or randomized clinical trials with notable limitations. Clinicians should consider the circumstances and unique needs of each patient when providing care.”
• “When opioids are started, clinicians should prescribe the lowest effective dosage… should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥ 50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥ 90 MME/day or carefully justify a decision to titrate dosage to ≥ 90 MME/day.”
• “When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.”

Proposed Action:

The Board recommends that the House of Delegates adopt resolutions that:

1. Support balanced opioid-sparing policies based on patient individuality, not hard thresholds.
2. Oppose the use of “high prescriber” lists that lack due process and lead to blacklisting of physicians.

This briefing document summarizes the key aspects of the AMA Board of Trustees report regarding the inappropriate application of the CDC’s opioid prescribing guidelines and the resulting negative impact on patient care.

Study Guide: Addressing Inappropriate Application of Opioid Prescribing Guidelines

I. Short Answer Quiz

1. What was the primary concern that led to the AMA addressing the use of the CDC guidelines?
2. How have health insurance companies, national pharmacy chains, and PBMs used the CDC guidelines?
3. According to the document, what is the AMA’s stance on physician-pharmacist interactions regarding opioid prescriptions?
4. What are the two specific recommendations from the CDC guideline that are often cited in pharmacy, payer, and PBM policies?
5. What caution did the U.S. Department of Health and Human Services Interagency Pain Care Task Force make regarding opioid prescription limits?
6. What specific example does the AMA President share regarding inappropriate denial of opioid prescriptions?
7. What was the outcome of the AMA’s early discussions with the National Association of Boards of Pharmacy (NABP) and the Federation of State Medical Boards (FSMB)?
8. What actions has Walmart taken that concern the AMA?
9. How has the AMA engaged with the National Association of Insurance Commissioners (NAIC) regarding payer policies?
10. What specific AMA policies support optimal patient pain care and removal of arbitrary restrictions?

II. Answer Key to Short Answer Quiz

1. The primary concern was the inappropriate use of CDC guidelines for prescribing opioids by pharmacy chains and PBMs, leading to blanket proscriptions against filling prescriptions that exceeded numerical thresholds without considering individual patient needs and clinical nuances.
2. They have implemented their own policies governing physician prescribing of controlled substances and patients’ abilities to have prescriptions dispensed, often based on the CDC’s guidelines.
3. The AMA supports pharmacists as key partners in ensuring medication safety as part of the patient-physician-pharmacist triad and encourage judicious prescribing decisions.
4. These are 1) caution when prescribing opioids at any dosage, reassessing individual benefits and risks when increasing dosage to ≥ 50 MME/day, and avoiding increasing dosage to ≥ 90 MME/day and 2) when opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain, often 3 days or less.
5. They cautioned against implementing the guideline without recognizing that its intended audience was primary care providers; using legislation for medical decision-making; and applying it to all physicians, dentists, NPs, and PAs.
6. She shared an instance where a pharmacy denied an opioid prescription to one of her prostate cancer patients, accusing him of being a drug seeker.
7. It resulted in a consensus statement highlighting the legal and professional obligations of physicians and the corresponding responsibility of pharmacists.
8. Walmart has sent “blacklist” letters to physicians, stating they will no longer fill their controlled substance prescriptions due to reviewed prescribing patterns and practices.
9. The AMA has raised concerns about payer policies directly to the NAIC, highlighting patients’ need for greater access to comprehensive, multidisciplinary, multimodal pain care.
10. AMA Policy H-95.930 opposes legislative or other policies that arbitrarily restrict a patient’s ability to receive effective, patient-specific, evidence-based, comprehensive pain care, and Policy D-120.932 supports ensuring patients are not harmed by the misapplication of the CDC guidelines.

III. Essay Questions

1. Analyze the ethical implications of pharmacy chains and PBMs implementing policies that restrict opioid prescriptions based on numerical thresholds derived from the CDC guidelines. Consider the perspectives of physicians, pharmacists, and patients.
2. Discuss the AMA’s advocacy efforts to address the inappropriate use of CDC guidelines for opioid prescribing. What strategies has the AMA employed, and how effective have these strategies been in influencing policy and practice?
3. Compare and contrast the roles and responsibilities of physicians and pharmacists in managing opioid prescriptions and patient care. How can these professionals collaborate effectively to ensure both medication safety and adequate pain management?
4. Evaluate the impact of state and federal policies aimed at curbing the opioid epidemic on patient access to pain management. Are these policies achieving their intended goals, or are they creating unintended consequences for patients with legitimate pain needs?
5. Considering the information provided, propose a comprehensive strategy to balance the need to address the opioid crisis with the importance of ensuring that patients with chronic pain receive adequate and appropriate treatment.