Regulated Opioid Prescriptions - Impact on Improve Clinical Practice

Regulations for Doctors Regarding Opioid Prescriptions have been triggered by the opioid misuse that has been called a public health crisis.  Data indicates that there were over 70,000 overdose deaths in the U.S. in 2021 alone and that number has increased yearly.  One year later there 107,941 drug overdose deaths reported in 2022.  73,838 overdose deaths reported in 2022 were from synthetic opioids.  Now the data does not tell us how many deaths related to physician prescribed opioids and that is a flaw in the anti-opioid political process.  

It is undisputed that opioids remain essential for managing severe pain in conditions like cancer, chronic orthopedic conditions and post-surgical recovery. The challenge lies in balancing access for those who need them with safeguards to prevent abuse. This blog explores how opioid regulation, including recent actions by the Medical Board of California (MBC), can drive better clinical practices without compromising patient care.  But there is an 2000 pound elephant in the living room.  How do we define "abuse" in a medical context?  If a patient gets real pain relief and functions should the physician be concerned if it also gets the patient "high"?   After all, PCP's and psychiatrists prescribe many mental health drugs that affect mood and cognition.  Isn't that a type of "high" as well?

Current Regulatory Landscape

The U.S. has implemented measures like prescription drug monitoring programs (PDMPs), which track opioid prescriptions to curb "doctor shopping." The DEA’s scheduling system classifies opioids based on abuse potential, imposing stricter controls on drugs like oxycodone. In California, the Controlled Substances Utilization Review and Evaluation System (CURES) mandates prescribers to check patient prescription histories before issuing Schedule II-IV controlled substances. However, these policies can limit access for patients with chronic pain, as clinicians fear legal repercussions. A 2022 study found 40% of physicians reduced opioid prescribing due to regulatory pressures, even for appropriate cases.

The MBC has taken significant steps to address opioid prescribing while aiming to balance patient safety and access to care:

1. Updated Opioid Prescribing Guidelines (2023): The MBC revised its guidelines to provide clearer recommendations for prescribing opioids for non-cancer pain. The updated guidelines move away from strict dosage thresholds, aligning with the CDC’s 2022 recommendations, and emphasize individualized care. They encourage clinicians to assess risks versus benefits and consider non-opioid alternatives, reducing the “chilling effect” of previous rigid policies.

2. SB 607 (Effective January 1, 2025): This new law requires prescribers to discuss opioid risks—including addiction, overdose, and interactions with substances like benzodiazepines—with patients (or their guardians) before issuing the first opioid prescription in a treatment course. Exceptions are allowed if the discussion would harm the patient’s health or violate confidentiality. This aims to enhance patient education and informed consent.

3. CURES Fee Increase (July 1, 2025): The MBC announced an increase in the CURES fee from $9 to $15 annually for prescribers of controlled substances, reflecting the biennial renewal cycle (totaling $30). This supports the Department of Justice’s efforts to maintain CURES, a critical tool for monitoring opioid prescriptions and preventing misuse.

4. Response to Pain Management Clinic Closures (2021): Following the abrupt closure of 29 pain management centers in California, affecting over 20,000 patients, the MBC’s Statewide Overdose Safety Workgroup issued best practices for physicians inheriting patients on opioid therapy. These guidelines emphasized continuity of care and careful management to prevent withdrawal or overdose risks.

5. Criticism of Past Actions: The MBC’s controversial Death Certificate Project (launched in 2012) investigated doctors linked to opioid-related deaths, even if they didn’t prescribe the fatal dose. This led to over 450 physician investigations and was criticized for discouraging legitimate prescribing, with a study linking it to increased overdose deaths from street drugs. The MBC has since softened its approach, with less accusatory letters and a focus on education over punishment.

A Balanced Approach to Regulation

To motivate better clinical practice, regulations should focus on education, precision, and flexibility:

1. Enhanced Clinician Training: Mandating ongoing education on pain management and addiction risk can equip doctors to prescribe opioids judiciously. Programs like the CDC’s opioid prescribing guidelines and MBC’s resources offer evidence-based frameworks.

2. Tailored Prescribing Guidelines: Regulations should differentiate between acute pain, chronic pain, and palliative care. The MBC’s 2023 guidelines reflect this by avoiding one-size-fits-all dosage limits.

3. Improved PDMP Integration: Real-time, interoperable PDMPs like CURES, now bolstered by increased funding, can flag misuse without burdening clinicians. Streamlining access reduces administrative hurdles.

4. Support for Non-Opioid Alternatives: Regulations could incentivize research and insurance coverage for non-opioid pain relief, like acupuncture (covered by Medi-Cal since 2016) or nerve blocks, reducing reliance on opioids.

5. Patient-Centered Policies: Involving patients in regulatory discussions ensures their pain management needs are not sidelined. Shared decision-making, as required by SB 607, aligns treatment with individual risks and benefits.

Ethical Considerations

Regulations must balance beneficence (helping patients) with nonmaleficence (avoiding harm). Overly restrictive policies, like the Death Certificate Project, risk undertreating pain, disproportionately affecting marginalized groups with limited healthcare access. Conversely, lax oversight fuels addiction. Ethical regulation prioritizes both individual patient needs and public health.

Finally confusing medical prescribed opioids with street drugs is a common political tool.  It ends up with legitimate medical care providers facing charges before the medical board for over prescribing, failure to administer urine tests, failure to taper, repeated negligence and gross negligence.  These punitive medical board actions lead physicians to under prescribed pain killers at the expense of their patients.

Physician lawyer Daniel Horowitz has defended many physicians who are 100% legitimate but simply do not follow the current, past and everchanging political guidelines that interfere with their treatment of patients.  If you are such a physician and need legal help, call Daniel Horowitz.