This document is so long and so detailed that I spent hours working it over to add my own voluminous commentary. I posted the first part yesterday: HHS Report on Pain Mgmt Best Practices – part 1.
Below is the second part, covering more about opioid medication with all its “risk” and then the final, most significant section, covering the problems and errors of the CDC Opioid Prescribing Guidelines:
184.108.40.206 Prescription Drug Monitoring Programs
Prescription drug monitoring programs (PDMPs) are state-managed electronic databases of controlled substances dispensed (typically schedule II – IV), with the majority of the data being reported by community-based pharmacie
PDMPs allow prescribers and pharmacists (and in some states, insurers, researchers, and medical licensing boards) to access the data, monitor use by patients, monitor prescribing practices by practitioners, and check population-level drug use trends.
PDMPs can support safe prescribing and dispensing practices and help curb opioid prescription by detecting patterns that can alert clinicians to the potential that patients are at risk of SUD.
Let’s not forget that PDMPs can be and are used by law enforcement to troll through and find doctors who prescribe “more than average”, who are then selected for prosecution on this basis alone.
The information found in the PDMP can prompt the clinician to take action to improve patient safety by having a conversation about safety concerns and understanding the patient’s goals and needs
…or the information can be used to prompt law enforcement to raid a clinic.
PDMPs can assist in determining whether a patient is obtaining medications from multiple providers and filling prescriptions at multiple pharmacies, especially when prescriptions are filled in quick succession or on the same day.
The need to modernize and enhance functionality of PDMPs is widely acknowledged
Yet nothing is being done about this because it’s a low priority.
I believe the DEA prefers to keep these databases out of the limelight because they enjoy their borderline illicit access to conduct regular warrant-less searches.
But the main problem is that PDMPs do nothing to prevent the rising rates of overdoses. As mentioned early in this report, illicit fentanyl is now the driver of overdoses and drug dealers don’t use PDMPs.
Gaps and Recommendations
Gap 1: PDMP use varies greatly across the United States, with variability in PDMP design; the state’s health information technology infrastructure; and current regulations on prescriber registration, access, and use.
220.127.116.11 Screening and Monitoring
Screening and monitoring in pain management seek to identify and reduce the risk of substance misuse, abuse, and overdose as well as improve overall patient care
Screening tools can help clinicians identify risks in individual patients that can be help in identifying which medication classes may be appropriate for the patient, including for long-term opioid therapy.
Urine drug tests (UDTs) can provide information about drug use that is not reported by the patient, including not using prescribed medications as intended and unreported drug use. UDTs can also potentially inform treatment decisions by assessing an individual’s drug metabolism rate.
But that’s not how they’re used. If you show less than expected of your prescribed opioid in your urine, you will be accused of selling your medication and kicked out of the pain clinic long before anyone thinks to suspect you may not be metabolizing your medication normally.
These days, it’s always “accuse and assume abuse, ask questions later”
To mitigate the risks of prescription opioid misuse, medical societies, with state and federal regulatory agencies, have recommended specific risk-reduction strategies, including written treatment agreements for patients with chronic pain who are prescribed opioids.
First of all, they are not valid contracts because one side is being threatened with unrelieved pain, and thus coerced into signing these utterly one-sided “agreements” (as if the patient had any choice).
- The Tyranny of Pain Management Contracts
- The downside of opioid agreements and pain contracts (From the Journal of Medical Ethics!)
- Opioid contracts can harm patients
- Opioid contracts harm the doctor-patient relationship
- Restorative therapies include
- physical therapy (PT),
- occupational therapy (OT),
- therapeutic exercise, and
- other movement modalities
that are provided as a component of interdisciplinary, multimodal pain care.
Restorative therapies play a significant role in acute and chronic pain management, and positive clinical outcomes are more likely if restorative therapy is part of a multidisciplinary treatment plan following a comprehensive assessment
Patient outcomes related to restorative and physical therapies tend to emphasize improvement in outcomes, but there is value in restorative therapies to help maintain functionality. Use of restorative therapies is often challenged by incomplete or inconsistent reimbursement policies.
The role of therapeutic exercise in the treatment of pain is tied to the underlying diagnosis responsible for the pain
Thank you for “tying” exercise to the underlying diagnosis, which, in some cases like EDS and CFS/ME, can be counterproductive.
The media and medical community make exercise sound like a universally applicable and beneficial treatment for pain, but this is glaringly false for many painful conditions, like the genetic defects that lead to pain in syndromes like EDS and sickle-cell.
Bed rest was scientifically recognized and prescribed as a treatment for low-back pain as recently as the 1980
but high-quality scientific evidence has since emerged establishing the superiority of movement therapies over rest
Transcutaneous electric nerve stimulation (TENS) has been applied to treat pain, but studies of its efficacy are lacking in number and design, with high risks of bias commonly reported
Massage therapy can be effective in reducing pain
Yet even this universally accepted as benign intervention can actually increase pain and even cause damage in my case.
Because my physical problem arises from connective tissue that’s too loose, the muscle relaxation induced by massage allows my bones to shift away from their correct position. This causes excruciating pain when I try to stand up again.
Traction is a technique from the PT field that is used to treat spinal pain.
Here’s another seemingly benign treatment that’s extremely hazardous for my condition of EDS. Because my joints aren’t held together tightly enough as it is, traction could pull them apart enough to cause damage.
Cold and heat have been used in the treatment of symptoms of a variety of acute and chronic pain conditions
The application of cold has long been used as a component of the RICE (rest, ice, compression, elevation) paradigm for the treatment of acute pain syndromes.
Even this modality may be counterproductive:
Evidence is not robust for all locations and types of pain, but there is significant evidence for the efficacy and safety of heat wraps in specific conditions, most notably for acute low-back pain
I believe that heat and ice are seen as helpful mainly because they “feel good”, but as soon as the effect wears off, the pain returns.
Therapeutic ultrasound (TU) is thought to deliver heat to deep tissues for improved injury healing. A 2001 review concluded that there was little evidence that TU is more effective than placebo for pain treatment in a range of musculoskeletal conditions
Bracing has generally been discouraged in pain management because of fears of deconditioning and muscle atrophy.
Gaps and Recommendations
Gap 1: There is a lack of clarity on which restorative therapy modalities are indicated in the various pain syndromes.
Too many “alternate” modalities claim the ability to cure all people of almost anything. Each one will happily see you and tell you how they are going to cure your pain. I believed that many more times than I should have, desperate for relief from my soul-crushing pain, and was always disappointed.
Interventional pain management is part of the pain specialty that applies image-guided and minimally invasive procedures toward the diagnosis and treatment of pain conditions.
Often, “interventional pain management” also includes surgeries, like spine fusions or disc repair.
Diagnostic and therapeutic interventional techniques can be valuable options prior to the initiation of extensive surgical or opioid treatment or in concert with other treatment modalities.
It sure sounds like they’re trying to make a case for all the “epidurals” they order for all pain patients, one of the most profitable procedures for offer.
Finally, in certain types of pain conditions where there is a specific physical cause of the pain, direct surgical intervention can be therapeutic and beneficial to patients.
The following paragraphs briefly describe interventional procedures that can be considered singularly or as part of a multimodal approach to the management of chronic and acute pain, depending on the patient and his or her medical conditions.
Epidural steroid injections (ESIs) deliver anti-inflammatory medication directly into the epidural space — the region outside the sac of fluid surrounding the spinal cord
I don’t understand why these are mentioned here when the FDA has repeatedly warned about the dangers inherent in these procedures:
- Update: Hidden Danger of Intraspinal Steroid Injections
- How Safe Is Epidural Steroid Injection
- Epidural Steroid Injections: Danger Worth the Benefits?
- Serious Neurologic Events after Epidural Glucocorticoid Injection
- Spinal injections: comprehensive review of the literature
- Potential Complications Of Epidural Steroid Injections
Doctors might be pushing these procedures to prove they tried something besides opioid medication.
However, considering how potentially damaging such injections can be, it’s hard not to believe these doctors are just blinded by greed:
- Epidural Steroid Injections Overused
- Untrained pain docs performing epidural steroid injections
- Interventional pain procedures increasing faster than opioid prescribing
- Doctors Turn to a Risky Treatment for Back Pain
ESIs are one the most common procedures in pain management and, in well-selected patients, can provide significant pain relief as part of a pain management plan
These are extremely profitable for doctors and some pain clinics actually require a patient submit to them in order to be given what really works: opioid medication.
I’m going to leave the rest of this section on interventional procedures for tomorrow’s post: HHS Report on Pain Mgmt Best Practices – part 3.
Several factors act as barriers to adequate care, including
- poorly functioning drug supply systems,
- inadequate insurance coverage for pain management services,
- shortages in medical and behavioral pain management specialists,
- provider underestimation of patients’ reports of pain,
- lack of research on innovative and effective pain management approaches
- and — more recently — widespread fear among providers of regulatory scrutiny.
The current anti-opioid sentiment, PROPaganda, and involvement of the DEA are valid reasons for doctors to be fearful, but at least a few of them are starting to become vocal about their opposition to such draconian restrictions.
However, I would say that the most profound barrier to adequate care for pain is that “providers” do not believe the extent of or even the existence of our pain.
If there are no physical signs of damage, few doctors are able to truly believe a patient who continues complaining of pain even after the first two or three (or twelve) therapies they try.
A very kind and compassionate (to a point) neurologist once had me try the treatments that had been effective for many of her previous patients with mysterious pain. After none of them worked and I told her my pain wasn’t relieved and I still needed opioid medication, she finally stopped believing me and accused me of trying to deceive her just to get more drugs.
I was so angry and embarrassed that I fled her office and never went back. When I reported these results to my PCP, she surprised me and said she would prescribe my opioid therapy herself.
The recent advent of retail pharmacies limiting the duration of prescriptions, making changes to dosage, amounts, or placing restrictive barriers to obtaining properly prescribed pain medications has had the unintended consequence of limiting access to pain care.
Without access to sufficient pain care, many patients face unnecessary medical complications, prolonged suffering, and increased risk for psychiatric conditions.
Medical complications from inadequately treated acute pain may include prolonged recovery time, unanticipated readmissions, and transition to chronic and persistent pain.
Unremitting and inadequately treated pain is also associated with increased anxiety, depression, disability, unemployment, and lost income.
Heroin, fentanyl, and other illicit synthetic opioids continue to drive increasing numbers of overdose deaths.
Understanding the indicators associated with inappropriate opioid use may improve the ability of health care providers to tailor treatments and surveillance without placing arbitrary limitations on all patients who are prescribed opioids. This understanding could also potentially improve access to effective care.
…the report goes on to cover the following topics, but I skipped them for now in order to focus on the last section which I believe is the most critical.
- Cross-Cutting Clinical and Policy Best Practices
3.2.1 Public Education
3.2.2 Patient Education
3.2.3 Provider Education
3.3 Access to Pain Care (commented above)
3.3.1 Medication Shortage
3.3.2 Insurance Coverage for Complex Management Situations
…and then finally comes the most critical part of this report for pain patients, the validation we’ve been waiting for…
In 2016, in response to growing concerns about overprescribing opioids for pain management and opioid-related overdose, the CDC published a widely read guideline on opioid therapy for chronic pain
important limitations have been highlighted by various clinicians, patients, professional organizations and other stakeholders in the two years since publication.
A commentary by Busse et al. identified several limitations to the CDC guideline related to
- expert selection,
- evidence inclusion criteria,
- method of evidence quality grading,
- support of recommendations with low-quality evidence, and
- instances of vague recommendations
In addition, the CDC used the criterion of a lack of clinical trials with a duration of one year or longer as lack of evidence for the clinical effectiveness of opioids, whereas Tayeb et al. found that that was true for all common medication and behavioral therapy studies.
Noting that the CDC guideline focused primarily on patients initiating opioid treatment, Gordon and Connoly discussed application of the guidelines to patients who are already receiving opioid maintenance therapy for chronic pain.
Given that chronic pain has many different underlying conditions, with great patient variability in metabolism, risk for abuse and medical conditions, further studies are needed to assess the value of long-term opioids when other measures have failed to relieve a patient’s pain, coupled with risk assessment and periodic reevaluation.
I don’t understand why this critical sentence is buried so deep in the report when this is of primary importance in the whole argument about opioids.
Individual genetic and psychological variations determine whether any specific patient will become addicted, achieve good pain control, or find opioids completely ineffective.
Interpretation of the guideline, in addition to some gaps in the guideline, have led to unintended consequences, some of which are the result of misapplication or misinterpretation of the CDC guideline.
The guidelines accomplished exactly what PROP wanted them to: labeling ALL prescribed opioid use over 90 days as addiction in need of their addiction-recovery services.
The 2016 CDC guideline was intended as a tool for PCPs to help inform their decisions about managing pain with opioids and to encourage dialogue and discussion of risks between providers and patients (shared decision making
However, at least 28 states have enacted legislation related to opioid prescription limits, and many states and organizations have implemented the guideline without recognizing that the intended audience was PCPs; have used legislation for what should be medical decision making by healthcare professionals; and have applied them to all physicians, dentists, NPs, and PAs, including pain specialists, Some stakeholders have interpreted the guideline as intended to broadly reduc
An unintended consequence of the guideline is the forced tapering or patient abandonment that many patients with chronic pain on stable long-term doses of opioids have experienced.
The Task Force received public comments indicating that many patients have experienced access issues related to provider fears and concerns with how the guideline would be interpreted and have caused some to consider obtaining opioids from illicit sources or suicide.
the amount of opioids prescribed for treating pain; some experts have noted that the guideline emphasizes the risk of opioids while minimizing the benefit of this medication class when properly managed. The CDC guideline was not intended to be model legislation for state legislators to enact.
The CDC guideline, along with concern about undue burdens of investigation and prosecution by drug enforcement, has been cited in part by doctors and other key health care providers when deciding to limit or not to provide pain treatment.
This is the result PROP wanted and knew it would get when they steamrolled the CDC into using anti-opioid materials they had already written.
Experts have also noted that the CDC guideline does not sufficiently emphasize that optimal pain management begins with identification of the cause of the pain and the biopsychosocial mechanisms that contribute to its severity and associated disability.
The CDC guideline recommends that opioids prescribed for acute pain be limited to three or fewer days and that more than a seven-day supply is rarely necessary.
Various health insurance plans, retail pharmacies, and local and state governments are implementing the CDC guideline as policy, limiting the number of days a patient can receive prescription opioids
A more even-handed approach would balance addressing opioid overuse with the need to protect the patient-provider relationship by preserving access to medically necessary drug regimens, and reducing the potential for unintended consequences.
Policies should help ensure safe prescribing practices, minimize workflow disruption, and ensure that beneficiaries have access to their medications in a timely manner, without additional, cumbersome documentation requirements.
In essence, clinicians should be able to use their clinical judgement to determine opioid duration for their patients.
This is exactly what this long, long document is saying:
Let individual doctors make medical decisions about individual patients.
…and don’t limit their decisions by creating bureaucratic obstacles. I thought this was the way all medical care was supposed to work – why is it so unusual when it comes to pain care?
The report ends with the following:
1: There is an absence of high-quality data on the duration of opioid effectiveness for chronic pain, which has been interpreted as a lack of benefit.
- Recommendation 1a: Support studies to determine the long-term efficacy of opioids in the treatment of chronic pain syndromes (primary and secondary) in different populations as determined by clinical context, clinical conditions, and comorbidities.
- Recommendation 1b: Conduct clinical trials on specific disease entities, with a focus on patient variability and response to tissue injury and on the effectiveness of opioid analgesics. Design trials to be applicable in real-world settings (e.g., patients receiving trialed opioid medications while maintaining the usual multimodal therapy).
2: There is an absence of criteria for identifying the sub-population of patients for whom opioids may make up a significant part of pain management.
- Recommendation 2: Conduct clinical studies or complete systematic reviews to identify which sub-populations of patients with different chronic pain conditions may be appropriate for long-term opioid treatment in conjunction with the various nonopioid modalities.
3: There is wide variation in factors that affect the optimal dose of opioids.
- Recommendation 3a: Consider patient variables that may affect opioid dose in patients prior to initiation of opioid therapy, including respiratory compromise, individual patient metabolic variables, or differences between opioid medications that could affect plasma opioid concentrations.
- Recommendation 3b: Perform comprehensive initial assessments for patient management, with an understanding of the need for periodic comprehensive reevaluation to adjust the medication dose.
- Recommendation 3c: Careful consideration should be given to patients on an opioid pain regimen who have additional risk factors for OUD.
4: Specific guidelines addressing opioid tapering and escalation need further elucidation.
- Recommendation 4a: Undertake opioid tapering or escalation with a thorough assessment of the risk-benefit ratio. This should be done in collaboration with the patient whenever possible.
- Recommendation 4b: Develop guidelines for tapering and dose escalation for the sub-populations of patients who have chronic pain conditions that includes consideration of their comorbidities.
- Recommendation 4c: Consider maintaining therapy for patients who are stable on long-term opioid therapy and for whom the benefits outweigh the risks.
5: There are multiple potential causes of worsening pain that are often not recognized or considered. Non-tolerance-related factors include iatrogenic causes such as surgery, flares of the underlying disease or injury, and increased ergonomic demands or emotional distress (e.g., anxiety disorders, catastrophizing, depression).
- Recommendation 5a: When a stable dose has been established for at least two months, avoid increases in the dose until the patient is reevaluated for the underlying causes of elevated pain or possible OUD risk.
- Recommendation 5b: Considerations to avoid dose escalation should include opioid rotation, non-opioid medications, interventional strategies, cognitive behavioral strategies, complementary and integrative health approaches, and PT.
6: Although the risk of overdose by benzodiazepine co-prescription with opioids is well established, this combination may still have clinical value in patients who have chronic pain and comorbid anxiety, which commonly accompanies pain, and in patients who have chronic pain and spasticity.
- Recommendation 6a: If clinically indicated, co-prescription should be managed and coordinated by physicians, providers, and clinician specialists who have knowledge, training, and experience in co-prescribing benzodiazepines with opioids. For those patients who have anxiety disorders or SUD who have been prescribed benzodiazepines, collaboration with experts in mental health and the use of psychological modalities should be considered.
- Recommendation 6b: Develop CPGs that focus on tapering for co-prescription of benzodiazepines and opioids.
7: The risk-benefit balance for opioid management may vary for individual patients. Similarly, the balance of benefit and risk for doses above 90 MME/day may be favorable to some patients, while for other patients, doses below 90 MME/day may be a greater risk because of individual patient factors. The variability in the effectiveness and safety of low doses of opioids and the variability in the effectiveness and safety of high doses of opioids are not clearly defined. The clinician should maintain caution with higher doses in general.
- Recommendation 7a: Use the lowest effective opioid dose that balances benefits, risks, and adverse reactions. Physicians and other health care providers should individualize doses based on a carefully monitored medication trial by the patient, with frequent monitoring of analgesic effectiveness with each dose adjustment and with regular risk reassessment.
- Recommendation 7b: Additional factors influence risk and benefit that should be considered; therefore, guidance regarding dose should not be applied as strict limits. Providers can use established and measurable goals such as functionality, ADL, and QoL measures.
8: The duration of pain following an acute, severely painful event such as trauma, surgery, or burn is widely variable.
- Recommendation 8a: Appropriate duration of therapy is best considered within guidelines, and then ultimately determined by the treating clinician. The CDC recommendation for duration of treatment should be emphasized as guidance only for a general approach, with individualized patient care as the primary goal and the clinician then considering all modalities for best outcomes.
- Recommendation 8b: Develop acute pain management guidelines for common surgical procedures and trauma management, as noted in Acute Pain Recommendation 2a.
- Recommendation 8c: To address this variability and provide an easy solution to the challenges of medication duration, consideration should be given to a partial refill system.
Here is the outline of the report with links to each section: