Best Practices Education, Part III: Regulatory and Advisory Issues Related to Opioid Therapy for Pain




(1)
Northern Anesthesia & Pain Medicine, LLC, Eagle River, Alaska, USA

(2)
WWAMI Program, University of Washington School of Medicine, Anchorage, Alaska, USA

 



Keywords
Drug Enforcement AdministrationPractitioner’s manualControlled Substance ActDrug Addiction Treatment ActDATA 2000Comprehensive Addiction Recovery ActCARA 2016Prescription drug monitoring programPDMPFederation of State Medical BoardsModel policyRisk stratification“4As” treatment agreementOpioid contractUrine drug screeningPill countX-numberCancer painAnalgesic ladderBreakthrough painRescue doseDriving under the influence of drugsDUIDImpairmentZero toleranceEugeroicModafinilArmodafinilNaloxoneCommunity NarcanRotationEquianalgesic tableHolidaysWeaning


A 55-year-old local small business owner is referred to you by his primary care physician, who is requesting that you provide an epidural steroid injection for subacute low back pain with painful paresthesias into the left calf and foot that began 3 weeks ago, after he was moving equipment into a new office. He denies any weakness or cauda equina symptoms . The pain is worsened by movement of any sort, although spinal flexion, i.e., sitting is the worst provocative maneuver, and his activity has been markedly reduced. Despite his primary physician’s admonition not to, he is using ibuprofen, 800 mg to 1600 mg qid and also admits to drinking “one or two drinks” in the evening to try to palliate the pain, ostensibly. He is also using cyclobenzaprine, 10 mg bid. His chiropractor has been unable to help him with this episode.

His history is otherwise notable for hypertension, GERD, and tobacco use. He has had a recent arthroscopic rotator cuff repair and remote right inguinal herniorrhaphy. Medications include lisinopril/HCTZ, omeprazole, and ibuprofen and cyclobenzaprine as above. His only allergy is to penicillin.

Physical exam reveals a mildly overweight male in moderate discomfort who is recumbent on your exam table and resists physical exam. He is dysphoric and admits during exam that he has had suicidal ideation but no plans, due to the financial stress of his company’s recent troubles, “downsizing” and move, compounded by the pain. He is hyperalgesic in the left L5 dermatome, but dorsiflexion and hallux extension are preserved, and ankle jerk is 2/4 at both ankles. Ipsilateral supine straight leg raise is markedly positive at 40°.

After discussing his likely pathology with him (suspected annular tear with or without L4/5 paracentral or L5/S1 foraminal intervertebral disc protrusion), you explain to him that in the absence of “red flag” symptoms and signs, advanced imaging is not indicated at this point and furthermore his “payer” requires prior authorization before MRI. They also require that his symptoms persist for longer than 3 months and that he have documented failure of 3 months or more physical therapy for this condition.

You explain that he is at high risk of gastritis, peptic ulcer disease, gastrointestinal bleeding, renal injury, and cardiovascular/cerebrovascular injury with his excessive NSAID use and comorbidities. You instruct him to stop NSAIDs at this point, as well as alcohol use and smoking (after explaining to him the association between smoking and intervertebral disc disease not to mention serious morbidity and mortality) and explain to him that a trial of bupropion is in his best interest for assistance in smoking cessation as well as depressive symptoms (after reviewing the FDA “black box” warning with him) and also potentially for neuropathic pain. After spending some time with him explaining the anatomy and pathophysiology of his suspected condition and necessary postural and ergonomic corrections, you order 6 weeks of physical therapy with avoidance of sit-ups.

After discussing the risks of worsened depression, dependence and addiction, gastrointestinal complications, respiratory complications, especially if he uses alcohol, and giving him instructions not to drive under the sedative effects of the medication, you advise him that you are going to prescribe a limited supply of acetaminophen with codeine (which he has used previously without adverse effects) to be used half an hour prior to physical therapy and in the evening after physical therapy to help facilitate rehabilitation. You explain that this will only be prescribed for the next few weeks while he is getting established with physical therapy and HEP. You also advise that in a week or two, after confirmation of no immediate adverse effects from bupropion, which he is naive to, if the painful paresthesias persist , you will call in a course of gabapentin. You conclude the encounter by reassuring him again that there is no evidence of serious pathology and that he has a greater than 2/3 likelihood of this situation resolving in the next few months without any complication including chronification if he stops smoking and corrects his posture/ergonomics and is diligent with physical rehabilitation. You plan on reevaluation in 6 weeks or sooner if his condition worsens and assure him once again that there is no indication for surgery here, but if his condition persists or worsens, then the issue of advanced imaging and possible interventional care (i.e., epidural steroids) can be revisited.


Introduction


In the previous chapter, we began exploring the role that opioids play within the context of treating both acute and chronic pain and examined why and when the practitioner might consider prescribing opioids. In this chapter, we cover both regulatory and advisory (including recent consensus guidelines) aspects of how opioids can and should be prescribed, which as the past 2 decades have taught us, is more fraught with difficulties and negative consequences than was appreciated at the outset of the opioid epidemic.

The focus of this chapter is to improve prescription patterns; evidence of widespread flaws in opioid-prescribing practice confronts us every day in the news. These flaws need to be exposed systematically and corrected accordingly; at a “big picture” level, they can be categorized roughly into:



  • (Fairly rare) ignorance of federal and state laws applicable to opioid prescription


  • (Fairly common) ignorance of state medical board rules and policies applicable to opioid prescription


  • (Fairly common) ignorance of best practices to reduce diversion of prescription opioids


  • (Rampant) ignorance of best practices to optimize overall patient benefit (analgesia, improved function and quality of life): risk (physiologic, psychological, functional, relational, societal) ratio from opioid prescription

The first category is addressed briefly in the initial “regulatory” section; the prescriber however is referred to the US Drug Enforcement Administration (DEA) Practitioner’s Manual [1] for definitive instruction. The latter three categories are addressed in the “Advisory” section which follows. “How to” start and trial patients on opioids is introduced in this section; the subject of weaning and discontinuing opioid therapy is dealt with primarily in Chap. 11.

Finally, a brief overview of current recommendations for the use of opioids in treating cancer pain is provided.


How to Prescribe Opioids: Regulatory Issues


Regulations (and guidelines, discussed below) regarding opioid prescription evidence quandaries and difficulties unique among medication classes. While other controlled substances are subject to regulations, none of them carry indications associated with the same degree of emotional urgency experienced and communicated by most patients in pain and felt by providers. In many cases, there are no viable alternatives to the prescription of opioids if severe pain is to be treated efficaciously, and “undertreated pain” is a real issue. Conversely, overtreated pain is a real issue as well, at the level of the individual patient and also at a societal level, with adverse effects and diversion comprising the two chief concerns.

As the opioid crisis in this country has grown over the past 20 years, so has scrutiny of prescriber behavior by both the medical and legal communities. In 1980, the American Medical Association (AMA) proposed a framework for categorizing prescribers who are knowingly or unknowingly complicit with prescription opioid misusers, abusers, and diverters [2]. Referred to as the “4D” model, this framework has been widely discussed by policymakers and authorities for the past few decades as a means of attempting to assist in stratifying the culpability of providers involved in overprescription/misprescription, and in guiding disciplinary measures. The 4D model is presented in a more recent iteration borrowed from the American College of Preventive Medicine in Table 8.1.


Table 8.1
The 4Ds of prescriber involvement in prescription abuse [3]



















Deficient (dated)

Duped

• Unaware of federal and state laws regarding opioid prescription

• Unaware of multimodal treatment options

• Unaware of signs and symptoms of addiction

• Too busy (or disinterested) to keep up with CME; education comes primarily from pharmaceutical companies

• Isolated from peers, medical community, and ignorant of standards of care

• Fails to exercise “due diligence” in assessing patient’s risk of abuse and diversion; trusts but does not verify

• Fails to secure prescription pads or use tamper-proof prescription means

• Fails to direct care appropriately and allows patient to dictate care (“OK, here’s a script for your “percs”)

• Fails to exercise boundaries regarding aberrant behavior (early refill requests, dose escalation, etc.)

Deliberate (dealing)

Drug dependent

• Deliberately/knowingly prescribes opioids for nonmedical purposes, e.g., recreational use/abuse and diversion

• Trades prescriptions for money, sex, street drugs, etc.

• “Pill-mill”

• Forges prescriptions from other providers

• Prescribes to others, real or fictitious, and intercepts prescriptions

More recently, a “3C” model (Careless, Corrupt, Compromised) has been proposed that attempts to remove patient factors from the equation and in essence collapses the first two categories of “Dated” and “Duped” into the category of “Careless” [4]. While no effective (or appropriate) remedy aside from prosecution and sanction, respectively, exists for the latter two “C” categories in this author’s opinion, prevention of misdeeds attributable to carelessness begins with (but is by no means limited to) understanding the laws (acts and regulations) pertaining to opioid prescribing.


History of (Federal) Opioid Prescribing Legislation


The quandary of opioid misuse and prescription negligence has long been recognized by the government, and federal regulation has evolved over the past century. Despite widespread claims (especially in the 1990s) that dependence and addiction are exceedingly rare sequelae of opioid therapy, it has been evident to elected leadership that from a public health perspective at least, opioid addiction is a significant societal burden closely intertwined with the medical profession. While early legislation focused more on consumer safety, the issues of psycho-/behavioral effects of mind-altering substances including opium and dependence/addiction have been more than implicit in local, state, and federal governmental policy for over a century. Virtually, all legislation for the past 50 years having to do with opioids has been written to address abuse liability and frank addiction management.

The first major legislative effort by Congress to control opioid distribution was the Harrison Narcotics Tax Act of 1914, which dealt primarily with commercial registration and taxation issues pertaining to “opium or coca leaves, their salts, derivatives, or preparations” but also introduced legal requirement for recordkeeping of prescriptions for these substances. Five years later, in Webb vs. United States, the US Supreme Court ruled that physicians could not prescribe opioids solely for maintenance of addiction.

In 1924, the Heroin Act rendered manufacture or importation and possession of heroin illegal for all purposes. In 1932, the Uniform State Narcotic Act called for states to pass legislation in line with federal legislation (the Narcotic Drug Import and Export Act). The Food, Drug, and Cosmetic Act in 1938 brought the determination of safety of these substances under the control of the Food and Drug Administration (FDA), mandating new drug approval by that agency prior to marketing, and also required safe use instruction labeling. The Durham-Humphrey Amendment of 1951 further established the classification of certain drugs, especially those that are “habit-forming” as prescription only.

The Controlled Substance Act (CSA) of 1970 reorganized and consolidated several previous laws regulating drugs and substances with high abuse potential. Five “Schedules” were created, based primarily upon abuse and addiction potential, with Schedule I containing drugs with no recognized legitimate medical use (e.g., heroin, LSD, marijuana) and Schedules II through V containing drugs such as opioids, sedatives, stimulants, and others in tiers of decreasing risk.

The Narcotic Addict Treatment Act of 1974 amended the CSA to provide for the federally supervised treatment of opioid dependence by either maintenance of dependence using prescription opioids for longer than 21 days or detoxification using a weaning schedule of 21 days or less. This provided the legal basis for methadone maintenance therapy.

The Drug Addiction Treatment Act of 2000 (DATA 2000) established office-based treatment (OBT) of opioid dependence using FDA-approved Schedule III–V opioids (the only one currently approved is buprenorphine). Physicians must obtain a special DEA number (“waiver” or “X-number ”) in order to prescribe buprenorphine for OBT; requirements for waiver include:



  • Board certification in addiction psychiatry


  • Certification in addiction medicine by the American Society of Addiction Medicine (at the time of this writing responsibility for this certification has been transferred to the American Board of Preventive Medicine)


  • Certified in Addiction Medicine by American Osteopathic Association (AOA)


  • Investigator in buprenorphine clinical trials


  • Completion of 8 h of CME provided by American Psychiatric Association, American Academy of Addiction Psychiatry, ASAM, American Medical Association, AOA, (or other organizations designated by Health and Human Services)

Subsequent amendments in 2005, 2006, and 2016 have sequentially increased the limit or “cap” on how many patients may be treated with OBT per qualifying physician.

The Comprehensive Addiction and Recovery Act of 2016 (CARA 2016) represents the first major piece of legislation attempting to comprehensively address the opioid epidemic, with components including prevention, treatment, recovery, law enforcement, criminal justice reform, and overdose reversal. Among other initiatives, an interagency group (comprising HHS, VA, DEA, CDC, other federal agencies, addiction treatment organizations, and other stakeholder communities) have been tasked with the development of best practices for opioid prescription. Mandatory prescriber education recommendations have been assigned to the Secretary of Health and Human Services (HHS) . Among the vast scope and provisions of CARA 2016, one of the more striking decisions is the amendment of the CSA to allow mid-level practitioners to become eligible to prescribe buprenorphine for the treatment of opioid use disorder.


Federal Regulations for Opioid Prescribing


The CSA and Title 21 of the Code of Federal Regulations 1300–1316 (the “DEA Regulations”) allow, inform, and direct legal prescription of opioids, including:



  • Providing the legal basis for prescribing opioids (21 CFR 1306.07— “May administer, prescribe or dispense a Schedule II controlled substance to a person with intractable pain, in which no relief or cure is possible or none has been found after a reasonable effort”


  • Delineating which opioids (and other controlled substances) can be prescribed


  • Delineating who can prescribe them


  • Regulating how they can be prescribed (e.g., means of prescribing, whether or not they may be refilled, etc.)

Regulatory and enforcement authority is delegated primarily to the FDA and the DEA. The FDA’s “scope of practice” pertinent to prescription opioids is to ensure public safety by determining the safety of the drug, recommending scheduling within the five CSA schedules, and recommending indications for use. The DEA is ultimately responsible for the scheduling of controlled substances and is also tasked with enforcing the CSA.

The CSA and DEA regulations are summarized for providers within the DEA’s Practitioner’s Manual , available online at ​www.​deadiversion.​usdoj.​gov/​pubs/​manuals/​pract/​index.​html; a cursory review of highlights follows below.

Opioids (with the exception of heroin, which is classified as Schedule I, i.e., no medical use) fall within Schedules II through V as shown in Table 8.2, with the majority classified as Schedule II, the most stringently controlled category. Considerable differences in prescriptive regulation exist between Schedule II and lower categories and are highlighted in Table 8.2. All controlled substances, however, by law must be prescribed only for “legitimate medical purpose by a practitioner acting in the usual course of professional practice” [1].


Table 8.2
Oral, sublingual, and transdermal opioids by controlled substance schedule


































Schedule

Commonly prescribed opioids (excluding intravenous forms)

Legal means of prescribing

Refills

II

Codeine (≥ 90 mg)

Fentanyl

Hydrocodone (including combination products)

Hydromorphone

Levorphanol

Meperidine

Methadone

Morphine

Oxycodone (including combination products)

Oxymorphone

Tapentadol

Electronic or written prescription only*

*a telephoned emergency prescription not exceeding three (3) days’ supply may be prescribed so long as a written copy follows within 7 days

Schedule II prescriptions for residents of long-term care facilities or those enrolled in a hospice program may be FAXed to the dispensing pharmacy

Not allowed

III

Buprenorphine

Codeine combination products

Electronic, written, FAXed, or telephoned prescription

≤five (5) refills within six mo.

IV

Butorphanol

Pentazocine

Tramadol (including combination products)

Electronic, written, FAXed, or telephoned prescription

≤five (5) refills within six mo.

V

Codeine cough syrups ≤200 mg/100 mL or 100 g

Electronic, written, FAXed, or telephoned prescription

Not limited by federal law

Federal law restricts opioid prescription privileges to practitioners who are registered with the DEA to prescribe controlled substances within Schedules II through V and then assigned a registration number (“DEA number”). Practitioners in training, or who work solely as employees of a hospital may use the hospital’s DEA registration, and federal government practitioners (e.g., armed services or US Public Health Services or Prison Bureau practitioners) receive a waiver of this requirement.

Strict legal requirements concerning the security and accounting of stored and administered or dispensed controlled substances do not apply to most practitioners. Security of prescriptions however are the responsibility of all prescribers and tamper-resistant prescription pads or paper are advised by the DEA (and mandated by several states). In addition, by federal law, controlled prescriptions require notation of the patient’s address as well as name and date of birth. The drug name, dosage form, strength, quantity, and directions for use, and of course the name, address, and registration number of the prescriber must also be on the prescription. Until recently, when electronic prescription of Schedules II through V substances was allowed, Schedule II substances required hard copy/paper prescription with a manual signature (no stamps).

Recordkeeping of controlled substances prescribed (not administered/dispensed) is not mandatory unless said prescriptions are for maintenance or detoxification purposes.


State Regulations for Opioid Prescribing


In 1970, after the CSA was enacted, the states commissioned a Uniform Controlled Substances Act (UCSA) as a model for individual states to consider when updating and revising their own drug laws, with the intent of promoting uniformity and a means of achieving consistent and more effective control of the possession, use, sale, distribution, and manufacture of controlled substances. The most recent revision took place in 1994 and may be accessed at (​www.​uniformlaws.​org/​shared/​docs/​controlled%20​substances/​UCSA_​final%20​_​94%20​with%20​95amends.​pdf).

The diversity of state-specific statutes concerning controlled substances is complex to the point that a comprehensive presentation of these laws state-by-state is prohibitive. Every prescriber should be aware of their own state’s legislation concerning the prescription of controlled substances, and the internet has rendered that task a relatively simple one. For those interested in an overview of state regulations, the National Criminal Justice Association created a Guide to State Controlled Substances Acts in 1988 that presents a thorough albeit currently dated compilation of state-specific regulations [5]. At present, the National Association of State Controlled Substances Authorities provides an easily navigable website (​www.​nascsa.​org/​stateprofiles.​htm) with links to each state’s statutes and rules pertinent to controlled substances, current authorities, and other pertinent deviations from federal regulations/scheduling.

Despite recent confusion (and frank violation of national law) surrounding the marijuana controversy in several states, the states may not enact controlled substance schedules less stringent than the national schedule determined by the DEA. Some states have historically classified some controlled substances more restrictively than the national schedule; for example, codeine cough syrups are assigned a category more restricted than Schedule V in several states, and many states controlled tramadol prior to federal categorization as a controlled substance in 2014. The state of Massachusetts recently passed legislation restricting initial opioid prescriptions for adults (and all opioid prescriptions for minors) to a seven-day prescription; this is to date the most stringent limitation on prescription duration in this nation.

At the time of this writing, 22 states, the District of Columbia, Puerto Rico, and Guam also require a state (or territory)-specific controlled substance prescription registration as well. While most states currently allow mid-level practitioners (e.g., physician assistants and nurse practitioners) to prescribe most controlled substances, there are several that restrict Schedule II drugs to the order of a physician only, and some states do not allow controlled substance prescribing at all by mid-levels. The question of whether or not opioids should be prescribed by physicians or mid-level practitioners who have not been adequately trained to do so is a “hot-bed issue” enjoying discussion in many circles and at various levels of governance. There is no easy answer to this question, and in many cases there are no providers available who have undergone formal residency or fellowship-level training in opioid prescription. This will always remain impractical for many communities, and regarding these situations where nonspecialists are responsible for the pain management component of the health and well-being of their communities, the question should not be so much “should they be prescribing?” but rather “how can we best educate them and provide guidance?” This book is one such attempt to answer that question, and a significant amount of continuing medical education has become available over the past several years in order to assist with this endeavor as well. In many states, it is now becoming mandatory for prescribers to undergo opioid-related continuing medical education (CME) , in some cases once in a lifetime and in others on an ongoing basis. At the time of this writing:



  • Florida mandates controlled substances CME on a regular basis for allopathic physicians working in a pain clinic.


  • Kentucky mandates regular CME related to pain management, addiction disorders, and the use of their PDMP.


  • Maryland requires regular opioid prescribing CME.


  • Massachusetts requires regular opioid prescribing CME.


  • New Mexico mandates controlled substances CME on a regular basis for allopathic physicians with a DEA number.


  • Ohio requires physician owner/operators of pain management clinics to complete regular CME in pain medicine every 2 years, to include one or more courses addressing the potential for addiction.


  • Oklahoma requires regular CME on controlled substances prescribing for osteopathic physicians.


  • South Carolina requires regular CME on controlled substances prescribing for physicians.


  • Texas mandates controlled substances CME on a regular basis for physicians working in a pain clinic.


  • Vermont mandates controlled substances CME on a regular basis for allopathic physicians with a DEA number.


  • West Virginia requires regular CME on controlled substances prescribing and diversion prevention for physicians.

Several other states require pain management CME on a regular basis without specifying a requirement for controlled substances/opioid education.

State Prescription Drug Monitoring Programs/Databases (PDMPs) have become a ubiquitous tool in the monitoring of controlled substance prescriptions and serve a valuable role in diversion prevention. At the time of this writing, all but one state (Missouri) have adopted legislation requiring creation of a PDMP, and many states have been using them for several years now. At the time of this writing, 16 states require checking the State Prescription Drug Monitoring Program prior to issuing controlled substance prescriptions [6]. (Interestingly only 11 states, not all of which are represented in the 16 mentioned above require registering with the PDMP.) These requirements are summarized in Table 8.3.


Table 8.3
State requirements regarding use of prescription drug monitoring programs prior to prescribing controlled substances






























State

Bill

Provisions

Alaska

SB 74

PDMP to be checked before prescribing or dispensing Schedule II–III controlled substance with exceptions

Arizona

SB 1283

PDMP to be checked before prescribing a Schedule II–IV opioid or benzodiazepine for a new course of treatment. Subsequent check at least quarterly while the substances remains part of the treatment. Exceptions may apply

California

SB 482

PDMP to be checked before first-time prescribing, ordering, administering, or furnishing of a Schedule II–IV controlled substance except for veterinarians, pharmacists, and other specified exemptions; check shall not be earlier than 24 h or the previous business day prior to first-time prescribing, ordering, administering, or furnishing. Subsequent check every 4 months if the substance remains part of the treatment

Connecticut

HB 5053

PDMP to be checked before prescribing more than a 72 h supply of a controlled substance. Check required at least every 90 days when prescribing other than a Schedule V non-narcotic controlled substance for continuous or prolonged treatment. Prescribing a Schedule V non-narcotic controlled substance for continuous or prolonged treatment requires a PMP check not less than annually. Exceptions may apply

Indiana

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Apr 12, 2018 | Posted by in Uncategorized | Comments Off on Best Practices Education, Part III: Regulatory and Advisory Issues Related to Opioid Therapy for Pain
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