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5 Articles in Volume 3, Issue #2
Balancing Pain Management and Professional Risk
Chronic Opioid Rules
Distraction Techniques for Lumbar Pain
Legal Landscape of Pain Treatment
National Pain Data Bank Minimizes Professional Risk

Balancing Pain Management and Professional Risk

A discussion on how to provide adequate pain relief while avoiding potential legal complications in prescribing controlled substances.

In the past, practitioners were grateful if they were just compensated for their services within a reasonable period of time by payers. Their concerns then shifted toward medical malpractice prevention techniques and strategies for avoiding billing errors leading to audits by federal authorities. Now, practitioners must seriously ask themselves if they face criminal prosecution, possible incarceration and ruin if they even prescribe controlled substances for the management of pain. One physician recently described the current practice environment as “see a patient and go to jail.” Lost in this sentiment was the fate of patients suffering with chronic intractable pain.

Historical Perspective

Newspaper headlines for the past two years have left most prescribing pain practitioners wondering what they are supposed to do to practice effective pain management in light of the new anti-opioid hysteria. A sampling of these headlines includes: 200 Indicted Over Illegal Trade in Painkiller; A Painkiller’s Double Life as an Illegal Street Drug; Doctor Arrested on Fifth Manslaughter Charge; Doctor Faces 165 Years In Drug-Deaths Conviction; Doctor Guilty Of Manslaughter; Drug Deaths in Florida Skyrocketing; More Docs Face Murder Charges In Overdose Deaths; Overdoses of Painkiller Are Linked to 282 Deaths; Prescription Drug Abuse High In Rural Maine; Prescription Drug Fraud Steadily Rising; Use of Painkiller Raises Questions. These headlines stand in sharp contrast to the public pro-opioid position statements of the American Pain Society (APS) and the American Academy of Pain Medicine (AAPM),.1 U.S. Federation of State Medical Boards,.2 U.S. Drug Enforcement Administration3 and others.

The rationale for using controlled-release (i.e. fentanyl, morphine and oxycodone) or long half-lived medications (i.e. methadone) has always been better blood level stability with more consistent, sustained pain control—while permitting patients more predictability in their lives from one day to the next. The controlled-release medications have been found to improve sleep, decrease vomiting, give better control pain, and potentially improve rehabilitation outcomes.4 While long-half lived medications are more toxic in overdoses, they can still be used effectively by many patients and are considerably less expensive for those with financial limitations. However, what started as a rational attempt to ease the pain of millions of sufferers has been marred by substance abuse involving prescription opioids and consequently has set the field of pain management back a good number of years.

The same “when-are-the-use-of-opioids-ever-justified” questions are back now with a frightening draconian twist. If pain practitioners give controlled substances to the “wrong patients” they may risk their reputations, careers, and freedom.

In the 1980s, pain practitioners offered opioids only for the short-term management of post-operative pain and pain associated with terminal illness. Most comfortably agreed that pain should be addressed with opioid analgesics after surgery or trauma. Further, no one disputed that dying patients should have their pain eased and the quality of the remainder of their lives improved. Addiction risks were considered trivial for these clinical circumstances. For those who had “non-malignant” chronic pain, however, only non-opioid medications, behavioral, and physical modality therapies were available despite the reduced functioning of these patients.

By the late 1980s and early 1990s pain management conferences began to offer scientific sessions, keynote addresses and even debates on the emerging role of opioid therapy for non-cancer chronic pain management. In late 1996, the American Pain Society and the American Academy of Pain Medicine proposed rational opioid therapy guidelines to help practitioners better manage the pain of their patients (these guidelines were endorsed by the Board of Directors of the American Academy of Pain Management in 1998.)1 In 1998, the U.S. Federation of State Medical Boards proposed national guidelines to help all U.S. state medical boards craft reasonable public policy concerning opioid therapy.2 These actions collectively appeared very helpful, balanced, and offered practitioners the potential to widen the range of therapeutic offerings for their patients suffering with chronic pain. Based upon the Drug Abuse Warning Network (DAWN) data through December 1996 — demonstrating that increased opioid prescribing was not associated with higher ER events.5 — published articles and lectures by many notable pain specialists gave comfort to most pain practitioners and non-pain practitioners alike, and encouraged them to stop worrying so much about prescribing opioids and start focusing on chronic pain relief.

Lost in the media hype was the fact that there were real patients—suffering from real pain—for which no other therapies had been effective other than opioid medications.

Coupled with the widely disseminated information that opioid use was clinically safe — as long as guidelines were followed — were two troubling legal actions taken against U.S. physicians for their under-treatment of pain in certain patients. In 1999, Oregon physician Dr. Paul Bilder was disciplined by the Oregon Board of Medical Examiners for failing to relieve pain in several of his patients..6 In 2001, California physician Dr. Wing Chin was sued by the estate of his former patient, William Bergman, for elder abuse after failing to relieve the pain associated with end stage lung cancer. These two actions involved allegations of under-treatment of pain and cost Bilder his ability to practice medicine without ongoing supervision and cost Chin $1.5 million in the initial jury award (subsequently reduced by the trial judge to $250,000)..7 With these two high profile cases, American physicians were put on notice that they would be in serious trouble for not managing pain effectively.

The 2001 Joint Commission of Accreditation of Hospitals Organization (JCAHO) pain-related standards of care now require that pain reported by patients must be treated seriously by practitioners; pain must be properly assessed and effectively managed..8,9 Yet recent changes in California law now effectively give patients the final decision-making role about what therapies will be used for the management of their pain. These patients will not even have to try alternatives to opioids under the provisions of the California Pain Patients Bill of Rights;.10 they will only have to receive proper informed consent before making their decision in selecting opioids as a preferred modality.

Legitimate Concerns/Media Hype

The first real concerns about the possible diversion of licit opioid analgesics to illicit markets appeared in the spring of 2000. A story from rural Maine reporting on the profits associated with the diversion of controlled release oxycodone by a few “patients” initially led to similar stories from other rural locations and then from metropolitan areas. In 2001, every major American newspaper, news magazine and network news program ran stories about the abuse of oxycodone (particularly the controlled-release formulation.) What initally seemed an isolated situation in Maine became a national “crisis” due in part to the unintended effects of news media attention.

Lost in the media hype was the fact that there were real patients—suffering from real pain—for which no other therapies had been effective other than opioid medications..11 Also lost in the frenzy that has been ongoing for the past two years was that the actual number of prosecuted physicians was insignificant compared to the total number of licensed prescribing practitioners in the United States. While a few practitioners may have been guilty of bad faith prescribing practices, the vast majority of the medical profession has acted honorably in mitigating their patients’ pain. However, within a matter of months politicians were calling for state and federal hearings, increased use of complex monitoring systems for prescription tracking, bans on all products containing certain opioid analgesics (eg. oxycodone), and other similarly misdirected actions. As if trying to put the genie back into the bottle, well-intentioned, but sadly naïve, politicians thought that complex social problems such as substance abuse could be easily remedied with more stringent rules and regulations.

Finding a Balance

In trying to bring balance back to the discussion surrounding the use of opioid analgesics for the management of chronic non-cancer pain, it is important for prescribing practitioners to understand that there are indeed several common denominators associated with these high profile cases. The practitioners in question were generally not formally trained pain practitioners. Mostly they were well-intentioned and compassionate physicians lacking basic pain management skills or, in some cases, were greedy individuals cashing in on their ability to write prescriptions for their own profit.

Whether by ignorance or outright greed, some practitioners did unwittingly or knowingly allow themselves to be used as conduits for the diversion of controlled substances to the streets of America and did inadvertently contribute to the deaths of some people who misused the medications for non-therapeutic purposes. These practitioners often failed to take the most basic steps required when prescribing controlled substances. For example, they failed to: 1) thoroughly evaluate their patients by obtaining medical records, taking a medical history or performing a physical examination; 2) failing to make a medical diagnosis prior to the initiation of opioid therapy; 3) failing to communicate with prior treating practitioners; 4) failing to establish goals for treatment; and 5) failing to recognize classic patient behavior pointing to potential substance abuse—or even questioning such behavior.

Striking a reasonable balance between public good and adherence to state and federal controlled substance medication regulation is the only workable solution.

Many physicians did not adequately document their clinical findings, rationale for treatment or ongoing monitoring efforts to determine if opioid treatment was being effective. Some actually made inappropriate comments in their medical records that were not helpful to their case when questioned by regulators about their prescribing practice (i.e. “Ms. Jones, my little meperidine addict returns for her monthly prescription.”) Often, their own procedures for working with patients taking opioids were not consistently followed, giving patients too many chances before being dropped for non-compliance. One physician gave more than 90 prescriptions to one patient in a two year period while only seeing the patient on 8 occasions and documenting in the medical records that the patient was having serious problems with substance abuse. Another physician let a patient have three controlled substance prescriptions without signing an opioid agreement — despite that being a requirement of the practice as a prerequisite to the initiation of opioid therapy. Failing to hold patients to the terms of opioid agreements and blindly accepting what was said by patients placed many practitioners in the uncomfortable position of trying to justify prescriptions — after the fact — when questioned by medical boards, boards of pharmacy and even the legal authorities..12

What Are Pain Practitioners To Do?

Ignoring the problem or relinquishing DEA certificates (and never prescribing controlled substances again) are not practical alternatives for the majority of pain practitioners. Striking a reasonable balance between public good and adherence to state and federal controlled substance medication regulations is the only workable solution. In order to meet the needs of patients in pain — and to stay clear of trouble — there are a number of actions practitioners can immediately undertake..12,13

Patient history and physical exam. All patients—without exception—must have thorough histories and physical examinations performed as a condition of treatment. Patients that are unwilling to undertake such evaluations by their new practitioners must not be interested in having appropriate care rendered and therefor must not be treated. First-rate medical care necessitates having all of the facts gathered in one location, having the right environment to talk with and examine patients, and having sufficient time allowed for appointments. Not obtaining past medical records is a fundamental error when working with patients having chronic pain. Since they have been suffering more than 3-6 months (the definition of chronic pain is pain persisting more than 3-6 months), they must have records describing their initial presentations, early evaluations, diagnostic studies, and any prior treatments provided. Obtaining these records and reading them as part of the initial evaluation for any patient being considered for long-term opioid analgesic therapy is an absolute necessity. Practitioners must set aside, at a minimum, 30 to 60 minutes to be properly evaluate a patient. If patients cannot be properly evaluated for their chronic pain complaints, they should not be accepted into the practice. It is never defensible to claim that, in trying to see a great many patients, it is justifiable to not see each of them adequately.

Document treatment outcomes. Charting is never optional. If practitioners are too busy to properly chart their patients’ histories, physical findings or treatment outcomes, then too many patients are being seen. Charting must be viewed as obligatory and what is charted must be sufficiently detailed to justify treatments provided. There must be chart entries for each and every prescription issued, even for the ones that are telephoned to pharmacies. The conclusion that opioid analgesics are the appropriate therapeutic option must be clearly stated in medical records, along with alternatives considered, monitoring options to be employed and behaviorally defined goals that can be observed. “Off the cuff” remarks, casual opinions and derogatory statements must never have a place in medical records. If any medical record entries read aloud in a courtroom would make a practitioner uncomfortable, then it should be charted differently or, if not appropriate, simply not charted at all.

Informed consent and formal contract. Although most believe that their patients implicitly provide full informed consent prior to any therapies, how many practitioners actually personally provide informed consent briefings or even use consistent documentation? Full explanations about opioid therapy must discuss expected risks and benefits from treatment, alternatives — if any exist — and define the “house rules.” Prescribing controlled substances is always a privilege for practitioners and is never a fundamental right of patients. Negotiated agreements between practitioners and their patients define behaviors bi-directionally. If patients breach their agreements they must not receive subsequent prescriptions and, conversely, practitioners must not unduly burden their patients with draconian measures if they are doing what has been mutually agreed upon.

Single prescribing practitioner and drug source. Opioid agreements between practitioners and patients must include fidelity to one prescribing practitioner—and one only. Patients never need multiple sources for their opioid prescriptions, and that includes using only a single pharmacy. Practitioners should be cognizant of the pharmacies used by their patients and must be certain that the opioid medications being prescribed are available at those pharmacies before giving patients prescriptions. When questioned by pharmacists wanting additional information to satisfy their independent licensure requirements regarding controlled substance prescriptions, practitioners must work cooperatively with them. While authority rests with practitioners to prescribe controlled substances, pharmacists have their own dispensing duties including a minimal determination that prescriptions are legitimate. Together — according to the DEA — prescribing practitioners and dispensing pharmacists, as members of a treatment team, are the front line defense in the prevention of illicit medication diversion.

Following the proper protocols, a practitioner can effectively manage pain, legally prescribe opioid analgesics for patients, and stay out of trouble with regulators.

Appropriate referrals. When faced with challenging patients having complex medical needs, primary care practitioners must utilize consultants (addiction, pain management, specialists in the pathophysiology or organ system involved) to be certain that the right diagnoses are made and that all treatment options are explored before opioid therapy. Specialists describing themselves as pain practitioners may even want to seek independent confirmation of their therapies over time. Pain practitioners may want to limit their practices to “by referral only” status to eliminate self-referrals by medication seekers. Requiring established relationships with primary care practitioners may protect pain practitioners and have the added benefit of ensuring that basic medical problems are being addressed and thereby allowing pain practitioners to focus more exclusively on pain-related problems.

Regular doctor visits. Patients having their pain managed with opioids must be seen regularly. They are not twice-yearly patients for the most part and often must be seen at least monthly to quarterly. When evaluating their continued need for opioid therapy, practitioners must document why opioids are still needed, what other options might be feasible and what improvements are being seen to justify the risks involved. Limiting subsequent visits by chronic opioid patients to only document that those patients are still having pain — while failing to try any alternatives — is basically only documenting treatment failure. Similarly, just continuing prescriptions from one appointment to the next because patients are already on opioid therapy does little to establish the justification of ongoing need. Practitioners must challenge the status quo and determine what is happening at various time points. Open-ended prescriptions without adequate medical supervision should not be given under any circumstances.

Avoidance of “pick up” prescribing. Telephone and “pick up” prescriptions are poor medical practices and invite regulatory scrutiny. If patients continue to need opioids to manage their pain, practitioners should continue to see them. Under no circumstances should signed prescription blanks be left around the office for anyone to use. Every prescription should be written and telephone prescribing should, as a rule, be avoided. In the rare instance when telephone prescribing is done for a short-term emergency, there must always be an accompanying chart entry. When covering for another practitioner and responding to patient requests for additional medication, it is a far better practice to meet these patients in the ER than to blindly prescribe controlled substances without a good faith history or physical examination. It is imperative that a call is given to the prescribing practitioner of record on the next business day, or that dictated progress notes are sent to that practitioner as soon as possible.

Periodic dose level re-evaluation. Practitioners routinely adjust medication doses to account for basal pain level, pain associated with activity and other factors. While most practitioners expect medication doses to slowly increase over time—how many routinely anticipate that doses may be decreased over time if improvement has occurred? When should dose decreases be attempted? After six months of relative stability it may be warranted to decrease the dose by 25-35 percent. If patients are able to maintain the same level of function with less medication, then dose reduction is typically beneficial. If patients clinically regress with less medication, then restoration to the previous dose is warranted and continues to establish the minimally effective dose for them.

Random drug testing to confirm compliance. Drug testing is useful in determining if patients abuse illicit drugs or to confirm that prescribed medications are actually being used as prescribed. Both types of information can be obtained from urine drug testing, but only if the methodological limits of the test technique are known to practitioners. There are interferences making “dip stick” methods relatively unreliable (falsely reading positive with quinolone antibiotics or falsely reading negative with fentanyl and oxycodone — even when used as prescribed). More expensive chromatographic techniques yield more accurate results than simple “dip sticks” but cost more to utilize. When patients are seen and medication doses are increased time and time again—yet their urine always tests negative for these drugs—it’s time to question where these drugs went.

Staying informed. Education continues to be lacking for most practitioners regarding opioid therapies and pain management. Practitioners are responsible for remaining current about abuse trends, evolving concepts about the role of opioids for chronic non-cancer pain, and non-pharmacological options. Part of the educational process involves enlightening regulators and law enforcement about the proper positioning of opioid therapies. The DEA Diversion website has several interesting recommendations beyond the ones listed above..14 Practitioners should consider requesting a picture ID for inclusion in the medical record to aid in the positive identification of patients, confirm all telephone numbers provided by patients and addresses they use for each visit. Try to write prescriptions for specific time-limited quantities and document everything. When in doubt, do not just accept the patient’s word, but maintain a healthy level of disbelief and verify details.

Summary

Pain practitioners have many tools, techniques and options available for the management of pain. No treatment approach is best for every patient under every circumstance. Although opioids have been used for thousands of years with great success, practitioners cannot be ignorant about the possibility of abuse. Following a formal guideline or protocol for opioid prescribing, and monitoring outcome with the use of an easy-to-use measurement tool (see accompanying article by Drs. Campbell and Raven in this issue of Practical Pain Management), will likely lead to more consistency in practice and fewer headaches for practitioners. The vast majority of prescribing practitioners have never been investigated for their prescribing practices. Following the proper protocols, a practitioner can effectively manage pain, legally prescribe opioid analgesics for patients, and stay out of trouble with regulators. n

Last updated on: January 6, 2012
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