Tampa Pain Clinic Blog

Over the last year the media has focused on the public health crisis that has resulted from the local proliferation of pill mills and the resultant spike in abuse, diversion and fatal overdoses. Easy access to opiate-based pain medication via “pill mills” and online pharmacies combined with a high street value has promoted widespread abuse. The resultant “market” has promoted doctor shopping and diversion. Fortunately, there appears to be a solution in sight – pain clinics are now being regulated, and a controlled substance database should be in effect by early 2011.  These changes are applauded by those pain doctors who truly want to help their chronic pain patients.

However, while we applaud these steps we must not over look the fact that pain is severely undertreated in our society.  Close to fifty-million Americans suffer from chronic pain so severe that they are regarded as partially or totally disabled.

For quite some time the medical community has been afflicted with “opiodphobia” – a fear of opiates, either due to concern that the patient will become addicted or that the physician will be unfairly prosecuted. This has been exacerbated by medical schools’ failure to spend adequate time dealing with opiate-based pain management – only a few hours are spent on the subject at most schools. This is unfortunate; in many cases, the only way to provide relief to a patient with chronic intractable pain is through a multi-disciplinary approach that includes the provision of opiate pain medication.

Studies show that when a patient takes (properly prescribed) opiate pain medication as directed the risk of addiction is extremely low. This article proceeds to make a case for the use of opiates in a subset of pain patients while emphasizing the drawbacks associated with their use.

WHICH MODALITY?
Patients have a right to have their pain managed. Choosing the proper pain management regime can, however, be quite difficult. Many of the mainstay treatment regimes are ineffective for moderate to severe chronic pain. For example, consider back pain – a condition that eighty percent of the American population will experience at some point in their life. In most cases their pain is acute, and can be resolved through conservative treatment, i.e.: physical therapy, NSAIDs, etcetera. However, for those individuals who have moderate to severe chronic pain – pain that has lasted six months or more – there are few viable alternatives.

Surgical procedures, such as laminectomies and fusion, are typically ineffective at relieving chronic pain. Our clinical experience indicates that roughly one third of patients suffer from more pain after surgery than before. Another third report that the surgery had no effect on their pain. While the remaining third report that surgery provided a significant benefit, especially with radicular pain, many still report experiencing some degree of chronic pain.

Other treatment modalities, such as electrical stimulation, are often successful in lessoning mild pain; but, when used as the sole modality, they tend to be ineffective for patients with moderate to severe chronic pain. The same is true with traction and massage. Though, when such modalities are used in combination with oral medication they can typically provide short-term relief, even in cases of severe chronic pain.

One of the most frequent treatments for chronic lower back pain, especially at clinics that focus on interventional procedures, involves epidural steroid injections. Yet, to date, there have been no prospective randomized studies showing these injections to be effective for more than a very short period of time – a few days to a few weeks. One possible explanation for their use, and overuse, is that this procedure can be performed in office and typically yields over a thousand dollars in reimbursement.

 OPIATES: RISK VS. BENEFIT
More than half of the individuals who suffer from severe chronic pain do not receive adequate pain relief – many have never been offered opiates. Oral medication has been found to be the most efficacious treatment for chronic back pain, as well as many other painful conditions. These agents include: neuropathic medications (e.g.: neurontin), antispasmodics (e.g.: baclofen), as well as opiates.

Although opiates can literally give someone their life back, there are many drawbacks associated with their use – thus, before beginning such a regime, a physician must decide that the risks associated with long-term opiate use are outweighed by the potential benefits. The physician must also ensure that the patient is sufficiently informed to make a decision on this issue.

Prolonged use of opiate pain medication results in significant dependency, meaning that if a patient fails to take their medication in a timely fashion they will experience withdrawal symptoms, which are often quite severe. Dependency is a normal result of opiate usage, and must be distinguished from addiction. Opiates also result in tolerance, and tend to have side-effects such as constipation, weight-gain, and in some cases sedation.

Nonetheless, opiates can be taken for an indefinite period of time without any significant organ damage. The same cannot be said for over the counter medications such as Tylenol. Given their ability to provide long-term pain relief, for many patients with moderate to severe chronic pain, these drawbacks are outweighed by the benefits associated with opiate-based pain management. If you have a patient with chronic intractable pain who you believe might be a candidate for a pain management regime that includes opiates feel free to refer them to our office for a thorough consultation.

Over a million Americans suffer from Interstitial Cystitis, an inflammatory condition of the bladder. Nine out of ten sufferers are female. The fact that most sufferers are female, and until recently most physicians were male, contributed to an initial belief among many physicians that the symptoms associated with IC were simply a manifestation of an underlying psychiatric disorder. Although its cause is still unknown, over the past thirty years the medical community has come to acknowledge that IC is not “supratentorial” – rather, it is a under recognized condition with an underlying physiological basis.

Despite this increased awareness, IC patients continue to have difficulty obtaining adequate pain control. The pain associated with IC can be quite severe – in fact, a 1987 study rated IC pain as being often equivalent to that of cancer pain. Studies indicate that those IC patients unable to obtain proper pain management have a quality of life similar to that of a patient with end-stage renal failure.

ETIOLOGY OF IC:
Interstitial Cystitis is characterized by an inflamed or irritated urothelium. Typically, IC patients experience feelings of pressure, pain and tenderness around their bladder, pelvis and perineum; male IC sufferers also, or alternatively, have pain in their penis, testicles and/or scrotum. There is wide variability among IC patients, both with respect to their pathology, history, and amenability to treatment.

Many hypothesize that IC is not one specific disease, but rather a group of diseases that we are currently unable to distinguish between. Nonetheless, IC patients are typically classified as having either nonulcerative or ulcerative IC. The former is the more common form of IC and is typically found in young to middle-aged women. When a cystoscopy is performed on such a patient simultaneous with hydrodistention bladder hemorrhages (glomerulations) should be evident. Nonulcerative IC typically has little to no effect on bladder capacity. Conversely, ulcerative IC, typically found in middle-age to older women, is associated with low bladder capacity. Ulcerative IC is considered “classic IC,” but only accounts for ten percent of IC sufferers. Ulcerative IC is characterized by Hunner’s ulcers – these are not true ulcers, but rather star-shaped lesions in the bladder wall.

DIAGNOSIS OF IC:
The use of the term IC and the method of diagnosis is still, to this day, quite controversial. Until recently, in the United States, the predominant method of diagnosis was, once other more common disorders had been excluded, to perform a cystoscopy with hydrodistention – the presence of glomerulations or Hunner’s ulcers was indicative of IC. However, recent research indicates that this test is unreliable – the classic cystoscopic features are not present in all IC patients, and yet are sometimes present in patients who are asymptomatic.
The American Urological Association is in the process of creating guidelines regarding the nomenclature, diagnosis, and treatment of IC. These guidelines, the draft of which was presented at a recent conference, highlight the importance of multidisciplinary treatment as well as the need to manage IC pain, even in the early stages of treatment. When a patient presents with an unpleasant sensation, perceived to be related to the bladder, and has associated urinary tract symptoms, the first step is to exclude other identifiable causes, such as a urinary tract infection, bladder cancer, kidney stones, etc. If the case is uncomplicated cystoscopy is no longer considered a prerequisite to diagnosis; however, there is controversy as to whether the correct diagnosis in such a case is IC or IC/Painful Bladder Syndrome (PBS).

The first line of therapy for an IC patient is the use of oral medication (i.e.: tricyclic antidepressants, anti-spasmodic agents, anti-convulsants, antihistamines, etc.) and/or instillations using DMSO, heparin, and lidocaine. It is only if these methods fail or there are complications that cystoscopy is recommended.

PAIN MANAGEMENT OF AN IC PATIENT:
For some patients, first and second line therapy is ineffective. While there are more drastic treatment methods, such as implantation of a neurostimulation device, use of Botox A, or even surgical intervention, if the first two lines of therapy fail a pain management consult should be obtained.

Initial pain management can often be provided by the urologist via anti-inflammatory medications, tricyclic antidepressants, and other such agents; however, for some patients, these medications provide little to no relief, or exacerbate the situation due to associated urinary retention. In these cases, the use of opiate pain medication can be invaluable, especially when combined with various first line therapies – such a multidisciplinary approach often allows a patient to avoid more drastic measures, such as surgery. Either way, it is vital that pain management be provided from the get go. If you have a patient with a diagnosis of IC or IC/PBS, and need assistance managing their pain, feel free to refer the patient to our office for a consult.

Whether or not one chooses to control a patient’s chronic pain with opiates requires very careful consideration. Although it has been demonstrated that opiates are the most efficacious method of controlling moderate to severe chronic pain, one must also take into consideration that once such a regime has begun, a patient will become dependent upon the medication, and if the medication is withdrawn without proper tapering the patient will suffer severe withdrawals. Despite these facts, when used judiciously, opiates are an appropriate method of controlling intractable chronic pain.

A physician hoping to control their patient’s chronic pain with opiates must wade through a plethora of regulations. This area of medicine is becoming carefully regulated due to the sub-set of pain physicians who operate “pill mills” – clinics that dispense large amounts of opiate pain medication with little to no work-up or physical exam. Due to the ambiguity involved in pain management, and the strong stigma against opiate pain medication, even legitimate doctors, who are attempting to “do it right,” are at risk of getting caught in the regulatory cross-hairs. This article provides a brief overview of applicable legislation, focusing in on the draft rules put forth by the Board of Medicine.

LEGISLATIVE OVERVIEW:
In 2009, in an attempt to combat the problems associated with pill mills, the Florida Legislature passed legislation mandating that the Board of Medicine regulate and inspect pain management clinics (Fla. Statute § 458.309). The legislation provided the Board with the appropriate rule-making authority, and tasked them with creating a set of rules applicable to all clinics that (1) advertise pain management services, of any type, or (2) prescribe opiate pain medication to more than fifty percent of their patients. There are a few exceptions to this definition, which are not discussed in this article.

To create these rules the Board of Medicine held a number of workshops, culminating in the formulation of draft rules setting forth the standards of practice for physicians practicing in pain management clinics. These rules are nearing the end of the final approval process, and are soon to be put into effect. This article details a few of the more salient requirements contained in the draft rules.

Urine tests:
Under the draft rules, controlled substances cannot be provided to a new patient until a drug screen has been conducted and the results have been obtained. Thereafter, urine tests, screening for drugs of abuse, must be conducted at least twice a year as well as whenever requested by the prescribing physician. Once collected, the urine can either be tested in-house, or sent to an outside laboratory.

If done in-house there are a number of requirements that must be followed – the test must be CLIA-waived or the clinic must be CLIA-certified and the test CLIA-approved; in either case, the test, screening for drugs of abuse, must include: pH, specific gravity, and temperature. When done in-house, if either the physician or the patient questions the results the sample must be sent out for further testing. If the patient’s urine contains an un-prescribed or illicit substance, or otherwise indicates drug abuse, the patient must be referred out to a mental health addiction facility, or seen by a physician who is either boarded in pain management or certified as an addictionologist.

Documentation:
The provisions relating to documentation are quite extensive. It is important that each clinic have a check-list of some sort to ensure that all necessary aspects of the patient’s treatment are being documented. A history and physical must be conducted, and the following must be addressed: intensity of pain, effect of pain on physical and psychological function, patient’s history regarding addiction or abuse, and medical indication for use of a controlled substance. As part of the history, the patient’s previous medical records must be reviewed, and the salient features documented.

As part of the chart there must be a multi-modality treatment plan – the plan must specify: the objectives used to determine success, diagnostic evaluations or treatments planned for the future, and other treatment modalities that will be used. Once every three months the physician must conduct a re-evaluation, addressing: efficacy of treatment, etiology of patient’s pain, and patient’s compliance thus far with treatment plan. Additionally, the physician must evaluate the patient for signs of substance abuse or diversion. If the physician concludes that treatment goals are not being met, despite medication adjustments, the physician must re-evaluate the continued appropriateness of controlled-substance therapy.

Reporting Requirements:
We are currently waiting for the Board to finalize the above mentioned draft rules. Once the draft rules are finalized and put into effect, pain management clinics will become responsible for reporting various statistics to the Board of Medicine. Specifically, such clinics must report: the number of patients treated or seen in office, the number of patients domiciled outside of Florida, the number of patients receiving controlled substance pain medication, and the number of patients discharged due to drug abuse or diversion.

The Tampa Pain Clinic is complying with the Board’s draft rules; we also implement other methods of screening new patients. Our clinic provides a referral network where physicians can send patients whose intractable pain necessitates opioid-based pain management. If you have a patient that you think our program would be appropriate for please feel free to refer them to our website, tampapainclinic.com.