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Apr 26 2011

Prescribing controlled substances responsibly

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Patients and physicians benefit from safe and effective treatment of chronic pain. However, the risks of prescribing opioids and other controlled substances for use over the long term are undeniable.

In NC, unintentional overdose from prescription medications accounts for nearly three deaths a day, according to the latest data from the NC State Center for Health Statistics. Fatalities are not limited to young people who acquire drugs from dealers, friends or by taking them from family medicine cabinets (though this type of activity does, of course, lead to some deaths). In fact, the highest mortality occurs among adults between the ages of 45 and 54 who are prescribed high daily doses of opioids by their own family medicine or internal medicine doctors. The single largest source of prescription medications associated with unintentional overdoses is established physician-patient relationships.

Improper prescribing was a factor in 68 NCMB cases that resulted in public discipline last year, or about 30 percent of the total. Most, though not all, of these cases involved one or more opioids or other controlled substances. Board actions, which are determined based on the unique facts of each situation, ranged from non-disciplinary Public Letters of Concern to indefinite suspension of the practitioner’s license. In one case last year, the Board voted on an emergency basis to suspend a prescriber whose practice essentially consisted of writing high doses of controlled substances for no legitimate medical purpose, in exchange for a $100 office visit fee.

The NCMB has heard that some physicians are reluctant to prescribe opiates for chronic pain because they are afraid they will be disciplined by the Board. These concerns may have led some licensees to limit or even discontinue care of patients with chronic pain, making it difficult for some patients with a legitimate need for treatment to receive care. The Board recognizes that quality medical care includes the appropriate, effective treatment of chronic pain and supports patients’ rights to access such care. The Board further recognizes that prescribing controlled substances over the long term may be an essential part of an appropriate treatment program.

This article will clarify the Board’s perspective on prescribing controlled substances for the treatment of chronic pain, both by identifying poor practices that frequently lead the Board to take action against licensees and by suggesting some steps prescribers can take to improve their care. Although this article is primarily directed to prescribing opioids for treatment of chronic pain, many of the same concepts and practice management principles apply to long term prescribing of all controlled substances for other conditions.

Improper prescribing: examples
Licensees should also understand that, while the Board views improper prescribing of controlled substances as a serious problem, the NCMB takes a reasoned approach when evaluating care. Cases that result in public discipline typically involve significant departures from recognized standards of care, failures to act in the face of evidence of abuse or diversion or other aggravating factors.

For example, last year the Board indefinitely suspended the license of a physician who was found to have prescribed controlled substances to multiple pain patients in a manner that was clearly substandard. Concerns identified included: lack of appropriate physical examination or pain evaluation; failure to recognize or monitor ongoing medical conditions that might complicate use of long term opioids; failure to attempt any alternative methods of treatment; failure to recognize or respond appropriately to several clear warning signs of medication diversion or abuse; failure to appropriately document treatment or prescribing; failure to monitor for potential adverse reactions to medications prescribed; inadequate discussions or counseling regarding the risks of long term or high dose opioid treatment; failure to employ any means of ongoing assessment or documentation of the patient’s response to treatment; and failure to arrange for referral for specialist care when treatment was ineffective.

By contrast, a physician assistant who prescribed controlled substances to a family member on an occasional basis, without an examination or appropriate documentation, received a Public Letter of Concern.

Appropriate care for pain patients
Licensees who are concerned about the possibility of discipline can best protect themselves (and their patients) by following the accepted standards of care for pain patients. It sounds simple, but in case after case, the Board finds that many prescribers don’t do this. The instances when the Board becomes involved in educating or disciplining licensees universally involve failures of the prescribers to use widely recognized principles of acceptable medical care, such as performing a thorough examination and patient history and documenting a legitimate medical purpose for the controlled substance prescriptions. Often, prescribers who come under Board scrutiny also overlooked red flags (lost or stolen prescriptions, running out of medication before refills available) that should have indicated the possibility of diversion, abuse or misuse.

At minimum, practitioners who regularly treat patients for chronic pain should educate themselves about the current standards of care for these patients. Good resources include guidelines developed by the American Society of Interventional Pain Physicians and the University of Wisconsin’s Pain and Policies Study Group, as well as the NCMB’s own position statement on prescribing controlled substances for the treatment of chronic pain. Generally accepted guidelines for treatment of patients with complaints of chronic pain include: documentation of an appropriately thorough new patient evaluation to include prior medical records; establishing a specific or reasonable differential diagnosis; development of a meaningful treatment plan; evidence of informed consent regarding the risks and benefits of long term controlled substance use; periodic review of the patient’s current status with accurate documentation of progress relative to the established treatment plan and goals; indicated adjustments to the course of treatment; review of alternative treatment options; and consultation with specialists as appropriate. Medical records should accurately reflect the care and clearly indicate medications prescribed. While published literature is equivocal on the value of behavioral screening, urine drug screens, pill counts, medication or prescribing agreements, and other tools used to identify the potential of medication misuse, these are all approaches that should be considered when prescribing controlled substances to patients over the long term.

NC Controlled Substances Reporting System
In addition, anyone who prescribes controlled substances for chronic pain in North Carolina should use the NC Controlled Substance Reporting System (CSRS). The CSRS is a state-administered database of all controlled substance prescriptions dispensed in North Carolina outpatient pharmacies. Any authorized prescriber of controlled substances may register for access to the system. A prescriber can look up a patient to discover what controlled substances that patient has received recently, the amount dispensed, whether prescriptions are new or refills, the number of refills, the pharmacies where medications were dispensed and the names of practitioners who wrote the prescriptions.

There is no fail-safe means to prevent patients from acquiring controlled substances by deception, but the CSRS is an invaluable resource that can help a practitioner avoid prescribing to a patient who may be “doctor shopping.” For example, a licensee who recently contacted the Board related that he used the CSRS to evaluate a new patient who came to him seeking a prescription for Adderall, stating that the prescription from her previous physician had run out two days ago. In addition to running the patient’s CSRS profile, the licensee also had the patient take a urine drug screen. The drug screen was negative for Adderall, even though the drug should have been present based on the patient’s story, and the CSRS data indicated that the patient had received Adderall from six other prescribers in the area. The licensee said he declined to prescribe and expressed concern about the patient’s history. Now this licensee is considering contacting the six other prescribers to suggest that they check the patient’s CSRS profile. This type of communication among prescribers treating a common patient is specifically authorized under state law.

Information obtained from the CSRS should ideally be used as an intervention tool to improve patient care, not to exclude patients from care. Although not currently considered the standard of care, I believe routine use of the CSRS should be a part of the practice of any physician who prescribes controlled substances for chronic pain. As with all assessment tools, data from the CSR system is not infallible and should not be the only factor considered when making patient care decisions.

Other assessment tools
Additional tools that should be considered are urine drug screens and enforced controlled substance prescribing agreements. Many versions of these prescribing agreement documents are available. Some question their utility and argue that they interfere with the physician-patient relationship. Nonetheless, the principles embodied in those agreements are basic good medical practice applicable to all safe prescribing, such as obtaining controlled substances from a single source, no sharing of medications, no early refills and instructions to take medications as directed. If agreements and urine drug screens are used, practitioners must monitor patients and take action when there is evidence of noncompliance. The Board regularly sees cases where patients repeatedly violate pro forma prescribing agreements or fail urine drug screens. Yet, time and again, prescribing continues without even an acknowledgement in the medical record that there may be a problem or that any discussion with the patient occurred.

Assessing the patient’s progress
Finally, a word about assessing patients who have been prescribed controlled substances over the long term. Current standards of care dictate that prescribing for chronic pain should be accompanied by documentation of unrelieved pain associated with some assessment of impact on the functional status of the patient. Review of relevant controlled substance cases shows that, although physicians may begin with good intentions, they often do not undertake periodic assessment of the patient’s progress (or lack of progress) toward specific treatment objectives. Nor do they periodically reassess the risks and benefits of continued treatment. To provide quality care, practitioners must employ some means of periodically assessing the effectiveness and appropriateness of the current treatment plan, the continued prescribing of controlled substances and consideration of alternatives.

In summation, when prescribers learn and follow basic principles of good medical care outlined in numerous and widely available consensus guidelines and management protocols, concerns that come to Board attention are typically resolved without incident. It is always easier to suggest patient care guidelines and procedures than it is to implement them. But I do so with the knowledge and experience that adherence to accepted standards for good practice will result in improved patient care, lessened attention from the Board and fewer unintentional overdose deaths.

Prescribing for chronic pain: Elements of appropriate care

Evaluation of the patient
  • Medical history and physical examination is obtained, evaluated and documented in the medical record

  • Medical record should document the nature and intensity of pain, current and past treatments for pain, underlying or coexisting diseases or conditions, effect of pain on physical and psychological function, and history of substance abuse.

  • Medical record should also document one or more recognized medical indications for use of a controlled substance

Treatment plan
  • Should state objectives that will be used to determine treatment success, including pain relief and/or improved physical and psychosocial function

  • Should indicate if further diagnostic evaluations or other treatments are planned

  • After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient.

  • Alternative treatment modalities or a rehab program may be needed

Informed consent
  • Physician should discuss risks and benefits of the use of controlled substances with the patient, persons designated by the patient or with the patient’s surrogate or guardian if the patient is without medical decision-making capacity

  • Patient should receive medications from one physician and one pharmacy

  • If patient is at high risk for medication abuse or has a history of substance abuse, physician should consider use of a written agreement that states the number and frequency of all prescription refills, the reasons for which drug therapy may be discontinued (e.g. for violation of agreement) and requiring the patient to submit to urine/serum screening when requested

Periodic review
  • Physician should periodically review the course of pain treatment and any new information about the etiology of pain or the patient’s state of health

  • Continuation or modification of controlled substances for pain management depends on physician’s evaluation of progress toward treatment goals

  • Satisfactory response to treatment may be indicated by: decreased pain, increased level of function or improved quality of life

  • Objective evidence of improved or diminished function should be monitored and information from family members or caregivers considered in determining patient’s response to treatment

  • If progress is unsatisfactory, physician should evaluate the appropriateness of continuing current treatment and consider use of alternative modalities

  • Physician should be willing to transfer the patient as needed for additional evaluation and treatment in order to achieve treatment objectives

  • Special attention should be given to patients at risk for medication misuse, abuse or diversion.

  • Management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation and consultation with/referral to an expert in the management of such patients

Source: Federation of State Medical Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain

NC Controlled Substances Reporting System
NC Medical Board Position Statement
Federation of State Medical Boards’ Pain Policy Resource Center

 Comments on this article:

Well written, concise statement on chronic pain treatment that does not tip-toe around the realities of abuse, diversion, co-morbid psych disorders.  Far too many of these patients get put on these meds inappropriately, leading to years of problems.

By wfnagel on Apr 28, 2011 at 3:20pm

I think that NCMB should work with the SBI and local law enforcement to determine a HIPPA acceptable process to report suspected doctor shoppers and/or diverters.  We are currently having a difficult time with this at our insitution.

By Edward LaMay on Apr 28, 2011 at 3:45pm

Frankly, this epistle ignores the 1000 lb. guerilla in the room - these chronic pain patients eventually all are narcotic addicts, requiring more and more medication to keep them going.  One aspect of addiction, which is almost universal, is a complete lack of insight on the part of the patient as to their addiction.  There is nothing in this missive which would make me want to do anything but minimize my involvement with prescribing controlled drugs, which as an orthopaedic spine surgeon is part of my lot in life.

By S. Michael T. Tooke on Apr 28, 2011 at 7:42pm

Excellent article. Could you comment on the following: how do you advise patients about the use of lock boxes for their controlled substances? Where can they get them? Do you insist upon their use and how do you verify?

By Harriett Burns on Apr 28, 2011 at 9:17pm

Excellent summary!  The examples were particularly helpful.  Thanks!

By Charles Lapp, MD on Apr 29, 2011 at 10:31am

I like the article.  What do you consider as “high” daily doses of opioids?  When would be the best time to refer to a pain specialist?

By acuriale on May 05, 2011 at 10:25pm
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