CE ARTICLE

Avoiding regulatory complaints when treating chronic painpatients with opioidsRandall S. Hudspeth,MS, APRN-CNP, FRE, FAANP (Fellow)

Institute of Regulatory Excellence, NCSBN

KeywordsPain management; regulatory; abuse; litigation.

CorrespondenceRandall S. Hudspeth, MS, APRN-CNP, FRE,

FAANP, 3875 North Sawgrass Pl., Boise, ID

83704.

Tel: 208-375-8945;

E-mail: raning2@msn.com

Received: April 2011;

accepted: June 2011

doi: 10.1111/j.1745-7599.2011.00666.x

To obtain CE credit for this activity, go to

www.aanp.org and click on the CE Center.

Locate the listing for this article and complete

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Abstract

Purpose: To provide nurse practitioners (NPs) in primary care settings whotreat chronic pain with opioids information on nationally accepted standards,assessment tools, pain management contracts, and effective documentationstrategies to evidence safe practice to protect patients, the public, and to de-fend the NP against complaints that lead to regulatory investigations.Data sources: Existing screening tools and national pain managementstandards.Conclusions: Many NPs lack formal pain management education and pre-ceptorships, thus leaving them at risk for incomplete assessments, poor doc-umentation, and failing to implement necessary safeguards that can lead toregulatory complaint investigations and discipline against their license.Implications for practice: NPs often lack awareness of national pain man-agement standards and the risks of chronic opioid prescribing. When adverseevents occur, the NP can become the focus of a regulatory investigation thatresults in formal discipline against their license to practice. Using standard as-sessment tools, pain management contracts, and implementing safeguards toprotect the patient and the public evidence safe practice and, help avoid regu-latory discipline against the NP license.

No nurse practitioner (NP) wants to be the subject of aregulatory investigation, but as autonomous practice in-creases nationally, so do the numbers of complaints toboards of nursing and other regulatory agencies aboutNP practice. Complaints about violations of the UniformControlled Substance Act, which is enacted in every stateand based on federal code, and questions about NP pre-scribing practices are also more frequent (United StatesCode). Primary care NPs treat increasing numbers of pa-tients who suffer from chronic pain and use opioids.Pain complaints remain the primary reason people ini-tially seek care and the American Chronic Pain Associa-tion states that 50 million Americans suffer from chronicpain (American Chronic Pain Association, 2006). In thelast decade attention on treating pain has increased bothfrom the media and the “fifth vital sign” initiative aimedat increasing pain awareness among providers. This at-tention places an expectation on NPs to use treatmentmodalities that pose risks to patients and society in gen-eral. There is also risk to the individual NP, even whenthe NP may be reluctant to prescribe opioid therapy and

when outcomes of these initiatives have been questioned(Mularski, 2006).

This article discusses ways that NPs in primary caresettings can implement strategies that promote patientand public safety. Understanding and documentingthe use of currently accepted standards of care, usingnationally accepted assessment tools for pain, and riskstratification in treating pain can serve as evidenceof safe practice if the NP ever becomes the subject ofa regulatory investigation. Two things an NP shouldremember when an investigation occurs are that havinggood documentation that meets national standards canserve as evidence of competent and safe practice, andthat the pursuit of an investigation is not the same as thepursuit of discipline by a regulatory board.

Background

Competency in pain management begins with educa-tion. NP education is increasingly complex, and manytimes clinical experience and preceptorship time become

515Journal of the American Academy of Nurse Practitioners 23 (2011) 515–520 C©2011 The Author(s)Journal compilation C©2011 American Academy of Nurse Practitioners

Avoiding regulatory complaints when treating patients with opioids R. S. Hudspeth

the responsibility of the NP student to coordinate. Thereis pressure to seek broad-based experiences that allowstudents the greatest learning opportunities. Preceptor-ships in organized pain clinics are rare and usually nota part of the overall clinical experience. NPs in primarycare settings do see an increasing number of chronicpain patients, but often times they themselves have nothad the opportunity or benefit of a pain preceptorship,or been exposed to the standards of care established bynational pain societies and the American Society of PainManagement Nurses (Pain Management Nursing, 2005).Their pain management practices may be self-developedthrough experience or learned from others who alsolacked formal pain management education. This ed-ucational situation allows new graduate NPs to enterpractice without much, if any, formal pain managementcoursework or clinical exposure to managing complexpain issues.

Thus, it is important for individual NPs who treatchronic pain in the outpatient setting to become awareof nationally vetted standards and to implement mech-anisms to effectively evaluate patients, use interventionsthat have safeguards in place, and maintain ongoing doc-umentation about the assessment of patient complianceand adherence to the standards and the agreed plan ofcare.

Understanding pain-related definitions andconcepts

NPs who treat acute and chronic pain patients re-quire an understanding of basic pain management con-cepts, and this understanding can be evidenced by or-ganized documentation in the patient’s medical record.Acute pain is defined as pain associated with a specificcause, normally of short duration and resolving as theinjury heals (Summers, 2000). Pain, from cuts, burns,and surgery are examples; as wounds heal the pain de-creases. Chronic pain is defined as pain that lasts longerthan would be expected and may or may not be linkedto a specific source (Greener, 2009). Back pain and fi-bromyalgia are examples.

Types of pain are further identified as nocicep-tive, neuropathic, cancer related, or depression related(Chakravarty & Sen, 2010). Nociceptive pain results fromnoxious stimulation of peripheral nerve fibers due to in-juries of cuts, crushing, or burns among others. Neuro-pathic pain is caused by damage or disease affecting sen-sory or peripheral nerves. It is commonly described asburning, tingling, stabbing, or pins- and-needles sensa-tion. Providing a good narrative of how the patient de-scribes their pain can serve as evidence for prescriptiondecisions. For example, if a patient presents with tran-

sient knee joint pain after prolonged exercise, a medica-tion used to treat neuropathic pain may not be appropri-ate. Whereas, descriptions such as tingling and burningpain associated with herpes zoster or peripheral diabeticneuralgia could indicate the need for a neuropathic agentversus a narcotic. In some diseases, such as fibromyalgia,patients can benefit from a combination of both.

Pain-related behaviors also require understanding anddescribing. Tolerance is the body’s adjustment to pro-longed use of pain medication whereby over time an in-creasing dose is required to maintain effect. Tolerancevaries between patients and often the request for an in-creased dose is confused with drug-seeking behaviors oraddiction (Benedict, 2008). Addiction is the loss of con-trol in using drugs. Addicts place themselves and oth-ers at risk in order to obtain the medication and oftenuse the medication for recreational purposes, to achievethe euphoria sensation or for other reasons not relatedto why the drug was originally prescribed. Pseudoaddic-tion is often confused with addiction, but it is very dif-ferent. Pseudoaddictive behaviors result from a fear ofbeing in pain. Common pseudoaddictive behaviors areclock watching, requesting to be awakened to receivepain medication, keeping a written medication admin-istration schedule, and stock-piling medications due tothe fear of nonavailability. As pain resolves and healingoccurs, the pseudoaddictive behaviors decrease and ulti-mately cease (Dimsey, 2010).

Using documentation effectively

Consistent documentation is the best source of evi-dence about what NPs do during patient visits. Most NPsdocument subjective and objective data adequately, andwhen treating pain there needs to be information per-tinent to the pain complaints. Often times, because ofpayment mechanisms and time constraints, NPs tend touse the assessment section as a listing of diagnoses with-out much supporting discussion. It is more beneficial asa source of evidence to use the assessment as a narrativewhere the NP documents the thought process in analyz-ing the subjective and objective data to form a plan ofcare.

Subjective data should include specific pain-related in-formation that documents how patients describe theirpain in terms of intensity, location, any modifying factors,recent pain level alterations, and causes. Additionally, itis important to document issues of compliance with anexisting pain management contract, recent emergencydepartment or other provider visits for pain issues, andany assessment tools administered. Identification and useof a consistent pain rating scale for patient self-assessmentshould be included here. An essential component is the

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listing of all prescribed and nonprescribed pain medica-tions taken and the dose frequency used, along with astatement of the drugs’ effect on pain relief and any ad-verse reactions such as sedation or nausea.

It is important to organize and focus documentation onthe reason for the visit. If the patient has hypertension ordiabetes and also is a chronic pain patient, a good methodis to organize the narrative so that all issues are addressedseparately with identification of the primary reason forthe visit. Poor documentation about a patient who comesfor a blood pressure check and leaves with a hydrocodoneprescription can lead to regulatory questions during aninvestigation.

Objective data are used to document outcomes of thephysical exam, pain testing, and laboratory results, in-cluding urine drug screens. Urine drug screens are im-portant. If a positive result is expected and the test is neg-ative for a patient who is seeking a controlled drug refill,the NP should question the need and evaluate if the pa-tient is actually taking the drug or if a diversion situationexists.

Assessment is one of the most important documenta-tion areas as a source of evidence. It provides a synthesisof the information provided by the patient and objectivelyobtained by the NP. Here the NP can explain the think-ing that leads to a specific course of action. An examplewould be explaining why a fentanyl patch was selectedas the drug of choice versus a hydrocodone or an oxy-codone for a patient suffering from chronic joint pain.Easy route of delivery, consistent dosing, and control ofpatch application may outweigh patch costs, and the risksof diversion associated with prescribing a large number ofhydrocodone tablets could be a factor. An additional con-sideration for documentation is discussion of the equalanalgesic dosing considerations between an oral agent,such as hydrocodone, and a transdermal (TD) adminis-tration method. Changing to a TD fentanyl can result insignificant dose increases for a patient and thus the pos-sibility of adverse effects.

Plans need to be clearly identified. Controlled drug pre-scriptions and instructions given need to be specificallydocumented. If a pain management contract exists, re-view and reinforcement of the contract components canserve to document safety standards. If a pain manage-ment contract is lacking, there should be serious consid-eration given to implementing one or significant docu-mentation stating why a contract is not used.

How NPs place themselves at risk

Many NPs lack awareness of Federal Drug EnforcementAgency (DEA) guidelines specific to controlled medica-tion prescribing. They are available on the Department

of Justice website and should be reviewed at regularintervals to maintain an awareness of updated guide-lines. DEA numbers are site specific, and changing prac-tice locations or practicing at multiple sites, even withinthe same health system, requires compliance with propernotifications and approvals (Federal Drug EnforcementAgency, 2011).

State boards of pharmacy have regulatory responsibil-ity for prescription monitoring and control. Currently,34 states have web-based prescription drug monitoringprograms for providers to access that provide detailed in-formation about individual patient’s prescription history(Federal Drug Enforcement Agency, 2010). Whenever anNP enters into a prescribing relationship with acute orchronic pain patients on an outpatient basis, a baselineprescription history should be obtained, reviewed, andthe assessment documented in the record. Informationabout multiple providers, frequency of prescription fill-ing, use of multiple pain medications, and use of morethan one pharmacy can be obtained and can serve asclues about future prescribing issues that may occur witha patient. Lack of truthfulness is a common issue in thepain management world and a good baseline prescrib-ing history is essential. Authorization to access prescrip-tion monitoring programs can be obtained from the stateboard of pharmacy.

Authorization to prescribe is more commonly solelyregulated by the state board of nursing that issues theNP license. Authorization is based on statute and rulesthat have been promulgated with input for other pro-fessional stakeholders, such as boards of pharmacy andmedicine. Some states have continuing education re-quirements specific to pharmacotherapeutics that NPsmust meet during the licensure cycle for renewal. Thismay only involve signing an attestation of compliancestatement with the renewal application. Other states re-quire specific documentation to be submitted, and manyconduct random compliance audits. If an NP has a sig-nificant pain management practice, continuing educationfocused on prescribing pain medications adds strength tocompetency arguments during an investigation.

Using a formal pain management contract is a goodpractice and an essential piece of documentation thatdemonstrates patient safety concerns when initiatingtreatment. Failure to comply with this standard of painmanagement practice places the NP in the position ofhaving to justify lack of compliance during an investiga-tion. Contract forms are available from multiple nationalpain organizations by accessing their websites (WebMD,2011). Most contain similar information and terms. TheNP should review the contract with patients on a regu-lar basis and any deviations from the contract should bedocumented in the visit note. In some instances, ongoing

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noncompliance can be sufficient reason to terminate theprovider–patient relationship. This decision should alsobe documented in the medical record along with any con-tingencies offered to continue care for a defined time pe-riod while the patient establishes with another provider.

Poor prescribing practices that lead to adverse patientoutcomes are frequently identified during investigations.Some examples that become issues of concern includeinitiation of treatment using multiple long-acting opi-oids concurrently, or prolonged visit intervals wherethe patient’s response to a changed medication is notevaluated in a timely manner and thus places the patientat risk (Nelson, 2006). Methadone prescribing withouthaving documentation to support NP education in dosingand monitoring of methadone and not using sufficientdose escalation and monitoring parameters poses riskto both the patient and the NP (Chhabra & Bull, 2008).Lack of clear reasoning in using drugs intended to treatneuropathic pain, when treating nociceptive pain, callsto question NP prescribing competencies. Allowingprescription refills authorized by staff without directpatient evaluation by the NP and without documentationother than a refill can pose problems for the NP duringan investigation.

Treating patients with opioids is not the problem forthe NP. The problems arise when assessments are incom-plete or missing, safeguards are not used, monitoring issporadic or lax, noncompliance with a pain managementcontract is allowed, and documentation is poor so thatthere is no evidence that the NP maintained control of therelationship and prescribing practices, used appropriatecollaboration with other providers, and modified treat-ment interventions when problems were identified.

Accepting to treat a patient for acute or chronic painwho is a known abuser or self-reports illicit drug use,even in the distant past, is an immediate concern. With-out implementing necessary safety guidelines such asusing a contract, obtaining a baseline urine screen, assess-ing for potential future abuse, and implementing mech-anisms for controlled medication distribution using onlyone pharmacy places the NP at risk for having a complaintfiled and being the subject of an investigation.

Whenever a patient self-reports illicit drug use, or hasa known history of abuse, and the NP is considering im-plementing opioid treatment, a risk assessment tool thatwill help determine the potential of future abuse shouldbe completed and included in the medical record. Twoself-administered tools are easily available for use: theScreener and Opioid Assessment for Patients with Pain(SOAPP) and the Opioid Risk Tool (ORT). The ease ofapplication and interpretation of each tool makes themvaluable to the NP in a primary care setting. Both toolshave limitations and they are not intended to be an exact

assessment, but rather to provide clues in future problemidentification and to help the NP more accurately assessrisk of abuse and diversion (Passik & Kirsh, 2008).

Medications that do not require signed prescriptionforms are often called in to pharmacies for filling. Thesecalls can be made by either nurses or nonlicensed officepersonnel. NPs must remember that if someone knowl-edgeable about the process wants to divert this level ofmedication, calling in a prescription would be easy andmost providers have no way of checking exactly whatprescriptions are being authorized using their name by acall-in system unless they work directly with the board ofpharmacy to audit filled prescriptions credited to them.

Case study

This case study illustrates common situations that canpose investigative issues for providers. It is based on acombination of the real experiences of three NPs fromseparate jurisdictions who were all investigated by theFederal DEA as well as by their respective boards of nurs-ing. The information is deidentified in terms of jurisdic-tion, time, and ongoing disciplinary action. Two of thecases resulted in formal discipline based on violations ofthe nurse practice act because the NPs failed to meet thestandard of nursing care established by a national asso-ciation and endorsed by the board of nursing, and thatfailure placed the patient and the public at risk for harm.The third case resulted in the NP voluntarily surrenderingthe NP license and retiring from active practice.

M.E. is a family nurse practitioner with 15 years’ expe-rience. She recently changed jobs when the family physi-cian she worked with retired and the practice closed. Formost of the past 15 years she treated the same patientgroup who had stable chronic illnesses of hypertension,diabetes, asthma, and some isolated respiratory and uri-nary infections. Her patients respected and admired her.She is well known in the community and active in pro-fessional and social organizations. She is now working ina free clinic that sees a high number of Medicaid and in-digent patients who lack the resources to pay for theirnecessary medications and usually rely on subsidies forliving. This is a new case-mix experience for her.

Patient A.B. comes to the clinic complaining of the flu.His presentation is common for a 42-year-old man withthe flu. During the initial visit he tells M.E. that his backcontinues to hurt from an auto accident 4 years ago. Thepain has increased to the point that he feels he could notwork at any job requiring standing and he is currentlyunemployed. He shares a history that he has used hy-drocodone in the past but that he did not notice any sig-nificant improvement so he stopped because it was tooexpensive. M.E. performs a brief exam and talks to A.B.

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about his back pain. She gives him a prescription for fen-tanyl TD patch 50 μg with a 3-day change interval and afollow-up appointment in 1 month.

Her documentation states, “S: Comes to clinic c/o flu.Has history of back pain greater than 4 yrs. No currentmeds. Cannot work due to pain. Homeless. Intermittentlylives at mission. Verbal history illicit drug use, marijuanaand cocaine. No family locally. No PCP. O: BP 148/90,HR 82, R18, A&O x3, skin warm, no rash, lungs con-gested, RRR no murmur, Abd soft, BS+x4. Has difficultywalking, cannot stand erect. A: Chronic low back painnegatively impacting ADLs. P: Trial 30 days fentanyl TD50mcg. RTC 1 month.”

This initial documentation fails to address what she didfor his flu, which was the reason for his visit. It also fails toidentify her thinking as to why she began back pain treat-ment with a drug like fentanyl instead of an oral agentwith lesser potency. Investigation revealed that free sam-ples of fentanyl were available through the clinic and hy-drocodone and oxycodone were not available. This lack ofdocumentation posed a later problem for her during theinvestigation. There were also questions about the higherinitial dose of fentanyl, although dosing is the decision ofthe NP and does not constitute any violation of the nursepractice act.

M.E. continued to care for A.B. for 4 years, and he wasone of the few patients that she regularly treated for anypain-related issues. Most of her patients were treated fordiabetes, hypertension, or other diseases. After 2 years,A.B. had progressed to the fentanyl 75-μg dose patch.He continued to complain of unresolved back pain andcontinued his homeless lifestyle and financial struggles.M.E.’s documentation continued to describe his overalllack of pain control and his social issues.

Four years after M.E. began treating A.B., a local19-year old was found dead from narcotic overdose anda police investigation occurs. The outcome of the investi-gation was that the dead girl was given fentanyl by herboyfriend, who purchased it for recreational use. Thesource was traced to a local man who had a previousconviction for drug trafficking. Upon investigation, thepolice discovered that the man bought fentanyl patchesfrom A.B. on a regular basis for the past 24 months. Thesource of A.B getting the fentanyl patches was traced toNP M.E. At this time the DEA began an investigation ofM.E.’s prescribing practices. The DEA worked with theboard of pharmacy during the investigation. The phar-macy board notified the board of nursing who also joinedthe investigation.

There are numerous violations of the law in selling andbuying fentanyl for illicit use. Now the NP is being inves-tigated for poor practice, although she had no awarenessthat A.B. was selling the patches she prescribed. The fun-

damental question asked was did her practice meet thestandard of care for treating a chronic pain patient in anoutpatient setting and did she have in place the necessarysafeguards to protect the patient, the public, and herself?

An oral interview with M.E. clearly demonstrated thatshe had good intentions in treating pain. She chose afentanyl TD because the number of patches could bemore easily accounted for than numerous pills being pre-scribed, the patient had no resources to pay for oral meds,and there were free patches available. Even though sheverbalized this concern when interviewed, her documen-tation lacked any demonstration as to why a higher leveldrug like fentanyl TD was initially chosen over a lessermedication like hydrocodone, or that possible diversionwas a consideration.

A review of A.B.’s medical record showed that the NPfailed to meet the standard of care for caring for a painpatient. The initial visit was not for pain, but treatingpain was the outcome of the visit. There were no demon-strated safeguards put in place by the NP when prescrib-ing a controlled drug. The patient admitted to a historyof illicit drug use, yet no urine screen was performedbefore fentanyl was prescribed, and no abuse potentialassessment was completed. There was no evidence inthe record of a pain management contract being imple-mented. There was no assessment as to the nature of theback pain, no referral to other providers for their opin-ions, no physical therapy evaluations, and no attemptsto alter or lower the medication dose over time. Becausethe patient was able to sell the patches and he continuedto function without using pain medication, this called toquestion the accuracy and effectiveness of any ongoingfunctional assessments conducted by the NP during hisfollow-up visits.

The outcome of this investigation was devastating forthe NP, who otherwise provided a competent and valuedservice to many other patients. Her prescription licensewas restricted and this disciplinary action was recordedon the national provider database. The loss of prescriptionability negatively impacted her continuing in an NP roleat her current job site.

Conclusion

Lessons learned from a situation such as this arehard for NPs who enter into patient relationships andtreatments with good intentions to do no harm. Mostfeel that they have little control over what a patientdoes outside of the office, but poor safeguards canenable diversion and other abuse behaviors. Good-intentioned NPs whose primary clinical practice is not inpain management or addiction recovery must seek outinformation on acceptable practice standards when they

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treat chronic pain patients. Increasing street values forthese medications, increasing prescription use among thegeneral population, and increasing illicit drug use anddiversion mandate the use of more stringent applicationof the standards for pain management by all providers.Using these recognized tools and maintaining thoroughdocumentation can help NPs avoid discipline whenthey are subjects of regulatory investigations related totreating chronic pain patients with opioids.

References

American Chronic Pain Association. (2006). Partners for understanding pain

supplement. Retrieved June 6, 2011, from http://www.theacpa.org

Benedict, D. (2008). Walking the tightrope: Chronic pain and substance abuse.

Journal for Nurse Practitioners, 4(8), 604–609.

Chakravarty, A., & Sen, A. (2010). Migraine, neuropathic pain and nociceptive

pain: Towards a unifying concept. Medical Hypotheses, 74(2), 225–231.

Chhabra, L., & Bull, J. (2008). Methadone. American Journal of Hospice and

Palliative Care, 25(2), 146–150.

Dimsey, A. (2010). Addictive behaviors: New readings on etiology, prevention,

and treatment. Drug and Alcohol Review, 29(1), 117–118.

Federal Drug Enforcement Agency. (2011). Retrieved April 15, 2011, from

http://www.deadiversion.usdoj.gov

Federal Drug Enforcement Agency. (2010). Prescription monitoring program.

Retrieved April 15, 2011, from http://www.deadiversion.usdoj.gov/

faq/rx˙monitor.htm

Greener, M. (2009). Chronic pain: Nociceptive versus neuropathic. Nurse

Prescribing, 7(12), 540.

Mularski, R. A., White-Chu, F., Overbay, D., Miller, L., Asch, S. M., & Ganzini,

L. (2006). Measuring pain as the 5th vital sign does not improve quality of

pain management. Journal General Internal Medicine, 21(6), 607–612.

Nelson, B. (2006). Combining long-acting opioids that are active at different mu

receptors for pain management. Retrieved April 14, 2011, from Medscape:

http://www.medscape.com/viewarticle/528357

Pain Management Nursing: Scope and Standards of Care. (2005). American

Society of Pain Management Nurses and American Nurses Association.

Passik, S. D., & Kirsh, K. L.,(2008). Screening for opioid abuse potential. Pain:

Clinical Updates. 16(7), 1–4.

Summers, S. (2000). Evidence-based practice part I: Pain definitions,

pathophysiologic mechanisms, and theories. Journal of Perianesthesia

Nursing, 15(5), 357–365.

United States Code, Uniform Controlled Substance Act, title 21, chapter 13,

subchapter 1, part A, § 801. Retrieved April 14, 2011, from http://

www.law.cornell.edu/uscode/21/usc sec 21 00000801—-000-.html

WebMD. Pain management contract templates. Retrieved April 15, 2011, from

http://www.webmd.com/pain-management/guide/pain-management-

pain-treatment-agreement

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