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Debra B. Gordon, RN, MS; June Dahl, PhD; Peggy Phillips, RN, BSN; Jan Frandsen, MSN, RN, CRNP; Charlene Cowley, MS, RN, CPNP; Roxie L. Foster, PhD, RN; Perry G. Fine, MD; Christine Miaskowski, PhD, RN; Scott Fishman, MD; Rebecca S. Finley, PharmD, MS

Pain Manag Nurs 24(6):808-811, 2004. © 2004 W.B. Saunders

Posted 07/06/2004

Abstract

The use of "as needed" or "PRN" range orders for opioid analgesics in the management of acute pain is a common clinical practice. This approach provides flexibility in dosing to meet individual patients' unique analgesic requirements. Range orders enable necessary and safe dose adjustments based on an individual's response to treatment. The purpose of this paper is to present the consensus statement of the American Society for Pain Management Nursing and the American Pain Society on the use of "as-needed" range orders for opioid analgesics in the management of acute pain. The implementation of this statement should promote quality pain management through safe medication practices and the appropriate use of range orders for opioid analgesics in acute pain management.

Introduction

Quality pain management begins with an affirmation by clinicians that patients should have access to the best pain relief that can safely be provided (APS, 2004). The most effective treatment for all pain is a multimodal and balanced approach that combines both pharmacologic and nonpharmacologic strategies. However, pharmacologic therapy is the mainstay of treatment for many painful conditions. Clinical trials of opioid, nonopioid, and adjuvant analgesics (e.g., neuromodulating drugs) demonstrate variable efficacy for a wide variety of acute and chronic painful conditions (Chou, Clark, & Helfand, 2003; Deyo, 1996; Raja et al., 2002; Rawal, Allvin, Amilon, Ohlsson, & Hallen, 2001). Combinations of analgesics that work by different mechanisms of action often provide optimal pain control with minimal side effects, but few "head-to-head" comparative trials provide clear-cut choices based on efficacy and side effect data (Moore, Collins, Carroll, McQuay, & Edwards, 2003). A key issue in the quality and safety of pharmacologic treatment is the recognition that each patient represents an individual therapeutic experiment that requires careful selection and titration of analgesics.

Inter- and intra-individual differences in responses to painful stimuli and to analgesics are well recognized in all age groups (APS, 2003). The choice of analgesic should be based on the nature and severity of pain and on an individual's response to empiric trials. Additionally, it is essential that most analgesics be started at a low dose and gradually titrated to pain relief with close monitoring of side effects. This approach is particularly true when opioid analgesics are used for acute pain. A nonlinear relationship between opioid dose and the visualanalog scale has been demonstrated (Aubrun, Langeron, Quesnel, Coriat, & Riou, 2003). This lack of a predictable relationship between an opioid dose and pain relief means one should not prescribe a predetermined opioid dose based on pain intensity. Although a number of factors that predict opioid analgesic response have been identified, including age, gender, and ethnicity (Cepeda et al., 2001; Craft, 2003; Mercadante, Casuccio, Pumo, & Fulfaro, 2000), no evidence exists to support uniform responsiveness to opioid dosing (McCaffery & Pasero, 1999; APS, 2003). This lack of uniformity may be due in part to unique individual genetic differences in analgesic receptor systems (Mogil et al., 2003) and the particular type of pain (McCaffery & Pasero, 1999; Slappendel, Weber, Bugter, & Dirksen, 1999).

Experience with the use of intravenous patient-controlled analgesia (IV PCA) supports the premise of variable patient needs and responses to opioids. Initial clinical trials that sought to establish optimal dosing regimens for IV PCA for postoperative pain management demonstrated a 4-fold to 6-fold range in individual hourly morphine requirements (6 to 36 mg/hour) following similar surgeries (Smythe, 1992; White, 1988). More recently, a 40-fold range in morphine requirements was observed during IV titration of morphine when morphine was administered in a controlled fashion to permit quantification of individual differences in postoperative pain (Aubrun et al., 2003). In the same way, highly variable individual responses to opioids have been shown in patients with cancer pain (Morita, Tsunoda, Inoue, & Chihara, 2001; Palangio et al., 2002) and neuropathic pain (Benedetti et al., 1998; Gimbel, Richards, & Portenoy, 2003).

The use of "as-needed" or "PRN" range orders for opioid analgesics in acute pain management is a common clinical practice. This approach provides flexibility in dosing to meet individual patients' unique needs and analgesic requirements. However, PRN range orders for opioids have been a common source of inadequate pain management. Acute pain is often undertreated because physicians underprescribe opioid analgesics (e.g., order inappropriately low doses or prolonged dosing intervals) and nurses give inadequate doses (often less than what is ordered) (Cleeland et al., 1994; McCaffery & Pasero, 1999; Pargeon & Hailey, 1999). The purpose of this paper is to present the consensus statement of the American Society for Pain Management Nursing (ASPMN) and the American Pain Society (APS) on the use of "as-needed" range orders for opioid analgesics in the management of acute pain. The implementation of this statement should promote quality pain management through safe medication practices and the appropriate use of range orders for opioid analgesics in acute pain management.

Few actions have generated as much interest in the field of pain management as the release of Pain Management Standards by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (Dahl & Gordon, 2002). The standards became a formal part of the survey and accreditation process in January 2001 and required that accredited health care facilities recognize the right of patients to appropriate assessment and management of pain; assess pain in all patients; record the assessment in a way that facilitates regular reassessment and follow-up; educate patients, families, and providers about effective pain management; establish policies that support appropriate prescription or ordering of pain medicines; include patients' needs for symptom control in discharge planning; and collect data to monitor the appropriateness and effectiveness of pain management.

Although the JCAHO standards support the need for more aggressive pain management, nurses became concerned about statements on the Joint Commission's Web site that implied that organizations could no longer use PRN range orders for analgesic medications without specific implementation protocols. Nurses felt this approach would prevent them from exercising clinical judgment and force them to follow rigid, unsafe protocols as well as prevent them from responding appropriately to patients' individual needs for opioid analgesics. The controversy seemed resolved when the JCAHO made it clear that patient safety was the issue. The JCAHO stated that its recommendation to develop more rigid guidelines or protocols for range orders was never meant to limit nursing judgment or decrease the quality of care. The purpose of this approach is to reduce medication errors and assure patient safety. The problem is that range orders, by themselves, are often not clear, and there is no assurance that the physician who ordered the medication and the nurse who administers it have the same understanding of how the patient will be treated. "The litmus test on survey would be if two nurses would interpret the range orders for a patient in the same way"(Rich, 2003).

In addition, concerns about range orders were raised by groups such as the Institute for Safe Medication Practices (ISMP). The ISMP noted that overaggressive pain management led to alarming increases in oversedation and fatal respiratory depression events (ISMP, 2002). The JCAHO tracks sentinel events, which are defined as incidents that result in death or major permanent loss of function. From January 1995 through 2003, of 276 medication-error-related sentinel events in the JCAHO database, 21% involved opioids (Croteau, 2004). This category represents the largest number of sentinel events. Ninety-eight percent of the opioid-related events resulted in patient death.

In January 2003, after several calls for action from the Institute of Medicine to improve the quality and safety of health care (Chassin, Galvin, & National Roundtable on Healthcare Quality, 1998), the JCAHO released a set of national patient safety goals (Joint Commission Resources, 2003). Among these goals is an emphasis on safety issues related to the use of high-alert medications (e.g., opioids), medication orders, and medication policies, again raising questions about the regulation and use of PRN range orders for opioid analgesics. The associate director of surveyor management and development at the JCAHO once again clarified:

There is no change in 2004 with regard to range orders with one exception; we now require organizations to have a policy on what are the required elements (e.g. drug name, dose, route) for all medication orders, based on law and regulation. In addition, for range orders, the organization needs to specify any special requirements they wish with regards to how orders are written. For example, the dose or dosage interval can vary but not both in the same order, or the maximum allowable difference between the high and low dose is four times the lowest dose. This standard (MM.3.20) is directly related to physician order writing and not nursing. In addition, we only require that the policy exist—the content of the policy is strictly up tothe organization (Rich, 2003).

As in all areas of accreditation review, the JCAHO does not provide specific examples of ways standards may be implemented. Repeatedly, the JCAHO has emphasized that it does not write clinical practice guidelines, nor does it dictate specifically how facilities must implement standards. However, it does require that accredited organizations develop and implement processes and policies that are likely to result in improvements in the quality of care. The JCAHO has also stated that its pain standards are its first evidence-based standards. That is, these pain standards were derived from evidence-based clinical practice guidelines developed by groups such as the APS and the Agency for Healthcare Research and Quality (formerly the Agency for Healthcare Policy and Research). From their inception, it was recognized that JCAHO standards could not address all of the specific clinical practice decisions regarding pain management.

In order to provide clarification and a more directed clinical approach for safe and appropriate writing, implementation, and evaluation of PRN range orders for opioid analgesics, ASPMN established a task force with APS to develop a consensus statement (Appendix) for clinicians and institutions on the use of PRN range orders for opioid analgesics in the management of acute pain. Although the principles in the consensus statement are generally applicable to the initiation of analgesic therapy for any painful condition, they were narrowed to provide recommendations for the most commonly written range orders, namely opioid analgesics for the management of acute pain. The recommendations are applicable to both inpatient and outpatient settings and for all age groups.

Because many clinicians may have inadequate knowledge and skills in pain assessment and management, information about pain assessment, analgesic titration, equianalgesic dosing, and nonpharmacologic methods of pain control should be made available to staff to facilitate competency and safety (APS, 1995; 2004). Although institutions are encouraged to develop policies that provide practical information about pain management, these policies should not include explicit dosing recommendations. For example, policies or protocols that require clinicians to begin at a certain dose or administer a specific dose based on pain intensity ratings are not appropriate and are unsafe. In addition, open-ended orders such as "titrate to comfort" are not acceptable because they are vague, lack specific parameters, and are prone to variable or unsafe interpretation. Rather, an order should specify an appropriate dose range and frequency of administration based on the pharmacokinetics of the opioid, the patient characteristics, and the situation (Table 1).

Although an explicit approach to titration of opioids and reassessment of a patient's response is warranted, flexibility in dosing and clinical decision making must be ensured to provide safe and effective pain management. An individual patient's response to analgesics is not solely dependent on the severity of pain or the etiology of the pain. Pain perception and responses to all forms of therapy are complex phenomena related to numerous individual factors that cannot easily be identified, much less predicted. Rational and appropriate use of opioids should be individually tailored on the basis of a sound working knowledge of analgesic pharmacology, appropriately timed reassessments and adjustments, and patient response.

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American Pain Society (APS). Principles of analgesic use in the treatment of acute pain and cancer pain, APS, Glenview, IL 2003.

American Pain Society (APS). Guideline for the management of cancer pain. APS, Glenview, IL 2004.

Aubrun F, Langeron O, Quesnel C, Coriat P, Riou B. Relationship between measurement of pain using visual analog score and morphine requirements during postoperative intravenous morphine titration. Anesthesiology 2003;98:1415-1421.

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Chou R, Clark E, Helfand M. Comparative efficacy and safety of long-acting oral opioids for chronic non-cancer pain: a systematic review. Journal of Pain & Symptom Management 2003;26:1026-1048.

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American Pain Society. Principles of analgesic use in the treatment of acute pain and cancer pain, Author, Glenview, IL 2003.

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A consensus statement of the American Society for Pain Management Nursing and the American Pain Society

Position

Effective pain management requires careful individual titration of analgesics that is based on a valid and reliable assessment of pain and pain relief. A registered nurse who is competent in pain assessment and analgesic administration can safely interpret and implement properly written "as-needed" or PRN range orders for analgesic medications. The American Society for Pain Management Nursing (ASPMN) and the American Pain Society (APS) support safe medication practices and the appropriate use of PRN range orders for opioid analgesics in the management of acute pain.

Background

PRN range orders for opioids (e.g., "morphine, 2 to 6 mg IV every 2h PRN for pain") are commonly used to provide flexibility in dosing to meet individual patient needs because wide variability exists in patients' responses to analgesics. Evidence-based clinical practice guidelines support the need for individual titration of the dose of opioid analgesics. Range orders enable necessary and safe adjustments in doses based on individual responses to treatment. To promote patient safety and reduce medication errors, it is critical that physicians, nurses, and pharmacists share a common understanding of how to properly write, interpret, and carry out PRN range orders.

Recommendations

Prescribers

Construct orders that contain a dosage range with a fixed time interval. Consider patient and drug characteristics including, but not limited to pain type and intensity, pain duration, patient age, past exposure and prior response to analgesics (both pain relief and side effects), comorbidities, end organ function, concomitant administration of other drugs, and pharmacokinetics of the analgesic to be ordered. Provide a dosage range large enough to permit appropriate and safe dose titration. The maximum dose within the range should not be greater than four times the minimum dose. The dosing interval should be appropriate for the drug and route of administration, taking into account usual absorption and distribution characteristics, time to onset, time to peak effect, and duration of action. Open-ended orders such as "titrate to comfort" are not acceptable.

Nurses

Base decisions about the implementation of range orders on a thorough pain assessment and knowledge of the drug to be administered. Assessment should include at minimum pain intensity, temporal characteristics of the pain, and the patient's previous response to this or other analgesics (e.g., pain relief, side effects, and impact on function). The nurse should be familiar with the anticipated time of onset, time to peak effect, duration of action, and side effects of the analgesic to be administered. Verify the appropriateness of the dose and the dosing interval for the current situation. Verify patient's drug allergy status. Tell the patient the name of the drug and the dose to be administered. Evaluate the patient's response to the analgesic dose and dosing interval. Ensure complete documentation and communication of patient's response to dose and dosing interval. Assist with the development of policies and processes that enhance patient comfort and assure medication safety.

Institutions

Ensure that prescribers are writing appropriate range orders for analgesics. Provide ongoing education for safe medication practices. Ensure the implementation of policies and processes that provide safe, effective analgesic dosing of analgesics.

Summary

The treatment of pain requires individual titration of analgesics by a practitioner competent in pain assessment, analgesic administration, and evaluation of response to treatment. PRN range orders for analgesics must be written in accordance with evidence-based clinical practice guidelines. Institutions should allow PRN range orders for opioid analgesics in order to meet the mandate for safe and effective pain management. Processes are required to ensure staff competency in the writing, interpretation, and implementation of these orders. The safety and quality of pain management practices should be monitored.

References

American Geriatric Society. (2002). The management of persistent pain in older persons. The Journal of the American Geriatrics Society, 50(6), 1–20.

American Pain Society. (n.d.). The assessment and management of acute pain in infants, children, and adolescents. Retrieved from http://www.ampainsoc.org/advocacy/pediatric2.htm

American Pain Society. (2003). Principles of analgesic use in the treatment of acute pain and cancer pain (5th Ed.). Glenview, IL: Author.

American Pain Society. (2004). Guideline for the management of cancer pain. Glenview, IL: Author.

Joint Commission on Accreditation of Healthcare Organizations. (n.d.). Pain assessment and management standards. Retrieved from http://www.jcaho.org

McCaffery, M. & Pasero, C. (1999). Pain: Clinical manual (2nd Ed.). St. Louis, MO: Mosby.

Acknowledgements

The authors would like to thank Darryl S. Rich, PharmD, MBA, FASHP, Associate Director, Surveyor Management and Development, Joint Commission on Accreditation of Healthcare Organizations, for review of the manuscript.

Reprint Address

Address correspondence and reprint requests to Debra B. Gordon, R.N., M.S., University of Wisconsin Hospital & Clinics, 600 Highland Avenue-1535, Madison, WI 53792 USA; Email: db.gordon@hosp.wisc.edu

Debra B. Gordon, RN, MS^*, June Dahl, PhD^†, Peggy Phillips, RN, BSN^‡, Jan Frandsen, MSN, RN, CRNP^§, Charlene Cowley, MS, RN, CPNP^||, Roxie L. Foster, PhD, RN^¶, Perry G. Fine, MD^#, Christine Miaskowski, PhD, RN^**, Scott Fishman, MD^††, Rebecca S. Finley, PharmD, MS<sup>‡‡

*</sup>University of Wisconsin Hospital & Clinics, Madison, WI, USA, ^†University of Wisconsin-Madison Medical School, Madison, WI, USA, ^‡Greater Houston Anesthesiology, Houston, TX, USA, ^§Cleveland Clinic Foundation, Cleveland, OH, USA, ^||Phoenix Children's Hospital, Phoenix, AZ, USA, ^¶University of Colorado School of Nursing, Denver, CO, USA, ^#University of Utah Pain Management Center, Salt Lake City, UT, USA, ^**University of California San Francisco School of Nursing, San Francisco, CA, USA, ^††University of California Davis Department of Anesthesiology and Pain Medicine, Sacramento, CA, USA, ^‡‡University of Science Philadelphia, Philadelphia, PA, USA