JULY/AUGUST 2004 • VOLUME 14, NUMBER 4

Consensus Statement

The Use of ‘As-Needed’ Range Orders for Opioid Analgesics in the Management of Acute Pain:
A Consensus Statement of the American Society for Pain Management Nursing and the American Pain Society*
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 FAAN, Perry G. Fine, MD, Christine Miaskowski, PhD RN FAAN, Scott Fishman, MD, and Rebecca S. Finley, PharmD MS

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.

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 visual analog 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 (APS, 2003; McCaffery & Pasero, 1999). 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 under- treated 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.

Joint Commission on Accreditation of Healthcare Organizations Pain Standards
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 (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 Joint Commission 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 Joint Commission made it clear that patient safety was the issue. The Joint Commission 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 over- sedation and fatal respiratory depression events (ISMP, 2002). The Joint Commission 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 Joint Commission 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 Joint Commission 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 Joint Commission 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 to the organization (Rich, 2003).

As in all areas of accreditation review, the Joint Commission does not provide specific examples of ways standards may be implemented. Repeatedly, the Joint Commission 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 Joint Commission 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 Joint Commission standards could not address all of the specific clinical practice decisions regarding pain management.

The Consensus Statement
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 (see page 8) 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).

Conclusion
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.

The Use of 'As Needed' Range Orders for Opioid Analgesics in the Management of Acute Pain: A Consensus Statement of the American Society for Pain Management Nursing and the American Pain Society.

Acknowledgments
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.

Debra B. Gordon, MS RN, is from the University of Wisconsin Hospital & Clinics, Madison, WI. June Dahl, PhD, is from the University of Wisconsin–Madison Medical School, in Madison, WI. Jan Fransen, MSN RN CRNP, is from the Cleveland Clinic Foundation in Cleveland, OH. Charlene Cowley, MS RN CPNP, is from the Phoenix Children’s Hospital in Phoenix, AZ. Roxie L. Foster, PhD RN FAAN, is from the University of Colorado School of Nursing, Denver, CO. Perry G. Fine, MD, is from the University of Utah Pain Management Center, Salt Lake City, UT. Christine Miaskowski, PhD RN FAAN, is from the University of California San Francisco School of Nursing, San Francisco, CA. Scott Fishman, MD, is from the University of California Davis Department of Anesthesiology and Pain Medicine, Sacramento, CA. Rebecca S. Finley, PharmD MS, is from the University of Science at Philadelphia, Philadelphia, PA. Address correspondence to Debra B. Gordon, MS RN, University of Wisconsin Hospital & Clinics, 600 Highland Avenue 1535, Madison, WI 53792; e-mail db.gordon@hosp.wisc.edu.

*Reprinted from Pain Management Nursing, Vol. 5, Debra B. Gordon, June Dahl, Peggy Phillips, Jan Frandsen, Charlene Cowley, Roxie L. Foster, Perry G. Fine, Christine Miaskowski, Scott Fishman, and Rebecca S. Finley, The Use of ‘As-Needed’ Range Orders for Opioid Analgesics in the Management of Acute Pain: A Consensus Statement of the American Society for Pain Management Nursing and the American Pain Society, pp. 53–58, 2004, with permission from the American Society for Pain Management Nursing.