Dr. Planton is Clinical Consultant Pharmacist, Charleston, and Dr. Edlund is Professor and Coordinator, Gerontological and Palliative Care Nurse Practitioner Options, College of Nursing, Medical University of South Carolina, Charleston, South Carolina.
The authors disclose that they have no significant financial interests in any product or class of products discussed directly or indirectly in this activity, including research support.
Address correspondence to Barbara J. Edlund, PhD, RN, ANP, BC, Professor and Coordinator, Gerontological and Palliative Care Nurse Practitioner Options, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas Street, PO Box 250160, Charleston, SC 29452-8900; e-mail: firstname.lastname@example.org.
Pain is widely prevalent in long-term care facilities. Approximately 71% to 83% of older institutionalized individuals report one or more pain problems (Ferrell, 1991). Persistent or chronic pain is often unrecognized and undertreated (Cavalieri, 2002). In addition, older Americans are among the most undertreated populations for pain (Ferrell, Ferrell, & Osterweil, 1990). Potential barriers to providing optimal care for these individuals include lack of knowledge among health care providers of pain management principles, inadequate knowledge of medications or other treatment options, poor assessment and/or inappropriate identification of pain, failure to recognize that various kinds of pain may be present in the same individual, and the lack of use of evidence-based approaches in pain management. Reluctance to report pain or take pain medication, believing pain is a normal part of aging, stoicism, and lack of education about pain therapies are some of the barriers voiced by patients.
To address these barriers to optimal pain management and clearly enumerate the responsibilities of skilled nursing facilities to effectively treat and prevent pain, the Centers for Medicare & Medicaid Services (CMS) (2009) recently released a new pain management guidance and investigative protocol, F-Tag 309. Using this directive to ensure the appropriate treatment of pain and educate health care providers on all aspects of pain management will help skilled nursing facilities achieve optimal improvement in pain management for their residents.
New CMS Surveyor Guidance on Pain Management
This new surveyor guidance, termed F-Tag 309, states that “each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care” (CMS, 2009, Appendix PP, p. 9). Furthermore, the provision states the “facility must ensure that each resident obtains optimal improvement or doesn’t deteriorate within the limits of a resident’s right to refuse treatment, and within the limits of recognized pathology and the normal aging process” (CMS, 2009, Appendix PP, p. 11). This new guidance, which became effective March 31, 2009, focuses on the impact of identifying, assessing, and treating the underlying cause(s) of pain, as well as continually evaluating the resident’s outcomes and changing intervention as needed.
Skilled nursing facilities are advised to pay particular attention to residents who are or may be experiencing pain. Potential candidates include any residents who actively state they have pain or discomfort, who display possible indicators of pain that cannot be attributed to another cause, and who have another disease state or condition that may lead to worsening pain (e.g., wounds, infection, frequent therapy sessions). The new surveyor guidance endorses the presence of an interdisciplinary team (e.g., physician, nurse practitioner, nurses, pharmacist) that is responsible for developing a pain management plan specific to each resident who has pain or who has the potential for pain, such as during a treatment or procedure. Implementation of an effective interdisciplinary pain management program may help facilities avoid potential surveyor citations. The interdisciplinary team should be focused on all components of pain management—from the initial screening to the follow up and monitoring of treatment effectiveness.
Screening of residents for pain should be performed on all new admissions and routinely for residents who have a history of reported pain. Persistent or chronic pain can take into account conditions such as low back pain, degenerative joint disease, musculoskeletal injury or soft tissue disease, headache, neck pain, neuralgia, and peripheral neuropathy (Bonica, 2001; Hainline, 2005). This kind of pain decreases quality of life and can lead to depression, social isolation, anxiety, loss of appetite, sleep problems, and difficulty performing activities of daily living (Barkin, Barkin, & Barkin, 2005; Weiner, 2007).
It is important to note that pain should be properly assessed any time there is a change in condition, whether physical, emotional, or cognitive (Hadjistavropoulos et al., 2007). The assessment should be thorough and complete, including identifying when pain can be anticipated (McLennon, 2007). The assessment should define the specific type of pain (e.g., stabbing, throbbing, dull, cramping, aching), whether it is localized or generalized, and the frequency and duration of the pain (e.g., daily, occasionally, constant, intermittent, associated with an activity). Identifying the type of pain is essential for effective treatment so the most appropriate pharmacological interventions can be prescribed—a principle stressed in the F-Tag 309 guidance (CMS, 2009). The skilled nursing facility should attempt to address the causes of pain and aggressively manage pain if unable to prevent it.
Completion of the pain questions on the Minimum Data Set does not remove a facility’s responsibility to document a more detailed pain assessment. It is recommended in this new surveyor guidance that every facility use a standardized system or tool for assessing pain in residents. Ferrell and Charette (2009) provide a listing and helpful discussion of various pain scales. Assessment of pain in cognitively impaired older adults can present significant challenges; the Pain Assessment in Advanced Dementia is a helpful tool for assessing pain in individuals with varying degrees of cognitive impairment (Warden, Hurley, & Volicer, 2003).
Communication plays a large role in the resident’s plan of care. The plan of care should be addressed with the resident and/or family and among the health care staff. The new surveyor guidance emphasizes that residents and their goals are to be included in the plan of care. Skilled nursing facilities should actively train all staff involved in resident care in pain management principles, addressing myths and beliefs regarding pain and the components of proper pain management (McConnell et al., 2009). The training should be broad enough to cover the major points but should also emphasize that staff need to understand the individual necessities of all residents identified as having pain.
The education of health care providers should be ongoing due to the staff turnover rate in long-term care settings. Caregivers should know the components of the care plan and be encouraged to notify other members of the interdisciplinary team if they notice any negative trends. While nonpharmacological interventions should be attempted whenever possible (American Geriatrics Society Panel on Persistent Pain in Older Persons, 2002), and are encouraged by the new surveyor guidance in the treatment of pain, pharmacological interventions are often necessary in treating pain in older adults.
Despite their relatively high potential for side effects (Cavalieri, 2002), pharmacological interventions remain the primary modality for treating pain in older adults. Health care providers are frequently challenged by the physiological changes that take place in the body over time (Edlund, Sterrett, & McEnany, 2005). Therefore, when providers are prescribing drug therapy in older adults, it is crucial that clinicians familiarize themselves with age-associated changes in drug metabolism and elimination (Edlund & Haight, 1992), potential increases in adverse drug reactions, and increases in possible drug-drug and drug-disease interactions. Appropriately controlled pain in older adults comes through a combination of medication dosage titrations and routine monitoring of effects via follow up (Hitchcock, Ferrell, & McCaffery, 1994).
Specific starting and titrating dosage regimens for older adults have not been readily stated. Therefore, the approach of “start low and go slow” remains the general premise as it pertains to pain management in this population. In addition, it is vital that individually tailored therapeutic trials be the standard practice for effective pharmacotherapy in treating chronic pain.
By combining pharmacological and nonpharmacological treatments, larger reductions in pain and greater improvements in function are typically obtained (Dahlin, 2008; Ferrell, 1991). Likewise, it may be necessary to use more than one medication. In some cases, using two or more medications, at lower dosages, may provide greater pain relief with less risk for toxicity compared with higher dosages of single agents (Jacox et al., 1994). Because of the increased possibility for adverse events, drug-drug interactions, and drug-disease interactions, providers must be made aware of any new medications, herbal products, and over-the-counter supplements, and taper or discontinue any medications that do not provide a well-defined therapeutic outcome.
For mild to moderate persistent musculoskeletal pain, most individuals respond well to scheduled acetaminophen (Tylenol® and others) (Bradley, Brandt, Katz, Kalasinski, & Ryan, 1991). On the basis of its safety and efficacy profile, acetaminophen should be considered initial pharmacotherapy for treatment of persistent pain. The maximum daily dosage for individuals without kidney or liver function impairment is 4 grams per 24-hour period. However, in those with renal or hepatic dysfunctions a 50% to 75% reduction in dosage is advised. Likewise, some clinicians recommend that a maximum daily dosage of 3 grams per 24-hour period be established in older adults, regardless of organ function (Benson, 1983). It should be noted that acetaminophen is recommended for individuals who need only analgesic therapy. Due to its lack of anti-inflammatory properties, acetaminophen use is limited in those with severe inflammation.
There has been a great deal of research around the use of non-steroidal anti-inflammatory drugs (NSAIDs) in older adults. Nonselected NSAIDs, or cyclooxygenase-1 (COX-1) inhibitors, should be avoided for long-term use when possible because of the risk of adverse events. Gastrointestinal bleeding and renal dysfunction are significantly higher in older adults, due in part mostly to pharmacokinetic changes in the body over time. The nonacetylated salicylates (choline magnesium, salsalate) typically serve as safer alternatives than COX-1 inhibitors for older adults because they produce less gastrointestinal irritation/bleeding and inhibition of platelet aggregation.
COX-2 selective agents should be used rarely for individuals who require daily persistent therapy and have no specific contraindications. While these selective agents are considered safer alternatives for the treatment of osteoarthritis and rheumatoid arthritis, their associated drug-drug and drug-disease interactions have been highly researched and documented (Bombardier, Laine, & Reicin, 2000; Waxman, 2005). The COX-2 selective inhibitors can increase blood pressure, induce or worsen cardiac failure, and impair kidney function to the point of renal failure. Furthermore, in 2000, data suggested that rofecoxib (Vioxx®) use was associated with a significantly higher risk of myocardial infarctions. This research subsequently led to the voluntary withdrawal of the medication 4 years later (Kim & Reicin, 2005). When a COX-2 selective agent is prescribed for a resident at risk of thrombosis, health care providers are now being encouraged to maintain this medication at the lowest possible dosage and for short periods (fewer than 18 months) whenever possible.
Opioids have become essential for management of persistent pain due to their proven efficacy in reducing pain from multiple sources. Currently, opioids can be prescribed in either a short-acting formulation (e.g., morphine sulfate [MSIR® and others], codeine, hydrocodone [Vicodin® and others], oxycodone [Roxicodone® and others], hydromorphone [Dilaudid®]) or an extended-release formulation (e.g., sustained-release morphine [MS Contin®], sustained-release oxycodone [OxyContin®], fentanyl transdermal [Duragesic®], methadone). The longer-acting opioids should be used for the treatment of continuous pain, reserving the short-acting opioids to treat intermittent and/or breakthrough pain. Although little evidence exists to support superior safety and/or efficacy of the time-release products, it is proposed that these products may contribute to overall improved adherence due to greater ease of use. Titration of the maintenance dosage (extended-release formulation) should be based on the persistent need for and use of medications (short-acting formulation) for breakthrough pain (Table 1).
Table 1: Opioid Therapy Options
A few opioids on the market may not be the best options for the older adult population. Propoxyphene (Darvon®, Darvocet®) is an opioid commonly used for the diagnosis of mild to moderate pain. Several studies suggest minimal efficacy, significant central nervous system effects (i.e., dizziness, sedation, increase in falls), cardiovascular and anticholinergic complications, and increases in cost (Moertel, Ahmann, Taylor, & Schwartau, 1974). In February 2009, a panel of medical experts assembled by the U.S. Food and Drug Administration (FDA) recommended that Darvon and Darvocet be removed entirely from the market due to these safety risks (Mechcatie, 2009).
Meperidine (Demerol®) is another opioid that has well-documented side effects in older adults. This medication is not recommended for pain management in older adults due to the accumulation of its metabolite, normeperidine, which is associated with serious central nervous system side effects, including tremor and seizures (Fick et al., 2003).
Methadone is an opioid that many clinicians are hesitant to prescribe. However, due to its efficacy for treating neuropathic pain and delayed opioid tolerance, this medication has during the past several years regained the interest of pain management clinicians (Ripamonti & Dickerson, 2001). Methadone does have a variable half-life (22 to 55 hours) and should be initiated and titrated cautiously by clinicians well versed in its use and risks.
Due to opioids’ potential side effects, care should be taken when administering opioids to older adults. Whenever opioids are started, constipation prevention should be initiated through the use of stool softeners and bowel regimens. Some individuals report increased episodes of nausea and vomiting, in which case an antiemetic agent may be useful. While tolerance typically develops over time, sedation, cognitive impairment, and respiratory depression can be problematic early on with the initiation of opioids. In addition, the risk of physical and psychological dependence should be noted. However, potential for dependence and addiction should not be the top priority when choosing a pain intervention for individuals in any age group. The main goal with opioid therapy is to maximize symptom relief and functional improvement—while minimizing the risk of addiction, diversion, and side effects—for those in persistent pain.
Medications for Neuropathic Pain
Neuropathic pain “occurs because of injury to or disease of the nervous system” (Dahlin, 2008, p. 80). The most common forms of neuropathic pain in older adults are diabetic peripheral neuropathy (DPN) and post-herpetic neuralgia (PHN). Neuropathic pain is typically treated with some medications not used for other types of pain. These medications, or adjuvant agents, work to both relieve pain and discomfort, as well as improve function, sleep pattern regularity, and health-related quality of life. Firstline agents in the pharmacological management of neuropathic pain include oral tricyclic antidepressant agents (TCAs), gabapentin (Neurontin®), tramadol (Ultram®), mexiletine (Mexitil®), and topical lidocaine patch (Lidoderm®). In addition, pregabalin (Lyrica®), duloxetine (Cymbalta®), and carbamazepine (Equetro®, Tegretol®, and others) all have FDA-approved indications for various kinds of neuropathic pain (Table 2).
Table 2: Neuropathic Pain Treatment Options
Tricyclic Antidepressant Agents
While there is no one agent from this class that is FDA approved for neuropathic pain, strong evidence supports the use of desipramine (Norpramin®) and nortriptyline (Aventyl®, Pamelor®) for this indication (McCarberg, 2005; Mounsey, Matthew, & Slawson, 2005). One study estimated that the number needed to treat for TCAs is 3.5 for 50% pain relief in DPN and 2.1 for 50% pain relief in PHN (Ahmad & Goucke, 2002). However, due to poor tolerability secondary to anticholinergic side effects and orthostatic hypotension, some agents within this class may not be good candidates for older adults. These tertiary tricyclic agents include amitriptyline (Elavil®), imipramine (Tofranil®), and doxepin (Sinequan®). Desipramine and nortriptyline have the fewest anticholinergic and sedative effects and would be the safest alternatives of the TCAs for the older adult population.
The anticonvulsant gabapentin also has strong evidence for treating neuropathic pain and PHN (Berry & Petersen, 2005; Chandra, Shafiq, Pandhi, Gupta, & Malhotra, 2006). This agent should be started at low dosages due to sedation, dizziness, and gastrointestinal side effects. Gabapentin, when combined with morphine, has shown superior efficacy than use of either agent alone (Gilron et al., 2005). Pregabalin has numerous studies supporting its use for PHN, DPN, and fibromyalgia (Freynhagen, Strojek, Griesing, Whalen, & Balkenohl, 2005; Siddall et al., 2006). Pregabalin induced significant improvements in pain scores and sleep interference versus placebo (Freynhagen et al., 2005). The efficacy of pregabalin in the management of DPN has been shown to occur as early as the first week of treatment. Carbamazepine is FDA approved for trigeminal neuralgia, while oxcarbazepine (Trileptal®) may be beneficial for treatment of PHN in individuals refractory to carbamazepine and/or gabapentin (Criscuolo, Auletta, Lippi, Brogi, & Brogi, 2005).
Tramadol is a centrally acting analgesic agent that binds to opioid receptors and inhibits catecholamine reuptake. Tramadol has been found to relieve pain and allodynia associated with DPN and is recommended as a firstline agent for treatment of neuropathic pain (Sindrup et al., 1999). This medication has been associated with reduced seizure thresholds and may not be the best option for individuals with a previous history of epilepsy.
The topical lidocaine patch is FDA approved for management of PHN. The patch should be applied only to intact skin daily for up to 12 hours. Topical capsaicin has also been used as a treatment for arthritis, cystitis, HIV, DPN, and PHN (Robbins, 2000). Patients and providers should be instructed to thoroughly wash their hands after using, as the agent will cause a burning sensation if rubbed into mucus membranes.
Other Antidepressant Agents
Selective serotonin reuptake inhibitors (SSRIs) and selective serotonin-norepinephrine reuptake inhibitors (SSNRIs) have been prescribed for chronic pain. Currently, the SSNRI duloxetine is the only FDA-approved antidepressant agent for DPN and fibromyalgia. This agent should not be combined with any other catecholamine-reuptake inhibitor, but it can be combined with an anticonvulsant or topical agent. Paroxetine (Paxil®), venlafaxine (Effexor®), and buproprion (Wellbutrin®) have all been shown to be effective for treatment of neuropathic pain but are not FDA approved (Rowbotham, Goli, Kunz, & Lei, 2004; Semenchuk, Sherman, & Davis, 2001).
Once a treatment plan is implemented with any class of analgesic agents or combinations (e.g., non-opioid, opioid, neuropathic), the final step is to monitor the effectiveness of the interventions. Whether or not the care plan is working is determined by how thorough the assessment identifies the target signs and symptoms and how well the interdisciplinary team documents progress in their notes. In addition, the team should be focusing on adverse drug reactions. Some examples of inappropriate or adverse reactions to a medication may include decline in the resident’s activity level or appetite, increases in somnolence and constipation, onset of or increase in confusion, and worsened quality of life.
If a resident’s pain is not being adequately treated, or the risks outweigh the benefits of the current care plan, it is imperative the interdisciplinary team try to identify any causes for failure and make appropriate changes. Pain management consultations are often useful in the event that pain is not adequately controlled. Finally, it is important to remember that pain management is a continual disease state. Providers must continually assess and monitor whether residents have any components of pain once it is initially improved or alleviated.
The new CMS (2009) surveyor guidance delineates pain management principles to assist skilled nursing facilities in the recognition and adequate treatment of pain in older adults. The guidance clearly emphasizes the importance of interdisciplinary collaboration, ongoing education of health care providers on all aspects of pain management, involvement of the resident in the plan of care, development of policies and procedures that reflect current standards of practice, and commitment of the skilled nursing facility to aggressively manage pain in its residents if unable to prevent it.
Through the careful use of appropriate pharmacological and nonpharmacological strategies, pain management can be improved in long-term care residents. These strategies should be chosen on an individualized basis that is specific for balancing both safety and efficacy. As with all chronic degenerative disease processes, pain management does not stop with a simple one-time evaluation but needs to be an ongoing process. An interdisciplinary approach involving the resident and health care providers offers the best outcome for understanding the specific pain and treating it appropriately.
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Opioid Therapy Options
||Approximate Retail Cost Per Dosagea
|Acetaminophen 325 mg/codeine 30 mg
||Tylenol® #3, Empirin® with Codeine, Fiorinal® with Codeine, Robitussin® A–C
||30 mg to 60 mg codeine every 4 to 6 hours; maximum 12 tablets per 24-hour period
||$0.47 to $0.93
||Duragesic® (transdermal patch)
||12 mcg to 100 mcg patch every 72 hours
||$13.60 (12 mcg patch) to $38.31 (100 mcg patch)
||200 mcg every 4 hours or longer duration; individualize dosage based on current opioid intake
||$38.31 (200 mcg transmucosal, “Actiq on a stick”)
|Hydrocodone 5 mg/acetaminophen 500 mg
||Vicodin®, Lortab®, Lorcet®
||5 mg to 10 mg hydrocodone every 4 to 6 hours; maximum 8 tablets per 24-hour period
||$0.40 to $0.50
||2 mg every 3 to 6 hours (oral), 0.2 mg to 1 mg every 3 hours (intravenous)
||5 mg to 20 mg every 6 to 8 hours
|Morphine, immediate release
||MSIR®, Roxanol®, Duramorph®
||10 mg to 30 mg every 4 hours (oral), 1 mg to 10 mg every 2 to 4 hours (intravenous/subcutaneous)
||$0.65 (tablet), $1.10 to $3.30 (solution)
|Morphine, sustained release
||Split total daily dosage of immediate-release morphine into two to three dosages and administer every 8 to 12 hours
||$0.93 to $1.63
|Oxycodone, immediate release
||5 mg to 15 mg every 4 to 6 hours
||$1.04 to $1.14
|Oxycodone, sustained release
||Split total daily dosage of immediate-release oxycodone into two dosages and administer every 12 hours
||$2.40 (10 mg), $7.28 (40 mg)
||Percocet®, Percodan®, Tylox®
||2.5 mg to 10 mg every 6 hours
||$0.40 to $2.03
Neuropathic Pain Treatment Options
||Starting Dosage (Approximate Retail Cost Per Daya)
||Maximum Recommended Dosage
||Potential Drug Interactions
||0.075% applied to affected area 4 to 5 times per day ($4.21 per 60 g tube)
|Carbamazepine (Equetro®, Tegretol®, and others)
||100 mg twice per day ($0.32)
||1200 mg per day for trigeminal neuralgia
||Anticonvulsant agents, statins, benzodiazepines, macrolides, antifungal agents
||10 mg to 25 mg at every bedtime ($0.77 to $0.81)
||150 mg per day
||Antipsychotic agents, anticholinergic agents, some fluoroquinolones, MAOIs, SSRIs, cholinesterase inhibitors
||30 mg per day for 1 week, then increase to 60 mg per day ($5.00 to $5.14)
||60 mg per day
||SSRIs, MAOIs, tramadol, TCAs, tryptophans, platelet aggregators
||300 mg once per day on Day 1, 300 mg twice per day on Day 2, 300 mg three times per day on Day 3 ($0.67 to $2.00)
||3600 mg per day
||Sevelamer (Renagel®), antacids, and some opioids
|Nortriptyline (Aventyl®, Pamelor®)
||10 mg to 25 mg at every bedtime ($0.17 to $0.43)
||150 mg per day
||Antipsychotic agents, anticholinergic agents, some fluoroquinolones, MAOIs, SSRIs, cholinesterase inhibitors
||50 mg three times per day ($8.40)
||300 mg per day for DPN, 600 mg per day for PHN
||Thiazolidinediones, ACE inhibitors, CNS depressant drugs (e.g., sedative agents, anxiolytic agents)
||300 mg twice per day ($4.33)
||2400 mg per day
||Immunosuppressants, statins, anticonvulsant agents, some calcium channel blockers
|Topical lidocaine patch (Lidoderm®)
||one patch: 12 hours on, 12 hours off ($6.88)
||3 to 4 patches can be applied to one area per day
||Products containing acetaminophen, class I antiarrhythmics, nitrates, phenytoin (Dilantin®)
||50 mg to 100 mg per day ($2.53)
||100 mg per day for immediate-release tablet
||SSRIs, lithium, TCAs, MAOIs, buproprion (Wellbutrin®), CNS depressants