The study sample (N=2,825) represented approximately 648,600 hospice decedents nationwide who used opioids during the last week of life. Of hospice decedents who used opioids during the last week of life, 52.5% (representing approximately 340,180) used laxatives concomitantly. Of the study sample, 43.7% were aged 85 and older, 55.7% were female, and 92.5% were white (Table 1). Cancer accounted for the largest group of hospice discharges (40.9%), followed by heart disease (12.8%), debility (12.0%), dementia (11.1%), and lung disease (8.5%). Of the sample, 60.4% were in hospice for 8 or more days, and 45.3% received care in a private home at the time of death. Similar proportions of the sample had three or fewer comorbidities (57.3%) and used 10 or fewer medications (58.8%). The sample received care from agencies that were hospice only (65.9%), not for profit (72.0%), not chain affiliated (75.1%), and located in a metropolitan area (87.5%) (Table 2).

Preliminary multivariate regression with only individual characteristics (Model 1, Table 1) found that race and number of medications used were statistically significant at p<.05, and number of days enrolled in hospice and setting of care had a p-value <.10. The preliminary multivariate regression with only facility characteristics (Model 2) showed that metropolitan statistical area status had a p-value <.10. These characteristics were entered into the final multivariate regression model combining individual and agency characteristics.

The final individual–agency combined model (individual characteristics shown in Table 1 and agency characteristics shown in Table 2) shows that individuals taking opioids who were black or of other races had lower odds than whites (OR = 0.57, 95% CI = 0.33–0.99) of using laxatives concomitantly. Having been enrolled in hospice for 7 or fewer days was associated with lower odds of using opioids and laxatives concomitantly (OR=0.65, 95% CI=0.37–0.95) than having been enrolled for more days, as did receiving hospice care in hospital, inpatient hospice, and other settings (OR=0.45, 95% CI=0.43–0.93) rather than in nursing homes and skilled nursing facilities. Using six to 10 medications (OR = 6.01, 95% CI = 3.88–9.32) or 11 to 25 medications (OR = 13.80, 95% CI = 8.74–21.80) was associated with higher odds of using concomitant opioids and laxatives than using five or fewer medications. Hospice decedents in micropolitan areas had lower odds of using opioids and laxatives than those in metropolitan areas (OR = 0.66, 95% CI = 0.44–0.98).

Clinical guidelines recommend that, unless contraindicated, treatment of constipation with laxatives should start prophylactically when opioid therapy is initiated.^8–13 Recent policies that the Centers for Medicare and Medicaid Services have adopted are requiring hospice organizations to report quality-of-care measures including the Hospice Item Set, which incorporates an indicator on concomitant opioid and laxative use.¹⁴ If hospice agencies do not report or comply with these quality of care measures, they will face payment reductions.

To the knowledge of the authors of the current study, this is the first empirical study to examine concomitant opioid and laxative use in end-of-life care at the national level. Using the latest available, nationally representative survey data on hospice discharges, this study found that 52.5% of older adults in hospice taking opioids were using laxatives during the last week of life. These findings are consistent with prior smaller studies documenting that approximately 40% to 64% of individuals receiving palliative care are concomitantly prescribed a laxative and an opioid analgesic.^15,19,20

Previous studies have found that racial and ethnic minorities are significantly less likely to receive adequate pain management, including opioid analgesic use, than their white counterparts in a variety of healthcare settings.^21–23 This study, with adequate sample size, adds evidence to the existing literature on racial and ethnic differences that, of older hospice decedents who were taking opioids, blacks and persons of other races had lower odds than whites of using concomitant laxatives during the last week of life.

Individuals enrolled in hospice for 8 or more days also had higher odds of using opioids and laxatives than those enrolled for fewer days. Individuals with longer hospice enrollment might have a greater length of time to develop more-severe constipation and therefore be given laxatives. Individuals receiving hospice care in nursing homes or skilled nursing facilities also had greater odds of using opioids and laxatives concomitantly than those receiving care in inpatient facilities and other settings. Inpatient care might have focused on acute symptom management such as pain and secretions near the end of life, whereas prevention of constipation might have been prioritized less.

These findings indicate that, in individuals in hospice taking opioids, using more medications increased their odds of using concomitant laxatives during the last week of life. The odds of using concomitant laxatives was more than five times as great in individuals taking opioids who used six to 10 medications as in those using five or fewer medications and almost 13 times as great in those who used 11 to 25 medications. A previous national study found that the average number of medications used in the last week of life was 10.2, ranging from 9.5 in individuals with dementia to 11.4 in individuals with lung disease.² Taking a large number of medications in hospice presents challenges to hospice care providers, who need to find the balance between prescribing necessary medications to manage end-of-life symptoms effectively and minimizing the number of medications to avoid polypharmacy that may lead to adverse health outcomes and poor quality of end-of-life care.²⁴

There are limitations to this study. It was a cross-sectional, observational study. Although the models controlled for a number of confounding factors, the findings may reflect other unobserved factors. Causation should not be inferred. The 2007 NHHCS collected data on medications used only during the last week of life, rather than the entire hospice enrollment period. Clinical needs and medications that individuals in hospice use may fluctuate over the course of hospice enrollment. In the last days of life, when individuals may no longer be able to receive oral treatments, consciousness may diminish, or terminal delirium may develop, management of constipation may receive lower priority, and oral laxatives may be discontinued.¹² For individuals who have dysphagia, as-needed medications that can be administered rectally may be ordered for constipation as an alternative. Having more-detailed clinical information, including contraindications to laxatives and refusal to take laxatives, would have further informed the interpretation of these findings. Additionally, this study cannot discern whether medications “taken” represent those that were actually administered or simply provided as as-needed medications that were made available in the home in case the individual developed a symptom during the final dying process. Laxatives are known to be commonly prescribed on an as-needed basis for when constipation develops.⁷ Another limitation is that hospice staff who had access to medical and administrative data reported the medication data. Although survey items were asked uniformly across all sampled agencies, there might have been variations in how up to date hospice agencies kept their medication records. Over-the-counter medications and other supplements, especially those that individuals in home hospice use, might be undercounted if they were not documented in hospice records. Finally, information about on-site pharmacists may further inform these findings, but the 2007 HHCS did not capture information on these providers.

Ensuring proper use of medications in older adults, especially those receiving end-of-life care, is a recognized public health concern. The latest clinical guidelines and quality of hospice care indicators that federal regulatory agencies have adopted recommend laxative treatment whenever opioid therapy is initiated, unless contraindicated, to prevent opioid-induced constipation. Using the latest available nationally representative data, this study found that in 2007 slightly more than half of older adults in hospice taking opioids during their last week of life were using concomitant laxatives. Factors associated with using opioids and laxatives concomitantly included race, number of days enrolled in hospice, setting of care, number of medications, and metropolitan statistical area. Findings from this national study serve as a comparison for future examinations of how concomitant use of opioids and laxatives may change over time and have implications for future actions toward improving the quality of care near the end of life. Furthermore, this study provides evidence to inform policymakers about the inclusion of the hospice quality-of-care measure on concomitant use of opioids and laxatives. As hospice agencies begin to publish this and other quality indicators reported to the Centers for Medicare and Medicaid Services in the coming years, hospices will have incentives to improve quality as it relates to this and other measures being monitored.