Abstract
Background
Hospital admissions provide an opportunity to deprescribe ineffective medications and reduce pill burden. Docusate sodium is a stool softener that is frequently prescribed to treat constipation despite poor evidence for efficacy, thus providing a good target for deprescription. The aims of this study were to characterize rates of use and discontinuation of docusate among internal medicine inpatients, as well as use of other laxatives.
Methods
We conducted a retrospective observational study over 1 year on all patients admitted to internal medicine at 2 urban academic hospitals to determine rates of docusate use. We also evaluated laxative and opioid medication use on a random sample of 500 inpatients who received docusate to characterize patterns of prescription and deprescription.
Results
Fifteen percent (1169/7581) of all admitted patients received 1 or more doses of docusate. Among our random sample, 53% (238/452) received docusate before admission, and only 13% (31/238) had docusate deprescribed. Among patients not receiving docusate before admission, 33.2% (71/214) received a new prescription for docusate on discharge. Patients receiving opioids were frequently prescribed no laxatives or given docusate monotherapy (28%, 51/185).
Conclusions
Docusate was frequently prescribed to medical inpatients despite its known ineffectiveness, with low deprescription and high numbers of new prescriptions. Docusate use was common even among patients at high risk of constipation. One third of patients not receiving docusate before admission were prescribed docusate on discharge, potentially exacerbating polypharmacy. Among patients already receiving docusate, 80% had it continued on discharge, indicating significant missed opportunities for deprescribing. Given the availability of effective alternatives, our results suggest that quality-improvement initiatives are needed to promote evidence-based laxative use in hospitalized patients.
Keywords
Clinical Significance
- •Docusate is still frequently used as a stool softener among medical inpatients in our study despite poor evidence for efficacy.
- •Patterns of docusate use on hospital discharge revealed low deprescription rates (13%) and high numbers of new prescriptions (33%).
- •Up to one third of patients initiated on opioids in the hospital received no laxatives or docusate monotherapy, indicating significant opportunities for better prevention of constipation-related morbidity.
Inpatient admissions are an opportunity to reassess medications and identify candidate medications for deprescription.
1
Deprescribing refers to a systematic process of stopping ineffective medications to reduce polypharmacy.2
This is particularly important for hospitalized patients who constitute a population at high risk for polypharmacy and unnecessary medication use, with ensuing morbidity and mortality.3
, 4
, 5
Stool softeners are one class of potentially unnecessary medications that are frequently prescribed in the hospital, despite limited evidence of efficacy in treating constipation.
6
, 7
, 8
, 9
Indeed, the utility of docusate has been questioned in the medical literature for the last 25 years.10
, 11
, 12
A systematic review of treatments for constipation in The American Journal of Gastroenterology summarized evidence for docusate as Grade III level C (poor quality evidence, insufficient to provide a recommendation for or against use).13
At best, patients prescribed stool softeners such as docusate are receiving a weakly effective medication that contributes to polypharmacy. More concerning is the possibility of harm resulting from docusate prescription because of delay in administering more effective therapies.12
Constipation is a common clinical problem, and its healthcare burden is increasing, especially among the elderly.
14
, 15
In hospitalized medical patients, common causes of constipation are immobility, cerebrovascular disease, poor food and fluid intake, decreased functional status, and medications such as opioids and anticholinergics.15
, 16
Unrecognized constipation can have serious consequences in the elderly, including fecal impaction, fecal incontinence, urinary tract infection, delirium, bowel obstruction, and stercoral ulcer.17
Inadequately treated constipation has been associated with decreased quality of life,17
, 18
increased length of stay in hospital,19
, 20
and mortality.21
, 22
A wide variety of laxatives treat constipation through different mechanisms. Osmotic laxatives (eg, polyethylene glycol), stimulant laxatives (eg, bisacodyl), and prokinetics (eg, prucalopride) have the highest level of evidence for treating chronic constipation.
6
Laxative use in elderly patients has been studied in the outpatient23
and long-term care24
, 25
settings, but there are few data on laxative use in hospitalized medical patients.Given the questionable efficacy of docusate, we sought to characterize its use among hospitalized inpatients on internal medicine teaching units, including the frequency of new and continued prescriptions for docusate in hospital. To better understand the rationale for docusate use, we sought to characterize the use of other laxatives in this population. Finally, we specifically assessed laxative use in the subgroup of patients prescribed opioids because they are a high-risk group for developing constipation-related morbidity.
Materials and Methods
We performed a retrospective observational study of admissions to internal medicine at 2 large academic health sciences centers in Toronto, Canada, during a 1-year period between December 1, 2013, and November 30, 2014. We included all patients who received at least 1 dose of docusate. We excluded patients aged less than 18 years and with a short length of stay (<24 hours). The study was approved by the University Health Network Research Ethics Board.
For the entire cohort, we abstracted variables from the electronic health record, including age, sex, most responsible diagnosis, length of stay, comorbidity level, cancer diagnosis, and number of doses of docusate administered in hospital. We determined whether patients received at least 1 dose of the following: senna, lactulose, polyethylene glycol, or any opioid medications.
By using a random number generator, we selected a sample of 500 patients from this cohort, for whom detailed medication data were abstracted. In 48 of these, data were not available because of death (n = 41) or lack of discharge summary (n = 7). For the remaining 452 patients, we established medication reconciliation by comparing admission and discharge medication lists, including use of laxatives, stool softeners, and opioid medications. These medication lists include all prescription and nonprescription (ie, over-the-counter) medications and supplements.
For each medication in the discharge summary, we analyzed physicians' documented plan for the medication (eg, newly started in hospital, continued from home, adjusted, stopped, or administered in hospital only). We found that clinicians occasionally selected inconsistent discharge medication plan (eg, indicating “new in hospital” when the patient was taking a medication before admission, rather than the correct choice of “continued from home”). We were able to infer the intentions of the clinician in the majority of cases by using a standard classification rubric (Table 1).
Table 1Definitions of Medication Outcomes at Hospital Discharge
| Medication Outcome at Discharge | Medication Present on Admission Medication List | Medication Present on Discharge Medication List | Plan for Medication Indicated by Clinician on Discharge Summary |
|---|---|---|---|
| Continued | Yes | Yes | Same as home; or adjusted; or new in hospital |
| Deprescribed | Yes | Yes | Stopped; or hospital only |
| Unknown | Yes | No | – |
| New prescription | No | Yes | New in hospital; or adjusted; or same as home |
| Hospital only | No | Yes or no | Hospital only; or stopped |
To ensure that we did not miss cases in which docusate was listed on the admission medication list but a dose was not administered in hospital, we reviewed medication records on 100 consecutive charts in which docusate was not administered in hospital. None of these patients had docusate present on the admission medication list or the discharge medication list, supporting our methodology.
Results
During the observation period, 1169 of 7581 internal medicine inpatients (15.4%) received 1 or more doses of docusate in hospital. Compared with patients who did not receive docusate, those receiving at least 1 dose of docusate were significantly older (median, 75 vs 69 years), had a longer length of stay (median, 8.0 vs 5.0 days), had more comorbidities, and were less likely to be discharged to home (Table 2). Patients who received docusate also were more likely to receive an opioid medication in hospital (55.0% vs 34.8%), although there were no differences in the number of cancer diagnoses. Among patients who received docusate, the most frequent reasons for admission were congestive heart failure (9.8%), pneumonia (3.9%), and urinary tract infection (3.6%). Most patients in the docusate cohort received at least 1 dose of another laxative (senna in 62.9%, lactulose in 38.3%, polyethylene glycol in 19.1%, and magnesium hydroxide in 4.1%).
Table 2Characteristics of Patients on General Internal Medicine Given Docusate and Hospital and Those Not Given Docusate
| Characteristic (No. [%], Except Where Indicated) | No Docusate Given (n = 6412) | Docusate Given (at least 1 Dose in Hospital) (n = 1169) | Significance Level |
|---|---|---|---|
| Age (median ± IQR) | 69.0 (28.0) | 75.0 (24.0) | P < .001 |
| Length of stay (median ± IQR) | 5.0 (6.0) | 8.0 (13.0) | P < .001 |
| Doses of docusate (median ± IQR) | – | 7.0 (10.0) | – |
| Comorbidity score | |||
| 0 (no significant comorbidity) | 3283 (51.2) | 501 (42.9) | P < .001 |
| 1 (1.25×-1.5× more resource intensive) | 1151 (18.0) | 213 (18.2) | |
| 2 (1.5×-2× more resource intensive) | 1172 (18.3) | 225 (19.2) | |
| 3 (2×-3× more resource intensive) | 596 (9.3) | 161 (13.8) | |
| 4 (3× or more resource intensive) | 210 (3.3) | 69 (5.9) | |
| Female sex | 3225 (50.3) | 595 (50.7) | P = .81 |
| Cancer diagnosis | 1574 (24.5) | 308 (26.3) | P = .2 |
| Disposition | |||
| Home | 4960 (77.4) | 743 (63.6) | P < .001 |
| Other facility | 1053 (16.4) | 319 (27.3) | |
| Died | 399 (6.2) | 107 (9.2) | |
| Concomitant medication use (at least 1 dose received in hospital) | |||
| Opioid | 2230 (34.8) | 643 (55.0) | P < .001 |
| Senna | 1641 (25.6) | 735 (62.9) | P < .001 |
| Lactulose | 1260 (19.7) | 448 (38.3) | P < .001 |
| PEG | 585 (9.1) | 223 (19.1) | P < .001 |
| Magnesium hydroxide | 148 (2.3) | 48 (4.1) | P < .001 |
IQR = interquartile range; PEG = polyethylene glycol.
The characteristics of the random sample of 452 patients with detailed medication data who received at least 1 dose of docusate are shown in Table 3. The median number of docusate doses per patient was 7 (interquartile range, 10.25), and patients had a median of 10 medications on their discharge medication list (interquartile range, 8). Approximately half of the patients (52%) who were prescribed docusate in hospital did not have docusate on their admission medication list. For those not receiving docusate before admission, 66.8% received docusate in hospital only and 33.2% were given a prescription at discharge. Conversely, for patients with docusate on the admission medication list, 80% had docusate continued at the time of discharge and 13% had docusate deprescribed.
Table 3Characteristics of a Random Sample of Internal Medicine Inpatients Who Received at Least 1 Dose of Docusate in Hospital (n = 452)
| Characteristic | Median (IQR) |
|---|---|
| Age (y) | 75.0 (23) |
| Length of stay (d) | 8.0 (13) |
| No. of medications on discharge medication list | 10 (8) |
| No. of doses of docusate in hospital | 7 (10.25) |
| n (%) | |
| Female sex | 231 (51.5) |
| Cancer | 94 (20.8) |
| Comorbidity level | |
| 0 (No significant comorbidity) | 210 (46.5) |
| 1 (1.25×-1.5× more resource intensive) | 89 (19.7) |
| 2 (1.5×-2× more resource intensive) | 88 (19.5) |
| 3 (2×-3× more resource intensive) | 48 (10.5) |
| 4 (3× or more resource intensive) | 3.8 (17) |
| Laxative on admission medication list | |
| Docusate | 238 (52.7) |
| Senna | 149 (33.0) |
| Lactulose | 61 (13.5) |
| PEG | 15 (3.3) |
| Opioid on admission medication list | 154 (34.1) |
| Opioid on discharge medication list | 185 (40.9) |
| Outcome of docusate at hospital discharge | |
| Docusate taken before admission | 238 (52.7) |
| Continued | 192 (80.7) |
| Deprescribed | 31 (13) |
| Unknown | 15 (6.3) |
| Docusate not taken before admission | 214 (47.3) |
| New prescription | 71 (33.2) |
| Hospital only | 143 (66.8) |
IQR = interquartile range; PEG = polyethylene glycol.
Data on laxative use in patients receiving opioids are shown in Table 4. Senna was most the most frequently prescribed laxative in patients receiving opioids (64.3%), followed by docusate (63.2%), lactulose (43.8%), and polyethylene glycol (14.1%). Among patients newly initiated on opioids in hospital, most were prescribed only 1 laxative (39.6%). Twenty-eight percent (51/185) of patients discharged with an opioid prescription received no laxatives or were given docusate monotherapy. This was true both for patients receiving opioids before admission and for patients newly initiated on opioids (25%, 33/132, and 34%, 18/53, respectively). Errors in medication reconciliation occurred in 7.4% of instances (102/1376), including incorrect discharge medication status and omissions in the discharge medication list.
Table 4Laxative Use in Patients with an Opioid on the Discharge Medication List (n = 185)
| Laxative Use at Discharge | Any Opioid Prescription at Discharge (n = 185) | New Opioid Prescription at Discharge (n = 53) n (%) |
|---|---|---|
| No. of laxatives at discharge | ||
| 0 | 27 (14.6) | 11 (20.8) |
| 1 | 46 (24.9) | 21 (39.6) |
| 2 | 70 (37.8) | 14 (26.4) |
| 3 | 35 (18.9) | 6 (5.7) |
| 4 | 7 (3.8) | 1 (1.9) |
| Laxative at discharge | ||
| Docusate | 117 (63.2) | 27 (50.9) |
| Senna | 119 (64.3) | 31 (58.5) |
| Lactulose | 81 (43.8) | 26 (49.1) |
| PEG | 26 (14.1) | 9 (17.0) |
| Docusate monotherapy | 24 (13.0) | 7 (13.2) |
| Docusate monotherapy or no laxatives | 51 (27.6) | 18 (34.0) |
PEG = polyethylene glycol.
Discussion
We found that docusate was frequently prescribed on discharge to internal medicine inpatients because of both continuation of therapy and new prescriptions. These findings are surprising considering the paucity of evidence for docusate's efficacy and the availability of other effective laxatives. Ideally, ineffective medications should have high deprescription rates and limited, if any, new prescriptions.
Given the favorable safety profile of docusate, it may seem unimportant to focus on overprescription of a medication that does little more than placebo. However, there are at least 2 reasons why our findings are worthy of attention. First, polypharmacy in the elderly is an important health issue with an incidence of up to 66% in hospitalized patients and up to 23% of patients receiving unnecessary medications.
3
Higher pill burdens are associated with lower adherence to prescribed medications,26
, 27
a finding that is corroborated by meta-analysis across different diseases.28
Reducing use of ineffective medications such as docusate can reduce pill burden and result in higher adherence to medications with proven benefit. The number of medications is an important predictor of prescribing problems that lead to patient harm.4
Unfortunately, low rates of deprescription for docusate in our data indicate that only 1 of 7 patients benefited from an opportunity for mitigating polypharmacy. The high number (median, 10) of prescribed medications on discharge in our cohort indicates this is a tangible concern.Second, and as important, patients receiving docusate may suffer because of inadequate treatment of their constipation. Indeed, we found that patients newly started on opioids and receiving docusate in hospital were significantly undertreated for constipation on discharge, with 34% being prescribed no laxatives or docusate monotherapy, despite guidelines that suggest routine initiation of bowel regimens to prevent constipation in patients initiated on opioids.
29
In patients taking opioids, the best evidence suggests using senna, lactulose, or polyethylene glycol.Levy MH, Smith T, Alvarez-Perez A, et al. NCCN clinical practice guidelines in oncology: palliative care; 2016. [Internet]. Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed December 22, 2015.
7
This is an important care gap for a population at high risk of constipation and its related morbidity and mortality.There are a number of potential explanations for low deprescription rates, including both patient and provider factors.
2
Examples of patient-related factors include lack of desire to change, low health literacy, or beliefs that the medication is effective. Providers in turn may have a lack of knowledge about medication efficacy, lack of resources, or time to communicate with patients or outpatient providers, and low priority on deprescription due to a focus on more acute medical issues. Low risk of adverse events associated with docusate likely also contributed to lack of attention to this issue. Prescribing inertia also may contribute new prescriptions of docusate, because patients started on a medication in the hospital are more likely to have it reflexively continued at the time of hospital discharge. This phenomenon has been described in other settings, such as the inappropriate continuation of stress ulcer prophylaxis after intensive care unit discharge.30
Optimal deprescription rates for ineffective medications such as docusate are not well defined. However, our results can be put in context by comparing them with studies that examined deprescription in other contexts. An observational study of hospitalized patients at the end of life found higher rates of deprescription than we observed (59.3% for statin deprescription and 62.7% for antihypertensive deprescription).
31
This difference may be accounted for by a variety of factors, such as heightened awareness of deprescription at the end of life, patient inability to tolerate oral medications, and the potential for harm from continuing certain medications in these patients (eg, antihypertensives). A large observational study of treatment deintensification for patients with diabetes in primary care found a deintensification rate of 27%.32
Although this is closer to the deprescription rate we observed, it is not clear whether rates of deprescription and deintensification are directly comparable. A review of deprescribing interventions in primary care found rates of deprescribing ranging from 33% to 94%.33
A systematic review of 6 primary care studies of proton-pump inhibitor deprescription found rates ranging from 14% to 64%.34
The deprescription rates we observed were likely lower than in these trials because our study was observational and did not incorporate a formal deprescribing intervention. We would argue that deprescription rates for an ineffective medication such as docusate should be much higher, closer to 90% to 100%.Despite high rates of ineffective constipation treatments (34%) provided to new opioid users in our cohort, rates of laxative prescription in our study were higher than previously described.
35
This may reflect differences between the emergency department (where previous studies were conducted) and inpatient settings, or could represent heightened awareness among internal medicine clinicians on the need for preventative laxatives. Nevertheless, our results suggest that there remains significant room for improvement in prescribing preventative laxatives to hospitalized patients taking opioids.Docusate use in our setting was higher than previously reported. A study of medical patients in Italy found a prevalence of 0.3% of docusate use in hospital compared with 15.4% in our study.
36
This may reflect geographic differences in rates of docusate prescription or changes over the 20 years since the earlier study.An unexpected finding in our study was the error rate in medication reconciliation on discharge (7.8%). Although we could usually infer the intentions of the clinician for the purposes of our study, the misclassification of discharge medication plan on the discharge summary could result in confusion for patients or outpatient healthcare providers. This is consistent with previous studies that have documented significant quality gaps in discharge summaries.
37
, 38
In some cases, a medication was omitted completely from the discharge list, possibly because of issues with the electronic discharge summary tool. Selection of incorrect discharge medication plans by physicians could reflect a lack of knowledge of medication reconciliation techniques or could be due to inadvertent mistakes made by busy clinicians. Indeed, there is evidence that reducing housestaff workload in academic centers results in higher-quality discharge summaries,39
a finding that likely translates to medication reconciliation.Study Limitations
Despite a reasonably large sample size across 2 teaching hospitals, results come from a single location with similar practice patterns. The study design precluded assessment of important clinical variables, such as causes of constipation, efficacy and tolerability of laxatives, and morbidity resulting from constipation. We also are unable to comment on adherence to treatment, efficacy of medications, or clinical outcomes after hospitalization, because we focused on prescriptions at hospital discharge. We were unable to determine the causes of errors in medication reconciliation, and this warrants further study. In most medication reconciliation errors, we could infer the intentions of the clinician and determine an appropriate discharge medication status using a consistent classification scheme. However, it is possible that some reconciliations were misclassified despite our standardized rubric.
Another potential limitation to the accuracy of our data is the fact that docusate can be prescribed by a physician or purchased over-the-counter. Patients might be less likely to report taking over-the-counter medications, and physicians might be less likely to deprescribe nonprescription medications. However, our medication reconciliation system is designed to capture all prescription and nonprescription medications and supplements in a comprehensive admission medication list, and at the time of discharge, physicians have the option to select whether to continue or stop each medication, whether it was originally prescribed or not. We did not specifically measure the use of docusate combination pills such as docusate combined with senna, and clinicians could be less likely to deprescribe docusate in combination with a more effective laxative. However, docusate combination pills are not included in our provincial drug formulary that provides free drug coverage for persons aged more than 65 years (which represents the majority of our patients), making it unlikely that a significant number were taking docusate combination pills.
Further study is needed to define the optimal laxative strategy for hospitalized medical patients. It is apparent from our study that there is considerable practice variation in the use of laxatives in hospitalized medical patients. Practice variation may be a marker of quality gaps, and it can be mitigated through various methods, including education, audit and feedback, and the creation of protocols.
40
Few data exist on the optimal strategy for improving the quality of constipation management in hospital. A small quality-improvement project in the inpatient setting in the United Kingdom used a bundle of interventions including education and a suggested protocol, which reduced unnecessary laxative prescription by one third and improved adherence with the recommended laxatives.41
Further study clearly is warranted in this area.Conclusions
Docusate was used frequently among medical inpatients at our teaching hospitals, with low deprescription and frequent new prescriptions considering its poor evidence for efficacy. Docusate use was common even among patients at high risk for constipation, such as those newly prescribed opioids. Frequent use of docusate, as a new or continued prescription, indicates many missed opportunities for mitigating polypharmacy. Given the availability of effective therapies for constipation, our results suggest that quality-improvement initiatives are needed to promote evidence-based laxative use in hospitalized patients and discourage the use of less-effective medications such as docusate sodium. This is especially true for patients at high risk for constipation-related morbidity.
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Article info
Publication history
Published online: May 03, 2016
Footnotes
Funding: The work of TEM and RK is supported by the HoPingKong Centre for Excellence in Education and Practice at the University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada.
Conflict of Interest: None.
Authorship: All authors had access to the data and played a role in writing this manuscript.
Identification
Copyright
© 2016 Elsevier Inc. All rights reserved.
