FormalPara Key messages

A non-judgmental and patient-centric dialogue between the patient and pharmacy staff plays an essential role in selecting an appropriate treatment strategy and optimising outcomes, while giving patients reassurance and a sense of empowerment, enabling them to return to normal daily life.

Patients can self-manage acute constipation with over-the-counter medicines if there are no alarm symptoms (severe abdominal pain with/without vomiting and fever) that preclude self-management.

Long-term self-management of chronic constipation is appropriate only after a medical evaluation and in patients with a stable condition and satisfactory treatment outcomes.

In neonates and infants, treatment of constipation should be solely based on a medical diagnosis, while a parent/guardian can manage children aged ≥ 4 years for up to 4–8 weeks before a medical evaluation is needed.

Introduction

Constipation is one of the most common gastrointestinal (GI) disorders in the general population, with a mean prevalence of about 15% in Europe [1,2,3]. Chronic constipation can affect anyone, but is positively associated with older age, female sex and lower socioeconomic status [4,5,6,7]. Most cases of chronic constipation are idiopathic (primary), but some are secondary to disease, lifestyle factors or medications [4, 8, 9]. Constipation can adversely affect quality of life [10, 11], reduce productivity [12] and increase healthcare resource use [13].

Initial management involves diet and/or lifestyle changes, if appropriate [1, 8, 14, 15]; however, medical treatment is often required. Approximately one‐third of those with constipation self-medicate [16, 17], using treatments such as stool softeners, bulking agents, stimulant laxatives and osmotic laxatives [4, 18], many of which are available on an over-the-counter (OTC) basis. In a large survey from the United States (US) [19], 98.7% of patients with chronic idiopathic constipation relied at least partly on OTC medications to manage their symptoms.

Most people with constipation self-diagnose and self-manage their condition [17, 20, 21], a situation that creates opportunities, but also has limitations and risks. In general, OTC medications play a key role in the management of mild and/or transient conditions because they are easily accessible. Used appropriately, OTC medicines have important socioeconomic benefits because they free up physicians to focus on more complex health issues; additionally, they empower patients/consumers, enabling them in many cases to resume their normal daily activities.

Diagnostic and treatment guidelines for constipation are available, but, with few exceptions [1], focus primarily on the management of chronic constipation by physicians [6, 9, 15]. A definition of occasional constipation has recently been proposed [22], which acknowledges the existence of transient real-life variability in bowel habits in the broad community and the need to restore satisfactory bowel habits, primarily by means of self-management and without physician involvement. Professional organisations and expert panels have provided counselling algorithms for pharmacists [23,24,25], but these typically do not provide practical guidance for day-to-day management decisions. However, pharmacy staff should understand when it is appropriate to assist patients in the self-management of constipation, and when to refer them to a physician for further evaluation [26].

The objective of this article is to provide up-to-date clinical practice guidance for healthcare professionals (HCPs), particularly community pharmacists, to assist in the day-to-day management of patients who present with constipation.

Constipation assessment in pharmacy practice

Given that constipation means different things to different people, the requests for OTC medication and counselling present opportunities for pharmacy staff to correct misconceptions (e.g. fear of toxin build-up if there is no regular bowel movement), while at the same time ensuring that valid patient concerns are addressed.

Asking patients what symptoms they have, and why they think they may be constipated, can provide insight into their desired treatment outcome (e.g. increased frequency, softer stools, sense of complete evacuation and/or improved ease of defaecation). For HCPs, confirming a self-diagnosis of constipation via a non-judgmental, non-directive and patient-centred interview can help establish an effective patient–provider relationship, which in turn, can improve patient satisfaction, treatment adherence, symptoms and clinical outcomes [27]. Further relevant information includes whether the constipation is acute, recurrent or chronic, and whether there are factors that might preclude self-medication.

A recent survey of 300 German general practitioners (GPs), pharmacists and pharmacy technicians, conducted by Landes and colleagues, found that the majority of respondents were comfortable with patients self-managing acute constipation in the absence of alarm symptoms, such as blood in stool, severe abdominal pain and significant unexplained weight loss. The majority also agreed that patients can self-manage chronic constipation, even for a longer time period, if an initial physician consultation has been conducted (Table 1) [28]. However, differences between the HCP groups in their responses suggested that expert guidance on constipation self-management would be helpful for both patients and HCPs.

Table 1 Attitudes of German healthcare professionals (n = 300) to patient self-management of constipation in an online survey [28]. The available responses to each question were ‘fully agree’, ‘agree’, ‘neither agree nor disagree’, ‘do not agree’ and ‘do not agree at all’
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Constipation assessment and prioritisation in pharmacy practice

Patients who present to a community pharmacy with symptoms of constipation should be evaluated to rule out a more serious underlying condition. In Germany, the Federal Chamber of Pharmacists (Bundesapothekerkammer; BAK) has issued guidelines for the assessment of patients with constipation in a pharmacy setting [29]. Although helpful, they are insufficiently specific to support practice-orientated decision-making. We therefore recommend that pharmacists consider the following two factors before dispensing an OTC medication for the treatment of constipation:

  1. 1.

    Are the symptoms acute or recurrent/chronic?

  2. 2.

    Are alarm symptoms present or has there been a major change in symptoms?

Although there is no clear definition of acute constipation, symptoms lasting < 3 months can generally be considered acute or intermittent [1, 30]. There is general agreement that constipation episodes typically are self-limiting [5, 31, 32], but can evolve into a chronic state in some cases.

In patients presenting with constipation, two questions are particularly relevant to pharmacists: (1) in what time frame is an initial medical consultation required, if alarm symptoms are absent and the patient’s condition is stable? and (2) what circumstances or criteria require a timely medical consultation?

Time frame for initial medical consultation

In the survey by Landes and colleagues [28], there were differences of opinion between GPs, pharmacists and pharmacy technicians as to when medical evaluation was necessary in patients with constipation who did not have alarm symptoms and who reported successful self-management (Table 2). In such patients, only 44% of GPs recommended medical evaluation before 3 months, compared with 56% of pharmacists and 68% of pharmacy technicians [28]. In general, GPs were least concerned about medical evaluation, pharmacy technicians were most cautious, and pharmacists were in between. We speculate that this reflects the degree of medical training in the three groups of HCPs. Once a medical evaluation had been performed, only 11% of HCPs disagreed that long-term self-management was appropriate as long as no changes in symptoms occurred [28].

Table 2 Time after which medical evaluation of constipation was considered necessary by German healthcare professionals (n = 300) responding to an online survey [28], in two different scenarios (labelled ‘1A’ and ‘1B’)
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Pharmacists must consider the potential ‘hidden’ causes of constipation, and the consequences of a diagnostic delay; therefore, the duration of self-management until initial medical consultation is of particular importance. Although neurological and metabolic diseases (e.g. Parkinson’s disease, multiple sclerosis and diabetes) are associated with constipation [4, 14, 33], the value of constipation as a sole or typical indicator for such conditions is limited. Intestinal surgery and certain prescription medicines, such as opioids and muscarinic receptor antagonists, can also cause or contribute to constipation, but they are unlikely to be ‘hidden’ causes because they cannot occur without physician contact. In the case of medication-induced constipation, patients should be referred to the prescribing physician for review.

Colorectal cancer deserves specific mention in this context, because the consequences of delayed diagnosis could be particularly serious [34]. In a retrospective analysis of 19,764 lower GI tract endoscopies, 566 (2.9%) included constipation as an indication for the procedure; however, the prevalence of colorectal cancer in this population was comparable with that expected in asymptomatic individuals undergoing screening [35]. In a study of 200 patients with constipation, 50% of whom had colonoscopy and 50% of whom had computed tomography (CT) colonography, two adenocarcinomas were identified [36]; both cancers were found to be non-obstructive right-sided lesions unlikely to cause constipation. In a systematic review and meta-analysis of studies exploring associations between constipation and colorectal cancer, the odds ratio for detecting cancer when the primary indication for colonoscopy was constipation was 0.56 (95% confidence interval 0.36–0.89) [37], indicating a lack of association. Another systematic review also concluded that colorectal cancer was unlikely to be present in individuals with constipation [34]. Therefore, the available evidence suggests that, in the general population, the presence of constipation alone (i.e. in the absence of other alarm symptoms) does not signify the presence of colorectal cancer. Accordingly, some authors have recommended that patients with constipation should not be referred for colonoscopy to investigate possible colorectal cancer [38]. However, people aged ≥ 50 years should undergo regular screening for colorectal cancer in accordance with applicable guidelines.

Overall, it seems unlikely that, in the absence of alarm symptoms and in a stable symptom condition, the self-management of constipation for a few months would lead to a clinically significant delay in the diagnosis of a serious underlying medical condition. A comprehensive analysis of Medicare data indicated that a delay of up to 1 year in diagnosing colorectal cancer did not increase mortality [39]. Nevertheless, in accordance with chronic constipation guidelines [1], we recommend that patients presenting with constipation of > 3 months’ duration should be referred for medical evaluation, although this does not preclude dispensing an OTC laxative.

In practice, we recommend that patients are informed during counselling that if the condition persists, a medical work-up should be sought within 2–3 months. In cases where a patient presents with chronic constipation (i.e. constipation of > 3 months’ duration), they should be advised to seek a medical diagnosis within 2–4 weeks (if it has not already been diagnosed), although this does not preclude dispensing an OTC laxative. Once a medical diagnosis has been established and underlying organic causes have been excluded, long-term self-medication is appropriate provided that the patient’s condition is stable and treatment outcomes are satisfactory.

Circumstances/criteria for a timely medical consultation

In patients reporting a sudden worsening of existing constipation, or a substantial increase in laxative requirements, we recommend referral for medical evaluation in a timely manner (within 2–4 weeks) because these changes could indicate a serious underlying condition. Possible deviations from this recommendation may apply in pregnant or nursing women; however, a discussion of these patient populations is beyond the scope of the present article.

Referral for medical evaluation also holds true when treatment outcomes are unsatisfactory. It is important that patients get adequate relief from treatment, although patients can respond very differently to the different medicines. Surveys show that the majority of patients with chronic constipation have tried more than one therapy. In the 2020 survey of 300 German HCPs referred to above [28], participants were asked how they would respond if an intervention for constipation was insufficiently effective. If basal treatment (e.g. hydration) had not proven successful, 88% of respondents recommended trying another treatment, whereas 12% advised a medical referral. If osmotic laxatives were insufficiently effective, there was an approximately even split between trying an alternative treatment and referral to a physician. However, if a stimulant laxative was not effective, only 15% recommended switching to another treatment, with 85% in favour of medical referral.

In the medical setting, a time period of 2–4 weeks is typically sufficient to judge treatment success [1, 40]. Accordingly, we endorse a similar approach for self-management, meaning that if pharmacological treatment has failed to provide adequate relief, a physician should be consulted (to determine if further physiological testing is needed).

A pharmacist's primary responsibility is to identify factors that might preclude or limit the time of self-medication. As such, dispensing an OTC medicine for constipation prior to medical evaluation requires careful evaluation for the presence of alarm or ‘red flag’ symptoms. The reason for this recommendation is that acute constipation, especially if symptoms are progressive, is more likely than chronic constipation to be associated with organic disease that requires immediate or timely intervention. Thus, patients presenting with newly developed symptoms should be carefully evaluated for concomitant ‘red flags’ that may indicate a more serious condition. In acute settings, severe pain, vomiting, fever and GI bleeding are relevant alarm symptoms [24, 41]. In chronic settings, alarm symptoms and other ‘red flags’ include anaemia, unexplained weight loss > 10%, a family or personal history of GI tumours, enlarged lymph nodes, malnutrition, blood in stool, paradoxical diarrhoea, age > 50 years, progressive course of constipation or recent onset of severe symptoms [1, 24, 41].

Detection or confirmation of some of these factors requires a physical examination or laboratory investigation, and thus there are limits to what community pharmacists can ascertain. It is worth noting that alarm signs, such as significant weight loss and/or blood in stool, have low sensitivity and specificity in identifying patients with functional bowel disorders [42, 43]; thus, the value of these symptoms may be overstressed, especially in chronic constipation. Accordingly, in the context of these symptoms, self-management of constipation without the need for immediate physician referral is considered justified on the one hand, while on the other, these symptoms should still be viewed as potential indicators of a general health disorder that requires a timely physician consultation. To aid decision-making in the pharmacy setting, we have developed a pragmatic pharmacy-specific approach (Table 3) and an accompanying algorithm (Fig. 1). The relevant ‘red flags’ that can be identified during a pharmacy consultation, and that should trigger a medical referral, were selected following a review of expert panels, guidelines and textbooks [1, 24, 41] and validated by authors with specialist knowledge of gastroenterology (DP and TF).

Table 3 Evaluating alarm symptoms and other ‘red flags’ in a pharmacy setting prior to dispensing OTC medication for constipation
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Fig. 1
figure 1

Proposed algorithm for the assessment, treatment and referral of patients presenting to community pharmacies with symptoms of constipation. Pharmacy staff should first assess the patient’s overall status (❶); ask screening question (SQ) 1 (see Table 3); if the patient appears to be in poor health or their status is uncertain, refer them for medical evaluation if deemed necessary (❷). If the patient’s status is stable, staff should determine whether the symptoms are acute/occurring for the first time or if they are recurrent/chronic (❸). The next step should be to ask SQ2 (❹; see Table 3). Over-the-counter (OTC) medications can be dispensed, but if SQ2 indicates any alarm symptoms, medical evaluation should occur within 2–4 weeks. In the absence of alarm symptoms, patients with a first episode of acute constipation should be advised to see a physician within 2–3 months if their symptoms persist (❺). Patients with recurrent or chronic constipation without a previous diagnostic work-up should be advised to undergo medical examination within 2–4 weeks (❻). Colonoscopy may be appropriate, and is highly recommended in patients aged > 50 years. All patients who receive OTC medications for constipation should be advised to see a physician within 2–4 weeks if their symptoms worsen considerably, change in character or are not adequately relieved (❼)

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As shown in Table 3, we propose two general screening questions to help pharmacy staff identify patients who should be referred for medical evaluation either immediately (i.e. within 3 days) or in a timely manner (within 2–4 weeks), and to check the appropriateness of dispensing OTC medications. The referral deadlines are intended as a guide to the degree of urgency, rather than as fixed instructions; in general, patients should be advised to seek medical attention if their symptoms worsen and/or can no longer be self-managed with measures such as OTC medication.

Constipation in children and recommendations for the parent/guardian

Constipation is a common problem in children, and is one of the most frequent causes of referral to paediatric gastroenterology clinics [44]. Approximately 95% of children with constipation have functional constipation, meaning that no organic or anatomical cause can be identified [44]. In children aged > 6 years with functional defecation disorders, 75% have incontinence of stool or show behaviour of retaining stool [45].

The diagnosis of functional constipation requires the presence of symptoms for ≥ 2 weeks (ESPGHAN/NASPGHANFootnote 1 criteria) [46] or ≥ 1 month (Rome IV criteria) [30] in infants and toddlers, as well as in children and adolescents [47]. Accordingly, a constipation episode lasting 2–4 weeks can be considered as acute (or occasional) constipation. Management includes initial disimpaction (if necessary), followed by maintenance therapy with dietary modification, toilet training, bowel diary and laxatives [48].

Based on these general considerations [30, 44,45,46,47,48], we make the following recommendations for the parent/guardian-based management of constipation in children and young adults:

  1. 1.

    Management of constipation in neonates and infants should always be based on a medical diagnosis. Any constipation starting within the first 4 weeks of life is an alarm symptom; in the first year of life, organic diseases are frequently seen and need specific treatment.

  2. 2.

    All children aged < 4 years (or those who have intellectual or physical disabilities) should be seen by a physician before starting treatment.

  3. 3.

    Screaming and other indicators of significant distress during a bowel motion are also alarm symptoms and should prompt immediate assessment by a physician.

  4. 4.

    In the absence of alarm symptoms, including those applicable to adults (see Table 1), parent/guardian-based management with OTC laxatives (in accordance with labelling information) can be considered for up to 4 weeks in children aged ≥ 4 years without physical or intellectual disability and for up to 8 weeks in those aged ≥ 10 years before medical evaluation is needed.

  5. 5.

    If initial approaches fail to achieve a satisfactory response, a physician should be consulted in a timely manner. Reoccurrence of symptoms on a regular basis should also prompt medical evaluation.

Choice of over-the-counter laxatives

Although previously published algorithms have focused on the physician-led, rather than pharmacy-based, management of constipation [1, 6, 9, 24, 27], some have nevertheless recognised or endorsed self-management as the primary treatment option [1, 9]. There are advantages and disadvantages of different OTC laxatives; dialogue between the patient and pharmacy staff plays an essential role in selecting an appropriate treatment and optimising outcomes [49]. Pharmacy staff can help patients decide which OTC treatment(s) to use, as well as what results to expect and when. Thus, the choice of OTC treatment should be based on a mode of action that is likely to address the patient’s key symptoms, while acknowledging the individual’s preferences (e.g. medication time to onset, administration frequency and taste) and previous treatment experiences.

Guideline-recommended first-line OTC medications for the treatment of acute and chronic constipation include osmotic laxatives (e.g. macrogols) and stimulant laxatives [e.g. bisacodyl and sodium picosulfate (SPS)] [1, 6, 9, 24, 29]. There is no reason to limit the treatment period [1].

Macrogols (macrogol 3350/4000) are the osmotic laxatives of first choice in the treatment of constipation [1, 6, 9, 24] and are available in commercial formulations with or without added electrolytes [1]. Macrogols increase the water content of stools, improving stool consistency and progression in the colon. Their effect becomes apparent within 24–48 h, and due to their mode of action, macrogols should be taken continuously to support regular bowel movements. A disadvantage of electrolyte-supplemented macrogols is their salty taste; if this is reported by the patient, an electrolyte-free formulation of macrogol 4000 can be used as an alternative [50]. On balance, macrogols are considered superior to other osmotic laxatives [51]. Bisacodyl and SPS are the two stimulant laxatives recommended as first-line treatments [1, 6, 9, 24]. Both agents have a dual mode of action, stimulating the propulsive motility of the colon and increasing water content in the bowel, resulting in a more rapid onset of action (about 6–12 h) than with osmotic laxatives [52]. Due to their rapid onset of action, bisacodyl and SPS are particularly suitable for on-demand or intermittent therapy [1].

In general, laxative therapy can be carried out permanently (long periods of time/for life) without expected damage to the colon [1, 53]. In cases of medical indication, laxatives do not carry a risk of dependence or (with a suitable dosage) electrolyte disturbances. Over the course of life-time treatment, an increase in laxative dose may be necessary, not because of decreased effectiveness, but rather because of age-related slowing of colonic transit and increasingly difficult or prolonged defecation kinetics [53].

If the selected first-line OTC option is ineffective or not tolerated, switching to another first-line option is recommended [1, 29]; if the issue is tolerability, a change of drug class (e.g. from an osmotic to a stimulant laxative or vice versa) is appropriate.

Conclusions

Community pharmacy professionals play an essential role in helping patients self-manage symptoms of constipation. To perform this role optimally, pharmacy staff must know and understand when constipation can be safely and effectively managed using general measures and OTC medication, and when referral for medical evaluation is appropriate. We have developed screening questions and a patient management algorithm to help pharmacists and pharmacy technicians make appropriate decisions whenever a patient presents with symptoms of constipation, or requests advice after the initiation of OTC treatment.