pharmacological treatment for fecal elimination in a ... · pharmacological treatment for fecal...

February 2020 INESSS | Québec’s national medical protocol – Fecal elimination 1

Pharmacological treatment for fecal elimination in a person receiving palliative care or a person with a geriatric profile

No. 628016

Developed in collaboration with an advisory committee consisting of Québec clinicians and experts.

Validated by the Comité d’excellence clinique en usage optimal du medicaments, des protocoles médicaux nationaux et ordonnances of the Institut national d’excellence en santé et en services sociaux (INESSS).

CLINICAL SITUATION OR TARGET POPULATION Person 18 years of age or older who is receiving palliative care OR Person 18 years of age or older with a geriatric profile, defined as a person with a functional decline associated with a loss of autonomy or a major cognitive disorder AND Who is experiencing a decrease in their usual frequency of defecation and has had at least one of the following symptoms for the past 48 hours or longer:

Difficult-to-pass stools Small, hard or massive, bulky stools Pain or discomfort on defecation A sensation of incomplete defecation Straining at defecation or an unproductive urge to defecate No bowel movements

CONTRAINDICATIONS TO THE APPLICATION OF THIS PROTOCOL A known or suspected intestinal obstruction: vomiting with colic, fecaloid vomitus or severe abdominal pain A known intestinal perforation Acute abdominal pain An ostomy Inflammatory bowel disease: Crohn's disease, ulcerative colitis or diverticulitis Gastrointestinal bleeding Rectal, intestinal, abdominal, urinary, gynecological or pelvic surgery in the past 6 weeks pregnancy or breastfeeding Diarrhea, gastroenteritis or a C. difficile infection in the past 5 days A contraindication to the use of all the recommended drugs


INSTRUCTIONS

1. ASSESSMENT OF HEALTH STATUS

1.1 Symptoms

Inquire as to whether the person has had at least one of the following symptoms for the past 48 hours or longer:

Difficult-to-pass stools Small, hard or massive, bulky stools Pain or discomfort on defecation A sensation of incomplete defecation Straining at defecation or an unproductive urge to defecate No bowel movements

Inquire about:

Any leaks of liquid stool (suggestive of a fecaloma)

1.2 Bowel habits

Inquire as to whether there is a decrease in the person’s usual defecation frequency:

Usual defecation frequency Day of the last bowel movement

1.3 Health history

Inquire about the features associated with the geriatric profile:

Functional decline A loss of autonomy Neurocognitive disorders

Inquire about the following:

An intestinal obstruction or perforation: vomiting with colic, fecaloid vomitus or severe abdominal pain Acute abdominal pain An ostomy Inflammatory bowel disease: Crohn's disease, ulcerative colitis or diverticulitis Gastrointestinal bleeding Rectal, intestinal, abdominal, urinary, gynecological or pelvic surgery in the past 6 weeks Pregnancy or breastfeeding Diarrhea, gastroenteritis or C. difficile infection within the past 5 days A swallowing disorder that prevents the use of the oral approach

1.4 Medication history

Inquire about:

Laxative use Any contraindications to the use of the drugs recommended in Section 2.2 for the pharmacological treatment of

fecal elimination

1.5 Life habits

Inquire about:

Any fluid restriction

1.6 Digital rectal examination

When the rectal approach is being considered (see Section 2.3), check for any contraindications to its use in persons receiving chemotherapy or with a hematological disease other than anemia:

Known or suspected neutropenia (< 1 × 109/L) Severe thrombocytopenia (< 30 × 109/L)


In absence of contraindications, perform a digital rectal examination.

Check for:

Painful anal fissures or tears Painful or large external hemorrhoids The presence or absence of stool in the rectum A rectal mass Blood

Document:

Any dilation of the rectal ampulla The tonus of the anal sphincter

Proceed to the rectal approach (see Section 2.5 and Algorithm J in Appendix II).

2. TREATMENT APPROACH

2.1 Therapeutic objective

Relieve a one-time fecal elimination problem.

Treatment is effective if there is relief of the discomfort and an unstrained bowel movement

2.2 General information on pharmacological treatments for fecal elimination

The following general information on pharmacological treatments for fecal elimination is not exhaustive.

2.2.1 Osmotic laxatives

OSMOTIC LAXATIVE OF 1ST CHOICE: POLYETHYLENE GLYCOL 3350 (PEG)

OSMOTIC LAXATIVE OF 2ND CHOICE: LACTULOSE

Contraindications

A history of allergic reaction or intolerance to PEG

A history of allergic reaction or intolerance to lactulose or milk-derived products

Galactosemia

Known or suspected intestinal obstruction or perforation Inflammatory bowel disease (Crohn's disease, ulcerative colitis or diverticulitis)

Precautions None Electrocautery procedures during a

proctoscopy or colonoscopy Diabetes mellitus

Maximum dose 34 g/day (17 g BID) 30 mL/day (15 mL BID)

Time to onset of action 1 to 4 days 1 to 2 days

Mechanism of action Create intraluminal osmotic pressure, attract fluids into the intestine and stimulate peristalsis.

Details concerning administration

Take with 125 to 250 mL of fluid per 17-g dose o Fluid restriction: reduce the volume of fluid

(minimum: 90 mL)

Can be mixed in a drink (water, juice, milk, tea or coffee) to improve the taste, which some people find unpleasant.

Most common drug adverse effects

Nausea Bloating Abdominal cramps Diarrhea Flatulence (lactulose)

Most significant drug interactions Starch-based thickening agent: liquefies thickened liquids (PEG only)


2.2.2 Stimulant laxatives

SENNOSIDES BISACODYL

Contraindications

A history of allergic reaction or intolerance to sennosides

A history of allergic reaction or intolerance to bisacodyl, galactose, fructose or tartrazine

A known or suspected intestinal obstruction Acute abdominal pain Inflammatory bowel disease (Crohn's disease, ulcerative colitis or diverticulitis)

Precautions Using drugs that can exacerbate an electrolyte imbalance (e.g., thiazide diuretics or corticosteroids) Renal failure or using cardiac glycosides or antiarrhythmics

Maximum dose 34.4 mg/day (17.2 mg BID) 10 mg/day (5 mg BID)

Time to onset of action 6 to 12 hours

Mechanism of action Stimulate peristalsis, increase the amount of fluid in the bowel and modify electrolyte transport in the colon

Details concerning administration None

Swallow the tablet without chewing it Do not take milk or antacids within one hour

before or after taking bisacodyl


Abdominal cramps Diarrhea Discoloration of urine and feces: red-violet or yellow-brown (sennosides only) Electrolytic imbalance

Most significant drug interactions None

Substances that reduce upper gastrointestinal tract acidity and antacids: can prematurely dissolve the enteric coating

2.2.3 Suppositories

GLYCERIN BISACODYL

Contraindications

Neutropenia (<1 × 109/L) or thrombocytopenia (<30 × 109/L) A known or suspected intestinal obstruction Acute abdominal pain Inflammatory bowel disease (Crohn's disease, ulcerative colitis or diverticulitis) A history of allergic reaction or intolerance to bisacodyl (bisacodyl only)

Precautions None Anal fissures and ulcerative rectitis: may cause pain and local irritation

Maximum dose One 2-g glycerin suppository and one 10-mg bisacodyl suppository/12 hours

Time to onset of action 15 to 30 minutes 15 to 60 minutes

Mechanism of action

Stimulates peristaltic movements and reduces water resorption, thanks to its osmotic and hygroscopic power

Possesses a local irritant power that participates in reflex defecation

Stimulates peristalsis, increases the amount of fluid in the bowel and modifies electrolyte transport in the colon

Details regarding administration Keep in place for at least 15 minutes Place against the rectal wall

Do not insert into stool


Rectal discomfort Local irritation, burning sensation Diarrhea Fecal leakage



2.2.4 Enemas

SODIUM PHOSPHATE MINERAL OIL

Contraindications Neutropenia (< 1 × 109/L) or thrombocytopenia (< 30 × 109/L) Concomitant use with other products containing sodium phosphate (sodium phosphate only)

Precautions A strict sodium diet Renal failure None

Maximum dose One 130-mL bottle (dose administered: approximately 120 mL)

Time to onset of action 1 to 5 minutes 2 to 15 minutes

Mechanism of action Weakly absorbed ions that have an osmotic

effect and attract fluids into the bowel, which causes intestinal movements

Lubricates stool by delaying water reabsorption from the colon

Details regarding administration None


Local irritation Diarrhea (sodium phosphate only)


2.2.5 Microenemas

SORBITOL, SODIUM CITRATE AND SODIUM LAURYL SULFOACETATE

Contraindications Neutropenia (< 1 × 109/L) or thrombocytopenia (< 30 × 109/L) A history of allergic reaction or intolerance to sorbitol, sodium citrate or sodium lauryl sulfoacetate

Precautions None

Maximum dose Two 5-mL tubes (1 tube/30 minutes)

Time to onset of action 5 to 20 minutes

Mechanism of action Weakly absorbed ions that have an osmotic effect and attract fluids into the bowel, which causes intestinal movements

Details regarding administration None


Anal discomfort Local irritation

Most significant drug interactions Sodium polystyrene sulfonate: risk of intestinal necrosis

Note: At the time of writing of this protocol, microenemas were not covered by the Régie de l'assurance maladie du Québec's public prescription drug insurance plan and were not on the list of drugs that an institution can provide.


2.3 Choosing the pharmacological treatment

Prefer the oral approach for the initial pharmacological treatment (see Section 2.4 and the corresponding treatment algorithms in Appendix I).

Use the rectal approach (see Section 2.5 and Algorithm J in Appendix II) for initial pharmacological treatment in the following situations: The use of an osmotic laxative (PEG, lactulose or a magnesium-based laxative, such as milk of magnesia) in

combination with a stimulant laxative (sennosides, bisacodyl or cascara) when the protocol is applied Leakage of watery stools No bowel movements for the past 7 days Oral approach not an option

Proceed to the rectal approach at any time during treatment:

If the person being treated so requests If the person’s discomfort increases or requires faster relief If there is a contraindication to oral pharmacological treatment If the oral approach is ineffective

Check for any contraindication to using the rectal approach and proceed to the digital rectal examination (see Section 1.6).


2.4 Oral approach

To choose the appropriate oral treatment in the table below: Find, in the left-hand column, the medication in progress at the time of application of the protocol Follow steps 1 to 3 in the row corresponding to the medication in progress, or the algorithm in parentheses (X)

MEDICATION IN PROGRESS (CORRESPONDING

ALGORITHMS IN APPENDIX I)

INITIATING OR ADJUSTING ORAL PHARMACOLOGICAL TREATMENT ! SEE THE TABLE OF PROCEDURES FOR ADJUSTING ORAL LAXATIVE DOSAGES BELOW

STEP 1 STEP 2 STEP 3 NO LAXATIVE

Continue the medication in progress

and proceed to the rectal approach

(Section 2.5)

No laxative (A) Initiate PEG1 17 g/day and adjust it once, if necessary

Continue the PEG1, initiate a stimulant laxative2 and adjust it once, if necessary

No laxative, and use of PEG or lactulose not an option (E)

Initiate a stimulant laxative2 and adjust it once, if necessary Go to Step 3

STOOL SOFTENER

Sodium or calcium docusate (A)

Continue the medication in progress, initiate PEG1 17 g/day and adjust it once, if necessary

Continue the medication in progress, initiate a stimulant laxative2 and adjust it once, if necessary

BULK-FORMING LAXATIVE (FIBRE)

Psyllium (A) Continue the medication in progress, initiate PEG1 17 g/day and adjust it once, if necessary


OSMOTIC LAXATIVES

Magnesium-based laxative (e.g., milk of magnesia) (A)

Continue the medication in progress, initiate PEG1 17 g/day and adjust it once, if necessary


PEG < 34 g/day (A or B) Adjust the PEG up to 2 times, as needed Continue the medication in progress, initiate a stimulant laxative2 and adjust it once, if necessary

PEG ≥ 34 g/day (E) Continue the medication in progress, initiate a stimulant laxative2 and adjust it once, if necessary Go directly to Step 3

Lactulose < 30 mL/day (C or D) Adjust the lactulose up to 2 times, as needed Continue the medication in progress, initiate a

stimulant laxative2 and adjust it once, if necessary

Lactulose ≥ 30 mL/day (E) Continue the medication in progress, initiate a stimulant laxative2 and adjust it once, if necessary Go to Step 3

STIMULANT LAXATIVES

Sennosides < 34 mg/day (F or G) Adjust the sennosides up to 2 times, as needed Continue the medication in progress, initiate PEG1

and adjust it once, if necessary

Sennosides ≥ 34 mg/day (I) Continue the medication in progress, initiate PEG1 and adjust it once, if necessary Go to step 3

Bisacodyl 5 mg/day to < 10 mg/day (H) Adjust the bisacodyl once, if necessary Continue the medication in progress, initiate PEG1

and adjust it once, if necessary

Bisacodyl ≥ 10 mg/day (I) Continue the medication in progress, initiate PEG1 and adjust it once, if necessary Go to Step 3

COMBINATION OF OSMOTIC AND STIMULANT LAXATIVES

Use of an osmotic laxative in combination with a stimulant laxative (J)

Go to Step 3

1 For persons in whom the use of PEG is contraindicated, replace each 17-g dose of PEG with 15 mL of lactulose, if appropriate. 2 Opt for sennosides or bisacodyl and continue the medication chosen for the entire duration of the protocol.

DOSAGE ADJUSTMENT DETAILS FOR ORAL LAXATIVES Osmotic laxatives Dosage adjustment details Adjustment interval1

PEG 17 g PO QD → 17 g PO BID 2 days

Lactulose 15 mL PO QD → 15 mL PO BID Stimulant laxatives Dosage adjustment details Adjustment interval1

Sennosides 17.2 mg PO HS → 17.2 mg PO BID 12 hours

Bisacodyl 5 mg PO HS → 5 mg PO BID When the treatment is effective, stop the protocol and, if applicable4, return to the initial treatment (in progress at the time of application of

the protocol). 1 The adjustment interval indicated is the minimum amount of time required to achieve a bowel movement.


2.5 Rectal approach

Continue the medication in progress, if applicable, and proceed to the rectal approach, as detailed in the following table:

INITIATING AND ADJUSTING RECTAL PHARMACOLOGICAL TREATMENT (ALGORITHM (J) - SEE APPENDIX II)

! SEE THE TABLE OF DOSAGE ADJUSTMENT DETAILS FOR RECTAL LAXATIVES BELOW Contraindications to a digital rectal examination

Situations Instructions

In persons on chemotherapy or with a hematological disease other than anemia: Known or suspected neutropenia (<1×109/L) Thrombocytopenia (< 30×109/L).

Stop the protocol. Additional precautions or further investigation required.

Perform a digital rectal examination (see Section 1.6)

Findings Instructions

Painful or large external hemorrhoids Painful anal fissures or tears Rectal mass Blood

Stop the protocol. Additional precautions or further investigation required.

Stool in rectum

Step 1 Glycerin and bisacodyl suppositories. Repeat as needed.

OR Microenama (if available). Repeat once as needed.

Step 2

If suppositories were used in step 1: Sodium phosphate enema OR Microenema (if available). Repeat once as needed. If microenemas were used in step 1: Stop the protocol. Further investigation required.

Step 3 Stop the protocol. Further investigation required.

Rectum empty Step 1 Sodium phosphate enema OR

Microenama (if available). Repeat once as needed.


Rectal fecaloma

Step 1 Mineral oil enema Step 2 Rectal curettage


DOSAGE ADJUSTMENT DETAILS FOR RECTAL LAXATIVES Suppositories Dosage adjustment details Total number of

administrations

Glycerin/Bisacodyl One 2-g glycerin suppository and one 10-mg bisacodyl rectal suppository/12 hours 2

Enemas Dosage adjustment details Total number of administrations

Sodium phosphate One 130-mL bottle for rectal administration once 1

Mineral oil One 130-mL bottle for rectal administration once 1

Microenema One 5-mL tube for rectal administration/30 minutes 2

When the treatment is effective, stop the protocol and, if applicable, return to the initial treatment (in progress at the time of application of the protocol).


3. INFORMATION TO BE PROVIDED

Discuss the following with the person, his or her caregiver or the care team:

LIVING HABITS ENVIRONMENT Daily fluid intake Voluntary or prescribed diets, regimens or other "dietary

rules” Daily dietary fibre intake Usual defecation schedule (to be encouraged and adhered to

as much as possible) Physical activity and mobility

• Need for assistance • Availability of attendants, if needed

Access to a washroom when needed (including during fecal urgencies, which require quick access)

Enough time and privacy Special equipment needs

• Commode chair • Raised toilet seat • Bedpan • Other

Together with the interprofessional team, optimally manage the conditions conducive to fecal elimination, if necessary.

4. FOLLOW-UP FOR INDIVIDUALS IN RESIDENTIAL FACILITIES

Identify any adverse effects of the pharmacological treatment.

Assess the treatment’s effectiveness at least once a day. The frequency of assessment should be adjusted according to the treatment’s time to onset of action (see tables in Section 2.2).

5. SITUATIONS REQUIRING FURTHER INVESTIGATION OR REASSESSMENT

Failure of oral and rectal treatments

Persistent abdominal pain despite an unstrained bowel movement.

Suspected spinal cord compression (not documented): paresthesia, hypoesthesia, new lumbar pain or an increase in existing lumbar pain, or new bladder-sphincter dysfunction

REFERENCES This Québec’s national medical protocol is based on the latest scientific data and best practice recommendations, which were enhanced with contextual information and experiential knowledge provided by Québec clinicians and experts. For details on the process used to develop this protocol and to consult the references, see the report in support of this protocol (ajouter l’hyperlien).


APPENDIX I The algorithms in Appendix I show the pharmacological treatments for the situations presented in the table in Section 2.4.

ALGORITHM A: PERSON TAKING PSYLLIUM, DOCUSATE, A MAGNESIUM-BASED LAXATIVE OR LESS THAN 17 g OF PEG PER DAY

ALGORITHM B: PERSON TAKING 17 g TO LESS THAN 34 g OF PEG PER DAY


ALGORITHM C: PERSON TAKING LESS THAN 15 mL of LACTULOSE PER DAY

ALGORITHM D: PERSON TAKING 15 mL TO LESS THAN 30 mL OF LACTULOSE PER DAY


ALGORITHM E: PERSON TAKING 34 g OR MORE OF PEG PER DAY, 30 mL OR MORE OF LACTULOSE PER DAY OR WHO IS NOT TAKING ANY LAXATIVES AND IN WHOM THE USE OF PEG AND LACTULOSE IS CONTRAINDICATED

ALGORITHM F: PERSON TAKING LESS THAN 17 mg OF SENNOSIDES PER DAY


ALGORITHM G: PERSON TAKING 17 mg TO LESS THAN 34 mg OF SENNOSIDES PER DAY

ALGORITHM H: PERSON TAKING 5 mg TO LESS THAN 10 mg OF BISACODYL PER DAY


ALGORITHM I: PERSON TAKING 34 mg OR MORE OF SENNOSIDES PER DAY OR 10 mg OR MORE OF BISACODYL PER DAY


APPENDIX I I The algorithm below shows the appropriate procedure in the rectal approach presented in the table in Section 2.5.

ALGORITHM J: PERSON IN WHOM THE RECTAL APPROACH IS REQUIRED

pharmacological treatment for fecal elimination in a ... · pharmacological treatment for fecal...

Documents