CHRONIC DIARRHEA: WORKING WITH OLDER PATIENTS TO MEET PATIENT SPECIFIC NEEDS

Presented By: Cory Phillips

March 24, 2011

CASE SUMMARY

JS is an 82 yo WF whose husband presented to the compounding pharmacy looking for paregoric. JS had chronic, severe diarrhea and possibly IBS. The patient had used paregoric in the past, but was unable to find it because the manufacturers stopped supplying the medication. The husband stated that “She had tried everything!” She was set on getting paregoric because she had used this medication for years and it had worked well for her. In her opinion this was the only medication that helped.

PATIENT HISTORY

82 yo WF Average height Average weight NKDA KNA No nicotine, alcohol, or recreational drug use Overall good health for an 82 yo woman ROS: chronic diarrhea

PRIMARY PROBLEM

The patient had chronic diarrhea with possible IBS.

The manufacturer of paregoric no longer supplies the drug.

The patient’s husband presented to the compounding pharmacy in hopes of being able to have paregoric compounded.

BACKGROUND ON DISEASE STATE (IBS)

Chronic, episodic GI disorder Affects gut motility Characterized by

Abdominal pain Discomfort Defecation disturbances Bloating

~ 10-15% of adult population has symptoms consistent with IBS

Prevalence of IBS 2x higher in females than males

Symptoms present by age 35

BACKGROUND ON DISEASE STATE (IBS)

Causes unknown Alteration in

Intestinal motility Visceral

hypersensitivity Brain response to

visceral stimuli May follow bacterial

gastroenteritis in 7-30% of cases

PA

REG

OR

IC

•Paregoric, or camphorated opium tincture, is a schedule C-III controlled substance

•When compounded it becomes a C-II substance

HISTORY OF PAREGORIC Camphorated opium

tincture or tincture of paregoric

Oral alcoholic solution containing morphine

Opium obtained from Papaver somniferum Linne or album De Candolle

Contains several alkaloids not less than 9.5% anhydrous morphine

Small amounts of codeine, noscapine, papaverine, and thebaine

Paregoric 25x less potent than opium tincture

OLDER GENERATION USES One of the first agents

used for teething in babies

Use declined due to known and potential toxic effects of ingredients

Used to treat diarrhea or severe withdrawal in neonates born to women addicted to opiates

More effective and/or safer agents for the treatment of diarrhea have largely replaced paregoric

MECHANISM OF ACTION

Activity due to opiate agonist morphine Increase smooth muscle tone

Antral portion of stomach Small intestine (especially the duodenum) Large intestine Sphincters

Decrease secretions Stomach Pancreas Biliary tract

Results in constipation and delayed digestion

CONTRAINDICATIONS/PRECAUTIONS Sedation

Use caution when driving or operating machinery CI

Patients with diarrhea secondary to poisoning Infectious diarrhea

Use cautiously in pts with GI disease Obstruction Ulcerative colitis Pre-existing constipation

Biliary spasms Avoid in pts with severe pulmonary disease

Acute or chronic asthma COPD

SIDE EFFECTS (CHOLINERGIC)

Bradycardia Peripheral vasodilation

Problematic in pts with cardiac disease Urinary retention Oliguria

Pregnancy Category C

CNS depressants Mixed opiate

agonists/antagonists Opiate antagonists

Lightheadedness Dizziness Sedation N/V Constipation Ileus GI obstruction Dry mouth Blurred vision Miosis Respiratory depression/arrest Apnea Circulatory depression Coma Shock Cardiac arrest Physical dependence

following prolonged use

Drug Interactions Adverse Reactions

COMPOUNDING OF PAREGORIC

Ingredient Amount

Morphine Sulfate USP CII (Pentahydrate)

0.05317 gm

Glycerin USP (Natural) 4.0 mL

Flavor, Anise Oil FCC 0.1 mL

Ethyl Alcohol, 190 Proof USP 47 mL

Purified Water, USP q.s. 100 mL

OTHER OPTIONS FOR DIARRHEA

Individualized treatment

Lifestyle changes Dietary changes Cognitive-behavioral

therapies Complementary

therapies in ajunct to drug therapy

Atropine; Difenoxin Atropine;

Diphenoxylate Attapulgite Bismuth Subsalicylate Kaolin; Pectin Loperamide Loperamide;

Simethicone Opium Tincture

Nonpharmacological Pharmacological

SUMMARY OF PRIMARY LITERATURE

No recent literature due to paregoric being an older drug

Some early 2000s studies on paregoric in neonatal withdrawal syndrome

2008 Brazilian phase I study investigated the safety of Elixir paregoric® Investigated whether administration causes any

noticable toxic effects in healthy volunteers No serious adverse reactions were reported

following administration Mild adverse effects resolved themselves

RECOMMENDATIONS/SOLUTION

The solution was to compound the drug Compounded as a CII

prescription

The dosage given was 5—10 ml PO 1—4 times per day

Recommend the patient see her physician if problem persists Might have IBS which is

treated differently than diarrhea alone

CONCLUSION/FOLLOW-UP

The patient is satisfied with the paregoric which is working well for her.

APPLICATION

Pearls of Wisdom Pharmacists need to be able to work with a variety

of patients, including older patients, to meet patient specific needs.

It is important for pharmacists to have knowledge of older generation drugs and what they are indicated for.

Critical pharmacy problems can be solved when the pharmacist has a strong knowledge of the patient population and drugs associated with this population.

Pharmacy should not be limited to what drug manufacturers have to offer. We have access to a plethora of chemicals that can be compounded to fit patient specific needs.

REFERENCES

Patient and Preceptor (Dr. Randall Allen) Gold Standard, Inc. Clinical Pharmacology

[database online]. Tampa, FL: Gold Standard, Inc.; 2011. Available at http://clinicalpharmacology-ip.com/Defalt.aspx. Accessed March 19, 2011.

Irritable Bowel Syndrome. DISEASEDEX. [database online]. Available at http://www.thomsonhc.com. New York: Thomson Reuters; 2011. Accessed March 19, 2011.

MEA de Moraes, Bezerra MM, Bezerra FAF, et al. Safety evaluation of Elixir paregorico® in healthy volunteers: a phase I study. Human & Experimental Toxicity. 2008; 27(10): 751-756.