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EPI is largely a clinical diagnosis1-4*

Patients with EPI may present with signs and symptoms similar to other GI disorders. A careful workup is necessary when suspecting EPI and should include patient history, symptom assessment, and asking about underlying conditions. It's also important to get specific details about GI issues, including symptom onset, frequency, and severity, and patient diet.

*Tests can help confirm a diagnosis.

Evaluate patients for signs and symptoms of EPI

It is key to take a history in your patients suspected of having EPI since not all patients will present with typical signs and symptoms of EPI. Some patients may limit fat intake to minimize symptoms.3,4

Patients with EPI may present with one or more of the following signs and symptoms4-6:

  • Diarrhea
  • Flatulence
  • Bloating
  • Abdominal pain
  • Unexplained weight loss
  • Steatorrhea

Consider EPI in patients with underlying conditions

Know the underlying conditions and surgical procedures that can lead to EPI.

EPI may be present in patients with the following underlying conditions or procedures7-10:

  • Cystic fibrosis (CF)
  • Chronic pancreatitis (CP)
  • Pancreatectomy (PY)
  • Pancreatic cancer

Other underlying conditions and procedures in which EPI has been reported include11-15:

  • Acute pancreatitis (AP)
  • Crohn’s disease
  • Celiac disease
  • Type 1 diabetes
  • Gastric resection/bypass

Ask your patients specific questions to help them open up about their symptoms

Patients may find it difficult to discuss GI issues with their doctor and may be embarrassed to disclose their symptoms. Because EPI is largely a clinical diagnosis, asking specific questions may help you reach a diagnosis sooner.1,16*

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  • How urgently do you need to have bowel movements? How frequently?
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Stool Details

  • How would you describe your stool? Is it loose? Does it float? Is it greasy? Is the color pale?
  • Does it smell very foul? Is it difficult to flush?
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Other Considerations

  • Have you had any unexplained weight loss?
  • Do you feel like you are managing your symptoms by limiting what you eat?

Code directly for EPI using
ICD-10 code K86.8117

Image of EPI Conversation Guide

An open conversation can reveal the facts

Use the EPI Conversation Guide to help you reach a diagnosis sooner.*

*Tests can help confirm a diagnosis.

Tests that can help confirm a diagnosis of EPI

Non-invasive measures:

  • Fecal elastase concentration (FE-1)2
  • Qualitative fecal fat18
  • Quantitative fecal fat18

Invasive measures:

  • Secretin-pancreozymin stimulation (performed at specialized centers)1

EPI may be overlooked as a diagnosis2

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One in four

patients had their diagnosis changed to EPI after initially being diagnosed with another GI condition16†

Why the challenge?

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  • Patients may present with signs and symptoms similar to those of other GI conditions2
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  • EPI is due to another chronic condition the patient is living with2
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  • Patients may find it difficult to discuss GI issues with their doctor and may be embarrassed to disclose their symptoms16†

Some symptoms suggestive of EPI may be present up to 3 years before PERT initiation19‡

Average time from symptoms suggestive of EPI onset to the initiation of pancreatic enzyme replacement therapy (PERT) Rx claim19‡

Average time from symptom onset to initiation of pancreatic enzyme replacement therapy in a chart.  Patients with diarrhea take 33.8 months on average before being prescribed PERT.  Patients with abdominal pain generally take 31.9 months, those experiencing weight loss take 14.8 on average and those with pancreatic steatorrhea go on therapy quickly.

Source: Medical and pharmacy claims collected from the SHS database from 2011-H2 to 2017-H2.

Patients face many challenges along their diagnostic journey

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Extensive testing

On average, patients receive
4 GI diagnostic tests and

Source: SHS data 2016-2017.

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Low EPI knowledge

A lack of awareness and
education about EPI can make it difficult for patients to manage their condition20

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PERT dosing

36% of adult patients start
on a PERT dose meant for a
patient <100 lb

Source: SHS data 2018-2020.

EPI Uncovered is based on an online survey conducted by Harris Poll from May 17 through June 20, 2016. It included 1,001 U.S. adults ages 18 and older who experienced at least two gastrointestinal issues, three or more times in the past three months (“patients”), as well as 250 primary care physicians (“PCPs”) and 250 gastroenterologists (“GIs”) in the U.S. who are ages 18 years or older and licensed. Figures for patients were weighted where necessary based on age, education, gender, race/ethnicity, region, income, size of household, marital status, and likelihood to be online to bring them into line with their actual proportions in the population. Figures for PCPs and GIs were weighted on years in practice, gender and region, where necessary, to bring them into line with their actual proportions in the population.

Retrospective study to quantify the time between the presence of symptoms suggestive of EPI prior to initiating a PERT. To be eligible for the study, a patient must have a history of at least 1 medical claim during the 5-year study period of 2011-H2 to 2017-H2 AND at least one of the following criteria within study period: 1) 2 additional PERT claims after PERT initiation (3 total PERT claims) 2) a diagnosis of EPI, 3) the occurrence of a pancreatectomy procedure or 4) a diagnosis of either pancreatic cancer, cystic fibrosis or chronic pancreatitis. Time to PERT is based on the first occurrence of the symptom code to PERT Rx claim.


Source: SHS data (2018-2020), 2020. n=sample of 101,612 non-CF PERT patients with at least 1 PERT script present in given month observed between April 2018 and April 2020; only non-CF patients aged 18+ included; prescribed lipase units per day based on each patient’s average script size over the 2-year study period.

Learn about EPI management

References: 1. Fieker A, Philpott J, Armand M. Enzyme replacement therapy for pancreatic insufficiency: present and future. Clin Exp Gastroenterol. 2011;4:55-73. 2. Leeds JS, Oppong K, Sanders DS. The role of fecal elastase-1 in detecting exocrine pancreatic disease. Nat Rev Gastroenterol Hepatol. 2011;8(7):405-415. 3. Durie P, Baillargeon JD, Bouchard S, Donnellan F, Zepeda-Gomez S, Teshima C. Diagnosis and management of pancreatic exocrine insufficiency (PEI) in primary care: consensus guidance of a Canadian expert panel. Curr Med Res Opin. 2018;34(1):25-33. 4. Domínguez-Muñoz JE. Pancreatic enzyme therapy for pancreatic exocrine insufficiency. Curr Gastroenterol Rep. 2007;9(2):116-122. 5. Ferrone M, Raimondo M, Scolapio JS. Pancreatic enzyme pharmacotherapy. Pharmacotherapy. 2007;27(6):910-920. 6. Alkaade S, Vareedayah AA. A primer on exocrine pancreatic insufficiency, fat malabsorption, and fatty acid abnormalities. Am J Manag Care. 2017;23(suppl 12):203S-209S. 7. Keller J, Layer P. Human pancreatic exocrine response to nutrients in health and disease. Gut. 2005;54(suppl 6):1-28.
8. Kempeneers MA, Ali UA, Issa Y, et al. Natural course and treatment of pancreatic exocrine insufficiency in nationwide cohort on chronic pancreatitis. Pancreas. 2020;49:242-248. 9. Matsumoto J, Traverso LW. Exocrine function following the Whipple operation as assessed by stool elastase. J Gastrointestinal Surg. 2006;10(9):1225-1229. 10. Yuasa Y, Murakami Y, Nakamura H, et al. Histological loss of pancreatic exocrine cells correlates with pancreatic exocrine function after pancreatic surgery. Pancreas. 2012;41(6):928-933. 11. Hollemans RA, Hallensleben NDL, Mager DL, et al. Pancreatic exocrine insufficiency following acute pancreatitis: systematic review and study level meta-analysis. Pancreatology. 2018;1-10. 12. Huang W, de la Iglesia-Garcia D, I Baston-Rey, et al. Exocrine pancreatic insufficiency following acute pancreatitis: systematic review and meta-analysis. Dig Dis Sci. 2019;64(7):1985-2005. 13. Singh VK, Haupt ME, Geller DE, Hall JA, Quintana Diez PM. Less common etiologies of exocrine pancreatic insufficiency. World J Gastroenterol. 2017;23(39):7059-7076. 14. Chaudhary A, Dominguez-Munoz JE, Payer P, Lerch MM. Pancreatic exocrine insufficiency as a complication of gastrointestinal surgery and the impact of pancreatic enzyme replacement therapy. Dig Dis. 2020;38(1):53-68. 15. Pezzilli R, Andriulli A, Bassi C, et al. Exocrine Pancreatic Insufficiency Collaborative Group. Exocrine pancreatic insufficiency in adults: a shared position statement of the Italian Association for the Study of the Pancreas. World J Gastroenterol. 2013;19(44):7930-7944. 16. EPI Uncovered. American Gastroenterological Association website. Published October 24, 2016. Accessed December 4, 2018. 17. Centers for Disease Control and Prevention. ICD-10 Coordination and Maintenance Committee Meeting, March 18-19, 2015. 18. Hammer HF. Pancreatic exocrine insufficiency: diagnostic evaluation and replacement therapy with pancreatic enzymes. Dig Dis. 2010;28(2):339-343. 19. Data on file. AbbVie Inc. Source: SHS data (2015-2017), 2017. 20. Data on file. Ruder Finn GI Symptoms Study (by Harris Interactive); 2013. 21. Data on file. AbbVie Inc. Source: SHS data (2018-2020), 2020.