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APPROVED 20220112 Viatris PEI supplement_V.3 DIGITAL index image

This supplement has been commissioned, funded, and reviewed by Viatris and developed in partnership with Guidelines for Pharmacy. See bottom of page for full disclaimer.

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Foreword: Mr Keith Roberts, Consultant Pancreatic Surgeon, University Hospitals Birmingham and Pancreatic Surgery Lead, Royal College of Surgeons of England

Pancreatic enzymes are essential for normal digestion, without which affected persons suffer symptoms and consequences of maldigestion. This is termed pancreatic exocrine insufficiency (PEI) which is pancreatic organ failure. Pancreatic enzyme replacement therapy (PERT) can correct PEI, and yet a national audit of pancreatic cancer (RICOCHET) demonstrated that although recommended by NICE,1 less than half of patients with pancreatic cancer were receiving PERT.2 PERT is a simple treatment that can improve quality of life, nutritional status, and survival amongst patients with PEI.3–5 Medical treatment of other organ failure, such as diuretics in heart failure, is routine, yet medical treatment of PEI is often untreated and there is thus a missed opportunity to improve the care and outcomes among affected patients.

References

  1. NICE. Pancreatic cancer in adults: diagnosis and management. NICE Guideline 85. NICE, 2018. Available at: www.nice.org.uk/guidance/ng85 
  2. The RICOCHET Study Group on behalf of the West Midlands Research Collaborative. Pancreatology 2021. Doi: 10.1016/j.pan.2021.05.299.
  3. Roberts K et al. HPB 2017; 19: 859–867.
  4. Roberts K et al. Pancreatology 2019; 19: 114–121.
  5. Dominguez-Muñoz J. Current Opinion, 2018; 34.

Article: Dr Leyla Hannbeck, Chief Executive, Association of Independent Multiple Pharmacies

What is PEI?

The pancreas is comprised of both exocrine glands (secreting enzymes into the intestine for the digestion of food) and endocrine glands (secreting hormones directly into the blood stream that regulate metabolism).1,2 PEI is a disorder characterised by a deficiency in the secretion of pancreatic enzymes.3 This results in impaired digestion, with abnormal food breakdown leading to symptoms such as pain, malabsorption, and even malnutrition.3,4

Causes of PEI and pancreatic disease 

PEI does not arise on its own.5 It is commonly caused by damage or a reduction in functioning pancreatic tissue, such as in acute or chronic pancreatitis and pancreatic cancer.5,6 Other causes include cystic fibrosis, diabetes, or inflammation from digestive conditions such as coeliac disease.5 PEI can also arise as a consequence of pancreatic surgery.5

Prevalence

The prevalence of PEI in the general population is unknown due to a lack of reliable screening tools.6,7 However, it is understood that the presence of PEI increases with age, with prevalence being up to 20% higher in older individuals.6 The prevalence of PEI is more commonly reported in individuals with predisposing conditions (see Table 1).7

Table 1

PEI and diabetes

PEI may be described as a complicating factor of diabetes. The detection and treatment of PEI is therefore very important as it can lead to potentially improved glycaemic control for diabetic patients.8,9 It is estimated that up to 50% of individuals with type 1 diabetes and around 30-50% with type 2 diabetes have PEI.3 This combination of diabetes and PEI is likely due to damage of both the endocrine and exocrine glands of the pancreas.3

Symptoms

Gastrointestinal (GI) symptoms may be present in pharmacy settings. 

Symptoms include:

  • abdominal pain 
  • bloating 
  • flatulence 
  • diarrhoea 
  • steatorrhea 

Other symptoms include weight loss, failure to gain weight, weakness and fatigue, and long-term conditions as a result of malabsorption, such as osteoporosis.7,10 Endocrine symptoms are also common, including hypoglycaemia, altered glycaemic control, and reduced insulin requirements in patients with diabetes.3,10

Treatment and management of PEI

The decision to treat in the primary care setting will follow assessment in primary care and the exclusion of any underlying causes. Symptoms including GI bleeding or raised calprotectin levels may require specialist referral to exclude conditions such as inflammatory bowel disease.3  

Assuming management is appropriate with no suspicion of secondary causes, it is at this stage that community pharmacists can play a hugely beneficial role in supporting patients and improving their quality of life. 

Pancreatic Enzyme Replacement Therapy (PERT) 

PERT capsules contain replacement enzymes that our pancreas would normally produce. They can help digest food and may aid in managing the symptoms associated with PEI.11

Dosing

The initial dose of PERT is individualised and will be based upon the patient’s weight and clinical background. A minimum lipase dose of 40,000–50,000 PhU is recommended with main meals and 25,000 PhU for snacks.4 Although the dosing may sound like a lot, a healthy pancreas can produce around 720,000 units or more for just a small meal.12 A common mistake made by patients is not taking a high enough dose of PERT. 

Treatment can be titrated every 4–6 weeks, depending upon the patient’s clinical response.3 When titrating the dose, the patient’s weight must be considered, along with PEI severity, and how much the patient is eating.12 The maximum dose is 10,000 units of lipase/kg/day. Stricture of the ileocaecum and large bowel (fibrosing colonopathy) has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day. To try and avoid any side effects or adverse events, it is advised to start off at the lowest recommended dose and gradually increasing.12

How to take

The capsules should be taken with every meal or snack.3 Hot drinks should be avoided. If multiple medications are being taken at mealtimes, it is recommended to split them throughout the meal.

What is the efficacy of the treatment?

Treatment with PERT has been shown to be effective at improving PEI related symptoms in patients with chronic pancreatitis, cystic fibrosis, and those having undergone pancreatic surgery.11–14 PERT treatment improved fat absorption, reduced GI symptoms, and improved overall nutritional status and quality of life.13–16  

Monitoring and medication review

Through Structured Medication Reviews (SMRs) it is becoming increasingly clear that community pharmacists may play a significant role in supporting patients with pancreatic disease. Through SMRs, pharmacists can be of great assistance to patients requiring advice on how and when to take their medication, as well as playing a vital role in observing early detection of adverse reactions to treatment (see Box 1). Patients should be regularly monitored for their clinical response and symptoms. Improvements such as alleviated symptoms, weight gain, and improved nutritional status should be expected if a patient is responding to PERT.3

Box 1

Diet and nutritional support

Malnutrition is a concern in PEI. Nutrient malabsorption can often lead to deficiency, especially the fat-soluble vitamins A, D, E, and K.5 Vitamin D supplements are readily available through community pharmacies if appropriate and can form part of the care plan.

Fat-soluble vitamins should come from healthy sources such as nuts, seeds, olives, or oily fish rather than processed foods or red meat. A healthy diet should be supported, although fat control represents a matter of some controversy so referral to a dietician for expert advice may be required.3

Can PERT impact glycaemic control? 

PERT may assist in improving glycaemic control in patients with PEI and diabetes, although further research is needed to make robust claims. Pharmacists should be aware that blood glucose levels are checked frequently during treatment as doses of anti-diabetic therapies such as sufonylureas and insulin may require adjusting.3  

References

  1. Cade J, Hanison J. Anaesthesia Intensive Care Med 2017; 18: 527–31
  2. Carnie L et al.  BMJ Open 2021; 11: e042067.
  3. Hambling C et al. Gastrointestinal disorders in diabetes—could it be pancreatic exocrine insufficiency? Guidelines 2018. Available at: www.guidelines.co.uk/diabetes/pancreatic-exocrine-insufficiency-guideline/454173.article (accessed December 2021)
  4. Löhr J et al. UEG Journal 2017; 5(2): 153–199.
  5. GI Society. Pancreatic Exocrine Insufficiency. GI Society 2021. Available at: https://badgut.org/information-centre/a-z-digestive-topics/pancreatic-exocrine-insufficiency/ (accessed December 2021)
  6. Shandro B at al. World J Gastrointest Pharmacol Ther 2018; 9(5): 39–46.
  7. Othman M et al. Int J Clin Pract 2018; 72: e13066.
  8. Ebert R, Creutzfeldt W. Diabetologia 1980; 19: 198–204.
  9. Mohan V et al. Int J Pancreatol 1998; 24(1): 19–22 
  10. University Hospital of Leicester NHS Trust. Guidelines for the Use of Pancreatic Enzyme Replacement Therapy (PERT). NHS 2019. Available at: https://secure.library.leicestershospitals.nhs.uk/PAGL/Shared%20Documents/Pancreatic%20Enzyme%20Replacement%20Therapy%20(PERT)%20UHL%20Guideline.pdf (accessed December 2021)
  11. Pancreatic Cancer UK. Pancreatic enzyme replacement therapy (PERT). Available at: www.pancreaticcancer.org.uk/information/managing-symptoms-and-side-effects/diet-and-pancreatic-cancer/pancreatic-enzyme-replacement-therapy-pert/ (accessed December 2021)
  12. NHS Brighton and Sussex University Hospital. Pancreatic Exocrine Insufficiency (PEI) A patient information leaflet. NHS 2019. Available at: www.bsuh.nhs.uk/documents/pancreatic-exocrine-insufficiency-pei/pancreatic-exocrine-insufficiency-pei-2/ (accessed December 2021)
  13. de la Iglesia-García D et al. Gut 2017; 66: 1474–1486.
  14. Gan C et al. Oncotarget 2017; 8(55): 94920–94931
  15. Ramesh H et al. Pancreatology 2013; 13(2): 133–139
  16. Thorat V et al. Aliment Pharmacol Ther 2012; 36: 426–436

Please continue to report suspected adverse drug reactions with any medicine or vaccine to the MHRA through the Yellow Card Scheme. It is easiest and quickest to report adverse drug reactions online via the Yellow Card website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Alternatively, you can report via some clinical IT systems (EMIS/SystemOne/Vision/MiDatabank) or by calling the Commission on Human Medicines (CHM) free phone line: 0800-731-6789. Adverse reactions/events should also be reported to MAH at e-mail address: pv.uk@viatris.com

This supplement has been commissioned, funded, and reviewed by Viatris and developed in partnership with Guidelines for Pharmacy. Viatris suggested the topic and author for the foreword, and carried out full medical approval on all materials to ensure compliance with regulations. The sponsorship fee included an honorarium for the author of the article. Payment of the honorarium to the author of the foreword was made by Viatris. The views and opinions of the authors are not necessarily those of Viatris, or of Guidelines for Pharmacy, its publisher, advisers, or advertisers. No part of this publication may be reproduced in any form without the permission of the publisher.

CRE-2021-0272

Date of preparation: January 2022