Medicines Q&As Q&A What should be considered when prescribing medicines for patients who have undergone bariatric surgery?

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1 Q&A What should be considered when prescribing medicines for patients who have undergone bariatric surgery? Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals Before using this Q&A, read the disclaimer at Date prepared: 29 th May 2014 Background Bariatric surgery is recommended by NICE as a treatment option for patients who Have a BMI of 40kg/m2 or more, or 35-40kg/m 2 along with other significant disease which could improve due to weight loss (for example, type 2 diabetes or high blood pressure) Have tried and failed to achieve or maintain adequate weight loss for at least 6 months using all appropriate non-surgical measures. Have been receiving or who will receive intensive management in a specialist obesity service Are fit for anaesthesia and surgery Are committed to long term follow up. Have a BMI of 50kg/m 2, in whom bariatric surgery is considered a first line option. 1 In 2010, 26% of men and 26% of women were obese in the general population in England. 2 Given that obesity is rising, it is likely that the number of patients eligible for bariatric surgery will also increase. Indeed, figures from Hospital Episode Statistics suggest that the number of NHScommissioned bariatric surgeries have been increasing year on year since at least 2003/ As many of those patients undergoing bariatric surgery may have co-morbidities, it is increasingly likely that health professionals will encounter enquiries regarding medicines in these patients. There are many aspects to consider when it comes to medicines and bariatric surgery, including the type of surgery, drug considerations, and patient choice. Some areas of consideration are summarised below. Answer Type of Surgery 4 Restrictive In restrictive surgeries, the amount of space available for food is reduced by the creation of a small pouch at the top of the stomach. A small hole of about 1cm is created at the bottom of the pouch, which slows gastric emptying to create a prolonged feeling of fullness. Techniques include vertical banded gastroplasty and adjustable gastric banding. Combination restrictive-malabsorption procedures These types of procedures involve both reducing the amount of space available for food, as well as reducing the length of the bowel, prompting malabsorption. These types of surgical procedures are associated with dramatically more weight loss than restrictive surgeries, and include techniques such as biliopancreatic diversion and Roux-en-Y gastric bypass. Drug considerations 4-7 Stomach size The stomach is the primary area for disintegration of standard release tablets or capsules. This process involves a combination of mechanical forces, gastric acid, and saliva. Restriction in the size of the stomach pouch could therefore lead to a less complete disintegration. ph changes The ph within the gastric pouch created by bariatric surgery is higher than that found in a normal stomach. This may reduce the absorption of medicines which are soluble in acidic environments. Available through NICE Evidence Search at 1

2 Those that are soluble in alkaline environments are mainly absorbed in the small intestine. In restrictive malabsorption procedures, the majority of the small intestine may be bypassed, reducing the amount of drugs which are absorbed in this area. Surface Area Restrictive-malabsorption procedures significantly reduce the amount of surface area in the GI tract available for drug administration. Drugs which usually remain in the intestine for longer whilst being absorbed are likely to have their bioavailability reduced. Drugs which are primarily absorbed in the duodenum and jejunum may need to be given via a different route where possible, or doses may have to be adjusted accordingly. Supplements Patients who have undergone restrictive procedures are less likely to suffer from nutrient deficiencies than combination procedures. Patients may be prone to deficiencies of the fat soluble vitamins (A,D,E & K), calcium, iron, vitamin B12, and folate. All patients who have undergone a combination surgery should therefore be given a daily multivitamin and calcium supplement. Patients who develop anaemia should be treated symptomatically. Calcium citrate should be used in preference to calcium carbonate, as it is not dependent on the presence of acid for absorption. Iron salts should be combined with vitamin C, to acidify the stomach and increase absorption of the iron. Vitamin B12 may be given in parenteral form, or orally at a dose of 1000 micrograms per day. Drug Formulation Extended release formulations should be avoided. Enteric or film coated tablets may also prove problematic, as any delay in drug release may reduce absorption. Immediate release formulations should be used in preference. Drugs administered in an aqueous solution are more rapidly absorbed than those in sold form or in oily solutions. It is advised by some centres that patients should avoid sodas and carbonated beverages after the surgery, as they commonly cause discomfort. It may therefore be best to avoid effervescent drug formulations, or at least to ensure that the tablet is fully dissolved and allowed to settle prior to drinking. As yet there are no published guidelines on management of medicines in patients who have undergone bariatric surgery. For the most part, patients should be monitored for any decreased efficacy or adverse effects, and changes made accordingly, rather than a blanket change in medicines after surgery. Where decreases in absorption occur, changing to a liquid preparation or considering another route of administration may resolve the problem. Large tablets may pose a problem, as the openings produced by certain types of bariatric surgery may be only 1-1.5cm wide. Consider finding smaller formulations, or crushing or cutting tablets where appropriate, although this will render their use off-label. Drug Administration Route Alternative routes of drug delivery may be considered, including subcutaneous, intravenous, rectal, vaginal, intranasal, and transdermal. It is important to bear in mind that obesity may impact on drug absorption via the subcutaneous and transdermal routes. Adverse Drug Reactions (ADRs) Gastro-intestinal ADRs may be more likely in patients who have undergone bariatric surgery, due to the smaller size of the stomach. Non-steroidal anti-inflammatory drugs (NSAIDs) should be avoided where possible as patients are more at risk of ulceration, which could be fatal. Any ADRs to black triangle drugs, or serious ADRS to established drugs, should be reported via the MHRA s Yellow Card Scheme. For more information on the scheme, and to report online, please visit Available through NICE Evidence Search at 2

3 Guidance on the use of specific drugs 4,6,8-13 Medicine Advice Acid suppression The use of acid suppressive agents may lead to a delay in achievement of peak (proton pump weight loss following surgery. It is not currently known why this occurs. The inhibitors/ H2 extent of weight loss in the long term does not appear to be affected. blockers) Amiodarone Bioavailability may be reduced by shortened intestinal transit time. Monitor and adjust dose as required. Aspirin 75mg No data on safety- use should be based on an individual risk vs benefit decision daily dose Bisphosphonates Contraceptives Increased risk of GI adverse effects- avoid where possible. However, patients who have undergone bariatric surgery may also be at an increased risk of osteoporosis. Consider other options such as calcitonin salmon nasal spray, teriparatide, raloxifene etc where clinically suitable, or an IV bisphosphonate. Non hormonal barrier contraception should be recommended as reduced absorption cannot be easily monitored. Additionally, a reduction in weight following surgery may lead to increased fertility. If a hormonal method is required, a levonorgestrel-releasing intrauterine device may be a preferred option Digoxin Enalapril Fluoroquinolones Ketoconazole Lamotrigine Levothyroxine Metformin Metoprolol Niacin Non-Steroidal Anti-inflammatory Drugs Olanzapine Quetiapine Ramipril Oestrogen-containing contraceptives should be avoided before and after surgery to reduce the risk of venous thromboembolism. Digoxin absorption is dependent on both GI transit time and P-glycoprotein in the small intestine. The extent of absorption may therefore be reduced. Monitor and adjust dose as required. Prodrug: Converted to active form in the stomach. Efficacy may be reduced. Consider an alternative ACE Inhibitor if problematic. One case report describes the death of a woman due to complete heart block secondary to enalapril toxicity 11 days after undergoing bariatric surgery. The authors suggest that bypassing pre-systemic cytochrome P450 enzymes in the proximal short bowel led to a larger amount of free drug available. Absorption is via transported in the small intestine. Absorption may be reduced. Requires an acidic environment for absorption. Consider an alternative antifungal. Likely to be absorbed in the stomach and proximal small intestine. Monitor for decreased efficacy. Patients who have undergone Roux-en-Y surgery may require a reduction in levothyroxine dose after surgery. Patients should have regular thyroid function tests for 6 months post surgery, with dose adjustment as required. Absorbed slowly in the duodenum. Monitor blood glucose and adjust dose accordingly. Dose may need to be reduced as weight loss occurs. Likely to be absorbed in the stomach and duodenum. Monitor blood pressure and adjust dose accordingly. Dose may need to be reduced as weight loss occurs. Absorbed in the duodenum. Administer with a low fat snack to maximise absorption. Increased risk of GI adverse effects- avoid where possible. Absorbed in the stomach, even if administered in orodispersible form. Monitor for decreased efficacy. Adjust dose accordingly or consider switching to another antipsychotic. Likely to be absorbed in the stomach and duodenum. Monitor for decreased efficacy. Adjust dose accordingly or consider switching to another antipsychotic. Absorption decreased in patients with steatorrhoea and malabsorption: likely to also be decreased in patients who have undergone bariatric surgery. Consider using another ACE inhibitor if a lack of efficacy is problematic. Dose may need to be reduced as weight loss occurs. Available through NICE Evidence Search at 3

4 Simvastatin Valproic acid/ Sodium valproate Warfarin Zolpidem Likely converted into active form in the stomach. Efficacy may be reduced. Consider an alternative statin. Monitor serum lipids. The extent of absorption may be significantly reduced by malabsorptive procedures. It is currently unknown if sodium valproate is similarly affected. Patients should be closely monitored and doses adjusted accordingly. The effects of bariatric surgery may be unpredictable: reduced surface area may limit absorption, however a more alkaline stomach may increase levels of unionised drug. Vitamin K deficiency may lead to an increased risk of bleeding. Monitor closely and adjust dose as required. Absorption may be delayed. Take on an empty stomach. Summary Bariatric surgery may impact on the absorption and side effect profile of some medicines. Although this is a growing area, primary information in the field is limited. As a general rule, a blanket switch to liquid formulations is probably not required. However, patients should be carefully monitored for lack of efficacy and adverse effects, and dose, route, or formulation changes made as appropriate. NSAIDs, modified release preparations, and some film or enteric coated products should ideally be avoided. Doses of some medicines may need to be adjusted as the patient s weight changes. Limitations There is very limited information on the effects of bariatric surgery in patients. The list of specific drug recommendations is not exhaustive and many are based on theory or speculation. Much of the published literature takes the form of conference abstracts. Quality Assurance Prepared by Hayley Johnson, Regional Drug & Therapeutics Centre Date Prepared 29 th May 2014 Checked by Sarah Smith, Regional Drug & Therapeutics Centre Date of check 25 th June 2014 Search strategy Embase (incorporating Medline) *Bariatric Surgery AND Drug Therapy/ DrugDex Electronic Medicines Compendium ebnf Medicines Complete Past Enquiries References 1. National Institute for Health and Clinical Excellence. Clinical Guideline 43: Obesity Clinical Knowledge Summaries. Obesity: Background Information; Available through NICE Evidence Search at 4

5 3. National Obesity Observatory (NOO). Bariatric surgery for obesity; Miller AD & Smith KM. Medication and Nutrient administration considerations after bariatric surgery. American Journal of Health System Pharmacy 2006;36: Rogula T et al. Medications after bariatric surgery 6. Anderson H. Bariatric surgery in women: medication considerations. U.S. Pharmacist 2012;37:HS12-HS Mayo Clinic Staff. Gastric bypass diet: What to eat after the surgery ; Smith A et al. Pharmacokinetic considerations in Roux-en-Y gastric bypass patients. American Journal of Health System Pharmacy 2011; Viberga I. Hormonal contraception after bariatric surgery. European Journal of Contraception and Reproductive Health Care 2014;19: Tessnow A et al. Effect of bariatric surgery on levothyroxine (LT4) replacement in hypothyroidism. Thyroid 2013;23: Ward E et al. Acid suppression medications delay peak weight loss after bariatric surgery. Gastroenterology 2013;144: Wolter S et al. Valproic acid dosage in the post bariatric surgery patient. Obesity Surgery 2012;22: Noonan K et al. Decreased pre-systemic metabolism, increased bioavailability and lethal medication toxicity after roux-en-y gastric bypass: a cautionary tale. Surgery for Obersity and Related Diseases 2011;7: Available through NICE Evidence Search at 5

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