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OBES SURG (2010) 20:1654–1659DOI 10.1007/s11695-009-0050-1 Nutritional and Pharmacologic Challengesin the Bariatric Surgery Patient Mitsi H. Lizer & Heather Papageorgeon &Troy M. Glembot Received: 9 July 2009 / Accepted: 30 November 2009 / Published online: 27 January 2010 # Springer Science+Business Media, LLC 2010 Abstract The purpose of this study was to describe immediate-release formulations, 25.0% enteric-coated for- vitamin and nutrient supplement practices and assess mulations, and 40.3% both non-immediate-release and medication dosage formulations utilized in patients hospi- enteric-coated. Upon discharge from the institution, 50% talized with a history of bariatric surgery. Retrospective had inappropriate formulations continued. Patients with a pilot study was conducted from January 1, 2006 through history of bariatric surgery may not have their vitamin and December 31, 2007 in patients with a past history of nutrient needs met upon hospitalization. Prior bariatric bariatric surgery. Demographic data, vitamin and nutrient surgery is not consistently taken into consideration when supplements, and medication dosage formulations were ordering medications. Healthcare providers need to be evaluated upon admission. This was compared to published cognizant of vitamin regimens to recommend as well as guidelines. Compliance with the following supplementation medication dosage formulations to avoid.
was categorized: daily multivitamin, calcium, iron, vitaminB-12, and folic acid. The frequency of non-immediate- Keywords Bariatric surgery . Dosage formulations .
release and enteric-coated medication dosage forms was Dosage forms . Vitamin replacement . Nutrient replacement .
also examined. Discrepancies were identified as lack of one of the supplements or if an inappropriate dosage formula-tion was ordered. Of 133 admissions, 117 (88%) had ahistory of a malabsorptive procedure and at least one discrepancy was found. Only 33.3% of admissions wereordered a multivitamin, 5.1% were ordered supplemental Obesity is increasing at an alarming rate, and the prevalence vitamin B-12, and 7.7% received a calcium supplement.
of class III (extreme) obesity (BMI > 40 kg/m2) has Additional folic acid was ordered in 11.1% and iron increased significantly Many comorbidities are associ- ordered in 12.0%. Inappropriate medication formulations ated with class III obesity including type 2 diabetes were ordered in 61.5% of patients; 34.7% included non- mellitus, hyperlipidemia, obstructive sleep apnea, heartdisease, degenerative joint disease, and depression []. Forthese patients, diet and exercise, even with pharmacologictherapy, are unlikely to achieve desired weight loss TheAmerican Society for Metabolic and Bariatric Surgery (ASMBS) has estimated that the number of bariatric Shenandoah University School of Pharmacy, surgeries in the USA has increased dramatically from 16,000 procedures performed in the 1990s to 103,000 in Winchester, VA 22601, USAe-mail: mlizer@su.edu Vitamin and nutrient deficiencies are commonly reported after bariatric surgery. The type and frequency of deficiency is associated with the type of surgery performed and the 347 Westside Station Dr,Winchester, VA 22601, USA portion of the intestine affected ]. There are several types of bariatric surgery available delineated as restrictive intake. Invariably, there will be rises in the incidence of (limiting amount of food intake) or malabsorptive (affecting nutrient-related complications Currently, there are no food absorption) based on the mechanism of inducing data describing how well patients adhere to the lifelong weight loss Restrictive procedures such as gastric nutrient recommendations or how knowledgeable health- banding and gastroplasty, which restrict food intake, have care providers are at recognizing and prescribing appropri- the least impact on nutrient absorption since none of the ate dosage formulations in this population.
intestine is bypassed. Malabsorptive procedures, such as the The primary objectives of this pilot were twofold: (1) to jejuno-ileal bypass, are associated with the greatest impact describe current vitamin and nutrient supplement practices in patients admitted to a community hospital with a history currently the preferred method and is performed in more of bariatric surgery and (2) to assess the appropriateness of than 80% of cases. It is considered primarily restrictive with medication dosage formulations upon admission in the a malabsorptive component based on the length of the Clinical practice guidelines for the nutritional, metabolic, and nonsurgical support of the bariatric surgery patient have been developed jointly by the American Association ofClinical Endocrinologists, the Obesity Society, and the This pilot study was conducted in a 411-bed, not-for-profit American Society for Metabolic and Bariatric Surgery hospital in Virginia. Inclusion criteria consisted of admis- (Appendix These guidelines support lifelong nutrient sion to the hospital from January 1, 2006 through recommendations including multivitamin, vitamin B-12, December 31, 2007 and a diagnostic code of V45.86, folic acid, calcium, vitamin D, and iron supplementation, which indicated a past medical history of bariatric surgery, often more than what is available in a daily multivitamin gastric banding, gastric bypass (including Roux-en-Y), or with minerals ]. The guidelines list the following obesity surgery. There was not a requirement or limit on vitamin and nutritional supplementation for normal post- time since bariatric surgery. Institutional review board bariatric patients: multivitamin (one to two tablets daily); approval was obtained for this retrospective study from calcium citrate with vitamin D (1,200–2,000 mg/day + 400– the affiliated institution. The hospital does not have 800 U/day); folic acid (400 mcg/day); elemental iron (40– standardized orders for post-bariatric surgery patients.
65 mg/day); and vitamin B-12 (≥350 mcg/day by mouth or Demographic data obtained included age, gender, type 1,000 mcg/month IM or 3,000 mcg every 6 months IM or of bariatric surgery (gastric banding, gastroplasty, open 500 mcg every week intranasally). Patients with preoperative gastric bypass, Roux-en-Y gastric bypass, and unspeci- or postoperative biochemical deficits should be treated fied), and date of surgery. Even if the nutrients were not beyond these recommendations. Preoperatively, many obese continued or ordered upon admission, appropriateness of patients have nutritional deficits before bariatric surgery such nutrient supplementation was included if the patient was as vitamin D, folic acid, and vitamin B-12 ]. This taking the nutrients upon admission. Assessment of underscores the necessity of vitamin supplementation both appropriate vitamins, nutrients, and medication dosage forms was obtained from admission assessments, medica- Certain salt forms of these minerals are also critical for tion histories, and/or admitting medication orders. Nutrient absorption, such as the citrate form of calcium and ferrous supplementation upon admission was compared to the forms of iron Patients who do not follow these lifelong published guidelines in Appendix . Patients with identi- recommendations risk developing deficiencies and second- fied nutrient deficiencies are often treated beyond these ary conditions such as anemia, vitamin B-12 deficiency, recommendations. If that was the case, those patients were included as having appropriate supplementation. In sum, Medication formulations utilized are also critical to this included a daily multivitamin, calcium + vitamin D, ensure adequate absorption in the Roux-en-Y and other iron, folic acid, and vitamin B-12. Since this institution has malabsorptive procedures. These include liquid, immediate- a formulary substitution to calcium carbonate for all release, and non-enteric-coated formulations [, ].
calcium orders, appropriateness was assumed if any salt Incorrect formulations can lead to ineffective treatments form was ordered. A discrepancy was identified as a lack of With an increase in the number of bariatric surgeries, The frequency of non-immediate-release (extended- various healthcare practitioners are involved in the ongoing release (ER), sustained-release (SR), delayed-release, medication management of this patient population. These long-acting (LA)) and enteric-coated (EC) medications practitioners may not be aware of the concerns surrounding was also examined. A discrepancy was determined if an appropriate dosage formulations and vitamin and nutrient inappropriate dosage formulation was ordered upon admis- sion. In order to assess if prescribers or pharmacists (25.0%), and 29 included both non-immediate-release recognized the need to change formulations during hospi- and enteric-coated formulations (40.3%). Of the 72 talization, the frequency of patients who were discharged patients who received inappropriate medication formula- from the hospital with inappropriate formulations was also tions upon admission, 36 (50%) also had inappropriate formulations continued at discharge. The most commonlyfound inappropriate medications were pantoprazole(Protonix™), divalproex (Depakote™ SR, XR), metopro- lol long-acting (Toprol XL™), oxycodone (Oxycontin™),venlafaxine extended release (Effexor XR™), bupropion Data were entered into an Excel (Microsoft™ 2007) (Wellbutrin™SR, XL), and duloxetine (Cymbalta™).
spreadsheet. Descriptive statistics were utilized to reportdemographic data and the appropriateness of nutrientsupplements and drug formulations.
The study objectives were to evaluate the appropriate- ness of vitamin and nutrient supplementation as well asmedication dosage formulations in patients with a history Of the 133 admissions during the study period, there of bariatric surgery admitted to the hospital for any were 20 (15%) men and 113 (85%) women. The mean ± SD age of the study participants was 47.7 ± 9.3 years.
Bariatric surgeries are described as either restrictive, The types of bariatric surgery as detailed in the medical malabsorptive, or both depending on the mechanism of record were: one patient (0.7%) with open gastric action which is either limiting food intake (restrictive) or bypass, four patients (3%) with gastric banding, five affecting absorption by delivering food to a lower section in patients (3.8%) with gastroplasty, seven patients (5.3%) the intestine (malabsorptive) ]. This discussion will unspecified, and 116 patients (87.2%) with Roux-en-Y center on the more popular Roux-en-Y procedure which gastric bypass. Since past bariatric procedures may have accounted for the majority of our patients. It is primarily been performed at other institutions, it is unknown if the restrictive with a malabsorptive component. The extent of Roux-en-Y procedures were laparoscopic based on chart malabsorption increases with the length of the bypassed review and diagnosis codes. Those done within the last intestinal limb. Heavier patients tend to have a longer decade were most likely laparoscopic.
The remainder of the study results will be limited to the The Roux-en-Y procedure results in ingested food above 117 admissions with a past history of either Roux- bypassing the gastric fundus, body, antrum, duodenum, en-Y or open gastric bypass since these represent 88% of and a variable length of proximal jejunum. Multiple cases and have a malabsorptive component. In evaluating vitamin and nutritional deficiencies can occur. Iron time lapse since surgery, 82 patients (70%) had a deficiency and anemia are among the most commonly documented bariatric surgery date: 16 (20%) since 2005; reported nutritional complications after bariatric surgery.
49 (60%) in 2000–2004; 14 (17%) in 1990–1999; and three This is due to multiple factors including the reduced capacity of the gastrointestinal tract to convert Fe3+ into Within these 117 admissions, at least one discrepancy the more absorbable Fe2+ ion due to a reduction in gastric was found per admission. A daily multivitamin was hydrochloric acid production and to the bypass of the documented in 39 patients (33.3%). Only six patients duodenum and proximal jejunum which is the primary site (5.1%) had supplemental vitamin B-12. Nine patients of iron absorption The incidence of iron deficiency (7.7%) received a calcium supplement, which was the after Roux-en-Y surgery is reported to be anywhere from carbonate and not the more absorbable citrate salt form.
16% to 45% []. Our study reported that only 12.0% of Folic acid was ordered in 13 of the patients (11.1%), patients were ordered supplemental iron. Dosage of iron although the multivitamin utilized at this institution had the required 400 μg. Iron supplementation was ordered in 14 Vitamin B-12 deficiency may also result as a patients (12.0%). The correct salt form of iron, ferrous consequence of food no longer coming in contact with sulfate, was ordered in all 14 patients.
intrinsic factor. It occurs in approximately one third of Inappropriate medication formulations were ordered patients within 1 year after bariatric surgery [, upon admission in 72 patients (61.5%). Of the 72 Vitamin B-12 absorption is dependent on the presence of admissions, 25 included non-immediate-release formula- intrinsic factor produced in stomach parietal cells. Hydro- tions (34.7%), 18 included enteric-coated formulations chloric acid is needed as well for cleaving vitamin B-12 from food protein in the stomach. It is well established patients are encouraged to maintain lifelong vitamin and that supplemental vitamin B-12 in addition to a multivi- tamin with minerals is needed in this patient population Recommendations vary on how to supplement vita- mins and minerals. Documented established protocols Therapeutic options include post-surgery monthly vita- are consistent in recommending a complete multivitamin min B-12 injections or high-dose oral formulations ].
with iron daily as well as calcium with vitamin D [ The dose of vitamin B-12 needed to maintain body stores Some protocols recommend scheduled vitamin B-12, after surgery is much greater than the recommended daily iron, and folic acid, whereas others recommend these allowance of 2.4 mcg/day []. Published recommended vitamins and nutrients only in select patients or those with amounts of prophylactic B-12 vary between 250 and documented deficiency ]. It is important to note that the 500 mcg/day of oral B-12 Many authors recommend updated ASMBS guidelines were not available when an oral dose of 1,000 mcg/day [, ]. Another option is many of our patients had their procedures done, but there intramuscular vitamin B-12. Our study reported that was wide documentation of the need for nutrient approximately 5% of patients had supplemental vitamin supplementation prior to this [, , ]. Because our B-12 ordered. In this pilot, we considered those patients patients may have had their bariatric surgery performed without an order for supplemental vitamin B-12 as not elsewhere and 60% within the years 2000–2004, formal- meeting the criteria. Some patients may have been on ized patient post-surgical education programs may not monthly vitamin B-12 replacement, but if it was not indicated in the medication history or ordered upon Many institutions align along the following recommen- dations: multivitamin with iron daily, calcium citrate with Vitamin D and calcium absorption may also be reduced vitamin D 1,200–1,500 mg daily, vitamin D3 800–1,000 IU since the duodenum and proximal jejunum—preferential daily, oral vitamin B-12 1,000 mcg daily, ferrous sulfate sites of absorption—are bypassed. Brolin et al. 325 mg two to three times daily, and folic acid as needed reported that 2 years after Roux-en-Y surgery, 51% of patients were vitamin D-deficient and had evidence of The body’s ability to absorb medications is compro- increased bone turnover. Other bariatric procedures have mised as well after bariatric surgery. There are many yielded similar ranges of vitamin D deficiency from 25% to factors which influence drug absorption and bioavail- 57% Our study reported calcium supplementation in ability, including solubility, surface area for absorption, and blood flow to the gastrointestinal tract. Drug Folate absorption occurs throughout the small intes- solubility and surface area are affected by primarily tine with adequate food intake, and therefore, deficiency malabsorptive procedures. Drugs absorbed primarily in is less likely to occur unless there is reduced nutritional the stomach or duodenum are most likely to exhibit intake. Folate deficiency can occur in both restrictive altered drug absorption in patients with malabsorptive or and malabsorptive procedures. As well, vitamin B-12 restrictive–malabsorptive procedures.
deficiency can lead to folate deficiency since B-12 is Reduction in the amount of functional GI tract may needed to convert folate to its active form. Prenatal lead to reduced drug bioavailability. Medications with vitamins which contain 1 mg of folic acid or supple- long absorptive phases that remain in the intestine for mentation of 400 mcg–1 mg per day are recommended extended periods of time such as SR, XR, LA, and EC by many specialists , ]. Our study looked for a products will have compromised dissolution and absorp- separate folic acid order since many multivitamins did tion []. Malone [] advises that the use of slow-release not contain folic acid. A small study (n=30) by Vargas- products including ion exchange resins, those with semi- Ruiz et al. [] reported that a multivitamin supplemen- permeable membranes and those with slowly dissolving tation alone was not sufficient to prevent iron and vitamin characteristics, should be avoided after malabsorptive B-12 deficiencies in most patients up to 3 years after bariatric procedures. Immediate-release formulations or surgery. Folate deficiency was not observed in any liquids should be substituted [, , The solubility patient. Our study reported 11% of patients with a of drugs is also affected by pH. Those more soluble in an separate folic acid order. A multivitamin was ordered in acidic environment will be less soluble after bariatric surgery due to the decreased production of hydrochloric Although nutrient deficiencies intuitively would be more acid. Gastric bypass patients have a relatively achlorhy- commonplace in malabsorptive procedures, nutrient defi- dric environment since the majority of the parietal cells ciencies have been reported after restrictive procedures as well []. This most likely is due to food intolerances and In this study, medication dosage formulations were poor eating habits. Consequently, all bariatric surgery ordered upon admission that were less than ideal in malabsorptive procedures in approximately 62% of bariatric surgery. Standardized vitamin and nutrient cases. These suboptimal formulations were evenly order sets for this population would be the next step distributed among non-immediate-release formulations, enteric-coated formulations, and both non-immediate-release and enteric-coated. Half of the patients whowere prescribed these dosage formulations upon admis- sion or during their admission had them continued atdischarge. In this study, we assumed that all SR, ER, There were several limitations to this pilot. This pilot LA, and EC preparations were inappropriate in malab- looked at all admissions with appropriate DRG coding over a 2-year time frame. Some patients may not have There is a lack of information, testing, and specific received appropriate coding and would have not been recommendations on optimizing medications and dosage included in the study. At this institution, the DRG formulations within the various bariatric procedures [ coding for past medical history events is not completed Malone states that studies need to be conducted on until several days after admission. Therefore, electronic the impact of both obesity and bariatric surgery on drug medical records will not report the past procedure disposition [Often, all SR, ER, LA, and EC dosage immediately which limits being able to identify these forms are contraindicated after malabsorptive procedures by nature of the lack of absorptive surface and gastric There was a lack of comparative data available in the acid, but again, studies are lacking []. Seaman et al.
literature in order to draw conclusions about our results.
[compared the dissolution of 22 instant-release The duration since bariatric surgery in each admission was psychiatric medications versus controls in Roux-en-Y in not documented, although it is recommended that vitamin vitro models. He concluded that almost half of the and nutritional supplementation become lifelong expect- medications had significantly less dissolution and two ations. The same can be said for avoidance of inappropriate had significantly greater dissolution in the Roux-en-Y model than in the control. He also concluded that although We counted as discrepancies patients who did not dissolution data do not predict therapeutic efficacy, they receive supplemental calcium, vitamin B-12, iron, and folic do provide qualitative information about the availability acid in addition to a daily multivitamin. They may have of the medication since absorption is limited by dissolu- been receiving a daily multivitamin which included An additional result noted was the discovery that Lack of disclosure by the patient on vitamins and half of the patients who had inappropriate dosage forms nutritional supplements that might be consumed as an upon admission had the same dosage forms continued outpatient is another limitation. Patients may not be asked at hospital discharge. This is noteworthy in that the by the healthcare provider upon admission what vitamins or past surgical history of these patients and their nutritional supplements they consume. Patients may not medications was not taken into account upon admis- consider vitamins as medications in the home medication sion, during admission, or at discharge and was not list when asked upon admission to disclose their medica- identified upon medication reconciliation. Two potential tions. This may especially be true for monthly vitamin B-12 reasons for this would include the physician and other healthcare staff being unaware of the nutrient andpharmacologic needs of the bariatric patient as well asthe formulary limitations of the institution. There is not a pharmacist involved in the reconciliation process oras part of most healthcare teams at the study institu- Patients with a prior history of bariatric surgery are not tion. Inclusion of pharmacy in the medication reconcil- having their vitamin and nutrient needs met upon iation process, targeting patients with a history of admission to the hospital. A prior history of bariatric bariatric surgery early in hospitalization, and providing surgery is also not taken into consideration when an educational program for healthcare providers would ordering medications. With the increasing prevalence of all be methods to resolve inappropriate medication bariatric surgery, healthcare providers need to be cogni- dosage formulations and reinforce nutrient needs of zant of vitamin regimens to recommend as well as this population. Emphasis should be placed on the medication dosage formulations to avoid. Hospitalization obvious need to implement patient vitamin and nutrient gives healthcare providers the opportunity to educate and education pre- and post-bariatric surgery as well as evaluate proper vitamin and nutrient intake and dosage upon hospitalization for any patient with a history of ≥350 µg/day orallyOr 1,000 µg/month intramuscularly Or 3,000 µg every 6 month intramuscularly 9. Fussy SA. The skinny on gastric bypass what pharmacists need to 10. Miller AD, Smith KM. Medication and nutrient administration 1. Flegal KM, Carroll MD, Ogden CL, et al. Prevalence and trends in considerations after bariatric surgery. Am J Health-Syst Pharm.
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