NUTRIENT DEPLETION: HOW TO ANSWER PATIENT QUESTIONS

SATURDAY/11:30AM-12:30PM

ACPE UAN: 0107-9999-17-235-L01-P 0.1 CEU/1.0 hr 0107-9999-17-235-L01-T 0.1 CEU/1.0 hr Activity Type: Application-Based Learning Objectives for Pharmacists & Pharmacy Technicians: Upon completion of this CPE activity participants should be able to: 1. Identify disease states where current first line medications could cause nutrient depletion. 2. Discuss clinical practice guidelines that suggest nutrient replacements. 3. Create a patient-centered care plan that includes the use of over-the-counter supplements. 4. Describe standardization processes that exist for OTC products. Speaker: Wendy Mobley-Bukstein, PharmD, BCACP, CDE, CHWC Dr. Wendy Mobley-Bukstein is Assistant Professor of Pharmacy Practice in the College of Pharmacy and Health Sciences at Drake University. She received her Doctor of Pharmacy degree from Drake University in 1999. She is APhA certificate trained in Diabetes Care, Immunization Delivery and Medication Therapy Management. Currently, she teaches a Medication Therapy Management elective in the Pharmacy Skills and Applications course series and the Self Care & Nonprescription Products course. She maintains a clinical practice at Primary Health Care East Side Clinic where she precepts third year pharmacy students on their drug therapy problem solving or community introductory pharmacy practice experience (IPPE). Her specialty areas of practice and scholarship are diabetes, medication therapy management and community education. Speaker Disclosure: Wendy Mobley-Bukstein reports no actual or potential conflicts of interest in relation to this CPE activity. Off-label use of medications will not be discussed during this presentation.

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NutrientDepletion:HowtoAnswerPatientQuestionsWendy Mobley-Bukstein, PharmD,

BCACP, CDE, CHWC

Disclosure

• Wendy Mobley-Bukstein reports no actual or potential conflicts of interest associated with this presentation

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LearningObjectives

• Upon successful completion of this activity, participants should be able to:

1. Identify disease states where current first line medications could cause nutrient depletion.

2. Discuss clinical practice guidelines that suggest nutrient replacements.

3. Create a patient-centered care plan that includes the use of over-the-counter supplements.

4. Describe standardization processes that exist for OTC products.

QualityStandardsforOver-the-Counters

• Not all vitamins are created equal!

• USP-verified- USP Verified Mark

1. Contains the ingredients listed on the label, in the declared potency and amounts

2. Does not contain harmful levels of specified contaminants

3. Will break down and release into the body within a specified amount of time

4. Has been made according to FDA current Good Manufacturing Practices using sanitary and well-

controlled procedures

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QualityStandardsforOver-the-Counters

• NSF - National Science Foundation

1. International- testing facilities in Europe, China and US2. maintains and led the development of NSF/ANSI 173, the

only American National Standard for testing and certifying dietary supplements• Vitamins• Minerals• Herbs/botanicals• Amino acids• Sports supplements• Concentrates, metabolites, constituents and extracts

3. Test purity, safety and environmental controls on all products

QualityStandardsforOver-the-Counters

• Consumerlab.com- Have been certifying vitamins and supplements in the US

for many years

• Quality Standards DO NOT guarantee safety and effectiveness…ONLY ingredient purity and dose

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PharmacistPatientCareProcess

PrescriptionMedicationsandNutrientDepletion

• Antihypertensives- Calcium- Sodium- Potassium- Zinc- Magnesium- Vitamin B6, pyridoxine- Vitamin C, ascorbic acid- Coenzyme Q10- Melatonin

• PPIs/H2RAs/Antacids- Vitamin B-12- Folic Acid- Iron- Zinc- Calcium - Vitamin D

Cass, H; “A Practical Guide to Avoiding Drug-Induced Nutrient Depletion. Nutrition Review. December 11, 2016. https://nutritionreview.org/2016/12/practical-guide-avoiding-drug-induced-nutrient-depletion/ Accessed 1/4/2018.

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PrescriptionMedicationsandNutrientDepletion

• Oral Hypoglycemics- Specifically metformin- Vitamin B12- Folic Acid- Coenzyme Q10

• Hormone Replacement Therapy- Vitamin B6- Vitamin B12- Folic Acid - Magnesium

Cass, H; “A Practical Guide to Avoiding Drug-Induced Nutrient Depletion. Nutrition Review. December 11, 2016. https://nutritionreview.org/2016/12/practical-guide-avoiding-drug-induced-nutrient-depletion/ Accessed 1/4/2018.

NutrientDepletionSymptoms

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Antihypertensives- diuretics• ALLHAT Trial 20021

- Thiazide diuretics are superior in 1 or more major forms of CVD and less expensive

• Thiazides lead to potassium, sodium2, magnesium3 and zinc4

depletion

• Loop diuretics lead to potassium, sodium, magnesium, zinc, calcium, pyridoxine, thiamine5 and ascorbic acid depletion

• Supplementing potassium- OTC vs Rx

ALLHATTrial,JAMA. 2002Dec18;288(23):2981-97.Br J Clin Pharmacol 2006 Jan;61:87-95. ClinNephrol2000;54:271-275.SAfrMedJ. 1983Dec3;64(24):936-41Cardiovasc Res. 1980;14:537–540.

Antihypertensives- Case#1

• GH is a 59 year old, caucasian male, known to your pharmacy. He comes to the counter today asking for some guidance on the muscle cramps that he has been having at night. They are so severe that they are waking him up. He describes them as a cramp that starts in the lower calf and extends upward. He started taking furosemide 40mg daily last month for severe edema in his ankles and feet. He had heard about a product called Hyland’s Leg Cramps and wants to know if this is safe.

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Case#1

• What is the appropriate response to this gentleman?A. Hyland’s Leg Cramps is an official sponsor of the

Boston Marathon so it must be ok.B. Leg cramps can be caused from many different

issues. Would it be ok if you asked him some additional questions to get a better idea of what he has been doing?

C. Ask his permission to notify his physician and ask for his blood levels to be drawn.

D. Obtain more information from patient and notify physician of potential electrolyte issues.

Over-the-counterSupplementation:PracticePearls

• Patients should have electrolytes checked!- Potassium- Rx vs. OTC- Magnesium- provider may ask for you to recommend an

OTC product• Magnesium oxide 400mg• Magnesium

- Sodium- Diet vs. Rx- Zinc- Diet vs. OTC supplementation

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Antihypertensives- betablockers• Melatonin deficiency1

- Blockade of the alpha-1 and beta-1 receptors decreases secretion of melatonin

- 3 weeks of melatonin use increased total time slept and sleep efficiency2

- After discontinuation, there was carryover effect2

• Coenzyme Q103

- Low bioavailability- Serum levels 3mcg/ml4- 3-5mg/kg/day recommended dose4

- Takes 4 weeks to see maximal benefit4- Reduction of 15/10 mmHg4

- Effect is gone after 2 weeks of discontinuation1. Eur J Clin Pharmacol. Apr1999;55(2):111-15.2. Scheer FA, et al Repeated melatonin supplementation improves sleep in hypertensive patients treated with beta-blockers: a randomized controlled trial. Sleep. 2012 Oct 1;35(10):1395-402.3. Res Commun Chem Pathol Pharmacol 1977;17:157-164,4. Houston, M Nutrition and Nutraceutical Supplements for the Treatment of Hypertension: Part III, J Clin Hypertens (Greenwich). 2013;15:931–937

Case#2

• PL is a 72 year old African American female known to your pharmacy; she approaches you today with concerns that she hasn’t been sleeping well. She isn’t tired at night when she knows she should go to bed. She has had some nights where she finally dozes off but then wakes at 3am. She is exhausted and wants to know if there is anything over-the-counter that she can take to help her sleep?

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Case#2

• PL’s med list:- Metoprolol succinate 100mg daily- Amlodipine 10mg daily- HCTZ 25mg daily- Metformin 1000mg BID- Omeprazole 20mg BID- Atorvastatin 40mg at bedtime

• What is your recommendation for this patient? Why?

Over-the-counterSupplementation:PracticePearls

• Melatonin- Assists the body in regaining circadian pattern- Recommended doses for sleep:

• 0.2mg-5mg daily at 60 minutes prior to bedtime• TOO much melatonin can cause sleep disturbances• Start low and titrate• Clinical studies have shown its use for up to 9 months consistently; but

typically should only be needed for 4-8 weeks to get the body synced to its sleep pattern

• Coenzyme Q10- May assist in decreasing BP and reducing pill burden- 3-5mg/kg/day recommended dose4

- Takes 4 weeks to see maximal benefit4- Reduction of total BP by 15/10 mmHg4

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PPIs/H2RAs/Antacids• American Gastroenterological Association 2017• Best Practices for PPIs Use:

- Short term use for uncomplicated GERD- Probiotics should not be taken long term to prevent C. diff- Not necessary to increase calcium, Vitamin B12 or calcium- Not necessary to routinely screen or monitor bone mineral

density, serum creatinine, magnesium or vitamin B12• Population considerations

- Elderly- Malnourished

1. Best Practice Advice from the AGA Gastroenterology. 2017 Mar;152(4):706-715. doi: 10.1053/j.gastro.2017.01.0312. Katz, P Gerson, L, Vela, M Guidelines for the Diagnosis and Treatment of GERD Am J Gastroenterol 2013; 108:308–328; doi:10.1038/ajg.2012.444

PPIs/H2RAs/Antacids

• H2RAs- Long-term use may cause Vit B12 deficiency in patients

with poor diets1

• Antacids- Caution in special patient populations

• Reduced kidney function• Hyperaluminemia, hypercalcemia, hypermagnesemia

• Dialysis• Elderly• Malnourished

1. Force, R Nehata, M Effect of Histamine H2-Receptor Antagonists on Vitamin B12 Absorption Annals of Pharmacotherapy Vol 26, Issue 10, pp. 1283 – 1286.

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Case#3

• PL calls you today complaining of loose stools that have a foul odor.

• PL’s med list:- Metoprolol succinate 100mg daily- Amlodipine 10mg daily- HCTZ 25mg daily- Metformin 1000mg BID- Omeprazole 20mg BID - Atorvastatin 40mg at bedtime

• What is your recommendation for this patient? Why?

OralHypoglycemics

• Standards of Medical Care for Diabetes- Metformin

• B-12 deficiency• DPP/DPPOS Study

• Benefits of adequate B-12 levels• Preventearlyperipheralneuropathy• Delayautonomiccardiovascularneuropathy1

• Oral supplementation of 1000-2000mg daily is as effective as injectable 1-2 times per month2

• Folic Acid

1. Hansen, Christian S. et al.; Vitamin B12 deficiency is associated with cardiovascular autonomic neuropathy in patients with type 2 diabetes, Journal of Diabetes and Its Complications; Volume 31 , Issue 1, 202 – 208. 2. Butler,C Vidal-Alaball, J Cannings-John, R et al “Oral vitamin B12 versus intramuscular vitamin B12 for vitamin B12 deficiency: a systematic review of randomized controlled trials” Family Practice, Volume 23, Issue 3, 1 June 2006, Pages 279–285, https://doi.org/10.1093/fampra/cml008

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DPP/DPPOSResults

Aroda VR, Edelstein SL, Goldberg RB, et al. Long-term Metformin Use and Vitamin B12 Deficiency in the Diabetes Prevention Program Outcomes Study. The Journal of Clinical Endocrinology and Metabolism. 2016;101(4):1754-1761.

Copyright © 2016 by the Endocrine Society; Permission to use May 2017.

VitaminDDeficiency• Endocrine Society Clinical Practice

Guidelines 2011• Screen at-risk individuals only

• Includes inadequate exposure to sunlight, dark skin tone, obesity (BMI>30), fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, drug-induced, primary hyperparathyroidism, lymphomas, granuloma-forming disorders

• Monitor Vit D level by drawing [25(OH)D] level

• Considered gold standard lab value• Do NOT recommend 1,25(OH)2D

assay for detecting vitamin D deficiency

• Recommend the use of Vitamin D2 or D3• D2 is found in Rx only products

• See table at right for daily requirements

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OralHypoglycemics

• Vitamin C1

- No clinical data to support the need for supplementation in diabetes- Great antioxidant and free radical scavenger

• Vitamin E1

- No clinical data to support the need for supplementation in diabetes- Great antioxidant and free radical scavenger

• Cinnamon1

- Meta-Analysis in J Acad Nutr Diet. 2016 Nov;116(11):1794-1802. - 11 studies, 694 patients

• Concluded that current recommendations for diet, lifestyle change and drugs be followed

• Chromium picolinate1

- Thought to regulate carbohydrate metabolism- Clinical studies over the past 30 years have not proven statistical

significance

1. Evert AB, Boucher JL, Cypress M, et al. Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care. 2014;37 Suppl 1:S120- S143.

StatinUseandCoenzymeQ-10

• Coenzyme Q10 (Ubiquinone)- Potent lipid phase antioxidant

• Reduces the oxidation of low-density lipoprotein• Prevents the generation of free radicals and modifications of

proteins, lipids, and DNA- Energy transporter

• 50/50 in the literature if supplementation will reduce myopathies

The Lipid and Blood Pressure Meta-Analysis Group The Mayo Clinic Proceedings Volume 90, Issue 1, January 2015, Pages 24-34

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Case#4

• PL comes into the pharmacy to pick up her refills. She wants to talk with you about her hands and feet. She says that they feel like they are “asleep” all of the time. (e.g. tingling and burning)

• PL’s med list:- Metoprolol succinate 100mg daily- Amlodipine 10mg daily- HCTZ 25mg daily- Metformin 1000mg BID- Omeprazole 20mg BID- Atorvastatin 40mg at bedtime

• What is your recommendation for this patient? Why?

HormoneReplacementTherapy• Recommended daily dietary allowances for calcium and

vitamin D from the Institute of Medicine:- Persons nine to 18 years of age: 1,300 mg of calcium, 600 IU of

vitamin D- Persons 19 to 50 years of age: 1,000 mg of calcium, 600 IU of

vitamin D- Persons 51 to 70 years of age: 1,200 mg of calcium, 600 IU of

vitamin D- Persons 71 years and older: 1,200 mg of calcium, 800 IU of

vitamin D• Dietary calcium is best, no more than 600mg/serving• A serum vitamin D level of 20 ng per mL (50 nmol per L) is

recommended for good bone health.• Women >65 should have a DEXA scan every 2 years unless

patient has risk factors

https://www.aafp.org/afp/2013/0815/p269.html Accessed1/16/2018.

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HormoneReplacementTherapyWOMEN

Age50&younger 1,000mg*daily

Age51&older 1,200mg*daily

MEN

Age70&younger 1,000mg*daily

Age71&older 1,200mg*daily

Calcium Requirements

WOMEN AND MEN

Underage50 400-800internationalunits(IU)daily**

Age50andolder 800-1,000IUdaily**

Vitamin D Requirements

https://www.nof.org/patients/treatment/calciumvitamin-d/

National Osteoporosis Foundation Guidelines for Calcium and Vitamin D requirements.

HormoneReplacementTherapy

• Small study found decrease in trace elements when started on estrogen/progesterone HRT

- Chronic HRT users should be asked about symptoms of trace element deficiency

• Zinc• Copper• Magnesium• Calcium

• Decrease in endogenous sex hormones can cause vitamin deficiencies (menopause, heavy menstrual cycles)

- Vitamin B6- Vitamin B12- Folic Acid

• Recommend a multivitamin/mineral daily1. Clin Exp Obstet Gynecol. 2003;30(1):32-4.

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Case#5

• GR is a 65 year old woman well known to your pharmacy. She recently broke her arm from a fall on the snow and ice. Her provider has asked her to visit with you about her calcium and Vit D needs.

• She reports that she drinks an 8 oz glass of milk at breakfast and has a Greek yogurt (6 oz) every day with her lunch. How much calcium and Vit D is she getting in her diet? How much additional calcium and Vit D will she need to ingest at dinner time or supplement to meet her daily needs?

Case#5

• 8 oz milk = 300mg of calcium• 6 oz Greek yogurt = 200mg of calcium• 300mg + 200mg = 500 mg calcium

• 8 oz milk = 100 IU of Vitamin D (25% of RDA)• 6 oz Greek yogurt = 100 IU of Vitamin D (25% of

RDA)• 100 IU + 100 IU = 200 IU Vitamin D

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BariatricSurgery• Roux-en-Y bypass (RYGB)• Biliary pancreatic diversion with duodenal switch

(BPD/DS)Vitamin Deficiency Symptoms

VitaminB-1 Tachycardia,respiratorydistress,edma,neuropathy,nausea/vomiting, constipation

VitaminB-12 Fatigue,anorexia

Iron Fatigue,anemia, palpitations,GIeffects

Calcium andVitaminD Osteoporosis, legcramping,tetany

FatSolubleVitaminsRecommendations

Vitamin A5000IUVitaminD3000IUVitaminK90mcgVitaminE30IU

Mechanick JI, YoudimA, Jones DB, et al. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient--2013 update: cosponsored by American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & Bariatric Surgery. Surg Obes Relat Dis. 2013;9(2):159-91.

https://imedicare.com/articles/nutrient-depletion-tool-pharmacies-imedicare/. Accessed 11 January 2018.

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Resources

• Dietitians are OUR friends!• Look up guidelines

- www.guidelines.gov• Utilize students and technicians

- Have them look up evidence-based studies

TakeHomePoints

1. Listen 2. Ask questions3. Explain with evidence4. Communicate with providers5. Create a plan with the patient

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Questions?