NAPLEX: Pharmacy Foundations - Dietary Supplements, Natural, & Complementary Medicine

dietary supplement health and education act (DSHEA)

requires the manufacturer to ensure that their product is safe before they are marketed

how do dietary supplement regulations differ from drugs

drugs must be proven safe and effective before they can be sold vs dietary supplements just need to be proven safe

supplements cannot claim to treat, cure, or mitigate a condition vs drug claims are based on FDA approval

how can dietary supplements be removed from the market

FDA must demonstrate it is "unsafe"

where should adverse events from supplements be reported

FDA's safety reporting portal

supplement label requirements

similar to a food label

basically provides all ingredients, quantities, serving size, calories in measurable amounts, recommended daily intake

united states pharmacopeia (USP)

establishes standards for dietary supplements

pharmacists can help consumer choose a reputable product w the USP verified mark on a product label

st john's wort interactions

induces CYP450 3A4, 2C19, 2C9, and 1A2 enzymes, and p-gp which decrease level of other drugs

- avoid w oral contraceptives, transplant drugs, warfarin

serotonergic

- do not use w MAOi, linezolid

- concurrent use w other serotonergic drug can be dangerous (SSRI, SNRI)

photosensitivity

- increased risk w other photosensitizing drugs including diuretics, retinoids, quinolones, sulfamethoxalate, tetracyclines, transplant drugs

can lower seizure threshold

- caution w other drugs that lower seizure threshold including bupropion, quinolones, tramadol, penicillin, carbapenems

natural medicines that increase bleeding risk

5 g's:

- garlic

- gingko

- ginseng

- ginger

- glucosamine

- fish oil (at high doses)

- vitamin E

- dong quai

- willow bark (a salicylate - do not use w anticoag)

supplements w risk of liver toxicity

- black cohosh

- kava

- chaparral, comfrey

- green tea extracts

supplements w risk of CV toxicity

- ephedra

- bitter orange (inc BP + HR)

- DMAA (inc BP + HR)

- licorice (contains glycyrrhizin - can lower K and inc BP)

- yohimbe (inc BP, HR, seizure risk)

caffeine and health risks

can raise BP and inc HR

FDA requirements for medical foods

- taken enterally (PO or by feeding tube)

- taken under supervision of healthcare provider

- intended to treat a condition w a known nutritional requirement

commonly used supplements

anxiety

- valerian

- passionflower

- kava

- st johns wort

- chamomile

- 5 hydroxytryptophan (5-HTP)

- SAMe

commonly used supplements

cold sores

l-lysine

commonly used supplements

colds and flu

- echinacea

- zinc

- vitamin C (ascorbic acid)

- eucalyptus oil

- probiotics (align, culturelle)

commonly used supplements

dementia, memory loss

- gingko

- vitamin E

- vinpocetine

commonly used supplements

depression

- st johns wort

- SAMe

- 5 HTP

- valerian

commonly used supplements

DM

- alpha lipoic acid

- bitter melon

- chromium

- cassia cinnamon

- magnesium

- american ginseng

- panax ginseng

commonly used supplements

dyslipidemia

- fish oil

- red yeast rice

- omega 3 fatty acids

- garlic

- plant sterol

- fiber

- artichoke extract

commonly used supplements

dyspepsia

- calcium

- magnesium

- peppermint

- chamomile

commonly used supplements

energy / weight loss

- bitter orange

- caffeine

- guarana, green tea powder

- garcinia cambogia

commonly used supplements

erectile dysfunction

- ginseng

- l arginine

- yohimbe

commonly used supplements

heart failure

- coenzyme q10

- hawthorne

- omega 3 fatty acids

commonly used supplements

HTN

- coenzyme q

- fish oil

- l arginine

- tea (green, black)

- omega 3 fatty acids

- garlic

- fiber

- potassium

commonly used supplements

GI health

- fiber

- chamomile

- probiotics (culturelle, florastar, align)

- ginger

- peppermint

- horehound

- wheatgrass

commonly used supplements

inflammation

- omega 3 fatty acids

- flax seeds / oils

- tumeric

commonly used supplements

insomnia / sleep

- melatonin

- valerian

- chamomile

- lemon balm

- passionflower

- 5 HTP, L-tryptophan

commonly used supplements

liver disease

milk thistle

commonly used supplements

menopause

- black cohosh

- dong quai

- evening primrose oil

- soy, red clover, panax ginseng

commonly used supplements

migraine ppx

- feverfew

- butterbur

- magnesium

- riboflavin

- coenzyme q10

- guarana

commonly used supplements

motion sickness

- ginger

- peppermint

commonly used supplements

osteoarthritis

- glucosamine

- chondroitin

- SAMe

- tumeric

- ginger

commonly used supplements

osteoporosis

- calcium

- vitamin D

- soy

- ipriflavone

commonly used supplements

prostate health

- saw palmetto

- lycopene

- pygeum

- pumpkin seed

commonly used supplements

skin conditions

- tea tree oil

- aloe vera

- topical vitamin D

- biotin

commonly used supplements

UTI

- cranberry

- yogurt

- probiotics (align, culturelle)

safety issues w common supplements

5 HTP

serotonergic

inc risk w other serotonergic drugs

safety issues w common supplements

artichoke extract

allergic reactions

pt w allergies to asters, echinacea, chamomile, chrysanthemums, ragweed should avoid

safety issues w common supplements

beta carotene

inc risk of lung cancer (in smokers, asbestos exposure)

inc CV mortality

safety issues w common supplements

bitter melon

dec BG

caution w hypoglycemic drugs

safety issues w common supplements

bitter orange

stimulant

dose related inc BP, HR, arrhythmia risk

safety issues w common supplements

black cohosh

may be hepatotoxic

do not use w meds for HF (ACE/ARB/BB/amiodarone)

safety issues w common supplements

caffeine (guarana, green tea powder)

dose related dizziness, agitation, irritability, inc BP + HR

safety issues w common supplements

chamomile

allergic reactions

pt w allergies to asters, echinacea, chrysanthemums, ragweed should avoid

safety issues w common supplements

chondroitin

bleeding risk at higher doses

inc INR w warfarin

safety issues w common supplements

dong quai

inc bleeding risk w concurrent use of anticoag/antiplatelets/salicylates

safety issues w common supplements

echinacea

controversial safety w autoimmune disorders

pt w allergies to artichoke, asters, chamomile, chrysanthemums, ragweed should avoid

safety issues w common supplements

feverfew

mouth ulceration

inc bleeding risk w concurrent use of anticoag, antiplatelets, salicylate

safety issues w common supplements

fiber

GI effects (bloating, cramping, farting)

safety issues w common supplements

ginger, gingko, garlic, ginseng, glucosamine

inc bleeding risk - especially w concurrent use of other drugs that inc bleeding risk (SSRI, anticoag, antiplatelets, salicylates)

discontinue in advance to surgery

safety issues w common supplements

hawthorn

positive inotrope - avoid concurrent use w digoxin

dec BP - caution w additive effect w BP lowering drugs

safety issues w common supplements

kava

avoid d/t hepatotoxicity

safety issues w common supplements

l-arginine

converts to NO > dec BP + inc dizziness - caution w additive effect w BP lowering drugs

avoid concurrent use w nitrate

safety issues w common supplements

melatonin

if used chronically for sleep endogenous melatonin can be decreased > dependency to sleep

safety issues w common supplements

omega 3 fatty acids

inc bleeding risk w high dose

can inc LDL

safety issues w common supplements

passionflower

QT prolongation - avoid w other QT prolonging meds

safety issues w common supplements

probiotics

separate use from oral abx

safety concern w use of live bacteria in immunocompromised states

safety issues w common supplements

red yeast rice

CYP450 inhibitors (ex: amiodarone) will inc red rice level

dec coenzyme q10 which can inc myopathy risk

do not use w statins

safety issues w common supplements

SAMe

serotonergic - inc risk w other serotonergic drugs

inc bleeding risk

do not use in BPD d/t inc risk of manic behavior

safety issues w common supplements

soy, red clover, panax ginseng

contains mild phyto-(plant) estrogens

soy may increase breast cancer risk in postmenopausal women not producing estradiol

safety issues w common supplements

valerian

sedation

CNS depressant

risk w other CNS depressants

safety issues w common supplements

vinpocetine

semi synthetic derived from a plant product

FDA issued warning for fetal harm

safety issues w common supplements

vitamin C

nephrolithiasis w high doses

false negative stool occult blood 48-72 hrs after ascorbic acid ingestion

safety issues w common supplements

vitamin E (alpha tocopherol)

do not exceed 400 IU daily

bleeding risk

safety issues w common supplements

yohimbe

inc BP, HR

seizure risk

safety issues w common supplements

zinc

nasal products can cause loss of smell

vitamin A

retinol

vitamin B1

thiamine

vitamin B2

riboflavin

vitamin B3

niacin

vitamin B6

pyridoxine

vitamin B9

folic acid

vitamin B12

cobalamin

vitamin C

ascorbic acid

vitamin D2

ergocalciferol

vitamin D3

cholecalciferol

vitamin E

alpha tocopherol

calcium and vitamin D relationship

low levels of vitamin D impairs calcium absorption

folic acid 600 mcg DFE = ___ mcg of folic acid daily

360 mcg

daily folic acid recommendation for women of child bearing age

400 mcg DFE/day

daily folic acid recommendation for pregnant women

600 mcg DFE/day

when should pregnant women start taking folic acid

at least 1 mo before pregnancy and continued 2-3 mo of pregnancy

true or false

vitamin E supplementation is not recommended

true

not recommended for prevention of CV disease or cancer d/t lack of benefit in either condition

AAP vitamin D recommendations for infants + children

exclusively breastfed infants or babies drinking less than 1 L baby formula need 400 IU vitamin D daily

older children who do not drink at least 4 cups of vitamin D fortified milk/day need vitamin D supplementation

AAP iron recommendations

0-4 mo

supplemental iron not required

AAP iron recommendations

4-6 mo

formula contains adequate iron - supplementation not required

breastfed babies need 1 mg/kg/day from 4-6 mo old until consuming iron rich foods

at about 6 mo, breastfed babies get half their calories from other foods which may be adequate

AAP iron recommendations

6-12 mo

need 11 mg/day of iron

food sources preferred, supplement if needed

AAP iron recommendations

1-3 yrs

need 7 mg/day iron

food sources preferred, supplement as needed

pre-term (<37 wks) breastfed infants iron recommendation

2 mg/kg/day from age 1-2 mo

depleted nutrient

amphotericin B

magnesium

potassium

depleted nutrient

antiseizure medications (carbamazepine, lamotrigine, oxcarbazepine, phenobarbital, primidone, phenytoin, topiramate, valproic acid, zonisamide)

calcium

depleted nutrient

isoniazid

vitamin B6

depleted nutrient

loop diuretics

K

depleted nutrient

metformin

vitamin B12

depleted nutrient

methotrexate

folate

depleted nutrient

orlistat

beta carotene

fat soluble vitamins

depleted nutrient

PPI

magnesium

vitamin B12

>2 yrs of treatment

conditions w recommended supplements

alcohol use disorder

vitamin B1

folate

conditions w recommended supplements

crohn's disease

iron

zinc

folate

calcium

vitamin D

B vitamins

conditions w recommended supplements

CKD

vitamin D