Over the Counter Medications and Supplements: How to Use them Safely Kerry Hildreth, MD Division of Geriatric Medicine University of Colorado

Learning Objectives Over the counter medications and dietary supplements can be cost- effective and beneficial Over the counter medications and supplements can be harmful in many situations Older adults are at increased risk of harms from these products Over-the-Counter, “Natural” ≠ Safe

Over-the-Counter Medications Non-prescription medications, “OTCs” Can be bought and safely* used without the need for a prescription Must meet FDA quality, effectiveness, and safety standards May have one ingredient, or several *In most individuals when used according to instructions

Common Over-the-Counter Medications Pain medications

Common Over-the-Counter Medications Cough and cold medications

Common Over-the-Counter Medications Stomach upset and heartburn medications

Common Over-the-Counter Medications Diarrhea medications Constipation medications

Dietary Supplements Products taken by mouth that contain a “dietary ingredient” Considered “foods” not “drugs” May contain one ingredient, or many vitamin and mineral products "botanical" or herbal products amino acid products enzyme supplements Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases.

Are not required to be proven safe before they are marketed Do not require FDA approval before producing or selling It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease. Are not required to prove that labeling claims are accurate or truthful before marketing Regulation of Dietary Supplements

FDA monitors mandatory reporting of serious adverse events and voluntary adverse event reporting by consumers and health care professionals As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion. There are limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews substantiation for claims as resources permit. Regulation of Dietary Supplements

Common Dietary Supplements Multivitamins Calcium Vitamin D Fish Oil

Use of OTC medications and supplements Over 100,000 OTC medications on the market in 2009 More prescription medications becoming available over-the-counter Perception that OTC=Safe Perception that Natural=Safe Cost savings

Cost Savings with OTC Medications = $102 billion/year Employer-based Health Plans Individual patients Medicare and Medicaid

Use of OTC medications and supplements by older adults OTC Medications Don’t use Use Supplements Don’t use Use

Communication Breakdown Patients don’t tell Don’t tell Tell Don’t ask Ask Doctors don’t ask

Number of older adults at risk for a major drug-drug interaction

Why are the risks of OTC medications higher in older adults?

Polypharmacy Older adults make up 13% of the U.S. population, but account for 30% of OTC medication use

Polypharmacy Fewer than 5 5 or more Two-thirds of older adults take 5 or more medications and supplements of any kind

Polypharmacy: > 2

Declines in kidney and liver function with age affect how medications are absorbed, processed and eliminated from the body.

Age 19 Age 63

Compared to a young person of the same weight, an older adult has more fat and less muscle. This affects how medications are distributed and concentrated in the body. Age 19 Age 63

Problems with vision, hearing and cognition may make it harder to understand instructions for taking medications

1 in 6 older adults is at risk for a major drug- drug interaction use more medications have changes that affect how drugs are processed and stored in the body may have changes that affect ability to follow medication instructions

Common Prescription-OTC Interactions Blood Thinners Clopidogrel (Plavix) Warfarin (Coumadin) Aspirin NSAIDs Omega-3 Fish Oil Garlic Bleeding

Common Prescription-OTC Interactions Lisinopril (ACE-Inhibitor) Potassium High Potassium Heart Arrhythmia

Common Prescription-OTC Interactions Statins Niacin Muscle and Kidney Damage

Common OTC-OTC Interactions Aspirin NSAID Bleeding

A Case Study 80 years old, has high blood pressure, arthritis and glaucoma Medications include: Extra-strength Tylenol 1000mg twice a day Lisinopril 20mg daily for blood pressure Eye drops for glaucoma Develops cough, congestion, runny nose, body aches, mild temperature (99⁰) “Mary”

ACTIVE INGREDIENTSAMOUNTPURPOSES Acetaminophen500 mgPain reliever/fever reducer Dextromethorphan HBr20 mgCough suppressant Phenylephrine HCl10 mgNasal decongestant take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor ACTIVE INGREDIENTSAMOUNTPURPOSES Acetaminophen650 mgPain reliever/fever reducer Dextromethorphan HBr20 mgCough suppressant Phenylephrine HCl10 mgNasal decongestant Doxylamine succinate12.5mgAntihistamine take 30mL every 4 hours ACTIVE INGREDIENTSAMOUNTPURPOSES Oxymetolazine hydrochloride0.05%Nasal decongestant 2-3 sprays in each nostril every hours

Unintentional Overdose: Combination Products “Mary” Tylenol/Acetaminophen Dose Usual arthritis dose 1000mg twice daily2000mg Theraflu4 packets a day2000mg NyQuil2 doses overnight1300mg Total dose5300mg

“Mary” Phenylephrine Oxymetolazine High Blood Pressure Doxylamine Sleepiness Confusion Fall during the night Taken to ER Blood pressure 220/110 Hip fracture Liver damage

How can you use OTCs and supplements safely? Educate yourself Avoid certain OTCs and supplements Communicate with your doctor

Educate Yourself What is the purpose of this drug? Does this product contain more than one drug? Is there the possibility of interactions with other drugs or with foods? What are the possible side effects? How much of the medicine should I take?

Be aware that some supplement ingredients, including nutrients and plant components, can be toxic Do not assume that the term "natural" in relation to a product ensures that the product is wholesome or safe Be wary of hype and headlines Learn to spot false claims. If something sounds too good to be true, it probably is! Be a Safe and Informed Consumer

Medications to Avoid NSAIDs Examples: Ibuprofen, Motrin, Advil, Naproxen, Aleve Why? Increased risk of bleeding Kidney failure Elevated blood pressure Anticholinergic Antihistamines Examples: diphenhydramine, benadryl, chlorpheniramine, doxylamine, sleep aids Why? Dry mouth, constipation, difficulty emptying bladder Sleep disruption Cognitive impairment, confusion, hallucinations

Communicate with your Doctor Tell you doctor about any OTC medications or supplements you are using Ask your doctor before starting any new OTC medications or supplements Bring all of your prescription medications, OTC medications and supplements to your clinic visits

Conclusions Over the counter medications and dietary supplements can be cost- effective and beneficial Over the counter medications and supplements can be harmful in many situations Older adults are at increased risk of harms from these products

Take Home Points 1.Over-the-Counter ≠ Safe 2.Natural ≠ Safe 3.Talk to your doctor 4.Talk to your doctor 5.Talk to your doctor