OTC Medications and How They Can Cause Harm Presenter: Joseph DuPrey MS RPh February 26, 2009 Why are some Medications OTC? FDA has established safety profile FDA established OTC drug review FDA regulated OTC Drugs Facts label Active Ingredients Purpose Uses Warnings Directions Other information-storage, sodium content, etc Inactive Ingredients The Expanding OTC Market 300,000 OTC Medications on the market Brand name extension growing-common brand name with different ingredients (Tylenol has > 50 products) Safety and efficacy of OTC drugs Increased desire to self care Aging of population Increased health care costs prompts cost saving strategy-estimated t ti t that HC 1% cream saved $144 million the first year No 3 rd party constraints Increased generic options Effective marketing Rx-to OTC switch-over 700 products on market that used to be RX only 40-87% of adults >65 use at least one OTC product, 5.7% take five or more 1
The Problem Understanding ways medications are not used properly Improper Use Overuse Underuse OTC Drug Name Quiz (from ISM) What are the active ingredients in each of these OTC medications? a) Mylanta AR b) Mylanta cherry cream liquid id c) Mylanta Gas Relief d) Mylanta double strength tablets Answers to Mylanta Quiz a) Famotidine b) Aluminum hydroxide/magnesium hydroxide c) simethicone d) calcium carbonate and magnesium hydroxide When buying OTC products, carefully read the label to be sure it contains the ingredients you want. What if you do not know the ingredients, just a brand name? 2
Cough and Cold Products in Young Children The January 12, 2007 Morbidity and Mortality Weekly Report contained reports of 3 infants between the ages of 1-6 months who were found dead due to and accidental overdose of pseudoephedrine in cough and cold mixtures. One infant had the drug from both a Rx and OTC product. There were no dosing recommendations for children less than 2 years of age. This has since been advanced to children under 4. Infants Concentrated Tylenol Drops Tylenol (Acetaminophen) liquid is available in 100mg/ml (drops) and 160mg/5ml (elixir). Prescribing Tylenol liquid by volume has led to dosing errors as mothers are instructed to take a teaspoonful of Tylenol. This has lead to fatal Tylenol overdoses. One child needed a liver transplant. A parent almost gave her 27 month-old old child two teaspoonfuls of Tylenol Infant drops instead of two droppersful, but a call to her pharmacist to check the dose prevented this. Two teaspoonsful contain 1000mg. McNeil has produced a safety valve (Safe-Ty-Lock) in it s drops product which only permits withdrawal from the dropper, but this is not available on generic products. Accidental Tylenol Overdose A 17 year old female high school student was suffering from a migraine headache. She proceeded to take 20 Tylenol Extra Strength tablets in a 24 hour period. As her condition deteriorated she told her mother I thought it was OK. It s only Tylenol, Ma. She died 4 days later of liver and kidney failure. 3
Improper Use of OTC Medications Failure to read or understand the label Low health literacy seen in many patients 90 million Americans read below the 5 th grade level. Women are more likely than men to look at the Drug Facts medicine label Confusing product labeling Intentionally exceeding the dose recommendations Duplicate medication from different sources Skipping doses or taking the wrong drug Recent Product Misuse Report Benadryl topical product poses danger if swallowed Over the holidays, our consumer website (www.consumermedsafety.org) featured a warning about BENADRYL ITCH STOPPING GEL (diphenhydramine), an over- the-counter (OTC) topical product used to relieve itching. The FDA adverse event reporting system has collected at least seven reports of people who have swallowed the product, which has led to serious adverse reactions requiring hospitalization or emergency treatment. Figure 1. Benadryl Gel is dangerous if swallowed. 4
Safety of OTC Medications Despite the potential for harm, OTC medications are quite safe when used as directed. In young children, FDA research shows that dosing errors and accidental ingestions-not not the safety of the ingredients themselves when properly dosed-are the leading causes of rare adverse events. SPECIFIC DRUGS TO WATCH ACETAMINOPHEN FDA recommendation is to limit intake to 4 grams per day Mechanism of Toxicity Nature of Toxicity Sources of Acetaminophen What it all means Aspirin Mechanism of toxicity Nature of Toxicity Sources of Aspirin Recommendations 5
Antihistamines Nature of Toxicity Sources of Antihistamines Recommendations Decongestants Nature of Toxicity Sources of Decongestants Recommendations Natural Products Largely unregulated and untested Potential for drug interactions and side effects Vast body of data-not easy to master Refer to reference http://www.naturalstandard.com/ 6
Sugars Of concern in brittle diabetics OTC sources of sugars Metamucil Cough and Cold Syrups Antacids Recommendations Alcohol Nature of Toxicity Sources of Alcohol-Where to look. Recommendations NSAIDS Nature of Toxicity Sources of NSAIDS-usually in label name Recommendations 7
PPIs and H-2 Receptor Blockers Nature of toxicity Recommendations ISMP Guidelines for Choosing and Using OTC Drugs Make sure that the self diagnosis is as accurate as possible. Do not assume the problem is something going around Choose the product because the ingredients are appropriate for the condition, not because the product has a familiar name. Choose a product with the fewest appropriate ingredients. Products that attempt to relieve every possible symptom are likely to expose people to unnecessary drugs, pose additional risks, and cost more. ISMP Guidelines (Cont) Read the label carefully to determine the correct dose and precautions, including what conditions would make the drug a poor choice When in doubt, ask a pharmacist or doctor what the most appropriate ingredient or product is Ask a pharmacist to identify possible side effects 8
ISMP Guidelines (Cont) Do not take more than the recommended dose Do not take an OTC drug for longer than the maximum suggested time on the label. Stop taking the drug if symptoms worsen Keep all drugs, including OTC drugs, out of the reach of children Pharmacists Role Allow time for patient assessment Recognize problems that are self treatable with OTC medications Advise patients t on proper course of action (no treatment, self-treatment, referral to medical care) Assist in product selection What Pharmacy Needs to do Better Allow time for patient counseling Limit confusing names of products Incorporate OTC products in patient profiles (including natural products) 9
Questions? References Handbook of Nonprescription Drugs 1993; Washington DC: American Pharmaceutical Association No cough and cold medications for little ones, please: Source ISMP http://www.ismp.org/newsletters/ambulatory/archives/200702_1.asp?ptr=y accessed 1/4/2009 OTC drug names-is what you see really what you get?; ; Source ISMP http://www.ismp.org/newsletters/consumer/alerts/otc.asp accessed 12/24/2008 Protecting U.S. Citizens from Inappropriate Medication Use; from ISMP http://www.ismp.org/pressroom/viewpoints/communitypharmacy.pdf accessed 12/24/2008 FDA Statement Following CHPS s Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children; http://www.fda.gov/bbs/topics/news/2008/new01899.html accessed 12/24/2008 Over-the Counter Medicines: Fast Facts http://www.otcsafety.org/media/over_the_counter_medicines_fast_facts.aspx accessed 12/23/2008 Can Over-the Counter Medications be Dangerous if I am Also Taking Prescribed Medications? : http://www.aakp.org/aakp-library/over-the-counter-- medications/index.cfm accessed 12/23/2008 Over the Counter Safety Tips; from AARP http://www.aarp.org/health/rx_drugs/usingmeds/otc_safety_tips.html accessed 12/23/2008 10