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OTC Medications: Need to Know Info for the ATC (how not to let Walgreens kill somebody) MATA Annual Meeting 2016 P. Brent Smith, MD, MSc, FAAFP Primary Care Sports Medicine Family Medical Clinic Cleveland, MS Objectives Review the “schedules” for classifying drugs Review the practical difference between prescription and “Over the Counter” (OTC) Meds Review the professional and legal ramifications of providing/administering OTC medications to athletes with or without physician oversight Review the most common types of over the counter medications including their common dosing, benefits, adverse effects, and interactions Review potential areas of misuse of over the counter medications Disclosures I have no professional relationships, conflicts of interests, etc… to disclose. I do shameless steal images off the internet....which is why there are so many pictures coming up. I tried to avoid deep biochemistry/pharmacology jargon However, I’m always open to new potential conflicts of interest. Why you ask? In all seriousness…. All that follows are suggestions. The dispensing of medication of any type by an ATC is a tricky proposition. (more on this later) Advice #1: If you’re giving it for more than 24-72you need to be talking about it with a doctor Advice #2: Have a primary care (preferably primary care sports medicine doctor) who loves you enough to give you their phone number. What makes a drug available over the counter…? Many drugs are available over the counter (OTC), but can also be prescribed Many dangerous drugs are available over the counter, in fact some drugs are available OTC and prescription Many OTC drugs have potentially dangerous side effects… Drug Schedules Originally began as a method to control addictive substances. Schedule I- illegal No Medically accepted use (Heroin) Schedule II- Highly addictive No refills (Norco) Schedule III- Addictive Considered less addictive than I and II (Ultram) Schedule IV- Potentially addictive Xanax Schedule V- Minimally addictive Lyrica Food and Drug Administration A division of the Department of Health and Human Services (Which also administers medicare/medicaid) 800 approved ingredients that are combined to create over 100000 OTC drugs Founded in 1906 Approximately 15000 employees in their headquarters and 223 field offices What does the FDA regulate…? Food Drugs Biologics Medical Devices Electronic products that give off radiation Cosmetics Veterinary Products Tobacco Products OTC versus Prescription Prescription- regulated by the FDA New Drug Application Process, prescribed by physician/NP/PA, available at a pharmacy, intended for one person OTC- regulated by the FDA through OTC Drug Monographs FDA Process for New Drugs Discovery of new drug molecule Patent filed (10 year timeline) Continued development FDA Trials Released to Public 1-800-BadDrug The Pain Relievers Aspirin NSAID’s Advil (Ibuprofen) Aleve (Naproxen) Acetaminophen (Tylenol) Aspirin (The OG NSAID) Acetysalycilic acid (ASA) Analgesis, anti-pyretic, anti-inflammatory Also decreases platelet activity (this is why we use it for heart attack patients) Inhibits Cyclooxygenase (more COX 1 than COX 2) Derived from willow tree bark, properties known for more than 2 millenia, first isolated in 1763, synthesized in 1897 Reye’s Syndrome Encephalopathy, brain edema, and fatty liver. Rare but occurs when given to children with viral illnesses. Varying recommendations for age at which it is safe to give… 12-16 yo. NSAID’s Non-Steroidal Anti-inflammatories Acts on prostaglandin and thromboxane synthesis Less adverse effects than steroids (weight gain, brittle bones, suppression of natural corticosteroid production) Principal adverse effects are gastric upset (10-20%) and renal damage Ibuprofen (Advil) and Naproxen (Aleve) Same drug OTC and prescription, difference is in strength NSAID’s continued Naproxen sold in 220 mg tablets, prescription is 250 or 500 mg tablets Ibuprofen 200 mg tablets sold in packs of two or advised to take 2 from bottle. Prescription is up to 800 mg. Max dose is 800mg every 8 hours Anti-inflammatory effects kick in above 600 mg. Tylenol Acetaminophen (paracetomol) Antipyretic, analgesic, not very anti-inflammatory (blocks COX 2 in the brain) Discovered in 1877, exact mechanism still unclear High doses can cause liver damage (4 grams in adults) Most effective for pain, fever reduction is mainly for higher temps. Commonly used in conjunction with opiates Excedrin Recommendations Keep a bottle of Tylenol and Ibuprofen (gel caps) in your bag/cabinet Give under 18 with parents permission Give over 18 x 1-2 days, before reconsidering Keep a bottle of chewable 325 mg Aspirin in your bag. Tape the lid on it. Hope it expires before you have to use it. Cough and Cold Antihistamines Decongestants Anti-tussives Expectorants (Mucinex) Often combinations with or without tylenol/ibuprofen Anti-histamines Stabilize histamine cells (H1 cells) making you less reactive to antigens and reduces the inflammatory cascade Claritin (loratidine), Allegra (fexofinadine), Zyrtec (ceterizine) Roughly equal efficacy, sometimes mixed with pseudoephedrine (Claritin-D) Decongestants Vaso-constrictors Can be intranasal or oral Stinging/burning sensation after use. Help with nose bleeds too. But can also cause nose bleeds with continuous use. Sudafed PE Pseudoephedrine Stronger and more effective decongestant Now prescription strength in MS, because it can be used in the manufacture of Methamphetamine Is still available OTC in neighboring states, though behind the counter and monitored It is ILLEGAL to buy and bring it back into MS even if just for personal use. Anti-tussives Dextromethorphan (Robitussin DM) Diphendyramine (Benadryl) Effective but principle side effect is sleepiness and has an abuse potential Remember that benadryl potentiates the affects of some other medications Recommendations Pick one decongestant and one cough suppressant, keep it in your bag. Give to minors with parents permission Give to Adults for up to 72 hours Consider keeping saline nasal spray and Afrin Nasal Spray in your bag Reflux Medications Proton pump inhibitors (Nexium), Histamine 2 blockers (Zantac) and acid neutralizers (Tums) Globally, there is no difference between OTC and Rx formulations, the Rx is just stronger OTC’s are safe and can be used for long periods of time, except frequent use of the acid neutralizers Milk-Alkali syndrome results from pH alterations and excess calcium and can lead to kidney failure or death Diuretics and Bowel Meds Anti-diarrheals Laxatives Diuretics Anti-diarrheal Work by slowing gastric motility, or by changing the pH of the gastric contents. Milk of Magnesia Bismuth subsalcylate (Pepto Bismol) Loperamide (Immodium) Main aim of treatment is stop/prevent dehydration Remember that not all diarrhea is bad…. Laxatives Stimulant versus bulk/osmotic Be very careful when using laxatives, especially stimulant laxatives Stimulant laxatives can negatively affect your electrolytes, can damage the colon over time, and can be abused for weight management purposes. Diuretics Most feature some form of caffeine Weight control, menstrual bloating “Family Planning” Plan B- Emergency birth control Levonorgestrel- which is a common ingredient in oral birth controls and is the hormone present in Mirena Vitamins and Supplements In some ways the trickiest category we will discuss, simply because some of these are not FDA approved/studied. Rules and Regulations related to ATC’s High Points Clearly defined policy regarding who can give OTC meds, how they are dispensed and what meds are stocked and how they are stored Avoidance of distribution to minors without parental consent My Recommendations Have a clearly defined, written and signed policy statement that covers drug administration in the training room and elsewhere Keep locked up, stored properly, and clearly labeled Keep a log of who, what, when and where Be strict about time limits for dispensing medications Have a team physician involved in your process Areas of Abuse Overuse of NSAID’s and tylenol Using laxatives to maintain weight, body image Using diuretics for the same Caffeine Cough syrup Thank you [email protected]