Navigating the Nonprescription Medication Aisle

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1 By: Meagan Freeze PharmD, BCPS Clinical Pharmacist Iowa Methodist Medical Center Meagan Freeze is currently a clinical pharmacist at Iowa Methodist Medical Center in Des Moines, IA. Dr. Freeze completed a PGY1 residency at Iowa Methodist Medical Center and became a board certified pharmacotherapy specialist in Prior to becoming a pharmacist, Dr. Freeze spent eight years working as a technician in the community setting and understands the important role pharmacist and pharmacy technicians serve while helping patients with over-the-counter medications. Dr. Freeze reports no actual or potential conflicts of interest in relation to this continuing pharmacy education activity. This CPE activity provides pharmacy technicians with a brief history of the rules and regulations concerning nonprescription medications, as well as a review of these medications by the disease state they treat or symptom they manage. Upon completion of this activity, Pharmacy Technicians will be able to: 1. Discuss the rules and regulations of non-prescription medications and what differentiates them from prescription medications 2. Idenitfy important points on a nonprescription medication label 3. Describe the different disease states or symptoms commonly treated or managed with non-prescription medications 4. Explain the mechanism of action of the most commonly used non-prescription medications 5. Identify potential contraindications and side effects associated with commonly used non-prescription medication CPE Information: UAN #: H01-T CEUs/Hours: 1 contact hour (0.1 CEU) Target Audience: Pharmacy Technicians Activity Type: Knowledge-based Initial Release Date: 1/1/2015 Planned Expiration Date: 1/1/2018 The Collaborative Education Institute is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity has been developed specifically for pharmacy technicians and is one of 10 activities in the TEAM series. Navigating the Nonprescription Medication Aisle Introduction The general public can purchase any over-the-counter (OTC) medication without medical advice or restrictions, except products containing pseudoephedrine and some Schedule V controlled substances. 2 Research has found that nearly 81% of adults use OTC medications as their first option for treatment of an ailment. 9 Nonprescription drug retail sales were over $33 billion in 2013, which is almost double the sales in 2008 ($16.9 billion). 1 Gaining more knowledge about OTC medications will benefit the pharmacy technician in selecting the necessary medications when self-treating or helping family or friends. It is also important for pharmacy technicians to better understand OTC medications to help identify patients who may be selecting inappropriate products based on comorbidities or wrong indication for use. By the end of this review, the pharmacy technician should gain a better understanding of the history of OTC medications, be able to identify for which disease-states certain OTC medications are commonly used and identify potential patients who would have contraindications to certain OTC products. Background: The OTC class of medications was created by an amendment in The Durham- Humphrey amendment established two classes of drugs: prescription and over-thecounter. 2 With the growing number of drugs available, the amendment was created to protect patients and make a class of medications only usable under medical advice (prescription medications). OTC medications were then further regulated by requiring user-friendly labeling. Examine the label of an OTC medication package. By law, it should contain the following eight items: 2 Clinical pearl: One of the most important concepts to understand about OTC medications is to always look at the active ingredients the product contains. Many brand names of medications (IE: Tylenol PM, Advil PM, etc) contain multiple active ingredients. This is extremely important when deciding which medication one actually needs to take to treat symptoms in order to avoid unnecessary medications and/or duplicate therapy. We will discuss this more in the cough/cold section as these medications often contain multiple active ingredients. Techn icians who work in the community pharmacy setting, may wonder why some medications are found on the pharmacy shelves and also in the OTC aisle. The Food and Drug Administration (FDA) decided some medications could be classified as both OTC and prescription. 2 As discussed earlier, OTC medications must be labeled with adequate directions for use. There are certain disease states that need proper medical advice for adequate use. One example is ibuprofen. OTC ibuprofen is only 2015 TEAM SERIES 1

2 The Use of Over-The-Counter Drugs During Pregnancy 1. Active ingredient and strength 2. Purpose or intended action 3. Uses or Indication 4. Warnings, side effects, contra-indications 5. Directions how to use for use 8. All labels must contain a Questions? area with phone number for patients to contact manufacturer 6. Required monograph information 7. Inactive ingredients (in alphabetical order) available as 200 mg tablets used for mild to moderate pain while prescription ibuprofen is available in 600 or 800 mg tablets and used for treatment of rheumatoid arthritis or osteoarthritis. It is possible for medications to change from prescription to over-the-counter status. Some recent examples include esomeprazole (Nexium ) and triamcinolone acetonide (Nasacort ) nasal spray. A manufacturer who wants overthe-counter status of a prescription medication can submit a supplemental application to its already approved new drug application, petition the FDA, or switch through the OTC drug review process. 2 For a medication review, it is important for techicians to examine how the OTC aisle is organized. All aisles are organized by indication, which is how the review below is set up. Each section is divided by the ailment (pain, allergies, cough/cold, etc) and the medications that are used as treatment. Focus is only on the most commonly used treatment options for adults. Any pregnant or breastfeeding woman should speak with the pharmacist prior to starting an OTC medication. Each listed medication includes the generic and brand name, the typical dose, the adverse events or potential side effects, precautions: individuals who may use but with caution and contraindications; individuals who should not use the OTC medication. Headache Pain is the most common ailment that patients will selftreat with OTC medications. In 2013, sales for OTC pain relievers were close to $4 billion. 1 There are several types of headaches. Tension-type headaches can either be episodic or chronic. More than 75% of the U.S. population will experience a tension-type headache at some point. 9 These headaches typically present as bilateral (both sides), diffuse pain usually described as a tight or a band constricting the head. Migraines headaches are typically recurrent and more likely to occur in women. They are commonly associated with flashing areas or blind spots in visual fields (called aura). Migraines can also occur without aura, but both types typically cause nausea, vomiting, photophobia, tinnitus, dizziness and aggravated by physical activity. Sinus headaches are associated with acute or chronic sinusitis. Pain from sinus headaches is typically focused around the facial areas over the sinuses. Bending over or pain with blowing the nose usually worsens the headache. Treatment options for headaches include: Acetylated Salicylate (Aspirin ) 14,15 Dose: mg every 4 to 6 hours (Max 4000 mg/ day) Mechanism of action: Salicylates inhibit prostaglandin (which is a signal for pain) formation. The reduction in 2015 TEAM SERIES 2

3 prostaglandins thus reduces the pain signal. Adverse events: Aspirin damages the gastrointestinal (GI) lining which can cause inflammation of the stomach and potentially cause an ulcer. Precautions: Those with asthma with nasal polyps may be intolerant to aspirin. Contraindications: Patients on blood thinning medications warfarin (Coumadin ); rivaroxaban (Xarelto ), dabigatran (Pradaxa ) or apixaban (Eliquis ), patients who drink alcohol, before surgery or tooth extraction, hemophilia, bleeding disorders, history of peptic ulcer, history of a GI bleed, vitamin k deficiency, or gout. Those who have had a previous allergic reaction to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs). Acetaminophen (Tylenol ) 14,15 Dose: mg every 4 to 6 hours (Max 3000 mg/ day) Mechanism of action: Exact mechanism is not fully understood but likely inhibits the formation of prostaglandins in the central nervous system, blocks pain impulse and inhibits the heat-regulating center to lower fever. Adverse Events: Typically tolerated well Precautions: For patients on warfarin, limit acetaminophen to no more than 2 grams/day. 16 Contraindications: Existing liver disease, patients who drink alcohol, patients with glucose-6-phosphate dehydrogenase deficiency. Hypersensitivity to acetaminophen. NSAIDs - ibuprofen (Advil, Motrin ) naproxen (Aleve, Naprosyn ) 14,15 Ibuprofen Dose: mg every 4 to 6 hours (Max 1200 mg/day) Naproxen Dose: 220 mg every 6 to 8 hours (Max 660 mg/ day) Mechanism of action: Inhibit the cyclooxygenase enzyme which then inhibits prostaglandin formation thus reducing pain signal. Adverse events: NSAIDs can damage the GI lining which can cause inflammation of the stomach and potentially cause an ulcer. Side effects can include: upset stomach, heartburn, nausea, dizziness, fluid retention Precautions: Those with asthma with nasal polyps may be intolerant to NSAIDs. Contraindications: Those who have had a previous allergic reaction to aspirin or NSAIDs. Patients with heart failure due to risk of fluid retention. History of GI bleed or ulcer. Patients with kidney disease. Clinical Pearls: Typically most patients tolerate any of the above equally for pain relief. 9 As a general rule of thumb, those with liver problems should avoid acetaminophen. Those with kidney problems or who have heart failure should avoid NSAIDs. Patients with ulcers, bleeding disorders, or on blood thinning medications should be advised to choose acetaminophen for pain relief. NSAIDs and aspirin are commonly formulated as enteric coated or EC to help avoid irritating the stomach and should be the formulation chosen when using for pain. Patients should take NSAIDs or aspirin with food to also help with stomach irritation. Case Study #1: A 65-year-old male comes to the pharmacy wanting help selecting a pain reliever for an occasional tension headache. He says he was started on a blood thinner a couple months ago and didn t want anything to interact with his medicine. What further information would you like to know from the patient? A. Have you ever had a stomach ulcer? B. Do you have any problems with your kidneys? C. Do you have any problems with your liver? D. Do you have asthma? Answer: C - Because the patient tells you he is on a blood thinner, he would be excluded from using NSAIDs or aspirin (choices A, B and D). Answers A, B and D are potential contraindications or precautions that may exclude a patient from using NSAIDs or aspirin which we already know the patient should avoid due to his blood thinner. The only option would be acetaminophen for the pain and we would want to know if he has any liver problems because if he did, he may not be able to use acetaminophen. Cough/Cold/Allergies Cough When discussing treatment for cough, it is important to determine whether the cough is productive or nonproductive (cough with phlegm or not). Productive coughs should be treated with guaifenesin as this is an expectorant or a medication that can help thin secretions and make the cough more productive. If it is a dry cough with no production, codeine or dextromethorphan can be used to suppress the cough. Codeine: 14,15 Indication: Cough suppressant of non-productive cough Dose: mg every 4 to 6 hours (Max: 120 mg/day) Mechanism of action: Acts centrally on the medulla to increase the cough threshold. Adverse events: Nausea, vomiting, sedation, dizziness and constipation. Precautions: Use of other depressants such as barbiturates, sedatives, alcohol. Patients with impaired respiratory function (asthma, COPD, emphysema) Contraindications: Hypersensitivity to product Dextromethorphan: 14,15 Indication: Cough suppressant of non-productive cough Dose: mg every 4 hours or 30 mg every 6-8 hours (Max: 120 mg/day) Mechanism of action: Acts centrally on the medulla to increase the cough threshold 2015 TEAM SERIES 3

4 Adverse events: Typically well tolerated but may cause drowsiness, nausea, vomiting, constipation Precautions: Can be abused causing euphoric effects, psychosis, mania. Using with other CNS depressive agents such as alcohol, antihistamines should be avoided. Contraindications: Those on any MAOI medications or who have hypersensitivity to product Guaifenesin: 14,15 Indications: Only FDA approved expectorant. Helps makes coughs more productive Dose: mg every 4 hours (Max: 2400 mg/day) Mechanism of action: Loosens and thins respiratory tract secretions making coughs more productive Adverse events: Generally well tolerated, but can cause nausea, vomiting, dizziness Precautions: High doses may cause kidney stones Contraindications: Hypersensitivity to product Clinical Pearls: Guaifenesin should be taken with a lot of water. The increase in water intake also helps aid in thinning secretions. Codeine-containing cough syrups are sold OTC in some states. In Iowa, they are sold as OTC in select pharmacies. Surrounding states, such as Missouri, require a prescription for cough syrup with codeine. Colds A viral infection of the upper respiratory tract is one of the top five illnesses diagnosed in the United States. 10 Adults on average experience 2-3 colds per year. 11 Cold symptoms typically appear 1-3 days after infection. Usually sore throat is the first symptom followed by nasal symptoms around day 2-3 and occasionally cough 9. The mainstay of treatment is decongestants. These can either be topical or oral. Decongestants Topical Decongestants (Nasal sprays) Oxymetazoline (Afrin, Dristan ): 2-3 sprays every 10 to 12 hours (Max 2 doses/24 hours, max use 72 hours) 14,15 Phenylephrine: (Neo-synephrine ): 2-3 sprays every 4 hours 14,15 Naphazoline (Privine ): 1-2 sprays every 6 hours 14,15 Oral Decongestants Phenylephrine 10 mg PO every 4 hours (Max 60 mg/day) 14,15 Pseudoephedrine 60 mg PO every 4-6 hours (Max 240 mg/day) 14,15 Mechanism of action: Stimulates the alpha-adrenergic receptors which cause constriction of the blood vessels and thus decrease vessel size and mucosal edema. Adverse Events: From oral tablets - elevated blood pressure, increase heart rate, palpitations, restlessness, insomnia, anxiety, tremors) From nasal spray propellants - burning, stinging, local dryness, sneezing. Oxymetazoline - rebound nasal congestion occurs when used longer than 3 days. Precautions: Use with caution in those with high blood pressure, glaucoma, or seizure disorders. Contraindications: Patients may not use oral decongestants if they have taken a monoamine oxidase inhibitor (MAOI) medication within the last 14 days. Hypersensitivity to any of the active ingredients. Clinical Pearls: Cold symptom treatment is typically centered on congestion and a stuffy nose. The most effective treatment is a decongestant. People often complain about ear pain associated with colds. If patients are able to pop the ears, this means there is an increase in pressure and a decongestant would alleviate this symptom. The nasal spray oxymetazoline is often used by patients but should be limited to only 72 hours to avoid rebound congestion. Most patients opt for an oral decongestant to help with symptoms. Patients often choose products containing phenylephrine as these are found over-the-counter, while pseudoephedrine must be purchased at the pharmacy counter. However, studies have often shown that phenylephrine is not an effective decongestant and often does not improve symptoms. Pseudoephedrine has been shown in studies to be a much more effective decongestant. 12 Allergies An estimated 20% of adults have been diagnosed with allergic rhinitis from a study conducted in 2002, but this number continues to climb every year. 8 Typically patients with allergies experience itchy eyes, sneezing, postnasal drip, nasal congestion, fatigue, malaise, cognitive impairment. Mainstay treatments for allergies are antihistamines or intranasal corticosteroids. Intranasal corticosteroids have been shown to be the most effective agents for controlling allergy symptoms. 7 Oral antihistamine medications are classified as first generation and secondgeneration antihistamines. Overall, the main difference is first generation agents will cross into the brain resulting in a better reduction of symptoms but causing severe, typically unwanted, side effects such as drowsiness, dry mouth, constipation, decreased urination. Second-generation antihistamines are usually less effective to treat allergic symptoms but cause fewer side effects. Typically, these are advertised as non-sedating antihistamines. Antihistamines First Generation Antihistamines: Chlorpheniramine (Chlor-Trimeton ): 4 mg every 4 to 6 hours (Max 24mg/day) 14,15 Diphenhydramine (Benadryl ): mg every 6 to 8 hours (Max 300mg/day) 14,15 Doxylamine (Vicks NyQuil ): mg every 4 to 6 hours (Max 75mg/day) 14,15 Pharmacy 2015 TEAM SERIES Series 4 4

5 Pheniramine: mg every 4 to 6 hours (Max 150 mg/day) 14,15 Brompheniramine (Dimetapp ): 4 mg every 4 to 6 hours (Max 24 mg/day) 14,15 Second Generation Antihistamines: Loratadine (Claritin, Alavert ): 10 mg daily (Max dose: 10 mg/day) 14,15 Cetirizine (Zyrtec ): 5-10 mg daily (Max 10 mg/ day) 14,15 Fexofenadine (Allegra ): 60 mg twice daily or 180 mg once daily (Max 180 mg/day) 14,15 Mechanism of action: Antihistamines compete with histamine receptors in central and peripheral sites. Blocking the histamine receptors decreases secretions, itching, etc. Adverse Events: Headache, drowsiness, dry mouth, blurry vision, constipation Precautions: Those with emphysema or COPD, avoid activities that require mental alertness (driving, using heavy machinery), wear sunscreen as medications increase sun sensitivity Contraindications: Acute asthma exacerbation, glaucoma, peptic ulcers. Hypersensitivity to any of the active ingredients. Nasal sprays: Fluticasone Propionate 50 mcg (Flonase ): 14,15 Potential release date: Early 2015 Dose: 2 sprays in each nostril daily or 1 spray each nostril twice a day (maximum 2 sprays per nostril per day) Mechanism of action: Steroid spray that inhibits the inflammatory response Side effects: headache, nose bleeds, cough, sore throat Contraindications: Hypersensitivity to milk proteins or fluticasone Special instructions: When administering, point tip to outside of nose to prevent thinning of septum and nose bleeds Triamcinolone Acetonide 55 mcg (Nasacort ): 14,15 Dose: 2 sprays in each nostril once a day until symptoms are relieved then decrease to 1 spray in each nostril once a day Mechanism of action: Steroid spray that inhibits the inflammatory response Side Effects: headache, nose bleeds, cough, sore throat Contraindication: Hypersensitivity to triamcinolone Special instructions: When administering, point tip to outside of nose to prevent thinning of septum and nose bleeds Cromolyn (Crolom, Nasalcrom ) 14,15 Dose: 1 spray in each nostril 3-6 times daily; (may take 3 to 7 days to start to take effect and 2-4 weeks to reach maximum therapeutic effects) Mechanism of action: It stabilizes mast cells thus prevents the inflammatory response. Side Effects: Sneezing, nasal stinging or burning, bad taste in mouth Precautions: Patients with history of coronary artery disease or irregular heart beat Contraindications: Hypersensitivity to cromolyn products Clinical Pearl: Both Nasacort and Flonase should be equally effective for patients. When steroid sprays were compared, the clinical response did not vary between products. 7 Typically nasal sprays are more effective for allergy symptoms than oral antihistamines because steroid sprays block histamine, eosinophils, leukotrienes, cytokines and prostaglandins. 6 Oral antihistamines block only histamine. Nasal sprays usually take a full week to feel the most symptom relief. Case study #2: A 26-year-old female comes to the pharmacy counter requesting help relieving her allergy symptoms. She says she takes no other medications and has no significant past medical history. She says her allergies are awful. She has been sneezing all weekend. Her eyes are itchy and her nose is running nonstop. She also mentions she has a long week at work and doesn t want to be tired all day at work. She hands you the medication she picked up in the allergy aisle: Tylenol Sinus which contains acetaminophen and phenylephrine per the active ingredients on the label. Your advice should be: A. The active ingredients in this product (acetaminophen and phenylephrine) will not treat your current symptoms. B. The product you selected will be great! Hope it helps your allergies! C. You should try loratadine (Claritin ) 10 mg daily for allergy relief. D. You should try diphenhydramine (Benadryl ) 25 mg every 6 hours for allergy relief. E. A & C F. A & D Answer: E - As discussed earlier, it is extremely important to look at active ingredients of a product, especially cough, cold and allergy medications. This specific product only contained acetaminophen and phenylephrine. The patient did not complain of pain so acetaminophen is not indicated. Phenylephrine is a decongestant, which would exacerbate the patient s already runny nose. The product does not contain any antihistamines which is the mainstay treatment for allergies. (F) would technically be correct; however, the patient did not want a medication that would make her drowsy. Diphenhydramine has more potent side effects because it crosses the blood brain barrier. Loratadine would be the best non-sedating option. Gastrointestinal Disorders Patients frequently seek OTC products for gastrointestinal disorders such as constipation, gas and diarrhea. Below are the main OTC products used to treat these conditions TEAM SERIES 5

6 Heartburn: Heartburn is a term typically used to describe the burning sensation in the esophagus. The symptoms are caused by stomach acid pressing through the lower esophageal sphincter. Treatments are aimed at neutralizing the acid and decreasing acid production. Antacids: 14,15 Magnesium hydroxide Calcium carbonate Aluminum hydroxide Sodium bicarbonate Bismuth subsalicylates Dose: Doses varies from type of product but typically 1-2 tablets as needed for heartburn symptoms. Mechanism of action: Acts as a buffer agent, increases the gastric ph, increases the lower esophageal pressure Adverse events: Typically depends on which cation is in the antacid. Magnesium-based is associated with diarrhea. Aluminum-based can cause constipation. Calcium and sodium bicarbonate-based can cause belching and gas. Precautions: Prolonged use of aluminum-based antacids can cause low phosphorus levels. Antacids can bind other medications so separate use from other medications by at least 2 hours. Contraindications: Magnesium and aluminum-based antacids should be avoided in those with significant renal impairment. Sodium-based products should be avoided in those with congestive heart failure, sodium-restricted diets, cirrhosis, renal failure. Those on itraconazole, ketoconazole and iron (as these medications depend on low ph for absorption) should avoid antacids. Avoid aluminum products if on isoniazid. Clinical Pearls: The most important concept to understand is the side effects of the specific cations. Remember that magnesium is associated with diarrhea, aluminum can cause constipation and calcium and sodium bicarbonate can cause gas. Histamine-2 Receptor Antagonists: Cimetidine (Tagamet HB ): 200 mg with glass of water (Max 400 mg/day) 14,15 Nizatidine (Axid ): 75 mg with glass of water (Max 150 mg/day) 14,15 Famotidine (Pepcid ): mg with glass of water (Max 40 mg/day) 14,15 Ranitidine (Zantac ): mg with glass of water (Max 300 mg/day) 14,15 Mechanism of action: Inhibits the histamine effect from the histamine-2 receptor in the stomach thus decreasing gastric acid secretion. Adverse events: Headache, diarrhea, constipation, dizziness, drowsiness. Cimetidine has the most side effects and can also cause decreased libido, impotence, or gynecomastia in men. Precautions: Those with renal impairment, as often dose reductions are needed in this population. Cimetidine has the most drug interactions. Patients should check with pharmacist for drug interactions prior to starting cimetidine. Contraindications: Hypersensitivity to any of the products. Proton-pump inhibitors (PPI s) 14,15 Lansoprazole (Prevacid ): 15 mg daily for 14 days Omeprazole (Prilosec ): 20 mg once daily for 14 days Esomeprazole (Nexium ): 20 mg daily for 14 days Mechanism of action: Inhibits the proton pump, which irreversibly blocks the final step of gastric acid section. PPI s are considered potent and prolonged anti-secretory medications. Adverse events: diarrhea, constipation, headache Precautions: Do not use for longer than 14 days every 4 months. Patients should check with pharmacist for potential drug interactions (mainly those on clopidogrel) prior to starting. Contraindications: Hypersensitivity to any of the products Clinical Pearls: Esomeprazole (Nexium ) is expected to be released in 2015 and is a similar medication to omeprazole (Prilosec ) and lansoprazole (Prevacid ) which are currently out on the market. Esomeprazole will not necessarily be more effective for most patients, so choosing the cheapest option of the three is the best starting point. Gas: Simethicone (Mylicon, Gas-X ) 14,15 Dose: mg four times daily after meals and at bedtime (Max: 500 mg/day) Mechanism of action: Not fully understood Adverse events: Loose stools Precautions: None Contraindications: Intestinal perforation or obstruction, hypersensitivity to simethicone Constipation: Bulk-forming Agents: Methylcellulose, polycarbophil, carboxymethyl cellulose sodium 14,15 Dose: Dosing varies with product, follow directions per product Mechanism of action: Brings in water into the small intestines which results in a softer and more frequent bowel movement. Adverse events: Diarrhea, flatulence, nausea, stomach cramps Precautions: None Contraindications: Bowel obstruction or perforation 2015 TEAM SERIES 6

7 Emollient: Docusate 14,15 Dose: mg daily or else mg twice daily Mechanism of action: Actively draws water into the stool to soften and ease bowel movement Adverse events: Abnormal taste in mouth, diarrhea, nausea, cramps Precautions: Sudden change in bowel habits of over 2 weeks in duration; use for longer than 1 week, rectal bleeding Contraindications: Do not use with mineral oil. Do not use if you have an intestinal obstruction, acute abdominal pain. Lubricant: Magnesium citrate: 14,15 Dose: ml given once or may be divided into two doses Mechanism of action: Promotes bowel evacuation by causing osmotic retention of fluid, distending colon and increasing peristaltic activity Adverse events: Abdominal pain, diarrhea, gas, nausea, vomiting Precautions: Those with kidney problems, myasthenia gravis, or other neuromuscular disease must check with a health care provider first. Contraindications: Kidney impairment due to risk of causing elevated magnesium levels in the body Hyperosmotic: Polyethylene glycol (Miralax ) 14,15 Dose: 17 g dissolved in 4-8 ounces of water one daily Mechanism of action: As an osmotic agent, it causes water retention in the stool increasing stool frequency Adverse events: Abdominal bloating, cramping, diarrhea, flatulence Precautions: Patients should not use routinely as longterm use can cause electrolyte disturbances. Patients with additional nausea, vomiting, abdominal pain, irritable bowel syndrome or possible bowel obstruction should talk with a health care provider first. Contraindications: Hypersensitivity to polyethylene glycol Stimulants: Senna: 15 mg daily (max: mg/day divided into two doses) or 8.6 mg (max 34.4 mg/day divided into two doses) Refer to product 14,15 Bisacodyl: 5-15 mg as a single dose or 10 mg suppository as a single dose 14,15 Mechanism of action: Stimulates peristalsis by directly irritating the smooth muscle of the intestine. Also alters water and electrolyte secretion, producing net intestinal fluid accumulation and laxation. Adverse events: Abdominal cramps, diarrhea, nausea, vomiting Precautions: Those patients who experience nausea, vomiting, or sudden change in bowel movements lasting >2 weeks Contraindications: Intestinal obstruction, Crohn s disease, ulcerative colitis, appendicitis, Diarrhea: Loperamide (Imodium ) 14,15 Dose: 4 mg after the first loose bowel movement then 2 mg after subsequent loose bowels (Max 8 mg/day) Mechanism of action: Acts directly on the intestinal muscles through the opioid receptor to inhibit peristalsis and prolong transit time. It also reduces fecal volume and increases viscosity. Finally it increases the tone on the anal sphincter. Adverse events: Dizziness, drowsiness, constipation, abdominal cramping, nausea Precautions: Discontinue if constipation, abdominal pain, abdominal distention, or blood in the stool occurs. Those with liver problems should use with caution. Do not continue longer than two days without medical advice. Contraindications: Avoid in those with bloody or black tarry stools, Crohn s or ulcerative colitis and a bacterial cause (IE: salmonella, campylobacter) Bismuth subsalicylate (Pepto-Bismol ) 14,15 Dose: 524 mg every 30 minutes to 1 hour as needed up to 8 doses in 24 hours Mechanism of action: Anti-secretory and antimicrobial action. It also provides anti-inflammatory action. Adverse events: Anxiety, confusion, headache, discoloration of tongue (will turn dark), grayish black stools, ringing in ears Precautions: Use with caution in those also taking aspirin. Avoid taking larger doses than recommended, as it could cause neurotoxicity. Contraindications: History of GI bleeding, bleeding disorder, those with a hypersensitivity to aspirin or bismuth Conclusion As OTC medication use increases, it is important for pharmacy technicians to be familiar with the most common OTC medications. Make sure to always check the active ingredients on the package label and follow instructions carefully. Pay close attention to any specific precautions or contraindications that would exclude an individual from using certain OTC products TEAM SERIES 7

8 REFERENCES: 1. Statistics on OTC Use. Consumer Healthcare Products Association (CHPA). Available at OTCRetailSales.aspx. Accessed on Sept. 26, Abood R. Pharmacy Practice and the Law - Fourth Edition. Sudbury, MA: Jones and Bartlett Publishers; Stein J. New products for pharmacists Drug Topics. Available at: com/drug-topics/news/new-products-pharmacists ?page=0,3. Accessed on Sept. 29, Stein J. New products 6/10/14. Drug Topics. Available at news/new-products-5. Accessed on Sept. 29, Stein J. New Products for Pharmacists. 3/10/2014. Available at com/drug-topics/news/new-products-pharmacists- 2?page=0,3. Accessed on Sept. 29, Nasacort Package Insert. Chattanooga, TN: Chattam, Inc., a Sanofi Company Available at nasacort.com/hcp/downloads/nas_drugfacts_fnl-4. pdf. Accessed on Oct. 2, Wallace DV, Dykewicz MS, Bernstein DI, et al; Joint Task Force on Practice: American Academy of Allergy, Asthma, & Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. The diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin Immunology. 2008;122(suppl 2):S1-S84 8. Fineman SM. The burden of allergic rhinitis; beyond dollars and cents. Ann Allergy Asthma Immunology. 2002;88:S2-S7 9. Berardi RR et al. Handbook of Nonprescription Drugs Fifteenth Ed. Washington DC: American Pharmacists Association; Woodwell DA and Cherry DK. National Ambulatory Medical Care Survey: 2002 Summary. Advance data from vital and health statistics; no.346. Hyattsville, MD: National Center for Health Statistics. August 26, National Institute of Allergy and Infectious Diseases. The common cold. National Institutes of Health. August Available at: Pages/default.aspx Accessed Sept. 16, Horak F et al. A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber. Ann Allergy Asthma Immunology Feb;102(2): Nexium Package Insert. Wilington, DE: AstraZeneca; Micromedex Database. Micromedex 2.0. Truven Health Analytics, Inc. Greenwood Village, CO. Available at: Accessed on Oct. 2, Lexicomp Database. Wolters Kluwer Health, Inc. Hudson, OH. Available at: Accessed Oct. 2, Parra D, Beckey NP, Stevens GR. The effect of acetaminophen on the international normalized ratio in patients stabilized on warfarin therapy. Pharmacotherapy May;27(5): TEAM SERIES 8

9 POST ASSESSMENT QUESTIONS: 1. By law, an OTC medication label must include all of the following except: A. Potential side effects of the medication B. How long it should take for the medication to start working C. Directions on how to take the medication D. Who to call if you have any questions 2. Which amendment divided medications into two classes: prescription and over-the-counter? A. Prescription Drug Marketing Act of 1987 B. Kefauver-Harris Amendment of 1962 C. Federal Food, Drug and Cosmetics Act of 1938 D. Durham-Humphrey Amendment of If a manufacturer wants its product to be changed from a prescription medication to an over-the-counter medication, the manufacturer must: A. Submit a supplemental application to the already approved new drug application B. Petition the FDA C. Have it switched through the OTC drug review process D. Any of the above 4. A patient with high blood pressure presents to the pharmacy with an OTC product and asks if the box of phenylephrine is safe for him to take. Which part of the label would give quick guidance if a patient with high blood pressure should avoid or use caution while taking? A. Directions B. Other Information C. Warnings D. Call the number listed and speak to the manufacturer 5. Your family member recently started using oxymetazoline (Afrin ) nasal spray for her cold symptoms. What advice should you give her concerning potential side effects of the medication? A. Do not use the nasal spray longer than 3 days or you may get rebound congestion B. Do not use the nasal spray longer than 1 week or you may get rebound congestion C. It is ok to use the nasal spray as long as you need, but you may notice some burning when administered D. The nasal spray is likely going to make you drowsy so only use at bedtime 6. Patients with kidney impairment should avoid which of the following constipation medications? A. Magnesium citrate B. Senna C. Bisacodyl D. Docusate 7. A patient comes in to the pharmacy wanting a medication to help his cough. Upon questioning, you learn that he has a very productive cough and is producing a lot of mucus. Which would be the best cough medication to recommend? A. Codeine B. Dextromethorphan C. Diphenhydramine D. Guaifenesin 8. A patient comes to the pharmacy complaining of a headache. He describes his pain as a tight band around his head and asks what he could take to relieve the pain. The headache would be classified as a: A. Tension-type headache and he could try an antihistamine B. Sinus headache and he will need a prescription for an antibiotic C. Tension-type headache and he could try an NSAID D. Sinus headache and he could try pseudoephedrine 9. Which of the following is the correct mechanism of action of dextromethorphan? A. Stimulates the alpha-adrenergic receptors which cause constriction of the blood vessels and thus decreases vessel size and mucosal edema. B. Acts centrally on the medulla to increase the cough threshold C. Loosens and thins respiratory tract secretions making coughs more productive D. Stabilizes mast cells thus prevents the inflammatory response 10. Which medication works by inhibiting the proton pump which irreversibly blocks the final step of gastric acid section and helps relieve heartburn? A. Esomeprazole B. Lansoprazole C. Omeprazole D. All of the above CPE Instructions: 1. Go to click on Technician tab 2. Scroll down to Pharmacy TEAM Series 2015 and click on Register and Log-In (if this is your first time in CEI s website you will need to set up a quick profile by clicking New To CEI ) 3. Click on the box to select the TEAM Series 2015 and click Register 4. On the Payment Transaction Page, scroll down to Pay With An Access Code and type in the access code given to you by your association and click Continue 5. You can now start the TEAM Series right away by clicking Click Here to Go to Activity. Scroll down to activity and all 10 TEAM articles are within your profile! 6. Whenever you want to go back in and complete a TEAM Series activity, go to Log-In, and click on your Profile. Any questions, please contact Cindy Smith at csmith@gotocei.org or TEAM SERIES 69