Nonprescription medications, perhaps more commonly known as over-the-counter (OTC) medications, are medications that are available without a prescription and are available in most cases without restriction. There are a few medications that do not require a prescription but are kept behind the pharmacy counter and ID is required for purchase. An example of this would be any medication containing the decongestant pseudoephedrine. Pseudoephedrine when combined with other easily obtainable items can be used to make crystal meth. In recent years, many medications that once required a prescription are now available OTC. Common examples of this would be the allergy medication loratadine (Claritin) or the acid blocker esomeprazole (Nexium). It is important to note the degree of oversight varies between OTC medications and other options like dietary and herbal supplements. Starting in 1972, the FDA started an OTC drug review with the goal of ensuring these medications are both safe and effective. In general, there are commonly accepted criteria that would make a medication appropriate for OTC status. Table 2.1 below lists this criterion. The second goal was to establish appropriate labeling standards. During this initial review, many drugs were either found to be ineffective or in some cases even unsafe. The medications determined to be unsafe were removed from the market. Over time, most drugs that were deemed ineffective have also disappeared from the shelves. Table 2.1 Criteria for Over-the-Counter Status Consumer must be able to: Indications for use · Diagnose the condition · Monitor effectiveness Benefits of correct use are greater than the risks Drugs Must have: Safety Profile · Favorable adverse events profile · Limited interactions with other drugs · Low potential for abuse · High Therapeutic Index Drugs must be: Practicality for OTC Use · Easy to use · Easy to monitor It is important to keep in mind that OTC medications are not without their risks, especially for patients that may have other comorbidities (other chronic diseases). Many of the medications available over the counter may cause harm in patients with diseases such as diabetes, hypertension, cardiovascular disease, and glaucoma. It is important to educate patients that have comorbidities to ask a health care professional prior to taking OTC medications, especially if they intend to take the medication continuously. In most cases, OTC medications are simply treating symptoms and are not getting to the cause of the problem. In some cases, the use of OTC medication can prevent someone from seeking the necessary treatment needed for the underlying cause of their symptoms. In other cases, such as the common cold, the symptoms will resolve on their own. The OTC medications do not shorten the length of the cold; they only help ease the patient’s discomfort. For this reason, depending on the patient’s comorbidities, it may be appropriate to recommend against a certain OTC treatment. Drug Facts Labels As a result of the FDA review of OTC medications, a new requirement was established stating that all OTC medications were to include a ‘Drug Facts’ label with the following information: purpose and uses of the product, specific warnings, side effects, substances or activities to avoid, dosage ingredients, and active ingredients, warning, storage information, and inactive ingredients. Although all consumers should understand the ‘Drug Facts’ label on OTC medications, it is especially important for health care professionals to understand this label. As shown in Figure 2.1 below, the Drug Facts label is a representation of what would be found on a typical OTC medication available today. When interpreting a “Drug Facts” label, the most important information is at the top. Active Ingredient and Purpose. Listed together in the first row, these are two pieces of information that quickly tell you what is in the OTC product and what class of drug it is in, which tells you what it could be used to treat. Uses. The recommended uses of the drug are listed out for the consumer. Warnings. As previously mentioned, there are many OTC medications that may not be safe if you have other comorbidities. Essential information is usually included under this section. Additional information within this section may include when to consult a doctor or pharmacist prior to use as well as common side effects that can occur. For instance, there is often a statement regarding if a patient is pregnant or breastfeeding, then they should ask their health care professional prior to use. This is the case even for medications that are rated a pregnancy category A (see Module 1). A warning for keeping medication out of the reach of children is also included in this section. Directions. Standard dosages are often divided by age and include information on the amount/number and frequency someone should take of the medication. Other Information. This section often contains important information relative to the proper storage conditions. Avoiding certain conditions such as extremes in temperate (cold or hot) or excessive moisture ensures the stability of the medication. Inactive Ingredients. The presence of certain ingredients, although inactive, may cause unwanted allergic reactions. It is important to keep in mind that OTC medications are generally intended for short term use. If a patient feels that they need an OTC medication for daily use for more than a 7-10 day period, that patient should seek the advice of a health care professional to rule out any serious conditions that may be going on. There are literally hundreds of thousands of OTC medications available to the US consumer. However, many of these medications use the same active ingredients. This can be quite confusing to the average consumer trying to select a product off the shelves. However, with some basic understanding of the most common active ingredients used in these products, what once seemed overwhelming can become much more manageable. Cough and Cold Cough and cold products are probably the most confusing to the average consumer. They are marketed heavily by the manufacturers with different wording on the front of the package. It is always best to simply turn the package around and look at the Drug Facts label. By doing so, you will know exactly what is in the product and what symptoms it can and should be used to treat. Often times, if you go by the marketing on the front, you will end up taking a medication that has more than what you need or something in it that you do not actually need to take. See Table 2.2 below for a list of common active ingredients found in many cough and cold products found on the shelves. Table 2.2 Common Active Ingredients Found in OTC Cough and Cold Products Drug Name Guaifenesin Dextromethorphan Chlorpheniramine Phenylephrine Acetaminophen Ibuprofen Pharmacologic Class Expectorant Antitussive Antihistamine Decongestant Analgesic/antipyretic NSAID/antipyretic Indication/Use Productive cough Dry Cough Sneezing/runny nose Nasal Congestion Pain/fever Pain/fever Allergies Allergies are a very common ailment that can often be treated with OTC medications. In fact, antihistamine, the primary medication class used to treat allergies, is a good example of a class of medications that only recently became OTC status. As recently as 15 years ago, the majority of these medications were available by prescription only. This included some of the more common oral dosage forms such as loratadine (Claritin) as well as the nasal steroids such as fluticasone (Flonase). Antihistamines are not all the same. Specifically, there are two types of histamine receptors in the body. Depending on if the drug is targeting H1 receptors or H2 receptors, their therapeutic effect is going to vary greatly. H1 receptors act on smooth muscle contractions and the dilation of capillaries, while H2 receptors play a role in gastric acid secretion. When using the term “antihistamine,” it is referencing drugs that block H1 receptors. Alternatively, drugs that block H2 receptors are simply called “H2 blockers.” Antihistamines function by competing with histamines found within the body for the H1 receptors. There are several antihistamines available, all of which vary in their potency and adverse effects, especially in their amount of drowsiness produced. One factor that determines their adverse event profile is how strongly they exhibit something called anticholinergic effects. Anticholinergic effects occur when a drug blocks acetylcholine at its receptor site. Anticholinergic effects include drying effects such as dry mouth, dry eyes, blurred vision, trouble urinating, and constipation. Table 2.3 below provides some examples of common antihistamines and how they differ in their characteristics. Table 2.3 Select Antihistamines Select Antihistamines Anticholinergic effect Sedative Effect Chlorpheniramine Moderate Low Diphenhydramine (Benadryl) High High Fexofenadine (Allegra) Loratadine (Claritin) Low to None Low Low to None Low to None Comments Less drowsiness, more CNS stimulation making it appropriate for daytime use. Causes drowsiness in about 50% of patients. Also used for insomnia and nausea Longer acting and less side effects Longer acting and less side effects Antihistamines are commonly indicated for the management of nasal allergies, urticaria (itching) and symptoms of the common cold. Other uses of some antihistamines include motion sickness, Parkinson’s symptoms, vertigo, and insomnia. Nasal Steroids are another example of medications that are new to the OTC classification. Examples of OTC nasal steroids include fluticasone (Flonase) and triamcinolone acetonide (Nasocort). Heartburn Heartburn is another common condition that affects many people. Depending on severity, it can often be treated with OTC medications. Once again, there are OTC medications used to treat heartburn that only recently became OTC. For example, a common Proton Pump Inhibitor (PPI), esomeprazole (Nexium) became available without a prescription in 2014. Prior to esomeprazole going OTC, omeprazole (Prilosec OTC) became the first in the class of PPIs to be available without a prescription. Other classes of medications used to treat stomach acid include antacids and H2 receptor antagonists. Acid-related pathophysiology will be covered in more detail in the GI module later in this course. This section will focus on the OTC treatments available to patients when self-treating typical heartburn symptoms (see Table 2.4 below). Table 2.4 OTC Treatment Options for Heartburn Acid Controlling Drug Classes Examples Mechanism Special Considerations Antacids Tums, Gaviscon, milk of magnesia, Maalox Neutralize gastric acidity Available in many dosage forms Cimetidine (Tagamet) Competitively block the H2 receptors in Cimetidine (Tagamet) has a acid producing cells in higher risk of drug interactions the stomach H2 Receptor Blockers Famotidine (Pepcid) Ranitidine (Zantac) Omeprazole (Prilosec) PPIs Esomeprazole (Nexium) PPIs bind to the proton pump responsible for secretion of gastric acid If need daily treatment for more than 14 days should consult with a physician prior to Pantoprazole (Protonix) continuing use. Pain/Fever Analgesics (pain medications) and antipyretics (anti-fever) medications make up a large portion of the OTC shelves in today’s pharmacies. The majority of the products vary in strength, dosage form, or in some cases different combinations of medications. The main analgesics available OTC include acetaminophen (Tylenol), ibuprofen (Motrin or Advil), naproxen (Aleve), and aspirin. Note: Analgesics as a class will be covered in more detail in the Neurology/Psychiatry Module. This module will focus on the OTC medications available for the treatment of pain or fever. Acetaminophen is the most widely used non-opioid analgesic. Although historically abbreviated APAP, the abbreviated form is falling out of favor in an effort to reduce medication errors. Additionally, patients may not recognize the abbreviation and could possibly use OTC acetaminophen in addition to a prescription medication containing acetaminophen leading to the risk of overdose. Taking more than the recommended daily dose of acetaminophen can lead to liver toxicity. NSAID (Non-steroidal anti-inflammatory drug) is an additional class of analgesics from those mentioned above (ibuprofen, naproxen, aspirin). They differ from acetaminophen in that they also treat inflammation, making them particularly helpful in treating pain associated with inflammation. There are actually 23 different NSAIDs available in the US, most of which require a prescription. This section will focus on the few commonly available OTC. See Table 2.5 below. Acetylsalicylic acid (Aspirin) was first marketed in 1899 and quickly became the most widely used drug in the world. It quickly became clear that aspirin provided pain relief, fever reduction, and had anti-inflammatory properties. However, it also became clear that it had the potential of causing many adverse events including GI intolerance, bleeding, and renal impairment. For these reasons, efforts to develop drugs that did not have the same side effect profile were initiated. These other NSAIDs, for example, ibuprofen and naproxen, are generally better tolerated having lower incidence and less serious side effects compared to aspirin. Table 2.5 OTC Analgesics OTC Pain medications Class Acetaminophen Analgesic Aspirin NSAID- salicylate Other NSAIDs (ibuprofen, naproxen) NSAID- propionic acid derivative Special Considerations Taking more than 4g daily can lead to liver failure. Acetaminophen is in many combination products. Inhibits platelet aggregation- should be given at first sign of heart attack. This is also why a 81mg (baby aspirin) is recommended for cardiac protection. Better tolerated than aspirin. Naproxen has a longer duration of action allowing for less frequent dosing. Smoking Cessation Nicotine replacement therapy (NRT) is the last category of OTC medication that we will cover in this module. Although prescribers will often request written prescriptions for these products, it is only necessary in order to bill the insurance. These products are available to purchase without a prescription; however, they are often kept behind either the pharmacy counter or the front cashier within a pharmacy. As shown in Table 2.6, nicotine is available in multiple dosage forms. No single smoking cessation product has been shown to be more efficacious than another. However, it is always recommended that patients undergo some sort of behavioral counseling along with the drug therapy to help have the highest success in quitting smoking. Table 2.6 Examples of Nicotine Replacement Therapy Dosage Forms Dosage Form Transdermal Patch Gum Lozenge Unique characteristics Uses a stepwise reduction in dose over time Best for acute relief of symptoms although the onset of action is 30 minutes compared to 10 minutes with a cigarette. Can also be used for acute symptoms It should also be mentioned that there are two additional NRT dosage forms available, but they require a physician’s order. They include a nicotine nasal spray called Nicotrol NS and a nicotine inhaler called Nicotrol. Dietary Supplements and Herbal Therapies A Dietary supplement is a product that contains an ingredient intended to complement the diet, such as vitamins, minerals, herbs, or other botanicals. Herbs come from nature and have been used for thousands of years to help maintain good health. In fact, about 30% of all modern drugs are derived from plants. Herbal medicine, which is defined as the practice of using herbs (plant components including bark, roots, leaves, seeds, flowers, fruit of trees, and extracts of these plants) to heal, fell out of favor in the early part of the twentieth century. However, in the last 75 years, there has been increased interest and attention given to this area of medicine. Alternative medicine can be defined as herbal medicine, chiropractic, acupuncture, massage, reflexology, and any other therapies traditionally not emphasized in Western medical schools. This increase of interest in alternative medicine led to the establishment of the Office of Alternative Medicine in 1992 by the National Institutes of Health. However, the name was later changed to The Center for Complementary and Alternative Medicine. Complementary medicine is defined as alternative medicine when used simultaneously with, rather than instead of, standard Western medicine. The main difference regarding the regulation of dietary supplements and herbal supplements relative to prescription and OTC medication is that they have no requirement to show proof of efficacy. Despite the lack of requirements, there have been some improvements in recent years. In 2002, the US Pharmacopeia began certifying products for quality and purity standards. However, the US Pharmacopeia is an independent organization and products are not required to be certified. Another recent change came in 2007 when the FDA began requiring manufacturers of dietary supplements to comply with good manufacturing practices. Good manufacturing practices meant that for the first time manufacturers would be required to provide data demonstrating product identity, composition, quality, purity, and strength of active ingredients. Companies must also demonstrate that their products are free from any contaminants. There is a general mindset that since dietary supplements and herbal remedies are natural, that they are safe. However, this is not the case. Dietary and herbal products can cause adverse effects, toxic effects and allergic reactions just like prescription and OTC medications. One major concern is that many patients taking these supplements do not disclose it to their physician. This can cause problems because supplements can have drug interactions with other medications causing unwanted side effects. Table 2.7 below will highlight some of the more commonly used supplements and those that have some evidence supporting their use. Table 2.7 Commonly Used Supplements with known Evidence and Safety Data Supplement Common Uses Depression, St. John’s Wort anxiety, sleep disorders Evidence There is some evidence to support the use for Should not be combined with certain antidepressants. depression although it is Also has many potential drug interactions. inconsistent at best The most recent Ginkgo research shows a lack of efficacy Conflicting evidence for lowering cholesterol. Garlic Cardiac Health Minimal, weak evidence for lowering blood pressure Will not shorten the Stimulate the length of a cold but may Echinacea immune prevent you from getting system a cold Yes- there is even an Omega-3 Fatty Cholesterol FDA approved Acids reduction prescription product available- Lovaza Prevent memory loss Glucosamine Arthritis pain and Chondroitin Safety Evidence is conflicting, and experts disagree Generally safe and well tolerated Generally safe in the amounts ingested in food. Does increase bleeding and has some known drug interactions. Generally safe and well tolerated for people taking it orally for short term use Generally safe and well tolerated Generally safe and well tolerated. Drug interaction with warfarin a blood thinning agent. Table 2.7 (above) gives a representation of the evidence available for the use of supplements. Most commonly, even when there are studies conducted, the evidence is either weak or conflicting. In the instance above where there was strong evidence (see Table 2.7; Omega-3 Fatty Acids), there is actually a prescription product available called Lovaza that has been approved by the FDA meeting safety and efficacy standards.
