PHARMACOLOGY MODULE 2

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 combines 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 Indications for use Consumer must be able to: · Diagnose the condition · Monitor effectiveness Benefits of correct use are greater than the risks Safety Profile Drugs Must have: · Favorable adverse events profile · Limited interactions with other drugs · Low potential for abuse · High Therapeutic Index Practicality for OTC Use Drugs must be: · 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. This study source was downloaded by from CourseH on :33:53 GMT -05:00 PHARMACOLOGY MODULE 2 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. Figure 2.1 Example of a Drug Facts Label 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. This study source was downloaded by from CourseH on :33:53 GMT -05:00 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 days period, that patient should seek the advice of a health care professional to rule out any serious conditions that may be going on. 2.2: Common Over-the-Counter Medications (Part 1) 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 Pharmacologic Class Indication/Use Guaifenesin Expectorant Productive cough Dextromethorphan Antitussive Dry Cough Chlorpheniramine Antihistamine Sneezing/runny nose Phenylephrine Decongestant Nasal Congestion Acetaminophen Analgesic/antipyretic Pain/fever Ibuprofen NSAID/antipyretic 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, This study source was downloaded by from CourseH on :33:53 GMT -05:00 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, 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 Comments Chlorpheniramine Moderate Low Less drowsiness, more CNS stimulation making it appropriate for daytime use. Diphenhydramine (Benadryl) High High Causes drowsiness in about 50% of patients. Also used for insomnia and nausea Fexofenadine (Allegra) Low to None Low to None Longer acting and less side effects Loratadine (Claritin) Low Low to None 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 (diarrhea), 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).