PHARMACOLO NURS 251 MODULE 2

Module 2 2.1: Introduction 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 :25:24 GMT -06:00 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.