2.1 INTRODUCTION
→ WATCH VIDEO 2.1 PART 1
Nonprescription medications, perhaps more commonly known as Table 2.1 Criteria for Over-the-Counter Status
over-the- counter (OTC) medications, are medications
that are available without a prescription and are available in most
Indications for use Consumer must be able to:
cases without restriction. There are a few medications that do not
require a prescription but are kept behind the pharmacy counter and
v Diagnose the condition
v Monitor effectiveness
ID is required for purchase. An example of this would be any
medication containing the decongestant pseudoephedrine.
Benefits of correct use are greater than the risks
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) Safety Profile Drugs Must have:
or the acid blocker esomeprazole (Nexium).
v Favorable adverse events profile
It is important to note the degree of oversight varies between OTC v Limited interactions with other drugs
medications and other options like dietary and herbal supplements. v Low potential for abuse
Starting in 1972, the FDA started an OTC drug review with the goal of v High Therapeutic Index
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.
Practicality for OTC Use Drugs must be:
The second goal was to establish appropriate labeling standards. v Easy to use
During this initial review, many drugs were either found to be v Easy to monitor
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.
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
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glaucoma. It is important to educate patients that have 2
comorbidities to ask a
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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 Figure 2.1 Example of a Drug Facts Label
→ WATCH VIDEO 2.1 PART 2
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.
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