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 100000836551366 from CourseHero.com on 02-16-2022 08:39:05 GMT -06:00
https://www.coursehero.com/file/78909334/Pharmacology-Module-2docx/
, 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 100000836551366 from CourseHero.com on 02-16-2022 08:39:05 GMT -06:00
https://www.coursehero.com/file/78909334/Pharmacology-Module-2docx/
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 100000836551366 from CourseHero.com on 02-16-2022 08:39:05 GMT -06:00
https://www.coursehero.com/file/78909334/Pharmacology-Module-2docx/
, 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 100000836551366 from CourseHero.com on 02-16-2022 08:39:05 GMT -06:00
https://www.coursehero.com/file/78909334/Pharmacology-Module-2docx/
