Portage NURS 251 Test 2

OTC are use for what length?

only short term

Pseudoephedrine when combines with other items can make

Crystal Meth

Medications that once required a prescription and are now available OTC

-Allergy medication: Loratadine (Claritin)

-Acid blocker: Esomeprazole (Nexium)

Two goals of FDA OTC drug review

1. Ensuring these medications are both safe and effective

2. Establish appropriate labeling standards

Criteria for OTC status

-Indication for use

-Safety profile

-Practicality for OTC use

Indication for use

Consumer must be able to easily:

-Diagnose condition

-Monitor effectiveness

-Benefits of correct usage must outweigh risks.

Safety profile

Drugs must have:

-favorable adverse event profile

-limited interaction with other drugs

-low potential for abuse

-high therapeutic index

Practicality for OTC Use

Drugs must be:

-Easy to use

-Easy to monitor

Many OTC medications 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

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 include:

-purpose and uses of the product

-specific warnings

-side effects

-substances or activities to avoid

-dosage ingredients

-active ingredients

-warning

-storage information

-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.

When interpreting a "Drug Facts" label, the most important information is

at the top

Active Ingredient and Purpose

Listed together in the first row, quickly tells you:

-what is in the OTC product

-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

-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. 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.

When should a patient seek advice of a health care professional when taking OTC medications?

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.

Many OTC medications use the same

active ingredients

Over-the-counter (OCT) Medications

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.

Medications that do not require a prescription but are kept behind the pharmacy for ID

decongestant pseudoephedrine

What is the best way to understand cough and cold products?

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.

OTC Cough/Cold Medications Common Active Ingredients

1. Guaifenesin

2. Dextromethorphan

3. Chlorpheniramine

4. Phenylephrine

5. Acetaminophen

6. Ibuprofen

Guaifenesin (Pharmacologic class & Use)

-Expectorant

-Productive cough

Dextromethorphan (Pharmacologic class & Use)

-Antitussive

-Dry Cough

Ibuprofen (Pharmacologic class & Use)

-NSAID/antipyretic

-Pain/fever

Phenylephrine (Pharmacologic class & Use)

-Decongestant

-Nasal Congestion

Chlorpheniramine (Pharmacologic class & Use)

-Antihistamine

-Sneezing/runny nose

Acetaminophen (Pharmacologic class & Use)

-Analgesic/antipyretic

-Pain/fever

Allergies

a very common ailment that can often be treated with OTC medications

OTC Allergy Medication Class

Antihistamine

*only recently became OTC status

As recently as 15 years ago, the majority of these medications were available by prescription only.

Antihistamines

-Oral dosage: loratadine (Claritin)

-Nasal steroids: fluticasone (Flonase)

Antihistamines are

not all the same.

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

H2 receptors

play a role in gastric acid secretion

"Antihistamine," it is referencing drugs that

block H1 receptors

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, trouble urinating, and constipation

Select Antihistamines

1. Clorpheniramine

2. Diphenhydramine (Benadryl)

3. Fexofenadine (Allegra)

4. Loratadine (Claritin)

Clorpheniramine

-MODERATE Anticholinergic effect

-LOW Sedative Effect

-Comments: Less drowsiness, more CNS stimulation making it appropriate for daytime use.

Diphenhydramine (Benadryl)

-HIGH Anticholinergic effect

-HIGH Sedative Effect

-Comments: Causes drowsiness in about 50% of patients. Also used for insomnia and nausea

Fexofenadine (Allegra)

-LOW TO NONE Anticholinergic effect

-LOW TO NONE Sedative Effect

-Comments: Longer acting and less side effects

Loratadine (Claritin)

-LOW Anticholinergic effect

-LOW TO NONE Sedative Effect

-Comments: 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.

OTC nasal steroids

-fluticasone (Flonase)

-triamcinolone acetonide (Nasocort)

Another common condition that affects many people

Heartburn

Heartburn OTC medications

Proton Pump Inhibitor (PPI) Examples:

-Esomeprazole (Nexium)

-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.

OTC Heartburn Medications

-Antacids

-H2 Receptor Blockers

-PPIs

Antacids

-Neutralize gastric acidity

-Examples: Tums, Gaviscon, milk of magnesia, Maalox

-Available in many dosage forms

H2 Receptor Blockers

-Competitively block the H2 receptors in acid producing cells in the stomach

Examples of H2 Receptor Blockers

-Cimetidine (Tagamet) *higher drug interaction risks

-Famotidine (Pepcid)

-Ranitidine (Zantac)

PPIs

-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 continuing use.

Examples of PPIs

-Omeprazole (Prilosec)

-Esomeprazole (Nexium)

-Pantoprazole (Protonix)

Pain Medications

Analgesics

Anti-Fever

Antipyretics

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

-in some cases different combinations of medications

The main analgesics available OTC include

-acetaminophen (Tylenol)

-ibuprofen (Motrin or Advil)

-naproxen (Aleve)

-aspirin

The most widely used non-opioid analgesic.

Acetaminophen

APAP abbreviated is falling out of favor in an effort to reduce medication errors. Why?

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 (ibuprofen, naproxen, aspirin)

How does NSAIDs differ from acetaminophen?

they also treat inflammation, making them particularly helpful in treating pain associated with inflammation.

How many different NSAIDs are available in the US?

23 different ones (most of which require a prescription)

Acetylsalicylic acid is also called

Aspirin

Drug marketed in 1899 and quickly became the most widely used drug in the world

Aspirin

Aspirin (taken for & adverse effects)

-provides: pain relief, fever reduction, and had anti-inflammatory properties

-adverse effects: GI intolerance, bleeding, and renal impairment

What drugs were developed like aspirin but without the same side effects?

NSAIDs: ibuprofen and naproxen, are generally better tolerated having lower incidence and less serious side effects compared to aspirin.

OTC Pain Medications

1. Acetaminophen

2. Aspirin

3. Other NSAIDs (Ibuprofen, naproxen)

Acetaminophen (class and special considerations)

-Analgesic class

-Taking more than 4g daily can lead to liver failure. Acetaminophen is in many combination products.

Aspirin (class and special considerations)

-NSAID-salicylate class

-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

NSIAD (class and special considerations)

-propionic acid derivative

-ibuprofen, naproxen

-better tolerated than aspirin. Naproxen has a longer duration of action allowing for less frequent dosing.

Nicotine Replacement Therapy (NRT)

-Prescribers will often request written prescriptions for these products, it is only necessary in order to bill the insurance.

-Available to purchase without a prescription; however, they are often kept behind either the pharmacy counter or the front cashier within a pharmacy.

-Always recommended that patients undergo some sort of behavioral counseling along with the drug therapy to help have the highest success in quitting smoking.

Nicotine is available is how many dosage forms?

-Multiple forms!

-No single smoking cessation product has been shown to be more efficacious than another

Examples of Nicotine Replacement Therapy Dosage Forms

-Transdermal Patch

-Gum

-Lozenge

Transdermal Patch

Uses a stepwise reduction in dose over time

Gum

Best for acute relief of symptoms although the onset of action is 30 minutes compared to 10 minutes with a cigarette.

Lozenge

Can also be used for acute symptoms

Two additional NRT dosage forms available, but they require a physician's order:

-nicotine nasal spray called Nicotrol NS

-nicotine inhaler called Nicotrol

Dietary Supplements

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.

What percent of all all modern drugs are derived from plants

30%

Herbal medicine

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.

*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.

The 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 dietary and herbal supplements regulations:

-In 2002, the US Pharmacopeia began certifying products for purity standards. However, the US Pharmacopeia is an independent organization and products are not required to be certified.

-In 2007 when the FDA began requiring manufacturers of dietary supplements to comply with good manufacturing practices (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.

Dietary and herbal products 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.