Pharmacy Practice 305

What are 4 reasons people use OTC drugs?

More Accessibility, Affordability, Trust, and Empowerment

Why are OTC drugs more accessible than prescription medication?

You don't have to get a prescription from a doctor in order to buy OTC drugs, they are virtually everywhere in the world: convenience store, hotels, gas stations, supermarkets, etc.

Why are OTC drugs more affordable?

Individuals don't need to go to a doctor's appointment which costs money and prescription drugs are much more expensive than OTC's.

Besides the patients gaining from OTC's who else is?

The U.S healthcare system saves billions of dollars , doctors save time from unnecessary visits.

Why do users of OTC trust the medications?

Doctors recommend OTC before recommending Rx drugs and consumers prefer taking OTC when available over prescriptions.

How do OTC drugs help consumers feel empowered?

Consumers believe that OTC's make it easier to treat minor health problems/conditions (96%), they will treat with OTC's first prior to seeking medical help (93%), 70-90% of illness episodes start with OTC's/self-treatment.

What have been the top 5 (in order) of OTC sales?

1) Upper respiratory products

2) Internal analgesics

3) Toothpaste

4) Antiperspirants

5) Heartburn

What is included on a Drug Facts Label?

The Active Ingredients/Purpose, The Uses, The Warnings, The Directions, Other Information, and The Inactive Ingredients.

What does the Active Ingredients section in a Drug Facts label tell you?

About the part of the medicine that makes it work- it's name, what it does, and how much is in each pill or teaspoon.

What does the Uses section in a Drug Facts label tell you?

The problems the medicine will treat

What does the Warning section in a Drug Facts label tell you?

- when you should talk to your doctor first

- how the medicine might make you feel

- when you should stop using the medicine

- when you shouldn't use the medicine

- things you shouldn't do while using the medicine

- to check with a doctor before using medicine if you are pregnant or breast feeding

- to keep medicines away from children

What does the Direction section in a Drug Facts label tell you?

- how much to use

- how to use it

- how often to use it (how many times per day/how many hours apart)

- how long you can use it

What does the Other Information section in a Drug Facts label tell you?

How to keep your medicine when you aren't using it/how to store it.

What does the Inactive Ingredients section in a Drug Facts label tell you?

Any parts of the medicine that aren't active. These ingredients help form a pill, add flavor or color, or help the medicine last longer.

How many adults admit to taking more than the recommended dose of OTC medications?

1 in 5 adults, most people only read some of the Drug Facts label and miss information essential to the drug's proper use.

Why is it easy to overdoes on acetaminophen?

It is used in a lot of other OTC's (Tylenol, cough medicines, allergy remedies, prescribed pain relievers, etc.)

How many people read the Drug Facts Label thoroughly?

1 in 10 people

Who mainly consumes OTC drugs?

40% of OTC consumers are 65 years and older.

Who is most at risk with the use of OTC drugs?

Those with chronic health problems.

What is not an OTC drug?

dietary supplements, vitamins, deodorant (Antiperspirant is an OTC)

Why do some people take more than the recommended daily dose of OTC drugs?

- Consumers are in a higher pain state, they will take more thinking it will help the pain go away faster or take the medication too soon after their previous dose.

- Consumers that don't have knowledge on medical language .

What was established in 1906?

The Pure Food and Drug Act.

What did the Pure Food and Drug Act do?

Established the FDA and this is how regulations of drug started. This act also required that things were labeled with what was in the food or drugs.

3 Big Topics:

- Strength and Purity

- Adulteration and misbranding

- Establish the FDA

What was established in 1938?

Food, Drug, and Cosmetic Act.

Why was the Food, Drug, and Cosmetic Act passed?

Due to the Elixir of Sulfanilamide Tragedy, this is what started the FDCA. It was an antibiotic that was given to children but was actually antifreeze.

What did the Food, Drug, and Cosmetic Act do?

Drugs has to be tested for safety before selling to consumers as well as direction for drug use and warnings. Cosmetic and devices were added to the things that the FDCA regulated.

What was established in 1951?

The Durham-Humphrey Amendment.

What did the Durham-Humphrey Amendment do?

Created a distinction between OTC and prescription drugs, some drugs were too difficult to take/monitor or there was too much variability in dosing.

How do you distinct the differences between Legend (Rx) and Non-legend (OTC)?

Needs a prescription in order to take the drug, consumers can safely use with the Drug Facts label that includes directions.

What was established in 1962?

The Kefauver-Harris Amendment.

Why was the Kefauver-Harris Amendment created?

Due to the Thalomide disaster, this amendment strengthens the pre-approval clinical trials to study more in-depth of safety and effectiveness of drugs.

How can someone change a drug to an OTC medication?

FDA authorized to switch:

- Drug manufacturer can request approval of switch

- Manufacturer many petition FDA

- Drug may be switched through the OTC drug review process (primary way)

What is the Wide Safety Margin?

What determines a drug to be an OTC, meaning that if large amounts of the drug is ingested then a negative effect would happen.

What is a Drug Defined as by the FCDA?

- A substance recognized by official pharmacopeia or formulary.

- A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

- A substance (other than food) intended to affect the structure or any function of the body.

Who are the Official Compenida?

- US Pharmacopeia (USP)

- National Formulary (NF)

- Homeopathic Pharmacopeia of the US (HPUS)

What is the process that a product has to go through in order to be classified as a Drug?

1) Drug Approval Process

- Testing, NDA, post-market surveillance

2) Label + Labeling requirements

- Tamper evident packaging

3) Package

- Print, TV, Internet

What are the requirements for label and labeling?

- Includes label on container as well as the box containing the container

- Labeling is all other material, including package insert

- All text is approved by the FDA

- Package needs to be tamper evident

What are the advertising regulations for OTCs?

- claims need to be true

- no misleading of informed consumer choice

What are primary headaches?

- Migraine

- Tension-type

- Cluster

What are secondary headaches?

- Tumor

- Meningitis

- Sinus

- Alcohol use hangover

Can all headaches be treated with OTC medications?

No, sometimes OTC medications can make it worse!

What are some signs that you need to go to the ER?

Sudden crushing headache pain and clouded thinking or if one side of the body stops working.

What are some symptoms of a Sinus Headache?

Deep constant pain in the cheekbones, forehead, and bridge of the nose. Sudden movement of head intensifies pain, there is nasal discharge, feeling of fullness in the ears, fever and facial swelling.

What are some symptoms of a Tension Headache?

Mild to moderate pain on the front, top, or sides of the head. Pain begins gradually, often occurs in the middle of the day. Pain lasts 30 minutes to several days.

Can prescription drugs help with Tension Headaches?

No, OTC medications work!

How many Americans over the age of 12 suffer from Migraines?

29.5 million Americans, that is 1 of every 10 people.

What sex is more likely to suffer from Migraines?

Women are more likely than Men (3:1).

Can children get Migraines?

Yes.

Is Migraines a disabling disease?

Yes, one of the 19 most.

What age do migraines peak?

- 30-60 years of age, the most productive time in age.

- Women is around 20-40 years of age, migraines tend to go away after menopause age.

What is a Migraine?

A neurological disorder of the central nervous system and is hypersensitive to specific triggers and stimuli and can be family/genetic connection. There's an inflammatory response!

What are the phases of a Migraine Attack?

1) Premonitory/Prodrome

2) Aura

3) Headache

- Mild

- Moderate to Severe

4) Postdrome

What phase of a Migraine attack is the early intervention point?

In the Headache stage where it is mild.

What are some premonitory behaviors in MIgraines?

Elated, irritable, depressed, neck stiffness, food cravings, fluid retention, thirsty, or drowsy.

- Family members can notice these subtle psychological changes.

What is the Aura stage in a Migraine Attack?

This is the stage where visual field looks weird, like a dark circle in the middle of the visual field.

- This stage only lasts minutes.

What is the Headache stage in a Migraine Attack?

- Moderate to severe unilateral, throbbing pain

- Symptoms include: nausea, vomiting, photophobia(light), phonophobia ( sound)

What is the best non-drug solution for Migraine Attacks?

Sleep.

What is the Postheadache stage in a Migraine Attack?

Mood changes - a lot of people become depressed

Muscular weakness - medicine CAN'T fix this

Physical Tiredness

Reduced Appetite

What are some signs or symptoms of possible migraines?

- One sided pain

- Moderate or severe pain

- Throbbing pain

- Pain aggravated by routine activity

- Nausea or vomiting

- Aversion to light or sound

Are Migraines genetic?

Yes, people with parents that get reoccurring migraines are very likely to get Migraines as well.

What are some triggers and aggravating factors that induce Migraines?

- Fasting

- Medication - analgesic overuse

- Circadian Rhythms - changes in sleep/wake cycles

- Environment - weather, lighting, fragrances/odors

- Hormones - PMS, oral contraceptives, pregnancy, menopause, menses

- Stress/Overexertion

What is the Migraine Evolution?

- All headache disorders are on a spectrum

1) Episodic Migraines

2) Tension-Type Migraine

3) Mixed Headache

4) Chronic Daily Headache

What kinds of treatments help with Migraine Attacks?

Medications

- Acute: Taken when a migraine is experienced and treats pain and other symptoms AFTER the attack has begun

- Preventative: Taken daily and reduced the frequency and intensity of attacks

What are Acute Migraine Medications?

These are prescription only drugs are not meant to be taken a lot.

What are some common Non-Rx Headache Medicines?

Tylenol and Aspirin

Is Tylenol the best option to take for headaches?

No, not that good of an anti-inflammatory drug.

What are some side affects of Tylenol when taken over the maximum daily does?

Irreversible liver failure, be careful when taking other drugs with Tylenol as lot of OTC's have acetaminophen in them.

What is the maximum daily dose of Tylenol?

4000 mg/day or 4g/day

What should you not have when taking Tylenol?

Alcohol because it increases cytochrome levels which is bad as this is what metabolizes acetaminophen. But most importantly don't take Tylenol after a night of drinking it makes it worse!

Is Aspirin a good medication to take when having a Migraine Attack?

Yes, it is a good anti-inflammatory drug and should be taken early in the migraine attack to be the most helpful.

What are some side affects of Aspirin?

Can cause an upset stomach, GI bleeding/ulcers, and Tinnitus.

What is ASA and Reye's Syndrome?

A 2-phase illness and is a disease that affects the liver and brain. This disease occurs in kids that take aspirin when they're sick. After the age of 12 the risk goes away.

What are the stages of Reyes Syndrome?

Stage 1:

- Persistent or continuous vomiting

- Drowsiness, loss of pep and energy, and listlessness

Stage 2:

- Personality Change: Irritable, Aggressive

- Disorientation: Irrational behavior, Combative, delirium, convulsions, coma

Can caffeine help with migraines?

Yes, caffeine helps with migraines as it speeds up the gut activity that is why there are caffeine-containing medications. But, caffeine withdrawl can trigger migraines.

What is a NSAIDs?

non-steroidal anti-inflammatory drugs

(ex: Ibuprofen or Naproxen)

What are some risk factors for Upper Gastrointestinal Ulceration?

- Chronically taking high doses of medications

- Using two NSAIDS at the same time

- Prolonged use of NSAID

- High does of NSAID

- Increasing age

- Concurrent use of certain steroids

What can you do to Mitigate Upper Gastrointestinal Ulceration?

- Making sure to drink fluids

- Wait for a couple of minutes until laying down after taking NSAID

- Making sure to eat!

Why do some products contain antihistamines?

Consumers use this when having headaches because they make you sleepy and sleep is good for headaches.

Can chronic daily use of medications cause headaches?

Yes, taking acute medication for headache should only be limits to 1-2 days per week not a daily occurrence.