Pharm Chapter 1: Info Sources, Regulatory Agencies, Drug Legislation, & Prescription Writing

STUDY GUIDE:

Be able to recognize online sources for drug information.

• Mosby's Dental Drug Reference

•Lexi-Comp's Drug Information Handbook for Dentistry

• Phone App: Epocrates

• PDR for Herbal Meds

• Merck Manual for Medical Info

• Drug Interaction Facts

• mayo clinic

• FDA

• STOP GOOGLING...Wikipedia may not be a reliable sources

What is the Harrison Narcotic Act about?

Established in 1914 and developed regulations governing the use of opium, opiates, and cocaine

• in 1937, marijuana laws were added

• type of regulatory agency

When was the US FDA founded? What year?

established in 1906

• part of the US Dept of Health & Human Services (DHHS)

What does the US Food and Drug Administration regulate?

• Grants approval for drugs marketed in the US

• Sets standards for quality control in drug manufacturing plants

• Determines which drugs can be sold by prescription and OTC

• Regulates the labeling and advertising of prescription drugs

Know the difference between chemical, generic, and trade names.

• Trade name is also known as the brand name -- can have multiple

• Only one generic name per drug

• Chemical names are determined by chemical structure, using a unique code

Are there any differences in trade and generic drugs?

the active ingredient is identical, but the formulation may be different

• usually, the brand name drugs are more expensive

When can a drug NOT have a generic brand?

when the patent for a new drug is still active

• a patent for a drug is good for 20 years (from the date of filing it)

• but it takes up to 8-10 years for a drug to hit the market

Know common trade names for ibuprofen.

• Motrin

• Advil

In order for drug substitution (a drug to have a generic brand), what 3 things should happen?

1. Chemically equivalent

2. Biologically equivalent

3. Therapeutically equivalent

What does chemically equivalent mean?

two formulations of a drug meet the chemical and physical standards established by regulatory agencies

What does biologically equivalent mean?

Two formulations of a drug produce similar concentrations of the drug in blood and tissues

What does therapeutically equivalent mean?

Two formulations of a drug have an equal therapeutic effect

What information does the "package insert" contain?

• Chemical makeup of the drug

• FDA-approved indications for use

• Contraindications

• Warnings

• Adverse reactions

• Drug interactions

• Dose & administration

• How supplied

What is a "Black Box Warning" in the prescribing information (package insert) for an FDA approved drug?

required by FDA

• purpose: to draw attention to specific, serious safety concerns associated with the drug

○ potentially fatal, life-threatening, or disabling adverse effects

• educates both prescriber and patient about serious safety concerns associated with the drug

• it gets updated as new info becomes available...

○ you shouldn't consult an outdated product insert

What is the process of new drug development?

• Preclinical

• Clinical: phase 1, 2, 3

• NDA Review

• Post-marketing surveillance: phase 4

Know the phases of the clinical trial. What are they?

• Phase 1

• Phase 2

• Phase 3

• Phase 4

What is Phase 1?

small and then increasing doses are administered to a limited number of healthy human volunteers

• determines biologic effects, metabolism, safe dose

• the main purpose: is it safe?

What is Phase 2?

larger groups of humans are given the drug

• the main purpose: to test effectiveness (efficacy) of the drug

• adverse reactions are reported to the FDA

What is Phase 3?

clinical evaluation involving a large number of patients who have the condition for which the drug is indicated

• multi-center

• double-blind & placebo-controlled

• safety and efficacy must be demonstrated

• dosage is determined

What is Phase 4?

post-marketing surveillance

• toxicity that occurs in patients (adverse reactions) taking the drug after it is released is recorded

• drugs gone through preclinical and clinical studies and approved by FDA can be removed from the market due to unforeseen serious adverse reactions

When is a drug put on the market?

After the NDA review and right before phase 4

What are "scheduled" drugs?

controlled substances

• drugs with abuse potential (addiction)

• usually psychoactive drugs

How are scheduled drugs categorized?

categorized into 5 (I to V) schedules according to their abuse potential:

• Schedule I drugs have the highest abuse potential (illegal street drugs)

• Schedule V drugs have the least

What are examples of schedule I and schedule II drugs?

• Schedule I: heroin, LSD, hallucinogens → NOT prescribed; research only

• Schedule II: oxycodone, morphine, amphetamine, secobarbital → no prescription via telephone; must be written in pen or typed; no refills; max quantity for 30 days

Know the difference between "labeled" and "off-label" uses of a drug.

• Labeled use indicates that the FDA has approved the drug for specific use (specific disease or condition)

○ a doctor prescribes the drug for the condition

• Off-label use is use outside the stated FDA indications

○ a dr prescribes the drug for a different condition OR

○ at a different dosage than the FDA has approved

When a dentist writes a prescription for a drug, what types of information goes on the prescription?

• use correct format

• write carefully and legibly

• keep copy of prescription in pt's chart

• avoid latin abbreviations

• keep prescription blanks in secure place

• write DEA number only when needed

• follow state laws for duplicates, triplicates

When is the DEA number required?

for schedules drugs (II-V) only

POWERPOINT:

What is the difference between pharmacodynamics and pharmacokinetics?

• Pharmacodynamics: the study of the action of drugs on living organisms

• Pharmacokinetics: the study of what the body does to a drug; the measurement of the absorption, distribution, metabolism, and excretion of drug from the body

What are indications of a drug?

• clinical circumstances where use of a particular drug is appropriate

• conditions or diseases where it's OK to use the drug

What are contraindications of a drug?

• any condition which renders a particular line of treatment improper or undesirable

• conditions or diseases where it's NOT OK to use the drug

Why should dental hygienists care about pharmacology?

• obtain a health (and medication) history

• administer drugs in the office

• handle emergency situations

• plan appts

• discuss nonprescription medication

• discuss nutritional or herbal supplements

• discuss drugs & interactions

What are some examples of drugs that affect oral health?

• Calcium channel blockers - xerostomia

• Aspirin - increased risk of gingival bleeding

Can a drug have multiple chemical names?

Yes and No. Usually No.

• determined by chemical structure - code name

• each chemical has a unique code

Can a drug have multiple trade names?

Yes.

• brand names

• it depends on the company that sells it

• often confusing

Can a drug have multiple generic names?

No. Only one.

How is a drug formulated?

active ingredient + inactive ingredients (coatings, stabilizers, fillers, binders, flavorings, diluents, and others)

• called Pharmaceutics

What is the Drug Price Competition and Patent Term Restoration Act of 1984?

the FDA requires the active ingredient of the generic product to enter the bloodstream at the same rate as of the trade name product

• in order to have a generic, must have chemical, biologic, and therapeutic equivalence

What is the DEA?

Drug Enforcement Administration

• part of the dept of justice

• administers the controlled substance act of 1970

• regulates the manufacture and distribution of substances that have a potential for abuse, including opioids (narcotics), stimulants, and sedatives

What is a drug recall?

when medications are taken off the market by the FDA

• if there is reasonable probability that use will result in serious adverse health consequences or death

What is Rofecoxib (Vioxx)?

selective NSAD for arthritis

• time on market: 1999-2004

• increased the risks for heart attack and stroke

• linked to about 28,000 heart attacks in the US between 1999 and 2004

What is the Food and Drug Act of 1906?

regulates interstate commerce in drugs

What are phase III drugs?

codeine (tylenol 3), hydrocodone (vicodin) mixtures

• prescriptions may be called into the pharmacy

• no more than 5 prescriptions within 6 months

What are phase IV drugs?

diazepam (valium), tramadol (utlram)

• prescriptions may be called into the pharmacy

• no more than 5 prescriptions within 6 months

What are phase V drugs?

some codeine-containing cough syrups

• least abuse potential

• may be bought OTC in some states

What are orphan drugs?

drugs developed to treat rare medical conditions

• rare medical conditions = disease that occurs in fewer than 200,000 in the US

• often they wouldn't get enough attention

• they would not be profitable to produce without govt assistance

• in the US and EU, it is easier to get approved for an orphan drug