Fundamentals Flashcards
1
Q
- Effectively __, __, or __ the patients condition
- Produces a __, __ response
- Produces no __ effects
- Can be taken __, usually by mouth
- Can be taken __, usually once a day for a short period of time
- Is __ and __ accessible
- Is __ eliminated by the body after it produces its beneficial effect
- Does not __ with other medications
A
- treats, prevents or cures
- rapid, predictable
- adverse
- conveniently
- infrequently
- inexpensive,easily
- quickly
- interact
2
Q
Most common med error?
A
wrong drug
3
Q
SSRI
A
Sliding scale regular insulin
4
Q
4 dosing errors
A
trailing 0, naked decimal, name/dose run together, large doses without comma
5
Q
Sources of drug info
A
package insert = drug label
6
Q
Package insert info includes
A
- trade/generic name
- description
- pharmacology/moa
- contraindications
- warnings
- adverse rxn/se’s
- OD info
- storage
- how supplied
7
Q
Selected References
A
- American Hospital Formulary Service – Drug Information
- United States Pharmacopoeia Dispensing Information (USPDI)
- Physicians’ Desk Reference (PDR)
- The Cochrane Library
- Drugs in Pregnancy and Lactation
8
Q
On-Line Resources
A
Micromedex Clinical Pharmacology Lexi-Comp Natural Medicines DailyMed Drugs@FDA
9
Q
No drug laws before..
A
1906
10
Q
Pure food and drug act
A
- 1906
- no adulterated/mislabled
- disclose any of 11 dangerous/addictive ingredients
- no false/misleading claims about curative properties on package
- covered interstate commerce only
- US Pharmacopoeia and National Formulary as standards
11
Q
Shirley Amendment
A
- 1912
- no fraudulent therapeutic claims
12
Q
Food, Drug and Cosmetic Act
A
- 1938
- mfg must test for harmful effects
- labels accurate and complete
13
Q
Durham-Humphrey Amendment
A
- 1952
- how rx drugs ordered and dispensed
14
Q
Kefauver-Harris Amentdment
A
- 1962
- req proof of safety and efficacy for approval
- generics for 1938-1962 ok
15
Q
Phase I
A
- initial pharm eval
- small number normal volunteers
16
Q
Phase II
A
- limited, controlled eval
- increasing dose
- pts w/disease
- effectiveness and se’s
17
Q
Phase III
A
- Investigational new drug
- extended clinical eval
- objectives: determine effectiveness, safety, dosing
18
Q
NDA
A
New Drug Application
-after phase III
19
Q
Patent vs. Market Exclusivity
A
Patent granted by Patent and Trademark Office
-Good for 20 years (in general)
Market exclusivity granted by the FDA at the time of approval
- New chemical: 5 years
- Orphan drug: 7 years
20
Q
Product Extension
A
- desvenlafaxine = active metabolite
- levocetirizine = active enantiomer
- Simcor = combo drugs
21
Q
All prescription drugs are approved by the FDA?
A
False
22
Q
Marketed Unapproved Drugs
A
- Wrap-Up Drugs
- -On the market before 1938
- DESI Drugs
- -Refers to drugs subject to safety only ”approval” (1938- 1962)
- -Falsely claimed GRASE or grandfathered
- Post 1962 drugs that were never approved
23
Q
Drug Price Competition and Patent Term Restoration Act
A
- 1984
- abbreviated application
- 5 yr market exclusivity for pioneer drugs (extended for new indications, dosage forms/regimens)
- generics could be approved for drugs introduced after 1962
24
Q
Generic Drug Approval Criteria
A
- Pharmaceutical Equivalence
- -Same active ingredients, dosage form, strength, route
- -May differ in shape, scoring, excipients
- Bioequivalence - 80-125%
- -Rate and extent of absorption are not significantly different from pioneer drug
- -AUC, Cmax, Tmax
25
Branded Generics
- Novel dosage form of off-patent drugs
- -OxyContin® (oxycodone)
- Give a generic drug a trade name
- -Levo-T® (levothyroxine)
26
Authorized Generics
Generic drugs manufactured or licensed by brand manufacturer
| -Used to counter the 180 day “first generic” advantage
27
Approved FDA equivalence
"Orange Book"
28
Controlled Substances Act
- 1970
| - according to abuse potential
29
Schedule I
- High abuse potential
- No accepted medical use
- Research protocol only
- May lead to severe dependence
- Heroin, Marijuana, LSD, Mescaline, Peyote, Psilocybin
30
Schedule II
- High abuse potential
- Accepted medical use
- May lead to severe dependence
- Written prescription, no refills
- Morphine, meperidine, cocaine, secobarbital, dextroamphetamine
31
Schedule III
- Less abuse potential than I & II
- Accepted medical use
- Low/moderate physical dependence, high psychological dependence
- Written or oral prescription, 6 months of refills
- APAP w/codeine, anabolic steroids, ketamine
32
Schedule IV
- Less abuse potential than III
- Accepted medical use
- Limited dependence
- Written or oral prescription, 6 months of refills
- Phenobarbital, Diazepam, Carisoprodol
33
Schedule V
-Less abuse potential than IV
-Accepted medical use
-Limited dependence
-May or may not require prescription
Codeine in limited quantities, Ezogabine (Potiga®)
34
Types of Drugs
- Legend/prescription
- OTC
- BTC
- Dietary Supplements
35
Prescription Drugs
- defined federally
- clinicians prescribe
- rules govern ordering, dist and admin
36
OTC
- condition can be self-dx
- tx efficacy/tox easily assessed by consumer
- NDA
37
Rx-to-OTC Switch
- Vaginal antifungals
- NSAIDs
- Non-Sedating Antihistamines
- Nicotine Replacement
- H2RAs and PPIs
- Emergency Contraception
- Nasal steroids
- Oxytrol®
- Statins?
38
Behind the Counter
- Schedule V Drugs
- -Some states (not Texas)
- -Codeine cough syrup
- Combat Methamphetamine Epidemic Act of 2005
- -Requires ID and log books to buy pseudoephedrine
- Insulin (regular and NPH)
39
Dietary Supplements/Herbals
- Governed by the Dietary Supplement Health and Education Act
- Includes plant parts, extracts and essential oils
- Considered safe until proven unsafe
- Not required to test ingredients in clinical trials
- Cannot make claims to treat disease
- -“boost immune system”
- -“aids digestion”
- -“improves heart health”
- -“increases energy”
