Pharmacology Chapter 3

Harris-Kefauver Amendment
1962, Provision that drugs be proven effective
Required animal testing
Risk-to-benefit ratio must be reasonable
Package insert requires adverse reactions
Post-market reporting of adverse reactions required

Thalidomide
Drug that tragically caused thousands of phocomelia birth defects

Controlled Substances Act
1970, rules for drugs with potential for abuse, 5 schedules

Schedule I drugs
No accepted medical use
Heroin, LSD, mescaline, marijuana

Schedule II-V drugs
Acceptable medical use with lessening abuse potential from II to V.

FDA Amendment Act
(FDAAA)
Added rigorous oversight of drug safety following drug approval – post marketing safety studies, safety labeling, restrict distribution

Family Smoking Prevention and Tobacco Control Act
Allows FDA to regulate cigarettes, require warning labels/disclosure of ingredients, nicotine reduction, marketing restrictions

Process of testing new drugs outcome
6-12 yrs for approval
Few of thousands enter clinical trials
1 in 5 are approved
Cost can exceed 1 billion

Randomized Controlled Trial (RCTs)
Most reliable to assess drug therapies, used for all new drugs
Uses controls, randomization, and blinding

Use of Control
Comparing new drug to control group (standard drug or placebo)

Randomization
Prevents bias of researchers in selecting group
(Difference in Tx should = difference in outcome, not difference in disease severity/biased factors)

Blinding
When people involved do not know which group individuals have been randomized to

Single Blind
Only subjects are blind to which group

Double Blind
Researchers and subjects are both blind to group

Which is more objective, a Single or double blind study?
Double-blind trials

Preclinical testing
Animal testing for toxicity, pharmacokinetic properties, potential useful biological effects (1-5 yrs)

Clinical Testing
Human testing (2-10 yrs), 4 phases, must have Investigational New Drug status from FDA

Phase I Clinical Trial
Healthy volunteers
Volunteers with the disease if likely severe side effects
Evaluates drug metabolism, pharmacokinetics, biological effects

Phase II and III Clinical trial
Tested in patients
Evaluates therapeutic effect, dosage range, safety. 500-5000 pts, few hundred 3-6 months
Application for Phase IV

Phase IV Clinical trial
New drug status approved
Released for general use with continued observation of effects

2 Limitations of testing procedures
-Use in women and children weren’t studied until recently
-New drugs may have adverse effects not detected in trials

Adverse Effects
1/2 of drugs have serious adverse effects that went undetected prior to marketing

3 Types of Drug Names
1-Chemical
2-generic
3-trade

Generic Name
-Only 1 assigned to a drug, -AKA nonproprietary name or US adopted name
– less complex than the chemical name, more complex than trade
– final syllables = drug class

Trade Name
– brand/proprietary name
– marketing name
– many assigned to 1 drug
– must be FDA approved
– can’t imply efficacy

Little Problem with generic name
Length/#of syllables

Big problem with trade name
-Too many
– Could double Rx same med
– 2 OTC drugs could have same name but different active ingredients
-Ingredients change but name doesn’t
– confuse travelers from other countries
– it would make more sense to have generic name with company logo

OTC drugs
Purchased /s rx
Determined by FDA
Save expense/give relief
Some rx change to OTC

Sources of Drug Info
People: Clinicians, Pharmacists
Poison Control Center
Pharm Sales Rep
Published Info: text books, newsletters, reference books, Internet

The classic pharmacology reference book
Goodman & Gilman’s The Pharmacological Basis of Therapeutics

Drug Name that facilitates communication
Generic

Drug name that confuses communication
Trade

True or false: the same trade name may be used for more than one drug?
True

True or false: trade names for the same drug are similar in other countries
False

A drug info source that may be non-educational or biased
Drug sales representatives

Federal Pure Food and Drug Act 1906
First American Drug Law, drugs must be free of adulterants

Food Drug and Cosmetic Act 1938
Required Drug toxicity testing to be reviewed by FDA

Accelerated Approval 1992
for AIDS and cancer, market prior to Phase III trials
Required drug companies to notify when d/c drugs
“off label” use to MD’s

Best Pharmaceuticals for Children Act BPCA 2002
Pediatric Research Equity Act PREA 2003
promote research on drug efficacy and safety in children
FDA can require pediatric trials

Pregnancy Categories
A – No risk
B – No risk in animal studies
C – Risk in animal studies
D – Risk in human studies, but may have benefit
X – No benefit, risky

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