MN553 ADVANCED PHARMACOLOGY
AND PHARMACOTHERAPEUTICS -
Chapter 1, Chapter 3, Chapter 4
1962: Harris-Kefauver Amendment - correct answer-Required both safety and efficacy of a
drug be proven before marketed
Mandated preclinical animal trials before testing drugs in children
Best Pharmaceuticals for Children Act (BPCA) of 2003 - correct answer-Reinstated pediatric
exclusivity
Mandates a list of requested studies
Experts in pediatrics are consulted.
List is updated annually
Bioavailability Studies - correct answer-Healthy volunteers are used to document the rate of
absorption and excretion from the body.
BPCA Reauthorized in Sept 2007/2012 - correct answer-The research program will address
Therapeutic gaps
Particular pediatric diseases
The adequacy of infrastructure to conduct pediatric pharmacology research
The BPCA received permanent authorization in 2012
Choose the Treatment - correct answer-Use evidence-based guidelines.
Individualize for each patient.
Novice providers use analytic, step-by-step decision making.
Experienced providers use experience and pattern recognition.
Use more systematic approach with complex patients.
Clinical Judgment in Prescribing - correct answer-Is a prescription the right treatment?
What are the effective drugs for the disease?
Goals of therapy?
Monitoring to see if drug it meeting goals?
Duplications in medications patient is taking?
OTC vs prescription drugs
Cost?
Sources of information
Clinical Studies Phase 1 - correct answer-1st testing of a new compound in subjects
Purpose to establish tolerance of healthy human subjects at different doses
Define pharmacological effects at anticipated therapeutic levels
Study absorption, distribution, metabolism, and excretion patterns
, Clinical Studies Phase II - correct answer-Controlled studies performed on patients with the
target disease or disorder
Determine the compounds potential usefulness and short term risks
Small number of subjects, no more then several hundred
Clinical Studies Phase III - correct answer-Controlled and uncontrolled clinical trials of a
drugs safety and efficacy in hospital and outpatient settings
Precise information on the drugs efficacy for specific indications
Verifies the acceptable risk/benefit ratio
Used in a larger sample
Controlled Substance Act of 1970 - correct answer-Classifies 5 levels of drugs that have
potential for abuse and are restricted in their distribution. The DEA was created by the CAS
to enforce its regulations
CII records must be kept for 7 years and stored separately
Define the Patient's Problem - correct answer-Assess patient.
Early screening of high-risk patients maximizes the benefit of pharmacological treatment
Develop working and differential diagnosis.
Use diagnostic tests to confirm.
Drug Factors Influencing Drug Selection - correct answer-Pharmacokinetic factors
Pharmacodynamic factors
Therapeutic factors
Safety
Cost (to patient and to society)
Patient factors
Provider factor
Educate the Patient - correct answer-Poor adherence contributes to worsening disease,
hospital admissions, and death.
Patient education should be at the 5th or 6th grade level.
Include in education
Purpose of medication
Instructions for administration
Adverse drug reactions (ADRs)
FDA Modernization Act of 1997 - correct answer-The U.S. Food and Drug Administration
(FDA) can make a request for pediatric data on drugs that may be used in children.
Provides a 6-month extension of the patent of medications that are studied in children
Implications for pediatric practice
More drugs studied for effectiveness in childre
Federal Food and Drug Act of 1906 - correct answer-First federal law designed to protect the
public by restricting the manufacture and distribution of drugs
Drugs must meet official standards of strength and purity
Due to children dying from tainted food products
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Hkane. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for £6.37. You're not tied to anything after your purchase.
