Professional Documents
Culture Documents
Our Story
At 29 years old and 34 weeks pregnant with my second
child, I was diagnosed with Stage 3 triple negative
inflammatory breast cancer. I was able to deliver a healthy
baby boy named David at 37 weeks as my first son, Noah,
turned 18 months old. At the same time, my husband,
Brad, and I celebrated seven amazing years of marriage.
We believe God can work a miracle in our lives and are
thankful for the hundreds of believers across the globe
praying for my healing. This is our story.
The past couple of weeks I've been getting a lot of questions
around the next steps and timeline of my treatment. So I made a
process flow chart and a gantt chart to illustrate what's next.
(That's normal, right?)
My chemo started with two drugs that I had four rounds of in July and August. I'm
currently half way through my second phase of chemo with another set of two
drugs. If I have no delays, I would get my last treatment December 1st. That's six
more weekly rounds of chemo.
I need 4ish weeks to recover from the chemo before surgery. They want my
platelets and WBCs nice and high before such a significant operation. This puts
us right around Christmas/the first of the year for surgery.
I will need 4ish weeks to recover from surgery before we start radiation.
Radiation will also take place in Houston at MD Anderson. The plan is to have 44
rounds, twice daily, each weekday. That will take 5ish weeks to complete.
All the treatments should wrap up late spring/early summer. This is assuming
everything goes perfectly of course. There are a couple deviant paths I'm
currently aware of. I've outlined those in the flow chart below:
Overview: What is the FDA?
It is an agency of the United States Department of Health and
Human Services(DHHS), one of the United States federal
executive departments.
The FDA is responsible for protecting and promoting public
health through the regulation and supervision of:
Food
Drug
Medical devices
Radiation-emitting products
Vaccines,blood and biologics
Animal and vetrinary products
Cosmetics
Tobacco products
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DHHS operating divisions
Department
of Health and Human
Services(DHHS)
Agency for National Institutes
Healthcare of Health (NIH)
Research and
Quality. National Cancer
(AHRQ) Institute (NCI)
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Approves
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FDA Drug Approval Process
Preclinical studies
Laboratory and animal studies that assess safety and
biologic activity.
Toxicological studies completed.
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FDA Drug Approval Process
The sponsor submits an NDA to the FDA for approval to
6 market the drug.
A New Drug Application (NDA) is the vehicle through which
drug sponsors formally propose that the FDA approve a new
pharmaceutical for sale and marketing in the United States.
7
Phase IV Drug Trial
Because premarket review can't catch all potential problems with
a drug, the FDA continues to track approved drugs for adverse
events through a post marketing surveillance program.
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Generic Drugs
Same medicine- Lower cost!
Around 69% of all drugs dispensed are generic.
A generic drug product is one that is identical
(bioequivalent) to an innovator drug(Patent) product
in dosage form, strength, route of administration,
quality, performance characteristics, and intended
use.
In most cases, generic products are available once
the patent protections afforded to the original
developer have expired. When generic products
become available, the market competition often
leads to substantially lower prices for both the
original brand name product and the generic forms
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Generic Drugs
Same medicine- Lower cost!
An Abbreviated New Drug Application (ANDA) that contains data
about the generic drug should be submitted to the FDAs CDER, Office of
Generic Drugs to allow the review and ultimate approval of the generic
drug product.
Once an ANDA is submitted to and approved by CDERs Office of
Generic Drugs, the applicant can manufacture and market the generic
drug as a safe, effective, and low-cost option to the public.
ANDAs generally do not require preclinical or clinical data, but rather,
they must demonstrate bioequivalence.
Example of generic drugs: On April 6, the U.S. Food and Drug Administration approved the
first generic versions of two drugs used for the treatment of hypertension. Losartan potassium
tablets and losartan potassium and hydrochlorothiazide tablets (a combination drug) are the
generic equivalents of Cozaar and Hyzaar tablets, respectively.
Cozaar and Hyzaar tablets are widely-used antihypertensive drugs. Both generic
losartan products will carry the same safety warnings as their brand counterparts.
These warnings include a boxed warning against the use of these products during the
second and third trimesters of pregnancy.
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Criteria for Medications to be
Pharmaceutical Equivalents
Three criteria:
Must contain the same active ingredient
Must be the same dosage form
Must be of identical strength or concentration
Differences allowed:
Shape
Releasing mechanism
Labeling (limited differences)
Scoring
Excipients (colors, flavors, preservatives)
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What after FDAs approval?
All approved products are listed in the FDAs Approved
Drug Products with Therapeutic Equivalence Evaluations
(Orange Book).
The FDA "Orange Book" contains drugs approved by
FDA under New Drug Applications (NDAs) and
Abbreviated New Drug Applications (ANDAs). This site is
regularly updated and shows the date of the most
current update at the top of the page.
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Medwatch
It is the FDA gateway for clinically important safety
information and reporting serious problems with
human medical products.
It is a Voluntary Reporting program.
Examples of recent Safety Alerts by Medwatch:
Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of
Potentially Fatal Heart Rhythms. FDA is warning the public that azithromycin
can cause abnormal changes in the electrical activity of the heart that may
lead to a potentially fatal irregular heart rhythm. Posted 03/12/2013
Symbios GOPump Elastomeric Infusion PumpKit: Class 1 Recall - Flow
Restrictor Bead May Become Displaced from its Fitting May permit solutions to
flow at a higher rate than intended, and may cause serious adverse health
consequences, including death. Posted 03/18/2013
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Risk Evaluation and Mitigation
Strategy (REMS)
A Risk Evaluation and Mitigation Strategy (REMS) is a
strategy to manage a known or potential serious risk
associated with a drug or biological product to ensure
that the benefits of certain prescription drugs outweigh
their risks.
FDA can require a REMS before or after a drug is
approved
Examples of the Types of Risk REMS Requirements
Aim to Mitigate:
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Off-label use
Off-label use of medications is very common. Up to one-fifth of all
drugs are prescribed off-label
The FDA does not have the legal authority to regulate the practice of
the medicine, and the physician may prescribe a drug off-label!
Under the Food, Drug, and Cosmetic Act (FDAC), manufacturers
are prohibited from directly marketing a drug for a use other than the
FDA approved indication.
However, once a drug has been approved for sale for one purpose,
physicians are free to prescribe it for any other purpose that in their
professional judgment is both safe and effective, and are not limited
to official, FDA-approved indications. This off-label prescribing is
most commonly done with older, generic medications that have
found new uses but have not had the formal (and often costly)
applications and studies required by the FDA to formally approve the
drug for these new indications.
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Example of Off-label use drug!
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Efforts for improving HCQ in the
USA
THE JOINT COMMISSION (TJC)
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National Committee For Quality Assurance
(NCQA)
Offers accreditation programs to health plans
HEDIS,domains:
(a) Asthma medication use
(b) Persistence of -blocker treatment after a heart
attack
(c) Controlling high blood pressure
(d) Comprehensive diabetes care
(e) Breast cancer screening
(f) Antidepressant medication management
(g) Childhood and adolescent immunization status
(h) Advising smokers to quit
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The Occupational Safety and Health Act allows OSHA to issue workplace health and safety
regulations.
Healthcare workers face a number of serious safety and health hazards. They include
bloodborne pathogens, biological hazards, potential chemical and drug exposures, waste
anesthetic gas exposures, respiratory hazards, ergonomic hazards from lifting and repetitive
tasks, laser hazards, workplace violence, hazards associated with laboratories, and
radioactive material and x-ray hazards. Some of the potential chemical exposures include
formaldehyde, used for preservation of specimens for pathology and many other hazards.
Workers have a right to a safe workplace. The law requires employers to provide their
employees with working conditions that are free of known dangers.
OSHA regulations include:
limits on chemical exposure
requirements for the use of personal protective equipment
requirements for safety procedures.
Emergency Preparedness
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LEAPFROG
The Leapfrog Group aims to:
Inform Americans about their hospital
safety and quality
Promote full public disclosure of hospital
performance information
Help employers provide the best
healthcare benefits to their employees
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professional development programs
collaborate with health care facilities to accelerate
improvement in vital areas, including maternal and
neonatal health, end-of-life care, avoidable hospital
readmissions, waste and cost reduction, person-
and family-centered care, and the spread of the
Triple Aim.(Population Health, Individual Care, and
Cost Control Optimization)
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Includes information about:
Methods of controlling infections
Outbreaks
Immunization schedules
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