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6 sequential steps in Delphi technique

It is a modification of the brainstorming technique


and involves obtaining the opinion of experts
physically separated and unknown to each other.
All these opinions are handled by a central
coordinator, who consolidates the opinions and
this information is sent back to the experts for
further analysis and opinion refinement. The
Delphi technique is characterized by the following
sequential- steps:
(1) The problem is identified and a set of questions are built
relating to the problem so that the answers to these questions
would generate solutions to the problem. These questions
are consolidated in the form of a questionnaire.
(2) Experts in the problem area are identified and contacted.
The questionnaire is sent to each member who anonymously
and independently answers the questions and sends it back
to the central coordinator.
(3) The results of this questionnaire are compiled and
analyzed and on the basis of the responses received, a
second questionnaire is developed, which is mailed back to
participating members.
(4) The members are asked again to comment,
suggest and answer the questions, possibly
generating new ideas and solutions.
(5) The responses to this second questionnaire
are complied and analyzed and if a consensus
has not been reached, then a third questionnaire
is developed, pinpointing the issue and
unresolved areas of concern.
(6) The above process is repeated until a
consensus (agreement) is obtained. Then the
final report is prepared.
Example

1- Design the questionnaire


2- Invite participants to take part
3- Send out first round of questionnaire
4.Analyse responses from round 1 questionnaire
5.Prepare the second round questionnaire
6.Send out second round questionnaire - the follow up to the first round question above might
be-
Cancer has been identified as a high priority for developing an evidence base relating to
minority ethnic groups. Within this clinical area, what aspects should research focus on?
a useful decision-making technique. It
helps you make a decision by analyzing
the forces for and against a change, and it
helps you communicate the reasoning
behind your decision.
You can use it for two purposes: to decide
whether to go ahead with the change; and
to increase your chances of success, by
strengthening the forces supporting
change and weakening those against it.
About the tool
Force Field Analysis was created by Kurt Lewin in the 1940s. Lewin
originally used the tool in his work as a social psychologist. Today,
however, Force Field Analysis is also used in business, for making
and communicating go/no-go decisions.
You use the tool by listing all of the factors (forces) for and against
your decision or change. You then score each factor based on its
influence, and add up the scores for and against change to find out
which of these wins.
You can then look at strengthening the forces that support the
change and managing the forces against the change, so that
it's more successful.
To carry out a Force Field Analysis, use a blank sheet of
paper or whiteboard.
Then describe your plan or proposal for change in a box in
the middle of the paper.
List the forces for change in a column on the left-hand
side, and the forces against change in a column on the
right-hand side.
What business benefit will the change deliver?
Who supports the change? Who is against it? Why?
How easy will it be to make the change? Do you have
enough time and resources to make it work?
What costs are involved?
What other business processes will be affected by the
change?
What are the risks ?
Next, assign a score to each force, from, say, 1 (weak)
to 5 (strong), and then add up the scores for each
column (for and against).
For a visual representation of the influence that each
force has, draw arrows around them. Use bigger arrows
for the forces that will have a greater influence on the
change, and smaller arrows for forces that will have less
of an influence.
http://www.gantt.com
What is a Gantt chart?
A Gantt chart, commonly used in project management, is one of the
most popular and useful ways of showing activities (tasks or events)
displayed against time. On the left of the chart is a list of the activities
and along the top is a suitable time scale. Each activity is represented by
a bar; the position and length of the bar reflects the start date, duration
and end date of the activity. This allows you to see at a glance:
What the various activities are
When each activity begins and ends
How long each activity is scheduled to last
Where activities overlap with other activities, and by how much
The start and end date of the whole project
To summarize, a Gantt chart shows you what has to be done (the
activities) and when (the schedule).
My Journey with Inflammatory
Breast Cancer Sunday, October 26, 2014

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.

Surgery will take place in Houston at MD Anderson. I will be getting a modified-


radical double mastectomy- meaning that they will remove both breasts, a whole
bunch of lymph nodes in my armpit, and a whole lot of skin. The modified part
means they leave muscle behind. I will only stay in the hospital for one night but
will stay in Houston for a few nights afterwards just to make sure my recovery
begins smoothly.

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)

Food and Drug


Administration (FDA)
Centers for Medicare
& Medicaid Services Centers for Disease
(CMS) Control and Prevention
(CDC)

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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.

An IND application is drafted and submitted to the FDA.


An Investigational New Drug (IND) application is used
for a new drug, a new indication, or off-label use that will be used in
a clinical investigations preclinical development in order for that new
drug to be distributed across state lines before undergoing full FDA
review.
Phase I Drug Trial
Initial introduction of an IND into humans, typically 20100
healthy volunteers.
Goal is to garner information on the pharmacokinetic and
pharmacodynamic properties of the investigational drug to
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design a well-controlled phase II trial.
FDA Drug Approval Process
Phase II Drug Trial
Controlled clinical studies conducted in no more than several
hundred subjects (100-300)
Goal is to evaluate the drugs effectiveness for a particular
indication in patients with the disease or condition under
investigation and to determine the common short-term
adverse effects and risks associated with the drug.

Phase III Drug Trial


Administering the investigational drug to a range of several hundred to
several thousand patient subjects (1000-3000)
Goal is to gather additional information about effectiveness, efficacy,
appropriate dosage and safety of the drug.

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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.

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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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REMS Requirements
Requirements that a drug be dispensed with one of the
following:
A. Medication guide and/or patient package inserts:
-Required to be dispensed with the drug
-Written in non-technical language

B. Communication plan to health care providers


Eg: Exenatide, a drug to treat type 2 diabetes mellitus.
The goal of the REMS is to inform healthcare professionals
about the risk of acute pancreatitis and the potential risk of
medullary thyroid carcinoma associated with its use.

C. Elements to ensure safe use:


actions healthcare professionals need to execute prior to
prescribing or dispensing the drug to the patient.
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Orphan Drug Act
An orphan drug is a pharmaceutical agent that has
been developed specifically to treat a rare medical
condition, the condition itself being referred to as an
orphan disease.
In the US and EU it is easier to gain marketing
approval for an orphan drug, and there may be other
financial incentives, such as extended exclusivity
periods, all intended to encourage the development of
drugs which might otherwise lack a sufficient profit
motive.
Example: Penicillamine was developed to treat
Wilson's Disease, a rare hereditary disease that can
lead to a fatal accumulation of copper in the body.

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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!

In 1993, the US FDA approved gabapentin, marketed by


Pfizer under the name "Neurontin", only for treatment of
seizures. Pfizer subsidiary Warner-Lambert illegally used
scientific activities, including continuing medical education
and research, to commercially promote gabapentin, so that
within 5 years the drug was being widely used for the off-label
treatment of pain and psychiatric conditions - conditions that
had not been approved by FDA. In 2004, Warner-Lambert
admitted to charges that it violated FDA regulations by
promoting the drug for these off label uses: pain, psychiatric
conditions, migraine, and other unapproved uses.The
company paid $430 million to the federal government to settle
the case.

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Efforts for improving HCQ in the
USA
THE JOINT COMMISSION (TJC)

NATIONAL COMMITTEE FOR QUALITY


ASSURANCE (NCQA)

NATIONAL QUALITY FORUM (NQF)

AGENCY FOR HEALTHCARE RESEARCH AND


QUALITY (AHRQ)

PHARMACY QUALITY ALLIANCE (PQA)

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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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