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making recommendations in drug therapy
taking verbal prescriptions
clarifying orders
presentations
when and where does interprofessional communication occur?
distractions
physical proximity
personalities
workload
varying communication styles
conflict
lack of verification of information
shift changes
what are the communication barriers in healthcare?
only share what is necessary, when it is necessary, with whomever necessary
ask for patient identifiers
do not speak in public or crowded areas (i.e. elevators, cafes, etc)
how should you consider HIPAA when considering communication with other healthcare providers?
Situation, Background, Assessment, Recommendation
what does SBAR stand for?
a verbal or written communication tool that helps provide essential and concise information
what is the purpose of SBAR?
by the US military in the 1940s and has been adapted to aviation and healthcare
who created SBAR?
Introduction, Situation, Background, Assessment, Recommendations
what does ISBAR stand for?
who are you and what is your role
who is the patient
include two identifiers unless EHR is used to communicate
what takes place in the introduction step of ISBAR?
explain what is going on with the patient and give a brief statement of the problem
what takes place in the situation step of ISBAR?
what is the clinical background (diagnoses, medical history, fate, medication, anything that is relevant)
what takes place in the background step of ISBAR?
what do you think the problem is
what takes place in the assessment step of ISBAR?
what would you recommend
clearly state the recommendation
be specific about suggested action, time frame, and assign responsibility or assign accountability
what takes place in the recommendation step of ISBAR?
four
how many phases does a drug have to go through?
randomized controlled trails
what is the standard for drug testing?
drug discovery
preclinical
clinical trials
phase 1
phase 2
phase 3
FDA review
submission of NDA or BLA
post marketing surveillance (phase 4)
what are the steps to a drug development?
testing on animals
what takes place in the pre clinical trials?
gene mutations
carcinogens
impairment of fertility
what is determined in the preclinical trials?
3-6 years
how long is the pre discovery (pre clinical) trials?
between the preclinical and clinical trials
when is the IND applied for?
FDA’s center for drug evaluation and research (CDER)
where does the IND go?
investigational new drug application
what does IND stand for?
6-7 years
how long are clinical trials?
protect volunteers who participate in clinical trials from unreasonable and significant risk
what is the goal of the IND?
FDA indicates proposed clinical studies are safe
FDA issuances a clinical hold and no studies can be done
what are the two possibilities of CDER review?
20-100
how many volunteers participate in phase 1 of clinical trials?
is the drug safe
what are the side effects
how does the drug work in the body
what are they looking for in phase 1 of clinical trials?
healthy volunteers that do not have the condition they are studying
who can participate in phase 1 of clinical trials?
pharmocodynamics
what a drug does to the body
pharmacokinetics
what a body does to the drug
100-500
how many participants in phase 2 of clinical trials?
looking at safety, dosage, and frequency
what are they looking for in phase 2 of clinical trials?
people with that disease or condition
who can participate in phase 2 of clinical trials?
indication
drug is indicated for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition in age group
60%
what percent of drugs that goes through clinical trials make it from phase 2 to phase 3?
is the drug safe and effective
is there a benefit or risk to a specific population
how does it compare to other drugs on the market
what are they looking for in phase 3 of clinical trials?
phase 3
which phase of clinical trials is most expensive?
1,000 to 5,000
how many people participate in clinical trials?
patients that have that medical condition the drug is intended to treat
who can participate in phase 3 of clinical trials?
between clinical trials and FDA review
when is NDA or BLA submitted?
conventional and chemical drugs
what is an new drug application (NDA) for?
biologics
what is a biologics license application (BLA) for?
CDER
who is the NDA or BLA submitted to?
review all human and animal data including adverse effects that occurred during clinical trials
check accuracy of information
review drug labeling
review how the drug will be manufactured
visit manufacturing facility
what does the CDER review on an NDA or BLA?
60%
what percent of drugs move on from phase 3 of clinical trials to approval?
post marketing surveillance
what is phase 4 of clinical trials called?
study the drugs safety and effectiveness in real life scenarios
study long term risks and benefits
discover side effects that did not show up in clinical trials
what is the purpose of phase 4 trials?
the manufacturer must submit a supplemental new drug application (sNDA) after conduction phase 3 and 4 again
what happens if a company wants to get their drug approved for an additional indication?
change in package label
how is a new indication shown by a manufacturer?
off-label drug use
practice of prescribing a drug for a different purpose than what the FDA has approved
yes only if there is reasonable scientific evidence that the drug is effective for that use
can prescribers prescribe a prescription for off-label use?
based on reasonable medical evidence done in good faith in the best interest of the patient
what is the off label level of evidence that prescribers should use when writing a prescription for off label use?
birth to 16 years (neonates, infants, children, adolescents)
what does the FDA define as pediatric population?
pediatric patients couldn’t give consent
why were pediatric studies never done during clinical trials?
incentivize companies to do research
what did the Best Pharmaceuticals for Children act (BPCA) of 2002 do?
mandate companies to do pediatric research
what did the Pediatric Research Equity Act (PREA) of 2003 do?
assess the safety and effectiveness of the drugs claimed indications in all relevant pediatric subpopulations
support dosing and administration for each pediatric subpopulation for the claimed indication
what information did the PREA require pediatric studies to gather?
phase 3
what trail does the PREA require drug companies to repeat?
pediatric assessment
what does the PREA require to be included in NDA or BLA applications?
the disease for which the drug is intended to treat is not encountered in pediatric populations
there is little to no perceived values in children
the drug may pose an unacceptable risk in children
what are the requirements to get a PREA waiver criteria?
drug/biologic is ready for approval before completion of pediatric studies or more information is needed regarding safety and effectiveness
company requests the pediatric studies be delayed
deferral require post marketing studies
what is the criteria to receive a PREA deferral?
FDA provides a financial incentive to companies who voluntarily conduct pediatric studies for an approved drug that has no prior pediatric studies
can be studies for off label or indicated use of drug
what did the Best Pharmaceuticals for Children Act do?
drug must be intended to treat a serious condition and preliminary human clinical evidence must indicate that the drug demonstrates improvement over available therapy on a clinically significant endpoint
what is needed to get a breakthrough therapy designation (BTD)?
disease or condition associated with morbidity that has substantial impact on day to day function
what qualifies a disease as a serious condition?
endpoint
a measure of an effect on irreversible morbidity or mortality
(i.e. blindness due to macular degeneration)
available therapy
a drug approved in the US for the same indication being considered for the new drug
receive intensive guidance from FDA for efficient drug development
submit chunks of BLA or NDA for review (aka rolling review)
what are the benefits of getting a BTD?
drug must be intended to treat a serious condition and fills and unmet medical need based on a surrogate endpoint
what are the requirements of an accelerated approval requirement?
surrogate endpoint
results used in place of clinical endpoint when the clinical outcomes might take a very long time to study or when the clinical benefit related to improving the surrogate endpoint is well understood
(i.e. a drug that shrinks a tumor will stop cancer)
the company can get drugs to the patients more quickly but the company still seeks full approval of the drug
what are the benefits of accelerated approval?
the FDA requires a confirmatory trial to verify the drugs clinical benefit after which the drug can receive full approval
what is the requirement of a company for accelerated approval?
if the drug is approved it would be a significant improvement in the treatment or prevention of a serious condition
what is the requirement for priority review?
FDA will direct attention and resources to the evaluation of an NDA or BLA and commit to review the application in 6 months (4-10 months shorter than normal)
what are the benefits of priority review?
drug jumps from phase 2 to the market
what happens to the drug timeline if accelerated approval is granted?
facilitates the development and expedites review of drugs that are intended to treat a serious condition
preliminary clinical, nonclinical, or predictive evidence indicates that the drug fills an unmet medical need
what are the requirements of fast track status?
expedites the development and review of drugs that are
intended to treat a serious condition
preliminary clinical evidence indicate the drug may demonstrate substantial improvement over available therapy on clinically significant endpoint
what are the requirements for breakthrough therapy designation?
rolling review
more frequent meetings and communication with FDA related to devlpment plan and design
what are the benefits of fast track?
rolling review
intensive guidance from FDA for efficient drug development
what are the benefits of breakthrough therapy?
accelerated approval, priority review, BTT designation
what are trails on fast track eligible for?
accelerated approval, priority review
what are trials on BTT designation eligible for?
awarded to drug company if it develops a drug for a rare pediatric disease or a neglected tropical disease and the drug is approved
how does a company get a priority review voucher?
if a patient has an immediately life threatening condition or disease they can try and gain access to an investigational drug when no other alternative therapy options are available and patient enrollment in a clinical drug trials isn’t possible
what is the expanded access program?
physician agrees to file paperwork with FDA and IRB
manufacturer says yes or no
FDA reviews the request and determines if it can proceed
institutional review board (IRB) reviews protocol and determines if it is ethical
patient signs informed consent and receives drug
what are the steps to being apart of the FDA expanded access process?
federal law that amends the FD&C act to create second pathway for certain patients to access investigational drugs outside a clinical trial
what is the right to try act?
physician agrees to oversee patient treatment and obtains written informed consent
manufacturer says yes or no
patient signs form
what are the steps to the right to try act?
emergency use authorization
expedited authorization and use of an unapproved product in a declared emergency involving a chemical, biological, radiological, or nuclear agent where there are no adequate, approved, and available alternatives
book with all the generics and information on them, helps figure out what brands can be substituted for what generics
what is the orange book?
new molecular entity
what does NME stand for?
new biological entity
what does NBE stand for?
new chemical entity (brand new drug)
what does NCE stand for?
new therapeutic entity
what does NTE stand for?
patent
form of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of years
the US patent and trademark office
who grants patents?
20 years
how long do patents last?
patent thickets
multiple patents to cover the same product
evergreening
strategy of getting a new patent to extend life of original patent by making minor changes to drug, dosage form, device, etc
exclusivity
the time period during which the brand name product is protected from generic product competition
when the drug is approved
when does exclusivity start?
FDA
who grants exclusivity?
5 years
how long is exclusivity for a NCE?
12 years
how long is exclusivity for NBE?
Note 
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