approval to administration exam 2

• 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?

1. drug discovery

2. preclinical

3. clinical trials

   1. phase 1

   2. phase 2

   3. phase 3

4. FDA review

   1. submission of NDA or BLA

5. 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?

1. physician agrees to file paperwork with FDA and IRB

2. manufacturer says yes or no

3. FDA reviews the request and determines if it can proceed

4. institutional review board (IRB) reviews protocol and determines if it is ethical

5. 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?

1. physician agrees to oversee patient treatment and obtains written informed consent

2. manufacturer says yes or no

3. 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?