Drug Regulatory Process / Prescription Writing Flashcards
(42 cards)
Hospital Quality Alliance
Group formed to encourage hospitals to voluntarily collect and report hospital quality performance data.
The object is to make performance data available to the public and encourage efforts to improve quality
National Hospital Quality Measures
CMS and JCo got together and published a set of national quality measures
CMS
Federal agency that evaluates the quality of care in hospitals, especially the care for those on medicare and medicaid.
As long as hospitals meet or exceed these requirements, patients are ensured quality care and healthcare providers receive reimbursement for the care of these patients.
The Joint Commission (JCo)
Non-profit organization that sets the standards by which health care quality is measured both in the US and abroad.
Governed by MDs, RNs, and consumers.
Requires providers to submit performance data. Also surveys hospitals regularly to evaluate their performance and publishes this info to the public.
National Hospital Quality (NHQ) measures that relate to aneshesia
Antibiotic must be given within 1 hour prior to incision
Temperature must be taken post-op
Those on BBs must be kept on BBs
Anesthesia charting that must be done according to the NHQ
Charting and appropriate actions will determine the hospital’s outcomes. If we don’t chart, it means we didn’t do it, and we don’t get paid for it.
Start and end time of anesthesia
Incision time
Antibx name, dose, route, time, and allergy
BB administration (or reason for not giving a BB)
Temperature
Med errors kill __ people daily and injure about _____ annually in the US
1 daily
1.3 million injured yearly
Proper Needle and Syringe Practices
Never use the same syringe on 2 patients, even if the needle is changed
Never reuse a needle, even on the same patient.
Never refill a syringe even if it’s to be used on the same patient
Never re-use a syringe or needle to withdraw meds from a multi-dose vial
Never re-enter a single-use med vial (single use only!! no double dipping!)
4 Major principles of ethics in clinical drug investigation
1) Risks must be limited
2) The researcher must terminate the trial if the risk becomes incompatible with goals
3) Provisions must be made for overall care of the patient
4) Adverse events must be reported immediately
Are IRBs mandated and monitored by the FDA?
Yes
What does the IRB ensure?
That pts are fully informed and give their consent before studies begin
That the rights and welfare of ppl in the trials are protected both before and during the trial
Who makes up the IRB?
No less than 5 experts and lay people with varying backgrounds. This ensures a complete and adequate review of the activities to be conducted.
Purpose of Pre-Clinical Research
To get authorization from the FDA to start clinical trials.
Show the FDA that the drug is reasonably safe enough to start initial small-scale clinical trials.
Shows the FDA info from in vitro and animal studies
Shows data from previous clinical testing (if available)
Proof that the med should be safe
To move on to clinical trials, you have to submit this form to the FDA
INDA (Investigational New Drug Application)
With this, the FDA will review the preclinical research done and make a decision about whether trials can begin within 30 days
1) Looks at the drug’s chemistry
2) Pharm / toxicology review
3) Medical review- it is useful enough to bother putting people at risk?
How many animals should the med be tested on before humans?
As few animals as possible to get the needed info
At least 2 or more species (one rodent and one non-rodent)
Phases of Clinical Drug Testing
Phase I
- 20-100 subjects
- Several months
- Tests safety
Phase II
- Several hundred
- Several months - 2 years
- Tests effectiveness and short-term safety
Phase III
- Several hundred - several thousand
- 1-4 Years
- Tests long-term safety, dosage, and effectiveness
Detailed Phase I
- 20-100 HEALTHY subjects
- Looks for safety and tolerability and major adverse effects
- If high toxicity is expected (like CA drugs), the target population may be used instead of healthy participants
- Focuses on kinetics (max dose, absorption, distribution, metabolism, and excretion)
- Non-blinded
- Info helps to establish phase II design
Detailed Phase II
- Several hundred pts WITH the target disorder*
- Tests the effectiveness for that disease*
- Helps determine other SE of the drug
- Establish dosing regiments
- Drug is tested against a placebo or existing drug (Usually single-blind or double-blind)
- Info helps guide info that needs to be investigated in phase III
Detailed Phase III
- Hundreds to thousands
- 1-4 years in length
- Use randomization and double-blind trials
- These results are able to be extrapolated to the general population**
After trials, the company submits a New Drug Application (NDA), which tells the FDA
- Animal trials
- Human trials
- Drug information
- Manufacturing information (can strength and quality be assured?)
- Proposed labeling
Fast Track Status
Approval process is expedited for serious and life-threatening diseases
Orphan drugs affect fewer than ____ people in the US
200,000
Compassionate Use Protocol
Expands access to investigational drugs
1) The drug must show that it’s working in preliminary trials
2) Pts are likely to die or suffer rapid disease progression within several months, or die prematurely without treatment
3) There is no comparable approved therapy available to treat the disease at that stage
Phase IV
Post drug approval
May be required by the FDA
- Gives more info about SE and safety
- Long term risks and benefits
- Shows the efficacy when used in the general population
