Term
| a physician may have __ full time PAs or _ half time equivalents. |
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Definition
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Term
| what kinds of Rx can PAs write for? |
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Definition
- dangerous drugs
- schedule III through V
NOT SCHEDULE II DRUGS |
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Term
| written delegation of authority for PA to write prescription must be present. |
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| physicians that delegate prescriptive authority must register with the board the PAs name and license number. |
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Definition
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| a physician can supervise ___ full time PAs, but can only delegate prescriptive authority to ___. |
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Definition
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Term
| All prescriptions must have: |
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Definition
- patient name (and address if not readily available)
- providers name (DEA and DPS numbers for controlled drug)
- drug name and strength
- drug quantity: must be written in words and numbers with controlled substances
- directions for use
- indication for use
- date written
- signature
Please Play Delirious Dalmations Daily In Dull Summers. |
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Term
| Prescriptions written by a PA must have: |
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Definition
Now Now Now A Name Does Indicate Date Number.
- name and address of patient
- name, address, telephone number, and DEA and DPS if controlled drug of supervising physician
- name, ID number, original signature, and if controlled drug DEA and DPS of the PA
- address and telephone number of where Rx was written
- name, strength, and quantity of drug
- directions for use
- indications for use
- Date of issuance
- number of refills authorized |
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Term
Texas Department of Public Safety
DPS & DEA numbers on all C V – C II prescription (note: both DEA & DPS #s are required)
In effect since September 1, 2008
Usual business address & phone number of prescriber |
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Definition
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Term
| Must use pre-printed, tamper-resistant prescription pads for Medicaid prescriptions |
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Definition
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| Have to go through the department of public safety to get a DEA number, DPS gives you a DPS number and then apply to feds for DEA number. If working for university its free. If not, its about $400. |
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Definition
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Term
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Definition
| high abuse potential & no accepted medical use; ex. heroin, LSD |
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Term
| Schedule II drugs (CANNOT prescribe for): |
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Definition
| high abuse potential with an accepted medical use; ex. morphine, codeine, oxycodone |
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Term
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Definition
| abuse potential < Schedule II; ex. <15mg hydrocodone/unit, dronabinol |
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Definition
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Term
| what information do you have to have before writing a Rx? |
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Definition
1. pregnant?
2. breastfeeding?
3. allergies?
4. liver or kidney problems
5. other current medications (herbs and birth control)
6. other medical problems?
7. have you taken this medication before and respnse |
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Term
| Specify the route of administration regardless of whether or not the medication is intended for oral use. |
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Definition
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Term
Specify all active ingredients in a compounded prescription.
In general, the amount of active ingredient per dosage unit should be specified. e.g.
Amoxicillin 250 mg/5ml.
Phenergan 25 mg/suppository. |
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Definition
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Term
| succinate has sustained action so you take it ___ a day. |
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Definition
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Term
| tartrate you take ___ a day. |
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Definition
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Term
Be specific with the counter-ion such as HCL, tartrate, succinate.
For example metoprolol comes in both tartrate and succinate forms and each one has different durations of action and also different approved uses.
Similarly calcium can be prescibed as calcium chloride, calcium acetate, calcium carbonate or calcium gluconate |
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Definition
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Term
When dispensing medications in bulk, such as solutions, suspensions, emulsions, ointments, or creams, the amounts of active ingredients are expressed as a percentage strength. This is almost always true of topical preparations.
e.g. Hydrocortisone cream 1% or Betadine solution 2% |
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Definition
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Term
| top ten requirements to make it legal: |
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Definition
Date
Patient Name and Address
Medication Name
Medication Strength/Dose (milligrams, milligrams/milliliter, etc.)
Directions for use
Indications for use
Quantity of Medication (# pills/tabs, milliliters, etc)
Number of Refills
Signature
License/DEA#
http://www.tapa.org/displaycommon.cfm?an=1&subarticlenbr=12 |
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Term
| TREATMENT OF FAMILY MEMBERS. The Board of Councilors cautions a physician treating his or her own family, either medically or surgically, except under emergency situations, because of the many potentially hazardous medical consequences |
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Definition
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Definition
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Definition
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Term
| steps of a drug passing from discovery stage to marketing? |
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Definition
| - in vitro studies> animal testing> phase 1> phase 2> phase 3> drug application> phase 4 |
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Term
| define the 4 phases of getting drug on the market: |
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Definition
- phase 1: is it safe?, pharmacokinetics
- phase 2: Does it work in patients?
- phase 3: Does it work double blind?
- phase 4: postmarketing surveilance |
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Term
| patent expries 20 years after filling application, once patent is up, generics can be made. |
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Definition
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Term
| preclinical studies are looking at: |
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Definition
- does the drug produce the desired response at the target?
- molecular, cellular, and whole animal studies
- only 1 in 5 companies make it past preclinical stage
- |
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Term
| preclinical safety and toxicity testing: |
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Definition
Risk versus benefit ratio
Defining the toxicity in animal studies.
Define the mechanisms underlying observed toxicity.
If lead compound makes it to clinical studies, what toxicities should be monitored? |
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Term
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Definition
“No-effect” Dose
Minimum Lethal Dose
Median Lethal Dose (LD50)
Limitations
time-consuming and expensive
need for whole animal testing
applicability in humans
rare toxic events missed |
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Term
| When moving to clinical trials with a human population you must file with the FDA a : |
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Definition
Notice of Claimed Investigational Exemption for a New Drug (IND)
Includes information on drug source and composition, all data obtained in in vitro and animal studies, and proposed clinical trials design and plans
Operation overseen by FDA, sponsoring organization, and institutional review board (IRB) |
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Term
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Definition
- open
- non blind study
- dose dependent drug effects in a small population (25-50)
- safe clinical dose range
- pharmacokinetics |
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Term
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Definition
- single blinded studies in patients with the disease state
- determination of drug efficacy
- observe for toxicities |
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Definition
double blind
100-1000s subjects with disease state
saftey and efficacy
observe for toxicity |
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Term
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Definition
Usually filed after discovery is complete, at time of IND
20 years from time of patent filing for exclusive rights
After 20 years, generic form available
Sometimes extensions of up to 5 years are granted on patent rights
$150 - $900 million to develop a drug |
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Term
| drug laws in the U.S. over last 100 years: |
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Definition
No mislabeling or adulteration
Safety Requirements: not acutely toxic and later expanded to broader safety requirements
Efficacy Requirements
Disclosure of Side Effects
OTC Drug Regulation
Regulation of Narcotics and other Abused Drugs
Abbreviated NDA for generics
Expedited Drug Act
Orphan Drug Act
Dietary (Herbal) Supplements- Labeling requirements, but no efficacy and safety requirements, food supply |
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Definition
| cancer patients can gain access to therapeutics more quickly |
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| Orphan drug act: put in act for drugs that affect a small percentage of people |
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