Drug Standards
What is a Generic Drug?
A drug not protected by a trademark but regulated by the FDA.
What US Dept Of Health and Human Services is responsible for reviewing the testing of all drugs before they are released to the public.
Food and Drug Administration or FDA
Name the Drug Schedule with moderate potential for abuse, high psychological dependence, low physical dependence and, accepted for medical uses.
What is Schedule III.
How often do physicians renew their DEA number?
What is every 3 years.
A manufactures way of promoting sales to healthcare professionals and should not be sold?
By providing free drug samples.
OTC stands for ?
What is none as Over The Counter.
Agency that enforces laws against unlawful drug activities.
Drug Enforcement Administration or DEA
A large C constitutes what on a drug label?
What is a Controlled Drug
How are outdated, non controlled medications disposed of in the ambulatory office setting?
Dependent on state law, they must be flushed down the toilet, washed down the sink, or placed in the trash with the physician making sure to maintain security to ensure these medications do not fall into the wrong hands.
Can any healthcare worker in the office setting approve drug samples to be given to from drug representatives? What is the procedure steps?
1. No
2. Samples are distributed to healthcare professionals ( prescribers) only when the physician provides a written request for any sample and identifies the desired quantity of the drug, manufacturer's name, and prescribers name.
The process of FDA approval uses up to half of the patent time, leaving the company with about 10 years of marketability under patent, or trade name. At the end of that time, another company may manufacture the dug under another ___________ or use the generic name that has been assigned by the USP.
What is called Brand Name.
Assigns identification numbers for entities that prescribe, dispense, and manufacture scheduled drugs.
Known as the DEA.
Schedule I Drug Characteristics?
High Potential for abuse, severe physical or psychological dependence / For research only
If theft of the inventory of an Scheduled II drug occurs, it is significant. What local office must be notified first and then name the second local contact?
1. Local DEA office
2. Local police Dept
Why are allied health workers at risk for drug abuse and misuse?
Because of the easy availability of medicines in the medical office setting.
A generic medication must go through testing to ensure that the inert ingredients provide ___________
and that the active ingredients have not changed from those in the trademarked drug.
bioequivalence
A company introducing a new drug has approximately how many years to have exclusive use of the drug?
What is ten years.
Schedule V drugs prescription regulation's ?
What are OTC narcotic drugs that may be sold by registered pharmacist depending on state laws.
To dispose of controlled drugs, such as expired drugs, the Allied Professional should do what?
Call the nearest DEA office for instructions.
Some states allow allied health professionals to write prescriptions for a physician's signature or allow a physician agent to sign, others may allow medication administration by allied workers. The allied healthcare worker must have a strong knowledge of what to in order to safe guard themselves?
What is a firm understanding of their state laws as they pertain to the medical practice and federal laws concerning medications and prescriptions.
When is a pharmacist required to use less expensive generic drugs for dispensing?
When the state its prescribed in has mandatory substitution.
Controlled substances are grouped into categories, or schedules, each with its own prescription and dispensing restrictions. How many categories are there?
What is five categories.
Two examples of Schedule I drugs.
1. Heroin
2. LSD
3. Crack
4. Marijuana
5. Meth
Name 2 things the Allied Professional should do when controlled substances are received in the office setting?
1. Record on a special inventory form
2.The receipt should be signed by 2 employees and show the exact amount of stock meds received.
As an Allied Professional we are working under the Physician's license or the legal premise of __________.
Respondeat Superior