Exam (elaborations)
PTCB Latest Exam Questions And Verified Solutions @ 2024
- Course
- Institution
PTCB Latest Exam Questions And Verified Solutions @ 2024...
[Show more]
Content preview
PTCB Latest Exam Questions And VerifiedSolutions @ 2024
food and drug administration -Answer the leading enforcement agency at the federal level
for regulations concerning drug products
drug enforcement administration DEA -Answer the agency that controls the distribution
of drugs that may be easily abused
food and drug act of 1906 -Answer prohibited interstate commerce in adulterated or
misbranded food drinks and drugs.government preapproved of drugs is required.
1938 Food, Drug and Cosmetic Act In response to the fatal poisoning of 107 people,
most of them children, by an untested sulfanilamide concoction this far-reaching law
mandates that new drugs be proven safe before being sold
1951 Durham Humphrey Amendment- This law defines what drugs require a prescription
by a licensed practioner and requires them to include this legend on the label"Caution
federal law prohibits dispensing without a prescription
1962 Kegauver-Harris Amendment- requires drug manufacturers to provide proof of
bothsafety and effectiveness before marketing the drug
1970 poison prevention packaging act- Response should include childproof packaging on
all controlled and most prescription drugs dispensed by pharmacies
1907 controlled substances act CSA- Response should classify drugs that can be readily
abused and ban their distribution.it is policed by the drug enforcement administration
DEA within the justice department
1990 Omnibus Budget Reconciliation Act OBRA - Answer among other things this act
,required pharmacists to offer counseling to Medicaid patients regarding medications,
effectively putting the common practice into law
1996 Health Insurance Portability and Accountability Act
HIPAA - Answer provided broad and stringent regulations to protect patients privacy
Patent Protection ANSWER Patent for a new drug gives its manufacturer an exclusive
right to market the drug for a certain period of time under a brand name. A drug's patent
is in effect for 17 years from the date of the drug's discovery. Hatch-Waxman Act of 1984
provided for up to five-year extensions of patent protection to the patent holders to
makeup for time lost while the products went through the FDA approval process.
Prescription minimum requirements - Answer name
address of dispenser
prescription serial number
date of prescription or filling
name of prescriber
name of patient
directions for use
cautionary statements
ndc - Answer national drug code the number assigned by the manufacturer each ndc has
three parts or sets of number the first set indicates the manufacturer the next set
indicates the medication ,its strength and dosage form,the last set indicates the package
size.
formula dea number - 2 letters followed by seven single digit numbers. the formula for
checking a dea number on a prescription form is :take the sum of the first,third,and fifth
digits *add this to the next number* the 2nd,4th,6th, numbers *times this by 2* *add the 2
totals together. the second number in the total should match the last number of the dea.
Recall Class I - where there is a strong likelyhood that the product may cause serious
, adverse effects or death
Recall Class II - Where product may cause temporary but reversible adverse effects or in
which there is little likelyhood of serious adverse effects
Recall Class III - Where a product is not likely to cause adverse effects
medwatch- Answer fda reporting program for health care professionals to report adverse
effects that occur from the use of an approved drug or other medical product
medwatch online voluntary reporting form 3500- Answer used for fda regulated
drugs,biologics,medical devices,and special nutritional products and cosmetics
liability- Answer legal liability means you can be prosecuted for misconduct
negligence- Answer failing to do something that should or must be done
schedule I - Answer no accepted medical use in the US it may not be prescribed.
heroin, various opium derivatives, hallucinogenic substances
schedule II - Answer high potential for abuse and may lead to physcial or psychological
dependence but also has a currently accepted medical use in the US
amphetamines
cocaine
methadone
various opiates
schedule III-Answer abuse may lead to moderate to low physical dependence or high
psychological dependence. anabolic steroids and various compounds containing limited
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Easton. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $13.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
72042 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now