Multistate Pharmacy Jurisprudence Exam (MPJE)
Review (FEDERAL LAW)
- ANS-On 11/19/2007, in the preamble to the Final Rule entitled Issuance of Multiple Rxs for CII
Controlled Substances, the DEA stated that
"The essential elements of the CII prescription (i.e. name of the controlled substance, strength,
dosage form, and quantity prescribed) MAY NOT BE MODIFIED ORALLY.
This is in opposition to the DEA's previous policy which treated CII's like CV's
_______________________ must be created and must specify the parameters of the authority
granted to the agent - ANS-A written document
-database on adverse events and med error reports given to FDA
-info used to ID possible safety concerns
-manufacturers who receive adverse drug event report must submit info to FDA - ANS-FDA
Adverse Event Reporting System (FAERS)
-must be used whenever Sch I or II drugs are bought, sold or transferred between pharmacies
or qualified distributors - ANS-DEA Form 222
"Immediate Precursor" means a Substance: (3 things) - ANS-A. The Attorney General has
designated to be the principal compound used, or produced primarily for use, in manufacture of
a controlled substance;
B. Is an immediate chemical intermediary used or likely to be used in the manufacture of such
controlled substance; AND
C. The control of which is necessary to prevent, curtail, or limit the manufacture of such
controlled substance
A bill that was passed to help clarify points of the Controlled Substances Act and facilitate a
greater collaboration between Federal entities and drug supply chains - ANS-Ensuring Patient
Access and Effective Drug Enforcement Act of 2016
A codification of the rules published in the Federal Register by the Executive departments and
agencies of the Federal Government. - ANS-Code of Federal Regulations (CFR) - under the
CSA
A drug is dependent on _____________ - ANS-Intended Use
A drug, other substance, or immediate precursor, which is regulated by the CSA because it has
a potential for abuse - ANS-controlled substances
,a federal agency in the Department of Health and Human Services established to regulate the
release of new foods and health-related products - ANS-Food and Drug Administration
A lot number or the National Drug Code is required by law to be put on the manufacturer's
container - ANS-False
A pharmacist may not knowingly......(3 things) - ANS-1. Fill an Rx that is illegitimate
2. Fill an Rx for a doctor to dispense in his/her office
3. Fill an Rx for detox or maintenance
A pharmacist without their own DEA # may dispense controlled substances IF - ANS-Pharmacy
is licensed
A pharmacy-distributor license is required if - ANS-If the total number of dosage units distributed
exceeds 5% of all controlled substances dispensed per calendar year
A representative of a prescriber authorized to communicate prescriptions on behalf of the
prescriber - ANS-Agent
A schedule V - non prescription must be dispensed directly by whom - ANS-Pharmacist only
According to OBRA 90, the pharmacist must offer to counsel the patient. Who is covered by this
requirement? - ANS-Medicaid patients with new prescriptions only
All controlled drugs must have this on the manufacturing label - ANS-Symbol of CII, etc
Clear and large enough to promptly identify
All solid dosage forms shall have a code imprint that provides unique identification - ANS-Tablet
ID
Ambien is considered what schedule and why - ANS-Schedule IV: despite having a lower risk of
dependence and fewer side effects than benzodiazepines which are also C-IV
An emergency kit follows a ___________ of ______________ so that you always know who is
responsible for it - ANS-Chain of custody
An example of an OTC medication requiring special labeling - ANS-Ipecac syrup
An order for medication which is dispensed to or for an ultimate user but does not include an
order for medication which is dispensed for immediate administration to an ultimate user -
ANS-Prescription
An organization or person that administers or dispenses a narcotic to an addict and provides
comprehensive medical and rehab
, Approved by state and FDA - ANS-Narcotic treatment program
Any drug after June 25, 1938 that was subject to the Food and Drug Act of 1906 - ANS-New
Drug
Are pharmacists allowed to have samples in their retail pharmacy - ANS-No
As of 9/15/15, what was the final state to legalize electronic prescriptions for all controlled
substances - ANS-Vermont
Before 2002, what could pharmacists advertise about compounding - ANS-Pharmacists could
not advertise specific drug compounds that they made, only that they compounded
Can a prescription for a controlled substance be written in pencil - ANS-NO
Can agents of a prescriber phone in emergency CII prescriptions - ANS-NO
Can an emergency kit contain a narcotic and give an example - ANS-Yes -like morphine in an
emergency kit for a heart attack patient
Can hospital pharmacies have samples in the pharmacy - ANS-Yes
Can prescription controlled substances by mailed by the pharmacist - ANS-Yes; any quantity per
US Postal regulations
Caution: Federal law prohibits dispensing without a prescription. (FEDERAL LEGEND) -
ANS-Rx only
Characteristics of forged prescriptions would include: - ANS-1. Rx looks "too good"; the
prescriber's handwriting is too legible
2. Quantities, directions, or dosages differ from usual medical dosage
3. Prescription does not comply with the acceptable standard abbreviations or appear to be
textbook presentations
4. Rx appears to be photocopied
5. Directions written in full with no abbreviations
6. Rx written in DIFFERENT COLOR inks or written in different handwriting
7. Apparent erasure marks
Circumstances which are indicative prescription was not issued for a legitimate medical purpose
- ANS-1. The prescriber writes significantly more Rxs (or in larger quantities)
2. The patient appears to be returning too frequently
3. The prescriber writes Rxs for the antagonistic drugs, such as depressants and stimulants, at
the same time
4. Patient appears presenting Rxs written in the names of other people
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